WO2025038073A1

WO2025038073A1 - Systems and methods for monitoring delivery of radioembolization mixed particulate

Info

Publication number: WO2025038073A1
Application number: PCT/US2023/030078
Authority: WO
Inventors: Terry A. Cruse; Christopher D. Drobnik; Brandon Simmons; Amanda THYSTRUP; Ryan T. TOOLEY; Mark Nicholas Wright
Original assignee: Bard Peripheral Vascular Inc
Current assignee: Bard Peripheral Vascular Inc
Priority date: 2023-08-11
Filing date: 2023-08-11
Publication date: 2025-02-20
Anticipated expiration: 2026-02-11

Abstract

Systems and methods for operating a radioembolization device to deliver a mixed particulate may include a controller to conduct a pre-delivery measurement of radiation within a vial assembly for the radioembolization device with an onboard sensor within a window of time prior to delivery, determine and calibrate an estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement, display the calibrated pre-delivery amount indicative of radiation in the vial assembly on a graphical user interface communicatively coupled to the radioembolization device, and monitor delivery of the mixed particulate in the vial assembly based on display of the calibrated pre-delivery amount indicative of radiation.

Description

SYSTEMS AND METHODS FOR MONITORING DELIVERY OF RADIOEMBOLIZATION MIXED PARTICULATE

TECHNICAL FIELD

[0001] The present disclosure generally relates to medical device systems and methods for treating cancer, and more particularly to monitoring delivery of radioactive compounds via vial assembly systems of medical devices configured and operable to deliver the radioactive compounds to a treatment area within a patient’s body in procedures such as transarterial radioembolization.

BACKGROUND

[0002] In cancer treatments involving radiation therapy, inadvertent or excess exposure to radiation from radioactive therapeutic agents can be harmful and potentially lethal to patients or medical personnel. Accordingly, medical instruments for radiation therapies must be configured to localize the delivery of radioactive material to a particular area of the patient’s body while shielding others from unnecessarily being exposed to radiation.

[0003] Transarterial Radioembolization is a transcatheter intra-arterial procedure performed by interventional radiology and is commonly employed for the treatment of malignant tumors. During this medical procedure, a microcatheter is navigated into a patient’s liver where radioembolizing microspheres loaded with a radioactive compound, such as yttrium-90 (⁹⁰Y), are delivered to the targeted tumors. The microspheres embolize blood vessels that supply the tumors while also delivering radiation to kill tumor cells.

[0004] Accordingly, a need exists for efficient delivery of a radioactive compounds via a medical device configured and operable to optimize flow when delivering the radioactive compound to the patient’s body.

SUMMARY

[0005] In accordance with an embodiment of the disclosure, a system for operating a radioembolization device to deliver a mixed particulate may include a graphical user interface, an onboard sensor coupled to the radioembolization device, and a controller communicatively coupled to the radioembolization device. The controller may be programmed to: conduct a predelivery measurement of radiation within a vial assembly for the radioembolization device with the onboard sensor within a window of time prior to delivery of the mixed particulate in the vial assembly; determine an estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement; calibrate the estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement prior to delivery of the mixed particulate as a calibrated pre-delivery amount indicative of radiation; display the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface communicatively coupled to the radioembolization device; and monitor delivery of the mixed particulate in the vial assembly based on display of the calibrated pre-delivery amount indicative of radiation.

[0006] In another embodiment, a system for operating a radioembolization device to deliver a mixed particulate includes a graphical user interface, an onboard sensor coupled to the radioembolization device, and a controller communicatively coupled to the radioembolization device. The controller may be programmed to: conduct a pre-delivery measurement of radiation within a vial assembly for the radioembolization device with the onboard sensor for a window of time prior to delivery of the mixed particulate in the vial assembly; determine an estimated predelivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement; calibrate the estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement prior to delivery of the mixed particulate as a calibrated pre-delivery amount indicative of radiation; display the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface communicatively coupled to the radioembolization device; monitor delivery of the mixed particulate in the vial assembly via the radioembolization device based on display of the calibrated pre-delivery amount indicative of radiation; and display a real-time estimated amount indicative of radiation remaining in the vial assembly during delivery of the mixed particulate on the graphical user interface based on the calibrated pre-delivery amount indicative of radiation. The controller may be further programmed to: conduct a post-delivery measurement with the onboard sensor for the window of time; determine a percentage of estimated radiation delivered by an end of the delivery based on the post-delivery measurement and the calibrated pre-delivery amount indicative of radiation; and display the percentage of estimated radiation delivered during the delivery on the graphical user interface.

[0007] In yet another embodiment, a method of operating a radioembolization device to deliver a mixed particulate may include conducting a pre-delivery measurement of radiation within a vial assembly for the radioembolization device with an onboard sensor coupled to the radioembolization device for a window of time prior to delivery of the mixed particulate in the vial assembly, determining an estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement, and calibrating the estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement prior to delivery of the mixed particulate as a calibrated pre-delivery amount indicative of radiation. The method may further include displaying the calibrated pre-delivery amount indicative of radiation in the vial assembly on a graphical user interface communicatively coupled to the radioembolization device, and monitoring delivery of the mixed particulate in the vial assembly via the radioembolization device based on display of the calibrated pre-delivery amount indicative of radiation.

[0008] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 is a perspective view of a delivery device including a console assembly and a vial sled according to one or more embodiments shown and described herein;

[0010] FIG. 2 is a cross-sectional view of the vial sled of FIG. 1 according to one or more embodiments shown and described herein, the cross-section along line 2-2 of FIG. 1;

[0011] FIG. 3 is a perspective view of a vial assembly including an engagement head according to one or more embodiments shown and described herein; [0012] FIG. 4 is a perspective view of the vial sled of FIG. 1 with the vial assembly of FIG. 3 received therein, with a series of delivery lines coupled to the vial sled, according to one or more embodiments shown and described herein;

[0013] FIG. 5 is a partial perspective view of the delivery device of FIG. 1 illustrating an onboard sensor, according to one or more embodiments shown and described herein;

[0014] FIG. 6 is a schematic view of a display interface of the delivery device of FIGS. 1-5 during a pre-delivery measurement of radiation within a vial assembly of the delivery device with the onboard sensor, according to one or more embodiments shown and described herein;

[0015] FIG. 7 is a schematic view of a display interface of the delivery device of FIGS. 1-5 indicating to a user that delivery of a mixed particulate via the delivery device may begin, according to one or more embodiments shown and described herein;

[0016] FIG. 8 is a schematic view of a display interface of the delivery device of FIGS. 1-5 illustrating a procedure screen showing an amount indicative of radiation remaining in the vial assembly, the percentage of radiation, and an infusion rate, according to one or more embodiments shown and described herein;

[0017] FIG. 9 is a schematic view of a display interface of the delivery device of FIGS. 1-5 during a post-delivery measurement of radiation within the vial assembly of the delivery device with the onboard sensor, according to one or more embodiments shown and described herein;

[0018] FIG. 10 is a schematic view of a display interface of the delivery device of FIGS. 1-5 displaying a percentage of radiation delivered from the vial assembly, according to one or more embodiments shown and described herein;

[0019] FIG. 11 is a flowchart of a process for operating the delivery device of FIGS. 1-5, including the display interfaces of FIG. 6-10, to deliver the mixed particulate, according to one or more embodiments shown and described herein; and [0020] FIG. 12 schematically illustrates a system for implementing computer and software based methods to utilize the delivery device of FIGS. 1-5, including the display interfaces of FIG. 6-10, to implement the process of FIG. 11, according to one or more embodiments shown and described herein.

DETAILED DESCRIPTION

[0021] Reference will now be made in detail to various embodiments of delivery devices for administering radioactive compounds to a patient, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts. Directional terms as used herein — for example up, down, right, left, front, back, top, bottom, distal, and proximal — are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

[0022] Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0023] Unless otherwise expressly stated, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred, in any respect. This holds for any possible non-express basis for interpretation, including: matters of logic with respect to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of embodiments described in the specification. [0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs. The terminology used in the description herein is for describing particular embodiments only and is not intended to be limiting. As used in the specification and appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0025] As used herein, the terms “horizontal,” “vertical,” “distal” and “proximal” are relative terms only, are indicative of a general relative orientation only, and do not necessarily indicate perpendicularity. These terms also may be used for convenience to refer to orientations used in the figures, which orientations are used as a matter of convention only and are not intended as characteristic of the devices shown. The present disclosure and the embodiments thereof to be described herein may be used in any desired orientation. Moreover, horizontal and vertical walls need generally only be intersecting walls, and need not be perpendicular. As used herein, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0026] In embodiments described herein, a particulate material delivery assembly may include a radioembolization delivery device. A radioembolization delivery device (also referenced herein as “radioembolization device” or “delivery device”) comprises a medical device configured to deliver radioactive compounds to a treatment area within a patient’s body in procedures such as transarterial radioembolization. The radioactive compounds may be a mixed solution of saline and radioactive microspheres (i.e., a mixed particulate) mixed in a vial of a vial assembly. The needle may include one or more ports as an outlet to inject fluid (i.e., saline), such as from a syringe or catheter line, into a vial including the radioactive microspheres to generate the mixed solution and as an inlet to deliver the mixed solution to the patient. As will be described in greater detail below with respect to FIGS. 1-12, the systems and methods herein are directed to operating the radioembolization device to deliver the mixed particulate, the systems including a graphical user interface and an onboard sensor coupled to the radioembolization device. A pre-delivery measurement of radiation within a vial assembly of the radioembolization device is conducted with the onboard sensor, an estimated pre-delivery amount indicative of radiation is determined, calibrated, and displayed on the graphical user interface, and delivery of the mixed particulate is monitored based on the display. The description related to FIGS. 1-5 below describes an overall operation of the delivery device, as described in greater detail below. The description related to FIGS. 6-10 below describes operation of the delivery device that is communicatively coupled with a graphical user interface and an onboard sensor to measure radiation in a vial assembly of the delivery device, as described in greater detail further below.

I. Mechanical Delivery Device with Removable Sled Assembly

[0027] FIGS. 1-5 show an embodiment of a delivery device 500 that is configured and operable to deliver a radioactive material (e.g., radioembolizing beads via a mixed particulate, such as of beads in a saline solution) while reducing radioactive emissions during use of the delivery device 500. The delivery device 500 may operate as described in International PCT App. No. PCT/2019/033001, filed May 17, 2019, corresponding to U.S. Patent Application Serial No. 17/054,552, the entirety of which is incorporated herein, except with respect to components, systems, and methods as described in greater detail below with respect to FIGS. 6-12 and in one or more embodiments herein.

[0028] Referring initially to FIG. 1, the delivery device 500 comprises a console assembly 510, which includes a console. The delivery device 500 may include a sled assembly 540 that is operable to transition between a coupled state and decoupled state relative to the console assembly 510. The console assembly 510 of the delivery device 500 comprises a base 512 defined by and extending between a proximal end 514 and a distal end 516. The proximal end 514 of the base 512 includes a handle (delivery handle) 528 movably coupled to the console assembly 510 and an interface display 530 positioned on the console assembly 510.

[0029] The proximal end 514 of the base 512 further includes an attachment device 538 that is configured to securely retain an external device to the base 512 of the console assembly 510. The attachment device 538 is operable to facilitate an attachment of a complimentary device to the console assembly 510 for use with the delivery device 500 during a procedure.

[0030] Still referring to FIG. 1, the distal end 516 of the console assembly 510 defines a vial containment region 518 that is sized and shaped to receive a vial assembly 580 therein, as will be described in greater detail herein. The console assembly 510 further includes a vial engagement mechanism 520 extending from the base 512 adjacent to the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outward from the base 512 of the console assembly 510 toward the distal end 516. The vial engagement mechanism 520 is positioned within the vial containment region 518 of the console assembly 510 and is movably coupled to the handle 528. In particular, the handle 528 of the console assembly 510 is operable to move, and in particular translate, the vial engagement mechanism 520 within the vial containment region 518 in response to an actuation of the handle 528.

[0031] The console assembly 510 includes a mechanical assembly disposed within the base 512 that is configured and operable to convert a manual motion of the handle 528 to a corresponding linear displacement of the vial engagement mechanism 520. In the present example, the mechanical assembly is coupled to the handle 528 and the vial engagement mechanism 520 such that selective actuation of the handle 528 at the proximal end 514 causes a simultaneous actuation of the vial engagement mechanism 520 at the distal end 516.

[0032] The sled cavity 532 is sized and shaped to receive the sled assembly 540 therein. As will be described in greater detail herein, the sled assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, medium) therethrough. In particular, the sled assembly 540 is configured to partially receive a vial assembly 580 therein for administering the therapeutic particles from the delivery device 500 and to a patient during a procedure.

[0033] In embodiments, and referring to FIG. 2, a flow sensor of the delivery device 500 may be positioned in-line with the tubing set of the delivery device 500, and in particular the needle 559, the manifolds 555A, 555B, and/or one or more of the ports 556, and may be configured to measure an amount of fluid (e.g., suspension liquid after the therapeutic particles have effectively mixed with the fluid medium) that passes thereby. Referring back to FIG. 1, the vial engagement mechanism 520 comprises a pair of lever arms 522 extending outwardly from a neck 524 of the vial engagement mechanism 520, with the neck 524 extending laterally outward from the base 512 of the console assembly 510. The neck 524 of the vial engagement mechanism 520 is disposed within a protective cover 525 such that only the pair of lever arms 522 of the vial engagement mechanism 520 extends through the protective cover 525. The protective cover 525 is operable to shield one or more internal components of the console assembly 510 from an exterior of the console assembly 510, and in particular from the vial containment region 518.

[0034] The pair of lever arms 522 is simultaneously movable with the neck 524 of the vial engagement mechanism 520 in response to an actuation of the handle 528 of the console assembly 510. Further, the pair of lever arms 522 are fixed relative to one another such that a spacing formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 is configured to securely engage the vial assembly 580 therebetween, and in particular within the spacing formed by the pair of lever arms 522. Accordingly, the vial engagement mechanism 520 is operable to securely attach the vial assembly 580 to the console assembly 510 at the vial containment region 518. Although the vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, it should be understood that the vial engagement mechanism 520 may include various other structural configurations suitable for engaging the vial assembly 580. In a non-limiting example, the vial engagement mechanism 520 may include one or more magnets configured to engage with one or more corresponding magnets on the vial assembly.

[0035] Still referring to FIG. 1, the console assembly 510 further includes a safety shield 526 secured to the distal end 516 of the base 512 along the vial containment region 518. In particular, the safety shield 526 is a protective covering that is sized and shaped to enclose the vial containment region 518 of the console assembly 510 when secured thereon. The safety shield 526 is selectively attachable to the distal end 516 of the base 512 and is formed of a material that is configured to inhibit radioactive emissions from one or more radioactive doses stored within the vial containment region 518.

[0036] The distal end 516 of the console assembly 510 further includes a sled cavity 532 that is sized and shaped to receive the sled assembly 540 therein. The sled cavity 532 includes one or more or a pair of alignment features 534 extending therein, with the alignment features 534 sized and shaped to correspond with complimentary alignment features of the sled assembly 540 (e.g., alignment ribs 554) to thereby facilitate a coupling of the sled assembly 540 with the base 512 of the console assembly 510 within the sled cavity 532. [0037] Still referring to FIG. 1, the sled assembly 540 is configured to partially receive a vial assembly 580 therein for administering therapeutic particles (e.g., radioactive fluid medium) from the delivery device 500 and to a patient. In particular, the sled assembly 540 comprises a distal end 542 and a proximal end 544 with a pair of sidewalls 546 extending therebetween. The distal end 542 of the sled assembly 540 includes a handle 552 extending proximally therefrom. The handle 552 is configured to facilitate movement of the sled assembly 540, and in particular, an insertion of the sled assembly 540 into the sled cavity 532 of the console assembly 510. The distal end 542 further includes one or more ports 556 for coupling one or more delivery lines (i.e., tubing) to the sled assembly 540. With the one or more delivery lines further be coupled to one or more external devices at an end of the line opposite of the ports 556, the ports 556 effectively serve to fluidly couple the sled assembly 540 to the one or more external devices via the delivery lines connected thereto. The pair of sidewalls 546 of the sled assembly 540 includes at least one alignment rib 554 extending laterally outward therefrom, where the alignment ribs 554 are sized and shaped to correspond with and mate to the pair of alignment features 534 of the console assembly 510. Accordingly, the pair of alignment ribs 554 are configured to facilitate an alignment and engagement of the sled assembly 540 with the console assembly 510 when the proximal end 544 is slidably received within the sled cavity 532 of the base 512.

[0038] The sled assembly 540 further includes a top surface 548 extending from the distal end 542 and the proximal end 544 and positioned between the pair of sidewalls 546. The top surface 548 of the sled assembly includes a recessed region 549 and a locking system 550. The recessed region 549 is sized and shaped to form a recess and/or cavity along the top surface 548, where the recessed region 549 is capable of receiving and/or collecting various materials therein, including, for example, leaks of various fluid media during use of the delivery device 500. The locking system 550 of the sled assembly 540 forms an opening along the top surface 548 that is sized and shaped to receive one or more devices therein, such as a priming assembly 560 and a vial assembly 580. In some embodiments, the sled assembly 540 comes preloaded with the priming assembly 560 disposed within the locking system 550. The priming assembly 560 includes a priming line 562 extending outwardly from the locking system 550 of the sled assembly 540. The priming assembly 560 connects the priming line 562 to needle 559 and manifolds 555A and 555B and serves to purge the delivery device 500, including the manifolds 555A and 555B, of air prior to utilizing the delivery device 500 in a procedure. [0039] Referring now to FIG. 2, the locking system 550 includes an annular array of projections 551 extending outwardly therefrom, and in particular, extending laterally into the aperture formed by the locking system 550 along the top surface 548. The annular array of projections 551 are formed within an inner perimeter of the locking system 550 and extend along at least two sequentially-arranged rows. In embodiments, a single row may be used. The annular array of projections 551 included in the locking system 550 are configured to engage a corresponding locking feature 586 of the vial assembly 580 (See FIG. 3) to thereby securely fasten the vial assembly 580 to the sled assembly 540. It should be understood that the multiple rows of projections 551 of the locking system 550 serve to provide a double-locking system to ensure the sled assembly 540, and in particular a needle 559 of the sled assembly 540, is securely maintained through a septum 592 of the vial assembly 580 See FIG. 3) during use of the delivery device 500 in a procedure.

[0040] The sled assembly 540 further includes a vial chamber 558 that is sized and shaped to receive the priming assembly 560 and the vial assembly 580 therein, respectively. In other words, the vial chamber 558 is sized to individually receive both the priming assembly 560 and the vial assembly 580 separate from one another. The vial chamber 558 is encapsulated around a protective chamber or shield 557 disposed about the vial chamber 558. The protective shield 557 is formed of a material configured to inhibit radioactive emissions from extending outwardly from the vial chamber 558, such as, for example, a metal or plastic. Additionally, the sled assembly 540 includes a needle extending through the protective shield 557 and into the vial chamber 558 along a bottom end of the vial chamber 558. The needle 559 is fixedly secured relative to the vial chamber 558 such that any devices received through the aperture of the locking system 550 and into the vial chamber 558 are to encounter and interact with the needle 559 (e.g., the priming assembly 560, the vial assembly 580, and the like).

[0041] Still referring to FIG. 2, the needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the sled assembly 540, and in particular the manifold 555A, 555B is positioned beneath the vial chamber 558 and the protective shield 557. The proximal manifold 555B is fluidly coupled to the needle 559 and the distal manifold 555A is fluidly couplable to one or more delivery lines via the one or more ports 556 of the sled assembly 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A through a one-way check valve 553 disposed therebetween.

[0042] Accordingly, the proximal manifold 555B is in fluid communication with the one or more ports 556 via the distal manifold 555A, however, the one or more ports 556 are not in fluid communication with the proximal manifold 555B due to a position of the one-way check valve 553 disposed between the manifolds 555A, 555B. Thus, the needle 559 is in fluid communication with the one or more delivery lines and/or devices coupled to the sled assembly 540 at the one or more ports 556 via the manifolds 555A, 555B secured therebetween. The one or more ports 556 of the sled assembly 540 may be coupled to a bag (e.g., saline bag), a syringe, a catheter, and/or the like via one or more delivery lines coupled thereto. In other embodiments, the needle 559 may be a cannula, catheter, or similar mechanism through which to inject and receive fluid and/or a solution as described herein.

[0043] Still referring to FIG. 2, the sled assembly 540 includes a removable battery pack 570 coupled to the sled assembly 540 along the proximal end 544. The removable battery pack 570 comprises a battery 572, electrical contacts 574, and a removable tab 576. The battery 572 of the delivery device 500 is isolated from one or more fluid paths and radiation sources due to a location of the battery 572 in the removable battery pack 570.

[0044] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to contact against and interact with corresponding electrical contacts 511 of the console assembly 510 (See FIG. 1) when the sled assembly 540 is coupled to the base 512 at the sled cavity 532. Accordingly, the removable battery pack 570 is operable to provide electrical power to the delivery device 500, and in particular the console assembly 510, when the sled assembly 540 is coupled to the console assembly 510.

[0045] Additionally, as will be described in greater detail herein, in some embodiments the locking system 550 may include at least one planar wall relative to a remaining circular orientation of the locking system 550. In this instance, an aperture formed by the locking system 550 through the top surface 548 of the sled assembly 540 is irregularly-shaped, rather than circularly-shaped as shown and described above. In this instance, the vial assembly 580 includes a locking feature 586 that has a shape and size that corresponds to the locking system 550, and in particular the at least one planar wall such that the vial assembly 580 is received within the sled assembly 540 only when an orientation of the vial assembly 580 corresponds with an alignment of the locking feature 586 and the locking system 550. In other words, a corresponding planar wall 586A of the locking feature 586 (See FIG. 3) must be aligned with the planar wall of the locking system 550 for the vial assembly 580 to be receivable within an aperture formed by the locking system 550 of the sled assembly 540.

[0046] Referring now to FIG. 3, the vial assembly 580 of the delivery device 500 is depicted. The vial assembly 580 comprises an engagement head 582, a plunger 584, a locking feature 586, and a vial body 589. In particular, the engagement head 582 of the vial assembly 580 is positioned at a terminal end of the plunger 584 opposite of the locking feature 586 and the vial body 589. The engagement head 582 includes a pair of arms 581 extending laterally outward relative to a longitudinal length of the plunger 584 extending downwardly therefrom. In the present example, the engagement head 582 is integrally formed with the plunger 584, however, it should be understood that in other embodiments the engagement head 582 and the plunger 584 may be separate features fastened thereto. In either instance, the engagement head 582 and the plunger 584 is movable relative to the locking feature 586 and the vial body 589 such that the engagement head 582 and the plunger 584 are slidably translatable through the locking feature 586 and the vial body 589. In particular, as will be described in greater detail herein, the plunger 584 may translate into and out of an internal chamber 588 of the vial body 589 in response to a linear translation of the vial engagement mechanism 520 when the engagement head 582 is secured to the pair of lever arms 522.

[0047] The plunger 584 includes a plurality of indicia and/or markings 583 positioned along a longitudinal length of the plunger 584. The plurality of markings 583 is indicative of a relative extension of the engagement head 582 and the plunger 584 from the locking feature 586 and the vial body 589. As briefly noted above, the engagement head 582 is configured to attach the vial assembly 580 to the vial engagement mechanism 520. In particular, the pair of arms 581 of the engagement head 582 are sized and shaped to couple with the pair of lever arms 522 of the vial engagement mechanism 520 when the vial assembly 580 is received within the sled assembly 540 and the sled assembly is inserted into the sled cavity 532 of the console assembly 510. As will be described in greater detail herein, the pair of lever arms 522 are received between the pair of arms 581 of the engagement head 582 and the plunger 584 in response to a predetermined translation force applied to the vial engagement mechanism 520. The engagement head 582 and the plunger

584 may be formed of various materials, including, but not limited to, a metal, plastic, and/or the like.

[0048] Still referring to FIG. 3, the vial assembly 580 further includes a safety tab 585 coupled to the plunger 584 relatively above the locking feature 586 and below the engagement head 582 such that the safety tab 585 is positioned along the longitudinal length of the plunger 584. The safety tab 585 may be formed of various materials, such as, for example, a plastic, and is preassembled onto the vial assembly 580 prior to a use of the delivery device 500. The safety tab

585 is removably fastened to the plunger 584 and inhibits the plunger 584 from translating relative to the vial body 589. In particular, the safety tab 585 abuts against the locking feature 586 in response to an application of linear force onto the plunger 584 to translate the plunger 584 relatively downward into the vial body 589. In this instance, the safety tab 585 is configured to inhibit an inadvertent movement of the plunger 584, and in response, an inadvertent delivery of a fluid media stored within the internal chamber 588 of the vial body 589 (e.g., therapeutic particles, radioembolizing beads). As will be described in greater detail herein, the safety tab 585 is selectively disengaged from the plunger 584 in response to a coupling of the vial assembly 580 with the vial engagement mechanism 520, and in particular an engagement of the pair of lever arms 522 with the engagement head 582.

[0049] Referring back to FIG. 3, the locking feature 586 extends about a top end of the vial body 589. In the present example, the locking feature 586 of the vial assembly 580 comprises a bushing that defines a lateral edge 587 extending laterally outward along an outer perimeter of the locking feature 586. The lateral edge 587 of the locking feature 586 is sized and shaped to engage the annular array of projections 551 of the locking system 550 when the vial assembly 580 is received within the vial chamber 558 of the sled assembly 540. As will be described in greater detail herein, the locking feature 586, and in particular the lateral edge 587 of the locking feature 586, is configured to securely fasten the vial assembly 580 to the locking system 550 to inhibit removal of the vial body 589 from the vial chamber 558 of the sled assembly 540 during use of the delivery device 500 in a procedure. In some embodiments, as briefly described above, the locking feature 586 includes at least one planar wall 586 A such that the locking feature 586 comprises an irregular-profile. The at least one planar wall 586A is configured to correspond to the planar wall 550A of the locking system 550 such that an alignment of the planar walls 550A, 586A is required for the vial assembly 580 to be received through an aperture formed by the locking system 550.

[0050] Still referring to FIG. 3, the vial body 589 extends downwardly relative from the locking feature 586 and has a longitudinal length that is sized to receive at least a portion of a longitudinal length of the plunger 584 therein. Accordingly, in some embodiments a longitudinal length of the plunger 584 exceed a longitudinal length of the vial body 589 such that a translation of the plunger 584 into the internal chamber 588 of the vial body 589 causes a fluid media stored therein to be transferred outward from the vial body 589. As will be described in greater detail herein, a translation of the plunger 584 through the internal chamber 588 of the vial body 589 provides for an administration of a fluid media stored within the vial body 589 outward from the vial assembly 580. The vial body 589 may be formed of various materials, including, for example, a thermoplastic polymer, copolyester, polycarbonate, a biocompatible plastic, polysulfone, ceramics, metals, and/or the like.

[0051] The vial body 589 is of the present example is formed of a material that is configured to inhibit radioactive emissions from a fluid media stored within the internal chamber 588 of the vial body 589. For example, the vial body 589 may be formed of a plastic, such as polycarbonate, and have a width. A density and material composition of the vial body 589 may collectively inhibit beta radiation emission from electron particles stored within the internal chamber 588. In the present example, a chemical composition of the plastic of the vial body 589, along with the 9 mm wall thickness, provides a plurality of atoms disposed within the vial body 589 that are capable of encountering the electron particles generating beta radiation and reducing an emission of said radiation from the vial assembly 580. Accordingly, the vial assembly 580 allows an operator to handle the radioactive material stored within the vial body 589 without being exposed to beta radiation. It should be understood that various other materials and/or wall sections may be incorporated in the vial body 589 of the vial assembly 580 in other embodiments without departing from the scope of the present disclosure. [0052] Still referring to FIG. 3, the vial body 589 of the vial assembly 580 is sealed at a first terminal end 598 by the locking feature 586. The vial assembly 580 further includes a cap 590 positioned at an opposing, terminal end of the vial body 589 opposite of the locking feature 586, such that the cap 590 seals a second terminal end of the vial body 589 of the vial assembly 580. Additionally, the vial assembly 580 includes a septum 592 positioned adjacent to the cap 590 and in fluid communication with a terminal end of the vial body 589 opposite of the locking feature 586. The septum 592 forms a seal against a terminal end of the vial body 589 and the cap 590 retains the septum 592 therein. The septum 592 may be formed of various materials, including, for example, an elastomer, silicon, bromobutyl elastomer, rubber, urethanes, and/or the like. The septum 592 is configured to provide an air-tight seal for the vial body 589 to thereby inhibit a release of a fluid media stored therein (e.g., radioembolizing beads). As will be described in greater detail herein, the septum 592 of the vial assembly 580 is configured to be punctured by the needle 559 of the sled assembly 540 when the vial assembly 580 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the sled assembly 540. In other embodiments, the septum 592 may be omitted entirely for an alternative device, such as, for example, a valve system, needle injection port, and/or the like.

[0053] Referring now to FIG. 4, in response to determining that the battery 572 contains or other power source provides a sufficient amount of power, one or more delivery lines are coupled to the sled assembly 540 via the one or more ports 556. In particular, a dose delivery line 10A is coupled to the sled assembly 540 at a delivery port 556A, a contrast line 10B is coupled to the sled assembly 540 at a contrast port 556B, and a flushing line 10C is coupled to the sled assembly 540 at a flushing port 556C. An opposing end of the dose delivery line 10A is initially coupled to a fluid reservoir, such as, for example, a collection bowl. As will be described in greater detail herein, the dose delivery line 10A may be subsequently coupled to an external device, such as a catheter, once the sled assembly 540 has been effectively primed by a fluid medium via the contrast line 10B. An opposing end of the flushing line 10C is coupled to an external device, such as, for example, a syringe. With both the dose delivery line 10A and the flushing line 10C coupled to the sled assembly 540, the sled assembly 540 is flushed with a fluid medium (e.g., saline) from the syringe coupled to the flushing line 10C. In this instance, the fluid medium is injected through the flushing line 10C, into the distal manifold 555A of the sled assembly 540, and out of the sled assembly 540 through the dose delivery line 10A. Accordingly, the fluid medium is ultimately received at the collection bowl and disposed thereat by the dose delivery line 10A.

[0054] With the distal manifold 555A of the sled assembly 540 separated from the proximal manifold 555B by the one-way valve 553 disposed therebetween, the fluid medium flushed through the distal manifold 555A from the syringe (via the flushing port 556C) is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. Rather, the fluid medium injected from the syringe and through the flushing line 10C is received at the flushing port 556C, passed through the distal manifold 555A in fluid communication with the flushing port 556C, and redirected by the one-way valve 553 towards the dose delivery port 556 A that is coupled to the dose delivery line 10A. In this instance, the dose delivery line 10A receives and transfers the fluid medium to the collection bowl coupled thereto, such that the fluid medium is not directed beyond the one-way valve 553 and into the proximal manifold 555B that is in fluid communication with the needle 559.

[0055] The contrast line 10B is coupled to the sled assembly 540 at a contrast port 556B. An opposing end of the contrast line 10B is coupled to a fluid medium supply, such as, for example, a bag secured to the console assembly 510 via the attachment device 538. In the present example, the bag is a saline bag such that the fluid medium stored therein is saline. In this instance, with the sled assembly 540 including the priming assembly 560 positioned within the vial chamber 558 and the needle end 568 in fluid communication with the needle 559, a syringe is fluidly coupled to the priming line 562 of the priming assembly 560 and a plunger of the syringe is drawn back to pull saline through the contrast line 10B, the contrast port 556B, the sled assembly 540, the priming line 562 and into the syringe from the saline bag. The plunger of the syringe is thereafter pushed inwards to transfer the extracted saline back through the priming line 562, the central body 564, the elongated shaft 566, and the needle end of the priming assembly 560 such that the saline is received into the needle 559 of the sled assembly 540. Accordingly, the manifolds 555A, 555B of the sled assembly 540 are effectively primed with the saline from the syringe as the needle 559 that received the saline from the priming assembly 560 is in fluid communication with the manifolds 555 A, 555B. With the manifolds 555 A, 555B in further fluid communication with the dose delivery line 10A via the delivery port 556 A, the saline is effectively distributed to the collection bowl coupled thereto. [0056] The sled assembly 540 is coupled to one or more external devices via the one or more ports 556. In particular, the sled assembly 540 is fluidly coupled to a catheter (e.g., microcatheter) via the dose delivery line 10A that is coupled to the delivery port 556A of the sled assembly 540. In this instance, the catheter is in fluid communication with the sled assembly 540 via the dose delivery line 10A. Further, the sled assembly 540 is fluidly coupled to a contrast source, such as, for example, a saline bag secured to the console assembly 510 via the attachment device 538 (See FIG. 1). The sled assembly 540 is in fluid communication with the saline bag via a contrast line 10B coupled to the contrast port 556B of the sled assembly 540. In this instance, the saline bag is in fluid communication with the sled assembly 540 via the contrast line 10B secured to the contrast port 556B.

[0057] The contrast port 556B is in fluid communication with the proximal manifold 555B while the delivery port 556A is in fluid communication with the distal manifold 555A. As will be described in greater detail herein, saline from the saline bag may be withdrawn through the needle 559 of the sled assembly 540 and into the vial body 589 of the vial assembly 580 as the contrast port 556B is coupled to the proximal manifold 555B, rather than the distal manifold 555A which is separated from the proximal manifold 555B by the one-way check valve 553 disposed therebetween.

[0058] Referring again to FIGS. 1 and 3, with the vial assembly 580 securely coupled to the sled assembly 540, the sled assembly 540 is coupled to the console assembly 510 by translating the distal end 542 of the sled assembly 540 toward and into the distal end 516 of the console assembly 510. In particular, the distal end 542 of the sled assembly 540 is directed into the sled cavity 532 of the console assembly 510 by aligning the alignment ribs 554 of the sled assembly 540 with the alignment features 534 of the console assembly 510. Once the proximal end 544 and the distal end 542 of the sled assembly 540 are fully seated within the sled cavity 532 of the console assembly 510, the electrical contacts 574 (FIG. 2) of the removable battery pack 570 interact with corresponding electrical contacts 511 (FIG. 1) of the console assembly 510. In this instance, power from the battery 572 is transmitted to the console assembly 510 via the electrical contacts 574, thereby activating the console assembly 510 of the delivery device 500. In this instance, the interface display 530 of the console assembly 510 is activated to display pertinent, real-time information relating to the delivery device 500 during a procedure. [0059] Referring again to FIG. 4, as the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial containment region 518, a negative pressure is generated within the internal chamber 588 of the vial body 589 due to a retraction of the stopper 594. In this instance, with the saline bag coupled to the sled assembly 540 via the contrast line 10B and the contrast port 556B, saline from the saline bag is pulled into the internal chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Accordingly, with the vial body 589 being preloaded with a radioactive fluid media (e.g., radioembolizing microspheres), the saline is effectively mixed with the radioactive fluid media within the vial body 589 as the plunger 584 is retracted from the internal chamber 588 and the negative pressure is generated through the delivery device 500.

[0060] The sled assembly 540 further includes one-way check valves 553A in-line with the contrast line 10B and the flushing line 10C. In particular, the one-way check valves 553A are configured to permit fluid communication from the contrast port 556B and the flushing port 556C into the manifolds 555 A, 555B, and further configured to prevent fluid communication from the manifolds 555A, 555B to the contrast port 556B and the flushing port 556C. Accordingly, it should be understood that the dose delivered from the vial body 589 to the manifold 555 A, 555B is incapable of being directed into the contrast line 10B or the flushing line 10C due to the oneway check valves 553A positioned therein. Thus, the dose is directed to the dose delivery port 556A and received at the catheter fluidly coupled thereto by the dose delivery line 10A. In other words, the one-way check valves 553A prevent a backflow of fluid into the sled assembly 540 and/or the vial assembly 580 coupled thereto.

[0061] Referring to FIG. 5, an interface display communicatively coupled to the delivery device 500 may be operable to transmit information and/or data to an operator of the delivery device 500, and in particular data detected by an electrical system of the delivery device 500 which may comprise one or more sensors disposed within the delivery device 500, such as an onboard sensor (that may be, for example, radiation sensor 533 as described in greater detail further below). It should be understood that the delivery device 500 may include an electrical microprocessor that operates the interface display. In other embodiments, the interface display may comprise a remote smart device, a tablet, and/or the like. [0062] The console assembly 510 includes a mechanical assembly 529 disposed within the base 512 that is configured and operable to convert a manual motion of the handle 528 to a corresponding linear displacement of the vial engagement mechanism 520. In the present example, the mechanical assembly 529 is coupled to the handle 528 and the vial engagement mechanism 520 such that selective actuation of the handle 528 at the proximal end 514 causes a simultaneous actuation of the vial engagement mechanism 520 at the distal end 516. As will be described in greater detail herein, the mechanical assembly 529 of the present example allows for fluid volume control and fluid flow volume control during a dose delivery with the delivery device 500. It should be understood that a mechanical configuration of the mechanical assembly 529 of the present example may comprise various linkages, gears, pulleys, springs and/or the like that are specifically configured to amplify a force applied to the handle 528 with a corresponding displacement of the vial engagement mechanism 520. In some embodiments, the mechanical assembly 529 may comprise and/or be substituted by one or more electrically-driven systems, motors, and/or other devices operable to provide for a movement of the vial engagement mechanism 520 relative to the vial containment region 518 and/or provide a feedback to an operator as the handle 528 is actuated.

[0063] In other embodiments the mechanical assembly 529 may be configured such that the handle 528 may be actuated (i.e., moved) in various other arrangements or orientations than that shown and described herein to generate a corresponding linear displacement of the vial engagement mechanism 520. For example, the mechanical assembly 529 of the console assembly 510 may be configured to convert a linear, rotational, lateral and/or other various motions of the handle 528 to generate a disproportionate displacement of the vial engagement mechanism 520, with the displacement exceeding a force applied at the handle 528.

[0064] Still referring to FIG. 5, and as briefly described above, the console assembly 510 includes one or more sensors for monitoring and detecting certain conditions and/or materials stored in the console assembly 510 during use of the delivery device 500. In the present example, the console assembly 510 includes a linear displacement sensor 531 and a radiation sensor 533. The linear displacement sensor 531 is securely attached to the mechanical assembly 529 of the console assembly 510 such that the linear displacement sensor 531 is operable to move within the console assembly 510 in response to an actuation of the handle 528 and a corresponding movement of the vial engagement mechanism 520. The linear displacement sensor 531 is configured to detect and monitor a displacement distance, a velocity of displacement, and/or the like of the handle 528 and the vial engagement mechanism 520.

[0065] As will be described in greater detail herein, by measuring a displacement distance or velocity of the handle 528 and/or the vial engagement mechanism 520, computer readable and executable instructions of the delivery device 500, when executed by a processor of the delivery device 500, may determine a flow rate of a fluid media being delivered by the delivery device 500. Additionally or alternatively, the computer readable and executable instructions of the delivery device 500, when executed by a processor of the delivery device 500, may further determine a remaining volume of a fluid media stored within the delivery device 500. As briefly noted above, the data detected by the linear displacement sensor 531 and the information determined by the processor of the delivery device 500 may be displayed at the interface display 530 for operator review.

[0066] Still referring to FIG. 5, the radiation sensor 533 is securely attached to the base 512 of the console assembly 510 at a location adjacent to the vial containment region 518. In particular, the radiation sensor 533 is positioned proximate to the sled cavity 532 that is sized and shaped to receive the sled assembly 540 therein. As will be described in greater detail herein, the sled assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, medium) therethrough such that the radiation sensor 533 is operable to detect and monitor a radiation level of the therapeutic particles due to a proximate location of the radiation sensor 533 with the sled assembly 540. In particular, the sled assembly 540 is configured to partially receive a vial assembly 580 therein for administering the therapeutic particles from the delivery device 500 and to a patient.

[0067] As will further be described herein, by detecting a radiation level of the radioactive medium stored and transferred through the sled assembly 540, computer readable and executable instructions of the delivery device 500, when executed by a processor of the delivery device 500, may determine a radiation dosage delivered from the delivery device 500. Additionally or alternatively, the computer readable and executable instructions executed by a processor of the delivery device 500 may further determine a remaining radiation dosage contained within the delivery device 500 during a procedure. As briefly noted above, the data detected by the radiation sensor 533 and the information determined by the processor of the delivery device 500 may be displayed at the interface display for operator review. It should be understood that in other embodiments the delivery device 500 may include additional or fewer sensors than those shown and described herein (e.g., a dosimeter, a linear encoder, an optical sensor, a linear displacement sensor, a flow sensor, an ultrasonic sensor, a magnetic encoder, a laser distance sensor, an inductance sensor, a radial encoder, a volumetric sensor, mechanical transducers, etc.). A dosimeter and/or radiation sensor of the delivery device 500 may be configured to measure a remaining exposure to ionizing radiation stored within the delivery device 500, and in particularly the sled assembly 540 and/or the vial assembly 580.

[0068] By way of further examples, a flow sensor of the delivery device 500 may be positioned in-line with the tubing set of the delivery device 500, and in particular the needle 559, the manifolds 555A, 555B, and/or one or more of the ports 556, and may be configured to measure an amount of fluid (e.g., suspension liquid after the therapeutic particles have effectively mixed with the fluid medium) that passes thereby. An ultrasonic sensor of the delivery device 500 may comprise a transmitter, receiver, and/or transceiver configured to measure a distance to an object (e.g., remaining volume of dosage within the vial assembly 580) based on transmitting ultrasonic signals (i.e. sound waves) therein and measuring an elapsed time before receiving back the bounced sound waves. A radial encoder of the delivery device 500 may comprise an absolute encoder and/or an incremental encoder configured to convert an angular position or motion of the handle 528, the plunger 584, the mechanical assembly 529, and/or other components of the delivery device 500 to analog or digital output signals corresponding to a remaining dosage within the vial assembly 580.

II. Graphical User Interface and Radiation Measurement Embodiments

[0069] As briefly noted above and depicted in FIG. 1, the delivery device 500 described herein may include an interface display 530, such as a graphical user interface. FIGS. 6-10 schematically depict different embodiments of a graphical user interface (GUI) 602 that may be the interface display 530 and/or a separate display otherwise coupled to the delivery device 500. The GUI 602 may be configured to display data related to the delivery device 500, such as data detected by one or more onboard sensors (e.g., the radiation sensor 533) and determined by a processor, as discussed in more detail below. The GUI 602 may provide a user of a delivery device 500 with real-time feedback of the contents, quantities, and operability of the delivery device 500 as described herein and in greater detail further below.

[0070] The GUI 602 may be configured to receive and display delivery information associated with use of the delivery device 500 to monitor delivery of the mixed particulate by the delivery device 500 during a procedure. For example, the delivery information displayed on the GUI 602 may include, but is not limited to, a rate of flow (ml/min), a current volume of media in the chambers, an infused volume of media from the chambers, a remaining percentage of radioactive activity in a vial assembly 580, and/or the like. As the use of the delivery device 500 progresses to deliver the mixed particulate, the data displayed on the GUI 602 (and referable to as GUI 602) may concurrently update to reflect a current real-time condition and characteristics of the delivery device 500. It should be understood that the various information items shown and described herein are merely for illustrative purposes such that additional and/or fewer data aspects associated with delivery of the mixed particulate by the delivery device 500 may be detected, monitored, and displayed by the GUI 602.

[0071] Referring to FIG. 6, a display view 600 is shown of the GUI 602 during a pre-delivery measurement (e.g., a pre-treatment survey) of radiation within the vial assembly 580 of the delivery device 500 with the onboard sensor (e.g., the radiation sensor 533) within a window of time prior to delivery of the mixed particulate in the vial assembly 580. As described herein and above, the onboard sensor is configured to detect an amount indicative of radiation within the mixed particulate. The onboard sensor may measure the amount indicative of radiation in the vial using a radiation level, such as counts per minute, or a dose, such as rad, gray, Sieverts, curie, and/or Becquerel. The onboard sensor may detect any combination of energy, such as gamma radiation and x-rays, and particles, such as alpha and beta particles. One or more output signals are generated, via the onboard sensor, based on the detected radiation within the vial assembly 580. In embodiments, and as described herein, the one or more onboard sensors may include Geiger counters, dosimeters, scintillation counters, semiconductors, ionization chambers, proportional counters, hermetic detectors and the like [0072] In embodiments, the window of time is fifteen seconds, thirty seconds, forty-five seconds, one minute, one minute and thirty seconds, two minutes, two minutes and thirty seconds, or any range having endpoints defined by any of the aforementioned values, though any time period is contemplated and possible. The window of time may be selected or adjusted based on the anticipated length of treatment, the treatment site, the type of mixed particulate being used, and the like. The onboard sensor may conduct one or more measurements within the window of time. In some embodiments, the onboard sensor conducts a plurality of measurements within the window of time. In some embodiments, an average of the plurality of measurements may be calculated to generate the pre-delivery measurement based on the plurality of measurements.

[0073] The GUI 602 may be a display of a computing device (such as computing device 1224, described in greater detail below with respect to FIG. 12). The computing device is communicatively coupled to the delivery device 500. As merely an illustrative example, GUI 602 displays data relating to a duration 604 of the window of time of the pre-delivery measurement and/or a power status 606 of a battery (e.g., which may be battery 572 of FIG. 2). In embodiments, the removable battery pack 570 (FIG. 2) is inserted into the console assembly 510 and a feedback output is generated identifying a power status of the battery 572 of the removable battery pack 570. The power status 606 may be the power status of the battery 572 for display on the GUI 602

[0074] The duration 604 of the pre-delivery measurement corresponds to the window of time that the onboard sensor is configured to measure the amount indicative of radiation from the mixed particulate within the vial assembly 580 prior to delivery of the mixed particulate in the vial assembly 580. The duration 604 of the pre-delivery measurement may be displayed as a total time of the pre-treatment survey, the time elapsed during the pre-delivery measurement, the time remaining in the pre-delivery measurement, or combinations thereof. The duration 604 of the predelivery measurement may be displayed as a countdown timer, a digital clock, or any other suitable mechanism to indicate the window of time of the pre-delivery measurement.

[0075] Referring now to FIG. 7, a display view 700 on the graphical user interface GUI 602 provides an indication to a user that delivery of the mixed particulate via the delivery device 500 may begin. As merely an illustrative example, the display view 700 displays on the GUI 602 an indication 702 to advance a handle to initiate delivery of the mixed particulate via the delivery device 500 and data relating to a current status of the flow rate 704 with respect to delivery of the mixed particulate by the delivery device 500 (e.g. indicating the real-time flow rate of the mixed particulate). Although the indication 702 is depicted in Fig. 7 as comprising a schematic of the handle and an arrow, any suitable indication may be shown such as any word, symbol or alphanumeric indication. Similarly the flow rate 704 may be indicated by any suitable means such as a meter or numerical value.

[0076] Delivery of the mixed particulate can be controlled automatically, partially automatically, or manually by an operator through, for example, a joystick, foot pedal, or button to control start, pause, and/or stop injection operations. As shown in FIG. 7, the graphic may via the indication 702 instruct an operator to actuate the handle 528 of the delivery device 500 in an upward direction to initiate delivery of the mixed particulate from the vial assembly 580 and via the delivery device 500. In other embodiments, the GUI 602 may include a user selectable input configured to initiate delivery of the mixed particulate. In embodiments, selection of the selectable input on the GUI 602 permits delivery of the mixed particulate after the calibrated pre-delivery amount indicative of radiation in the vial assembly is displayed on the graphical user interface, as will be described in greater detail further below. In still other embodiments, the delivery device 500 is configured to automatically initiate delivery of the mixed particulate following the predelivery measurement. In embodiments, the amount indicative of radiation in the vial assembly 580 before delivery may be obtained or be a factor of an input of an ordered activity or dose identification configured to obtain activity from an order. Alternatively, the amount indicative of radiation in the vial assembly 580 before delivery may be obtained or be a factor of data received from a storage location, such as data stored on a radio-frequency identification (RFID) chip on a label of the vial assembly 580. Data from the RFID chip including an amount indicative of radiation in the vial assembly 580 may be read with the value(s) imported in as the amount indicative of radiation to be assigned and calibrated to 100% as described herein.

[0077] Referring to FIG. 8, a display view 800 on the GUI 602 shows a procedure screen indicating an amount indicative of radiation remaining in the vial assembly 580 (before or during delivery of the mixed particulate by the delivery device 500) as a calibrated pre-delivery amount indicative of radiation 802, a percentage of radiation 804 remaining, and an infusion rate 806 (e.g., similar to the flow rate 704) with respect to delivery of the calibrated pre-delivery amount indicative of radiation 802. The procedure screen further shows a termination selectable input 808 selectable to end delivery of the mixed particulate by the delivery device 500. In embodiments, the termination selectable input 808 is configured to terminate the delivery of the mixed particulate at any moment during delivery. The termination selectable input 808 may be configured to be selected to terminate the delivery when a real-time estimated amount indicative of radiation reaches a predetermined threshold. In other embodiments, delivery of the mixed particulate is automatically terminated by the delivery device 500 when the real-time estimated amount indicative of radiation reaches the predetermined threshold. Termination of the delivery of the mixed particulate may be controlled automatically, partially automatically, or manually by an operator through, for example, a joystick, foot pedal, or button to control start, pause, and/or stop injection operations. The display view 800 and/or any other display views described herein may also display additional parameters related to the operation of the delivery device 500, such as a remaining amount of delivery time, battery status, error messages, and the like.

[0078] In embodiments, the GUI 602 is configured to display a real-time estimated amount indicative of radiation remaining in the vial assembly 580 during delivery of the mixed particulate on the GUI 602 based on the calibrated pre-delivery amount indicative of radiation. In embodiments, the real-time amount indicative of radiation may be estimated from the calibrated pre-delivery amount indicative of radiation 802, the infusion rate 806, and associated decay characteristics of the particulate over time. In additional or alternative embodiments, the onboard sensor is configured to measure the amount indicative of radiation at various time intervals or continuously through the delivery of the mixed particulate via the delivery device 500.

[0079] Referring now to FIG. 9, a display view 900 shows on the GUI 602 data relating to a duration 902 of a post-delivery measurement of radiation within the vial assembly 580 of the delivery device 500 with the onboard sensor and after termination of the delivery of the mixed particulate by the delivery device 500. The duration 902 of the post-delivery measurement corresponds to a window of time that the onboard sensor is measuring the amount indicative of radiation within the mixed particulate during the post-delivery measurement. The window of time may be set as the same window of time as conducted for the pre-delivery measurement or a different window of time. The duration 902 of the post-delivery measurement may be displayed as a total time of the post-delivery measurement, the time elapsed during the post-delivery measurement, the time remaining in the post-delivery measurement, or combinations thereof. The duration 902 of the post-delivery measurement may be displayed as a countdown timer, a digital clock, or any other suitable mechanism to indicate the window of time of the post-delivery measurement.

[0080] Referring to FIG. 10, a display view 1000 on the GUI 602 shows a percentage of radiation delivered 1002 from the vial assembly 580 as determined via sensor measurement as described herein after termination of delivery of the mixed particulate by the delivery device 500. In embodiments, after delivery of the mixed particulate is terminated, the display via 900 may provide instructions 1004 to an operator or user of the delivery device 500. By way of example, and not as a limitation, the GUI 602 may display graphics or words, such as shown in display view 1000 of FIG. 10, indicating that an operator needs to remove an administration set including the vial assembly 580 and/or battery pack 570 from the delivery device 500. It is within the scope of the present disclosure that the GUI 602 may display graphics or words on any of the display views and/or interfaces as described herein.

[0081] Referring to FIG. 11, a process 1100 is shown for a method of operating the delivery device 500 as described herein to deliver the mixed particulate based on a calibrated and displayed pre-delivery amount indicative of radiation in the vial assembly 580. In block 1102, a pre-delivery measurement of radiation within a vial assembly 580 for the radioembolization device (e.g., delivery device 500) is conducted with an onboard sensor, as described herein, coupled to the radioembolization device for a window of time, as described herein, prior to delivery of the mixed particulate in the vial assembly 580. As shown in FIG. 6, described above, the pre-delivery measurement may be taken as a pre-treatment survey during a window of time during a duration 604 as reflected on display view 600 of GUI 602, which status of the duration 604 may be presented in real-time during the ongoing pre-treatment survey.

[0082] Referring again to FIG. 11, in block 1104, an estimated pre-delivery amount indicative of radiation in the vial assembly 580 is determined based on the pre-delivery measurement. As a non-limiting example, the estimated pre-delivery amount indicative of radiation in the vial assembly 580 based on the pre-delivery measurement may be 10.0 mL, 8.0 mL, or other suitable value.

[0083] In block 1106, the estimated pre-delivery amount indicative of radiation in the vial assembly 580 is calibrated based on the pre-delivery measurement prior to delivery of the mixed particulate as a calibrated pre-delivery amount indicative of radiation 802 (FIG. 8). A calibration module 1216 of FIG. 12, as described in greater detail below, may be configured to calibrate the estimated pre-delivery amount indicative of radiation in the vial assembly 580 to generate the calibrated pre-delivery amount indicative of radiation 802. As a non-limiting example, as shown on display view 800 on GUI 602 in FIG. 8, an estimated pre-delivery amount indicative of radiation of 10.0 mL may be set to 100% as the percentage of radiation 804 and thus calibrated to 100% such that the 10.0 mL value is representative of 100% of the calibrated pre-delivery amount indicative of radiation 802. In an example where the estimated pre-delivery amount indicative of radiation is 8.0 mL, then the 8.0 mL value may be set to 100% as the percentage of radiation 804 and thus calibrated to 100% such that the 8.0 mL value is representative of 100% of the calibrated pre-delivery amount indicative of radiation 802.

[0084] Referring again to FIG. 11 , in block 1106, the calibrated pre-delivery amount indicative of radiation 802 in the vial assembly 580 is displayed on a GUI 602 that is communicatively coupled to the radioembolization device. As described above, FIG .8 depicts the display view 800 that displays the calibrated pre-delivery amount indicative of radiation 802 on the GUI 602 communicatively coupled to delivery device 500 as the radioembolization device.

[0085] Referring again to FIG. 11, in block 1108, delivery of the mixed particulate in the vial assembly 580 via the radioembolization device is monitored based on display of the calibrated pre-delivery amount indicative of radiation 802 as described herein. In some embodiments, the process 1100 may further include displaying a real-time estimated amount indicative of radiation remaining in the vial assembly 580 during delivery of the mixed particulate on the GUI 602 based on the calibrated pre-delivery amount indicative of radiation 802. Referring to FIG. 8, the display view 800 of GUI 602 may be dynamically changed in real-time to show changing parameters associated with delivery of the mixed particulate from the vial assembly 580 by the delivery device 500. As a non-limiting example, the calibrated pre-delivery amount indicative of radiation 802 initially shown in FIG. 8 is then adjusted to show on the GUI 602 a real-time estimated amount indicative of radiation remaining in the vial assembly 580 during delivery of the mixed particulate, an associated real-time remaining percentage of radiation 804 in the vial assembly 580, and an associated real-time infusion rate 806 of the flow rate of delivery of the mixed particulate from the vial assembly 580 during the delivery in real-time, which may be measured, for example, in mL/s or other suitable metric. While the calibrated pre-delivery amount indicative of radiation 802 is shown in FIG. 8 to be associated with a volume calibrated to 100%, it is to be understood that the volume is a parameter indicative of and associated with a final determination of amount of radiation, which amount of radiation may be measured in an amount of activity, such as in mCi or GBq. Thus, a percentage of volume delivered may translate to an amount of activity delivered. As described herein, an amount indicative of radiation may thus be a parameter of radiation and/or an amount of radiation or activity.

[0086] Optionally, the process 1100 may include conducting a post-delivery measurement with the onboard sensor for the window of time based on a difference between the calibrated predelivery amount indicative of radiation 802 and the real-time estimated amount indicative of radiation remaining at an end of the delivery of the mixed particulate. As a non-limiting example, the display view 900 of FIG. 9 shows the duration 902 of the window of time when conducting the post-delivery measurement as an ongoing post-treatment survey. In an non-limiting example in which a 10.0 mL value is representative of 100% of the calibrated pre-delivery amount indicative of radiation 802, a post-delivery measurement may determine that the real-time estimated amount indicative of radiation remaining at an end of the delivery of the mixed particulate may be 2.0 mL. In such an example, the amount indicative of radiation delivered would be estimated to be the difference of the calibrated pre-delivery amount indicative of radiation 802 of 10.0 mL and the real-time estimated amount indicative of radiation remaining at an end of the delivery of 2.0 mL, which would be 8.0 mL delivered.

[0087] The process 1100 may further include determining a percentage of estimated radiation delivered by the end of the delivery based on the post-delivery measurement. The percentage of estimated radiation delivered during the delivery may be displayed on the GUI 602. As a nonlimiting example, the display view of FIG. 10 shows that 98.2% of the calibrated pre-delivery amount indicative of radiation 802 of FIG. 8 was delivered as reflect the percentage of radiation delivered 1002. In the non-limiting example from above in which 8.0 mL was determined to be delivered from an initial 10.0 mL of the mixed particulate, the determined percentage of estimated delivered by the end of the delivered based on the post-delivery measurement would be 80%. The determined percentage of estimated delivered during the delivery may further be displayed on the GUI 602, as shown as an example in the in the display view 1000 of FIG. 10 as the percentage of radiation delivered 1002.

[0088] In some embodiments, a user selection of a selectable input may be received on the GUI 602 to permit delivery of the mixed particulate after display of the calibrated pre-delivery amount indicative of radiation in the vial assembly 580 on the GUI 602. Additionally or alternatively, a remaining amount of delivery time may be displayed on the GUI 602, a plurality of measurements during the window of time may be conducted to generate the pre-delivery measurement based on the plurality of measurements, a measurement may be conducted with the onboard sensor during delivery to generate a real-time estimated amount indicative of radiation remaining in the vial assembly 580 during delivery at any moment of delivery, or combinations thereof.

[0089] As described above, the delivery may be terminated via selection of the termination selectable input when the real-time estimated amount indicative of radiation reaches a predetermined threshold. In additional or alternative embodiments, the GUI 602 is a mobile computing device remote from the radioembolization device, the mixed particulate in the vial assembly comprises radioactive microspheres, or combinations thereof. In other additional or alternative embodiments, user input of a desired percentage of estimated radiation to deliver may be received, and an alert may be generated when the desired percentage of estimated radiation to deliver is achieved based on a comparison of a real-time estimated amount indicative of radiation remaining in the vial assembly during delivery and the calibrated pre-delivery amount indicative of radiation. As a non-limiting example, the user input may reflect a desired percentage of 98% of mixed particulate to deliver such that an alert is generated when the 98% value is achieved based on a comparison of a real-time estimated amount indicative of radiation remaining and the calibrated pre-delivery amount indicative of radiation 802. With respect to a non-limiting example, an alert may be generated for a set 98% desired percentage when under 0.2 mL is the real-time estimated amount indicative of radiation remaining compared to a calibrated pre- delivery amount indicative of radiation of 10.0 mL. A controller, as will be described in greater detail further below with respect to FIG. 12, may be configured and programmed to implement any of the processes as described herein, such as the process 1100 of FIG. 11.

[0090] Referring to FIG. 12, a system 1200 is shown for implementing one or more computer and software-based methods to utilize the delivery device 500 and display interfaces as described herein to deliver the mixed particulate based on a calibrated and displayed pre-delivery amount indicative of radiation in the vial assembly 580. The system 1200 includes a communication path 1202, one or more processors 1204 (e.g., as one or more controllers), a memory component 1206, a radioembolization device 1212 to deliver a mixed particulate (e.g., the delivery device 500), an onboard sensor 1212A (e.g., the radiation sensor 533), a storage or database 1214, a calibration module 1216, a network interface hardware 1218, a server 1220, a network 1222, and at least one computing device 1224. The various components of the system 1200 and the interaction thereof will be described in detail below.

[0091] While only one server 1220 and one computing device 1224 are illustrated, the system 1200 can comprise multiple servers containing one or more applications and/or multiple computing devices. In some embodiments, the system 1200 is implemented using a wide area network (WAN) or network 1222, such as an intranet or the Internet, or other wired or wireless communication network that may include a cloud computing-based network configuration. The computing device 1224 may be a laptop or desk computer or a smart mobile device such as a smartphone, a tablet, or the like, and may include digital systems and other devices permitting connection to and navigation of the network. The lines depicted in FIG. 12 indicate communication rather than physical connections between the various components.

[0092] As noted above, the system 1200 includes the communication path 1202. The communication path 1202 may be formed from any medium that is capable of transmitting a signal such as, for example, conductive wires, conductive traces, optical waveguides, or other media capable of transmitting signals, or from a combination of media capable of transmitting signals. The communication path 1202 communicatively couples the various components of the system 1200. As used herein, the term “communicatively coupled” means that coupled components are capable of exchanging data signals with one another such as, for example, electrical signals via conductive medium, electromagnetic signals via air, optical signals via optical waveguides, or other data signals via a corresponding data signal exchange medium.

[0093] As previously described, the system 1200 includes a processor 1204. The processor 1204 can be any device capable of executing machine readable instructions. Accordingly, the processor 1204 may be a controller such as the circuit controller described herein, an integrated circuit, a microchip, a computer, or any other computing device. The processor 1204 is communicatively coupled to the other components of the system 1200 by the communication path 1202. Accordingly, the communication path 1202 may communicatively couple any number of processors with one another, and allow the modules coupled to the communication path 1202 to operate in a distributed computing environment. Specifically, each of the modules can operate as a node that may send and/or receive data. The processor 1204 may process the input signals received from the system modules and/or extract information from such signals. In some embodiments, the processor is a controller.

[0094] As previously described, the system 1200 includes the memory component 1206 coupled to the communication path 1202 and communicatively coupled to the processor 1204. The memory component 1206 may be a non-transitory computer readable medium or non- transitory computer readable memory and may be configured as a nonvolatile computer readable medium. The memory component 1206 may comprise RAM, ROM, flash memories, hard drives, or any device capable of storing machine readable instructions such that the machine readable instructions can be accessed and executed by the processor 1204. The machine readable instructions may comprise logic or algorithm(s) written in any programming language such as, for example, machine language that may be directly executed by the processor, or assembly language, object-oriented programming (OOP), scripting languages, microcode, etc., that may be compiled or assembled into machine readable instructions and stored on the memory component 1206. Alternatively, the machine readable instructions may be written in a hardware description language (HDL), such as logic implemented via either a field-programmable gate array (FPGA) configuration or an application-specific integrated circuit (ASIC), or their equivalents. Accordingly, the methods described herein may be implemented in any conventional computer programming language, as pre-programmed hardware elements, or as a combination of hardware and software components. In embodiments, the system 1200 may include the processor 1204 communicatively coupled to the memory component 1206 that stores instructions that, when executed by the processor 1204, cause the processor 1204 to perform one or more functions, such as processes, as described herein.

[0095] As briefly described above, the system 1200 includes a radioembolization device 1212 to deliver a mixed particulate. The radioembolization device 1212 may be any suitable radioembolization delivery device, such as the delivery device 500 described herein, although it will be understood that the radioembolization device 1212 is not necessarily limited to any of the features of the delivery device 500. The radioembolization device 1212 may include one or more onboard sensors 1212A as described herein for monitoring radiation levels of the mixed particulate within the radioembolization device 1212. Any suitable onboard sensor 1212A may be used, such as radiation sensor 533 (FIG. 5). By way of example only, such onboard sensors 1212A may be highly sensitive radiation sensors (e.g., microcircuit, Geiger counter, etc.) that are configured to detect radiation and measure a total ionizing dose (TID) of radiation. Such onboard sensors 1212A may be positioned at various locations within the radioembolization device 1212. For example, and referring now to FIGS. 1-5, such sensors may be placed along the path of the mixed particulate within the delivery device 500, and in particular within the console assembly 510 near the vial assembly 580 of the radioactive materials stored therein when the vial assembly 580 is housed within the delivery device 500 to determine a percent of radioactivity of the mixed particulate in the vial assembly 580.

[0096] The system 1200 may comprise the onboard sensor 1212A to detect an amount indicative of radiation in the mixed particulate, as per one or more of the embodiments described herein, and to transmit radiation signal information used to compute one or more parameters of radioactivity based on the radiation signal information. For example, the onboard sensor 1212A may be communicatively coupled to the computing device 1224 such that an operator or user of the delivery device 1212 may monitor data detected by the onboard sensor 1212A. The calibration module 1216 may be configured to calibrate received amounts of radiation generated based on radioactivity detected by onboard sensor 1212A.

[0097] As will be described in further detail below, the processor 1204 may process the input signals received from the system modules and/or extract information from such signals. For example, in embodiments, the processor 1204 may execute instructions stored in the memory component 1206 to implement the processes described herein.

[0098] Still referring to FIG. 12, as noted above, the system 1200 comprises a computing device 1224. The computing device 1224 may include one or more computing devices across platforms, or may be communicatively coupled to devices across platforms, such as mobile smart devices including smartphones, tablets, laptops, and/or other smart devices. In embodiments, the computing device 1224 is a mobile computing device remote from the radioembolization device 1212, integral with the radioembolization device 1212, or combinations thereof. The computing device 1224 may include one or more displays, such as an interface display 530 (FIG. 1), a GUI 602 (FIGS. 6-10), or combinations thereof, for providing visual output such as, for example, information, graphical reports, messages, or a combination thereof. The display of the computing device 1224 is coupled to the communication path 1202 and communicatively coupled to the processor 1204 and the radioembolization device 1212. Accordingly, the communication path 1202 communicatively couples the display to other modules of the system 1200. The display can include any medium capable of transmitting an optical output such as, for example, a cathode ray tube, light emitting diodes, a liquid crystal display, a plasma display, or other optical output transmission mediums. The display may display various measurements related to the operation of the radioembolization device 121 and provide real time monitoring of these measurements. Additionally, it is noted that the display or the computing device 1224 can include at least one of the processor 1204 and the memory component 1206. It should be understood that in other embodiments the data and information described above may be transmitted (e.g., wirelessly or wired) to a remote device such that a display of the remote device provides said outputs to an operator thereon. While the system 1200 is illustrated as a single, integrated system in FIG. 12, in other embodiments, the systems can be independent systems.

[0099] The system 1200 includes the network interface hardware 1218 for communicatively coupling the system 1200 with a computer network such as network 1222. The network interface hardware 1218 is coupled to the communication path 1202 such that the communication path 1202 communicatively couples the network interface hardware 1218 to other modules of the system 1200. The network interface hardware 1218 can be any device capable of transmitting and/or receiving data via a wireless network. Accordingly, the network interface hardware 1218 can include a communication transceiver for sending and/or receiving data according to any wireless communication standard. For example, the network interface hardware 1218 can include a chipset (e.g., antenna, processors, machine readable instructions, etc.) to communicate over wired and/or wireless computer networks such as, for example, wireless fidelity (Wi-Fi), WIMAX, BLUETOOTH, IRDA, WIRELESS USB, Z-WAVE, ZIGBEE, or other chipsets.

[00100] Still referring to FIG. 12, data from various applications running on the computing device 1224 can be provided from the computing device 1224 to the system 1200 via the network interface hardware 1218. The computing device 1224 can be any device having hardware (e.g., chipsets, processors, memory, etc.) for communicatively coupling with the network interface hardware 1218 and a network 1222. Specifically, the computing device 1224 can include an input device having an antenna for communicating over one or more of the wireless computer networks described above.

[00101] The network 1222 can include any wired and/or wireless network such as, for example, wide area networks, metropolitan area networks, the Internet, an intranet, the cloud, satellite networks, or other networks. Accordingly, the network 1222 can be utilized as a wireless access point by the computer 1224 to access one or more servers (e.g., a server 1220). The server 1220 and any additional servers generally include processors, memory, and chipset for delivering resources via the network 1222. Resources can include providing, for example, processing, storage, software, and information from the server 1220 to the system 1200 via the network 1222. Additionally, it is noted that the server 1220 and any additional servers can share resources with one another over the network 1222 such as, for example, via the wired portion of the network, the wireless portion of the network, or combinations thereof.

[00102] In embodiments and as described herein, the system 1200 for operating a radioembolization device 1212 to deliver a mixed particulate includes a GUI 602, an onboard sensor 1212A coupled to the radioembolization device 1212, and a processor 1204, such as a controller. The controller may be communicatively coupled to the radioembolization device 1212 and programmed to implement functions, such as process 1100, described herein. III. Aspects Listing

[00103] Aspect 1. A system for operating a radioembolization device to deliver a mixed particulate, the system comprising: a graphical user interface; an onboard sensor coupled to the radioembolization device; and a controller communicatively coupled to the radioembolization device and programmed to: conduct a pre-delivery measurement of radiation within a vial assembly for the radioembolization device with the onboard sensor within a window of time prior to delivery of the mixed particulate in the vial assembly; determine an estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement; calibrate the estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement prior to delivery of the mixed particulate as a calibrated pre-delivery amount indicative of radiation; display the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface communicatively coupled to the radioembolization device; and monitor delivery of the mixed particulate in the vial assembly based on display of the calibrated pre-delivery amount indicative of radiation.

[00104] Aspect 2. The system of Aspect 1, the controller further programmed to: display a realtime estimated amount indicative of radiation remaining in the vial assembly during delivery of the mixed particulate on the graphical user interface based on the calibrated pre-delivery amount indicative of radiation; conduct a post-delivery measurement with the onboard sensor for the window of time based on a difference between the calibrated pre-delivery amount indicative of radiation and the real-time estimated amount indicative of radiation remaining at an end of the delivery of the mixed particulate; determine a percentage of estimated radiation delivered by the end of the delivery based on the post-delivery measurement; and display the percentage of estimated radiation delivered during the delivery on the graphical user interface.

[00105] Aspect s. The system of any of Aspect 1 to Aspect 2, the controller further programmed to receive user selection of a selectable input on the graphical user interface to permit delivery of the mixed particulate after display of the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface.

[00106] Aspect 4. The system of any of Aspect 1 to Aspect 3, the controller further programmed to display on the graphical user interface a remaining amount of delivery time. [00107] Aspect s. The system of any of Aspect 1 to Aspect 4, the controller further programmed to conduct a plurality of measurements during the window of time to generate the pre-delivery measurement based on the plurality of measurements.

[00108] Aspect 6. The system of any of Aspect 1 to Aspect 5, the controller further programmed to conduct a measurement with the onboard sensor during delivery to generate a realtime estimated amount indicative of radiation remaining in the vial assembly during delivery at any moment of delivery.

[00109] Aspect 7. The system of any of Aspect 1 to Aspect 6, the controller further programmed to display on the graphical user interface a termination selectable input configured to terminate the delivery at any moment during delivery.

[00110] Aspect 8. The system of Aspect 7, the controller further programmed to terminate the delivery via selection of the termination selectable input when a real-time estimated amount indicative of radiation reaches a predetermined threshold.

[00111] Aspect 9. The system of any of Aspect 1 to Aspect 8, wherein the graphical user interface is a mobile computing device remote from the radioembolization device.

[00112] Aspect 10. The system of any of Aspect 1 to Aspect 9, wherein the mixed particulate in the vial assembly comprises radioactive microspheres.

[00113] Aspect 11. The system of any of Aspect 1 to Aspect 10, the controller further programmed to receive user input of a desired percentage of estimated radiation to deliver and generate an alert when the desired percentage of estimated radiation to deliver is achieved based on a comparison of a real-time estimated amount indicative of radiation remaining in the vial assembly during delivery and the calibrated pre-delivery amount indicative of radiation.

[00114] Aspect 12. A system for operating a radioembolization device to deliver a mixed particulate, the system comprising: a graphical user interface; an onboard sensor coupled to the radioembolization device; and a controller communicatively coupled to the radioembolization device and programmed to: conduct a pre-delivery measurement of radiation within a vial assembly for the radioembolization device with the onboard sensor for a window of time prior to delivery of the mixed particulate in the vial assembly; determine an estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement; calibrate the estimated pre-delivery amount indicative of radiation in the vial assembly based on the predelivery measurement prior to delivery of the mixed particulate as a calibrated pre-delivery amount indicative of radiation; display the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface communicatively coupled to the radioembolization device; monitor delivery of the mixed particulate in the vial assembly via the radioembolization device based on display of the calibrated pre-delivery amount indicative of radiation; display a real-time estimated amount indicative of radiation remaining in the vial assembly during delivery of the mixed particulate on the graphical user interface based on the calibrated pre-delivery amount indicative of radiation; conduct a post-delivery measurement with the onboard sensor for the window of time; determine a percentage of estimated radiation delivered by an end of the delivery based on the post-delivery measurement and the calibrated pre-delivery amount indicative of radiation; and display the percentage of estimated radiation delivered during the delivery on the graphical user interface.

[00115] Aspect 13. The system of Aspect 12, the controller further programmed to receive user selection of a selectable input on the graphical user interface to permit delivery of the mixed particulate after display of the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface.

[00116] Aspect 14. The system of any of Aspects 12 or 13, the controller further programmed to display on the graphical user interface a remaining amount of delivery time.

[00117] Aspect 15. The system of any of Aspects 12 to 14, the controller further programmed to conduct a plurality of measurements during the window of time to generate the pre-delivery measurement based on the plurality of measurements.

[00118] Aspect 16. The system of any of Aspects 12 to 15, the controller further programmed to conduct a measurement with the onboard sensor during delivery to generate the real-time estimated amount indicative of radiation remaining in the vial assembly during delivery at any moment of delivery. [00119] Aspect 17. The system of any of Aspects 12 to 16, the controller further programmed to display on the graphical user interface a termination selectable input configured to terminate the delivery at any moment during delivery.

[00120] Aspect 18. A method of operating a radioembolization device to deliver a mixed particulate, the method comprising: conducting a pre-delivery measurement of radiation within a vial assembly for the radioembolization device with an onboard sensor coupled to the radioembolization device for a window of time prior to delivery of the mixed particulate in the vial assembly; determining an estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement; calibrating the estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement prior to delivery of the mixed particulate as a calibrated pre-delivery amount indicative of radiation; displaying the calibrated pre-delivery amount indicative of radiation in the vial assembly on a graphical user interface communicatively coupled to the radioembolization device; and monitoring delivery of the mixed particulate in the vial assembly via the radioembolization device based on display of the calibrated pre-delivery amount indicative of radiation.

[00121] Aspect 19. The method of Aspect 18, further comprising displaying a real-time estimated amount indicative of radiation remaining in the vial assembly during delivery of the mixed particulate on the graphical user interface based on the calibrated pre-delivery amount indicative of radiation; conducting a post-delivery measurement with the onboard sensor for the window of time based on a difference between the calibrated pre-delivery amount indicative of radiation and the real-time estimated amount indicative of radiation remaining at an end of the delivery of the mixed particulate; determining a percentage of estimated radiation delivered by the end of the delivery based on the post-delivery measurement; and displaying the percentage of estimated radiation delivered during the delivery on the graphical user interface.

[00122] Aspect 20. The method of any of Aspects 18 or 19, further comprising receiving user selection of a selectable input on the graphical user interface to permit delivery of the mixed particulate after display of the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface. [00123] It is noted that the terms “substantially” and “about” may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[00124] For the purposes of describing and defining the present disclosure it is noted that the term “substantially” is used herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The term “substantially” is used herein also to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. As such, it is used to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation, referring to an arrangement of elements or features that, while in theory would be expected to exhibit exact correspondence or behavior, may in practice embody something slightly less than exact.

[00125] It is noted that recitations herein of a component of the present disclosure being "configured" or “programmed” in a particular way, to embody a particular property, or to function in a particular manner, are structural recitations, as opposed to recitations of intended use. More specifically, the references herein to the manner in which a component is "configured" or “programmed” denotes an existing physical condition of the component and, as such, is to be taken as a definite recitation of the structural characteristics of the component.

[00126] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

1. A system for operating a radioembolization device to deliver a mixed particulate, the system comprising: a graphical user interface; an onboard sensor coupled to the radioembolization device; and a controller communicatively coupled to the radioembolization device and programmed to: conduct a pre-delivery measurement of radiation within a vial assembly for the radioembolization device with the onboard sensor within a window of time prior to delivery of the mixed particulate in the vial assembly; determine an estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement; calibrate the estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement prior to delivery of the mixed particulate as a calibrated pre-delivery amount indicative of radiation; display the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface communicatively coupled to the radioembolization device; and monitor delivery of the mixed particulate in the vial assembly based on display of the calibrated pre-delivery amount indicative of radiation.

2. The system of claim 1, the controller further programmed to: display a real-time estimated amount indicative of radiation remaining in the vial assembly during delivery of the mixed particulate on the graphical user interface based on the calibrated pre-delivery amount indicative of radiation; conduct a post-delivery measurement with the onboard sensor for the window of time based on a difference between the calibrated pre-delivery amount indicative of radiation and the real-time estimated amount indicative of radiation remaining at an end of the delivery of the mixed particulate; determine a percentage of estimated radiation delivered by the end of the delivery based on the post-delivery measurement; and display the percentage of estimated radiation delivered during the delivery on the graphical user interface.

3. The system of claim 1, the controller further programmed to receive user selection of a selectable input on the graphical user interface to permit delivery of the mixed particulate after display of the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface.

4. The system of claim 1, the controller further programmed to display on the graphical user interface a remaining amount of delivery time.

5. The system of claim 1, the controller further programmed to conduct a plurality of measurements during the window of time to generate the pre-delivery measurement based on the plurality of measurements.

6. The system of claim 1, the controller further programmed to conduct a measurement with the onboard sensor during delivery to generate a real-time estimated amount indicative of radiation remaining in the vial assembly during delivery at any moment of delivery.

7. The system of claim 1, the controller further programmed to display on the graphical user interface a termination selectable input configured to terminate the delivery at any moment during delivery.

8. The system of claim 7, the controller further programmed to terminate the delivery via selection of the termination selectable input when a real-time estimated amount indicative of radiation reaches a predetermined threshold.

9. The system of claim 1, wherein the graphical user interface is a mobile computing device remote from the radioembolization device.

10. The system of claim 1, wherein the mixed particulate in the vial assembly comprises radioactive microspheres.

11. The system of claim 1, the controller further programmed to receive user input of a desired percentage of estimated radiation to deliver and generate an alert when the desired percentage of estimated radiation to deliver is achieved based on a comparison of a real-time estimated amount indicative of radiation remaining in the vial assembly during delivery and the calibrated pre-delivery amount indicative of radiation.

12. A system for operating a radioembolization device to deliver a mixed particulate, the system comprising: a graphical user interface; an onboard sensor coupled to the radioembolization device; and a controller communicatively coupled to the radioembolization device and programmed to: conduct a pre-delivery measurement of radiation within a vial assembly for the radioembolization device with the onboard sensor for a window of time prior to delivery of the mixed particulate in the vial assembly; determine an estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement; calibrate the estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement prior to delivery of the mixed particulate as a calibrated pre-delivery amount indicative of radiation; display the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface communicatively coupled to the radioembolization device; monitor delivery of the mixed particulate in the vial assembly via the radioembolization device based on display of the calibrated pre-delivery amount indicative of radiation; display a real-time estimated amount indicative of radiation remaining in the vial assembly during delivery of the mixed particulate on the graphical user interface based on the calibrated pre-delivery amount indicative of radiation; conduct a post-delivery measurement with the onboard sensor for the window of time; determine a percentage of estimated radiation delivered by an end of the delivery based on the post-delivery measurement and the calibrated pre-delivery amount indicative of radiation; and display the percentage of estimated radiation delivered during the delivery on the graphical user interface.

13. The system of claim 12, the controller further programmed to receive user selection of a selectable input on the graphical user interface to permit delivery of the mixed particulate after display of the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface.

14. The system of claim 12, the controller further programmed to display on the graphical user interface a remaining amount of delivery time.

15. The system of claim 12, the controller further programmed to conduct a plurality of measurements during the window of time to generate the pre-delivery measurement based on the plurality of measurements.

16. The system of claim 12, the controller further programmed to conduct a measurement with the onboard sensor during delivery to generate the real-time estimated amount indicative of radiation remaining in the vial assembly during delivery at any moment of delivery.

17. The system of claim 12, the controller further programmed to display on the graphical user interface a termination selectable input configured to terminate the delivery at any moment during delivery.

18. A method of operating a radioembolization device to deliver a mixed particulate, the method comprising: conducting a pre-delivery measurement of radiation within a vial assembly for the radioembolization device with an onboard sensor coupled to the radioembolization device for a window of time prior to delivery of the mixed particulate in the vial assembly; determining an estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement; calibrating the estimated pre-delivery amount indicative of radiation in the vial assembly based on the pre-delivery measurement prior to delivery of the mixed particulate as a calibrated pre-delivery amount indicative of radiation; displaying the calibrated pre-delivery amount indicative of radiation in the vial assembly on a graphical user interface communicatively coupled to the radioembolization device; and monitoring delivery of the mixed particulate in the vial assembly via the radioembolization device based on display of the calibrated pre-delivery amount indicative of radiation.

19. The method of claim 18, further comprising displaying a real-time estimated amount indicative of radiation remaining in the vial assembly during delivery of the mixed particulate on the graphical user interface based on the calibrated pre-delivery amount indicative of radiation; conducting a post-delivery measurement with the onboard sensor for the window of time based on a difference between the calibrated pre-delivery amount indicative of radiation and the real-time estimated amount indicative of radiation remaining at an end of the delivery of the mixed particulate; determining a percentage of estimated radiation delivered by the end of the delivery based on the post-delivery measurement; and displaying the percentage of estimated radiation delivered during the delivery on the graphical user interface.

20. The method of claim 18, further comprising receiving user selection of a selectable input on the graphical user interface to permit delivery of the mixed particulate after display of the calibrated pre-delivery amount indicative of radiation in the vial assembly on the graphical user interface.