Systems and methods for using dosimetry application software tools to customize dosimetry and sphere selection for radioembolization treatment planning

Abstract

To provide methods and systems for selection of dosimetry levels and sphere amounts of radioactive compounds for use in a radioembolization procedure for procedure planning.SOLUTION: The methods and systems may include: inputting radioactivity parameter information into a dosimetry portal of a dosimetry selection tool; determining customized radioactivity based on the radioactivity parameter information and one or more customized radioactivity algorithms; generating one or more sphere amounts and dosage recommendations based on the customized radioactivity and one or more dosimetry selection algorithms; selecting one of the one or more sphere amounts and dosage recommendations as a selected sphere amount and dosage recommendation; and generating a radioactive compound order for the radioembolization procedure based on the customized radioactivity and the selected sphere amount and dosage recommendation.SELECTED DRAWING: Figure 12

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application was filed on May 18, 2018, and relates to a "DUAL-STAGE SYR INGES WITH LOCKING MECHANISM (Two-stage with locking mechanism) U.S. Provisional Patent Application No. 62 / 673,628 entitled "A Method and Apparatus for Providing a High-Frequency Injection Syringe" and U.S. Provisional Patent Application No. 62 / 673,628 filed on May 1, 2018. The application was filed on the 8th and is titled "RADIOEMBOLIZATION DELIVERY DEVI U.S. Provisional Patent Application No. 62 / 673,632 entitled "Radioembolization Delivery Device (CE)" No. 6,299,499, filed on Oct. 1, 2004, the disclosure of which is hereby incorporated by reference in its entirety.

[0002]

[0001] This specification generally relates to treatment regimens utilizing medical devices for treating cancer, and For more information, see the section on treatments such as hepatic artery radioembolization. an operable device configured to deliver a radioactive compound to a treatment region within a patient at a Treatment planning utilizing such medical devices and the use of such radioembolization delivery devices Customized dosimetry and sphere selection determination of radioactive compounds for use in do. [Background technology]

[0003]

[0002] In cancer treatment, including radiation therapy, inadvertent exposure to radiation from radioactive therapeutic agents or excessive exposure can be harmful and potentially fatal to patients or medical personnel. Therefore, medical devices for radiation therapy should be designed to prevent unnecessary exposure to radiation. localizing the delivery of radioactive material to specific areas of the patient's body while shielding others from the It needs to be configured as follows.

[0004] Hepatic arterial radioembolization is a transcatheter intra-arterial procedure performed under radiological guidance. It is commonly used for the treatment of malignant tumors. During this medical procedure, A catheter is navigated into the patient's liver and filled with yttrium-90 ( 90 Y) and other radioactive Compound-loaded radioembolization microspheres are delivered to the target tumor. It embolizes the blood vessels supplying the tumor while simultaneously delivering radiation to destroy tumor cells.

[0005] Generally, medical devices for performing radioembolization procedures include multiple syringes, external Containing and shielding the external tube, vial containing the radioactive compound, and the radioactive vial Such devices typically require time and effort to install. Complex devices are generally fixed and require a physician in the operating room. Restricts the Master's movement to within a certain proximity range of the device.

[0006] During a radioembolization procedure, the routine handling of product containers storing radioactive material typically involves Nuclear physicians who handle materials with forceps or tweezers We need a nuclear medicine technician. This process increases the risk of further exposure of medical personnel to radiation and possible contamination of the operating room. The radioactive compound may be administered manually as a dosing solution (administrator). Syringes for r) are prone to inconsistent flow rates and pressures. Insufficient injection rate. In such cases, bead dispersion may be reduced, affecting the efficacy of the treatment. Summary of the Invention [Problem to be solved by the invention]

[0007]

[0006] Accordingly, a simplified radioembolization system configured and operable to perform radioembolization is provided. A tool for determining the effective amount of radioactive compound to administer to a patient by a medical device. A rule is necessary. [Means for solving the problem]

[0008] In one embodiment, for use in radioembolization procedures for treatment planning. Dosimetry level and spherical quantity (sp The computer-implemented method for the selection of the dose amount is Select the tool and add the activity parameters to the dosimetry portal. r) inputting information and customizing the radioactivity by the processor; Based on the parameter information and one or more customized radioactivity algorithms and customized activity and one or more dosimetric selection algorithms. Based on the rhythm, one or more sphere amounts and dosage recommendations are The method may further include generating one or One of the multiple sphere amounts and recommended values is selected as the selected sphere amount and recommended value. and radioactive compound ordering for radioembolization procedures. e compound order) by the processor, customized radiation The method may include generating a sphere based on the selected sphere amount and recommended dosage.

[0009] In another embodiment, a radioactive material for use in radioembolization procedures for treatment planning is provided. The system for the selection of dosimetry levels and sphere quantities of radioactive compounds is available through the Dosimetry Portal and dosimetry selection tools including a graphical user interface and dosimetry selection a processor communicatively coupled to a tool and a non-transitory computer storage medium. The non-transitory computer storage medium, when executed by a processor, For processors, the input of radioactivity parameter information into the dosimetry portal of the dosimetry selection tool is Forces can be received through a graphical user interface and customized release The radioactivity is calculated by a processor using the radioactivity parameter information and one or more customizations. and a radioactivity algorithm based on the dose of one or more spheres and a recommended dose. The processor then converts the customized activity and one or more dose measurements into The instructions may be stored to cause the processor to generate the image based on a selection algorithm. When executed, the processor is further provided with one or more sphere quantities and a recommended investment value. The graphical user selects one of the following as the selected sphere amount and the recommended input value: radioactive compound orders for radioembolization procedures received through the user interface The processor allows for customized radioactivity and selected sphere amounts and dosage recommendations. The value may be generated based on the

[0010] These and additional features provided by the embodiments described herein include: A more complete understanding will be obtained from the following detailed description taken in conjunction with the drawings.

[0010] The embodiments set forth in the drawings are illustrative and exemplary in nature and are not intended to limit the scope of the claims. The following exemplary embodiments are not intended to limit the subject matter defined by the scope. This detailed description should be understood when read in conjunction with the following drawings, in which like structure is indicated with like reference numerals and in which: It is possible. [Brief explanation of the drawings]

[0011] [Figure 1]

[0011] FIG. 1 is a home page screen view of a graphical user interface (GUI) of a dosimetry portal of a dosimetry selection tool for radioembolization treatment planning according to one or more embodiments shown and described herein. [Figure 2]

[0012] FIG. 2 is a screen shot of an order page of the dosimetry portal of FIG. 1 for issuing one or more dosimetry inputs and selecting order details based on dosimetry and sphere recommendations, according to one or more embodiments shown and described herein. [Figure 3]

[0013] 2 is a screen shot of a review order page of the dosimetry portal of FIG. 1 according to one or more embodiments shown and described herein. [Figure 4]

[0014] 2 is a screen shot of a confirmation order page of the dosimetry portal of FIG. 1 for entering treatment and shipping information according to one or more embodiments shown and described herein. [Figure 5]

[0015] 10 is a screen shot of a confirmation order page of the dosimetry portal of FIG. 1 for assigning shipping information entries to appropriate review parties, according to one or more embodiments shown and described herein. [Figure 6]

[0016] FIG. 10 is another basic order page screen view of the dosimetry portal of FIG. 1 for issuing one or more dosimetry inputs and selecting order details based on dosimetry and sphere recommendations on a basic screen including one radioactivity customization algorithm, according to one or more embodiments shown and described herein. [Figure 7]

[0017] 10 is a first portion of another expanded order page screen view of the dosimetry portal of FIG. 1 for issuing one or more dosimetry inputs and selecting order details, including three different radioactivity customization algorithms, based on dosimetry and sphere recommendations on the expanded screen, according to one or more embodiments shown and described herein. [Figure 8]

[0018] 8 is a second portion of the expanded order page screen view of FIG. 7 to show treatment, dose, and sphere selection information according to one or more embodiments shown and described herein. [Figure 9]

[0019] 2 is a screen shot of an order form for the dosimetry portal of FIG. 1 according to one or more embodiments shown and described herein. [Figure 10]

[0020] 2 is an illustration of an approval order screen of the dosimetry portal of FIG. 1 according to one or more embodiments shown and described herein. [Figure 11]

[0021] FIG. 2 is an order history screen view of the dosimetry portal of FIG. 1 according to one or more embodiments shown and described herein. [Figure 12]

[0022] 12 is a flowchart of a process for utilizing the dosimetry portal screens of FIGS. 1-11 according to one or more embodiments shown and described herein. [Figure 13]

[0023] 13 is a schematic diagram of a system for implementing a computer and software-based method for applying the process of FIG. 12 using the dosimetry portal of FIG. 1, according to one or more embodiments shown and described herein. DETAILED DESCRIPTION OF THE INVENTION

[0012]

[0024] As generally shown and illustrated in the drawings, embodiments of the present disclosure are described herein. Dosimetry of radioactive compounds for use in radioembolization procedures for such treatment planning The present invention relates to a system and method for selecting levels and sphere quantities. Various embodiments of the method and method are described in detail herein.

[0013]

[0025] The present disclosure provides a method for ordering radioembolization for yttrium-90 (Y90) radioembolization procedures. Web-based and mobile applications for determining radioactivity and ball counts Converged as a platform-wide software application tool Regarding portals. Patients scheduled for radioembolization usually have a portal vein that is positioned, sized, shaped, Vascularity, tumor uptake, and / or particles (even Several imaging studies are performed to determine whether to shunt the thoracic graft (e.g., a sphere) to another organ. The determined information is then used to calculate the radiation dose required during treatment. Current dosimetry models include MIRD, Body Surface Area (BSA), Area) model, partition model, or modified version to make this determination; These may include mobile applications, online applications, and / or This can be used through a spreadsheet for model evaluation. Creating a disjointed process requiring additional physician steps distributed from the platform and somewhat coordinate logistics for the hospital regarding ordering based on the determined required radiation dose. Furthermore, market suppliers assign doses based on pre-set activity per sphere. In current dosimetry models, the model steps are performed individually. The results are collated manually for comparison with the controlled dose. One or more models of the present disclosure that alter dosage selection and reduce delays in treatment regimens In contrast to one or more technical effects of the above, this increases the delay in the treatment plan.

[0014]

[0026] As an example, SIRTeX spheres have a radioactivity of 50-80 Bq / sphere, and BT A G sphere is approximately 2500 Bq / sphere. A becquerel (Bq) is the number of times an atomic nucleus decays in one second. It is a unit of radioactivity defined as the amount of radioactivity of a radioactive material per sphere. Depending on the activity set, the supplier may need to increase the dose ordered beyond what the doctor prescribes. This is to allow the order to age and decay to the desired dose. However, this results in extended delivery times and extraneous material usage. Also, increasing the number of spheres simply increases the total dose due to the pre-set activity per sphere. Therefore, the physician is not presented with the option to prescribe the number of spheres and the dosage per sphere. Instead, physicians are likely to be more likely to use much higher doses than are needed to meet the requirements for sphere counts. There is a tendency to order doses and further extend radioactive decay and delivery times.

[0015]

[0027] Dosimetry Selection Software Application Tool as described herein is the injection that the physician and user desires to deliver to the patient for the radioembolization procedure. A centralized platform that allows you to prescribe and select both the volume and the number of spheres. The user is configured to function as a dosimeter. Through the tool, multiple dosimetry models and one or more dosimetry selection algorithms can be selected. and simultaneously evaluate and order the selected dose per sphere for radioembolization procedures. Dosimetry Selection Software Application Tool is one or more based on previous treatment and / or specific treatment strategy or treatment location. Furthermore, it can facilitate hospital logistics and processing. To assist with this, selected ordering information is translated directly into order forms and other clinical documents. The dosimetry selection software application tool may be used in conjunction with the system described herein. System and portal internal and / or external responsibility, e.g., for hospitals The system may include a notification and / or tracking system that allows the user to

[0016]

[0028] Referring to FIG. 1, a graphical user interface for radioembolization treatment planning is shown. The dosimetry selection tool 1312 includes a GUI interface 1326 (FIG. 13). A home page screen 103 of the TAL 100 is shown, which is described in more detail below. The Dosimetry Portal allows you to navigate to the Dosimetry Portal through the selection of menu navigation options. The navigation menu 101 is included for navigating to a desired screen of the main screen 100. The Dosimetry Portal uses the Home tab 102 for navigation to each screen. an order fulfillment tab 104, an order fulfillment tab 106 that allows a user to review the history of one or more orders; An order history tab 106, allowing a user to review, update, or delete one or more saved orders and / or approval. 3 includes a list of items to be accomplished for users of the Dosimetry Portal 100, 1. By way of example and not limitation, To Do subscreen 110 of FIG. 10 (1) reviews the order from Dr. Stephens and (2) adds the procedure date and time to the order. Contains a user-specific list of tasks for the signed-in user. Surface 103 is one or more pages that the signed-in user has access to view. 1 further shows an order status sub-screen 114 containing a list of order statuses.

[0017]

[0029] In an embodiment, the dosimetry portal 100 may include user-specified portal usage, data One or more users for security and / or data collaboration Therefore, the dosimetry portion 10 0 allows one or more users to perform dosimetry based on the access rights assigned to them. A security system that allows access to one or more different levels of the portal 100. The first user may be granted a security clearance based on the base security clearance level. , a second user may access a particular set of GUI screens in the dosimetry portion 100. The first user has access based on the enhanced security clearance level. to another specific set of GUI screens in the dosimetry section 100 which contains more screens than With respect to the dosimetry portion 100, different levels of access to the GUI screens are possible. Different levels of security, assigning one or more users corresponding access rights and permissions It should be understood that security clearance is contemplated and within the scope of this disclosure.

[0018]

[0030] Additionally, the first user may review and Another user may be selected to approve, or the dosimetry portion 100 may select the first user. After the user generates the first draft purchase order, the user submits it for review and approval by another user. , can be configured to automatically allocate orders. A first user with a clearance level may place an order as described herein. The first user may be permitted to enter a review and create a first draft order. and a second user with an enhanced security clearance level for authorization. or the dosimetry portion 100 may assign the first order draft. a review order approvals page that lists one or more orders for approval by a second user; and / or the first draft purchase order is placed in the approval GUI for review by the second user. The second user may be configured to notify the second user that the request is ready for approval.

[0019]

[0031] In an embodiment, the dosimetry portion 100 may include one or more dosimeters, as described herein. Multiple orders may be placed for one or more security clearance levels and one or more Created and edited by multiple users with user-specific access rights to multiple orders , view, approve, and / or act on the data collaboration platform. Thus, multiple users can share information through a centralized platform, for example. the hospital's responsibility in sharing, reviewing, and issuing such orders on the Platform. To help facilitate logistics, we provide order and multiple order history data. The data may be available for viewing and / or review.

[0020]

[0032] Referring to FIG. 2, an order page screen 200A is shown. A is accessible, for example, via execution of the order tab 104 of FIG. 1. Order Page Screen 200A includes a dosimetry input subscreen 202, a customized radioactivity algorithm The radioactivity parameter information includes a sub-screen 206, and an order details sub-screen 208. In the embodiments described herein, the dosimetry portal 100 may be entered, such The radioactivity parameter information may be obtained using one or more models and / or methods as described herein. or may contain information used to estimate the dose of radiation using an algorithm. By way of non-limiting example, the dosimetry input sub-screen 202 may include the following radioactivity parameter information input: (1) LSF (lung shunt fraction) as a percentage t fraction), (2) Expected residual waste as a percentage of 1 kg of material A derived unit of ionizing radiation defined as the absorption of one joule of radiation energy per gram (3) the previous dose to the lungs in Gray (Gy), where volume, and (4) target liver volume (t target liver volume), As a non-limiting example, the dosimetry input sub-screen 202 of FIG. %LSF to be measured, expected residual waste to be 1%, previous dose to lungs to be 0 Gy, 200 The desired dose to the liver is 1 Gy, and the target liver volume is 300 cc. Parameter inputs include time zone, treatment date, treatment time, patient-specific parameters, and previous treatments. The dosimetry input subscreen 202 may further include radioactivity parameter information input. and customized radioactivity based on customized radioactivity algorithms. It further includes a calculate button 204 for performing calculations. The estimated radioactivity is the amount of radioactivity in the sphere that can be varied, thereby allowing different spheres to be Each amount option allows you to get a customized total activity level. sphere level, and may contain respective radioactivity as described herein. , with options for different sphere quantities based on associated customized radioactivity algorithms A new version is generated.

[0021]

[0033] As a non-limiting example, the Customized Radioactivity Algorithm subscreen 206 may include: , determine customized activity based on input from the dosimetry input subscreen 202 As a non-limiting example, the MIRD dosimetry calculation algorithm for Customized radioactivity algorithms based on inputs in the Measurement Input subscreen 202 The MIRD dosimetry calculations on the MUSUB screen 206 are based on a target liver mass of 0.31 kg (e.g. , customized radioactivity) radioactivity value at the time of administration of 1.27 GBq, 1.26 G Calculated dose to lungs of 1.26 Gy, dose limit to lungs of 30 Gy, and a cumulative dose limit to the lungs of 50 Gy. Any undeveloped dosimetry calculation algorithm can be used by the dosimetry portal 100. It should be understood that the present invention may be used within the scope of the present invention. The dosimetry calculation algorithm as a simulated radioactivity algorithm is calculation algorithm, BSA dosimetry calculation algorithm, or division known to those skilled in the art It may include dosimetry calculation algorithms.

[0022]

[0034] The Order Details subscreen 208 displays the customized activity and MIRD dose of FIG. Based on the measurement calculation algorithm and the dosimetry selection algorithm used, one Or include multiple sphere amounts and dosage recommendations. Display different recommendations from different models. This allows users to directly compare the different recommendations compared and also provides the same format. Decide which recommendations to choose from one or more models by viewing the results in In an embodiment, one or more sphere amounts and recommended dosage values are provided to assist the user. The dosimetry selection algorithm or algorithms for generating the doses are based on the per-sphere activity algorithm. rhythm, activity-based embolization loading algorithm embolic load algorithm), or a combination thereof. The radiation per sphere algorithm allows for customized radiation levels, such as 300Bq / sphere. A non-limiting example would be a 3 gigavec. Customized radioactivity is 300Bq / GBq divided by 300Bq / sphere. spheres, which amounts to 10,000,000 spheres. In an embodiment, the model results are expressed as Bq / number of spheres. Outputting in sphere number format allows the model output to be compared with the fixed activity of the supplier sphere. The comparison shows that the model results are consistent with the current dosimetric model, which is manually converted by the user. In contrast to Dell, they let users know immediately, in real time, what their available ordering options are. This will be revealed in the future.

[0023]

[0035] Alternatively, a radioactivity-based embolic loading algorithm may be used to determine the sphere and dose. , as a function of embolic loading, tissue volume input, and a given volume per cubic centimeter of tissue This may include use with embolic load determination. An example of a limiting embolic load may be, for example, 20,000 spheres / cc. If the tissue volume is 300cc, there will be 6,000,000 spheres. Decrease the sphere volume so that the sphere contains a larger amount of radioactivity, resulting in a customized total radioactivity. To achieve the desired radioactivity level, or to reduce the amount of spheres so that each sphere contains a smaller amount of radioactivity, Increase and adjust the amount of spheres to achieve a customized total activity level. In an embodiment, the user can achieve a customized radioactivity of 425 Bq / sphere. NOTE: From the Details subscreen 208, achieve a customized total activity level of 1.27. To do this, the user can select 3 million spheres, or the user can select a reduced 255Bq / 1.27 customized doses per sphere from the Order Details subscreen 208. A higher amount of spheres (5 million) may be selected to achieve a total radioactivity level. Choose from a drop-down sphere selection amount ranging from 1 million spheres to 40 million spheres to achieve a customized total activity level (e.g., 1.27 in Figure 2). In an embodiment, a user may create a range of 1 million spheres to 40 million spheres. You may be presented with up to 13 options.

[0024]

[0036] As a non-limiting example, the dosimetry selection algorithm may select 425 for the values in FIG. The recommended dose of 3 million spheres is 255 Bq / sphere of radioactivity. It can be provided with 5 million sphere replacement recommendations, which allows for The recommended values are for more spheres to be used at reduced activity levels. The physical size of the sphere, also called the However, to vary the amount of radioactivity per sphere ordered across the spheres, different dosage levels were used. It should be understood that different amounts of spheres may be ordered. In this state, the dosimetry portal 100 uses the size generated by the sizing algorithm. and / or providing a GUI that provides size distribution information. ,Using such information, we can estimate the size of the spheres, which varies based on the manufacturer's sphere manufacturing process. Spheres can be manufactured to order with specific distribution, activity, and / or quantity.

[0025]

[0037] The user can also use the order details sub-screen 208 to increase the price by +10%, and In an embodiment, the dose may be modified such that the dose is decreased by -10%. Additionally or alternatively, the user may enter the amount as a fractional amount rather than a percentage amount. , up to three vials total to achieve a 100% dose. Thus, the dose can be distributed over a wide area to treat the tumor during the radioembolization procedure. To achieve a customized total radioactivity value for each individual sample, between three major tissue regions or for tumors requiring up to three different radioactive dose levels The order review button 210 allows the user to The order can be reviewed on the order review page 212 of FIG.

[0026]

[0038] Referring to FIG. 3, the order review page 212 includes an order details subscreen 214, Quantitative Measurement Input Subscreen 216, and Customized Activity Algorithm Subscreen 21 8, from which the user can review the inputs and generated values and decide which issues to execute. In an embodiment, the accuracy of the notes can be verified. The model outputs include the target liver mass, the radioactivity at the time of administration, the calculated dose to the lungs, and the dose limit to the lungs. , cumulative lung dose, cumulative lung dose limit, and / or Y90 for radioembolization The number of recommended radioactive compound microspheres (e.g., spheres) may be included. The user may press the back button Use button 220 to return to the previous order page screen 200A of FIG. 2 and continue with order entry and / or Alternatively, the user can select the Confirm Order Details button 222 to Go through the dosimetry portal 100 to the order confirmation page screen 230 of FIG. 4 and confirm the order. and execute the order.

[0027]

[0039] Referring to the order confirmation page screen 230 of FIG. 4, the user clicks the Yes button. By selecting option 232, the user can select the disposition date and shipping date to prepare for fulfilling the order. The user can decide they are ready to enter information. The user can enter the procedure date, time, and time. Treatment information such as time zone and / or other relevant treatment information such as patient identifiers The user can also enter the shipping address and shipping recipient in the disposition information sub-screen 234. Shipping information, such as shipping information, can be entered on a shipping information sub-screen 236. In an embodiment, shipping information The information is either auto-populated or selected from pre-configured drop-down menus. obtain.

[0028]

[0040] Referring to the order confirmation page screen 230 of FIG. 5, the user may click the No button. Selection of option 238 allows the user to enter shipping information selected from the drop-down menu. You can decide that the power should be assigned to another user. In an alternative embodiment, use of the No button 238 or another allocation interface is possible. Through this interface, users can enter action dates and shipping information in preparation for fulfilling an order. are not ready to input the information and would rather have it submitted to the appropriate reviewers for review and approval. In an embodiment, the reviewer may indicate that they would like to assign the order to an appropriate reviewer. can approve the order and send it back to the user for execution, and You can place an order, edit the order, and / or submit the order to a user for editing. In one or more of the above-described embodiments, The user can then select the appropriate reviewer from the pre-populated person name list menu 240. The user can select the back button 242 to return to the previous screen, as described above. Return to the Order screen or select the Save and Next button 244 to save your order for review. , the order can be sent to the appropriate reviewer selected.

[0029]

[0041] Referring to FIG. 6, an alternative ordering page screen for the dosimetry portal 100 is shown. An order page screen 200B is displayed. The user can use the order page screen 200B to Issue multiple dosimetric inputs and run one such MIRD dosimetric calculation algorithm. The order page screen 200 is the base screen containing the customized radioactivity algorithm. In B, based on the dosimetry and sphere recommendations as described herein, order details The basic order page screen 200B is for a radioembolization procedure with simple analysis. Alternatively, the user may select the extended dosimetry button 250 to You can proceed to the extended order page screen 200C. and one or more customized radioactivity algorithms as described herein. Dosimetry models and sphere algorithms are evaluated to determine the dosimetry selection algorithm. Endosphere volume and dose per rhythm and each customized radioactivity algorithm The difference between the recommended values for use can be viewed on the Basic Order Page Screen 200B and the Extended Order Page Screen 2 00C for navigation and data transfer between them and for the execution of It can be linked to in the notes.

[0030]

[0042] Referring to Figure 7, a first portion of the expanded order page screen 200C is shown. The part of the figure shows the MIRD dose measurement information subscreen 252, the BSA dose measurement information subscreen 254, and split dosimetry information sub-screen 256, each of which may be customized. Contains one or more dosimetric inputs for the selected radioactivity algorithm. The Quantitative Information Subscreen 252, the BSA Dosimetry Information Subscreen 254, and the Split Dosimetry Information Subscreen The input of the sub-screen 256 is, for example, the MIRD calculation sub-screen 262, the BSA calculation sub-screen 263, and the like. 64, and the split calculation subscreen 266, respectively. Each is fed into a customized radioactivity algorithm to provide calculated values for can be.

[0031]

[0043] FIG. 8 shows, for example, the scroll-down view of the expanded order page screen 200C. The second part shows the MIRD calculation sub-screen 262, the BSA calculation sub-screen 264, and the The division calculation sub-screen 266 may be used to select, by way of non-limiting example, the number of Bq per radioactive microsphere. along with the treatment type selection option 270 and the recommended number of spheres selection option 272 It includes a set of recommended spheres or dosage options. The user selects the desired number of millions of spheres and enters the values in sub-screens 262, 264, and 266. Select the activity selection from the drop-down list that can be calculated from the model and modify the dose accordingly. Enter the percentage or change (for example, as a percentage or fractional value) The required radioactivity is calculated based on the radioactivity of the nuclear decays per second. Inserted in units of gigabecquerels (GBq), a unit of radioactivity defined as the amount of radioactivity in a substance. The change subscreen 274 allows the user to enter the order details. The expand button is used to display one or more different sphere selection algorithms. It is possible.

[0032]

[0044] The second portion of the expanded order page screen 200C of FIG. 8 further displays the patient's Target dose, therapeutic activity in GBq, number of spheres in millions, spheres as reference value 2 shows the final order details sub-screen 276, including GBq per unit and expected delivery date. Once the final order details on the order details sub-screen 276 have been confirmed, the user may click the order button 278 You can select to continue placing the order.

[0033]

[0045] The user may, for example, pre-populate the calculated values and contact the manufacturer to generate the order. Figure 9 Order Form ready for printing and / or further editing for publication to The order form screen 280 allows the user to select up to three different To be able to determine the selected sphere volume from the vial and the percentage of dose distribution Optional vial dispensing section 282 may also be included. An order form generated from the home screen 280 is received and printed based on the order form. It may be possible to generate a purchase order invoice that is updated accordingly.

[0034]

[0046] In an embodiment, FIG. 10 illustrates a process for generating a purchase order before issuing a purchase order to a manufacturer. , for the appropriate reviewers selected to review the entered purchase order. The order approval screen 300 is shown. Appropriate reviews can be saved using the save button 302. The information on the surface 300 is stored.

[0035]

[0047] Figure 11 shows whether the user needs approval, has been fulfilled, or is in delivery. 4 shows an order history screen 400 where the status of all orders can be reviewed, including whether they have been placed. Use the navigation sub-screen 402 on the history screen 400 to navigate between screens. to create, update, and approve purchase orders, view order status and history information, or In an embodiment, the dosimetry portal 100 may include an order history screen. 400, or, as described herein, the order status and Based on the historical information, the information can be saved, stored, analyzed, etc. through a separate reporting interface. The information is structured to analyze and / or report on the

[0036]

[0048] Referring to FIG. 12, the shipping and / or review as described herein A process for generating a purchase order as described herein may include an embodiment of the process. Process 12 using the dosimetry portal screens of Figures 1 to 11 of the dosimetry portal 100 A flowchart of process 1200 of FIG. 12 is shown. Selecting dosimetric levels and spherical amounts of radioactive compounds for use in radioembolization procedures The user may use the control scheme block to Sign into the Dosimetry Portal 100 with your assigned security clearance level. In block 1202, the radioactivity parameter information is As shown, the dosimetry portal 100 in the dosimetry selection tool 1312 (FIG. 13) In embodiments, the radioactivity parameter information is input to the order page screen described herein. Pulmonary shunt fraction percentage as shown in planes 200A, 200B, and 200C the dose value, the expected residual waste percentage value, the previous dose value to the lungs, the desired dose value to the liver, The values may include a volume value, and a target liver volume.

[0037]

[0049] In block 1204, the customized activity is Radioactivity parameter information and one or more customizable The radioactivity is determined based on one or more customized algorithms. The radioactivity algorithm is implemented in the order page screens 200A, 200B, and As shown in Fig. 200C, the MIRD dosimetry calculation algorithm, the BSA dosimetry or fractionated dosimetry calculation algorithm. In embodiments, the one or more customized radioactivity algorithms are Organ mass, radioactivity at time of administration, calculated dose to lung, lung dose limit, cumulative dose to lung, and Customized radiation information including lung and cumulative dose limits can be generated. The calculated radioactivity can be based on customized radioactivity information.

[0038]

[0050] In block 1206, one or more sphere quantities and recommended throw values are calculated. Customized activity and one or more dosimetry selections as described in the specification In an embodiment, the sphere volume and the throw are generated based on an algorithm. One or more dosimetric selection algorithms to generate recommendations for radiation per sphere or radioactivity-based embolic loading algorithm. The per-sphere radioactivity algorithm may be customized as described herein. The radioactivity is divided into a predetermined number of spherical volumes per unit of radioactivity. The load algorithm, as described herein, uses tissue volume input and cubic centimeters of tissue. This may include use with a predetermined embolic loading determination for each vessel. For example, the loading in a given embodiment is , which may contain 20,000 spheres per cubic centimeter of tissue.

[0039]

[0051] One or more sphere quantities and dosage recommendations will be applied to the selected sphere quantity and dosage. and the recommended amount of spheres to be used. In an embodiment, the selected amount of spheres and the recommended amount of spheres to be used are The selecting may include selecting a desired radioactivity level for each sphere and / or Or, as shown in the Order Details sub-screen 208 of FIG. 2, a positive or negative percentage value. 2. Also shown on the Order Details subscreen of FIG. As shown, the selected sphere volume and dosage recommendations are based on the percentage of vial Selected sphere volume and dosage recommendations across multiple vials based on cent delta and distributing the selected amount of spheres, the percentage difference adding up to 100%. and a recommended dosage value. In an embodiment, the plurality of vials includes up to three vials. It can be seen.

[0040]

[0052] In block 1208, a radioactive compound order for a radioembolization procedure is placed. Generated based on customized activity, selected sphere amount and recommended dosage, The process 200 is executed so that the purchase order is issued to the manufacturer for fulfillment. Transmitting radioactive compound orders to radioactive compound manufacturers for processing and order fulfillment; As a non-limiting example, if the Yes button 232 is selected and the user When the user enters and submits the disposition and shipping information, this is the order confirmation page screen shown in Figure 4. Alternatively, the process 200 may be executed by the radioactive compound order processing unit 206 through 230. The order is then sent to the radioactive compound manufacturer for processing and fulfillment after approval by the designated personnel. Assigns radioactive compound orders for review by assigned personnel so that orders can be In an embodiment, if the No button 238 is selected, the user may: As an assignee, if you assign an order for review by a colleague, This can occur through the order confirmation page screen 230 of FIG.

[0041]

[0053] Referring to FIG. 13, a computer and software-based method is implemented to , utilizing embodiments of the dosimetry selection software application tool described herein. and administering the administered fluid for delivery by a radioembolization delivery device in the procedure. Dosimetry and sphere selection recommendations for one or more radioactive compounds to be used with The system 1300 for determining, for example, a computing device 1324 using a graphical user interface (GUI) 1326 communicatively coupled to The system 1300 is shown as being implemented in a communication path 1302, One or more processors 1304, a memory component 1306, a dosimetry selection tool 1 312, storage or database 1314, dosimetry as described herein A dose selection tool 1312 configured to provide one or more dose measurement recommendations Measurement selection algorithm 1316, network interface hardware 1318, A network 1322, a server 1320, which may include a cloud-based server, and a computer The various components of the system 1300 and the associated components include a computing device 1224. Their interactions are described in detail below. In an embodiment, the dosimetry selection tool 1 312 may be directed to a flow software application tool, dosimetry selection algorithm The algorithm 1316 may include radiation therapy for treatment planning, as described in more detail below. An optimization algorithm for flow rate determination for embolization procedures may be directed.

[0042]

[0054] In some embodiments, the system 1300 may be an intranet or an internet This is done using a wide area network (WAN) or network 1322, such as the The computing device 1324 may be configured to connect to and use the network. This may include digital systems and other devices that allow navigation of the computer. The computing device 1324 may be a smartphone, tablet, or similar handheld device. A laptop, or desk computer, such as a handheld smart device, or It may be a smart mobile device. As a non-limiting example, a computing device The 1324 is a smartphone such as an iPhone (registered trademark) or an iPad (registered trademark). and tablets such as the Apple Watch (registered trademark), both of which are manufactured in Cupertino, California. The lines shown in Figure 13 represent the connections between the various components. This refers to communication rather than physical connection.

[0043]

[0055] As described above, the system 1300 includes a communication path 1302. 2 is a material that can transmit signals, such as conductive wires, conductive traces, and optical waveguides. A communication path may be formed from any medium or combination of media capable of transmitting a signal. 1302 communicatively couples the various components of the system 1300. When used in conjunction with a network, the term "communicatively coupled" is used to indicate that the coupled components are, e.g., , electrical signals through conductive media, electromagnetic signals through air, optical signals through optical waveguides, etc. This means that data signals can be exchanged between them.

[0044]

[0056] As described above, the system 1300 includes a processor 1304. 304 can be any device capable of executing machine-readable instructions. The one or more algorithms stored in the processor 1304 may be implemented in hardware such as a processor 1304. The processor 1304 in an embodiment may be local or may be directly integrated. and / or from a database that may be stored on a cloud server. or algorithm parameters. controller, integrated circuit, microchip, computer, or any other computing device The processor 1304 may be connected to the system 1 via the communication path 1302. 300. Thus, communication path 1302 may be The number of processors may be communicatively coupled to each other, and the modules coupled to the communication path 1302 This may enable the module to operate in a distributed computing environment. Each of the nodes can act as a node that transmits and / or receives data.

[0045]

[0057] As described above, the system 1300 includes a processor 1302 coupled to a communication path 1302. The memory component 1306 is communicatively coupled to the memory component 1304. 6 is a non-transitory computer-readable medium or non-transitory computer-readable memory The memory component 1306 may be configured as a non-volatile computer-readable medium. AM, ROM, flash memory, hard drive, or other device where machine-readable instructions are stored in processor 1 Any device capable of storing machine-readable instructions that can be accessed and executed by 304. The device may include a chair.

[0046]

[0058] Machine-readable instructions may, for example, be written in a machine language that may be executed directly by a processor, or or assembly language, object-oriented programming (OOP), scripting languages, It is compiled or assembled into machine-readable instructions, such as microcode, and stored in memory structures. Logic or applications written in any programming language may be stored in the configuration element 1306. Alternatively, the machine-readable instructions may comprise a field programmable gate array. FPGA configuration or application specific integrated circuit (ASIC), or their equivalents The logic is described in a hardware description language (HDL), such as Thus, the methods described herein can be implemented using any conventional computer program. programming language, as pre-programmed hardware elements, or The present invention may be implemented as a combination of hardware and software components.

[0047]

[0059] As noted above, and still referring to FIG. 13, the system 1300 may include, for example, , visual output such as information, graphical reports, messages, or a combination thereof; such as a GUI 1326 on the screen of the computing device 1324 for providing The display on the screen of the computing device 1324. is coupled to the communication path 1302 and communicatively coupled to the processor 1304. Thus, communication path 1302 allows the display to communicate with other modules in system 1300. The display may be, for example, a cathode ray tube, a light emitting diode, or a liquid crystal display. It can include any medium capable of transmitting optical power, such as a plasma display. In addition, the display or computing device 1324 can 13. The system may include at least one of a processor 1304 and a memory component 1306. Note that system 1300 is shown in FIG. Although shown, in other embodiments the systems may be stand-alone systems.

[0048]

[0060] The system 1300 may be implemented in accordance with one or more of the embodiments described herein. to calculate one or more dosimetry recommendations and sphere selection recommendations, and A dosimetry selection algorithm 1316 may be provided for providing the dosimetry selection algorithm 1316 to the rule 1312. As will be described in more detail below, the processor 1304 may also process data received from the system modules. It may process input signals and / or extract information from such signals. In an embodiment, the processor 1304 executes instructions stored in the memory component 1306. The processes described herein may be carried out using

[0049]

[0061] The system 1300 may be connected to a network such as a computer network 1322. Network interface hardware for communicatively coupling to a computer network The network interface hardware 1318 is The path 1302 connects the network interface hardware 1318 to the system 130 13. The network is coupled to a communication path 1302 so as to be communicatively coupled to other modules of the The network interface hardware 1318 communicates with the device over a wireless network. It can be any device that can send and / or receive data. The network interface hardware 1318 may be compatible with any wireless communication standard. As such, it may include a communications transceiver for transmitting and / or receiving data. For example, the network interface hardware 1318 may be, for example, Wireless Fidelity (Wi-Fi), WiMax, Bluetooth (registered trademark), Wired and wireless technologies such as IrDA, Wireless USB, Z-Wave, ZigBee, etc. and / or chipsets for communicating over wireless computer networks (e.g., an antenna, a processor, machine-readable instructions, etc.).

[0050]

[0062] Still referring to FIG. 13, the dosimetry selection tool 1312 Data from various applications is routed to the network interface hardware. 18 may be provided to the system 1300 from the computing device 1324. The computing device 1324 may include network interface hardware. 1318 and hardware (e.g., It can be any device that has a do.

[0051]

[0063] The network 1322 may be, for example, a wide area network, a metropolitan area Any network, such as the Internet, intranet, satellite network, etc. It may include wired and / or wireless networks. The network 1322 provides access to one or more servers (e.g., server 1320). The server 1320 and any Any additional servers may generally be used to distribute resources over the network 1322. The resources include, for example, processing, storage, and 1320 over a network 1322. In addition, the server 1320 and the and any additional servers, e.g., in the wired part of the network, 1322, such as through a wireless portion, or a combination thereof. Note that resources can be shared between the two.

[0052]

[0064] Dosimetry selection tool 13 described herein via dosimetry portal 100 Twelve embodiments allow the user to specify not only the desired sphere volume and dose per sphere, but also the planned Customized for the Y90 radioembolization procedure for the specific patient set for the procedure Calculate the customized required activity as the customized activity. Furthermore, the selection of the desired sphere volume allows for the determination of the tissue and / or blood vessel size. The medicaments can be dispensed into separate vials for individual delivery to the

[0053]

[0065] The dosimetry platform described herein allows physicians and users to Provides a vehicle for customizing each dose based on tumor vascularity, anatomy, Characteristics such as cancer type, patient age, and patient performance status are selected for each sphere. The radioactivity determined is a factor in selecting the desired sphere amount and is described herein. Based on dosimetric input and one or more algorithms, The user can enter appropriate dosimetry information to achieve a number of actions. View, evaluate, and compare algorithms to determine the appropriate number of balls or to determine the location of each ball value. After selecting the appropriate dose and number of spheres for the patient, extended dosimetry is performed. The data is then sent to other personnel for review and / or approval, or used for order processing and and imported into a purchase order form to be sent to the manufacturer for fulfillment.

[0054]

[0066] The dosimetry selection tool 1312 can also be used for other radioactive materials and isolates. scout dosing, which can be used and is bland, Other embolizations, such as chemotherapy (e.g., chemoembolization), and can be adapted to other spherical materials and delivery systems, and image viewing and / or may be directly integrated with analytics software and / or mobile platforms. It is intended that the information contained in this website may be used across the entire platform of the website. , are within the scope of this disclosure.

[0055]

[0067] Further, by way of non-limiting example, during a radioembolization procedure, spheres (e.g., particles) Determining the injection flow rate of the administered fluid containing the spheres can affect the dispersion and the spheres themselves. The software application tools described herein will provide recommended flow rates and , reflux probability, and pre-procedure and / or during the procedure in real time. An algorithm aimed at determining the recommended flow rate for a user that may be provided Alternatively or additionally, the software application tools may include a mobile application application ("App") or a separate application, such as a web-based app may be provided in an application-based platform and / or radioembolization It may be an integrated part of a delivery device and / or system for the treatment, Thus, a display communicatively coupled to the delivery device may be configured to display a software application. You can view the output information generated by the application tool.

[0056]

[0068] In an embodiment, computational fluid dynamics (CFD) analysis is performed. uid dynamics) to study dispersion and particle dynamics during radioembolization procedures. The effect of flow rate can be determined. Furthermore, the movement of inappropriate injected particles can be measured by flowing backward relative to the blood flow. and can migrate into adjacent vasculature and organs, which can adversely affect healthy tissue. A software application tool may receive one or more inputs. recommended flow rate based on inputs and / or recommended flow rate based on inputs and / or The input is a set of parameters such as shape, size, density, etc. Inputs may additionally or alternatively include fluid type, catheter It may include clinical treatment planning inputs for radioembolization procedures such as tip angle, blood flow rate, etc. A flow software application tool is a set of one or more inputs within the tool and a calculation Infusion flow rate in milliliters / minute, and / or inverse, based on a calculation algorithm The probability of the flow may be output.

[0057]

[0069] In embodiments, during a scout dose procedure in preparation for a radioembolization procedure, a clinician is a method for measuring particle flow by injecting technetium-99 (99Tc or Tc-99) into the vascular system. and feeds and evaluate one or more may monitor and record clinically relevant information for use as multiple inputs. Such information may be, for example, the catheter tip angle, blood flow rate, etc. One or more inputs may be entered into the Flow software application tool. The software application tool may include one or more of the software applications described herein. Applying algorithms to optimize flow rate, minimize backflow, and one or more recommended flow rates and / or a probability of backflow based on the recommended flow rates and as selected by the clinician.

[0058]

[0070] During the radioembolization procedure, clinicians use flow software application tools Through this, the procedure is matched with previous clinician input such as catheter tip angle, blood flow rate, etc. Alternatively, the clinician may be new to the flow software application tools. Enter one or more inputs to generate one or more updated flow rate recommendations and / or The delivery device may then generate a corresponding probability of reflux. The device may be configured to inject the fluid into the patient automatically, partially automatically, or manually.

[0059]

[0071] Therefore, the flow software application tool is One or more flow rate recommendations for the optimal injection flow rate of a given size (e.g., spheres or particles) and then calculates the flow rate and minimizes backflow using one or more inputs. The optimization algorithm may be configured to evaluate the associated probability of reflux based on the algorithm. The system is based on information, data, and / or engineering fluid dynamics calculations, integrated Clinical data and / or transport of Y90 radioembolization spheres through the patient's hepatic artery High-performance computational fluid dynamics simulation utilizing physics-based partial differential equations to explain Other stored sub-algorithms targeting the application, based on parameters and factors such as Such parameters and factors can be derived from data lookup tables, regression models, available to optimization algorithms via filters, transfer functions, neural networks, etc. One or more inputs may be made for pre-treatment planning or during the radioembolization procedure. This can be done to provide near real-time insights for future adjustments. The wear application tool is Y90 radioembolization, as described herein. It can be used in technical settings where radioactivity and sphere counts for procedures are determined.

[0060]

[0072] The systems described herein may be used in conjunction with radioactive materials other than those described herein. Other spherical substances and isotopes may be used for the substances and isotopes described herein. Used for feed systems, input and / or output, or clinical documentation Configured to print other clinical information and directly interact with image viewing and / or analysis software It can be integrated with application platforms such as mobile apps and web-based apps. The system may be utilized across platforms and / or converted into mechanical systems.

[0061]

[0073] Item List

[0074] Item 1. Radioactive compounds for use in radioembolization procedures for treatment planning The computer-implemented method for the selection of dosimetry levels and sphere quantities is Entering radioactivity parameter information into the dosimetry portal of the setting selection tool and customizing The calculated radioactivity is then processed by a processor into radioactivity parameter information and one or more Decisions based on a customized radioactivity algorithm and a customized Based on the radioactivity and one or more dosimetric selection algorithms, one or more Generating a sphere amount and a recommended investment value; and One of them is selected as the recommended dose and dose, and radioembolization A radioactive compound order for a treatment is generated by a processor with customized radioactivity and and generating the sphere amount based on the selected sphere amount and the recommended dosage.

[0062]

[0075] Item 2. Submit your radioactive compound order to the radioactive compound manufacturer for processing and order fulfillment. 2. The method of item 1, further comprising transmitting the

[0076] Item 3. Assign radioactive compound orders for review by assigned personnel. Radioactive compound orders are processed and fulfilled after approval by the assigned personnel. Item 1 or 2 further includes having the information transmitted to the radioactive compound manufacturer for processing. Or the method in item 2.

[0063]

[0077] Item 4. Radioactivity parameter information includes pulmonary shunt fraction percentage values, predicted the residual waste percentage value to be measured, the previous dose value to the lungs, the desired dose value to the liver, and the target dose value. Any of the methods from items 1 to 3, including the target liver volume.

[0064]

[0078] Item 5. One or more customized radioactivity algorithms are included in the MIRD Dosimetry Calculation Algorithm, BSA Dosimetry Calculation Algorithm, or Fractionated Dosimetry Calculation 5. The method of any of items 1 to 4, including at least one of the algorithms.

[0065]

[0079] Item 6. One or more customized radioactivity algorithms target the liver mass, activity at time of administration, calculated dose to lung, dose limit to lung, cumulative dose to lung, and Generate customized radiation information with cumulative dose limits to the lungs and The radioactivity measured is based on customized radioactivity information and is one of items 1 to 5. Either way.

[0066]

[0080] Item 7. One or more methods for generating one or more sphere quantities and recommended dosage values Multiple dosimetry selection algorithms are available, including sphere-by-sphere activity algorithms, or activity-based 7. The method of claim 1, including at least one of the embolism loading algorithms.

[0067]

[0081] Item 8. The per-sphere radioactivity algorithm is a customized radioactivity 8. The method of item 7, comprising dividing by a predetermined amount of spheres per unit.

[0082] Item 9. The radioactivity-based embolic loading algorithm uses tissue volume input and the cubic volume of tissue. 8. The method of item 7, comprising use with a predetermined embolic loading determination per centimeter.

[0068]

[0083] Item 10. The loading of certain embodiments is 20.0 per cubic centimeter of tissue. Item 9. The method of item 9, comprising 00 spheres.

[0084] Item 11. The amount of spheres selected and the recommended dosage are determined by the desired amount per sphere. Any one of items 1 to 10 further comprising selecting a radioactivity level of Law.

[0069]

[0085] Item 12. The selected sphere volume and the recommended dosage are determined by positive or negative Item 1 through 11, further including entering the dose change as a percentage value. Either way.

[0070]

[0086] Item 13. Selecting the selected sphere quantity and recommended throwing value is Volume and dosage recommendations are calculated across multiple vials based on the percent difference per vial. The method further includes distributing the selected percentage difference by dividing the total by 100%. One of items 1 to 12 consisting of the amount of spheres selected and the recommended dosage. Law.

[0071]

[0087] Item 14. The method of item 13, wherein the plurality of vials includes up to three vials.

[0088] Item 15. Multiple users may submit a first draft order or one or more releases. Dose to be granted access to view at least one of the radioactive compound orders a measurement portal configured to provide data collaboration among multiple users; Users are assigned one of several security clearance levels and have access to several Security clearance levels are either the basic security clearance level or the Enhanced security clearance level that provides users with a greater amount of access than the basic security clearance level. Item 1 to Item 1, including at least one of the following: One of four ways.

[0072]

[0089] Item 16. The basic security clearance level allows a first user to The enhanced security clearance level allows for the creation of second-level orders. configured to allow a user to review and approve the first draft purchase order , Item 15 method.

[0073]

[0090] Item 17. Radioactive compounds for use in radioembolization procedures for treatment planning The system for selecting the dosimetry level and sphere quantity of an object is provided by the dosimetry portal and Dosimetry selection tool with graphical user interface and dosimetry selection tool and a processor communicatively coupled to a non-transitory computer storage medium; The non-transitory computer storage medium, when executed by a processor, In contrast, the input of radioactivity parameter information into the dosimetry portal of the dosimetry selection tool is performed by the group. Customized radioactivity can be received via a graphical user interface. The processor compiles the radioactivity parameter information and one or more customized radioactivity parameters. and determining one or more sphere amounts and recommended values based on a radioactivity algorithm; The processor allows for customized radioactivity and one or more dosimetric selections. and one or more sphere amounts and a recommended investment value. The selection of the spheres is displayed in the graphical user interface as a selected sphere amount and a recommended input value. and a processor to receive radioactive compound orders for radioembolization procedures via the Therefore, based on the customized activity and the selected sphere volume and dosage recommendations, Generate and store instructions.

[0074]

[0091] Item 18. When performed by a processor, the processor is and instructions to transmit radioactive compound orders to radioactive compound manufacturers for order fulfillment. Item 17 systems, including:

[0075]

[0092] Item 19. When performed by a processor, the processor is Assign compound orders for review by assigned personnel and Once the order is approved by the assigned personnel, it is sent to the radioactive The system of item 17 or item 18 further includes instructions to be transmitted to the compound manufacturer. Tem.

[0076]

[0093] Item 20. One or more customized radioactivity algorithms are used in MIR D dosimetry calculation algorithm, BSA dosimetry calculation algorithm, or fractionated dosimetry Any of items 17 to 19, including at least one of the following algorithms: system.

[0077]

[0094] Item 21. One or more lines to generate one or more sphere volume recommendations The dosimetry selection algorithm is based on either a sphere-by-sphere activity algorithm or an activity-based embolization device. Any of items 17 to 20, including at least one of the following loading algorithms: system.

[0078]

[0095] Item 22. When executed by a processor, the selected Graphical representation of percent distribution across multiple vials of sphere volume and recommended dosage values. Items 17 to 21 further include instructions received via a user interface. Any of the systems.

[0079]

[0096] Item 23. System for flow determination for radioembolization procedures for treatment planning The system includes a delivery device and a radioembolization system for receiving one or more inputs related to the radioembolization procedure. Flow software application tools including a graphical user interface for and feed devices, flow software application tools, and non-transient and a processor communicatively coupled to a computer storage medium, The computer storage medium, when executed by the processor, provides radiation blocking to the processor. One or more inputs related to the embolization procedure are entered via a graphical user interface. and receiving one or more flow rate recommendations from the processor, and one or more optimization algorithms to determine one or more a corresponding backflow probability of the flow rate of the flow rate sensor based on one or more flow rate recommendations by the processor. Generate a flow rate recommendation and select one of the one or more flow rate recommendations. and receive it through a graphical user interface and use a sending device. Based on the selected flow rate recommendation, the Y90 radioembolization sphere for radioembolization procedures It stores the command to send the body.

[0080]

[0097] The terms "substantially," "about," and "nearly" are used to describe any quantitative comparison, value, or is used herein to express the degree of inherent uncertainty that may result from a measurement, or other representation. Note that these terms may also be used to refer to the basics of the subject matter in question. To express the extent to which a quantitative expression can vary from a stated standard without changing its function Used herein.

[0081]

[0098] Although particular embodiments are illustrated and described herein, the subject matter claimed Various other modifications and alterations may be made without departing from the spirit and scope of the subject matter. It should be understood that various aspects of the claimed subject matter are described herein. However, it is not necessary to utilize such aspects in combination. The scope of the present invention covers all such variations and modifications that fall within the scope of the claimed subject matter. It is intended to

Claims

1. 1. A system for flow rate determination for a radioembolization procedure for treatment planning, comprising: A sending device; a dosimetry selection tool including a graphical user interface for receiving one or more inputs related to the radioembolization procedure; a processor communicatively coupled to the delivery device, the dosimetry selection tool, and a non-transitory computer storage medium, the non-transitory computer storage medium, when executed by the processor, causing the processor to: receiving the one or more inputs related to the radioembolization procedure via the graphical user interface; determining, by the processor, one or more flow rate recommendations based on the one or more inputs and one or more optimization algorithms; generating, by the processor, one or more corresponding reflux probabilities based on the one or more flow rate recommendations; receiving a selection of one of the one or more flow rate recommendations via the graphical user interface as a selected flow rate recommendation; and storing instructions for causing the delivery device to deliver a Y90 radioembolization sphere for the radioembolization procedure based on the selected flow rate recommendation.

2. 10. The system of claim 1, wherein the one or more inputs related to the radioembolization procedure include at least one of a shape of the Y90 radioembolization sphere, a size of the Y90 radioembolization sphere, a density of the Y90 radioembolization sphere, a fluid type, a tip angle of the delivery device, and a blood flow rate, and the one or more optimization algorithms are based on parameters and factors including information, data, and sub-algorithms directed to computational fluid dynamics simulations utilizing engineering fluid dynamics calculations, integrated clinical data, and physics-based partial differential equations to describe transport of the Y90 radioembolization sphere through a patient's hepatic artery.

3. The system of claim 1 , wherein the selected flow rate recommendation is selected based on optimizing flow rate and minimizing the probability of backflow.

4. 2. The system of claim 1, wherein the sphere volume of the Y90 radioembolization sphere is generated based on customized activity and one or more dosimetry selection algorithms, and the customized activity is based on activity parameter information and one or more customized activity algorithms.

5. 5. The system of claim 4, wherein the radioactivity parameter information comprises a pulmonary shunt fraction percentage value, an expected residual waste percentage value, a previous dose value to the lungs, a desired dose value to the liver, and a target liver volume.

6. The system of claim 4 , wherein the one or more customized radioactivity algorithms comprise at least one of a MIRD dosimetry calculation algorithm, a BSA dosimetry calculation algorithm, or a fractionated dosimetry calculation algorithm.

7. the one or more customized radioactivity algorithms generate customized radioactivity information comprising a target liver mass, radioactivity at administration, a calculated dose to the lungs, a dose limit to the lungs, a cumulative dose to the lungs, and a cumulative dose limit to the lungs; The system of claim 4 , wherein the customized radioactivity is further based on the customized radioactivity information.

8. 5. The system of claim 4, wherein the one or more dosimetry selection algorithms comprise at least one of an activity-per-sphere algorithm or an activity-based embolic loading algorithm, wherein the activity-per-sphere algorithm comprises dividing the customized activity by a predetermined sphere volume per activity unit, and the activity-based embolic loading algorithm comprises using a tissue volume input and a predetermined embolic loading determination per cubic centimeter of tissue.

9. The system of claim 8 , wherein the predetermined embolic loading determination comprises 20,000 spheres per cubic centimeter of tissue.

10. The dosimetry selection tool includes a dosimetry portal and the graphical user interface; The instructions, when executed by the processor, cause the processor to: receiving input of radioactivity parameter information into the dosimetry portal of the dosimetry selection tool via the graphical user interface; determining, by the processor, a customized radioactivity based on the radioactivity parameter information and one or more customized radioactivity algorithms; generating, by the processor, one or more sphere volumes and dosage recommendations for the Y90 radioembolization spheres based on the customized activity and one or more dosimetry selection algorithms; receiving a selection of one of the one or more sphere quantities and the recommended investment value via the graphical user interface as the selected sphere quantity and the recommended investment value; 2. The system of claim 1, wherein the processor generates a radioactive compound order for the radioembolization procedure based on the customized activity and the selected sphere amount and dosage recommendation for the Y90 radioembolization sphere, and the Y90 radioembolization sphere is received based on the radioactive compound order.

11. The system described in claim 10, wherein the non-transitory computer storage medium stores instructions that, when executed by the processor, cause the processor to transmit the radioactive compound order to a radioactive compound manufacturer for processing and order fulfillment.

12. The system of claim 10, wherein the non-transitory computer storage medium stores instructions that, when executed by the processor, cause the processor to assign the radioactive compound order for review by an assigned personnel, and, after approval by the assigned personnel, to transmit the radioactive compound order to a radioactive compound manufacturer for processing and order fulfillment.

13. The system described in claim 10, wherein the non-transitory computer storage medium stores instructions that, when executed by the processor, cause the processor to receive, via the graphical user interface, a percentage distribution of the selected sphere amount and recommended dosing value across multiple vials.

14. The system of claim 10 , wherein the selection of the selected sphere quantity and recommended dosage further comprises selection of a desired activity level per sphere.

15. The system of claim 10 , wherein the selection of the selected sphere volume and recommended dose value further comprises input of a dose change as a positive or negative percentage value.

16. 11. The system of claim 10, wherein selecting the selected sphere amount and recommended dosage value further comprises distributing the selected sphere amount and recommended dosage value across multiple vials based on a percent difference per vial, the percent difference consisting of the selected sphere amount and recommended dosage values that add up to 100%.

17. the dosimetry portal is configured to provide data collaboration among a plurality of users such that the plurality of users are granted access to view at least one of the first draft order or the one or more radioactive compound orders; Users are assigned one of multiple security clearance levels; 11. The system of claim 10, wherein the plurality of security clearance levels includes at least one of a basic security clearance level or an enhanced security clearance level that provides a user with a greater amount of access rights than the basic security clearance level.

18. 18. The system of claim 17, wherein the basic security clearance level is configured to allow a first user to create the first draft order and the enhanced security clearance level is configured to allow a second user to review and approve the first draft order.

Images