Image-guided intervention method and system

Abstract

A method and system for guiding kidney stone removal. The method comprises the steps of three stages for promoting or guiding the intervention: renal access, calculus removal and calculus-free examination. This is facilitated by a method comprising three phases: an intra-operative image guidance phase for obtaining a CT-based image of the kidney region; a kidney entry guiding stage in which the CT-based image is used for generating an intervention guiding image to guide kidney entry; and a lithiasis-free examination phase in which additional intra-operative CT images are acquired to examine a lithiasis-free state of the patient.

Description

Technical Field

[0001] The present invention relates to the field of image-guided interventions, in particular in the field of urology, such as in the field of renal interventions for eg kidney stone removal. Background Art

[0002] In the field of image-guided interventions, challenges remain in balancing the efficiency of the interventional workflow with patient safety and surgical success.

[0003] One area of ​​particular interest that inspired the creation of the present invention is image-guided interventions in the field of urology, and more specifically image guidance during percutaneous nephrolithotomy (PCNL).

[0004] In urolithiasis, or kidney stone disease, stones develop in the urine collecting system, which can cause blockage of the ureters, resulting in severe pain in the lower back or abdomen. In the United States, the lifetime prevalence of urolithiasis is about 12% for men and about 7% for women, and it is rising, probably due to dietary factors.

[0005] Urolithiasis can be treated by disrupting and / or removing the stones using extracorporeal shock wave lithotripsy (ESWL), ureteroscopy (URS), or PCNL. Treatment is chosen based on the location, size, and hardness of the stone, with PCNL being the option for larger (>2 cm in diameter) stones.

[0006] The PCNL procedure is usually performed by a team of medical specialists including a urologist, sterile nurses, non-sterile nurses, usual interventional radiologists, radiology technicians, anesthesiologists, anesthesia assistants, and possibly others.

[0007] While there are many workflow variations in performing PCNL procedures, a typical procedure involves collaboration between an interventional radiologist and a urologist. While the patient is under local anesthesia, the interventional radiologist begins by achieving renal access using fluoroscopic and / or ultrasound image guidance. This includes contrast administration through an inserted needle to improve fluoroscopic imaging, if necessary.

[0008] Once renal access is confirmed by urine flow through the needle, a guidewire is inserted and the patient is transported from the interventional radiology room to the operating room where the patient is given general anesthesia and placed in a prone or supine position. The urologist will then use the guidewire to dilate the access port to a 1 cm diameter, insert the endoscope into the urine collecting system of the kidney, and then perform lithotripsy. Larger stone fragments can be collected by the access sheath, while smaller stone fragments are automatically flushed out.

[0009] Fluoroscopy and nephroscopic imaging will be used to verify that all stone fragments have been removed. Ultimately, renal drainage will need to be secured by placement of a JJ catheter or nephrostomy tube under fluoroscopic guidance, and the access sheath can be removed, allowing closure of the incision with sutures.

[0010] After surgery, a diagnostic CT scan, usually performed one week after surgery, is needed to confirm the patient's stone-free status.

[0011] The clinical outcome of the PCNL procedure is highly dependent on the renal access strategy. For successful stone removal, it is important to achieve access through the correct renal calyx, allowing the urologist to easily reach the stone and visualize residual fragments, if present.

[0012] Removing kidney stones using PCNL is a challenging clinical procedure, and its success is highly dependent on renal access. It is necessary to determine the best entry strategy to reach the stone, and to avoid complications, it is necessary to enter the renal calyx at the correct angle. Urologists usually need interventional radiologist support to obtain renal access. In current clinical practice, obtaining renal access requires complex 3D navigation skills based on 2D projection, real-time fluoroscopy, or a combination of fluoroscopy and ultrasound imaging. Errors in this process may lead to unusable access, or no access at all. Renal access obtained through the wrong renal calyx is associated with a reduced stone-free rate. Inadequate renal access is associated with complications, such as renal artery branch damage causing (severe) bleeding, colon perforation, or lung damage causing pneumothorax. In this regard, for example, reference paper: JJTomaszweski et al. Renal access by urologist or radiologist during percutaneous nephrolithotomy, Journal of Endourology 24: 1733-1737, 2010.

[0013] After achieving renal access, the urologist will begin to disrupt the kidney stone, which may cause residual stone fragments to become stuck in the calyx or proximal ureter of the kidney. To identify these during surgery, the urologist will use interoperative (intraoperative) fluoroscopy and endoscopic imaging. As mentioned above, the process is also verified by postoperative CT imaging at some time after surgery (e.g., 1 week) to confirm the patient's stone-free status. In fact, postoperative examinations reveal residual stone fragments in up to 25% of cases. Up to 73% of these patients need to undergo additional treatment, such as ESWL, URS, or PCNL. In this regard, reference is made to the paper:

[0014] D. Olvera-Posada et al. Natural History of Residual Fragments AfterPercutaneous Nephrolithotomy: Evaluation of Factors Related to Clinical Events and Intervention, Urology 97:46-50, 2016; and

[0015] JD Raman et al. Natural history of residual fragments following percutaneous nephrostolithotomy, Journal of Urology, 181(3):1163-1168, 2009.

[0016] The complexity of achieving renal access and confirming stone-free status not only negatively impacts patient outcomes but also makes urologists dependent on other medical specialists, such as interventional and diagnostic radiologists. This is associated with a variety of clinical workflow difficulties and a substantial impact on the cost of these procedures.

[0017] Improvements in this area are generally beneficial. Summary of the invention

[0018] The invention is defined by the claims. The dependent claims define advantageous embodiments.

[0019] According to an example in accordance with one aspect of the present invention, a processing unit is provided, the processing unit comprising one or more processors configured to perform a computer-implemented method for interventional support during a renal interventional procedure for kidney stone removal.

[0020] The method includes at least one intraoperative image acquisition phase, which includes receiving computed tomography (CT) image data of an anatomical region including at least a portion of a kidney of a subject.

[0021] The method also includes an interventional image guidance phase, which includes: receiving real-time tool tracking data indicating the positioning of an interventional tool used in the interventional procedure; generating a real-time guidance image based on the CT image data and also based on the tracking data, the guidance image visualizing the position of the interventional tool relative to the anatomical region imaged in the received CT image data; and communicating with a user interface device to display the generated guidance image in real time on a display unit of the user interface device.

[0022] The method also includes a quality assurance check phase after the interventional image guidance phase, which includes: communicating with the CT imaging device to acquire additional CT image data of the anatomical region using the CT imaging device for visualization of any residual stones or stone fragments, for example for determining whether complete stone removal has been achieved. The additional CT image data is preferably cone beam CT image data. The CT imaging device for acquiring the additional CT image data may be a C-arm CT device or a flat panel CT device. It may be a cone beam CT device. The additional CT image data may be cone beam CT image data.

[0023] The method also includes communicating with a user interface device to display additional CT image data on a display unit of the user interface.

[0024] The proposed method advantageously facilitates performing all phases of the stone removal procedure, i.e., renal access, stone removal, and stone-free status, in one operation and by one primary surgeon. This is facilitated by CT image-based interventional guidance that guides the surgeon in achieving renal access, combined with the use of intraoperative CT images to check stone-free status prior to renal access removal.

[0025] The inventors' motivating goal in creating the present invention was to reduce the complexity of achieving renal access, particularly in PCNL procedures, and to improve the stone-free success rate of the procedure. By performing a stone-free check concurrently with the procedure, before renal access has been closed, this improves the likelihood of a stone-free status, as any remaining stone fragments can be immediately addressed by additional interventional steps.

[0026] In some embodiments, the method further comprises obtaining an indication of a result of the quality assurance check phase, and in response to the result of the quality assurance check indicating incomplete stone removal, controlling the performance of a further iteration of the interventional image-guided phase and a subsequent further performance of the quality assurance check phase. Further iterations of the interventional image-guided phase mean, for example, controlling the generation of further guidance images.

[0027] The results of the quality assurance check phase can be obtained manually from a user, or automatically based on image analysis. For example, in some embodiments, an indication of the results of the quality assurance check is obtained based on user input received at a user interface device. In some embodiments, the indication of the results of the quality assurance check is obtained based on applying a stone removal check algorithm to the obtained additional CT image data to automatically determine complete or incomplete stone removal.

[0028] In some embodiments, the quality assurance check phase includes obtaining position information associated with any residual stones present in the kidney based on user input or based on application of an automatic segmentation algorithm. In some embodiments, during the aforementioned additional iterations of the image-guided phase, the guided image may include a visualization of position information associated with the residual stones.

[0029] In some embodiments, the quality assurance check phase is triggered in response to receiving a predefined user input command from a user interface.

[0030] In some embodiments, at least one intraoperative image acquisition phase includes communicating with a CT imaging device to acquire CT image data of the anatomical region using the CT imaging device. Preferably, cone beam CT image data is acquired. The CT imaging device may be a cone beam CT imaging device. It may be a C-arm CT imaging device or a flat panel CT imaging device.

[0031] In some embodiments, the guidance image includes a visual overlay indicating the location of the interventional tool, which is fused with an anatomical image representing the anatomical region, the anatomical image being based on CT image data acquired during the intraoperative image acquisition phase. The anatomical image can be a separate CT image, or can be a composite fused image formed, for example, from a CT image and a preoperative image.

[0032] In some embodiments, the guidance image includes one or more visual overlays that provide navigation guidance for navigating the insertion of the interventional tool along a predefined tool entry path from an incision point on the skin to a predefined entry point in the kidney.

[0033] In some embodiments, the one or more visual overlays described above that provide navigation guidance provide a visual indication of the target location of the incision point (eg, relative to the patient's anatomy) and an indication of the target insertion angle of the tool.

[0034] In some advantageous embodiments, the method may include an intervention planning phase. The intervention planning phase may include obtaining an indication of a planned entry point for the kidney. The intervention planning phase may also include obtaining an indication of a planned entry path through the body to the entry point for the kidney. In some embodiments, one or more visual overlays for providing navigation guidance may be generated based on the obtained indications.

[0035] In some embodiments, the indication of a planned entry point of the kidney may include an indication of a planned calyx of the kidney through which kidney access is to be achieved.

[0036] In some embodiments, the method may include obtaining an indication of a planned calyx for entry into the kidney, manually or automatically segmenting the planned calyx within the received CT image data, and based thereon identifying a location of a planned entry point of the kidney relative to the CT image data.

[0037] In some embodiments, the aforementioned indication of a planned calyce of the kidney through which kidney access is to be achieved can be obtained based on user input received at a user interface. In some embodiments, the aforementioned planned entry path through the body and the planned incision point are automatically determined, for example based on the indication of a planned calyce of the kidney through which kidney access is to be achieved.

[0038] With respect to the guidance image, in some embodiments, it can be generated by fusing CT image data received during at least one intraoperative image acquisition phase with preoperative image data of the same anatomical region of the same patient retrieved from a data repository to generate synthetic image data. The benefit of doing so is that the preoperative image data can be obtained at a higher resolution than possible or actual resolution obtained intraoperatively (i.e., simultaneously with the interventional procedure), and thus can enhance detail. Moreover, the preoperative images can be obtained in the same or different modalities, allowing potential additional detail to be added through fusion. Furthermore, even if the same modality is used, the preoperative images can be further enhanced in some cases, for example, by contrast enhancement.

[0039] For example, in some embodiments, the CT image data acquired during at least one intraoperative image acquisition phase is non-contrast enhanced cone-beam CT image data, and wherein the method includes generating a composite image by fusing the acquired non-contrast enhanced CT image data with preoperative contrast enhanced cone-beam CT image data of the same anatomical region of the same patient retrieved from a data repository.

[0040] However, in other embodiments, the CT image data acquired during at least one intraoperative image acquisition phase may also be contrast-enhanced cone-beam CT image data.

[0041] In some embodiments, not only intraoperative CT images but also other imaging modalities are used to assist intervention. For example, the image-guided phase may also include receiving supplementary image data, which includes one or more of the following: real-time endoscopic imaging data from an endoscopic imaging system; real-time ultrasound imaging data from an ultrasound imaging system; real-time fluoroscopic imaging data from a cone-beam CT imaging device. These modalities supplement and enhance CT image data because they enable real-time imaging, while real-time CT imaging (with sufficient temporal resolution to be used for interventional guidance) is not a practical possibility at all (with the prior art). The resulting radiation dose would also be prohibitive.

[0042] In some embodiments, the image guidance phase includes communicating with the user interface to simultaneously display the guidance imagery and the supplemental image data, thereby creating a multimodal display output on the display unit.

[0043] In some embodiments, the processing unit further comprises a communication interface for wired or wireless connection to one or more of: a cone beam CT imaging apparatus; a user interface device; a tool tracking system; and an ultrasound imaging system and / or an endoscopic imaging system.

[0044] The present invention may be embodied in the form of a mobile base station that is movable within an operating room and includes a processing unit according to any embodiment described herein or according to any claim. Thus, this provides a mobile cart that can act as a hub for connecting all hardware and houses a processing unit that facilitates the computer-implemented method. For example, the mobile unit includes a base station mounted on rollers or wheels. This has the advantage of enabling the system to be wheeled between different operating rooms, thereby avoiding the need to completely re-equip the operating room with permanently installed instruments to perform the operation. Existing operating rooms can be immediately used to perform the method. The mobile base station may in fact also include the above-mentioned user interface with a display unit to avoid the need to manually connect and set up the video output from the processing unit to an existing display device in the operating room.

[0045] Another aspect of the present invention is a system comprising: a processing unit according to any embodiment or example described in the present disclosure, or a mobile base station comprising such a processing unit; an intraoperative cone beam CT imaging device; and a tracking system for tracking the positioning of an interventional tool in a patient. The intraoperative cone beam CT imaging device can be moved into and out of an imaging position relative to the patient without moving the patient. For example, it can have a C-arm configuration.

[0046] Another aspect of the invention is a computer-implemented method for interventional support during a renal interventional procedure for kidney stone removal. The method includes at least one intraoperative image acquisition phase, comprising: receiving computed tomography (CT) image data of an anatomical region including at least a portion of a kidney of a subject.

[0047] The method also includes an interventional image guidance phase, which includes: receiving real-time tool tracking data indicating the positioning of an interventional tool used in the interventional procedure; generating a real-time guidance image based on the CT image data and also based on the tracking data, the guidance image visualizing the position of the interventional tool relative to the anatomical region imaged in the received CT image data; and communicating with a user interface device to display the generated guidance image in real time on a display unit of the user interface device.

[0048] In some embodiments, receiving real-time tool tracking can be based on image-guided methods, and can include postoperative or preoperative images, rather than just real-time methods. In other words, the present application can be extended to different types of imaging modalities (e.g., MR, US, PET, SPECT), and is not only based on CT or cone beam CT.

[0049] The method also includes a quality assurance check phase after the interventional image guidance phase, which includes: communicating with the CT imaging device to acquire additional CT image data of the anatomical region using the CT imaging device for visualizing any residual stones or stone fragments, for example, thereby determining whether complete stone removal has been achieved. The additional CT image data is preferably cone beam CT image data.

[0050] The method also includes communicating with a user interface device to display additional CT image data on a display unit of the user interface.

[0051] Another aspect of the invention is a computer program product comprising computer program code configured to, when run on a processor, cause the processor to perform a method according to any embodiment described herein or according to any claim.

[0052] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] For a better understanding of the invention, and in order to more clearly show how the same may be put into practice, reference will now be made, by way of example only, to the accompanying drawings, in which:

[0054] Figure 1 The steps of an example method according to one or more embodiments of the present invention are outlined;

[0055] Figure 2 Outlines components of an example processing device according to one or more embodiments of the present invention; and

[0056] Figure 3 At least a subset of components of an example system are schematically illustrated in operation in accordance with one or more embodiments. DETAILED DESCRIPTION

[0057] The present invention will be described with reference to the accompanying drawings.

[0058] It should be understood that the detailed description and specific examples, although indicating exemplary embodiments of the device, system and method, are intended only for illustrative purposes and are not intended to limit the scope of the invention. These and other features, aspects and advantages of the device, system and method of the present invention will be better understood based on the following description, claims and drawings. It should be understood that the drawings are merely schematic and not drawn to scale. It should also be understood that the same reference numerals are used in all drawings to indicate the same or similar parts.

[0059] The present invention provides a method and system for guiding kidney stone removal in a single operation, wherein, for example, all steps can be performed by one primary surgeon, and also provides a method for improving the resulting stone-free rate of the operation. In particular, the method includes steps for facilitating or guiding three stages of intervention: kidney access, stone removal, and stone-free inspection. This is facilitated by a method including three stages: an intraoperative image guidance stage, which is used to obtain CT-based images of the kidney region; a kidney access guidance stage, wherein the above-mentioned CT-based images are used to generate intervention guidance images to guide kidney access along the access path; and a stone-free inspection stage, wherein additional intraoperative CT images are acquired to check the patient's stone-free status. Cone beam CT (CBCT) imaging is preferably used for the last stage because it is associated with a lower radiation dose to the patient for the same spatial resolution of the image. It is also preferred because it can be more easily obtained in the operating room compared to traditional cone beam CT imaging (e.g., spiral or axial fan beam imaging). It is also preferred because it allows acquisition using a smaller and simpler device structure. For example, a C-arm or flat-panel CT device can be used for cone beam imaging, allowing easier access to the patient compared to systems with a circular rotating gantry.

[0060] The inventors' motivating goal in creating the present invention was to reduce the complexity of achieving renal access, particularly in PCNL procedures, and to improve the stone-free success rate of the procedure. By performing a stone-free check concurrently with the procedure, before renal access has been closed, this improves the likelihood of a stone-free status, as any remaining stone fragments can be immediately addressed by additional interventional steps.

[0061] The above objects are achieved by a system and method for needle guidance utilizing tool tracking and CBCT imaging.

[0062] To explain further, typically a PCNL procedure involves two separately performed phases: a renal access phase and a stone removal phase. These are typically performed by separate clinicians. In the United States, in 90% of cases, an interventional radiologist achieves renal access for a PCNL procedure. While the patient is under local anesthesia, the interventional radiologist begins by achieving renal access using fluoroscopic or ultrasound image guidance. Once access is achieved a guidewire is inserted. At this point, the patient will be transported from the interventional radiology room to the operating room where the patient will receive general anesthesia. The stone removal process then begins.

[0063] This division in the interventional workflow creates additional overhead and surgical inefficiencies. An object of an embodiment of the present invention is to simplify the workflow, which results in surgical simplification, reduced communication errors regarding access strategies, reduced costs for hospitals, and improved patient satisfaction. A system and method for treatment guidance are proposed. In particular, a system is proposed that is capable of performing at least two of the following operations: a renal access guidance operation, which is used to guide needle navigation based on interoperative (intraoperative) CT images (preferably cone beam CT images); and a stone-free inspection operation, which enables confirmation of a stone-free state based on interoperative (intraoperative) CT images (preferably cone beam CT images).

[0064] As will be discussed further, it is contemplated that the treatment guidance and assessment methods according to at least one set of embodiments may be embodied or implemented by a hardware system comprising: a cone beam computed tomography (CBCT) image acquisition device; an interventional tool tracking unit; a computing unit (for hosting dedicated application software configured to perform the steps of the computer-implemented method); and a display.

[0065] Figure 1 The steps of an example computer-implemented method 10 according to one or more embodiments are summarized in block diagram form. The steps will be summarized before further explanation in the form of an example embodiment. The method 10 is used, for example, to provide interventional support during a renal interventional procedure for kidney stone removal.

[0066] The method comprises at least one intraoperative image acquisition phase 12, at least one interventional image guidance phase 14 and at least one quality assurance check phase 16 following the interventional image guidance phase.

[0067] The image acquisition phase comprises receiving 10 computed tomography (CT) image data of an anatomical region comprising at least a portion of a kidney of a subject. This may be cone beam CT image data or another type of CT image data.

[0068] The interventional image guidance stage 14 includes receiving 20 real-time tool tracking data indicating the positioning of an interventional tool used in the interventional procedure. The interventional image guidance stage 14 also includes generating 22 a real-time guidance image based on the CT image data and also based on the tracking data, the guidance image visualizing the position of the interventional tool relative to the anatomical region imaged in the CT image data. The interventional image guidance stage 14 also includes communicating with a user interface device to display 24 the generated guidance image in real time on a display unit of the user interface device.

[0069] After the interventional image-guided phase, the quality assurance check phase 16 includes communicating with the CT imaging device to acquire 26 additional CT image data of the anatomical region using the CT imaging device. The additional CT image data is used to visualize any residual stones or stone fragments. This allows a determination to be made as to whether complete stone removal has been achieved. In some examples, from the perspective of a computer-implemented method, this may include simply displaying the additional CT image data to enable a clinician to determine whether complete stone removal has been achieved. Optionally, in some embodiments, the method includes receiving user input indicating a clinician-assessed examination result: stone-free or stone-present. In some embodiments, the stone-free status may be automatically assessed by an image analysis algorithm. The quality assurance check phase preferably also includes communicating with a user interface device to display 28 additional CT image data on a display unit of the user interface.

[0070] In some embodiments, the additional CT image data acquired during the quality assurance inspection phase is cone beam CT image data.

[0071] As mentioned above, the method can also be embodied in the form of hardware, for example in the form of a processing unit configured to perform the method according to any example or embodiment described herein or according to any claim of the present application.

[0072] To further aid understanding, Figure 2 A schematic representation of an example processing unit 32 configured to perform a method according to one or more embodiments of the present invention is presented. The processing unit is shown in the context of a system 30 that includes the processing unit. The processing unit alone represents one aspect of the present invention. The system 30 is another aspect of the present invention. The system provided need not include all of the hardware components shown; it may include only a subset of them.

[0073] The processing unit comprises one or more processors 36 configured to perform the method according to the above summary or according to any embodiment described herein or any claim of the present application. In the illustrated example, the processing unit also comprises a communication interface 34 or input / output section.

[0074] exist Figure 2 In the illustrated example, the system 30 also includes a user interface 52, which includes a display unit. The system also includes an intraoperative CT imaging device 56 (e.g., a cone beam CT imaging device). The system also includes a tracking system or device 56 for tracking the positioning of the interventional tool in the patient's body. Of course, it is not necessary for the system to include all of these hardware components. A system according to the present invention can be provided that does not include these components or only includes one or more of these components.

[0075] The communication interface 34 is adapted to receive the previously mentioned CT image data, for transmitting the previously mentioned guide image outwardly to the user interface, for receiving the previously mentioned additional CT image data, and for transmitting the additional CT image data outwardly to the user interface. The CT image data in the intraoperative imaging phase may be received from the CT imaging device. It may alternatively be received from a data repository or from an intermediate communication device (e.g., a hub server or network node).

[0076] For example, the communication interface 34 may be adapted for wired or wireless connection to one or more external units. These may include any one or more of the following: a CT imaging device 56 (eg, a cone beam CT imaging device), a user interface device 52 and a tool tracking system or device 54.

[0077] The system 30 may also include a memory 38 for storing computer program code (i.e., computer executable code) configured to cause one or more processors 36 of the processing unit 32 to perform the method as outlined above, or a method according to any embodiment described in the present disclosure, or a method according to any claim.

[0078] As will be explained in more detail later, the system may also include one or more supplementary image data acquisition units. These may include, for example, one or more of the following: an ultrasound imaging system and an endoscopic imaging system. The communication module may also be adapted to communicate with one or more of these supplementary image data acquisition units.

[0079] As mentioned above, the present invention can also be embodied in software form. Therefore, another aspect of the present invention is a computer program product comprising a code module, which is configured to cause the processor to perform a method according to any example or embodiment of the present invention described herein or according to any claim of this patent application when it is run on a processor.

[0080] Regarding the processing unit 32, there are different options regarding its implementation. In some embodiments, the processing unit may be a processing unit of a CT imaging device. In some embodiments, it may be the same processing unit that controls the image acquisition function of the CT imaging device. In some embodiments, it may be a dedicated processing unit included by the CT imaging device. In some embodiments, the processing unit may be a dedicated processing unit provided separately to the CT imaging device, for example provided in a dedicated housing. For example, in some embodiments, the processing unit may be included as part of a mobile unit, i.e., a mobile cart structure. As another example, in some embodiments, the processing unit may be a cloud-based processing unit.

[0081] Reference has been made above to intraoperative imaging. Intraoperative in the context of the present disclosure means image acquisition performed simultaneously with the interventional procedure. This is sometimes also referred to as interoperative imaging. In other words, this is imaging performed while the patient is in the operating room or while the procedure is ongoing. For example, performed on the same day as the interventional procedure.

[0082] The scope of the method need not necessarily include the process of actually acquiring intraoperative image data. For example, image data may be acquired prior to the start of the claimed method or in parallel with the claimed method, and wherein the claimed method includes simply receiving the already acquired image data. Of course, optionally, the claimed method can include the step of acquiring image data.

[0083] It is contemplated that the intraoperative image data may be image data acquired in the operating room itself or in a nearby imaging room of the same institution.

[0084] It is contemplated that image data may be acquired using a mobile or movable CT imaging device, particularly one that is operable to move into and out of a position to image the patient while the patient remains stationary on an operating table. A movable system also allows the CT device to be moved between different operating rooms. However, an alternative is to provide a fixed CT imaging system, such as mounted to the floor or ceiling of an operating room.

[0085] Reference has been made above to a preference for (particularly intraoperative) CT image data as cone beam image data. At least one reason for this preference is that cone beam CT image data can acquire image data at a given resolution and across a given volume at a lower radiation dose to the patient than an equivalent non-cone beam system. Another advantage is that cone beam images can be acquired at a greater rate than more conventional CT imaging techniques due to the wider spatial spread of the x-ray beam. Thus, these advances in cone beam CT imaging have made intraoperative CT imaging more practical and safer than was previously the case, opening the possibility of using it to perform stone-free examinations such as the present invention while renal access remains open.

[0086] Reference is made above to interventional tools. The interventional tools may, for example, include a percutaneous nephrolithotomy (PCN) needle. The interventional tools may include a dilator for passing through an inserted guidewire (inserted after the insertion needle). The interventional tools may include a sheath. The interventional tools may include a nephroscope. In some cases, the interventional tools may include an ultrasound probe (e.g., for breaking up large stones). The interventional tools may include an obturator for placing a cannula. In some examples, the cannula itself may be tracked.

[0087] In some examples, a patient tracker may be placed on the patient for use, for example, in registering tracking with CBCT imaging.

[0088] There are various options regarding tool tracking data and tool tracking systems. Surgical tracking systems are known in the art. One example includes electromagnetic tracking. Another example includes optical tracking.

[0089] For example, a tracking system that analyzes the oscillations of an electromagnetic (EM) coil may be utilized. Specifically, one option is to incorporate at least one EM sensing element on or in an interventional tool comprising a coil, and wherein a reference electromagnetic field is generated by a transmitting coil device positioned close to the patient. The reference field induces a current in the coil of the interventional tool, which has electrical characteristics (particularly voltage amplitude) that depend on the distance of the tool from the transmitting coil device. This may require a data connection from the tracking device to a sensor element in the tool. In other examples, to avoid this, the tool can include a transmitting coil, and wherein a receiving coil or an array of receiving coils is arranged close to the patient, which is suitable for detecting electromagnetic signals emitted from the tool. Based on the signal strength, the distance from the tool transmitter to the associated receiver coil can be determined. More than one receiver or transmitting coil can be included on the tool to allow triangulation of the tool position and / or tool orientation. Using these general concepts, the position of the tool can be tracked in real time.

[0090] In another example, the tracking system can be configured to track the position of an object based on optical visual information. For example, a camera can be used to track the position of a tool based on visual tracking markers applied to the tool at one or more locations.

[0091] In all cases, the output of the tool tracking system 54 may be a data signal indicative of the coordinate position of the tool relative to a coordinate system of the tool tracking system.

[0092] In order to generate a guidance image, this may, for example, typically include a visual overlay indicating the position of the interventional tool, which is applied to or fused with an anatomical image representing an anatomical region, the anatomical image being based on CT image data acquired during the intraoperative image acquisition phase. In other words, it may typically be a synthetic image that represents the real-time position of the tool relative to an image acquired earlier. To this end, the method may include a step of spatially registering the relevant anatomical image with the coordinate system of the tool tracking system. In some examples, this can be accomplished in part using input from a user. For example, as part of a calibration operation, a user may touch the tool at multiple reference points on the patient's body to calibrate the coordinate positions output from the tracking system for those points with corresponding coordinate positions on the patient's anatomical structure as outlined in the image. For example, the points may be standard anatomical locations that are easily identified in the relevant anatomical image, and the user may point to these points using a user input device or may automatically detect these points using image segmentation, for example.

[0093] Optionally, in some embodiments, the interventional image-guided phase may also include receiving image data from one or more supplementary image data sources. For example, these may be real-time imaging sources, so that in addition to the synthetic images described above, real-time images can be used. As an example, these may include one or more of the following: real-time endoscopic imaging data from an endoscopic imaging system; real-time ultrasound imaging data from an ultrasound imaging system; real-time fluoroscopic imaging data. The fluoroscopic imaging data may be provided by a dedicated fluoroscopic imaging device, or the previously mentioned cone-beam CT imaging device may be suitable for both CT imaging and fluoroscopic imaging, and such dual-mode CT systems are known in the art. Typically, these may have a C-arm configuration, such as a gantry, allowing them to be moved in and out of position around a static patient. In the case of a dedicated fluoroscopic imaging device, this may be a digital x-ray device.

[0094] With regard to the optional endoscopic imaging system, it may generally include: one or more endoscopes; an imaging module carried by the one or more endoscopes; a light source carried by the one or more endoscopes; and a video processor for receiving video images output from the imaging module. Various endoscopes may be used in the context of renal interventional procedures. These may include, for example, any one or more of the following: a cystoscope, a nephroscope, a ureteroscope, and a ureterorenoscope.

[0095] As part of at least one embodiment of the present invention, an endoscopic imaging system may be provided in part or in whole. For example, where the processing unit is housed by a mobile base station, the endoscopic imaging system may be docked to or housed in the same base station for ease of transportation. Alternatively, the previously mentioned processing unit 32 may simply be adapted to be coupled to an external endoscopic imaging system.

[0096] If supplemental image data is available, the image guidance stage may include communicating with the user interface to simultaneously display the guidance image and the supplemental image data. For example, the two may be displayed side by side on a display unit of the user interface.

[0097] Regarding the quality assurance check stage, as previously described, confirmation of the stone-free state (i.e., the result of the quality assurance check) can include one or both of the following: an image review by the clinician performing the operation, or an automated check based on applying a stone removal check algorithm to the additional CT image data obtained to automatically determine complete or incomplete stone removal. Regarding the stone removal check algorithm, it utilizes a computer-aided detection method. In some examples, this can be applied in addition to the clinician checking the stone-free state to additionally prevent the loss of residual stone fragments. In practice, this can be implemented in the following manner: an output is generated from the processing unit for causing the display unit of the user interface to display additional CT image data (enabling the clinician to review the image(s)), and the stone removal check algorithm is additionally applied, and the results are displayed to the clinician on the display unit of the user interface.

[0098] In some embodiments, the method may further include receiving user input indicating the clinician's assessment of stone-free status.A negative result may trigger an additional iteration of the image-guided phase.

[0099] About the user interface, it may include a display unit for displaying a guide image and any other information for presenting to the clinician. The user interface may also include at least one user input device. It may include, for example, one or more foot pedal controls. The user interface may include a touch screen display, allowing user input by touch. As a more general concept, the user interface may include one or more sterile control elements used by clinicians in the sterile environment of the operating room, which are used to provide user input to the user interface device. The system may also include a remote control device, which is used to remotely control certain components of the system, such as table height or imaging instruments.

[0100] According to a preferred set of one or more embodiments, the system 30 comprises a mobile base station that houses or carries a processing unit 32 according to any embodiment described herein and which is movable, for example, within or between operating rooms. A preferred solution comprises, for example, a single mobile cart that interoperates with all other hardware components of the system (including any optional hardware components mentioned previously or hereinafter in this disclosure).

[0101] Using the systems and methods outlined above, clinical procedures can be performed entirely by a single clinician, such as a urologist (after anesthetizing the patient). For example, in practice, a patient can be placed in a lithotomy position to insert a ureteral catheter, such as with the aid of a cystoscope, under fluoroscopic guidance.

[0102] The patient can then be placed in a prone position so that the urologist can use cone beam CT (CBCT) image data with graphic enhancement to achieve renal access to facilitate needle navigation. Fluoroscopic ultrasound or other real-time imaging modalities can be used in addition for assistance. For CBCT and fluoroscopic imaging, contrast agents can be administered through a ureteral catheter. Once renal access is confirmed by urine flowing through the needle, the urologist will place and dilate the access port to a 2 cm diameter using a guide wire, and then perform lithotripsy. Larger stone fragments can be collected by the access sheath, while smaller stone fragments are automatically flushed out.

[0103] After stone removal, additional CBCT images were acquired to confirm that all stone fragments were removed.

[0104] Finally, renal drainage is performed by placing a JJ catheter or nephrostomy tube under fluoroscopic guidance, and the access sheath can be removed, allowing the incision to be closed with sutures.

[0105] An example implementation of a method according to a set of specific embodiments will now be described by way of illustration of the concepts outlined above. It should be understood that not all features of this set of specific embodiments are essential to the inventive concept and are described to aid understanding and provide examples to illustrate the inventive concept.

[0106] Figure 3 A patient 64 during an example invention is schematically depicted. A cone beam CT imaging device 56 having a C-arm configuration is schematically illustrated. An example receiver coil unit 54 of an interventional tool tracking system is also schematically illustrated. An example mobile base station 62 is also schematically illustrated, which accommodates a processing unit 32 suitable for performing a method according to any example or embodiment described in the present disclosure. It may be otherwise referred to as a mobile cart. In this example, the base station 62 is mounted on casters to allow it to be wheeled from one place to another. A user interface 52 including a display unit is also mounted to the base station. Alternatively, the user interface and / or the display unit may be mounted elsewhere. The base station may also carry other optional hardware, such as a processor or control unit for any other supplementary imaging system for intervention, as described above.

[0107] The method includes an intraoperative image acquisition phase. It includes acquiring CT image data of the internal anatomical structure of the kidney (urinary collecting system), and preferably also acquiring CT image data of the portion of the anatomical structure of the object extending from the kidney to the body surface of the patient, where an incision will be made for physical access. The CT image data is preferably cone beam CT image data. Preferably, the acquired CT image data is contrast enhanced CT image data, however this is not required.

[0108] In some embodiments, the CT image data acquired during at least one intraoperative image acquisition phase is itself contrast-enhanced cone-beam CT image data.

[0109] Additionally or alternatively, the composite image data may be generated by fusing CT image data received during at least one intraoperative image acquisition phase with preoperative image data of the same anatomical region of the same patient retrieved from a data repository. This may require registration of the preoperative image(s) and the intraoperative image(s). Registration between the intraoperative non-contrast CBCT image and the preoperative image may be performed using an image registration algorithm. Such algorithms are known in the art. Typically, registration can be based on: image appearance, one or more fiducial markers (which may be trackable), segmentation of the renal contour in the two images; and / or segmentation of the renal parenchyma in the two images. Segmentation can be performed using a segmentation algorithm, many examples of which are known in the art.

[0110] After the intraoperative images have been acquired, the method may include an intervention planning phase before the intervention begins.

[0111] As an example, the intervention planning phase may include the steps of obtaining an indication of a planned entry point to the kidney; and obtaining an indication of a planned entry path through the body to the entry point to the kidney. When an image guidance image is subsequently generated to guide the intervention, this can include images for guiding the clinician to the entry point along the entry path, in addition to images showing the real-time position of the tool. For example, the guidance image may include one or more visual overlays that provide navigation guidance for navigating the insertion of an interventional tool along a predefined tool entry path from an incision point on the skin to a predefined entry point in the kidney. For example, one or more visual overlays may provide navigation guidance that provides a visual indication of a target location for the incision point and an indication of a target insertion angle for the tool.

[0112] The indication of the planned entry point of the kidney may include an indication of the planned calyx of the kidney through which kidney access is to be achieved. Once the selected calyx is known, the desired needle trajectory may be defined manually or automatically. The selected calyx may be identified based on manual or automatic segmentation or based on a user indicated location.

[0113] For example, in some examples, an indication of a planned calyce of the kidney through which kidney access is to be achieved is obtained based on user input received at the user interface 52. In some examples, a planned entry path through the body and optionally a planned incision point are automatically determined based thereon. For example, the method may include obtaining an indication of a planned calyce for accessing the kidney, manually or automatically segmenting the planned calyce within the received CT image data, and based thereon identifying a location of a planned entry point of the kidney relative to the CT image data.

[0114] This is followed by an image-guided interventional phase.

[0115] Here, given a desired needle trajectory, a clinician user can be supported to insert a tracked tool (e.g., a needle). Initially, as described above, tracking can help the user find a planned skin entry point, and / or adopt a planned insertion angle of the tool so as to follow a planned entry path through the tissue given a planned insertion point. When inserting a tracked tool under image guidance, feedback provided by the system's visualization will help gain renal access.

[0116] More specifically, it is proposed to generate and draw a guidance image on a display unit of a user interface. This may advantageously include a visual overlay indicating the position of the interventional tool, which is fused with an anatomical image representing the anatomical region. More specifically, the guidance image, for example, includes one or more visual overlays providing navigation guidance for navigating the insertion of the interventional tool along a predefined tool entry path from an incision point on the skin to a predefined entry point of the kidney. For example, the one or more visual overlays providing navigation guidance may provide a visual indication of the target position of the incision point and an indication of the target insertion angle of the tool.

[0117] It has been explained above how to pre-plan a tool entry path using input from a user or fully automatically.The resulting planned tool entry path may be stored as a trajectory defined by a series of coordinates extending along the path relative to a coordinate system of a tool tracking system or image data, for example.

[0118] The anatomical image onto which the visual overlay is drawn can be based on CT image data acquired during the intraoperative image acquisition phase.The anatomical image may simply be a CT image, or may be a synthetic fused image formed from a CT image and a preoperative image.

[0119] Of course, the CT image data set is 3D (volume) image data. Therefore, generating a guide image can include extracting one or more relevant 2D image planes from the 3D image data. If the CT image data consists of a stack of axial 2D image slices, one of these axial slices can be selected. Alternatively, a multi-planar reformatting (MPR) visualization of a CBCT volume can be generated using MPR techniques common in the art. In this way, 2D slices through a 3D image field across any orientation can be generated. User control options can be presented to the user via a user interface to select the desired imaging plane orientation, or the most suitable image plane view can be automatically determined, for example, based on tool tracking data or based on a planned entry path through the body to the entry point of the kidney. For example, an image plane orientation that is best visualized for the planned entry path can be selected. For example, an image plane orientation parallel to the planned insertion path can be selected, that is, it contains the planned insertion path. In some examples, as the tool moves, the best plane to be visualized can be repeatedly updated so that the plane view presented at each given update point is a plane parallel to at least a partial portion of the tool insertion path currently positioned by the tool (as determined by the tool tracking data). In other examples, the planar view on which the graphical overlay of the tool position is drawn may be selected from a list of standard planar views, such as one or more of the common orthogonal views: axial, sagittal, and coronal.

[0120] Of course, another option is to generate a guidance image that presents the tool position relative to multiple different planar views of the relevant anatomy, and display all of these simultaneously.

[0121] Yet another option is to generate a volume rendering from the 3D CT image data for use in guided imaging. A volume rendering is a 2D image plane that presents a synthetic perspective view of some 3D object represented by a 3D image data set. It is most typically generated based on a ray casting technique, where, as part of the rendering algorithm, synthetic "rays" are cast through the image plane and into the imaging volume from an imaginary observer's viewpoint. Those skilled in the art will be aware of common techniques for volume rendering.

[0122] In addition to the tracked tool position, the presented guidance image can optionally include one or more graphical markers indicating the segmentation boundaries of one or more anatomical features. This can further assist the clinician in navigating the anatomical structure. For example, one or more segmentation algorithms can be applied to CT image data acquired during the intraoperative image acquisition phase to obtain segmentation data before then generating the guidance image.

[0123] As previously described, in addition to visualizing the tracked tool position relative to the CT image data, the method may include displaying real-time images of anatomical structures obtained, for example, from an ultrasound imaging system, a fluoroscopic imaging system, and / or an endoscopic imaging system during the interventional image guidance phase. For example, the image guidance phase may also include receiving supplemental image data, the supplemental image data including one or more of the following: real-time endoscopic imaging data from an endoscopic imaging system; real-time ultrasound imaging data from an ultrasound imaging system; real-time fluoroscopic imaging data from a cone beam CT imaging device.

[0124] It can be simultaneously presented on the same display unit as the one used to present the guidance image generated from the CT image data. Since the CT-based guidance image is partially synthetic (based on non-live CT images, fused with live tracking data), it may be helpful for the clinician to simultaneously see a live image of the anatomy to compare or confirm what the guidance image formed from the CT data is showing.

[0125] For example, when the patient is in a prone position, ultrasound imaging will typically obtain an oblique view in which the tool (e.g., a needle) is in a plane. For example, when the patient is in a prone position and the x-ray generator is above the patient, fluoroscopy will typically generate a view plane perpendicular to the needle (i.e., a so-called "bull's eye view").

[0126] Using live tool tracking data, guided imaging helps the user: (a) navigate to the planned entry point of the kidney (ie, access to the kidney); and (b) once access to a kidney has been achieved, perform the stone removal procedure.

[0127] It has been described above that an intraoperative image acquisition phase can be performed before the start of the intervention in order to obtain (preferably cone-beam) CT image data of the patient for generating the guidance images.

[0128] Additionally or alternatively, in some embodiments, one or more intraoperative image acquisition phases may be performed during the interventional procedure, after the interventional procedure has already begun. This may be, for example, updating CT image data. This can utilize, for example, a cone beam CT imaging device. This can utilize an imaging device that can be moved in and out of a position for imaging the patient without moving the patient, such as a C-arm structure. Such imaging performed during the intervention may be performed during the patient's induced apnea, which means a temporary cessation of breathing. This avoids the negative effects of respiratory motion. During the interventional procedure, the patient is usually anesthetized. For this purpose, the patient is intubated and connected to a ventilator that is continuously operated and monitored by an anesthesiologist. In this case, the patient's breathing is under control, making it easy to stop breathing for, for example, 45 seconds, during which the scan is performed.

[0129] Once stone removal has been performed, the proposed computer-implemented method involves a quality assurance check phase.

[0130] The bright appearance of kidney stones makes interoperative (intraoperative) CBCT imaging particularly suitable for confirming the patient's stone-free status at the conclusion of the PCNL procedure.

[0131] The quality assurance check phase may be triggered in practice in response to receiving a predefined user input command from the user interface. In other words, the clinician indicates that stone removal has been completed and a quality check should commence.

[0132] In order to confirm the stone-free state, additional CT image data representing the kidney is collected. This is preferably a non-contrast enhanced cone beam CT scan. This scan is performed intraoperatively while the kidney is kept open. The resulting CT image data can be plotted on a user interface display and presented to the clinician. Confirmation of the stone-free state can be achieved by a simple image review by the clinician. The clinician can input an indication of the results of the image review via the user interface, and thus input the results of the quality assurance check, which can be recorded and / or can trigger one or more subsequent actions.

[0133] Additionally or alternatively, a computer-aided detection method may be applied to the acquired further CT image data to detect the presence of any residual stone fragments. Thus, in this case, an indication of the results of the quality assurance check may be obtained based on applying a stone removal check algorithm to the acquired further CT image data to automatically determine complete or incomplete stone removal.

[0134] In CT and CBCT imaging, stones appear as bright areas in the image due to their composition. In other words, kidney stones have a different Hounsfield density value than the surrounding tissue.

[0135] An example stone removal inspection algorithm may be configured to identify such bright objects within the kidney.

[0136] The steps of an example algorithm may include the following:

[0137] (1) Segment the kidney within the CT image (eg, using an AI segmentation model or traditional methods such as active contours, active appearance models, or active shape models).

[0138] (2) Locate bright objects within the kidney (ie, above a certain Hounsfield density value).

[0139] (3) Optionally, detected objects are filtered based on size range to prevent false positives and to avoid detecting small fragments that do not require any attention from the physician.

[0140] Other CT image data for quality assurance inspection can be visualized using, for example, multi-plane reformatting to obtain one or more planar views representing the internal anatomical structure of the kidney. For example, a collection of two or more orthogonal planar views of the anatomical structure can be presented. Another option is to apply volume rendering to generate one or more volume rendering views of the anatomical structure. Preferably, these can be generated so that a 3D perspective view of any residual stone fragments is visualized. There are various techniques for volume rendering, such as direct volume rendering or maximum intensity projection, and the technician will know the different options for applying the rendering method.

[0141] Optionally, additional CT image data may be processed with additional visual overlays to provide supplemental information. For example, the overlays may include one or more segmentation overlays representing renal anatomical structures, including, for example, parenchyma, urinary collecting system, etc. In some examples, the overlays may include a visual overlay representing a live tool tracking position.

[0142] Preferably, the additional CT image data acquired during the quality assurance inspection phase can be manipulated according to the rendered view presented via user controls of the user interface. For example, the user controls can allow translation, rotation or scrolling. The user controls can be sterile user controls, such as a foot pedal, or a sterilizable touch screen display, or a sterilizable keypad or joystick.

[0143] If the result of the quality assurance check is negative, i.e., a residual stone fragment is still present, the surgical user can immediately intervene and remove the residual stone fragment. This is aided by the known location of the residual stone fragment, as shown on the CT image. Indeed, in some advantageous embodiments, the quality assurance check phase may include: obtaining position information associated with any residual stones present in the kidney based on user input or based on an automatic segmentation algorithm; and guiding the image, which includes visualization of the position information associated with the residual stone.

[0144] For example, the method may further include: obtaining an indication of the results of the quality assurance check; and in response to the results of the quality assurance check indicating incomplete stone removal, controlling the execution of a further iteration of the interventional image-guided phase, and optionally, the further execution of the subsequent quality assurance check phase. The results may be obtained automatically or from user input, as already discussed. Optionally, the further iteration of the interventional image-guided phase may include generating a further guidance image, the further guidance image including a visual overlay indicating the position of the interventional tool, the visual overlay being fused with an anatomical image representing the anatomical region. Preferably, the anatomical image in this iteration may be based on further CT image data acquired during the quality assurance check phase. In this case, it may not actually be necessary to obtain the position information of the residual stone and overlay it on the CT image data, because the further CT image data will already include a visual representation of the stone fragment. Of course, to aid visualization, a graphical overlay indicating the position of the stone fragment may be additionally added, such as an indication of the contour, or a highlight indicating the area / volume coverage of the stone fragment.

[0145] Once the further iteration of the image-guided phase is complete, optionally, another iteration of the quality assurance check may be performed to recheck the stone-free status. Of course, this may also be omitted. Here, the option to repeat the check or not may be provided to the clinician via the user interface. Here, a balance may need to be decided between additionally exposing the patient to radiation and better ensuring complete stone removal.

[0146] In some embodiments, archiving of all acquired intraoperative image data may be facilitated by the operational coupling of the processing unit 32 with a DICOM interface that allows exporting the medical image data to one or more databases. These may be third-party databases or local hospital databases. The export may be, for example, to a PACS or other DICOM node.

[0147] With the above brief overview, an example workflow of an intervention may be as follows.

[0148] First, interoperative (intraoperative) CBCT imaging is performed. The user can then define the selected calyx for achieving access to the kidney via a user interface and indicate the desired needle entry path. This can be facilitated by a dedicated clinical application software executed by the processing unit 32. The user is then supported by a visual overlay of real-time tool tracking data on the CT image data to insert a tracking needle to gain access to the kidney. Improved visualization of the internal anatomy of the kidney (urinary collecting system) can optionally be achieved by using a contrast agent when acquiring the CT image data or by fusing preoperative contrast-enhanced CT image data with the intraoperative CT image data before generating the visual overlay rendering. The registration between the intraoperative CBCT image and the preoperative image can be based on any one or more of the following, for example: image appearance; fiducial markers (trackable or non-trackable); segmentation of the kidney contour in the two images; segmentation of the kidney parenchyma in the two images. Registration techniques are well known in the art. As already discussed, the selected calyx can be identified by: segmented region (manual / automatic) or user-indicated position. Subsequently, when the tracking needle is inserted under image guidance, the feedback provided by the system's visualization (guiding image) will aid in obtaining renal access and stone removal. Thereafter, additional CT image data can be acquired as part of a quality assurance stone-free examination.

[0149] As already discussed, embodiments utilize a user interface display unit to display a guide image and to display additional CT image data for checking stone-free status.

[0150] In an advantageous set of embodiments, it is proposed to provide the processing unit with the ability to receive video input from a plurality of different imaging modalities. This has been discussed above, where it has been explained that real-time imaging feedback from ultrasound, fluoroscopy, endoscopy or any other imaging modality can be received and presented on the display unit of the user interface. In some embodiments, this can be done independently of the above with respect to Figure 1 Different stages of the main method discussed present these one or more further video feedbacks continuously. In other words, in some embodiments it is proposed that the processing unit hosts two parallel operations: one of video drawing and presentation of one or more live video feedbacks on a display on the user interface display unit, and a second one comprising e.g. Figure 1 The steps of the method outlined in , wherein a guidance image is generated based on the CT image data and is also presented on a display unit.

[0151] The video display function can thus provide a means for connecting multiple different video inputs, thereby enabling the display of, for example, side-by-side endoscopic imaging, real-time fluoroscopic imaging, or ultrasound imaging. This is convenient, for example, during the placement of a ureteral catheter at the beginning of an operation and during the placement of a JJ catheter or nephrostomy at the end of an operation.

[0152] Furthermore, the processing unit 32 may include functionality for capturing image snapshots or video clip records for storage and archiving. The processing unit may include functionality allowing these to be exported, for example via a DICOM interface operatively coupled to the processing unit.

[0153] Advantageously, an optional video display can help support all phases of a renal interventional procedure.

[0154] The embodiments of the present invention described above employ processing units. The processing unit may generally include a single processor or multiple processors. It may be located in a single containing device, structure or unit, or it may be distributed between multiple different devices, structures or units. Therefore, references to a processing unit adapted or configured to perform a particular step or task may correspond to the step or task performed by any one or more of a plurality of processing components individually or in combination. Those skilled in the art will understand how to implement such distributed processing devices. The processing unit may include a communication module or input / output portion for receiving data and outputting data to other components.

[0155] In some embodiments, the system acquires non-contrast enhanced intraoperative CBCT images and enhances the images with the help of segmentation techniques and / or computer-aided detection for detecting residual stones; acquires segmented end-of-operative stone-free examination CBCT images including residual stones; presents the two images side by side, or fuses or otherwise combines the images to show the abundance and absence of residual stones.

[0156] In some embodiments, the CBCT image may also include an overlay of the renal anatomy and the current device position.

[0157] In some embodiments, the patient's anatomy is being generated. The system generates a guide support (eg, via a guide wire), wherein the guide wire can be automatically drawn from the inner tip of the entry point to the residual stone.

[0158] In some embodiments, the system may provide feedback to the user regarding the absence / abundance of residual stones.

[0159] The one or more processors of the processing unit can be implemented in a variety of ways using software and / or hardware to perform the various functions required. The processors typically employ one or more microprocessors that can be programmed using software (e.g., microcode) to perform the required functions. The processors can be implemented as a combination of dedicated hardware for performing some functions and one or more programmed microprocessors and associated circuits for performing other functions.

[0160] Examples of circuits that may be employed in various embodiments of the present disclosure include, but are not limited to, conventional microprocessors, application specific integrated circuits (ASICs), and field programmable gate arrays (FPGAs).

[0161] In various embodiments, the processor may be associated with one or more storage media, such as volatile and non-volatile computer memory, such as RAM, PROM, EPROM, and EEPROM. The storage media may be encoded with one or more programs that, when executed on one or more processors and / or controllers, perform the desired functions. The various storage media may be fixed within the processor or controller, or may be transferable so that one or more programs stored thereon can be loaded into the processor.

[0162] By studying the drawings, the disclosure and the claims, those skilled in the art can understand and implement variations of the disclosed embodiments.In the claims, the word "comprising" does not exclude other elements or steps, and the word "a" or "an" does not exclude a plurality.

[0163] A single processor or other unit may fulfill the functions of several items recited in the claims.

[0164] The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

[0165] The computer program may be stored / distributed on suitable media such as optical storage media or solid-state media supplied together with or as part of other hardware, but may also be distributed in other forms such as via the Internet or other wired or wireless telecommunications systems.

[0166] If the term "suitable for" is used in the claims or the specification, it should be noted that the term "suitable for" is intended to be equivalent to the term "configured to".

[0167] Any reference signs in the claims should not be construed as limiting the scope.

Claims

1. A processing unit comprising one or more processors configured to perform a computer-implemented method for interventional support during a renal interventional procedure for kidney stone removal, the method comprising: At least one intraoperative image acquisition phase, which includes: receiving computed tomography (CT) image data of an anatomical region including at least a portion of a kidney of a subject; The interventional image-guided phase includes: receiving real-time tool tracking data indicating a positioning of an interventional tool used in the interventional procedure, generating a real-time guidance image based on the CT image data and also based on the tracking data, the guidance image visualizing the position of the interventional tool relative to the anatomical region imaged in the CT image data, communicating with a user interface device to display the generated guide image on a display unit of the user interface device in real time; and The interventional image-guided phase is followed by a quality assurance check phase, which includes: communicating with a CT imaging device to acquire additional CT image data of the anatomical region using the CT imaging device for visualizing any remaining stones or stone fragments for determining whether complete stone removal has been achieved, wherein the additional CT image data is cone beam CT image data, and Communicating with the user interface device to display the additional CT image data on the display unit of the user interface.

2. The processing unit according to claim 1, wherein: The method further comprises: obtaining an indication of the results of said quality assurance check; and In response to the result of the quality assurance check indicating incomplete stone removal, controlling the performance of a further iteration of the interventional image-guided phase and subsequently a further performance of the quality assurance check phase.

3. The processing unit according to claim 2, in, The indication of the result of the quality assurance check is obtained based on user input received at the user interface device; or Therein, the indication of the result of the quality assurance check is obtained based on applying a stone removal check algorithm to the obtained further CT image data to automatically determine complete or incomplete stone removal.

4. The processing unit according to claim 1-3, in, The quality assurance check phase includes: obtaining location information associated with any residual stones present in the kidney based on user input or based on an automated segmentation algorithm; and wherein, during additional iterations of the image-guided phase, the guidance images include visualization of the position information associated with the residual stone.

5. The processing unit according to any one of claims 1 to 4, wherein: The at least one intraoperative image acquisition phase includes communicating with a CT imaging device to acquire cone-beam CT image data of the anatomical region using the CT imaging device.

6. The processing unit according to any one of claims 1 to 5, wherein: The guidance image includes a visual overlay indicating a position of the interventional tool, the visual overlay being fused with an anatomical image representing the anatomical region, the anatomical image being based on the CT image data acquired during the intraoperative image acquisition phase.

7. The processing unit according to claim 6, wherein: The guidance image also includes one or more visual overlays that provide navigation guidance for navigating insertion of the interventional tool along a predefined tool entry path from an incision point on the skin to a predefined entry point in the kidney, and Optionally, wherein the one or more visual overlays providing navigation guidance provide a visual indication of a target location of the incision point and an indication of a target insertion angle of the tool.

8. The processing unit according to claim 7, wherein: The method comprises an intervention planning phase, which comprises: obtaining an indication of a planned entry point into the kidney; obtaining an indication of a planned access path through the body to the access point of the kidney; and Wherein the one or more visual overlays for providing navigation guidance are generated based on the obtained indications.

9. The processing unit according to claim 8, wherein: The indication of the planned entry point of the kidney includes an indication of a planned calyceum of the kidney through which kidney access is to be achieved.

10. The processing unit according to any one of claims 1 to 9, wherein: Generating the guide image includes: Composite image data is generated by fusing the CT image data received during the at least one intraoperative image acquisition phase with preoperative image data of the same anatomical region of the same patient retrieved from a data repository.

11. The processing unit according to any one of claims 1 to 10, wherein: The image-guided phase also includes receiving supplemental image data, the supplemental image data including one or more of: real-time endoscopic imaging data from an endoscopic imaging system; real-time ultrasound imaging data from an ultrasound imaging system; Real-time fluoroscopic imaging data from a cone-beam CT imaging device, and Optionally, wherein the image guidance stage includes: communicating with the user interface to simultaneously display the guidance image and the supplemental image data.

12. The processing unit according to any one of claims 1 to 11, wherein: The processing unit also includes a communication interface for wired or wireless connection to one or more of the following: Cone beam CT imaging device, User interface devices, Tool tracking systems, and Optionally, an ultrasound imaging system and / or an endoscopic imaging system.

13. A mobile base station capable of moving within an operating room and comprising a processing unit according to any one of claims 1-13.

14. A system comprising: The processing unit according to any one of claims 1 to 12, or the mobile base station according to claim 13; Cone beam CT imaging device; as well as A tracking system is used to track the positioning of an interventional tool within a patient's body.

15. A computer-implemented method for interventional support during a renal interventional procedure for kidney stone removal, comprising: At least one intraoperative image acquisition phase, which includes: receiving computed tomography (CT) image data of an anatomical region including at least a portion of a kidney of a subject; The interventional image-guided phase includes: receiving real-time tool tracking data indicating a positioning of an interventional tool used in the interventional procedure, generating a real-time guidance image based on the CT image data and also based on the tracking data, the guidance image visualizing the position of the interventional tool relative to the anatomical region imaged in the CT image data, communicating with a user interface device to display the generated guide image on a display unit of the user interface device in real time; and The interventional image-guided phase is followed by a quality assurance check phase, which includes: communicating with a CT imaging device to acquire additional CT image data of the anatomical region using the CT imaging device for visualization of any remaining stones or stone fragments for determining whether complete stone removal has been achieved, wherein the additional CT image data is cone beam CT image data; and Communicating with the user interface device to display the additional CT image data on the display unit of the user interface.

16. A computer program product comprising computer program code, the computer program code being configured to, when executed on a processor, cause the processor to perform the method according to claim 15.

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