Medical system

Abstract

The present disclosure relates to a medical system for a surgical procedure on an anatomical region of a patient, comprising registered radiological 3D image data of the anatomical region, a detection unit (2) configured to detect a current surface (O) of the anatomical region, a display device (6), and a control unit (8) configured to visually display the current surface (O) in the radiological 3D image data on the display device.

Description

[0001] Medical system

[0002] Description

[0003] Technical field

[0004] The present disclosure relates to a medical system for a surgical, in particular cranial / neurosurgical, intervention on an anatomical area of ​​a patient.

[0005] It is already known from the prior art to register a patient using radiological 3D image data and data on the current position and / or orientation of an anatomical region of the patient, in the case of cranial / neurosurgical procedures, particularly the patient's head or face. This involves linking the radiological 3D image data with the current position and / or orientation of the anatomical region in order to support the surgical procedure by navigating instruments, devices, etc., relative to the patient. Various methods can be used for registration, which generally capture an external surface of the anatomical region and assign it to the radiological 3D image data, or even permanently link them together.

[0006] From DE 102023118958 A1 a medical system is known with a camera for creating a real-time patient recording and a display device, wherein the real-time recording is displayed on the display device superimposed with a projected sectional view of 3D recording data.

[0007] From DE 102022 118990 A1 a navigation system is known in which annotation objects can be superimposed in a current patient recording.

[0008] BN3166P-EP-0012 : B. Braun New Ventures GmbH From US 2007 / 021669 A1 a method for registering preoperative images on the intraoperative cortical surface of the patient and for measuring the extent of brain displacement during surgery is known.

[0009] However, after opening the patient's anatomical area for surgical intervention, tissue located within the patient can shift relative to the outer surface, and the recorded radiological 3D imaging data may no longer correspond to the current position and / or orientation of the anatomical area, at least with regard to the tissue.

[0010] Particularly during cranial / neurosurgical procedures, the ingress of air and the resection of a portion of the anatomical area cause tissue or brain tissue to collapse, or to be partially absent. This phenomenon of tissue collapse is known as tissue shift or brain shift.

[0011] Due to tissue displacement, a discrepancy arises between the actual position and / or orientation of the tissue and the recorded 3D radiological data. Consequently, the recorded 3D radiological data is only valid with respect to the position and / or orientation of the skull bone, but no longer accurate with respect to the position and / or orientation of the tissue. This deviation makes precise localization and navigation of the tissue impossible, as the inaccuracy poses a high risk of tissue injury, which can have serious consequences for the patient.

[0012] There are already existing approaches in the art to correct navigation accuracy after such tissue displacement.

[0013] BN3166P-EP-0012: B. Braun New Ventures GmbH. For example, it is known from the prior art to use ultrasound imaging intraoperatively (especially after tissue repositioning) to update the patient registration locally. However, such ultrasound imaging is time-consuming and disrupts the surgical procedure. Furthermore, only local corrections can be made in this way.

[0014] It is also known from the state of the art to create and use (new) radiological 3D imaging data, such as MRI data, intraoperatively (especially after tissue displacement) to update the imaging data used for registration. However, re-creating radiological 3D imaging data is time-consuming and disrupts the surgical procedure.

[0015] Furthermore, it is known from the state of the art to use augmented reality to visually realign patient anatomy with a preoperative image. However, the accuracy of augmented reality is not high enough, depending on the data used.

[0016] Furthermore, it is known from the prior art to use biomechanical models to correct the registration based on meaningful intraoperative measurements, e.g., a reconstruction of the 3D surface of the patient's brain. However, such biomechanical models are not yet accurate enough, so that, in particular, it is not possible to distinguish between anatomical changes caused by tissue displacement and those caused by resection.

[0017] Furthermore, it is known from the prior art to use predictive models of tissue displacement to forecast anatomical changes using previous data from similar procedures. However, such predictive models are not yet accurate enough to predict the complex process of tissue displacement with sufficiently high precision.

[0018] Therefore, the present disclosure aims to avoid or at least reduce the disadvantages of the prior art. In particular, BN3166P-EP-0012: B. Braun New Ventures GmbH intends to provide a medical system that reduces the effects of tissue displacement during a navigated procedure in order to adequately ensure patient safety.

[0019] The problem addressed in the present disclosure is solved by a medical system having the features of claim 1. Advantageous further developments are the subject of the dependent claims.

[0020] The present disclosure relates to a medical system for a surgical, in particular cranial / neurosurgical, intervention on an anatomical area of ​​a patient.

[0021] The medical system contains registered, radiological 3D (3D, three-dimensional) image data of the patient's anatomical area. This radiological 3D image data can preferably be acquired preoperatively (and / or intraoperatively). Specifically, the radiological 3D image data can be MRI or CT scan data.

[0022] The radiological 3D scan data has been registered. This means that points on the patient's external surface (for example, points on the patient's face) were recorded as reference points and then mapped to the corresponding points in the radiological 3D scan data. Various registration methods, well-established in the art, are available for this purpose.

[0023] The medical system includes a data acquisition unit. This unit is configured to capture a real-time surface (i.e., an actual surface) of the patient's anatomical area. This means the unit is designed to generate three-dimensional surface data, including depth information, of this real-time surface. Data acquisition can be performed optically or tactilely, for example.

[0024] BN3166P-EP-0012: B. Braun New Ventures GmbH. The medical system has a display device. The display device can be, for example, a monitor / screen. The display device can be configured for two-dimensional and / or three-dimensional display.

[0025] The medical system has a control unit. This control unit is configured to visually display the current surface (i.e., the surface profile or contour) within the radiological 3D scan data on the display device. This means that the surface data is superimposed on the radiological 3D scan data to visualize any differences between the datasets.

[0026] This has the advantage that the surgeon can visualize, at least within the (original) 3D scan data, which is still accurate with regard to bone positioning, the extent to which an externally visible tissue surface has changed, i.e., whether it has been displaced by tissue movement or moved in terms of its external dimensions by a resection. This allows the surgeon to take these tissue changes into account and draw certain conclusions about the overall tissue displacement. Furthermore, using surface data has the advantage that it can be generated very easily, so the surgical procedure is not disrupted.

[0027] In this process, the surface data and the radiological 3D image data can be aligned with each other, particularly with regard to the position and / or orientation of the skull bone, since the registration of the radiological 3D image data is still usable in the area of ​​the skull bone. In other words, the surface data are not arbitrarily superimposed on the radiological 3D image data, but rather in such a way that the registered radiological 3D image data are superimposed with respect to the changed tissue position, so that the superimposed representation shows how the tissue (or a surface of the tissue) is positioned (in real time) relative to the registered radiological 3D image data of the skull bone.

[0028] BN3166P-EP-0012: B. Braun New Ventures GmbH. In other words, according to the present disclosure, the medical system displays the current surface, for example, during a tumor resection. To this end, the measured / captured current surface is displayed within the radiological, particularly preoperatively acquired, 3D image data to show the surgeon how much tissue has already been removed. Thus, a difference between the patient's current anatomy or surface and the radiological 3D image data can be visualized in real time. The actual / current (3D) surface of the patient's anatomy is superimposed with the recorded radiological, particularly preoperatively acquired, 3D image data.

[0029] According to a preferred embodiment, the control unit can be configured to display the current surface in a view plane on the display device that differs from the acquisition plane of the acquisition unit. This means that, in particular, processed data from the acquisition unit is projected onto the view of the radiological 3D acquisition data (and unprocessed data from the radiological 3D acquisition data is projected onto the view of the acquisition unit). In other words, the acquisition plane of the acquisition unit does not serve as the initial display for visually representing the current surface. This allows for a particularly intuitive interpretation of the current surface.

[0030] According to a preferred embodiment, the control unit can be configured to visually display the surface in a 2D cross-sectional image (2D, two-dimensional) of the radiological 3D scan data, i.e., as a superimposed representation, on the display device. In particular, the surface (i.e., the surface profile or surface contour (in the selected plane)) can be visualized as a line in the 2D cross-sectional image. The 2D cross-sectional image can, in particular, be a sagittal section. This allows for a particularly intuitive interpretation of the current surface profile.

[0031] According to a preferred embodiment, the control unit can be configured, based on the 3D scan data and the current surface, to determine tissue displacement of a cortex (i.e., a cerebral cortex) and to visually display the tissue displacement in the 2D cross-sectional image of the radiological 3D scan data on the display device. In particular, the control unit can be configured (based on the 3D scan data and the current surface) to determine and visualize the tissue displacement of a surface, for example, an outer or inner surface, of the cortex. Specifically, a direction and / or an amount of the tissue displacement can be visualized. For example, the direction can be visualized by the orientation of an arrow or a line. For example, the amount can be visualized by the length of an arrow or a line.This allows a user to intuitively interpret the display on the screen.

[0032] According to a preferred embodiment, the control unit can be configured to visually display a virtual cortical line of a resected anatomical area of ​​the patient on the display device within the 2D cross-sectional image of the radiological 3D image data, based on the 3D scan data and / or the current surface. The resected anatomical area of ​​the patient is, in particular, a sub-area of ​​the anatomical region. Especially in cases where part of the cortex has been resected, viewing the current surface is insufficient to differentiate between tissue displacement and a resection. The virtual cortical line therefore indicates where the cortex would have been located if no resection had been performed.In particular, the virtual cortical line can be determined by shifting the (original) cortical line of the 3D scan data, especially based on the (already determined) tissue displacement, or by completing the cortical line of the current surface that was interrupted by the resection, especially based on a known course of the (original) cortical line of the 3D scan data. This helps the user to identify which displacements between the 3D scan data and the current surface were caused by the tissue displacement and which were caused by the resection.

[0033] According to a preferred embodiment, the acquisition unit can be a digital, stereoscopic surgical microscope. The surgical microscope (BN3166P-EP-0012: B. Braun New Ventures GmbH) is configured to create a microscopic image of the current surface of the anatomical area. "Digital" means that the surgical microscope is configured to create a digital image and make it available (particularly for playback on the display device). "Stereoscopic" means that the surgical microscope has (spatial) depth perception, in which depth information is generated, in particular, from the disparity between two images taken from spatially displaced positions. Additionally, a stereoscopic camera can be used to reconstruct the current surface.The reconstruction of the current surface can be carried out using standard photogrammetry and / or machine learning approaches.

[0034] Preferably, the operating microscope or stereoscopic camera can be optically calibrated. This ensures that the current surface can be precisely captured.

[0035] According to a preferred embodiment, the medical system can have a robotic arm with a (terminal) end effector. The operating microscope can form the end effector or be attached to the end effector. This ensures movement of the operating microscope in space.

[0036] According to a preferred embodiment, the medical system may include a navigation system. The navigation system is configured to track the operating microscope. That is, the navigation system is configured to determine and provide the position and / or orientation of the operating microscope. In other words, the pose of the operating microscope within the global coordinate system is known. This allows for the consideration of any changes in the microscopic image resulting from movement of the operating microscope.

[0037] According to a preferred embodiment, the navigation system can include a patient tracker. The patient tracker is designed to be rigidly connected to the patient. The patient tracker serves, in particular, to reference the patient's position and / or orientation. The patient tracker can be rigidly connected (directly) to a part of the patient's body on which the procedure is to take place, or (indirectly) to a device rigidly attached to that body part (such as a patient restraint device), so that (as far as possible) no relative movement occurs. For example, during cranial surgery, the patient tracker can be attached directly to the cranium or to a head clamp that secures the patient (to an operating table).

[0038] According to a preferred embodiment, the control unit can be configured to visually display a field of view (FoV) of the operating microscope within the radiological 3D image data on the display device. This has the advantage that the user can more intuitively relate the microscopic image and the radiological 3D image data.

[0039] According to a preferred embodiment, the control unit can be configured to visually display a focal plane of the operating microscope in the radiological 3D image data on the display device. This has the advantage that the user can more intuitively relate the microscopic image and the radiological 3D image data.

[0040] It is important to understand that the term focal plane refers to an area, typically perpendicular to an optical axis of the operating microscope, within which an object located therein can be sharply focused. The focal plane can be defined as a line or a point. Particularly in stereoscopic operating microscopes, the optical axis, typically a center line, results from the individual optical axes. Similarly, the focal plane (as a cross-section) typically results from the individual focal planes. Thus, strictly speaking, the focal plane can be a point or a line, but it is still referred to as a focal plane. In other words, the term focal plane is functional and not purely geometric.

[0041] According to a preferred embodiment, the control unit can be configured to determine, based on the current surface and field of view of the BN3166P-EP-0012 : B. Braun New Ventures GmbH operating microscope, the resected anatomical area of ​​the patient and, based on the radiological 3D recording data and the resected anatomical area, to display a current surface model of the anatomical area of ​​the patient in three dimensions on the display device.

[0042] According to further training, the control unit can be configured to display the current surface model in color on the display device. This has the advantage that the representation of the surface model can be as realistic as possible and thus more easily associated with the real situation for the user.

[0043] According to a preferred embodiment, the control unit can be configured to create the current surface model using direct volume rendering. This means that the current surface model is created without explicitly extracting geometric surfaces from the radiological 3D scan data.

[0044] According to an alternative preferred embodiment, the detection unit can be a sensing unit, in particular a pointer. The sensing unit is configured to scan the current surface using tactile measurement. In this way, the current surface can be detected.

[0045] According to an alternative preferred embodiment, the detection unit can be a laser distance meter. The laser distance meter is configured to determine the current surface area using optical measurement. In this way, the current surface area can be detected.

[0046] In other words, the present disclosure relates to a medical system in which a 3D surface of the patient's anatomy is created using one or more image pairs from a stereoscopic digital microscope. This 3D surface can be positioned in space using patient registration data in relation to (preoperative) radiological image data of the patient. The intersection of this 3D surface with a specific (preoperative) radiological image can be calculated and displayed to the surgeon. Furthermore, the microscope's field of view and its focal plane can also be displayed. The surgeon can then visually determine the global tissue displacement and the resected area. Alternatively or additionally, a reconstructed surface and the microscope's field of view can be used to excise a region from the (preoperative) radiological 3D image.The surface's color texture can also be used to make the 3D rendering more realistic. More precisely, the extracted volume corresponds to a cone whose base matches the reconstructed surface and whose apex corresponds to the microscope's position. The patient's image data can then be rendered using direct volume rendering.

[0047] Brief description of the characters

[0048] Fig. 1 shows a schematic operating principle of a detection unit of a medical system according to the present disclosure,

[0049] Fig. 2 shows a 2D cross-sectional image of radiological 3D imaging data,

[0050] Fig. 3 shows a visualization of a surface detected by the detection unit and a tissue displacement in the medical system according to the present disclosure,

[0051] Fig. 4 shows a visualization in the medical system according to the present disclosure.

[0052] Figures 5 and 6 show a current surface model according to the present disclosure.

[0053] Description of the exemplary implementations

[0054] BN3166P-EP-0012 : B. Braun New Ventures GmbHThe present disclosure relates to a medical system for a surgical, in particular cranial / neurosurgical, intervention on an anatomical area of ​​a patient P, in particular on a patient's head.

[0055] The medical system has a data acquisition unit 2. Data acquisition unit 2 is configured to acquire a real-time surface 0 (i.e., an actual surface) of the patient's anatomical area. This means that the data acquisition unit is configured to create three-dimensional surface data, i.e., with depth information, of the real-time surface 0.

[0056] Fig. 1 shows a schematic diagram of the acquisition unit 2. Preferably, the acquisition unit 2 can be a digital operating microscope. The operating microscope is configured to create a microscopic image of the current surface 0 of the anatomical area. The operating microscope is stereoscopic and has two spatially offset cameras 4 in order to derive depth information of the current surface 0 from the disparity between the images of the two cameras 4. In Fig. 1, a viewing area of ​​each camera 4 is shown, with the operating microscope capturing the current surface 0 three-dimensionally in the overlapping viewing area of ​​the cameras 4.

[0057] Preferably, the detection unit 2 can be tracked by a navigation system. This means that the position and / or orientation of the detection unit 2 is known (even when the detection unit 2 is moving).

[0058] The medical system contains radiological 3D (3D, three-dimensional) image data of the anatomical area of ​​patient P. This radiological 3D image data can preferably be acquired preoperatively (and / or intraoperatively). In particular, the radiological 3D image data can be MRI or CT data.

[0059] Figure 2 shows such radiological 3D image data. The radiological 3D image data is registered, i.e., linked to the patient's actual positional data. In the radiological 3D image data, a skull bone K (BN3166P-EP-0012: B. Braun New Ventures GmbH) and a brain mass B located within the skull bone K are particularly visible. A tumor T is also visible. Figure 2 shows only a 2D cross-sectional image (here a sagittal section) of the 3D image data.

[0060] The position and orientation of the detection unit 2, or the operating microscope, are indicated in Fig. 2 by the field of view F of the operating microscope and the surface 0 detected by the operating microscope. Fig. 2 shows that the skull bone K has already been opened, and thus a portion of the surface of the brain mass B is visible from the outside and can be detected by the detection unit 2. Part of the tumor T has already been resected.

[0061] The medical system includes a display device 6. The display device 6 and the content displayed on the display device 6 are shown in Figures 3 to 6. The display device 6 can, for example, be a monitor / screen. The display device 6 can be configured for two-dimensional and / or three-dimensional display.

[0062] The medical system has a control unit 8. The control unit 8 is configured to visually display the current surface 0 in the radiological 3D image data on the display device 6. That is, the surface data is superimposed on the radiological 3D image data to visualize any difference between the data sets.

[0063] Figure 3 shows that the current surface 0 in the 2D cross-sectional image of the radiological 3D image data is visually displayed on the display device 6, i.e., as a superimposed representation. In particular, the surface 0 in the 2D cross-sectional image can be visualized as a line. That is, the line represents the course of the surface 0 in the plane depicted in the 2D cross-sectional image.

[0064] As can also be seen in Fig. 3, based on the 3D scan data and the real-time surface 0, a tissue displacement TS of a cortex (i.e., a cerebral cortex) can be visually displayed in the 2D cross-sectional image of the radiological 3D scan data on the display device 6. In Fig. 3, the tissue displacement BN3166P-EP-0012 : B. Braun New Ventures GmbHTS is indicated by arrows extending from a specific point of the cortex in the 3D scan data to the displaced specific point of the cortex on the real-time surface 0. In particular, the direction of the tissue displacement TS can be visualized by the orientation of an arrow. The magnitude of the tissue displacement TS can be visualized by the length of the arrow.

[0065] As can also be seen in Fig. 3, based on the 3D scan data and the real-time surface 0, a virtual cortex line L of a resected anatomical area of ​​the patient P can be visually displayed in the 2D cross-sectional image of the radiological 3D scan data on the display device 6. In Fig. 3, the virtual cortex line L is indicated by a dashed line. This virtual cortex line shows where the cortex would have been located if no resection had been performed.

[0066] As can also be seen in Fig. 3, the field of view F of the operating microscope can be visually displayed on the display device 6 in the 2D cross-sectional image of the radiological 3D acquisition data. In Fig. 3, the field of view F is indicated as a cone of view emanating from the acquisition unit 2 or the operating microscope. In order to display the field of view F, the position and / or orientation of the operating microscope must be known, which is ensured by the navigation system.

[0067] Furthermore, a focal plane of the operating microscope can be visually represented in the radiological 3D recording data on the display device, even if this is not explicitly shown.

[0068] As can be seen in Fig. 4, a missing anatomical area of ​​the patient P, which lies within the field of view F of the operating microscope, can be visually represented in the 2D section image Id of the radiological 3D image data on the display device 6. For example, the missing anatomical area can be indicated by hatching. The missing anatomical area can, in particular,

[0069] BN3166P-EP-0012 : B. Braun New Ventures GmbH from the opening of the skull bone K, the tissue displacement TS as well as the resection of tissue.

[0070] According to a further preferred embodiment, the control unit 8 can be configured to determine, based on the current surface 0 and the field of view F of the operating microscope, the resected anatomical area of ​​the patient P and, based on the radiological 3D image data and the resected anatomical area, to display a current surface model of the anatomical area of ​​the patient P three-dimensionally on the display device 6. Such a surface model is shown in particular in Figures 5 and 6.

[0071] Preferably, the current surface model can be displayed in color on the display device 6. The current surface model can be created using direct volume rendering.

[0072] BN3166P-EP-0012 : B. Braun New Ventures GmbH

Claims

Claims 1. Medical system for a surgical procedure in an anatomical area of ​​a patient, with registered, radiological 3D recording data of the anatomical area, a capture unit (2) which is set up to capture a real-time surface (0) of the anatomical area, a display device (6), and a control unit (8) which is set up to visually display the current surface (0) in the radiological 3D recording data on the display device (6).

2. Medical system according to claim 1, characterized in that the control unit (8) is configured to display the current surface (0) in a view plane on the display device (6) which is different from a recording plane of the detection unit (2).

3. Medical system according to claim 1 or 2, characterized in that the control unit (8) is configured to visually display the current surface (0) in a 2D cross-sectional image of the radiological 3D recording data on the display device (6).

4. Medical system according to claim 3, characterized in that the 2D cross-sectional image is a sagittal section.

5. Medical system according to claim 3 or 4, characterized in that the current surface (0) is visualized as a line.

6. Medical system according to one of claims 1 to 5, characterized in that the control unit (8) is configured to determine a tissue displacement (TS) of a cortex based on the radiological 3D recording data and the current surface (0) and to measure the tissue displacement BN3166P-EP-0012 : B. Braun New Ventures GmbH(TS) to visually display the radiological 3D recording data on the display device (6) in the 2D section.

7. Medical system according to one of claims 1 to 6, characterized in that the control unit (8) is configured to visually display a virtual cortex line (L) of a resected anatomical area of ​​the patient (P) in the 2D cross-sectional image of the radiological 3D recording data on the display device (6), based on the radiological 3D recording data and the current surface (0).

8. Medical system according to one of claims 1 to 7, characterized in that the acquisition unit (2) is a digital stereoscopic operating microscope which is configured to create a microscopic image of the current surface (0) of the anatomical area.

9. Medical system according to claim 8, characterized in that the medical system has a navigation system configured to track the operating microscope, and the control unit (8) is configured to visually display a field of view (F) of the operating microscope in the radiological 3D recording data on the display device (6).

10. Medical system according to claim 8 or 9, characterized in that the control unit (8) is configured to visually display a focal plane of the operating microscope in the radiological 3D recording data on the display device (6).

11. Medical system according to one of claims 8 to 10, characterized in that the control unit (8) is configured to determine a resected anatomical area of ​​the patient (P) based on the current surface (0) and a field of view (F) of the operating microscope and to display a current surface model of the anatomical area of ​​the patient (P) three-dimensionally visualized on the display device (6) based on the radiological 3D recording data and the resected anatomical area. BN3166P-EP-0012 : B. Braun New Ventures GmbH12. Medical system according to claim 11, characterized in that the control unit (8) is configured to create the current surface model by means of direct volume representation.

13. Medical system according to one of claims 1 to 7, characterized in that the detection unit (2) is a sensing unit configured to scan the current surface with a tactile measurement and / or that the detection unit (2) is a laser distance meter configured to determine the current surface with an optical measurement. BN3166P-EP-0012 : B. Braun New Ventures GmbH

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