Systems and methods for planning a medical procedure

Abstract

Computer systems and computer-implemented analysis methods can be used to assist in planning and / or performing a medical procedure, such as percutaneous nephrolithotomy or percutaneous nephroscopy. The method can include: receiving one or more radiographic images of a patient's anatomy, generating a display of the one or more radiographic images, generating at least one request for user input to identify features of the anatomy, receiving user input identifying features of the anatomy, identifying at least one access plan based on the received user input, and generating a display of the identified one or more access plans associated with the one or more radiographic images. The method can include generating a patient template indicating an insertion site based on the identified one or more access plans.

Description

[0001] Specification

[0002] This application is a divisional application of a Chinese patent application with the application number "201780005923.8", the application date of "January 5, 2017", and the title of "Systems and Methods for Planning a Medical Procedure". Technical Field

[0003] Aspects of the present disclosure generally relate to systems and methods for planning and / or performing a medical procedure. Background Art

[0004] Significant progress has been made in improving medical outcomes while reducing trauma and risk to patients. Many procedures that once required open surgery can now be performed with less invasive techniques that limit the size of the incision and thus provide the patient with less recovery time and risk of infection. Certain procedures that require biopsy, electrical stimulation, tissue ablation, or removal of natural or foreign bodies can be performed through minimally invasive surgery.

[0005] For example, in the field of urology, kidney stones or renal calculi can accumulate in the urinary tract and become lodged in the kidney. Kidney stones are deposits of substances from urine, usually minerals and salts. Although smaller stones may pass naturally from the body, larger stones may require surgical intervention to be removed. Although open surgery was once the standard treatment for removing stones, other minimally invasive techniques, such as ureteroscopy and percutaneous nephrolithotomy / nephrolithotripsy (PCNL), have become safer and more effective alternatives. However, procedures such as PCNL still carry risks.

[0006] Minimally invasive surgeries like PCNL provide benefits in patient recovery, but only provide a limited view of the treatment site to the doctor. Therefore, it may be difficult to gain sufficient access to the target site without causing collateral damage to the patient. Without sufficient knowledge of the patient's anatomy, the doctor may need to make multiple attempts to correctly position and orient the instrument to remove the stone. If the stone is larger or more difficult to grasp than expected on the first access route, a second access channel may be required. Repeated attempts at access increase the risk of collateral damage to blood vessels, surrounding tissues, and adjacent organs, and may increase the likelihood of bleeding, infection, and fluid leakage / sepsis.

[0007] Medical staff who do not routinely perform the PCNL procedure may be particularly concerned about the potential for harm due to incorrect triangulation of the stone. Although patient images such as computed tomography (CT) scans may be available for reference beforehand, they are typically obtained weeks or months before the PCNL surgery. During the intervening period, the size of the stone may have increased and / or the position may have changed, thus further increasing the uncertainty of successfully removing the stone with minimal harm to the patient. SUMMARY OF THE INVENTION

[0008] The present disclosure includes a method for determining a patient-specific surgical access plan for a medical procedure using at least one computer system, the method comprising receiving, on at least one computer system via an electronic network, one or more radiographic images of a patient's anatomy; generating a display of the one or more radiographic images; generating at least one request for user input identifying features of the anatomy in the one or more radiographic images; receiving a first user input identifying features of the anatomy; identifying, by the at least one computer system, at least one access plan for performing the medical procedure based on the received user input; and generating a display of the at least one identified access plan associated with the one or more radiographic images. In some examples, the medical procedure may be percutaneous nephrolithotomy or percutaneous nephroscopy, and the anatomy may be the kidney.

[0009] According to some aspects, the one or more radiographic images may include images obtained by computed tomography. The display may include, for example, a three-dimensional representation of the anatomy, which may be reconstructed from computed tomography and / or other imaging methods. The one or more radiographic images need not be obtained by computed tomography, or may include additional images obtained by imaging techniques other than computed tomography.

[0010] The method may further include one or more additional steps. For example, the method may further include modifying the one or more radiographic images based on the first user input. Modifying the one or more radiographic images may include, for example, comparing the one or more radiographic images with reference patient data for the medical procedure. Additionally or alternatively, the method may include manually and / or automatically identifying one or more features of the anatomy in the one or more radiographic images prior to generating the at least one request for user input.

[0011] In some examples, generating the at least one request for user input includes asking the user to identify and / or confirm the location of kidney stones in the one or more radiographic images. Additionally, for example, the method may include calculating, by the at least one computer system, at least one feature of the kidney stones based on the one or more radiographic images. According to some aspects, the one or more features may be selected from stone burden, stone density, skin-to-renal capsule distance, skin-to-kidney stone distance, or a combination thereof. Other features of the kidney stones may be calculated, identified, or otherwise determined. Identifying the at least one access plan may include calculating a needle trajectory based on the at least one calculated feature of the kidney stones.

[0012] According to some aspects, the method may include generating a patient template indicating one or more sites (e.g., one or more insertion sites for inserting a needle) based on one or more identified access plans. The one or more access plans may include the position and depth for inserting a needle at the insertion site, e.g., such that the one or more access plans identify suitable positions for the needle to enter the patient's anatomy to perform a medical procedure. Generating the patient template may include, for example, printing one or more markers identifying the insertion sites onto a sheet or other material adapted to be delivered to the patient prior to the medical procedure. For example, generating the patient template may include printing at least a first marker and a second marker, the at least first marker identifying the insertion site according to the access plan, and the second marker providing a reference relative to one or more anatomical features of the patient. Additionally or alternatively, the at least one access plan may include information regarding the trajectory of the needle to be inserted at the insertion site.

[0013] According to some aspects of the present disclosure, the method may include performing a medical procedure by inserting a needle at the insertion site according to at least one access plan. The insertion site may be identified by a light source, such as a laser light source or other light source of an imaging device, which may be directed at the patient's skin. The light source may communicate with an electronic network. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The drawings incorporated in and forming a part of this specification illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments.

[0015] Figure 1 Illustrates anatomical features of the kidney.

[0016] Figure 2 Is a schematic diagram of a system and environment for processing and displaying patient data according to aspects of the present disclosure.

[0017] Figure 3 Illustrates an exemplary imaging device according to aspects of the present disclosure.

[0018] Figure 4 Is a flowchart of an exemplary method for processing and displaying patient data according to aspects of the present disclosure.

[0019] Figure 5 and Figure 6 Illustrates an exemplary screenshot of a graphical user interface according to aspects of the present disclosure.

[0020] Figure 7A and Figure 7B Illustrates an exemplary patient template according to aspects of the present disclosure. DETAILED DESCRIPTION

[0021] Embodiments of the present disclosure include systems and methods for facilitating and improving the efficacy and safety of minimally invasive surgical procedures. For example, aspects of the present disclosure can provide a user (e.g., a doctor, a medical technician, or other healthcare provider) with the ability to manipulate patient-specific data to analyze and / or simulate different aspects of a medical procedure. In some embodiments, for example, the present disclosure can be used to plan and / or perform a PCNL procedure.

[0022] PCNL is a minimally invasive surgical procedure for removing kidney stones and is typically used when other techniques, such as ureteroscopy or extracorporeal shock wave lithotripsy, are not suitable. For example, PCNL can be applicable to stones of a larger size (e.g., stones with a diameter greater than about 2 cm) or stones located near the pelvis. Figure 1 The position and structure of the kidney 100 are shown. The left and right kidneys 100, 101 are located at the rear of the abdominal cavity and are connected to the circulatory system via the abdominal aorta 130 and the inferior vena cava 132. The renal capsule 102 is a tough fibrous tissue that houses the parenchyma 104 (the internal tissue of the kidney 100). A series of smaller renal calyces 106 direct urine into the major calyces 108, which lead into the renal pelvis 110, which becomes the ureter 112. The renal artery 120 and renal vein 122 supply blood to the blood vessels arranged throughout the parenchyma 104.

[0023] In a typical PCNL procedure, a small incision is made in the patient's back through the skin covering the affected kidney Then a small needle is inserted and advanced towards the kidney near the stone, and a guide wire is passed through the needle. The needle is then removed while the guide wire remains in place, and when the guide wire is withdrawn, a nephroscope is inserted onto the guide wire and positioned near the stone. The nephroscope typically includes a light source, an imaging device, and a working channel for aspiration / irrigation or for using auxiliary tools to capture and remove the stone. If the stone cannot be removed directly (nephrolithotomy), the stone can be fragmented into smaller pieces or fragments (nephrolithotripsy) using, for example, ultrasonic, laser, or electrohydraulic techniques to facilitate removal.

[0024] One of the more challenging aspects of PCNL is the insertion and correct placement of the needle. Incorrect positioning can puncture blood vessels, causing bleeding, damage to adjacent organs or tissues, or ultimately placing the nephroscope in an incorrect position to access the stone. A detailed understanding of the patient's anatomy and potential access routes can allow the doctor to adequately prepare for the surgery.

[0025] The systems and methods disclosed herein can facilitate the collection, acquisition, analysis, and / or manipulation of patient images and other data to facilitate the PCNL procedure. In some embodiments, the systems and methods disclosed herein can enable a doctor to identify, evaluate, and / or simulate different surgical access plans, e.g., paths or access routes through a patient's anatomy, to access a stone. For example, a doctor can execute a computer application via an electronic device to process images and / or obtain processed images to identify the presence of a stone and determine the size, density, composition, location, orientation, and / or positioning of the stone relative to the kidney and surrounding anatomy. Additionally, in some embodiments, the application can identify and / or simulate one or more access plans associated with a patient image. For example, the application can generate one or more access plans, e.g., by displaying one or more access routes on the patient image, and associate the one or more access plans with the patient image. Additionally or alternatively, the application can allow a doctor to identify and / or draw one or more access plans on the patient image. The application can be available to a doctor before the procedure (e.g., for planning an access route based on the location / characteristics of a stone), during the procedure (e.g., for comparison with real-time imaging to confirm a pre-determined access route and the location / characteristics of the stone), and / or after the procedure (e.g., for further post-operative analysis of the access route taken during the procedure).

[0026] Figure 2 A schematic diagram of an exemplary computer system and environment for collecting, processing, and displaying patient-specific data in accordance with an exemplary embodiment of the present disclosure is shown. The computer system 200 can include one or more user devices 202 for accessing and / or manipulating data and a server in communication with an electronic communication network 205, e.g., 206A, 206B, 206C, 206D (each of which can have a corresponding database 207A, 207B, 207C, 207D). The network 205 can include the Internet, a virtual private network, or any other combination of wired and / or wireless electronic communication networks. The system 200 can also include one or more imaging devices 204 for acquiring and accessing medical images of a patient.

[0027] Each user device 202 can be a fixed or mobile electronic device, including an electronic computing device. Non-limiting examples of such electronic devices include laptop computers, desktop computers, tablet computers (including, e.g., Apple iPad, Samsung Galaxy, Amazon Kindle, and Microsoft Surface devices), smart phones, digital cameras. Non-limiting examples of the imaging device 204 include CT scanners, stationary fluoroscopes, mobile C-arm devices, and other angiography / radiography devices, as well as cameras, ultrasound (transducer) devices, and magnetic resonance imaging (MRI) machines.

[0028] Each user device 202 may include a processor, a memory, a display, one or more user input devices, and a network communication interface. The user input device may be, for example, a display monitor, a touchpad, a touch screen, a keyboard or a mouse, and other types of devices and device features that provide user input / output capabilities. One or more user devices 202 may include a display or a graphical user interface for receiving user input and displaying data via an application ("app"). Figure 5 and Figure 6 An exemplary screenshot of a user device in the form of a tablet computer 500 is shown and discussed below. One or more user devices 202 may implement appropriate security protocols, such as requiring a user to enter login credentials to restrict access to patient data and comply with applicable health regulations, such as the Health Insurance Portability and Accountability Act (HIPAA).

[0029] Each user device 202 and the imaging device 204 may be configured to send and / or receive data including patient data via the network 205. Patient data obtained and / or accessed via the network 205 may include, but is not limited to, any imaging, detected, measured, processed, and / or computed physiological data, including, for example, data on various characteristics of the urinary, musculoskeletal, gastrointestinal, dermatological, respiratory, or vascular systems. For example, patient data may include one or more images of the left and / or right kidneys and surrounding anatomical structures (such as the left and / or right ureters, renal arteries, renal veins, pelvis, spine, adrenal glands, bladder, and / or urethra). Each image may be associated with the time, date, location, and / or instrument at which the image was taken. In some embodiments, patient data may include personal information (e.g., patient name, age, gender, etc.) and / or other physiological health parameters (e.g., average heart rate, body temperature, etc.).

[0030] Various medical imaging techniques may be used to collect patient data. For example, images may be generated by a CT scanner and / or rotational angiography. A CT scan typically provides a series of cross-sectional images or "slices" taken at different angles while the patient is stationary, and the slices may be assembled into a three-dimensional (3D) image. Rotational angiography may be performed, for example, by moving a C-arm during a surgical procedure or when the patient is stationary, but generally has lower quality than a CT scan. For some imaging procedures, a contrast agent may be used to help identify anatomical features in the image. For example, a contrast agent may be introduced into the patient's body (e.g., via the patient's urethra through the ureter) before imaging to help visualize the kidneys and urinary system.

[0031] Figure 3Illustrated is an exemplary mobile C-arm device 300 for collecting X-ray images of a patient 350 during the preparation for and / or during a PCNL procedure in accordance with some aspects of the present disclosure. As shown, the "C-arm" 305 of the imaging device 300 includes an X-ray tube 308 aligned with a detector 310 positioned on opposite sides of the patient 350. The C-arm 305 can be rotated relative to the patient in one or more planes (e.g., about an axis parallel to and / or perpendicular to the patient 350) to allow collection of images in different orientations without moving the patient 350. The images can be displayed and analyzed in real time on a monitor or display 316 of the imaging device 300 and / or can be stored locally or remotely for later viewing and analysis. For example, the C-arm device 300 can be used to collect patient images during a PCNL procedure, e.g., where a doctor can refer to the images for guidance on the proper positioning of inserted needles, nephroscopes, and other instruments during the surgery.

[0032] The mobile C-arm device 300 can include a light source to identify a specific target or area of the patient, such as an expected incision or insertion site. For example, the C-arm 305 can include a light source coupled to or incorporated into the X-ray tube 308, where the light source can be used to direct light to a predetermined insertion site for the PCNL procedure. Figure 3 Shown is light 311 focused in the form of an "X" or crosshairs on the back of the patient 350 to indicate the expected insertion site. As discussed further below, the direction, orientation, intensity, and / or shape of the light generated by the light source can be controlled via user input at the display 316 and / or instructions received over the network 205.

[0033] Returning to Figure 2 , the servers 206A - 206D can be configured to receive patient data over the network 205, e.g., from user devices 202, imaging devices 204, other servers, and / or a shared cloud network. Each of the servers 206A - 206D can perform different functions, or certain functions can be shared by two or more of the servers 206A - 206D. Each of the servers 206A - 206D can include a processor and a memory for executing and storing processor-readable instructions. One or more of the servers 206A - 206D can be communicatively coupled to corresponding databases 207A - 207D, which are configured to store data accessible to the servers 206A - 206D (e.g., patient data). At least one of the servers 206A - 206D can include a data analyzer configured to perform an analysis of the received data; and / or an application that allows a doctor to control analysis parameters, such as thresholds used by the data analyzer in performing the analysis.

[0034] In some embodiments, system 200 may include an imaging server 206A, a patient record server 206B, a reference data server 206C, and an application server 206D. As described above, more or fewer servers may be used. For example, in some embodiments, the functions performed by the imaging server 206A, patient record server 206B, reference data server 206C, and application server 206D (or any combination thereof) may be implemented by a single server.

[0035] The imaging server 206A may receive, process, and / or transmit patient images for viewing and analysis according to the methods herein. For example, the imaging server 206A may receive images generated by one or more imaging devices 204, perform one or more processing steps, and transmit the processed images for viewing on one or more user devices 202. Additionally or alternatively, the imaging server 206A may obtain images saved to the database 207A, which may correspond to previous images obtained for the patient. Image processing steps may include, but are not limited to, assembling multiple images into a 3D representation or model, associating the images with patient information, grouping images of similar type and / or date together, reducing noise, and / or identifying / marking specific anatomical features. Image processing may be performed by suitable algorithms commonly known in the art. In some embodiments, multiple images generated by the same or different devices may be layered (e.g., one image superimposed on another) and / or combined into a single two-dimensional or three-dimensional image.

[0036] The patient record server 206B may be used to obtain patient-specific information for association with the images and / or viewing on one or more user devices 202. For example, the patient record server 206B may correspond to the server of a hospital or medical office where the patient has previously received or routinely undergoes treatment. Information received and / or transmitted by the patient record server 206B may include, but is not limited to, patient name, date of birth, age, contact information, general medical condition, previous surgeries and other medical events (including previous kidney stone incidence), physiological information (e.g., average blood pressure, average heart rate, etc.), and other patient-specific information that may assist the doctor in planning the PCNL procedure or other medical procedures. In some embodiments, the patient record server 206B may obtain patient information from records stored in the database 207B.

[0037] The reference data server 206C can be used to access relevant data from medical case studies for reference and / or comparison with patient data. For example, summary data from medical case studies can be used to automatically identify different features in a patient image (e.g., the possible locations of the renal capsule, major / minor renal calyces, and renal pelvis, and / or kidney stones). In some embodiments, the reference data server 206C can compare patient data with various case study data (e.g., case study records optionally stored in the database 207C) to attempt to locate one or more reference patient profiles. For example, one or more reference patient profiles can include information about removing kidney stones of similar size and / or location to those of the patient.

[0038] The application server 206D can communicate with one or more user devices 202 to transmit and / or receive instructions for generating and displaying patient data suitable for the preferences and needs of the user. The application server 206D can, for example, assemble patient data from other servers 206A - 206C, imaging devices 204, and perform analyses, calculations, and / or generate simulations as needed. For example, the application server 206D can send instructions to one or more user devices 202 to prompt user input, and can process data received from one or more other servers 206A - 206C (or information stored in the database 206D) based on the user input to modify the information displayed on one or more user devices 202 accordingly.

[0039] Figure 4 A flowchart of an exemplary method 400 for collecting, processing, and displaying patient data using the Figure 2 system is shown. Method 400 can include, for example, receiving a patient image from the imaging device 204 and / or imaging server 206A as discussed above (step 401). The received patient image can then be processed, for example, via the imaging server 206A and / or the application server 206D (step 403). Step 403 can include any of the processing / modification techniques discussed above. In some embodiments, for example, step 403 can include generating a 3D representation of the kidney and surrounding anatomy from the received CT scan, automatically identifying different features of the kidney and / or surrounding tissue, and / or automatically identifying one or more access plans for removing kidney stones.

[0040] Subsequently, the processed / modified image can be displayed on one or more user devices 202 (such as a tablet computer) (step 405). Next, a request for user input can be generated (step 407), such as a prompt on the screen of the tablet computer. For example, the screen can display a text box asking the user to identify and / or confirm the specific structure of the kidney and the location of any kidney stones, for example, by touching the screen. In some embodiments, the user can be prompted to draw an access plan and / or highlight one or more portions of the access plan, for example, by dragging a digit (finger or thumb) or a stylus on the screen.

[0041] In some embodiments, the user input can include a request to further process / modify the patient image (step 409). For example, the user device 202 can receive a user request to calculate the size and / or density of the stones that the user has marked, or generate a new 3D model of the kidney based on different selections, different algorithms, or other parameters of the image. Thus, the method can include repeating step 403 one or more times. In some embodiments, processing / modifying the patient image can include accessing the patient record (step 411) and / or accessing reference data (step 413), such as the case study information discussed above. The re-processed image can be displayed on one or more user devices 202 (step 405).

[0042] In some embodiments, the user input may not require further processing of the image. For example, the user may wish to manipulate the image that has been processed and is displayed on one or more user devices 202, such as to zoom in, miniaturize, and / or rotate the image or a portion of the image to browse a series of images (e.g., individual slices from a CT scan), and / or change the layout of multiple images displayed on one or more user devices 202. When a user input to modify the display is received (step 415), the user device 202 can perform a corresponding function to effect the modification (step 417).

[0043] Each user device 202 can have an appropriate interface or controls to allow the user to select different options for manipulating the patient image. For example, the user can select from menu options via a keyboard or mouse or via a touch screen. For a user device 202 with a touch screen, such as some smart phones and tablet computers, the user device 202 can be configured to associate the type of user input with a specific function. For example, the user device 202 can be configured to determine when the user's finger pinches the surface of the touch screen. If the user's fingers come closer together, the user device 202 can zoom out from the displayed image, while if the user's fingers move apart from each other, the user device 202 can zoom in on the image being displayed. The amount of zoom can depend on the travel distance of one or more fingers pinching along the surface of the touch screen.

[0044] As described above, one or more user devices 202 may communicate with one or more of servers 206A - 206D via a network 205 to transmit data such as user instructions and / or receive data such as patient images (including any processed images) and other patient data, reference data, or instructions for generating prompts requesting user input. In some embodiments, one or more user devices 202 may be configured to perform some or all of the image processing or other data processing functions.

[0045] Figure 5 and Figure 6 FIG. shows an exemplary user interface of a tablet computer 500 as an exemplary user device 202 according to some embodiments of the present disclosure. The tablet computer 500 may have a touch screen configured to receive input from a user based on contact of at least one user's finger (e.g., one or more fingers or thumbs) on the surface of the touch screen. It will be appreciated that the touch screen may be configured to receive input from a user based on contact or sensing of proximity to the touch screen by one or more fingers of the user, one or more thumbs of the user, a stylus, another pointing object or instrument, or a combination thereof. Additionally, it should be understood that the user device 202 according to the present disclosure need not have a touch screen, but may receive user input via other input devices known in the art, including the above-described user input devices.

[0046] The tablet computer 500 may include a display 501 for displaying information and user elements 503, which may allow the user to exit an application and / or turn on / off the tablet computer 500. The display 501 may display one image or multiple images, e.g., divided into different panels. For example, Figure 5 FIG. shows a display 501 divided into four panels 502A, 502B, 502C, and 502D, and Figure 6 FIG. shows a display 501 divided into three panels 522A, 522B, and 522C. The panels may have the same or substantially the same size and shape as Figure 5 or may have a different shape and / or different size relative to other panels, as Figure 6As shown. Different types of images can be displayed in the respective panels, for example to highlight various anatomical structures and features. The panels can show raw data (e.g., raw images collected via CT scan, X-ray, fluoroscopy or rotational angiography), manipulated / processed data (including but not limited to simplified images or access plans / representations, annotated images, layered image data), simulation data (including but not limited to 3D simulations, access plans / representations with simulated access routes, and raw or processed images with simulated features). The panels can include annotations generated by the system or provided by user input to identify features and / or provide information or various metrics for reference. For example, the panels can display density information, stone burden, and / or skin-to-stone distance and other metrics.

[0047] For example, different panels can show one or more X-ray images, one or more CT images, which can be collected at different angles, providing planar views in various x, y, z coordinates (e.g., coronal, sagittal, and transverse views), and / or one or more fluoroscopy images. These different views can help the user determine the location and / or size of the kidney stone. For example, the user can use different views to label various features of the kidney such that multiple CT image views can be combined to visualize the structure of the kidney in three dimensions. Figure 5 Shows a transverse CT image in panel 502B, a sagittal CT image in panel 502C, a coronal CT image in panel 502D, and a renal-ureter-bladder X-ray in panel 502A. Figure 6 Shows a transverse CT image in panel 522A, which can be Figure 5 the same image shown in panel 502B, a coronal CT image in panel 522B, which can be Figure 5 the same image shown in panel 502D, and a 3D image in panel 522C reconstructed from the CT data, which shows the kidney, its calyces, and the kidney stone. The user can be able to manipulate the 3D image, such as by rotating the image and / or zooming in or out on specific features or regions of interest. For example, the user can manipulate the 3D image by rotating the image and / or zooming in or out on specific features to view different angles of needle insertion.

[0048] The display 501 can include a menu 510 having one or more menu options (icons 510A - 510F as shown) to allow the user to select among different options for displaying and / or processing the images. For example, a first menu option 510A can be selected to identify and / or characterize the different anatomical structures or features shown. An exemplary list of items is in Figure 5As shown, it includes the renal capsule, renal calyces, the kidney stone burden (stone size), and / or the location of any reference markers. The list may include a progress indicator for each item, which shows whether additional user input is desired or required. The user can use the touch screen to select and identify different features, where the user device 202 and / or other components of the system 200 can use image recognition algorithms to identify / outline the entire structure (e.g., by detecting the surrounding areas of the same contrast).

[0049] The second menu option 510B may allow the user to view data corresponding to a specific feature (such as a kidney stone). Figure 6 A list of data corresponding to the kidney stone 575 shown in the image corresponding to the panel 522C is shown. The data can be calculated by the system 200 or may already be associated with the patient image. As shown, the data may include the stone burden (e.g., the size of the stone in mm), the stone density (the radiation intensity calculated by CT scan according to the Hounsfield grading), the distances from the patient's skin surface to the renal capsule, renal calyces, and the stone 575, and the projection angle at which the needle is inserted to reach the stone during the PCNL procedure.

[0050] The third menu option 510C may allow the user to change various settings, such as sensitivity settings, different algorithms to be used, how many image panels are shown by default when the application starts, etc. The fourth menu option 510D may indicate information about the connectivity to the network 205, the fifth menu option 510E may allow the user to print information such as the surgical templates discussed below, and the sixth menu option 510F may allow the user to upload and / or download patient images or other patient data or information through the network 205. The menu options 510A - 510F are intended to be exemplary; the menu 510 may include other types of menu options, as well as fewer or more menu options than shown.

[0051] In some embodiments, a portion of the display 501 may show text and / or annotations for the shown images. For example, the text may include information about the patient, information about the images shown on the display 501, or comments from a doctor or other medical professional, as well as other types of information. Additionally, for example, the annotations may identify various anatomical features or reference markers, or may reflect information about the access plan or the expected needle trajectory. Figure 5 and Figure 6 Each of them shows a text box 505 covering a portion of the display 501, with information about the patient (patient name) and the shown image (date when the image was obtained). Figure 6 Annotations for the images shown in each of the panels 522A, 522B, and 522C are further shown to indicate a needle insertion depth of 8.02 cm (skin to stone) at an angle of 30 degrees.

[0052] As described above, system 200 may allow a doctor or other user to identify and evaluate different access plans. System 200 may automatically identify one or more access plans (e.g., during image processing, step 403 of method 400) and / or may highlight various access plans upon user input. For example, a user may select different images and / or rotate a 3D representation of the kidney to evaluate different paths to reach a stone, and may draw or highlight a selected access plan by dragging a digit (finger or thumb) or a stylus across the screen. After detecting a drag action, user device 202 and / or other components of system 200 may use an image recognition algorithm to identify / outline the entire path, e.g., identifying each access scenario in a different color. The user may select a desired access plan, and then user device 202 and / or other components of system 200 may generate a “final” access plan including the position, depth, and one or more trajectory angles of the needle relative to the skin surface where the needle should be inserted with minimal harm to the patient to reach the kidney and the stone.

[0053] In some embodiments, user device 202 may allow a user to generate and print a patient template to assist in performing the PCNL procedure. Figure 7A and Figure 7B A patient template 700 is shown in accordance with some aspects of the present disclosure. For example, patient template 700 may include one or more markers 705 to indicate the position for inserting the needle 730 and one or more markers 707 to indicate the trajectory of the needle 730 according to the access plan generated by system 200. For example, a first marker 705 (e.g., an X) may identify the position for inserting the needle 730, and a second marker 707 (e.g., a line) away from the first marker 705 may identify the trajectory of the needle 730 to follow for one insertion. For example, system 200 may generate an access plan with a 30-degree angle (see Figure 5 and Figure 6 ), which may correspond to the angle that the needle should form with the patient 750 when aligned with the second marker 707 and inserted at the first marker 750. In some embodiments, one or more trajectory angles of the needle 730 may be printed on the patient template 700. In some embodiments, the insertion site of the needle 730 may also be indicated by an imaging device light source (e.g., a light source coupled to or incorporated into the X-ray tube 308 of the mobile C-arm device 300, as Figure 3 shown) for use during the PCNL procedure.

[0054] Patient template 700 may include one or more additional markers to provide a reference for placing the patient template 700 correctly on the patient 750. Figure 7ATwo reference markers 715 are shown, represented as curves in this example, to assist in positioning the patient template 700 relative to anatomical features such as the patient's ribs or vertebrae, the positions of which can be derived from CT data and palpated preoperatively. The patient template 700 can be positioned on the patient such that the reference markers 715 match their respective anatomical features to serve as landmarks for the correct orientation of the patient template 700.

[0055] Additionally or alternatively, the patient template 700 can include reference markers 713 to align with corresponding reference markers (e.g., radiopaque fiducial points) placed externally on the patient's skin. For example, one or more reference markers placed at discrete locations on the patient can be visible during imaging and provide additional triangulation information for the correct insertion of the needle 730.

[0056] The type and position of any reference markers 713, 715 of the patient template 700 can be automatically generated by the user device 202 and / or other components of the system 200, or can be added to the user device 202 via user input. Additionally, the patient template 700 can include other information as needed, such as to confirm that the patient template 700 is being used with the correct patient 750.

[0057] The patient template 700 can be printed on a sheet of porous material (e.g., gauze or polymeric mesh fabric) for transferring the template to the patient 750. The material on which the patient template 700 is printed can be non-sterile. As Figure 7B shown, the various markers 705, 707, 713, 715 can then be traced and transferred to the patient 750. The markers 705, 707, 713, 715 can remain visible after the patient 750 is scrubbed to render the surgical environment sterile for the PCNL procedure.

[0058] In view of the description and practice of the embodiments disclosed herein, other embodiments of the present disclosure will be apparent to those skilled in the art. Although certain features of the present disclosure are discussed in the context of exemplary systems, devices, and methods, the present disclosure is not limited thereto and includes alternatives and variations of the examples herein in accordance with the general principles disclosed. It is intended that the specification and examples be considered only as exemplary, with the true scope and spirit of the present disclosure being indicated by the following claims.

Claims

1. An apparatus for determining a patient-specific surgical access plan for a medical procedure using at least one computer system, the at least one computer system being configured to: Receive a plurality of radiographic images of a patient's anatomy; Process the plurality of radiographic images to generate a three-dimensional representation of the anatomy; Identify an object in the three-dimensional representation; Provide to a user device the three-dimensional representation and a prompt for display on the user device, the prompt requesting user input via the user device to confirm the object and identify at least a portion of the access plan for performing the medical procedure to remove the object, wherein providing the prompt requesting user input is based on a selection of a menu option via a user interface displaying the three-dimensional representation; Receive via the user device the user input confirming the object and identifying the portion of the access plan on the displayed three-dimensional representation; Identify at least one access plan for performing the medical procedure based on the user input, wherein the at least one access plan includes the portion of the access plan identified by the user input; and Provide the three-dimensional representation including the at least one access plan to the user device for display.

2. The apparatus according to claim 1, wherein, Identifying the object in the three-dimensional representation includes: Determining one or more characteristics of the object, the one or more characteristics including the size of the object, the density of the object, the composition of the object, the location of the object, or the orientation of the object.

3. The apparatus according to claim 2, wherein, Identifying the at least one access plan for performing the medical procedure is further based on the one or more characteristics of the object.

4. The apparatus according to claim 1 or 2, wherein, The at least one computer system is further configured to: Receive user input from the user device for manipulating the three-dimensional representation; and Provide the three-dimensional representation corresponding to the manipulation to the user device for display.

5. The apparatus according to claim 1 or 2, wherein, The at least one computer system is further configured to: Receive patient data associated with the patient; and Provide at least a portion of the patient data to the user device for display in association with the three-dimensional representation.

6. The apparatus according to claim 5, wherein, The at least one computer system is further configured to: Receive patient data associated with a plurality of other patients; Compare the patient data associated with the patient with the patient data associated with the plurality of other patients to identify one or more reference patient profiles; and Further identify the at least one access plan for performing the medical procedure based on the one or more reference patient profiles.

7. The apparatus according to claim 1 or 2, wherein, The at least one access plan includes an insertion site, and the at least one computer system is further configured to: Generate a patient template indicating the insertion site.

8. The apparatus according to claim 7, wherein, The patient template includes a first marker identifying a location for inserting a needle and a second marker identifying the needle trajectory after insertion.

9. The apparatus according to claim 1 or 2, wherein, the at least one access plan includes an insertion site, and the at least one computer system is further configured to: provide the location of the insertion site to an imaging device, the imaging device including a light source operable to direct light to the location of the insertion site.

10. The apparatus according to claim 1 or 2, wherein, the anatomical structure includes a kidney and surrounding anatomical structures, the subject includes a kidney stone, and the medical procedure is percutaneous nephrolithotomy or percutaneous nephroscopy.

11. An apparatus for determining a patient-specific surgical access plan for a medical procedure using at least one computer system, the at least one computer system being configured to: receive a plurality of radiographic images of a patient's anatomical structure; process the plurality of radiographic images to generate a three-dimensional representation of the anatomical structure; provide the three-dimensional representation to a user device for display; automatically identify an object in the three-dimensional representation or receive one of user inputs identifying the object in the three-dimensional representation, wherein the object is to be removed as part of the medical procedure; based on a selection of menu options via a user interface displaying the three-dimensional representation on the user device, determine and provide to the user device one or more characteristics of the object identified in the three-dimensional representation for display, wherein the one or more characteristics of the object include the size of the object, the density of the object, the composition of the object, or the orientation of the object; receive user input from the user device, the user input identifying a portion of the access plan for performing the medical procedure on the displayed three-dimensional representation; using one or more image recognition processes, automatically identify the remaining portion of the access plan for performing the medical procedure based on the portion of the access plan identified by the user input, wherein automatically identifying the remaining portion of the access plan is further based on one or more characteristics of the object; and provide the three-dimensional representation including the overall access plan to the user device for display, the overall access plan including the portion of the access plan identified by the user input and the remaining portion.

12. The apparatus according to claim 11, wherein, automatically identify the object in the three-dimensional representation, and the at least one computer system is further configured to: provide a prompt for display to the user device, the prompt requesting user input via the user device to confirm the object.

13. The apparatus according to claim 11, wherein, the at least one computer system is further configured to: receive patient data associated with the patient; receive patient data associated with a plurality of other patients; and compare the patient data associated with the patient with the patient data associated with the plurality of other patients to identify one or more reference patient profiles, wherein automatically identifying the remainder of the access plan is further based on the one or more reference patient profiles.

14. The apparatus according to claim 11, wherein, the at least one computer system is further configured to: receive user input for manipulating the displayed three-dimensional representation from the user device; and provide the three-dimensional representation corresponding to the manipulation to the user device for display.

15. The apparatus according to claim 11, wherein, the access plan includes positions for inserting needles, and the at least one computer system is further configured to at least one of the following: generate a patient template that at least indicates the positions for inserting needles of the patient to be printed and transferred before the medical procedure; or provide the positions for inserting needles to an imaging device that includes a light source operable to direct light to the positions during the medical procedure.

16. An apparatus for determining a patient-specific surgical access plan for a medical procedure using at least one computer system, the at least one computer system being configured to: receive a plurality of radiography images of a patient's anatomy; process the plurality of radiography images to generate a three-dimensional representation of the anatomy; provide the three-dimensional representation to a user device for display on a user interface including a plurality of menu options; in response to receiving an indication of a selection of a first menu option among the plurality of menu options via the user interface from the user device, provide a prompt to the user device for display on the user interface, the prompt requesting confirmation via the user interface of an object identified in the three-dimensional representation; in response to receiving an indication of a selection of a second menu option among the plurality of menu options via the user interface from the user device, determine and provide one or more characteristics of the object to the user device for display on the user interface; receive user input from the user device that identifies a portion of the access plan for performing the medical procedure on the displayed three-dimensional representation; using one or more image recognition processes, automatically identify a plurality of access plans for performing the medical procedure based on the portion of the access plan identified by the user input, each of the plurality of access plans including the portion of the access plan identified by the user input and different options for the remainder of the access plan; provide the three-dimensional representation including each of the plurality of access plans to the user device for display; receive user input from the user device that selects one of the plurality of displayed access plans; and provide the three-dimensional representation including the selected one of the plurality of access plans to the user device for display.

17. The apparatus according to claim 16, wherein, the at least one computer system is further configured to: automatically identify the object in the three-dimensional representation or receive one of additional user input that identifies the object in the three-dimensional representation, wherein the object is to be removed as part of the medical procedure; One or more features of the object include the size of the object, the density of the object, the composition of the object, the location of the object, or the orientation of the object, and wherein the automatic identification of the plurality of access plans for performing the medical procedure is further based on the one or more features of the object.

18. The apparatus according to claim 17, wherein, the object in the three-dimensional representation is automatically identified, and the at least one computer system is further configured to: provide a prompt for display to the user device, the prompt requesting an input via the user device to confirm the object.

19. The apparatus according to claim 16 or 17, wherein, the selected one of the plurality of access plans includes a location for inserting a needle, and the at least one computer system is further configured to perform at least one of the following: generate a patient template that at least indicates the location for inserting the needle of the patient to be printed and transferred before the medical procedure; or provide the location for inserting the needle to an imaging device, the imaging device including a light source operable to direct light to the location during the medical procedure.

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