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

Abstract

The invention provides operation planning equipment, an operation planning method, a medical system and a computer readable storage medium, the operation planning equipment is used for implanting medical equipment into the head of a patient, the operation planning equipment comprises a memory and at least one processor, and the memory stores a computer program. The at least one processor is configured to implement the following steps when executing the computer program: acquiring medical image data of the skull of the patient; according to the medical image data, three-dimensional reconstruction is carried out on the skull of the patient to obtain a three-dimensional reconstruction result, and the three-dimensional reconstruction result comprises a skull thickness distribution result; and according to the skull thickness distribution result and a preset thickness screening condition, obtaining an implantation point of the medical equipment on the skull of the patient. According to the method, the implantation point is quickly and accurately selected according to the skull thickness distribution condition of the individual patient, and the treatment accuracy and efficiency are improved.

Description

Technical Field

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

[0002] In some disease treatment surgeries, medical devices need to be implanted in the patient's head. However, in order to reduce surgical risks, considering the impact of the volume of the medical device on scalp tension and the aesthetic effect after suturing, it is necessary to plan the implantation location before surgery.

[0003] The traditional method is to select a rough range for skull resection or bone grinding and implant medical devices based on preoperative imaging data and doctor experience. 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 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;

[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 selection is made from a plurality of 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 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;

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

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

[0017] If so, one or more points to be tested on the outer surface of the skull whose corresponding thickness is within the thickness range are placed into a pre-selected point set;

[0018] One of the preselected points is determined from the set of preselected points as an 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 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 when executing the computer program:

[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 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 skull of the patient.

[0023] In some possible implementations, the at least one processor is configured to, when executing the computer program, obtain the 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 according to 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 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 set based on the 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 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 projection point;

[0032] Calculate the sum of squares of the differences of the curvatures corresponding to all points on the upper 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] Generate a first color mapping image corresponding to the upper surface of the device according to the curvature of each point on the upper 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 the 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 pre-selected 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 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;

[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 selection is made from a plurality of 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 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;

[0052] The step of obtaining the implantation point of the medical device on the skull of the patient according to the skull thickness distribution result and the preset thickness screening condition comprises:

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

[0054] If so, one or more points to be tested on the outer surface of the skull whose corresponding thickness is within the thickness range are placed into a pre-selected point set;

[0055] One of the preselected points is determined from the set of preselected points as an 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 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 skull of the patient.

[0060] In some possible implementations, obtaining the 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 according to 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 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 set based on the 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 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 pre-selected point includes:

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

[0069] Calculate the sum of squares of the differences of the curvatures 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] Generate a first color mapping image corresponding to the upper surface of the device according to the curvature of each point on the upper 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 pre-selected point includes:

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

[0077] calculating the 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 pre-selected 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, the medical system comprising:

[0082] A surgical planning device for planning an implantation path of the electrode wire and obtaining an implantation point of the medical device on the skull of the patient using the method of claim 10;

[0083] A surgical robot, used for implanting the electrode wire into the head of the patient according to the planned implantation path;

[0084] The surgical navigation device is used to perform path navigation on 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 also used to determine whether the planned implantation path needs to be updated based on the electrophysiological data of the patient; if updating is required, the planned implantation path of the patient is updated.

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

[0089] 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.

[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 in conjunction with the accompanying drawings and specific implementation methods.

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

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

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

[0097] Figure 4 This 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 solution in the present application will be described below in conjunction with the drawings and specific implementation methods of the specification of the present 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 embodiments of the present application, the words "exemplary" or "for example" are used to indicate examples, illustrations or descriptions. Any implementation or design scheme described as "exemplary" or "for example" in the embodiments of the present application should not be interpreted as being more preferred or more advantageous than other implementations or designs. Specifically, the use of words such as "exemplary" or "for example" is intended to present related concepts in a specific way.

[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 any 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 neural stimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead switching systems. Examples of implantable neural stimulation systems include deep brain stimulation (DBS), implantable cortical nerve stimulation (CNS), implantable spinal cord stimulation (SCS), implantable sacral nerve stimulation (SNS), and implantable vagus nerve stimulation (VNS).

[0105] The implantable neural electrical stimulation system includes a stimulator implanted in the patient's body (i.e., an implantable neural stimulator) and a programmable device disposed outside the patient's body. In other words, the stimulator is a medical device, or in other words, the medical device includes the stimulator. The relevant neural regulation technology mainly implants electrodes (electrodes, for example, in the form of electrode wires) in specific parts of the tissues of the organism (i.e., target points) through stereotactic surgery, and emits discharge pulses to the target points through the electrodes to regulate the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and relieving pain.

[0106] As an example, DBS includes an IPG (Implantable Pulse Generator), an extension wire and an electrode wire, and the IPG is connected to the electrode wire via the extension wire. The IPG is implanted in the patient's body, for example, in the patient's chest or other body parts.

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

[0108] The IPG responds to the program-controlled instructions sent by the program-controlled device, and relies on sealed batteries and circuits to provide controllable electrical stimulation therapy (or electrical stimulation energy) to the tissues in the body. The IPG delivers one or more controllable specific electrical stimulations to specific areas of the tissues in the body through electrode wires.

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

[0110] In some embodiments, the electrical stimulation may be delivered in the form of a pulse signal or in the form of a non-pulse signal. For example, the electrical stimulation may be delivered as a signal having various waveform shapes, frequencies, and amplitudes. Thus, the electrical stimulation in the form of a non-pulse signal may be a continuous signal, which may 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 of the brain tissue. When the patient's disease type is different, the stimulated site is generally different, and the number of stimulation contacts (single source or multiple sources), the use of one or more (single channel or multiple channels) of specific electrical stimulation, and the stimulation parameters (values) are also different.

[0113] The embodiments of the present application do not limit the types of diseases that can be used, and they can be the types of diseases that deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation can be used for. Among them, the types of diseases that DBS can be used to treat or manage include, but are not limited to: spastic diseases (e.g., epilepsy), pain, migraine, mental illness (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety, post-traumatic stress disorder, mild 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 the embodiment of the present application, when the programmable device and the stimulator establish a programmable connection, the programmable device can be used to adjust one or more stimulation parameters of the stimulator (or one or more stimulation parameters of the pulse generator, different stimulation parameters correspond to different electrical stimulations), and the stimulator can also 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 (the 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 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 can be adjusted by the doctor) and upper and lower limits controlled by the patient (the range that can be adjusted autonomously by the patient).

[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 programmable devices (i.e. programmable devices used by doctors) and / or patient programmable devices (i.e. programmable devices used by patients). Doctor programmable devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones and other intelligent terminal devices equipped with programmable software. Patient programmable devices are, for example, tablet computers, laptop computers, desktop computers, mobile phones and other intelligent terminal devices equipped with programmable software. Patient programmable devices may also be other electronic devices with programmable functions (e.g., chargers with programmable functions, electrophysiological acquisition devices, etc.).

[0118] The embodiment of the present application does not restrict the data interaction between the doctor's programmable device and the stimulator. When the doctor performs remote programming, the doctor's programmable device can interact with the stimulator through the server and the patient's programmable device. When the doctor performs offline programming with the patient face to face, the doctor's programmable device can interact with the stimulator through the patient's programmable device, and the doctor's programmable device can also interact with the stimulator directly.

[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 the slave are communicatively connected. Among them, the doctor programmable device can exchange data with the server through a 3G / 4G / 5G network, the server can exchange data with the host through a 3G / 4G / 5G network, the host can exchange data with the slave through a Bluetooth protocol / WIFI protocol / USB protocol, the slave can exchange data with the stimulator through a 401MHz-406MHz working frequency band / 2.4GHz-2.48GHz working frequency band, and the doctor programmable device can directly exchange data with the stimulator through a 401MHz-406MHz working frequency band / 2.4GHz-2.48GHz working frequency band.

[0120] Patent CN112100631A discloses a processing method and terminal for determining whether a PPTX document is encrypted. However, when a 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. For data files of electrophysiological data (such as EEG data) collected by electrophysiological acquisition equipment, these data files are usually text files represented by ASCII characters. Computers cannot distinguish between encrypted and unencrypted files, which affects subsequent data processing.

[0121] The relevant patent is for PPTX documents, not for EEG data (for example, in the form of text files, binary data, hexadecimal data, etc.). In addition, the relevant patent mainly involves the judgment of encryption and non-encryption, and does not involve the compatibility processing 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 unencrypted data obtained by decryption (of encrypted data), but the relevant technology can only play one type of data and cannot be compatible with both encrypted and unencrypted data.

[0123] Based on this, the present application provides a surgical planning device, a surgical planning method, a medical system, a computer-readable storage medium, and a computer program product to improve the relevant technology. The present application provides a method for parsing and compatibly processing encrypted / unencrypted data, and can confirm illegal files. The 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 the present application involve technologies such as data processing and deep brain electrical stimulation, which are specifically described by the following embodiments. It should be noted that the description order of the following embodiments is not intended to limit the preferred order of the embodiments.

[0125] (Surgical Planning Method)

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

[0127] The present application embodiment 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: acquiring the implantation point of the medical device on the skull of the patient 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 diseases. In electrical stimulation therapy, medical devices are, for example, stimulation generators used to deliver electrical stimulation, such as pulse generators.

[0132] The skull refers to the skeletal structure of the human head, which is composed of multiple bones, including the parietal bone, the base of the skull, and the facial bones. The skull protects the brain and other important nerve tissues.

[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, magnetic resonance imaging (MRI), etc.

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

[0135] The skull thickness distribution result is a description of the skull thickness distribution obtained by 3D reconstruction of the skull. This result shows the thickness of different areas of the skull and is used to guide the selection of implant locations for medical devices.

[0136] The preset thickness screening conditions are pre-set conditions based on the skull thickness distribution results to screen out skull areas suitable for implanting medical devices. 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 the process of medical device implantation, the implantation point refers to the specific location of the medical device on the patient's skull. The selection of the implantation point is usually based on factors such as the anatomical structure of the skull, the characteristics of the disease, and the treatment needs.

[0138] The surgical planning method aims to implant a medical device into the patient's head. First, by using medical imaging technology (such as CT scan or MRI), detailed imaging data of the patient's skull is obtained. Secondly, the acquired medical imaging data is used to perform a three-dimensional reconstruction of the patient's skull through computer processing and image reconstruction algorithms, such as generating a three-dimensional model containing the shape and structure of the skull, i.e., a three-dimensional skull model. Based on the three-dimensional reconstruction, the thickness distribution results of each area of ​​the skull are calculated by analyzing the skull data, providing spatial information about the thickness of the skull. According to the skull thickness distribution results and the preset thickness screening conditions, the implantation point of the medical device on the patient's skull is determined. By selecting the implantation point in a specific skull area, 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 skull thickness distribution, excessive implantation of the implanted 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; and by planning the surgery in advance, the operating time and trauma during the operation can be reduced, improving the patient's surgical experience and recovery speed.

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

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

[0142] Model refers to different specifications, configurations or versions of a medical device. Different models of medical devices have different features such as functions, sizes, shapes, etc. As an example, the medical device is a pulse generator, and the pulse generator includes 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 refers to selecting a suitable device model from among the candidate medical devices. When selecting a model based on the skull thickness distribution results, the candidate medical device can be evaluated based on factors such as the degree of matching between the candidate medical device and the skull thickness, adaptability, and treatment effect. For example, a candidate medical device with a thickness close to the skull thickness can be selected as the medical device.

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

[0146] Therefore, by analyzing and calculating the thickness distribution of the patient's skull, the thickness information of different areas of the skull is obtained. According to the skull thickness distribution results, a selection is made from multiple models of candidate medical devices. The candidate devices may have different shapes, sizes, adaptability and functional characteristics. According to the skull thickness distribution results, the characteristics and adaptability of the candidate medical devices are comprehensively considered, and one model of the candidate medical device is selected as the final medical device.

[0147] The advantage of doing so is that by selecting from multiple models of alternative medical devices, it is ensured that all patients can be matched with a device model that suits them under the existing technology. Even under limited conditions (for example, some patients' skull thickness is too large or too small), as long as the alternative models are sufficient and extensive, patients can still obtain medical devices that suit them. Selecting appropriate medical devices based on the results of skull thickness distribution can achieve more individualized treatment. The skull thickness distribution of different patients may be different. The selection process can ensure that the selected medical device matches the patient's skull structure, thereby meeting the patient's individual treatment needs. It ensures that patients can match the device model that suits them and improves the success rate of treatment. The appropriate model of medical equipment 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 match the medical device model that suits them can enhance patient satisfaction. Individualized treatment options can improve patients' treatment experience, making them feel more satisfied and more 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] The skull thickness distribution heat map is a visualization method that presents the skull thickness distribution results in the form of a heat map. The heat map uses different colors to represent areas of different thicknesses, such as a color spectrum. For example, thinner areas may be represented by cool colors (such as blue), and thicker areas may be represented by warm colors (such as red).

[0150] The 2D contour map of the skull is a visualization method that represents the distribution of skull thickness in the form of contour lines. The contour map uses contour lines (or isovalue lines) to connect points with the same thickness to form contour lines. Each contour line represents a specific thickness of the skull, and the changes in skull thickness can be observed through the distribution and shape of different contour lines.

[0151] For example, a skull thickness distribution heat map can be presented as a colorful image, where different color areas represent skull areas of different thicknesses. Thicker skull areas may appear in red or orange, while thinner areas may appear in blue or green. Such a heat map can help doctors intuitively identify the location and extent of skull thickness changes.

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

[0153] Thus, 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 is that by using a skull thickness distribution heat map or a skull two-dimensional contour map, the spatial variation of skull thickness distribution can be intuitively displayed. This visualization allows doctors and other medical professionals to more intuitively understand the thickness of different areas of the skull; the skull thickness distribution heat map or the skull two-dimensional contour map can be used as a reference for the selection of implantation points in electrical stimulation therapy. Doctors can select appropriate implantation points based on these visualization results to ensure that the medical device has good contact with the skull and achieve the desired effect; by visually displaying the skull thickness distribution results, individualized treatment plans can be achieved. The skull thickness distribution of different patients may be different. According to the visualization results, a specific treatment plan can be formulated for each patient to ensure the accuracy of the implantation point and the personalization of the treatment; the skull thickness distribution heat map or the skull two-dimensional contour map can be used to assess the risks during the implantation process. By observing the skull thickness distribution in the image, over-implantation or mismatch with the skull structure can be avoided, reducing the risk of surgery and the occurrence of complications; these visualization forms can help doctors better understand the structure and thickness changes of the skull, thereby optimizing the positioning and stimulation parameter settings of electrical stimulation therapy. By accurately understanding the skull thickness distribution, the transmission 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, 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 range of a sum of squares of thickness differences corresponding to the medical device;

[0156] The step of obtaining the implantation point of the medical device on the skull of the patient according to the skull thickness distribution result and the preset thickness screening condition comprises:

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

[0158] Detect whether there is a point to be tested on the outer surface of the skull whose corresponding sum of squares of thickness difference is within the range of the sum of squares of thickness difference;

[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 pre-selected points and put into the pre-selected 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, 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 point to be measured, and the length direction of the three-dimensional model of the device is parallel or perpendicular to the median sagittal 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 the 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 result and the preset thickness screening condition 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 squares of the thickness difference of each test point on the outer surface of the skull; detecting whether there is a test point on the outer surface of the skull whose sum of the squares of the thickness difference is within a set range; placing the test points that meet the conditions as pre-selected points into the pre-selected point set; and determining a pre-selected point from the pre-selected point set as the implantation point of the medical device.

[0169] Among them, 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 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 squares of the thickness differences of all points on the device as the sum of squares of the thickness differences of the points to be measured.

[0170] The advantage of doing 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, through the screening of 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 thickness matching degree 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, 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;

[0172] The step of obtaining the implantation point of the medical device on the skull of the patient according to the skull thickness distribution result and the preset thickness screening condition comprises:

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

[0174] If so, one or more points to be tested on the outer surface of the skull whose corresponding thickness is within the thickness range are placed into a pre-selected point set;

[0175] One of the preselected points is determined from the set of preselected points as an 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 the medical image data. The three-dimensional skull model is a model that presents the patient's skull in three dimensions, including the internal surface of the skull (i.e., the inner surface of the skull) and the external surface (i.e., the outer surface of the skull), and may also have reconstruction results of other structures, which can be used for positioning, measurement, analysis, and planning treatment. The inner surface of the skull refers to the surface inside the skull that contacts the brain tissue, and the outer surface of the skull refers to the surface outside the skull that contacts the scalp.

[0177] The preselected point set is a set of potential implantation points (i.e., preselected points) formed by detecting the points to be tested on the outer surface of the skull within the applicable thickness range according to the skull thickness distribution result and the thickness screening condition. The embodiment of the present application does not limit the number of preselected points in the preselected point set, which may be 1, 10, 100, 1000, 10000, etc.

[0178] Assume that in the electrical stimulation treatment plan, patient A needs to implant a pulse generator 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 the test points within this range will be considered as possible implantation points. Assuming that in the skull thickness distribution results of patient A, the thickness of the outer surface of the skull at a test point is 5.5 mm, then the test point meets the thickness screening condition. Therefore, the test point can be used as a pre-selected point and included in the pre-selected point set as one of the possible implantation points.

[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. According to the skull thickness distribution result and the implantation requirements (for example, the shape parameters of the therapeutic device need to be taken into account), a thickness screening condition is set to indicate the applicable thickness range of the medical device. According to the skull thickness distribution result and the preset thickness screening condition, 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 taken as pre-selected points and put into 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 benefit 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, select the appropriate implantation point to ensure good contact between the medical device and the skull and achieve the expected treatment effect; determine the best implantation point for the medical device based on the skull thickness distribution results and the preset thickness screening conditions; determine the implantation point based on the skull thickness distribution results and thickness screening conditions, which can reduce surgical risks and reduce problems during the implantation process; ensure that the medical device is implanted at the appropriate point, which 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 skull of the patient comprises:

[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 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 skull of the patient.

[0185] The device 3D model is a 3D virtual model of the medical device generated in a computing device, which can represent the shape, size and features of the medical device and can be used to evaluate the fit between the medical device and the patient's skull. The medical device may have a shape such as a cuboid, a cylinder, a truncated cone, a sphere, or a shape similar to a cuboid (for example, the upper surface and the lower surface of the device are curved surfaces), and this application does not limit this.

[0186] The upper surface of a medical device refers to the surface of the device that is close 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] The fit is used to measure the degree of fit between the upper surface of the device and the outer surface of the skull. The fit can be evaluated by measuring the contact area, distance, shape matching, etc. between the upper surface of the device and the outer surface of the skull. The fit can be expressed in the form of a positive number, a tenth system, a hundredth system, a percentage, etc., and this application is not limited to this.

[0188] For example, assuming that the preselected point set includes multiple preselected points, the fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point is obtained. According to the fit, it is evaluated which preselected point on the outer surface of the skull is most suitable for the upper surface of the device, so as to select a preselected point as the final implantation point, which implantation point can be highlighted on the surgical planning device, for example.

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

[0190] Therefore, first, obtain the three-dimensional model of the medical device used for fit evaluation in the subsequent steps. For each point in the pre-selected point set, calculate its fit with the upper surface of the device and the outer surface of the skull. According to the fit between the upper surface of the device and the outer surface of the skull corresponding to the pre-selected point, select the pre-selected point with the highest fit as the final implantation point. The pre-selected point with the highest fit indicates that the device fits the patient's skull best and is expected to provide better treatment results.

[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, and selecting the most suitable implant point, 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 choosing the pre-selected point with the highest fit as the implantation point. Through fit assessment, choosing the implantation point with the highest fit can make the medical device fit better with the patient's skull surface, reduce possible bulges or protrusions, make the implantation site smoother and more natural, help the postoperative appearance to be more in line with the normal head shape, and improve the patient's aesthetic feeling; choosing the implantation point with the highest 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 their daily lives, 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, which helps 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 compression on the skin and tissues, and reduce the risk of postoperative infection, inflammation and other complications, which helps 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, which 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 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 according to 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 refers to the curvature measurement at a specific point or area, which is used to describe the degree of curvature of a surface. For example, it can be expressed by the radius of curvature. The smaller the radius of curvature, the greater the curvature and the steeper the curvature.

[0197] For example, the fit 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 a preselected point. For example, the radius of curvature of the upper surface of the device at its own center point is 2.0 mm, while the radius of curvature of the outer surface of the skull at a preselected point is 1.9 mm. Based on these values, the fit value can be calculated, for example, 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. According to the obtained curvature value, 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 the 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, for each preselected point, the degree of fit between the corresponding upper surface of the device and the outer surface of the skull is evaluated, 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] Comparing the curvature of the upper surface of the device and the outer surface of the skull to determine the degree of fit 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 calculations. Due to the small amount of calculation and simple calculations, the degree of fit of the preselected points can be quickly evaluated. In actual operations, the surgical planning equipment can quickly calculate and compare the degree of 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, a 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 calculations, this method is suitable for real-time operations and quick decision-making scenarios.

[0200] In some embodiments, obtaining the 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 set based on the 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 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 line is an imaginary line that is always perpendicular to a plane. The normal line of a point on a surface is the line (i.e., vector) that passes through the point and is perpendicular to the tangent plane at the point.

[0205] The median sagittal plane is an important reference plane in human anatomy, also known as the midline sagittal plane or the midsagittal plane. It is a plane perpendicular to the coronal plane and the transverse plane, dividing the human body into two symmetrical parts. Specifically, the median sagittal plane passes through the midline of the top of the head, extending from the front to the back of the head, dividing the body into two symmetrical parts. On this plane, the structures on the left and right sides are relatively mirror-symmetrical.

[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, assume that the preselected point is a specific point on the outer surface of the skull, located at the top of the temporal bone, and assume that the coordinates of the preselected point in the anatomical coordinate system are (x, y, z) = (50, 60, 70). The anatomical coordinate system, for example, takes the nose tip as the origin, the horizontal line is parallel to the ground, the vertical line is perpendicular to the ground, and the left-right direction, the front-back direction, and the up-down direction correspond to different coordinate axes. Among them, the x coordinate represents the left-right direction, the y coordinate represents the front-back direction, and the z coordinate represents the up-down direction.

[0208] Thus, 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 the 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. According to 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 with the skull at the preselected point can be evaluated.

[0209] The advantage of doing this is that, by setting up the 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 implant point more precise, helping 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 between the device and 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 implant site smoother and more natural; by calculating the fit of the pre-selected point, the best matching implant 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 degree of fit at the preselected points. In this embodiment, three alignment conditions are set.

[0211] The first condition is that the center point of the upper surface of the device coincides with the preselected point. By aligning the center point of the upper surface of the device with the preselected point, the device is accurately positioned at a specific location on the outer surface of the skull and does not protrude outward at the preselected point, thereby avoiding deviation or dislocation of the device during implantation and ensuring the accuracy of the treatment target.

[0212] The second condition is that 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. By making the height direction of the device parallel to the normal of the outer surface of the skull, it is ensured that the height direction of the device is consistent with the thickness direction of the skull.

[0213] The third condition: The length direction of the three-dimensional model of the device is parallel or perpendicular to the patient's median sagittal plane. By making the length direction of the device parallel or perpendicular to the patient's median sagittal plane, the device is aligned with the patient's anatomical structure in the lateral direction (i.e., the horizontal direction when the patient is standing), so that the device can better adapt to the patient's head shape and physiological structure, and improve the accuracy and effect of treatment. If the length direction of the device is parallel or perpendicular to the patient's median sagittal plane, the device will better conform to the side profile of the patient's head, thereby reducing irregular protrusions or depressions that may occur 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 pre-selected point includes:

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

[0217] Calculate the sum of squares of the differences of the curvatures 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 refers to the sum of squares of a set of values ​​(ie, differences in curvature).

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

[0223] For example, suppose there is a point A on the upper surface of the device, whose curvature is 5, and the corresponding projection point projected onto the outer surface of the skull is B, whose curvature is 3. Then the difference in curvature is 5-3=2. Similarly, the difference in curvature between all points on the upper surface of the device and its projection point is calculated, and the inverse of the sum of the squares of the differences is taken as the fit. According to the size of the sum of squares, the fit of the pre-selected points can be evaluated. For example, the smaller the sum of squares, the higher the fit between the upper surface of the device and the outer surface of the skull.

[0224] Thus, according to each point on the upper surface of the device, it is projected onto the outer surface of the skull to obtain the corresponding projection point. For each point, the difference between the curvature of the point and the curvature of its projection point on the outer surface of the skull is calculated. This represents the difference in curvature between the upper point on the device and the point on the outer surface of the skull. The curvature differences of all points are squared and then added to obtain the sum of squares. The sum of squares measures the overall adaptability of the curvature differences between all points on the device and the outer surface of the skull. The advantage of this is that by calculating the curvature difference and the sum of squares, the degree of fit between the upper surface of the device and the outer surface of the skull can be quantified, providing an objective indicator to evaluate the adaptability of the device on the patient's skull; by evaluating the fit of the preselected points, the optimal implantation position can be determined, for example, selecting the preselected point with the smallest sum of squares, that is, the point with the highest fit, can improve the fit between the implanted device and the outer surface of the skull; ensuring the fit between the upper surface of the device and the outer surface of the skull can improve the accuracy of the surgery, reduce the gap or inappropriate contact between the device and the skull, and thus improve the treatment effect.

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

[0226] The method further comprises:

[0227] Generate a first color mapping image corresponding to the upper surface of the device according to the curvature of each point on the upper 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 pre-selected point includes:

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

[0231] calculating the 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 pre-selected 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 a color-mapped image generated based on the curvature of each point on the upper surface of the device. Using a specific color-mapped rule, the curvature value is mapped to a corresponding color. The second color-mapped image is a color-mapped image generated based on the curvature of each point on the outer surface of the skull. The same color-mapped rule as the first color-mapped image is used to ensure consistency.

[0235] Color mapping is a technique for mapping data values ​​into a color space so that the characteristics or attributes of the data can be represented by color. By selecting a color mapping rule, the data range is mapped to different color values, thereby showing the characteristics and changes 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, etc.

[0237] Heatmaps mainly represent the relative value or density changes of data by using different intensities of colors. Heatmaps are a graphical representation method for visualizing the distribution and density of data. Generally, heatmaps use the intensity of colors to represent the relative value or density of data. Higher values ​​or densities are usually represented by warmer colors (such as red), while lower values ​​or densities are represented by cooler colors (such as blue). Therefore, heatmaps mainly focus on the relative intensity or density changes of data.

[0238] Color maps represent the range and variation of data by mapping data values ​​to different colors. Color maps usually use a predefined color map to map data values ​​to different colors. Typical color maps include grayscale images (mapping grayscale values ​​to black and white colors), and images using color maps such as rainbows and heat maps. Color maps focus on the specific size and range of data values.

[0239] In addition, 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 cyclic color sequence. 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 mapping image and the third color mapping image corresponding to the projection image. Various similarity measurement methods can be used, such as structural similarity index (SSIM) or mean square error (MSE).

[0241] The advantage of doing 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 provide 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 to the patient's skull; based on the results of the similarity evaluation, the fit of the pre-selected point can be determined, for example, a higher similarity indicates a higher fit, so that a more suitable implantation point can be selected, thereby improving the treatment effect and the patient's personalized treatment experience.

[0242] On the one hand, different forms of color mapping can highlight the characteristic differences between the upper surface of the device and the outer surface of the skull, making them more significant 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, a grayscale map can show changes in curvature, etc. On the other hand, color mapping images can help doctors better interpret the relationship between the device and the skull. By observing the changes and distribution of colors, information about the fit between the device and the skull, the distribution of curvature, and structural matching can be obtained. In addition, different forms of color mapping can be adjusted according to specific circumstances to meet the needs and individual differences of different patients. According to the patient's preferences, cognitive abilities, and perception of colors, choose the appropriate form of color mapping 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 difference in curvature 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. Different colors represent 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 finally 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, which is a device used for electrical stimulation therapy. First, the brain tissue that the electrode wire needs to pass through is determined to reach the target area. Secondly, the implantation point is determined by the above method for implanting the pulse generator on the patient's skull.

[0251] The benefits of this are that, by planning the implantation path, it is possible to ensure that the electrode wire is 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; and according to the patient's specific circumstances, 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, so as to determine 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] According to the medical imaging data, a three-dimensional reconstruction is performed on the skull of the patient to obtain a three-dimensional reconstruction result, wherein the three-dimensional reconstruction result includes 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 skull two-dimensional contour map; the three-dimensional skull model has a relative skull inner surface and a skull outer surface, 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 tested on the outer surface of the skull whose corresponding thickness is within the thickness range;

[0258] If so, one or more points to be tested on the outer surface of the skull whose corresponding thickness is within the thickness range are placed into a pre-selected 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 fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point;

[0261] 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 skull of the patient;

[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 according to 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 set based on the 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 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 projection point;

[0270] Calculate the sum of squares of the differences of the curvatures 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] Generate a first color mapping image corresponding to the upper surface of the device according to the curvature of each point on the upper 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 set based on the 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 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 the 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 pre-selected point is obtained.

[0280] Take the example of implanting a pulse generator (of a deep brain stimulation device) (as a medical device) into the head of patient A. 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 bulge upward to fit the skull structure.

[0281] First, a CT scan is performed on patient A to obtain CT data as medical imaging data. For example, the average thickness of the skull of patient A is detected to be 7 mm. Then, three-dimensional reconstruction is performed based on these CT data to obtain a three-dimensional skull model and a skull thickness distribution heat map. In this process, it can be detected whether the thickness of each point to be tested on the outer surface of the skull is within the thickness range of the pulse generator (for example, 6.5-7.5 mm). First, a rough search is performed with the first step length to obtain a rough search result (i.e., the skull thickness corresponding to each rough search point), and one or more areas to be tested are screened out according to the rough search result (for example, the rough search points corresponding to the skull thickness in the thickness range are clustered to obtain one or more areas to be tested), and then a second step length (less than the first step length) is used to perform a fine search on each area to be tested, assuming that 100 pre-selected points that meet the conditions are found. Then, a three-dimensional model of the pulse generator device is obtained, and the fit between the upper surface of the device and the outer surface of the skull corresponding to each pre-selected point is calculated.

[0282] According to the first method, the difference between 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 each preselected point can be calculated. For example, if the curvature of the upper surface of the device at the center point is 0.05, and the curvature of the outer surface of the skull at preselected point 1 is 0.07, the difference between the two curvatures is 0.02, and the reciprocal of the difference in curvature (taking the absolute value) is the fit, then the fit corresponding to preselected point 1 is 50. And so on, the fit of all preselected points is calculated.

[0283] According to the second method, the 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. Then the upper surface of the device is 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 reciprocal of the sum of squares as the fit, the fit of preselected point 2 is 0.76. And so on, calculate the fit of all preselected points.

[0284] According to the third method, a first color mapping image corresponding to the upper surface of the device and a second color mapping image corresponding to the outer surface of the skull are generated, and then the upper surface of the device is projected onto the outer surface of the skull, and a third color mapping image corresponding to the projected image is obtained from the color mapping image of the outer surface of the skull. Then, the similarity between the first color mapping image and the third color mapping image on the upper surface of the device is calculated. For example, the similarity of pre-selected point 3 is 0.95. If the similarity is the fit, the fit of pre-selected point 3 is 0.95. By analogy, the fit of all pre-selected points is calculated.

[0285] The fit degree of each preselected point is obtained according to any of the above three methods, and the preselected point with the highest fit degree (eg, preselected point 6) is selected as the implantation point of the device on the patient's skull. In addition, the surgical planning method can also plan the path of the electrode wire.

[0286] In the above embodiment, the points to be tested (for example, 1000) on the outer surface of the skull are screened for thickness, some of the points to be tested are put into a set of pre-selected points (for example, 100 pre-selected points) as pre-selected points, and then each pre-selected point is tested for fit, and one of the pre-selected points is selected as the implantation point according to the fit of all the pre-selected points. That is, the pre-selected points are screened out from the points to be tested, and the implantation point is selected from the pre-selected points.

[0287] When making a surgical plan, in addition to considering the structure of the skull, 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 best model and implant location of the medical device. In order 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 a three-dimensional skull model, calculate the skull thickness distribution results, and select the optimal medical device and implant location. Since different medical devices may have different effects on the human body, the biocompatibility of medical devices needs to be considered. For example, based on the material, design, and function of the medical device, its impact on the skull and surrounding tissues, as well as the possible immune response or other complications, can be evaluated, the patient can be informed before surgery, and the implant surgery can be performed on the premise of the patient's full decision-making to avoid medical disputes. In order to improve the doctor's surgical skills and the patient's preoperative preparation, a surgical simulation system can be established. The surgical simulation system can simulate the entire surgical process, including the selection of medical equipment, the selection of implant location (i.e., implant point), the planning of implant path, and possible problems and solutions, to help doctors prepare in advance and give patients a clearer understanding of the surgery.

[0288] It should be noted that, under the premise of being practicable, the order of the steps in the above embodiments can be adjusted, and this application is not limited to 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 recorded 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 comprises a memory and at least one processor, the memory stores a computer program, and 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 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;

[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 selection is made from a plurality of 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, 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;

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

[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 pre-selected point set;

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

[0303] In some embodiments, the at least one processor is configured to 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 when executing the computer program:

[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 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 skull of the patient.

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

[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 according to 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 obtain the fit degree between the upper surface of the device and the outer surface of the skull corresponding to each preselected point in the following manner when executing the computer program:

[0310] The three-dimensional model of the device is set based on the 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 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 projection point;

[0316] Calculate the sum of squares of the differences of the curvatures 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] Generate a first color mapping image corresponding to the upper surface of the device according to the curvature of each point on the upper 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 the 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 pre-selected 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] The memory 11 may include a (computer) readable medium in the form of a volatile memory, such as a random access memory (RAM) 111 and / or a cache memory 112, and may further include a read-only memory (ROM) 113. The memory 11 also stores a computer program, which can be executed by the processor 12, so that the processor 12 implements the steps of any of the above methods. The memory 11 may also include a utility 114 having at least one program module 115, such program module 115 includes but is not limited to: an operating system, one or more application programs, other program modules and program data, each of which or some combination thereof may include the implementation of a network environment.

[0331] Accordingly, the processor 12 may execute the above-mentioned computer program and may execute the utility 114. The processor 12 may be implemented by 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 be a local bus representing 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 any of a variety of bus architectures.

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

[0334] (Medical System)

[0335] The embodiments of the present application also provide a medical system, the specific embodiments of which are consistent with the embodiments recorded 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 It 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 an implantation path of the electrode wire and obtaining an implantation point of the medical device on the skull of the patient using the method of claim 10;

[0339] A surgical robot, used for implanting the electrode wire into the head of the patient according to the planned implantation path;

[0340] The surgical navigation device is used to perform path navigation on 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 refers to a device used for surgical planning, which is capable of planning the implantation path of the electrode wire and determining the implantation point of the medical device on the patient's skull by adopting any of the above surgical planning methods. It can be a computer-assisted tool or software system. For example, the surgical planning device can use CT data (or MRI data) and a calculation algorithm 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. The surgical robot implants the electrode wire into the patient's head according to a pre-planned implantation path. The surgical robot can perform implantation operations according to preset programs and instructions. For example, the surgical robot can implant the electrode wire into a designated location on the patient's head according to a pre-planned implantation path through an automated robotic arm.

[0343] A surgical navigation device is a device used for real-time navigation and monitoring of the implantation process of a surgical robot. The surgical navigation 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 position deviation and direction deviation are measured and fed back to the surgical robot so that the surgical robot can adjust the position and direction of the electrode wire in time. The surgical navigation 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 surgical navigation 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 can 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 navigate the path of the electrode wire implantation process 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 advantage 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, the doctor 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 also used to determine whether the planned implantation path needs to be updated based on the electrophysiological data of the patient; if updating is required, the planned implantation path of the patient is updated.

[0349] Electrophysiological acquisition equipment is a medical device used to collect electrophysiological data of patients. The electrophysiological data may include one or more of EEG data (e.g., electroencephalogram, EEG), ECG data (e.g., electrocardiogram, ECG), myoelectric data (e.g., electromyogram, EMG), and electrooculogram data (e.g., electrooculogram, EOG). Electrophysiological acquisition equipment includes, for example, components such as sensors, amplifiers, and data acquisition systems.

[0350] The surgical planning device is not only used to determine the implantation point of the medical device and the implantation path of the electrode wire based on the image data, but also can use the electrophysiological data to determine whether the implantation path needs to be updated. The surgical planning device is equipped with, for example, image processing algorithms, path planning algorithms, and data analysis tools.

[0351] The planned implantation path is determined based on the patient's anatomical structure and treatment needs, and is intended to ensure accurate implantation of the electrode lead and effectiveness of the treatment. When the currently planned implantation path is judged to be inappropriate based on electrophysiological data, the surgical planning device can be updated. Updating the implantation path is to replan and adjust the implantation path of the electrode lead based on real-time electrophysiological data and analysis results to better meet the needs of the patient. The updated planned implantation path will be provided to the surgical robot and surgical navigation equipment.

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

[0353] Therefore, 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, the surgical planning device can determine whether the implantation path needs to be adjusted by evaluating the patient's electrophysiological data. 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 and obtaining 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 detect 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 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] 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.

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

[0358] Deep brain stimulation devices are one type of stimulator. In addition to the pulse generator, deep brain stimulation devices also include electrode wires, each of which can be implanted manually or by a surgical robot. During the implantation process, the doctor or the surgical robot is navigated by a surgical navigation device.

[0359] See also Figure 4 and Figure 5 , Figure 4 is a structural block diagram of a deep brain electrical 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 includes 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 electrical 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 the electrode wires may be one or more. In the embodiment where an extension wire is provided, the number of the extension wires may be one or more. The extension wires and the electrode wires have a corresponding relationship. The extension wires and the electrode wires may correspond one to one, and each extension wire is provided between its corresponding electrode wire and the pulse generator (e.g., Figure 5 The extension wires and electrode wires can also be one-to-many, with one end of each extension wire connected to its corresponding N electrode wires through a switching device (e.g., a one-to-N switching connector), and the other end of each extension wire connected to a pulse generator (not shown in the figure). Wherein N is an integer greater than 1, such as 2, 3, 4, etc.

[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 wire can be implanted in the target area of ​​the patient, such as tissues, nuclei, fiber bundles, etc., such as the nucleus accumbens, the anterior limb of the internal capsule, the caudate nucleus, the lenticular nucleus, the putamen, etc. The number of electrode wires can be, for example, 1, 2, 3, 4, 5, 6, etc. The number of electrode contacts of each electrode wire can be, for example, 4, 6, 8, 9, 10, 12, 15, 18, etc. When a plurality of electrode wires are implanted in the patient's head, the plurality of electrode wires can be implanted in the same hemisphere of the brain, or can be implanted in the two hemispheres of the brain respectively.

[0365] In the embodiments of the present application, the electrode wire can be used to sense the electrophysiological activities of single cells and / or multiple cells to obtain electrophysiological signals of single cells and / or local field potentials. Local field potential (LFP) is a special type of electrophysiological signal. In vivo, the synaptic activity of dendrites in biological tissues of a certain volume will induce 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 wire. The deep brain stimulation device includes a pulse generator and at least one electrode wire implanted in the patient's head. The pulse generator is directly connected to each electrode wire, and the electrical stimulation is delivered to the target area through the electrode wire.

[0368] In the second configuration, the pulse generator is indirectly connected to the electrode wire through an extension wire. The deep brain electrical 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 has a corresponding relationship with the electrode wire, such as one-to-one or one-to-many, and the pulse generator is connected to each electrode wire through the extension wire to achieve the transmission of 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 circumstances. 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 areas of the brain. 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 recorded 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 steps of any of the above methods or the functions of any of the above surgical planning devices are implemented.

[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 of the above. 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 of the above.

[0376] The computer-readable storage medium may include a data signal propagated in a baseband or as part of a carrier wave, wherein a readable program code is carried. This propagated data signal may take a variety of forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above. The computer-readable storage medium may also be any computer-readable medium that can send, propagate, or transmit a program for use by an instruction execution system, an apparatus, or a device or used in combination with it. The program code contained on the computer-readable storage medium may be transmitted with any appropriate medium, including but not limited to wireless, wired, optical cable, RF, etc., or any suitable combination of the above. The program code for performing the operation 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, etc. The program code may be executed entirely on a user computing device, partially on a user device, as a separate software package, partially on a user device, partially on a remote computing device, or entirely on a remote computing device or server. In cases involving a remote computing device, 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 embodiment of the present application also provides a computer program product, the specific embodiments of which are consistent with the embodiments recorded in the above method embodiments and the technical effects achieved, and some contents will not be repeated here.

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

[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 above methods or to implement the functions of any of the above surgical planning devices. The computer program product may be a portable compact disk 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 the computer program product may be any combination of one or more computer-readable media.

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

Claims

1. A surgical planning device, characterized in that: For implanting a medical device into a patient's head, the surgical planning device comprises 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 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; 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.

2. The surgical planning device according to claim 1, characterized in that: 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, characterized in that: The three-dimensional reconstruction result also 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 acquire the implantation point of the medical device on the skull of the patient in the following manner when executing the computer program: According to the skull thickness distribution result, detecting whether there is a point to be tested on the outer surface of the skull whose corresponding thickness is within the thickness range; If so, one or more points to be tested on the outer surface of the skull whose corresponding thickness is within the thickness range are placed into a pre-selected point set; One of the preselected points is determined from the set of preselected points as an implantation point of the medical device on the skull of the patient.

4. The surgical planning device according to claim 3, characterized in that: The at least one processor is configured to 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 when executing the computer program: 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 fit between the upper surface of the device and the outer surface of the skull corresponding to each preselected point; 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 skull of the patient.

5. The surgical planning device according to claim 4, characterized in that: The at least one processor is configured to obtain the fit degree between the upper surface of the device and the outer surface of the skull corresponding to each preselected point in the following manner when executing the computer program: 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 according to 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.

6. The surgical planning device according to claim 4, characterized in that: The at least one processor is configured to obtain the fit degree between the upper surface of the device and the outer surface of the skull corresponding to each preselected point in the following manner when executing the computer program: The three-dimensional model of the device is set based on the 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 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.

7. The surgical planning device according to claim 6, 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 projection point; Calculate the sum of squares of the differences of the curvatures 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.

8. The surgical planning device according to claim 6, characterized in that: 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: Generate a first color mapping image corresponding to the upper surface of the device according to the curvature of each point on the upper 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 the similarity between the first color mapping image and the third color mapping image; According to the similarity, the degree of fit corresponding to the pre-selected point is obtained.

9. The surgical planning device according to claim 1, characterized in that: 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.

10. A surgical planning method, characterized in that: For implanting a medical device into a patient's head, the method comprising: Acquiring medical imaging data of the patient's skull; 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; 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.

11. A medical system, characterized in that: The medical system includes: A surgical planning device for planning an implantation path of the electrode wire and obtaining an implantation point of the medical device on the skull of the patient using the method of claim 10; A surgical robot, used for implanting the electrode wire into the head of the patient according to the planned implantation path; The surgical navigation device is used to perform path navigation on the implantation process of the electrode wire so that the actual implantation path of the electrode wire matches the planned implantation path.

12. The medical system according to claim 11, 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 also used to determine whether the planned implantation path needs to be updated based on the electrophysiological data of the patient; if updating is required, the planned implantation path of the patient is updated.

13. The medical system according to claim 12, 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.

14. The medical system according to claim 13, characterized in that The medical device is a pulse generator.

15. 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, the computer program implements the functions of the surgical planning device according to any one of claims 1 to 9 or implements the steps of the method according to claim 10.

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