System for implementing a surgical operation or procedure guided by imaging

Abstract

The invention relates to a system (1) for implementing a surgical operation or procedure guided by imaging, the system comprising at least one preparatory medical imaging device (3). This system is characterised in that it comprises: - a module for generating a 3D model (4) of a solid organ (2); - a module (7) for generating a database (8) of synthetic ultrasound images and / or signals generated from the 3D model, the images and / or signals simulating acquisitions of ultrasound images and / or signals corresponding to sections of the organ (2) according to a plurality of positions and orientations of an ultrasound probe; - at least one main ultrasound probe (9); - a processing module (11) configured to receive as input a signal or image corresponding to a section of the organ (2) and to determine, in real time, the position of the section of the organ (2) corresponding to this signal or image in the 3D model.

Description

[0001] DESCRIPTION

[0002] Title: System for performing image-guided surgery or procedures

[0003] technical field

[0004] The present invention relates to the field of image-guided surgery and procedures. More particularly, it relates to a system for performing image-guided surgery or procedures, thereby improving the surgeon's working conditions.

[0005] Previous technique

[0006] The incidence of primary liver cancer (i.e., hepatocellular carcinoma – HCC) is increasing worldwide. It ranks seventh globally among all cancers and accounted for 8.2% of cancer-related deaths in 2018. Furthermore, the liver is the most common site for metastatic tumors. Liver surgery (i.e., resection, either open or laparoscopic) remains the primary curative treatment option overall. In recent years, there has been a growing trend toward parenchyma-sparing techniques (such as parenchyma-sparing resections or tumor ablations), which aim to maximize the removal of cancer cells while minimizing the removal of healthy tissue.

[0007] Despite advances in computer-guided preoperative planning, the successful implementation of these plans in the operating room relies on the precise identification of anatomical landmarks (biologically significant locations that can be unambiguously defined and repeatedly located with a high degree of accuracy and precision), regardless of the surgical approach chosen (open surgery, laparoscopy, flexible endoscopy). This presents a challenge due to the dynamic nature of surgery and the changes that occur between the preoperative and intraoperative phases. In this context, laparoscopy has demonstrated significant advantages over open surgery, with fewer postoperative complications and similar oncological outcomes, thus expanding its indications.

[0008] Parenchyma-sparing surgery represents the cutting edge of liver resection techniques. This approach has been made possible by the increasing use of intraoperative ultrasound (IOUS) and complex IOUS-guided techniques, such as the hooking technique (among others). These advances allow for limited resections of deep tumors by following multiplanar trajectories, further increasing the complexity of these procedures. However, intraoperative ultrasound is still primarily used in open surgery, where image acquisition and interpretation are similar to external probe use on the patient's skin. The use of intraoperative ultrasound in a laparoscopic setting presents considerable challenges.Because surgeons are limited by the positioning of the trocars for inserting the laparoscopic ultrasound probe, they have a different viewing angle than they are used to. Furthermore, some surgeons prefer to insert the probe through the patient's navel, while others prefer to insert it laterally, resulting in completely different ultrasound images and consequently limiting the use of intraoperative laparoscopic ultrasound.

[0009] The success of intraoperative ultrasound depends heavily on the accurate identification of intrahepatic landmarks, such as blood vessels, to retrieve the correct resection plans established preoperatively. This is crucial to avoid unintentional vascular injury (secondary hemorrhage), which is the main challenge in achieving a balance between resecting enough tissue to minimize the risk of positive surgical margins and preserving as much healthy liver tissue as possible. This helps reduce the incidence of post-hepatectomy liver failure, a major cause of morbidity and mortality associated with this type of surgery.

[0010] Ultrasound imaging has immense potential as an interventional guidance method, primarily due to its widespread availability, attractive cost-effectiveness, and safety profile. Ultrasound imaging provides information on organs and vascular structures, but its adoption in the intraoperative setting remains limited, mainly due to its inherent drawbacks. One of the main challenges lies in the complex analysis of the images and their limited fields of view, which significantly impact the operators' capabilities (spatial orientation of the probe and contextualization of the resulting ultrasound images).Combined with poor ergonomics and difficult probe handling, these factors lead to cognitive overload for operators, steep learning curves, and a lack of reproducibility in ultrasound-guided procedures due to the absence of an established protocol between different operators. Furthermore, minimally invasive surgical environments, such as laparoscopy, present additional constraints, both ergonomic (limited space) and mechanical, with the fulcrum effect and the lack of haptic feedback resulting in more aggressive probe-tissue interaction, leading to deformation of anatomical structures and probe coupling problems. These constraints pose significant challenges, making the effective use of ultrasound methods by untrained operators difficult, if not impossible.

[0011] By its very nature, the use of trocars to access the surgical cavity limits access to the target organ, hindering efficient probe manipulation and tissue coupling. This, in turn, limits the scanable area, impacting image quality and complicating the analysis process. Furthermore, precise probe positioning within the surgical field necessitates the removal of surgical instruments, making it impossible to use ultrasound as a real-time instrument guide. This results in a tedious cycle of instrument insertion / probe removal and instrument removal / probe insertion, leading to multiple repetitions and asynchronous image acquisition.To avoid this asynchrony, surgeons performing liver surgery often mark the liver surface with superficial burns while guided by the IOUS (Integrated Ultrasound System) to locate and record the position of the hepatic vessels after removing the probe from the surgical field. This procedure results in unnecessary injuries. Furthermore, if the ultrasound probe is not visible in the laparoscopic video field, interpreting the ultrasound images becomes even more difficult, if not impossible, because the operator cannot "register" the ultrasound images with the anatomical structure being scanned.

[0012] Description of the invention

[0013] The present invention aims to overcome these drawbacks by proposing a system for the implementation of an image-guided surgical operation, or intervention, comprising at least one preparatory medical imaging device enabling the acquisition of a set of partial or complete views of a solid organ of the human body.

[0014] This system is unique in that it also includes:

[0015] - a module for generating a 3D model of said organ from ultrasound data, such as raw signals or images, acquired by the preparatory medical imaging device,

[0016] - a module for generating a database of synthetic ultrasound signals and / or images generated from said 3D model, said synthetic ultrasound signals and / or images simulating acquisitions of ultrasound signals and / or images corresponding to partial or complete sections of said organ according to several positions and orientations of an ultrasound probe, said database containing, for each virtual ultrasound signal and / or image, data relating to the position of the corresponding section in the 3D model of said organ,

[0017] - at least one main ultrasound probe,

[0018] - a processing module configured to take as input a signal or image corresponding to a partial or complete section of said solid organ acquired by said at least one main ultrasound probe, and to determine in real time the position of the section of the organ corresponding to this signal or image in the 3D model of said organ, using the database of synthetic ultrasound signals and / or images.

[0019] Thanks to these features, the signals and / or images captured by the primary ultrasound are automatically registered within the 3D model of the solid organ, eliminating the need for the surgeon to mentally reposition these images within the organ's volume. This allows the primary ultrasound probe(s) to be positioned outside the surgeon's field of vision, as they no longer need to visualize the probe's position relative to the organ to perform this registration themselves.

[0020] The preparatory medical imaging device can be a one-dimensional preparatory ultrasound probe comprising a position sensor, which is a simple and efficient embodiment of the invention, the position sensor data making it easy to generate the 3D model of the solid organ.

[0021] The said database may include synthetic ultrasound signals and / or images simulating acquisitions of ultrasound signals and / or images corresponding to a partial or complete section of said organ by means of at least one linear ultrasound probe and at least one curvilinear ultrasound probe, which allows the system to be adapted regardless of the type of main ultrasound probe.

[0022] The said database may include synthetic ultrasound signals and / or images simulating acquisitions of ultrasound signals and / or images corresponding to a partial or complete section of said organ by means of at least one ultrasound probe whose depth of field parameters and / or amplification of the received signal and / or beam focusing have different values, which allows the system to be adapted regardless of the parameterization of the main ultrasound probe.

[0023] The processing module may include a neural network specific to said organ, said neural network being trained by the synthetic ultrasound signals and / or images from said database, which allows the processing module to be particularly effective in determining the position of the section of the solid organ corresponding to the image captured by the main ultrasound probe in the 3D volume of the solid organ.

[0024] The 3D model generation module may include a sub-module for marking areas of interest on the 3D model of said organ configured to automatically recognize at least one area of ​​interest on the images captured by the preparatory medical imaging device and integrate it into the 3D model, which makes it possible to find the area of ​​interest on the images captured by the main ultrasound probe and make them visible to the surgeon during the intervention or surgical operation.

[0025] The said system may include an intraoperative display means of the 3D model of said organ and / or the images captured by said at least one main ultrasound probe, which allows the surgeon to easily visualize the 3D model and the registration of the images captured by the main ultrasound probe with respect to this 3D model.

[0026] The system may include a surgical instrument comprising a position sensor, the processing module being configured to determine the position of the surgical instrument relative to the 3D model of the organ, and the display means being configured to display the position of the surgical instrument relative to the 3D model of the organ, and / or relative to images captured by at least one primary ultrasound probe, in real time, thereby facilitating the surgeon's operations by providing him with precise visual information on the position of the surgical instrument relative to the solid organ.

[0027] The said display means can be configured to display at least one area of ​​interest on the 3D model of the organ, and / or on the images captured by said at least one main ultrasound probe, which facilitates the surgeon's operations by giving him access to precise visual information on the position of the areas of interest relative to the rest of the solid organ.

[0028] The said processing module can be configured to determine the position of said at least one primary ultrasound probe relative to the 3D model of the organ, and said display means can be configured to display the position of said at least one primary ultrasound probe relative to the 3D model of the organ, thereby facilitating the interpretation of images captured by the primary probe.

[0029] The said system may include at least two main ultrasound probes, the processing module being able to be configured to detect in the ultrasound signals acquired by each of said main ultrasound probes any interferences and / or interactions generated by at least one other main ultrasound probe, and to analyze these interferences and / or interactions in order to determine the relative positions of said main ultrasound probes in real time, and thus to determine more precisely their respective positions with respect to the 3D model of the solid organ.

[0030] The said system may include a deformation module, configured to deform the 3D model of said organ in real time according to the signals and / or images acquired by the main ultrasound probe, which makes it possible to take into account changes in the shape of the solid organ resulting from the time elapsed between the capture of the images used for the generation of the 3D model and the intervention or surgical operation, or from a change in the position of the patient, or other.

[0031] The main ultrasound probe can be configured to be positioned, during an intervention or surgical operation, outside the surgeon's workspace, which prevents the main ultrasound probe from hindering the surgeon's movements and / or the operations he must perform as part of the intervention or surgical operation.

[0032] The said solid organ may be a liver, kidney, lung, spleen, uterus, prostate or pancreas, which are organs for which laparoscopic surgery using a primary ultrasound probe is relevant, and which are therefore particularly suited to the invention.

[0033] Brief description of the drawings

[0034] The present invention and its advantages will become more apparent from the following description of several embodiments given by way of non-limiting examples, with reference to the accompanying drawings, in which:

[0035] [Fig 1] Fig. 1 is a schematic view of a system for carrying out a surgical intervention or operation according to a preferred embodiment of the invention, the elements used during the main phase being represented by dashed lines, [Fig 2] Fig. 2 is a schematic view of the system of Figure 1, the elements used in the preparatory phase being represented by dashed lines,

[0036] [Fig 3] Fig. 3 is a schematic view of part of the system in Figure 1, used during a preparatory phase,

[0037] [Fig 4] Fig. 4 is a schematic view of part of the system in Figure 2, used during a main phase.

[0038] Description of the implementation methods

[0039] The invention relates to a system for carrying out an intervention or surgical operation 1 on a solid organ 2 of the human body, this operation being guided by imaging techniques described below.

[0040] The present invention is particularly suitable, without this list being exhaustive, for the implementation of a percutaneous or surgical ablation, or even a resection in laparoscopic or open surgery.

[0041] A preferred embodiment of system 1 is shown in Figures 1 and 2. Part of system 1, shown in solid lines in Figure 1, is dedicated to preparatory processing steps, and part of system 1, shown in solid lines in Figure 2, is dedicated to main processing steps.

[0042] In the context of this invention, the term "preparatory" refers to steps that take place before the surgical procedure or operation. These steps may occur preoperatively, that is, before the patient is admitted to the hospital for the procedure or operation, for example, in a hepatologist's office. They may also occur perioperatively, that is, after the patient is admitted to the hospital but before entering the operating room. Finally, these steps may occur immediately before the surgical procedure or operation, in the operating room, for example, while the patient is under anesthesia.

[0043] The term "main" refers to the steps that take place intraoperatively, that is, during the operation, or the surgical intervention itself.

[0044] The second solid organ involved in the operation may be a liver, an organ for which the drawbacks of existing techniques are described above. The second solid organ involved in the operation may also be a kidney, lung, spleen, uterus, prostate, or pancreas, as operations on these organs present the same, or similar, problems, albeit on different scales, to those described above.

[0045] System 1 includes at least one preparatory medical imaging device 3, that is, one intended for use prior to the intervention or surgical operation. The preparatory medical imaging device 3 enables the acquisition of partial or complete views of the solid organ, with the aim of creating a 3D model of the solid organ.

[0046] System 1 also includes a 3D model generation module 4. This computer module takes as input data acquired by the preparatory medical imaging device 3, i.e., either raw data or images, possibly supplemented with position data from a position sensor as described below, in order to create a 3D model specific to the patient's solid organ 2. The 3D model is preferably generated from the raw data, i.e., radiofrequency signals, which contain more information than the images reconstructed from these signals, and therefore allow for the generation of a more accurate 3D model. The preparatory medical imaging device 3 may include a preparatory ultrasound probe 5, preferably external, preferably associated with an ultrasound scanner. The preparatory ultrasound probe 5 may be linear, curvilinear, or multi-element (also called "phased array").

[0047] The preparatory ultrasound probe 5, particularly when one-dimensional, may include a position sensor 6, electromagnetic or otherwise, enabling the acquisition of the position and orientation of the preparatory ultrasound probe 5 in three-dimensional space, relative to the electromagnetic field generator, or to a device that can serve as a reference frame, for example, a camera. This data is collected and saved with the data acquired by the preparatory ultrasound probe 5 by a collection and saving means of system 1. The data acquired by the position sensor 6 preferably includes three coordinates, to locate the position in a three-dimensional frame, and may also include angular orientation data. The data acquired by the position sensor 6 is synchronized with the data acquired by the preparatory ultrasound probe 5.Thus, position data allows the ultrasound images from the preparatory ultrasound probe 5 to be placed in a 3D environment in order to facilitate the generation of the 3D model.

[0048] The generation of the 3D model includes, for example, the following steps using data from position sensor 6:

[0049] - transposition of ultrasound data (raw signals or images) tracked in 3D volumetric space by interpolation, for example by linear interpolation.

[0050] - determination of the value of each voxel by a composite method, such as the weighted average of all coincident pixels.

[0051] - to avoid obtaining holes in the reconstructed volume, particularly in high-resolution volumes, application of a hole-filling algorithm by interpolating the values ​​of nearby voxels using a weighted average of known nearby voxels with a spherical Gaussian kernel of variable size.

[0052] It is also possible to carry out the invention using a preparatory ultrasound probe 5 without a position sensor 6. In this case, a first solution for generating the 3D model is to determine the positioning in space of each image acquired during the ultrasound relative to each other using a specific module using image processing methods, and preferably a neural network.

[0053] The publication "Trackerless Volume Reconstruction from Intraoperative Ultrasound Images", Sidaty El Hadramy et al. (2023) proposes such a method, the objective of which is, from a sequence of N images, to find the relative spatial transformation between each pair of images li and Ij with 0 < i <j < N - l. Cette transformation est notée T(i,j) et est un vecteur à six degrés de liberté représentant trois translations et trois angles d'Euler. Cette méthode comporte les étapes suivantes :

[0054] - As input, a sequence of 2k + 3 images is considered, k being a hyperparameter that represents the number of images between two images of interest, each image having been acquired by an ultrasound probe, the images being classified chronologically in the sequence,

[0055] - the sequence is divided into two sub-sequences of length k + 2, the last image of the first sub-sequence being identical to the first image of the second sub-sequence,

[0056] - Each sub-sequence is used to calculate a sparse optical flow, allowing us to track the trajectory of M points.

[0057] - then, Gaussian heat maps are used to describe the movement of the M points in a format similar to that of an image,

[0058] - finally, a Siamese architecture based on a Seq2Vec (“Sequence to Vector”) network with two shared weights takes as input the Gaussian heat maps as well as the first and last image and predicts the relative transformations.

[0059] In a second solution for implementing the invention using a preparatory ultrasound probe 5 without a position sensor 6, it is possible to use automatic recognition, or manual annotation, of anatomical landmarks, or areas of interest, specific to the solid organ 2, on the ultrasound images. In this case, the system 1 includes a means for automatic recognition, or an annotation interface allowing this manual annotation. These landmarks may, in particular, correspond to the surface of the organ, or to the location of blood vessels. These landmarks can be used, in combination or not with computer means as described above, to generate the 3D model of the solid organ 2.

[0060] In a third solution, the preparatory ultrasound probe 5 is a 1.75D or 2D type ultrasound probe. These probes perform an electronic scan at multiple angles without changing position, allowing the relative positions of the different acquired signals to be retrieved in three-dimensional space. This data can be used to generate the 3D model of the solid organ 2.

[0061] Of course, a combination of two of the three solutions presented above can also be implemented.

[0062] Whether or not they are used for the generation of the 3D model of solid organ 2, certain landmarks, automatically recognized or manually annotated, can be used to mark the generated 3D model, particularly to highlight them when displaying this 3D model. These landmarks, or areas of interest, can be blood vessels, target vessels, points of separation between two or more vessels, tumors, resection planes, the external surface of the organ, a specific anatomical structure of the organ (for example, the liver capsule, the vena cava, the portal vein, etc.).

[0063] The images acquired by the preparatory ultrasound probe 5 are preferably recorded in memory, where appropriate with the position data acquired by the position sensor 6.

[0064] When the generation of the 3D model is based on acquisitions from a preparatory ultrasound probe 5, the 3D model generation module 4 can use interpolation techniques to fill the inter-ultrasonic image gaps.

[0065] The preparatory ultrasound probe 5 can be used according to the so-called “lawnmower” technique, which involves making back-and-forth movements along a trajectory 15 with the probe over the entire surface of the patient's body 16 corresponding to the solid organ 2. This ultrasound data acquisition technique can be performed by a less experienced or novice ultrasound operator 17, as it does not require advanced knowledge of anatomy or of handling the preparatory ultrasound probe 5. This step is illustrated in Figure 3.

[0066] In other embodiments, the preparatory medical imaging device 3 may include, instead of the preparatory ultrasound probe 5, a magnetic resonance imaging (MRI) system, or a computed tomography (CT) imaging system. These types of systems also allow the generation of the 3D model of the solid organ 2.

[0067] In some embodiments, the preparatory medical imaging device 3 can be used to acquire views of a contralateral organ of the patient, and these views can be used to facilitate the generation of the specific 3D model of the solid organ 2. The 3D model of the solid organ 2 thus generated can be used to plan the intervention or surgical operation, in particular as an aid to decision-making regarding the equipment that will be required, for example the length, thickness or diameter of the surgical instruments that will be used during the intervention.

[0068] System 1 also includes a generation module 7 for a database 8 of synthetic ultrasound signals and / or images. Here, "ultrasound signal" refers to raw radiofrequency data acquired by an ultrasound probe, not yet converted into an ultrasound image. "Ultrasound image" refers to an image produced from the ultrasound data acquired by the ultrasound probe. "Virtual" refers to signals and / or images that were not acquired by an ultrasound probe but are generated by computer to simulate such signals and / or images. Depending on the type of algorithm used to generate the database, and the various applications that can be made of it, it may be preferable to augment database 8 with ultrasound signals, ultrasound images, or both.

[0069] The database 8 of synthetic ultrasound signals and / or images may also include, in the case where the preparatory medical imaging device 3 includes a preparatory ultrasound probe 5, ultrasound signals and / or images which are not synthetic, in the sense that they are acquired directly on the solid organ 2, during the acquisition described above in order to generate a 3D model.

[0070] The generation module 7 takes as input the 3D model of the solid organ generated by the 3D model generation module of the solid organ 2. It then generates synthetic ultrasound signals and / or images, simulating acquisitions of partial or complete sections of the solid organ 2, according to several different positions and orientations of an ultrasound probe. These signals and / or images are stored in the database 8, where they are associated with data relating to their positioning within the 3D model of the solid organ 2.

[0071] Preferably, database 8 includes synthetic ultrasound signals and / or images simulating acquisitions at any position and angle of the ultrasound probe relative to the solid organ 2.

[0072] Preferably, database 8 includes synthetic ultrasound signals and / or images simulating acquisitions via at least two types of ultrasound probes among linear, curvilinear, and multi-element probes.

[0073] Preferably, database 8 contains synthetic ultrasound signals and / or images simulating acquisitions via the same ultrasound probe, in the same position, with one or more parameters having different values. These parameters may be, for example, depth of field and / or amplification of the received signal and / or beam focusing and / or contrast and / or brightness.

[0074] When areas of interest have been automatically recognized or manually annotated so as to be integrated into the 3D model of the solid organ 2, these can be marked on the ultrasound images in database 8.

[0075] When the 3D model of the solid organ 2 and the database 8 are generated, the preparatory phase carried out using the system 1 according to the invention can be closed.

[0076] After the preparatory phase comes the main phase, that is to say the intervention, or the surgical operation itself.

[0077] System 1 still includes at least one main ultrasound probe 9, that is, one intended for use during at least part of the intervention or surgical operation. One or more main ultrasound probes 9 may be used.

[0078] The main ultrasound probe 9 can be identical to the preparatory ultrasound probe 5.

[0079] In the following description, when reference is made to a primary ultrasound probe 9, the relevant characteristics can be extrapolated to a plurality of primary ultrasound probes 9.

[0080] The main ultrasound probe 9 can be an external probe, meaning it is intended for use outside the human body, for example, on the patient's skin, preferably via a suitable coupling device such as a gel. Alternatively, the main ultrasound probe 9 can be an internal probe, meaning it is intended for use inside the human body, for example, in contact with the organ, preferably via a coupling system.

[0081] The primary ultrasound probe 9 can be curvilinear, linear, or multi-element. If the primary ultrasound probe 9 is one-dimensional, it can be associated with a position sensor 10, which allows the position and orientation of the primary ultrasound probe 9 to be determined in space, and thus the position of the acquired ultrasound images. The position sensor 10 is, for example, an electromagnetic position sensor.

[0082] The system 1 includes a processing module 11, configured to take as input an ultrasound signal, or an ultrasound image, acquired by the main ultrasound probe 9, and corresponding to a partial or complete section of the solid organ 2. The processing module 11 uses the database 8, and where appropriate the position and orientation data of the position sensor of the main ultrasound probe 9, in order to determine the position of the section of the organ corresponding to the signal or image acquired by the main ultrasound probe 9 in the 3D model of the solid organ 2 generated previously.

[0083] The processing module 11 is therefore capable of integrating the image produced by the main ultrasound probe 9 into the 3D model. The processing module 11 preferably operates in real time, so that this information is available to the surgeon during the operation. "Real time" here refers to a time frame sufficiently fast to be usable in this context. This could therefore be a latency of less than 0.5 seconds, preferably less than 0.1 seconds.

[0084] When the database 8 is set up to take into account any type of ultrasound probe, in any position, and according to different parameters, the processing module 11 is then effective regardless of the type and configuration of the main ultrasound probe 9 used.

[0085] The processing module 11 preferably includes a machine learning system, such as a neural network, specific to solid organ 2, meaning specific not only to the type of solid organ 2, for example a liver, or other, but also specific to the patient. The use of database 8 then consists, at least in part, of training this neural network using these signals and / or images.

[0086] The specific neural network is, for example, a U-Net type neural network, using, for instance, the "2D Attention U-Net" architecture. A neural network using a different architecture, for example, one developed specifically for an application of the invention, can also be used. The neural network can be trained to recognize, on ultrasound images, areas of interest specific to solid organ 2, identified automatically or annotated manually.

[0087] System 1 may include an intraoperative display means 12 for the 3D model of the organ. The intraoperative display means 12 may be a screen, an augmented reality device, and / or a virtual reality device. The intraoperative display means 12 may be used to display the 3D model of the solid organ 2 during the intervention or surgical operation, and may be used to display different types of information related to this 3D model. Alternatively or in addition, the intraoperative display means 12 may be used to integrate certain information, as described below, onto the images captured by the main ultrasound probe(s) 9, and the registration of this information with the images from the main ultrasound probe 9 is performed using the 3D model of the solid organ 2.

[0088] In a preferred embodiment, the system 1 includes a surgical instrument 13 comprising a position sensor 14, which allows the position and orientation of the surgical instrument 13 to be retrieved. The position sensor 14 is capable of communicating with the processing module 11, sending it the position and orientation data of the surgical instrument 13 in real time. The processing module 11 is then configured to calculate the position of the surgical instrument 13 relative to the 3D model of the solid organ 2. The main display means 12 is then configured to display the position of the surgical instrument 13 relative to the 3D model of the solid organ 2, and / or relative to the images from the main ultrasound probe 9, in real time.

[0089] In cases where areas of interest have been defined on the 3D model of the solid organ 2, as described previously, by automatic recognition or manual annotation, the intraoperative display means 12 can be configured to display one or more of these areas of interest. In particular, the system 1 may include an interface allowing the display or hiding of certain types of areas of interest.

[0090] When areas of interest have been annotated or automatically recognized and are present on the 3D model of the solid organ 2 and / or on the ultrasound images in the database 8, the processing module 11 can be configured to locate these areas of interest on the images acquired by the main ultrasound probe 9. The display means 12 can then display the images acquired by the main ultrasound probe 9, with these areas of interest highlighted.

[0091] In an embodiment where the main ultrasound probe 9 includes a position sensor 10, the processing module 11 can be configured to calculate the position of the main ultrasound probe 9 relative to the 3D model of the solid organ 2. The intraoperative display means 12 is then configured to display the position of the main ultrasound probe 9 relative to the 3D model of the solid organ 2, and / or relative to the images of the main ultrasound probe 9, in real time. If the main ultrasound probe 9 does not include a position sensor 10, its position can be determined by the processing module 11 based on the signals or images acquired by the main ultrasound probe 9 and the database 8, by comparing the acquired signals or images with the signals or images in the database 8, or by using a neural network trained with the signals and / or images in the database 8.

[0092] When the system 1 includes at least two main ultrasound probes 9, the processing module can take into account the interferences and / or interactions captured by each main ultrasound probe 9 from the other main ultrasound probes 9 in order to refine the determination of the position of the main ultrasound probes 9 relative to the solid organ 2, and thus to display as accurately as possible the position of the main ultrasound probes 9 relative to the 3D model of the solid organ 2, and / or relative to the images of the main ultrasound probe 9, on the intraoperative display means 12.

[0093] By "interaction" we mean here a particular configuration of at least two ultrasound probes, in which the probes are specifically programmed so that one of them detects the signals emitted by a second of them, whereas in a classic use, an ultrasound probe is programmed to detect the signals that it has itself emitted.

[0094] Interference, on the other hand, is not intentional, and generates noise in the signals of ultrasound probes which we usually try to reduce as much as possible.

[0095] System 1 may include a deformation module 14. The deformation module 14 is configured to deform the 3D model of the solid organ 2 in real time based on the signals or images acquired by the main ultrasound probe 9. The deformation module 14 may, in particular, use the database 8, possibly via a neural network trained on the database 8, and adapt the 3D model during the intervention or surgical procedure. This ensures that the 3D model is as faithful as possible to the anatomy of the solid organ 2, which may have changed since the generation of the 3D model, which may have been, for example, a few weeks prior. This also allows the 3D model to take into account deformations that may result from a different patient position, or from the intervention or surgical procedure itself.The deformation module 14 can take into account the regions of interest of the solid organ 2, as defined above, to more precisely detect deformations between the 3D model and the signals or images acquired by the main ultrasound probe 9. The deformation module 14 can also modify the position and / or shape of the regions of interest of the solid organ 2 on the 3D model. The system 1 allows the main ultrasound probe 9 to be positioned outside the surgeon's 18 surgical workspace during the procedure.The working space here refers to all or part of the solid organ 2 that the surgeon must be able to access to perform the intervention or surgical operation, for example, to make an incision or an ablation. Typically, the surgeon accesses the working space from above, meaning that the surgical instruments are oriented downwards. The main ultrasound probe 9 can, for example, be placed in a posterior position, that is, under the patient 16, as illustrated in Figure 4, or under the solid organ 2, within the surgical cavity. Alternatively, or in addition if several main ultrasound probes 9 are used, the main ultrasound probe 9 can also be placed in a lateral position, that is, on one side of the patient, or within the surgical cavity, lateral to the solid organ 2.

[0096] If the main ultrasound probe 9 is placed outside the patient, it must be secured to prevent movement during the procedure or surgery. This can be achieved by suction, adhesive, or any other suitable method. It must also be coupled to the patient's skin using a gel or a suitable standoff device. If the main ultrasound probe 9 is placed inside the surgical cavity, it also needs to be secured to prevent movement during the procedure or surgery, for example, by using an adhesive, and coupled to the solid organ 2, for example, by means of a gel, a water-filled cavity, or another suitable substance.

[0097] The present invention is not limited to the embodiments described but extends to any modification and variant obvious to a person skilled in the art, within the limits of the appended claims. Furthermore, the technical features of the various embodiments and variants mentioned above may be combined, in whole or in part.

Claims

Demands

1. A system (1) for performing an image-guided surgical operation or intervention, comprising at least one preparatory medical imaging device (3) enabling the acquisition of a set of partial or complete views of a solid organ (2) of the human body, and characterized in that it further comprises: - a module for generating a 3D model (4) of said organ (2) from the data acquired by the preparatory medical imaging device (3), - a generation module (7) for a database (8) of synthetic ultrasound signals and / or images generated from said 3D model, said synthetic ultrasound signals and / or images simulating acquisitions of ultrasound signals and / or images corresponding to partial or complete sections of said solid organ (2) according to several positions and orientations of an ultrasound probe, said database (8) comprising for each virtual ultrasound signal and / or image data relating to the position of the corresponding section in the 3D model of said solid organ (2), - at least one main ultrasound probe (9), - a processing module (11) configured to take as input a signal or image corresponding to a partial or complete section of said solid organ (2) acquired by said at least one main ultrasound probe (9), and to determine in real time the position of the section of the solid organ (2) corresponding to this signal or image in the 3D model of said solid organ (2), using the database (8) of synthetic ultrasound signals and / or images.

2. System (1) according to claim 1, wherein the preparatory medical imaging device (3) is a one-dimensional preparatory ultrasound probe (5) comprising a position sensor (6).

3. System (1) according to any one of claims 1 to 2, wherein said database (8) comprises synthetic ultrasound signals and / or images simulating acquisitions of ultrasound signals and / or images corresponding to a partial or complete section of said solid organ (2) by means of at least one linear ultrasound probe and at least one curvilinear ultrasound probe.

4. System (1) according to any one of claims 1 to 3, wherein said database (8) comprises synthetic ultrasound signals and / or images simulating acquisitions of ultrasound signals and / or images corresponding to a partial or complete section of said solid organ (2) by means of at least one ultrasound probe having different depth-of-field parameters and / or received signal amplification and / or beam focusing.

5. System (1) according to any one of claims 1 to 4, wherein the processing module (11) comprises a neural network specific to said solid organ (2), said neural network being trained by the synthetic ultrasound signals and / or images from said database (8).

6. System (1) according to any one of claims 1 to 5, wherein the 3D model generation module (4) comprises a sub-module for marking areas of interest on the 3D model of said solid organ (2) configured to automatically recognize at least one area of ​​interest on the images captured by the preparatory medical imaging device (3) and integrate it into the 3D model.

7. System (1) according to any one of claims 1 to 6, comprising an intraoperative display means (12) of the 3D model of said solid organ (2) and / or images captured by said at least one main ultrasound probe (9).

8. System (1) according to claim 7, comprising a surgical instrument (13) including a position sensor (14), said processing module (11) being configured to determine the position of said surgical instrument (13) by relative to the 3D model of the solid organ (2), and said display means (12) being configured to display the position of said surgical instrument (13) relative to the 3D model of the solid organ (2), and / or on the images captured by said at least one primary ultrasound probe (9), in real time.

9. System (1) according to claim 6 and any one of claims 7 to 8, wherein said display means (12) is configured to display at least one area of ​​interest on the 3D model of the solid organ (2), and / or on the images captured by said at least one primary ultrasound probe (9).

10. System (1) according to any one of claims 7 to 9, wherein said processing module (11) is configured to determine the position of said at least one primary ultrasound probe (9) relative to the 3D model of the solid organ (2), and said display means (12) is configured to display the position of said at least one primary ultrasound probe (9) relative to the 3D model of the solid organ (2).

11. System (1) according to claim 10, comprising at least two main ultrasound probes (9), the processing module (11) being configured to detect in the ultrasound signals acquired by each of said main ultrasound probes (9) the interferences and / or possible interactions generated by at least one other main ultrasound probe (9), and analyze these interferences and / or interactions in order to determine the relative positions of said main ultrasound probes (9) in real time, and thus to determine more precisely their respective positions with respect to the 3D model of the solid organ (2).

12. System (1) according to any one of claims 1 to 11, comprising a deformation modulus, configured to deform the 3D model of said solid element (2) in real time based on the signals and / or images acquired by the main ultrasound probe (9).

13. System according to any one of claims 1 to 12, wherein the main ultrasound probe (9) is configured to be positioned, during a surgical procedure or operation, outside the surgeon's working space.

14. System according to any one of claims 1 to 13, wherein said solid organ (2) is a liver, a kidney, a lung, a spleen, a uterus, a prostate or a pancreas.

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