阅读说明：本技术 用于实时波束雕刻术中放射治疗处理计划的系统和方法 (System and method for radiation therapy treatment planning in real-time beam sculpting ) 是由 凯尔曼·费雪曼 约纳坦·瓦伊纳 于 2019-10-21 设计创作，主要内容包括：用于放射治疗的系统和方法。所述方法包括：使用机器人雕刻波束放射处理系统(RCBRTS)获取处理区域的图像；通过可移动计算平台(MCP)在GUI中呈现所述图像；根据用户通过GUI向MCP的输入,为患者创建实时波束雕刻处理处理计划(RTBSTP)；使用GUI的虚拟测量部件(其中虚拟测量部件同时提供与患者的解剖结构和RTBSTP相关联的距离测量和放射剂量沉积测量)来验证RTBSTP的预期有效性；使用横截面3D视图和/或AR视图验证最终处理处理计划；对RCBRTS进行编程,使得根据RTBSTP提供放射治疗交付；设置RCBRTS,以便将其一部分插入医疗过程中形成的腔中；和/或通过RCBRTS执行操作以向患者施加放射。(Systems and methods for radiation therapy. The method comprises the following steps: acquiring an image of a treatment area using a robotic sculpted beam radiation processing system (RCBRTS); rendering, by a Movable Computing Platform (MCP), the image in a GUI; creating a real-time beam sculpting treatment plan (RTBSTP) for the patient based on the user input to the MCP via the GUI; verifying an expected effectiveness of the RTBSTP using a virtual measurement component of the GUI, wherein the virtual measurement component provides both distance measurements and radiation dose deposition measurements associated with the patient's anatomy and the RTBSTP; validating the final treatment plan using the cross-sectional 3D view and/or the AR view; programming the RCBRTS to provide radiation therapy delivery in accordance with RTBSTP; configuring the RCBRTS to insert a portion thereof into a lumen formed during a medical procedure; and/or performing an operation to deliver radiation to the patient via RCBRTS.)

1. A method for radiation therapy, comprising:

acquiring at least one image of the treatment region using a robotic sculpted beam radiation treatment system;

presenting, by the mobile computing platform, the at least one image in a Graphical User Interface (GUI);

creating a real-time beam sculpting treatment plan for the patient based on user input to the movable computing platform through the GUI;

verifying an expected validity of the real-time beam sculpting treatment plan using a virtual measurement component of the GUI, wherein the virtual measurement component simultaneously provides distance measurements and radiation dose deposition measurements associated with the patient's anatomy and the real-time beam sculpting treatment plan;

programming a robotic beam sculpting radiation treatment system to provide radiation treatment delivery according to the real-time beam sculpting treatment plan; and

performing an operation by a real-time beam sculpting radiation treatment system to apply radiation to the patient.

2. The method of claim 1, wherein the at least one image comprises a Digital Tomosynthesis (DT) scan, a Computed Tomography (CT) scan image, a Magnetic Resonance Imaging (MRI) image, or a Positron Emission Tomography (PET) scan image.

3. The method of claim 1, wherein the radiation is applied to the patient prior to inserting the robotic sculpted radiation treatment system into a cavity formed during a medical procedure.

4. The method of claim 1, wherein the at least one image is acquired using an X-ray system.

5. The method of claim 4, wherein the X-ray system:

precisely controlling the position of an X-ray source relative to the patient using a robotic arm;

obtaining a plurality of two-dimensional X-ray projection images of the patient from a plurality of different angles using an X-ray detector as the X-ray source is moved on a predetermined path by a robotic arm;

while obtaining each of the two-dimensional X-ray projection images, determining a position of the X-ray radiation source relative to an X-ray detector panel while moving the X-ray radiation source along the predetermined path by the robot arm; and

processing the plurality of two-dimensional X-ray projection images and the determined positions in a computer system to perform a digital tomosynthesis reconstruction in which a cross-sectional or slice image of the patient is reconstructed from the plurality of two-dimensional X-ray projection images that have been acquired;

wherein the X-ray radiation source is moved along a predetermined path by selectively controlling a plurality of joint positions associated with a plurality of joints, each of the plurality of joints associated with the robotic arm.

6. The method of claim 5, wherein the X-ray system further:

repositioning the X-ray radiation source with respect to the patient using the robotic arm such that the X-ray radiation source is placed in a treatment position with respect to the patient; and

activating the X-ray source when the X-ray source is in the treatment position to perform a therapeutic X-ray treatment on the patient.

7. The method of claim 6, wherein the therapeutic X-ray treatment is an intra-operative radiotherapy treatment.

8. The method of claim 6 wherein the X-ray radiation source is controlled to generate a first X-ray beam pattern for obtaining the two-dimensional X-ray projection images and a second X-ray beam pattern for the therapeutic X-ray treatment.

9. The method of claim 6 wherein the X-ray radiation source is controlled to produce an X-ray beam having a first X-ray beam intensity for obtaining the two-dimensional X-ray projection images and a second X-ray beam intensity for performing the therapeutic X-ray treatment, the first X-ray beam intensity being different from the second X-ray beam intensity.

10. The method of claim 5, wherein the predetermined path defines an arc having a center angle between 15 ° and 40 °.

11. The method of claim 7, wherein a deformable image fusion operation is performed in which the preoperative volumetric imaging of the patient is deformably fused with the plurality of two-dimensional X-ray projection images obtained using DT.

12. The method of claim 1, wherein the deformable image fusion operation is performed after the medical procedure has been performed on the patient, but immediately prior to performing an intra-operative radiation treatment procedure on the patient.

13. The method of claim 12, wherein the deformable image fusion operation includes fusing the pre-operative volume imaging with the intra-operative DT imaging to combine higher quality pre-operative volume imaging with lower quality but more recent results obtained using intra-operative DT imaging.

14. The method of claim 13, wherein the deformable image fusion operation is directed using a deep learning technique.

15. The method of claim 1, wherein a 3D sculpting beam tool is used in addition to the virtual measurement component to verify the expected validity of the real-time beam sculpting treatment plan.

16. The method of claim 15, wherein the 3D sculpted beam tool presents the cross-sectional anatomy of the patient as well as an isocenter and a radiation source.

17. The method of claim 16, wherein the rendered 3D iso-sphere presents a distribution of radiation inside the patient's anatomy that forms a shape of a beam.

18. The method of claim 17, wherein the 3D sculpted beam tool allows a user to see how dose or beam will be distributed within the patient during treatment, or allows the user to fine-tune the position and orientation of a radiation source if any corrections are needed to deliver the radiation more accurately.

19. A system, comprising:

a processor; and

a non-transitory computer-readable storage medium comprising programming instructions configured to cause the processor to implement a method for radiation therapy, wherein the programming instructions comprise instructions that cause:

acquiring at least one image of the treatment region using a robotic sculpted beam radiation treatment system;

presenting the at least one image in a Graphical User Interface (GUI) of the movable computing platform;

creating a real-time beam sculpting treatment plan for the patient according to the input facilitated by the user through the GUI;

receiving a user input indicating that an expected validity of the real-time beam sculpting treatment plan is verified using a virtual measurement component of the GUI, wherein the virtual measurement component simultaneously provides distance measurements and radiation dose deposition measurements associated with the patient's anatomy and the real-time beam sculpting treatment plan;

programming a robotic beam sculpting radiation treatment system to provide radiation treatment delivery according to the real-time beam sculpting treatment plan; and

performing an operation by a real-time beam sculpting radiation treatment system to apply radiation to the patient.

20. The system of claim 19, wherein the at least one image comprises a Digital Tomosynthesis (DT) scan, a Computed Tomography (CT) scan image, a Magnetic Resonance Imaging (MRI) image, or a Positron Emission Tomography (PET) scan image.

21. The system of claim 19, wherein the radiation is applied to the patient prior to inserting the robotic sculpted radiation treatment system into a cavity formed during a medical procedure.

22. The system of claim 19, wherein the at least one image is acquired using an X-ray system.

23. The system of claim 22, wherein the X-ray system:

accurately controlling the position of the X-ray source relative to the patient using a robotic arm;

obtaining a plurality of two-dimensional X-ray projection images of the patient from a plurality of different angles using an X-ray detector as the X-ray source is moved on a predetermined path by a robotic arm;

while obtaining each of the two-dimensional X-ray projection images, determining a position of the X-ray radiation source relative to an X-ray detector panel while moving the X-ray radiation source along the predetermined path by the robot arm; and

processing the plurality of two-dimensional X-ray projection images and the determined positions in a computer system to perform a digital tomosynthesis reconstruction in which a cross-sectional or slice image of the patient is reconstructed from the plurality of two-dimensional X-ray projection images that have been acquired;

wherein the X-ray radiation source is moved along a predetermined path by selectively controlling a plurality of joint positions associated with a plurality of joints, each of the plurality of joints associated with the robotic arm.

24. The system of claim 23, wherein the X-ray system further:

repositioning the X-ray radiation source with respect to the patient using the robotic arm such that the X-ray radiation source is placed in a treatment position with respect to the patient; and

activating the X-ray source when the X-ray source is in the treatment position to perform a therapeutic X-ray treatment on the patient.

25. The system of claim 24, wherein the therapeutic X-ray treatment is an intra-operative radiation therapy treatment.

26. The system of claim 24 wherein the X-ray radiation source is controlled to generate a first X-ray beam pattern for obtaining the two-dimensional X-ray projection images and a second X-ray beam pattern for the therapeutic X-ray treatment.

27. The method of claim 24 wherein the X-ray radiation source is controlled to produce an X-ray beam having a first X-ray beam intensity for obtaining the two-dimensional X-ray projection images and a second X-ray beam intensity for performing the therapeutic X-ray treatment, the first X-ray beam intensity being different from the second X-ray beam intensity.

28. The system of claim 23, wherein the predetermined path defines an arc having a center angle between 15 ° and 40 °.

29. The system of claim 28, wherein a deformable image fusion operation is performed in which the preoperative volumetric imaging of the patient is deformably fused with the plurality of two-dimensional X-ray projection images obtained using DT.

30. The system of claim 29, wherein the deformable image fusion operation is performed after the medical procedure has been performed on the patient, but immediately prior to an intra-operative radiation treatment procedure being performed on the patient.

31. The system of claim 29, wherein the deformable image fusion operation includes fusing the pre-operative volume imaging with the intra-operative DT imaging to combine higher quality pre-operative volume imaging with lower quality but more recent results obtained using intra-operative DT imaging.

32. The system of claim 31, wherein the deformable image fusion operation is directed using a deep learning technique.

33. The system of claim 19, wherein a 3D sculpting beam tool is used in addition to the virtual measurement component to verify the expected validity of the real-time beam sculpting treatment plan.

34. The system of claim 33, wherein the 3D sculpted beam tool presents the cross-sectional anatomy of the patient as well as an isocenter and a radiation source.

35. The system of claim 34, wherein the rendered 3D iso-sphere presents a distribution of radiation inside the patient's anatomy that forms a shape of a beam.

36. The system of claim 35, wherein the 3D sculpted beam tool allows a user to see how dose or beam will be distributed within the patient during treatment, or allows the user to fine-tune the position and orientation of a radiation source if any corrections are needed to deliver the radiation more accurately.

Technical Field

The present disclosure relates generally to computing systems. More particularly, the present disclosure relates to delivery systems and methods for radiation therapy treatment planning in real-time beam sculpting.

Background

Ionizing radiation is commonly used for different purposes in the medical field. One such application relates to medical imaging. There are many different types of medical imaging techniques, each using different techniques and methods to obtain the desired imaging product. The most basic of these are conventional radiography or X-ray imaging, which uses ionizing radiation to generate images of the human body. In conventional radiography, a single image is recorded for later evaluation. In Computed Tomography (CT) systems, sometimes also referred to as Computed axial Tomography (Computed axial Tomography) or CAT, a number of X-ray images are recorded as the detector moves around the patient's body. The computer reconstructs all individual images into cross-sectional images or "slices" of internal organs and tissues. For CT, a motorized table moves a patient through a circular opening in a CT imaging system while an X-ray source and detector assembly in the system are rotated around the patient. An X-ray source generates a narrow fan-shaped beam of X-ray radiation that traverses a portion of the patient's body, and a detector opposite the X-rays records the X-rays that traverse the patient's body to form a scan. This scan is then used in the process of creating the image. During one full revolution of the detector assembly, many different "scans" (through the patient from multiple angles) are collected. For each rotation of the X-ray source and detector assembly, the image data is sent to a computer to reconstruct all the individual scans into one or more cross-sectional images (slices) of the internal organs and tissues. The reconstruction is performed using the inverse Radon transform.

Digital Tomosynthesis (DT) is an imaging technique similar to CT. For DT, a plurality of two-dimensional (2D) projection images of an object (e.g. a patient) are obtained from a plurality of different angles while the X-ray source is moved over a predetermined path, again using ionizing radiation (e.g. X-ray radiation). From these projection images, the computer system reconstructs a cross-sectional image or slice image of the object. One difference between CT and DT is the angular range used. For example, in the case of DT, the total angular range of movement is typically less than 40 °. In this sense, DT can be considered a form of limited angle tomography. In conventional DT systems, image reconstruction is typically obtained using a technique known as Filtered Back Projection (FBP). FBP is a type of inverse Radon transform, as is well known.

Another purpose of using ionizing radiation in a medical environment involves the therapeutic treatment of patients. For example, radiation is often used to destroy cancer cells so that they no longer grow and spread within the patient. An example of one particular type of Radiation Therapy is intra-operative Radiation Therapy (IORT). IORT is a well known radiation treatment applied to the tumor bed during surgery. This process is intended to destroy any cancer cells that may remain in the tumor bed after the tumor is removed. Another type of radiation therapy is Brachytherapy (Brachytherapy), which is used to treat cancer by positioning a radiation source within the body of a cancer patient.

Disclosure of Invention

The present disclosure relates to systems and methods for radiation therapy. The method comprises the following steps: acquiring at least one image of a treatment region (e.g., a DT scan, a CT scan image, a Magnetic Resonance Imaging (MRI) image, or a Positron Emission Tomography (PET scan) image) using a robotic sculpted beam radiation treatment system (e.g., an X-ray system), presenting the at least one image in a Graphical User Interface (GUI) via a movable computing platform, creating a real-time beam sculpting treatment plan for a patient based on user input to the movable computing platform via the GUI, verifying an expected validity of the real-time beam sculpting treatment plan using a virtual measurement component of the GUI (wherein the virtual measurement component simultaneously provides distance measurements and radiation dose deposition measurements associated with an anatomy of the patient and the real-time beam sculpting treatment plan), programming the robotic beam sculpting radiation treatment system, to provide radiation treatment delivery according to the real-time beam sculpting treatment plan; and/or performing an operation by the real-time beam sculpted radiation treatment system to deliver radiation to the patient.

In some cases, the radiation is applied to the patient prior to inserting the robotic sculpted radiation treatment system into a cavity formed during a medical procedure. Additionally or alternatively, the at least one image is acquired using an X-ray system. The X-ray system: precisely controlling the position of an X-ray source relative to the patient using a robotic arm; obtaining a plurality of two-dimensional X-ray projection images of the patient from a plurality of different angles using an X-ray detector as the X-ray radiation source is moved through the robotic arm on a predetermined path; while obtaining each of the two-dimensional X-ray projection images, determining a position of the X-ray radiation source relative to an X-ray detector panel while moving the X-ray radiation source along the predetermined path by the robot arm; and processing the plurality of two-dimensional X-ray projection images and the determined positions in a computer system to perform a digital tomosynthesis reconstruction in which a cross-sectional or slice image of the patient is reconstructed from the plurality of acquired two-dimensional X-ray projection images. Moving the X-ray radiation source along the predetermined path by selectively controlling a plurality of joint positions associated with a plurality of joints, wherein each of the plurality of joints is associated with the robotic arm.

The X-ray system may further: repositioning the X-ray radiation source with respect to the patient using the robotic arm such that the X-ray radiation source is placed in a treatment position with respect to the patient; and activating the X-ray radiation source when the X-ray radiation source is in the treatment position to perform a therapeutic X-ray treatment on the patient. The therapeutic X-ray treatment may include, but is not limited to, an intra-operative radiation treatment. The X-ray radiation source may be controlled to generate a first X-ray beam pattern for obtaining the two-dimensional X-ray projection images and a second X-ray beam pattern for the therapeutic X-ray treatment. The X-ray source may alternatively or additionally be controlled to generate an X-ray beam having a first X-ray beam intensity for obtaining the two-dimensional X-ray projection images and having a second X-ray beam intensity for performing the therapeutic X-ray treatment, the first X-ray beam intensity being different from the second X-ray beam intensity. The predetermined path may define an arc having a central angle between 15 ° and 40 °.

In some cases, a deformable image fusion operation is performed in which the preoperative volumetric imaging of the patient is deformably fused with the plurality of two-dimensional X-ray projection images obtained using DT. The deformable image fusion procedure may be performed after the medical procedure has been performed on the patient, but immediately prior to performing an intra-operative radiation treatment procedure on the patient. The deformable image fusion procedure includes fusing the pre-operative volume imaging with the intra-operative DT imaging to combine higher quality pre-operative volume imaging with lower quality but more recent results obtained using intra-operative DT imaging. The deformable image fusion operation may be guided using deep learning or other artificial intelligence techniques.

In these or other cases, a 3D sculpting beam tool is used in addition to the virtual measurement component to verify the expected validity of the real-time beam sculpting process plan. The 3D sculpted beam tool presents the cross-sectional anatomy of the patient as well as an iso-sphere and a radiation source. The rendered 3D iso-sphere presents a distribution of radiation inside the patient's anatomy that forms the shape of a beam. The 3D sculpted beam tool allows the user to see how the dose or beam will be distributed within the patient during treatment. The 3D sculpted beam tool also allows the user to fine-tune the position and orientation of the radiation source in the event that any corrections are needed to deliver the radiation more accurately.

Drawings

The present solution will be described with reference to the following drawings, wherein like reference numerals refer to like items throughout.

Fig. 1 is a diagram of an illustrative system.

Fig. 2 is a diagram of an illustrative processing system.

Fig. 3 is a diagram for understanding an implementation of a robotic X-ray system.

Fig. 4 is a block diagram for understanding the architecture of a robotic X-ray system.

FIG. 5 is a block diagram useful in understanding certain aspects of a control system that may be used to perform certain processing operations associated with the robotic X-ray system described herein.

Figure 6 is a schematic diagram useful for understanding a controlled beam X-ray source that may be used with a robotic X-ray system.

Fig. 7 is an example of a first beam pattern that may be created using a steered beam X-ray source.

Fig. 8 is an example of a second beam pattern that may be created using a steered beam X-ray source.

Fig. 9-12 are a series of diagrams useful in understanding the process of tomosynthesis using a robotic X-ray system.

Fig. 13 is a diagram for understanding a scanning angle range that can be used by the robotic X-ray system when performing tomosynthesis operations.

Fig. 14A and 14B (collectively referred to herein as "fig. 14") provide a series of diagrams useful in understanding certain X-ray system components that facilitate DT operation.

Fig. 15 is a diagram for understanding how therapeutic X-ray processing is performed using the robotic X-ray system (when it is not used for tomosynthesis imaging).

FIG. 16 is a diagram of an illustrative architecture for a computing device.

Fig. 17-24 each provide a screenshot of an illustrative GUI for creating a treatment plan for a patient.

FIG. 25 provides a flow chart of an illustrative method for creating a treatment plan for a patient.

26A-26B (collectively referred to herein as FIG. 26) provide a flow diagram of another illustrative method for creating a treatment plan for a patient.

FIG. 27 provides a screenshot of an illustrative GUI for accessing and selecting a patient from a patient roster.

FIG. 28 provides a screenshot of an illustrative GUI for loading an image archived from a remote computing device to a local system.

FIG. 29 provides a screenshot of an illustrative GUI for assigning an image file to a patient.

FIG. 30 provides a screenshot of an illustrative GUI for selecting an image file for a process planning program.

FIG. 31 provides a screenshot of an illustrative GUI for entering a name for a processing plan.

Fig. 32 provides a screenshot of an illustrative GUI displaying images in various anatomical imaging modality views.

FIG. 33 provides a screenshot of an illustrative GUI for understanding how fiducial marker positions are set.

Fig. 34 provides a screen shot of an illustrative GUI showing balloon volume adjustment.

35-36 provide screenshots of illustrative GUIs showing how a user selects an operation point using a control.

Fig. 37 provides a screenshot of an illustrative GUI showing the isodose line profile in the open state.

Fig. 38 provides a screenshot of an illustrative GUI showing the isodose line profile in the off state.

FIG. 39 provides a screenshot of an illustrative GUI showing controls that can be used to turn a color wash on and off.

Fig. 40 provides a screenshot of an illustrative GUI showing additional intermediate dose boundaries.

FIG. 41 provides a screenshot of an illustrative GUI showing the ruler in an open state.

42-43 provide screenshots of illustrative GUIs showing a ruler scrolled to different positions or locations of a displayed image.

FIG. 44 provides a screenshot of an illustrative GUI useful for understanding how a grayscale value may be set.

FIG. 45 provides a screenshot of an illustrative GUI useful for understanding how distance measurements are made.

46-49 provide screenshots of illustrative GUIs showing how a user marks a contour using a control and compares the marked contour to a calculated contour.

FIG. 50 provides a screenshot of an illustrative GUI showing reconstructed coronal and sagittal plane images.

Fig. 51-59 provide screenshots of illustrative GUIs for understanding a 3D sculpting beam tool to validate a treatment plan.

FIGS. 60-68 provide screenshots of illustrative GUIs showing the use of an Augmented Reality (AR) tool to validate a treatment plan.

Detailed Description

It will be readily understood that the components of the embodiments, as generally described herein, and illustrated in the figures, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure, but is merely representative of various embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

The present solution may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the solution is, therefore, indicated by the appended claims rather than by the foregoing detailed description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Reference throughout this specification to features, advantages, or similar language does not imply that: all of the features and advantages that may be realized with the present solution should be or are in a single embodiment of the solution. Rather, language referring to the features and advantages is understood to mean: the particular features, advantages, or characteristics described in connection with the embodiments are included in at least one embodiment of the present disclosure. Thus, discussion of the features and advantages, and similar language, throughout this specification may, but do not necessarily, refer to the same embodiment.

Furthermore, the described features, advantages, and characteristics of the present solution may be combined in any suitable manner in one or more embodiments. One skilled in the relevant art will recognize, in light of the description herein, that the present solution may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments of the solution.

Reference throughout this specification to "one embodiment," "an embodiment," or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present solution. Thus, the phrases "in one embodiment," "in an embodiment," and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.

As used herein, the singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As used herein, the term "including" means "including but not limited to".

The present solution generally relates to a treatment planning system specifically designed for 3D beam sculpting radiation therapy systems. The system comprises: a computational algorithm derived directly from the beam sculpting hardware structure and physics, rather than a general beam simulator. The algorithm uniquely and accurately simulates the particle beam trajectory produced by the specific hardware and physics of the beam sculpting X-ray source. The treatment planning system and method is unique and specific to the beam sculpting X-ray source, which essentially simulates and renders the causes and effects of the X-ray beam to accurately simulate the beam sculpted treatment delivery system. Most current systems model electrons that strike, for example, tungsten atoms, resulting in isotropic X-ray photon release. The algorithm calculates a unique target hardware structure and physics to simulate the 3D beam sculpting effect as, for example, the effect of the location where the electron beam hits the diamond target and the segmentation and collimation effects of the molybdenum diaphragm.

The present solution is configured to provide a real-time beam sculpting IORT process plan. The present solution is implemented in a system such as that shown in fig. 1. As shown in fig. 1, the system 100 includes a computing device 102 communicatively coupled to a server 108 and/or a processing system 106 via a network 104 (e.g., the internet or an intranet). The network may be a wired network or a wireless network. Computing device 102 includes, but is not limited to, a personal computer, laptop computer, smart device, tablet device (e.g., iPhone, iPad,Surface^TMorDevice) or any other portable computing device. The server 108 and the processing system 106 are also communicatively coupled to each other via the network 104. An illustrative architecture for processing system 106 will be discussed below in conjunction with fig. 2. An illustrative architecture for computing device 102 and/or server 108 will be discussed below in conjunction with FIG. 3。

During operation, a user of the computing device 102 creates a treatment plan for a patient for whom radiation therapy is to be administered. The user can verify the expected effect of the treatment plan using the new functionality of the present solution. The novel features typically include a dynamic virtual measurement component (e.g., a ruler) that is presented on and controlled by a control of the GUI. The GUI and dynamic virtual measurement components are discussed below in conjunction with fig. 4-11. Notably, the GUI and the dynamic virtual measurement component are provided using a software program installed on the computing device 102 or are run by a software program installed on the server 108.

Referring now to FIG. 2, a diagram of the illustrative processing system 200 of FIG. 1 is provided. The processing system 106 of fig. 1 may be the same as or similar to the processing system 200. Treatment system 200 is the same as or substantially similar to that described in U.S. patent application No. 15/488071, U.S. patent application No. 15/649361, U.S. patent application No. 15/941547, U.S. patent application No. 16/038807, and/or U.S. patent application No. 16/103241. Each of these listed U.S. patent applications is incorporated by reference herein in its entirety.

Another illustrative processing system 300 will now be discussed with respect to fig. 3-15. The processing system 106 of fig. 1 may be the same as or similar to the processing system 300. The processing system 300 includes an X-ray device. X-ray devices are used in the medical field for imaging and therapeutic purposes. The different nature of these tasks and the corresponding differences in the technical requirements associated with such devices are such that: devices designed for X-ray imaging are not typically used to perform therapeutic treatments. However, new advances in robotics and X-ray sources have the potential to facilitate X-ray devices that can be used for a variety of purposes, which can include tasks related to tomosynthesis imaging and therapeutic processing. Accordingly, the robotic X-ray system disclosed herein includes an X-ray generation system and includes an X-ray treatment head secured to a movable end of a robotic arm. When the X-ray generation system is activated, X-ray energy is emitted or radiated from the treatment head. In some cases, the X-ray treatment head may be disposed at a tip of an elongated applicator body that is secured to the robotic arm by a base. By controlling the position of one or more robotic arm joints, the robotic arm may control the position of the treatment head relative to the patient. When combined with the special features of the X-ray source described herein, an accurate and adaptable robotic arm allows such a system to be used for performing medical imaging. With advanced control systems, this imaging can be extended to include Digital Tomography (DT). Furthermore, the high degree of adaptability of the robotic arm and X-ray source in such X-ray systems may allow the same system to be used to perform therapeutic X-ray treatments, including but not limited to IORT.

The X-ray system 300 as shown in fig. 3 comprises: a portable base unit or cart 302 (e.g., a mobile cart on casters) to which a robotic arm 304 is attached. The head unit 306 is secured to a first end of the robotic arm 304 that is distal from a second end of the robotic arm 304 that is attached to the portable base unit 302. Head unit 306 includes an X-ray source that is part of an X-ray system that generates X-ray radiation. The power and control unit (including the robotic arm) for the X-ray system may be integrated within the base unit 302.

A solid-state X-ray imaging array 308 is provided as part of the system. In some cases, the solid-state X-ray imaging array 308 may be separate from the base unit 302, as shown in fig. 3. However, in other cases, the solid-state X-ray imaging array 308 may be an integral part of the base unit 302 (e.g., on wheels and/or with a robotic arm) that may extend from the base unit 302. The solid-state X-ray imaging array 308 is communicatively coupled to the X-ray system 300 by a wired or wireless communication link. The purpose of the imaging array will be discussed in more detail below.

The base unit 302 is advantageously a compact unit, such as having a 30 "by 48" footprint, and may be mounted on casters 310 for ease of maneuvering. The base unit 302 may include a power cord (not shown) for optionally providing power to all components mounted in the base unit 102 or connected to the base unit 102. In this regard, the base unit 302 may contain one or more components of an X-ray system, which is described in further detail below with reference to fig. 4. For example, the display device 312 is shown mounted to the base unit 302 to facilitate a user interface. Likewise, a user interface device (such as a keyboard, mouse, or touchpad) may be included in the base unit. In some cases, display device 312 may be associated with a computer workstation (not shown in FIG. 3).

A rigid mechanical support 314 is provided on the base unit 302 for mounting the robotic arm 304 in a fixed position on the base unit. In the solution proposed herein, the robotic arm 304 is used to control the position of the head unit 306 with high precision. Control of the position of head unit 306 is also used to control the position of processing head 316 from which X-ray energy is emitted during an X-ray session. The controlled position may be a stationary position in which the treatment head 316 does not move during the time that the X-ray radiation is applied. However, the robotic arm 304 may also facilitate predetermined movements or movements of the processing head during an X-ray session. In some cases, the movement may occur simultaneously with the application of the X-ray radiation. In other cases, the application of X-ray radiation may be temporarily interrupted when the robotic arm repositions the treatment head.

In some cases, an elongated X-ray applicator body 318 extends from a portion of the head unit 306 to the treatment head 316. Under the control of the control unit, the robotic arm 304 is articulated with a suitable mechanical joint or articulation member 320. Although not shown in fig. 3, more or fewer hinge members 320 may be provided at different points of the robotic arm 304. Such a hinge member 320 may add or subtract degrees of freedom for placing, orienting, and moving X-ray treatment head 316. In addition, the number of hinge members shown in fig. 3 is for convenience of explanation only. The present disclosure contemplates: any number of hinge points may be provided as needed to dynamically position and orient the X-ray treatment head 316 with respect to the patient, so as to provide any number of degrees of freedom in the robotic arm 304.

In some cases, the robotic arm 304 is a robotic system that provides degrees of freedom of movement about multiple orthogonal axes (e.g., up to seven axes) and includes lightweight force and torque sensors to ensure safe operation of a person without the need for safety fences. Such illustrative robots are commercially available from a variety of sources. For example, KUKA robot limited, augsburg, germany, manufactures a production line of lightweight robots capable of direct human machine cooperation (HRC) that are suitable for direct human machine interaction. These robots include the LBR iwa model and/or LBR iisy model produced by KUKA. Such robots are well suited for the fine operation described herein because they include advanced joint torque sensors in all six axes that can detect minimal external forces due to contact with objects and can respond by immediately reducing the force and velocity levels associated with robot motion. The robotic arm 304 will accurately maintain the position of the X-ray treatment head relative to the subject patient. To achieve this result, the robotic arm may be moved along multiple axes of motion (e.g., up to seven axes of motion) to maintain the relative position of the X-ray treatment head at a particular location and/or along a predetermined path of motion.

In some cases, the X-ray generation system is distributed between the base unit 302 and the head unit 306. Power and/or control signal conduits (not shown in fig. 3) may facilitate communication of power and/or control signals between the base unit 302 and the head unit 306. These signals may be used to control and facilitate operation of the X-ray generation system. In some cases, the high voltage cables, fluid conduits, and control circuitry may not be included as part of the robotic arm, but may include a separate control cable bundle that is simply attached to the X-ray treatment head.

Referring now to fig. 4, fig. 4 illustrates a high-level block diagram representation of an X-ray system 300, which is useful for understanding certain aspects of the approaches presented herein. The block diagram shows the major subsystems comprising the base unit 302, the robot arm 304, and the head unit 306 described with reference to fig. 3, and includes specific component details that may be distributed among these various subsystems. For example, the base unit may include a system power supply 430, an Internet Protocol (IP) camera base section 416, and a robotic arm control unit 418. The base unit 302 includes various base unit components associated with the X-ray generation system. For example, the base unit components include a high voltage power supply 428, an ion pump controller 422, a beam steering coil control 424, and a water cooling system base unit portion 420. In some cases, the water cooling system uses water as a coolant to carry heat away from certain components of the X-ray generation system described herein. Although referred to herein as a water cooling system, it should be understood that water is only one example of a suitable coolant that may be used for this purpose. As will be appreciated by those skilled in the art, other types of fluid coolants may also be used for this purpose.

A system controller 426 is provided to control the overall operation of the X-ray system 300. As such, the system controller 426 is communicatively connected to one or more of the IP camera base section 416, the robotic arm control unit 418, the water cooling system base unit portion 420, the ion pump controller 422, the system power supply 430, and the high voltage power supply 428.

Head unit 306 may include various head unit components associated with the X-ray generation system, including a water cooling system head unit portion 306 and an ion pump 308. As described in further detail below, the ion pump may comprise part of an Electron Beam Generator (EBG) for the X-ray source 410. The X-ray source 410 includes an electron beam steering coil (not shown in fig. 4) for assisting in shaping the X-ray beam. The ion pump 408 operates under the control of an ion pump controller 422 and the X-ray source 410 operates under the control of a beam steering coil control unit 424. In some cases, X-ray source 410 is configured such that X-ray radiation is emitted from processing head 316 disposed on a movable end of robotic arm 304. The X-ray generation system described herein may be configured to facilitate treatment of a patient according to various treatment methods now known or in the future (e.g., IORT and/or brachytherapy).

The water chiller head unit section 406 operates in conjunction with and under the control of the water chiller base unit section 420. For example, the water cooling system head unit portion 406 may be configured to facilitate the flow of cooling water (or any other suitable coolant) to one or more components associated with the X-ray generation system. The head unit 306 also includes an IP camera/sensor head unit 402, a laser field of view (FOV) projector component 404. The IP camera/sensor head unit 402 is configured to capture one or more images that are used to facilitate X-ray imaging and/or processing sessions. The purpose and function of the IP camera/sensor system (402, 416) will be described in more detail below.

Communication of data, fluid, and/or control signals between various components of the X-ray system 300 disposed in the base unit 302 and the head unit 306 may be facilitated by cables and/or conduits routed internally or externally to the robotic arm 403. For clarity, these cables and/or pipes are shown outside the robot arm in fig. 3, but it should be understood that the solution is not limited thereto.

The robotic arm 304 may include a plurality of robotic arm actuators 412 that determine the position of the articulation member 320 under the control of a robotic arm control unit 418. Although not shown in fig. 3, more or fewer robotic arm actuators 412 may be provided in the robotic arm 304 to facilitate movement with respect to each of the articulating members. In some cases, the robotic arm includes a plurality of joint position sensors 414. These position sensors are advantageously associated with the robot arm joint 320. In some cases, the system controller 426 may use the position information to determine the pose of the robotic arm. As explained in further detail below, this information may be used to determine the exact position and orientation of the X-ray radiation treatment head 316 relative to the X-ray detector panel and/or the person undergoing therapeutic radiation treatment. The robotic arm 304 also optionally includes one or more force sensors 415 for determining or sensing forces exerted on the robotic arm 304. These force sensors can be used to facilitate position tracking, thereby automatically adjusting the position of the robotic arms in response to patient movement (e.g., respiratory motion) that occurs during an X-ray treatment session.

The X-ray system 300 may be controlled by a computer workstation 434. To facilitate such control, the computer workstation 434 is configured to communicate with the system controller 426 by way of a suitable high-speed data connection. The computer workstation includes an operating system and suitable application software to facilitate the various systems and methods described herein. Computer workstations are well known in the art and will not be described in detail herein. It should be noted, however, that a computer workstation includes, but is not limited to, a computer processor, memory, a display screen that may be a touch screen (such as display screen 312 of fig. 3), one or more user interface components (e.g., a keyboard and/or pointing device (e.g., a mouse)), and network interface components to facilitate communication with the X-ray system 300. The X-ray system 300 may also be operatively coupled to a Radiation Therapy Planning (RTP) computer workstation 436 configured to facilitate therapeutic Radiation treatment Planning. Data communication between the X-ray system 300 and external computer systems, such as the workstation 434 and the RTP workstation 436, may be facilitated through the network router 432.

The various components of the system 300, including the X-ray generation system, can be controlled to be selectively optimized for therapeutic radiation treatment and/or certain patient imaging operations, as described below. In some cases, a Superficial Radiation Therapy (SRT) type of X-ray source may be used for this purpose. It will be appreciated that an SRT type of X-ray unit generates low energy X-rays suitable for the purpose. In other cases, the therapeutic treatment may involve brachytherapy.

In some cases, solid-state X-ray imaging array 308 may be used to capture 2D X radiographic projection images of a subject patient when the patient is exposed to X-rays generated by X-ray source 410. These 2D X ray projection images may be acquired at a number of different positions relative to the patient using the X-ray source. In this case, 2D X projection X-ray images are captured with X-ray source 410 positioned at a plurality of different angles (relative to the patient) as the X-ray source (e.g., X-ray tube) is moved through robotic arm 304 in a predetermined path. Solid-state X-ray imaging arrays are well known in the art and will not be described in detail herein. However, it should be understood that the captured 2D X ray projection images may be communicated to an onboard processing element (e.g., system controller 426), a separate image processing computer (e.g., workstation 434 and/or RTP workstation 436), and/or a data storage device (not shown) for later processing.

The X-ray system 300 is controlled and operated by a system controller 426. The system controller 426 includes, but is not limited to: a central computer with a motherboard running operations, control software that allows the system control 426 to control, communicate, and monitor the various subcomponents and modules of the X-ray system 300. This enables a harmonic functionality between the main clinical components of the X-ray system 300 including the X-ray generating components 408, 410, 422, 424 and the robotic arm 304.

The system controller 426 communicates with a machine-readable medium, which may be a static memory having stored thereon one or more sets of instructions (e.g., software) embodying any one or more of the methodologies or functions described herein, including those methodologies described herein. The instructions may also reside, completely or at least partially, within a system data store, static memory, or processor, or a combination thereof, during execution thereof by the X-ray system 300. The system data store, patient data store, and processor may also constitute machine-readable media.

Patient-related data and processing parameters, such as patient records, processing session details, and disease documents and photographs, may be stored in one or more patient data stores 440 communicatively coupled to the RTP workstation 436. System-related data and parameters, such as system logs, X-ray calibration data, and system diagnostic results, may be stored in a data repository 438 associated with the workstation 434. The patient data repository and the system data repository may be separate devices or physically combined. Both data stores may be mirrored and backed up to a secure and encrypted HIPAA compliant cloud storage medium.

Referring now to FIG. 5, a diagram of an illustrative computer system 500 is provided that may be used as the system controller 426 to control the robotic X-ray system 300 as described herein. Computer system 500 is also sufficient for understanding the illustrative architecture associated with one or more workstations described herein. Computer system 500 may include, but is not limited to: a machine (or computing device) running a suitable operating system (e.g., Windows, Linux, macOS, or other types of operating systems now known or known in the future). Such machines (or computing devices) are well known in the art and will not be described in detail herein. It should be understood, however, that such a machine is modified to implement all or a portion of the methods described herein. Such modifications may include software modifications, hardware modifications, or a combination of both.

Computer system 500 may include more or fewer components than those shown in fig. 5. The components shown, however, are sufficient to disclose an illustrative embodiment for practicing the present solution. The hardware architecture of FIG. 5 represents one representative computing device configured to facilitate the operations described herein.

Some or all of the components of computer system 500 may be implemented as hardware, software, and/or a combination of hardware and software. The hardware includes, but is not limited to, one or more electronic circuits. The electronic circuit may include, but is not limited to, passive components (e.g., resistors and capacitors) and/or active components (e.g., amplifiers and/or microprocessors). The passive and/or active components may be adapted to be arranged and/or programmed to perform one or more of the methods, processes or functions described herein.

As shown in FIG. 5, computer system 500 includes a user interface 502, a Central Processing Unit (CPU)506, a system bus 510, a memory 512 connected to and accessible by other portions of the computing device 500 through the system bus 510, and a hardware entity 514 connected to the system bus 510. The user interface includes, but is not limited to, input devices and output devices that facilitate user-software interaction for controlling the operation of the computing device 500. Input devices include, but are not limited to: physical and/or touch keyboards 550. The input device is connected by a wired or wireless connection (e.g.,connected) to computing device 500. Output devices include, but are not limited to, a speaker 552, a display 554, and/or a light emitting diode 556.

At least some of the hardware entities 514 perform actions directed to accessing and using memory 512, which may be Random Access Memory (RAM), a magnetic disk drive, and/or a compact disk read-only memory (CD-ROM). The hardware entity 514 may include a disk drive unit 516, the disk drive unit 516 including a computer-readable storage medium 518 having stored thereon one or more sets of instructions 520 (e.g., software code) configured to implement one or more of the methodologies, processes, or functions described herein. The instructions 520 may also reside, completely or at least partially, within the memory 512 and/or within the CPU 506 during execution thereof by the computing apparatus 500. The memory 512 and the CPU 506 may also constitute machine-readable media. The term "machine-readable medium" as used herein refers to a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more sets of instructions 520. The term "machine-readable medium" as used herein also refers to any medium that is capable of storing, encoding or carrying a set of instructions 520 for execution by the computer system 500 and that cause the computer system 500 to perform any one or more of the presently disclosed methods.

Turning now to fig. 6, an illustrative X-ray source 600 is shown that may be used with the robotic X-ray systems described herein. This type of X-ray source is described in detail in the following documents: U.S. patent application No.15/941,547 entitled "three-dimensional beamforming X-ray source" filed 3, 30.2018. The disclosure of which is incorporated herein by reference. Briefly, the system includes an EBG 602 and a drift tube 604 supported on the end of the robot arm remote from the base. The EBG 602 includes an ion pump (e.g., the ion pump 408 of fig. 4). An X-ray generating element 622 is located at an end of the drift tube 604 remote from the EBG. In some cases, EBG 602 is located in a head cell (e.g., head cell 306 of fig. 3) as described herein. For example, EBG 602 may reside in a head unit attached to a robotic arm (e.g., robotic arm 304 of fig. 3). An elongated applicator body (e.g., applicator body 318 of fig. 3) includes a drift tube 604. The treatment head includes an X-ray generating element 622. The present solution is not limited to the details of this example.

Drift tube 604 comprises a conductive material such as stainless steel. Instead, drift tube 604 comprises a ceramic material, such as alumina or aluminum nitride, with a conductive liner. The hollow interior of the drift tube is maintained at a vacuum pressure (e.g., a suitable vacuum pressure for the system described herein may be in a range of less than about 10-5 torr or, specifically, between about 10-9 torr and 10-7 torr).

In the X-ray source shown in fig. 6, electrons e generated by the ion pump form an electron beam when accelerated by the EBG toward the X-ray target 618. These electrons have a significant momentum when they reach the entrance aperture of the drift tube. The hollow interior of the drift tube is maintained at vacuum pressure and at least the inner liner of the drift tube is maintained at ground potential. Thus, the momentum imparted to the electrons by the EBG 602 continues to carry the electrons along the length of the drift tube to the X-ray target 618 at a very high velocity (e.g., a velocity near the speed of light) as ballistic launch. As the electrons travel along the length of the drift tube 604, they are no longer electrostatically accelerated. When the electrons impinge on the X-ray target 618, X-rays are generated.

Details of beam steering and sculpting aspects of the X-ray source in fig. 6 are outside the scope of this disclosure. It should be noted, however, that the direction and shape of the X-ray beam generated by the X-ray source 600 may be sculpted or changed by using the electromagnetic steering coil 605. The steering coil 605 is under the control of a beam steering coil control 624 provided in the base unit. The steering coil 605 is configured to alter the portion of the X-ray target 618 that is struck by electrons comprising the electron beam. This steering process is facilitated by a wand element 619 placed in close proximity to the X-ray target 618. For example, in some cases, X-ray source 600 is dynamically configured or controlled to facilitate an isotropic pattern 700 for X-ray photonic particles, as shown in fig. 7. In other cases, X-ray source 600 is selectively controlled to instead facilitate directing X-ray beam 802, as shown in fig. 8. For example, the beam-steering radiation pattern may be facilitated using the X-ray generation system disclosed in the following documents: U.S. patent application No.15/941,547, entitled "three-dimensional beamforming X-ray source," filed 3, 30, 2018. The entire contents of this patent application are incorporated herein by reference.

The X-ray target 618 comprises a disk-shaped element arranged transverse to the direction of travel of the electron beam. For example, the disk-shaped elements are disposed in a plane substantially orthogonal to the direction of travel of the electron beam. In some cases, an X-ray target 618 surrounds the end of the drift tube distal from the EBG 602 to facilitate maintaining a vacuum pressure within the drift tube. The X-ray target 618 can be almost any material. However, the X-ray target 618 advantageously comprises a material having a high atomic number, such as molybdenum, gold, or tungsten, to facilitate X-ray generation with relatively high efficiency when bombarded by electrons. Generating X-rays at the X-ray target 618 generates a significant amount of heat. Thus, the coolant flow provided by the water cooling system 406 is provided to the processing head through the coolant conduit 606. The various components (e.g., EBG 602, drift tube 604, and processing head 622) that comprise X-ray source 600 are mounted on robotic arm 304 as shown in fig. 3 and 4.

As described in more detail below, the X-ray systems in fig. 3-8 include a multi-functional X-ray system that may be adapted or configured for a number of different tasks in a medical facility. One of the tasks relates to medical imaging, particularly DT. Referring now to fig. 9-12, robotic arm 304 precisely controls the position of an X-ray treatment head 316 that serves as an X-ray radiation source. The X-ray treatment head 316 is shown in fig. 9 positioned relative to a subject patient 902 such that a beam 904 of X-ray radiation may be projected through a portion of the patient to be imaged. The X-ray detector panel 308 is disposed on the side of the patient opposite the X-ray treatment head such that it is positioned to capture 2D X radiation projection images of the subject patient 902 when the patient is exposed to X-rays generated by the treatment head 316.

2D X ray projection images are captured or acquired with X-ray treatment head 316 located at a plurality of different positions relative to the patient. This concept is illustrated with reference to fig. 10-12, which show the X-ray treatment head 316 being moved by the robotic arm 304 along a predetermined path 1008 in the space around the patient. By selectively controlling (e.g., using the system controller 426) a plurality of joint positions associated with the plurality of robotic arm joints 320, the X-ray processing head 316 moves along a predetermined path 1008. As shown in fig. 13, the predetermined path 1008 may in some cases define an arc having a center angle β between 15 ° and 40 °.

In the system described herein, the X-ray beam 904 is shaped or sculpted to direct X-ray radiation primarily toward the X-ray detector panel 308. For example, the beam is steered in a manner similar to that shown in FIG. 8 to produce a cone-shaped geometry in which the X-ray radiation is directed primarily toward the patient and the X-ray detector panel 308. Further, when the X-ray system 300 is used for DT operation, a cover is provided on the processing head 316 for beam forming and beam hardening. The cover 1410 shown in fig. 14A and 14B includes a shielding portion 1414 that extends circumferentially around the treatment head 316 to ensure that transmission of X-ray radiation in undesired directions does not occur. The X-ray window 1412 allows collimation of the X-ray radiation such that energy is transmitted over a limited angular range. The collimation may be configured to facilitate a cone-beam geometry in which X-ray radiation is directed primarily toward patient 902 and X-ray detector panel 308. The X-ray window 1412 is formed of a suitable material, such as aluminum, to facilitate beam filtering and hardening. The cover 1410 includes registration slots or grooves that engage corresponding structures of the processing head 316 so that the cover can reside on the processing head in only one position. Thus, the X-ray window 1412 is known in advance and may be registered with the shaped X-ray beam generated at the processing head 316.

To perform the DT operations described herein, the X-ray system 300 is selectively controlled to cause an X-ray beam having an appropriate intensity. This may include selectively applying appropriate accelerating voltages within the X-ray source in order to form the X-ray beam. For example, the system controller 426 applies an energy level of 120kV for this purpose, which is commonly used in DTs. The system controller 426 controls the energy associated with the electron beam by selectively varying the output voltage of the h.v. power supply 428.

The laser FOV projector 404 is disposed on the cover 1410. The laser FOV projector 404 is configured to project a pattern of visible laser light 1408 on the patient 902. When projected onto a patient, the location of the pattern of laser light 1408 will correspond to the location that will be exposed to the X-ray beam generated by the X-ray system during DT operation. Thus, the technician can visually verify during the DT procedure that certain desired portions of the patient's anatomy will be irradiated with X-ray radiation.

The robotic arm 304 controls the position of the X-ray processing head 316 so that the beam is always directed in a direction toward the X-ray detector panel 308. In some cases, the predominant direction of beam 904 is dynamically controlled concurrently with the movement of X-ray treatment head 316. For example, the direction of the beam may change as the X-ray processing head is moved along a predetermined path by the robotic arm. The direction of the X-ray beam is controlled by selectively changing the position and/or orientation of the treatment head using a robotic arm. The direction of the X-ray beam may also be modified using the beamforming methods described herein with reference to fig. 7 and 8.

With the above arrangement, the X-ray detector panel 308 captures 2D projection images at different times when the X-ray processing head 316 is positioned at a plurality of different locations along the predetermined path 1008. As an X-ray source (e.g., an X-ray tube) is moved by the robotic arm 304 over a predetermined path 1008, 2DX projection images are captured by the X-ray source disposed at a plurality of different angles alpha (relative to the patient).

Solid-state X-ray imaging arrays are well known in the art and will not be described in detail herein. However, it should be appreciated that the captured 2D X ray projection images from the X-ray detector panel 308 are communicated to an on-board processing element (such as the system controller 426 of FIG. 4). These communications are facilitated by a wired or wireless link that communicatively couples the X-ray detector panel 308 to the X-ray system 300. In other cases, these projection images are transferred to a separate image processing computer (not shown) and/or data storage provided in the X-ray system 300.

While each 2D projection image is acquired, the system controller 426 determines the respective position of the X-ray source as it is moved along a predetermined path by the robotic arm. The position information may be determined based on information received by the system controller 426 (directly or indirectly) from a plurality of joint position sensors 315 associated with the joints 320 including the robotic arm 304. The position information may be used by the system controller 426 to determine the particular angle α and exact position of the X-ray source relative to the X-ray detector panel.

Once all of the 2D projection images are obtained in this manner, the plurality of 2D projection images and the position information are processed in a computer processing element (e.g., the system controller 426 of fig. 4) to perform the DT operation. As part of the DT operation, a sectional or slice image of the subject patient is reconstructed based on the 2D projection images. This reconstruction may be performed in a manner similar to that used in conventional DT systems. In some cases, image reconstruction is performed using a conventional technique known as FBP. As is well known, FBP is an inverse Radon transform.

To facilitate the X-ray imaging described herein, it is advantageous for the X-ray system 300 to be able to determine the position of the X-ray detector panel 308 relative to the X-ray source (in this case, the processing head 316 of FIG. 3). This information may be useful for determining an appropriate path 1008 for the processing head. This information also facilitates FBP processing associated with reconstruction of slice images of the object. In this regard, fiducial markers 322 are provided to facilitate position sensing of the X-ray detector panel 308. The fiducial markers 322 also facilitate registration of the images acquired by the imaging array. The exact type of fiducial marker selected for this purpose will depend on the registration system used. However, in some cases, the fiducial marks comprise simple optical marks suitable for detecting the imaging device.

One or more fiducial markers 322 are advantageously affixed to the X-ray detector panel 308 at locations that allow it to be imaged by the IP camera/imaging sensor 302. The optically imaged positions of these fiducial markers 322 can be used to determine the appropriate path 1008 and the position of the X-ray detector panel 308 relative to the treatment head 316. The position information is then used to facilitate the image collection process and the image reconstruction process.

The X-ray system 300 is multifunctional in the following regard: when not used for tomographic imaging as described herein, it can be used to perform therapeutic treatments such as IORT, brachytherapy, and External Beam Radiation Therapy (EBRT). For example, consider an IORT scenario in which a surgical procedure is performed to remove a cancerous tumor from a patient. During a surgical procedure, a practitioner may perform certain medical imaging procedures described herein using an X-ray system. The surgeon may examine the reconstructed image based on the 2D projection images and then use the X-ray system 300 to initiate an IORT procedure. The IORT procedure is illustrated in fig. 15, which shows that the surgeon may use the robotic arm 304 to reposition the X-ray treatment head 316 with respect to the subject patient 902. In particular, the X-ray source may be repositioned within the tumor bed of the removed cancerous tumor. Thereafter, the X-ray source may be activated while the treatment head 316 is disposed in the treatment position to perform therapeutic X-ray treatment on the subject patient. In some cases, DT imaging described herein is performed after a tumor is removed during surgery. This intra-operative imaging is particularly useful to aid RTP because it allows a practitioner to image tissue that is to be irradiated immediately after tumor resection, just prior to initiating an IORT procedure.

The usefulness of DT imaging as described herein can be further enhanced by using image fusion techniques. In this case, conventional imaging methods may be used to perform preoperative volumetric imaging of the patient undergoing treatment (e.g., tumor removal). Examples of suitable volumetric imaging methods that may be used for this purpose may include CT and MRI. However, the solution is not limited in this respect, and any other suitable volumetric imaging technique may be used for this purpose, whether now known or known in the future. The acquired preoperative volumetric imaging may then be stored in a database, such as patient data storage device 440 of fig. 4. Thereafter, the patient may be subjected to a surgical procedure, such as removal of a cancerous tumor. This step may be followed by intraoperative DT imaging as described herein. However, improved or enhanced results may be obtained in the deformable image fusion step, rather than relying solely on intra-operative DT imaging for RTP purposes. This step may involve fusing higher quality preoperative volumetric imaging with the somewhat inferior intraoperative results obtained using DT.

It will be appreciated that as a result of the surgical procedure involving removal of a cancerous tumor, the internal anatomy of the patient being treated will necessarily change. Thus, the deformable image fusion step described herein will utilize anatomical landmarks to facilitate image registration, but will advantageously match preoperative volumetric imaging with intraoperative DT imaging. The resulting fused volume image will combine higher quality preoperative volume imaging with lower quality but more recent results obtained using intraoperative DT imaging. Such a deformable image fusion process may be developed and guided using deep learning or other artificial intelligence techniques. Furthermore, artificial intelligence may be applied to the fusion process to ensure a deformable image fusion process. Once the deformable fusion process is complete, the RTP process may continue to facilitate any IORT processing. Such a fused image is particularly useful to aid RTP because it allows a practitioner to image tissue to be irradiated immediately after tumor resection prior to initiating an IORT procedure.

Notably, X-ray beams 904 suitable for tomosynthesis as described herein may not be suitable for therapeutic treatment such as IORT. However, the beam-forming capabilities of the X-ray source can be used to dynamically alter the beam shape to suit a particular therapeutic treatment. Accordingly, the control system 424 of fig. 4 may be used to selectively control the X-ray source to generate an X-ray beam 904 having a first beam shape for the purpose of obtaining 2D projection images, and subsequently to generate an X-ray beam having a different shape for the purpose of performing therapeutic X-ray treatment. Similarly, the control system 424 can control the X-ray beam intensity. In this regard, it should be appreciated that the beam intensity used for imaging may be controlled by the control system 424 such that it is different compared to the beam intensity used for therapeutic purposes (e.g., during IORT procedures). The X-ray system 300 may be controlled to emit low energy X-ray emission levels for IORT. In some cases, the X-ray system 300 reduces the X-ray energy to about 50kV or less for this purpose.

Referring now to fig. 16, an illustration of an illustrative architecture for a computing device 1600 is provided. Computing device 102 and/or server 108 of fig. 1 are the same as or similar to computing device 1600. Thus, the discussion of the computing device 1600 is sufficient to understand these components of the system 100.

In some cases, the present solution is used in a client-server architecture. Thus, the computing device architecture shown in fig. 16 is sufficient for understanding the details of the client computing device and the server.

Computing device 1600 may include more or fewer components than shown in fig. 16. The components shown, however, are sufficient to disclose an illustrative solution for implementing the present solution. The hardware architecture of fig. 16 represents one implementation of a representative computing device configured to provide a real-time beam sculpting IORT processing plan as described herein. As such, the computing device 1600 of fig. 16 implements at least a portion of the methods described herein. The computing device 1600 may include a battery (not shown) and/or be connected to an external power source.

Some or all of the components of computing device 1600 may be implemented as hardware, software, and/or a combination of hardware and software. The hardware includes, but is not limited to, one or more electronic circuits. The electronic circuit may include, but is not limited to, passive components (e.g., resistors and capacitors) and/or active components (e.g., amplifiers and/or microprocessors). The passive and/or active components may be adapted, arranged and/or programmed to perform one or more of the methods, processes or functions described herein.

As shown in fig. 16, computing device 1600 includes a user interface 1602, a Central Processing Unit (CPU)1606, a Graphics Processing Unit (GPU)1670, a system bus 1610, a memory 1612 connected to and accessible by other portions of the computing device 1600 through the system bus 1610, a system interface 1660, and a hardware entity 1614 connected to the system bus 1610. The user interface may include input devices and output devices that facilitate user-software interaction to control operation of the computing device 1600. Input devices include, but are not limited to, a physical and/or touch keyboard 1650, and/or a physical and/or touch pointing device (not shown in FIG. 16). The input device may be via a wired or wireless connection (e.g.,connected) to the computing device 1600. Output devices include, but are not limited to, a speaker 1652, a display 1654, and/or a light emitting diode 1656. System interface 1660 is configured to facilitate wired or wireless communication with external devices (e.g., network nodes such as access points).

At least some of the hardware entities 1614 perform actions involving accessing and using memory 1612, which may be Random Access Memory (RAM), solid state or magnetic disk drives, and/or compact disc read only memory (CD-ROM). The hardware entity 1614 may include a disk drive unit 1616, the disk drive unit 1616 including a computer-readable storage medium 1618, the computer-readable storage medium 1618 having stored thereon one or more sets of instructions 1620 (e.g., software code) configured to implement one or more of the methods, processes, or functions described herein. Instructions 1620 may also reside, completely or at least partially, within memory 1612 and/or within CPU 1606 during execution of instructions 1620 by computing device 1600. Memory 1612 and CPU 1606 may also constitute machine-readable media. The term "machine-readable medium" as used herein refers to a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more sets of instructions 1620. The term "machine-readable medium" as used herein also refers to any medium that is capable of storing, encoding or carrying a set of instructions 1620 for execution by computing device 1600 and that cause computing device 1600 to perform any one or more of the presently disclosed methods.

GPU 1670 is used for, but not limited to, 2D image rendering, 3D, etc. sphere rendering, augmented reality object rendering, and parallel mathematical processing tasks. As described with respect to the CPU, the GPU has its own instruction set.

The computing device 1600 implements a processing plan creation technique. In this regard, the computing device 1600 runs one or more software applications 1622 to facilitate a real-time beam sculpting IORT processing plan. The operation of software application 1622 will become apparent as the discussion proceeds.

Referring now to FIG. 17, FIG. 17 provides a screenshot of an illustrative GUI 1700 provided by software application 1622. GUI 1700 is designed to facilitate creation of a treatment plan for a patient to be radiation treated for cancer. In this regard, the GUI includes a first portion 1702 that illustrates a general imaging modality. Common imaging modalities include, but are not limited to, CT scan, MRI, PET, or tomosynthesis. The first portion 1702 has three portions: an original plane image set (e.g., an axial plane) and two reconstructed plane image sets (e.g., a coronal plane and a sagittal plane). Thus, the first portion 1702 of fig. 4 illustrates a primary plan view (e.g., an axial plane) and a secondary plan view (e.g., a coronal plane and a sagittal plane) of a medical image modality. Notably, the processing system 106 of FIG. 1 can be used to acquire images after a tumor has been ablated using a source internal to the treatment head. The location of each fiducial marker in a plurality of locations contained on the treatment head or on a prescribed model such as, but not limited to, a balloon applicator and a cannula, is shown by one or more cross markings 1704. These markings enable the user to know the position and orientation of the treatment head inside the patient. The processing head is generally circular in shape, shown on the image and located in the area enclosed by dashed line 1706. The location of the fiducial marker, the radius of the balloon applicator, and the intersection between the three planes may be selected and marked as shown in section 1720 using buttons in the control panel.

The treatment head has a plurality of apertures from which radiation beams can be emitted. A schematic of the processing head and its aperture is provided in the second portion 1708 of the GUI 1700. As shown in section 1708, the treatment head includes a plurality of holes represented by a plurality of regions, each region having a unique marking. For example, as shown in section 1708, these regions are labeled A1-A3, B1-B3, C1-C3, D1-D3, E1-E3, and F1-F3. Adjacent sets of apertures are separated from one another by outwardly projecting plates represented by lines 1710 passing through the center 1722 of the portion 1708. These plates facilitate the controlled application of radiation to only selected areas of a patient (e.g., patient 902 of fig. 9). The user of GUI 1700 may select the regions labeled A1-A3, B1-B3, C1-C3, D1-D3, E1-E3, and F1-F3 in portion 1708. GUI 1700 also includes controls 1712 that allow the user to select the intensity of radiation to be administered to the patient, and the duration of time radiation should be administered to the patient. The user can select the voltage and time of each processing item in section 1708 by using the selector shown in section 1712. When the user presses button 1716, a treatment item is added to the treatment plan and displayed in section 1718 of GUI 1700. Each process plan item may be adjusted using the control panel in section 1724. The user may use a correlator shown in section 1724 to adjust the correlation between the dose level and the equivalent dose percentage. Once the treatment plan is created, buttons 1726, 1728 in the control panel can be used to approve or reject the treatment plan. Once the treatment plan is approved, the treatment system 106 of FIG. 1 is programmed to deliver radiation to the patient according to the treatment plan. The programming may be implemented by the server 108 of fig. 1. Fig. 18-20 illustrate radiation patterns of various treatment plans implemented by the treatment system 106 of fig. 1.

Before programming the processing system 106 with the processing plan, the user of the computing device 102 may use tools of the software application 1622 to verify the expected validity of the processing plan. The tool includes a dynamic virtual measurement component presented in GUI 1700 to overlay on top of a medical image modality scan shown in the original planar image region 1702. An illustration showing a dynamic virtual measurement component superimposed on top of a medical image modality scan is provided in fig. 21-14.

Referring now to fig. 21, an illustration of a virtual measurement component 2100 superimposed on top of a medical modality scan image 2102 is provided. The virtual measurement component 2100 includes a centerline 2104 having equally spaced markings distributed along its elongated length. The markings include relatively small linear markings (e.g., lines) 2106 perpendicular to the centerline 2104. Numbers are provided on the left and right sides of each of the small lines 2106. The number 2108 to the left of the centerline 2104 represents the radiation dose in gray (Gy) at the intersection between the centerline 2104 and the small linear marker 2106. The number 2110 to the right of the center line 2104 represents a distance value measured in millimeters (mm) from the target center (represented by the balloon center cross tick) 1704 in fig. 17 to the intersection between the center line 2104 and the small linear marker 2106. Thus, the virtual measuring means has a dual purpose: allowing the user to measure the distance and allowing the user to measure the radiation dose. The distance measurement and the radiation dose measurement may be performed simultaneously or in parallel. The values of numbers 2108 and 2110 dynamically change as the virtual measurement component is moved horizontally in directions 2112, 2114 via control 2116. The virtual measurement component 2100 may be in the form of a vertical centerline 2104, a horizontal centerline, or a combination of both. Control 2116 is shown as a sliding scale. The present solution is not limited in this respect. Other types of controls may be used to move the virtual measurement component 2100 horizontally within the GUI. Fig. 22-24 provide enlarged views of the virtual measurement component 2100.

As shown in fig. 21-24, the number 2108 may have different values based on (1) the position of the vertical and/or horizontal centerline 2104 relative to the benchmark market point 2118 and (2) the parameters of the treatment plan. The value of the number 2108 may be determined using a look-up table (LUT) stored locally on the computing device 102 of fig. 1 or remotely from the computing device 102 of fig. 1 and/or using at least one predefined mathematical algorithm.

Referring now to fig. 25, fig. 25 provides a flow chart of an illustrative method 2500 for treating a patient having cancer. Method 2500 begins at 2502 and continues to 2504 where a medical procedure is performed to remove a tumor from a patient at 2504.

Next at 2506, a medical image modality scan of the treatment region is acquired using a processing system (e.g., processing system 106 of fig. 1). Subsequently, a treatment plan for radiation treatment is created at 2508 using a computing device (e.g., computing device 102 of fig. 1) and a server (e.g., server 108 of fig. 2). The processing plan is created using a software application installed on the computing device and/or may be accessed by a software application (e.g., software application 1622 of fig. 16) installed on a server (e.g., server 108 of fig. 1). The software application provides a GUI (e.g., GUI 1700 of fig. 17) in which the medical image modality scans are displayed along with a plurality of controls for defining parameters of the treatment plan. A dynamic virtual measurement component (e.g., virtual measurement component 2100 of fig. 21-24) is used in 2510 to verify the expected validity of the treatment plan. If the verification results are insufficient, the user may return 2508 and modify the treatment plan. If such verification is done, the processing system is programmed in 2512 so that it can perform operations according to the processing plan. This programming may be achieved by: transmitting a processing plan from a computing device to a server; the server performs operations to set operating parameters and other values according to a processing plan on the processing system.

Thereafter, radiation is applied to the patient (e.g., patient 902 of FIG. 9) as shown at 2514. Subsequently, execution 2516 is performed, wherein method 2500 ends or other processing is performed (e.g., return 2502).

The present solution also relates to a system for sculpting beam treatment planning applications. Such a system is the same as or similar to the system 100 of fig. 1. This system is also referred to herein as a "Treatment Planning System (TPS)". The TPS provides a dedicated method and system to create a real-time treatment plan for the robotic sculpting beam IORT system 300 of fig. 3-15. The TPS includes a software application running on a mobile computing device (e.g., computing device 102 of fig. 1) or other computing device.

In some cases, the TPS 100 includes a mobile computing device 102 that serves as a main user interface, implementing a parallel computing platform (e.g., a platform for computingOr other parallel processing platform), and a processing system 106. Processing system 106 includes, but is not limited to, the robotic sculpted beam IORT system 300 of fig. 3-15. All of these listed devices operate on dedicated secure closed-loop gigabit or faster networks. The TPS 100 is capable of creating multiple real-time sculpting beam treatment plans for multiple robotic sculpting beam IORT systems in a facility. In addition, the TPS 100 allows multiple users to work on the same treatment plan at the same time.

Referring now to fig. 26, a flow diagram of an illustrative method 2600 for operating a TPS (e.g., system 100 of fig. 1) is provided. Method 2600 begins at 2602 and continues to 2604 where a user logs into the TPS using a computing device (e.g., computing device 102 of fig. 1) at 2604. Techniques for logging into a system are well known in the art and therefore will not be described herein. Any known or to be known login technique may be used herein. In some cases, a user identifier and/or password may be used for login purposes. Additionally or alternatively, biometrics are used for login purposes (e.g., touch ID and/or face ID).

Once the user successfully logs into the TPS, the user accesses the electronic patient roster, as shown at 2606. Electronic patient rosters are well known in the art and, therefore, will not be described herein. Any known or to be known electronic patient roster may be used herein without limitation. The electronic patient roster may be stored in a data store remote from the user computing device. In this case, a server (e.g., server 108 of fig. 1) may facilitate access to the electronic patient roster. A screenshot of an illustrative GUI for accessing a patient roster 2700 is provided in fig. 27.

The user begins the treatment planning process at 2608 by selecting a patient name from an electronic patient roster and selecting an imaging modality from a plurality of imaging modalities (e.g., DT scans, CT scans, MRI, or PET scans). Fig. 27 also shows an illustrative manner of selecting a patient (e.g., Evan Pasley) from the patient roster 2700. For example, a patient is selected by moving the mouse over the name and pressing a mouse button. Alternatively, if the display is a touch screen display, a gesture may be made to select the patient. Once the patient is selected, the load file virtual button 2800 is pressed (e.g., using a mouse or by gesture), as shown in fig. 28. Pressing button 2800 causes an imaging file to be loaded from a remote server (e.g., server 108 of fig. 1 or a PACS in a hospital) to the TPS. FIG. 28 also shows an illustrative list 2800 of loaded imaging files (e.g., 1_4.sen, 1_3.sen, 1.2_ sen, 1_1. sen). Next, the user assigns an imaging modality to the selected patient. As shown in fig. 29, this allocation is achieved by: selecting a loaded imaging file (e.g., 1_1.sen) (e.g., by clicking a mouse or by a gesture); an assign virtual button 2900 is pressed to assign the selected imaging file to the treatment plan. Thereafter, the user selects the associated imaging modality. As shown in fig. 30, this selection is made by selecting one or more imaging subsets 3000 contained in the previously selected imaging file.

Next, in 2610, the user initiates creation of a new processing plan by pressing a virtual button (e.g., virtual button 3002 of FIG. 30). As shown in FIG. 31, the user may also be prompted to enter the name of the new treatment plan. The present solution is not limited in this respect. In other cases, a pre-created treatment plan is selected (e.g., from a list of previously created treatment plans) rather than initiating a new treatment plan creation. The pre-created treatment plan may be a pre-approved treatment plan or a pending treatment plan that still requires approval (e.g., by using virtual button 1726 of GUI 1700 shown in FIG. 17). If the pre-created treatment plan includes a pre-approved treatment plan, the user cannot edit the pre-created treatment plan and set it to be treated (i.e., sent to the robot sculpting beam IORT system). If the pre-created treatment plan includes a pending treatment plan, the pre-created treatment plan may be edited by the user and set to be treated upon approval by the user.

When the user initiates the creation of a new process plan, the process planning software (e.g., application 1622 of FIG. 16) is launched by the user's computing device (e.g., computing device 102 of FIG. 1), as shown at 2612. The treatment planning software provides a GUI (e.g., GUI 1700 of fig. 17 or GUI 3200 of fig. 32) to the user in 2614, the GUI displaying images (e.g., images 1800 and 1806 of fig. 18 or images 3202 and 3206 of fig. 32) in various anatomical imaging modality views of a patient selected from the electronic patient roster.

The anatomical imaging modality views may include, but are not limited to, sagittal image views, axial image views, and/or coronal image views. The displayed images may include, but are not limited to, sagittal images (e.g., image 1804 of fig. 18 or image 3206 of fig. 32), axial images (e.g., image 1800 of fig. 18 or image 3202 of fig. 32), and coronal images (e.g., image 1806 of fig. 18 or image 3204 of fig. 32). A first image (e.g., the image 1804 of fig. 18 or the image 3202 of fig. 32) of the images is displayed in the center of an image display portion (e.g., the portion 1702 of fig. 27 or the portion 3208 of fig. 32) of a GUI (e.g., the GUI 1700 of fig. 17 or the GUI 3200 of fig. 32), and the other two images (e.g., the images 1800 and 1806 of fig. 18 or the images 3204 and 3206 of fig. 32) are displayed in the side portions of the first image in the image display portion. The user can switch the display focus between these images to identify, for example, the best process delivery location. The locations of fiducial markers visible in the image are used to identify the optimal treatment delivery location. The image to which the focus has been switched is displayed in a larger size than the other two images. Once the optimal treatment delivery location is identified, the user sets the optimal treatment delivery location, for example, by clicking or touching a fiducial marker position shown in the image. An illustrative GUI is provided in fig. 33 for understanding how fiducial marker positions are set.

The user may also be able to change one or more characteristics of the GUI and/or the image displayed in the GUI window (e.g., display 1654 of fig. 16). GUI characteristics include, but are not limited to, window size and/or window width. Image characteristics include, but are not limited to, size, contrast, and/or brightness. The GUI/image characteristics may be adjusted to optimize the visual appearance of the objects shown in the image.

The user is also able to scroll through the slices of imaging data. The user may also zoom in and out of any displayed plane for any selected imaging data slice.

The user may triangulate the anatomical display by selecting a particular region of the patient's anatomy. An image of the corresponding viewing plane of the selected region of the patient's anatomy is then displayed in the GUI window.

The user may also adjust the volume of the balloon shown in the GUI. In some cases, the balloon volume adjustment is performed to fill the balloon with the contour of the tumor bed tissue. A diagram illustrating balloon volume adjustment is provided in fig. 34. In fig. 34, the balloon is represented by dashed line 3400. The present solution is not limited in this respect.

In some cases, the optimal process delivery location is determined automatically by the TPS, rather than manually by the user as described above. For example, the TPS performs the following operations: fusing a 3D preoperative image (e.g., a CT image) with a real-time X-ray image (e.g., a tomosynthesis image) to register fiducial marker positions in the 3D preoperative image; the fiducial marker positions are used to identify a designated treatment anatomical location. The designated treatment anatomical location is used to make the following determinations: how the X-ray source will be positioned relative to the patient's body.

In 2614, an anatomical image parameter (e.g., parameter 1808 of fig. 18) and/or a dose rate spectrum (e.g., dose rate spectrum 1810 of fig. 18) is also displayed within the GUI. Anatomical image parameters include, but are not limited to, voxel width, voxel height, voxel depth, image size in pixels and metric units (per pixel size), zoom rate, location of selected triangulation points, number of selected slice indices, and/or relative view depth in the patient anatomy. The dose rate spectrum is displayed as a reference guide and baseline for the user.

In 2618, the user selects an anatomical region and a viewing mode (e.g., axial, coronal, or sagittal) of the patient via the GUI. Next, in 2620, a symbol (e.g., the fountain 702 and/or the cross-hair 1704 of FIG. 17) representing the treatment head (e.g., the treatment head 316 of FIG. 3) and the fiducial markers contained in the treatment head is presented in the GUI so as to overlay the top of the image of interest (e.g., the image 1800 of FIG. 18). These symbols allow the user to visualize and/or know the position and orientation of the treatment head with respect to the patient's body as represented by the displayed image.

The GUI is designed to allow the user to manually adjust the position and/or orientation of the treatment head relative to the patient's body (e.g., by pointing and double-clicking on the desired position in the GUI window). Accordingly, method 2600 includes an optional 2620 wherein the user adjusts the position of the treatment head relative to the patient's body by manipulating the position and/or orientation of various symbols in the GUI.

In 2622, the TPS receives user input identifying one or more processing regions. Next in 2624, the TPS either performs an operation to automatically mark the isodose line profile of the identified processing region or receives user input to mark the isodose line profile of the identified processing region. Input devices (e.g., a stylus, trackball, and/or mouse) and/or gestures may be used to facilitate user input. The first contour is marked by the TPS or the user for the region of the patient's body that is to receive the minimum intensity radiation dose. The second contour is marked by the TPS or the user for the region of the patient's body that is to receive the maximum intensity radiation dose. The third contour or any additional contours may also be labeled for regions of the patient's body that are to receive radiation doses of any desired intensity.

The operations performed by the TPS to automatically calculate and display isodose line profiles include: mapping the area where radiation is to be deposited; and calculating the beam characteristics using one or more beam definition algorithms. Beam definition algorithms are well known in the art and therefore will not be described herein. Any known or to be known beam definition algorithm may be used herein. For example, a beamforming algorithm is employed herein that includes a combined implementation of the Monte Carlo algorithm based on the GEANT4 simulation toolkit. The monte carlo algorithm and the genant 4 simulation toolkit are well known in the art and are not described herein.

The operations performed by the user for calculating and displaying the isodose line profile may involve adjusting the minimum and maximum intensity levels using controls of the GUI (e.g., controls 1712 and/or 1714 of fig. 17 or controls 3500 and 3506 of fig. 35). For example, the user performs the following actions to define the beam characteristics as shown in fig. 35-36: selecting energy in kilovolts using control 3500 of fig. 35; selecting a dwell time using control 3502 of FIG. 35; and selects a dwell point (e.g., a (3)) from the plurality of dwell points 3508 in the area 3506 of fig. 35. In response to these user actions, the TPS calculates the volumetric radiation or volume of the beam from the selected energy, dwell time and dwell point. The TPS also provides a visual indication of the beam structure and registration on the image. For example, the TPS displays lines 3600, 3602 on the GUI. Line 3600 represents a 50% dose boundary, while line 3602 represents a 100% dose boundary. The present solution is not limited to the details of this example. These actions may be repeated with respect to any number of dwell points (e.g., dwell points a (3), a (5), a (7), B (3), B (5), B (7), C (3), C (5), C (7), D (3), D (5), D (7), E (3), E (5), E (7), F (3), F (5), and/or F (7)). An illustrative result from performing the second iteration of these actions is shown in FIG. 37. The user does not have to repeat this operation for each slice. The user may skip slices and the TPS interpolates the missing slices through a different algorithm. The system registers each contour action and other user actions on the main display slice through all anatomical planes.

Notably, the isodose line profile (e.g., represented by lines 3600, 3602, 3700, 3702 of fig. 37) can be opened and closed. An illustration showing the isodose line profile being open is provided in fig. 37, and an illustration showing the isodose line profile being closed is provided in fig. 38. Additionally or alternatively, controls 3900 of fig. 39 can be used to open and close the color wash, controls 3504 of fig. 35 can be used to open and close additional dose boundaries, and/or controls 4100 of fig. 41 can be used to open and close the ruler tool. A diagram showing an open illustrative color wash is provided in fig. 39. Color wash indicates the emission beam spectrum. A diagram showing additional intermediate dose boundaries (e.g., 80%, 40%, 20% dose boundaries) is provided in fig. 40. An illustration showing the outline ruler being opened is provided in fig. 41. The ruler can be scrolled to view the radiation dose at any particular point. An illustration showing the ruler being rolled to different positions is provided in fig. 42 and 43.

The user may also set a gray value for 100% of the isodose line. An illustration for understanding how the gradation value is set is provided in fig. 44. The threshold may be adjusted by setting the gray value based on what is to be achieved at a particular percentage treatment dose. After setting the gray value of the 100% isodose line, all other gray values for the remaining isodose line percentages are automatically calculated.

The user may also measure the distance between any two points. For example, measurement tools may be used to determine distances in the anatomy to ensure that radiation is not provided to certain areas of the body (e.g., organs at risk). An illustration for understanding how such distance measurements are made is provided in fig. 45.

The contours are then marked by selecting the color representing the isodose line and by drawing the contour on the GUI (e.g., by a gesture, mouse operation, or other pointing device operation). Illustrations showing the marked contours are provided in fig. 46-49. Next, reconstructed coronal and sagittal plane images are presented. A diagram illustrating such a reconstructed image is provided in fig. 50.

After completing 2624, the user performs a user-software interaction in 2626 to launch a Beam Sculpting Engine Parallel Processor (BSEPP) emulator. In 2628, BSEPP performed operations to specify the selected geometry and topology of the anatomy for the patient to be treated, generating the optimal treatment plan. The best treatment plan is derived from the contours marked in 2624. For example, in some cases, BSEPP performs the following operations: running an iterative computation cycle to optimize the geometry and volume of the planned sculpted beam in the most accurate manner to fit the minimum and maximum marker radiation dose profile and anatomical volume required by the user; and generates a final processing plan and beam transmit sequence to include energy, dwell time, and target segment index/position. At 2630, BSEPP performs operations to calculate and display a total dwell time of the X-ray source in a given physical location within the applicator.

Upon completion of 2630, method 2600 continues with 2632 of fig. 26B. As shown in fig. 26B, 2632 relates to rendering an optimal treatment plan in three planar views of the patient anatomy. The three plane views may include, but are not limited to, an axial view, a coronal view, and a sagittal view. At 2634, the sculpted beam with the optimized geometry is shown embedded in the GUI in an anatomical volume of the patient with isodose line contours and/or color washes. The isodose line profile and/or the color wash show the best actual dose shaping compared to the target volume defined by the user marked profile. The user can switch between a wash-out view, an isodose curve profile view and a clear view that does not present the wash-out or isodose curve profile.

In 2636, the user views the treatment plan using the GUI in 2636. The treatment plan may optionally be edited by the user in 2638. For example, a user may modify the emission sequence of the electron beam of the X-ray source 410, altering the Target Sculpting Factor (TSF) and the translation rate of the X-ray source. The TSF includes the target segment index, hit location within the segment, energy level (e.g., in kV), and dwell time (e.g., in seconds). The present solution is not limited to the details of this example.

Thereafter, in 2640, a treatment plan validation process begins. The system provides 2642 one or more specialized tools to the user to assist in the process plan validation process.

One such tool includes a virtual measurement component (e.g., virtual measurement component 2100 of fig. 21). The user may move the tool using a pointing device (e.g., a stylus, trackball, or mouse) or by gestures to scan the patient's anatomy and rendered sculpted beam geometry vertically or horizontally. Once the tool passes through the anatomical image pixels, the tool displays the reference distance measurement from the center of the target and the absorbed dose in each anatomical image pixel. Once the tool reaches the sculpting beam region, the tool begins to display the dose actually deposited at its location, the proportion of the pixel size for the given anatomical view, and the isodose line threshold for the sculpting beam region viewed. The virtual measurement component also measures and displays the distance between two points on the image master view to provide the user with additional reference and scale verification about the sculpted beam and the patient's anatomy.

Another such tool includes a 3D sculpted beam tool. The 3D sculpting beam tool is specifically designed for a robotic sculpting beam IORT system and can be initialized by pressing the virtual button 1812 presented on the GUI. The 3D sculpted beam tool must be able to create a full-form beam geometry. A beamforming algorithm may be used to create a full-shaped beam geometry. For example, a fully-shaped beam geometry is created using a combined implemented algorithm that includes the monte carlo algorithm and the gear 4 simulation toolkit. The monte carlo algorithm and the genant 4 simulation toolkit are well known in the art and are not described herein. The 3D sculpting beam tool renders the calculated sculpting beam in 3D (iso-sphere) and fuses it through three anatomical plane cross-sectional displays. The 3D sculpted beam tool then intersects the three view planes (axial, coronal, and sagittal) through the equiangular points of the X-ray source and target volume and renders the sculpted beam volume geometry through the three plane views. This provides the user with a final view of how the beam penetrates the target anatomy being treated and how the dose is deposited in each voxel, all with reference to adjacent organs and tissues that the user may avoid or prevent any treatment dose deposition. The 3D sculpted beam tool also includes and renders user-drawn contours that are fused in the same 3D view of the sculpted beam in the patient's anatomy. While running the 3D sculpted beam tool, the user can move each anatomical plane axis and see the corresponding cross-sectional sculpted beam profile and dose deposition.

Illustrations for understanding a 3D sculpting beam tool are provided in fig. 51-59. In FIG. 51, the user performs a user-software interaction for opening a 3D viewer. In response to the user-software interaction, the 3D sculpted beam tool presents a 3D image that shows the radiation source relative to the 3D anatomy of the patient. Next, the 3D sculpting beam tool prepares the model and renders a 3D isosphere, which displays the beam shape inside the patient's anatomy. The rendered 3D iso-sphere allows the user to see how the dose or beam will be distributed within the patient or other anatomical treatment target. An illustration showing the rendered 3D iso-sphere 5200 is provided in fig. 52. The 3D view may be rotated so that the user may view the rendered 3D iso-sphere 5200 from a different perspective relative to the patient anatomy within the GUI. Illustrations showing different views of the rendered 3D iso-sphere 5200 are provided in fig. 53-56. The user may also open and close the rendered 3D isosphere. A diagram showing the rendered 3D iso-sphere for a 50% dose in the closed state is provided in fig. 57. Indeed, the rendered 3D iso-sphere for 100% dose can be seen more clearly in fig. 57.

The user may also move the source relative to the human anatomy in the GUI. An illustration for understanding how to move the source within the GUI is provided in FIG. 58. Source movement can be performed to adjust how the source is placed within the anatomy to fine tune the actual location of the source during processing. The user may also move the axial, coronal, and sagittal images as shown in fig. 59.

Another such tool includes an Augmented Reality (AR) tool. The AR tool may be implemented using a portable device with a camera and/or AR glasses. The AR glasses may include, but are not limited to, the AR glasses described in U.S. patent application No.15/946,667 filed on 5.4.2018. Illustrative GUIs showing the use of AR tools are provided in FIGS. 60-68.

The system does not require the user to manually save the data of the treatment plan while planning the process. The system will automatically perform this operation at each step of the user creation and processing. The data will be automatically recorded and saved to the relational database engine of the system (which may be by the relational database engine) Or other available relational database engine drivers on the market). The system may operate with a relational database engine or a non-relational database engine.

Once the user verifies and approves the treatment plan, the treatment system (e.g., treatment system 106 of FIG. 1) is programmed with the treatment plan at 2644. The treatment system may then perform operations to deliver radiation to the patient according to the programmed treatment plan. Subsequently, 2646 is performed, wherein method 2600 ends or performs other processing.

Although the present solution has been shown and described with respect to one or more implementations, equivalent alterations and modifications will occur to others skilled in the art upon the reading and understanding of this specification and the annexed drawings. In addition, while a particular feature of the solution may have been disclosed with respect to only one of several implementations, such feature may be combined with one or more other features of the other implementations as may be desired and advantageous for any given or particular application. Thus, the breadth and scope of the present solution should not be limited by any of the above-described embodiments. But rather: the scope of the present solution should be defined in accordance with the appended claims and their equivalents.