Radiation Delivery Determination System and Method

Abstract

The radiation delivery determination system includes a container that includes a first compartment defining an internal notch sized and shaped to receive a periphery of a radioembolization therapy delivery set, and a second compartment defining a pocket configured to receive a tube, the tube being in fluid communication with and adhered to the radioembolization therapy delivery set. The radiation delivery determination system further includes a radioactivity measurement device that is outside the container and configured to measure the amount of radiation in the radioembolization therapy delivery set and the tube.

Description

Technical Field

[0001]

[0001] This disclosure generally relates to components of medical devices for treating diseases such as cancer, and more particularly to systems and methods for determining the amount of radiation within at least a portion of a medical treatment device.

Background Art

[0002]

[0002] In treatments involving radiation therapy such as cancer treatment, incorrect administration of the radiation dose can compromise the effectiveness of the treatment procedure. Thus, to ensure that a given amount of radiation has been administered to a patient, the amount of radiation still remaining within the medical treatment device can be measured after the treatment operation. However, due to the specific geometries of the various components of the medical treatment device and the different materials used for the different components of the medical treatment device, it can be difficult to obtain accurate and reproducible measurements of the amount of radiation remaining within the medical treatment device after the treatment procedure.

[0003]

[0003] Accordingly, there is a need for systems and methods for accurately determining, in a reproducible manner, the amount of radiation within at least a portion of a medical treatment device.

Summary of the Invention

[0004]

[0004] According to an embodiment of the present disclosure, a radiation delivery determination system may include a container. The container includes a first compartment defining an internal notch sized and shaped to receive a periphery of a radioembolization therapy administration set, and a second compartment defining a pocket configured to receive a tube, the tube being in fluid communication with and attached to the radioembolization therapy administration set. The radiation delivery determination system further includes a radioactive measurement device located outside the container and configured to measure the amount of radiation within the radioembolization therapy administration set and the tube.

[0005]

[0005] In another embodiment, the radiation delivery determination system includes a first compartment that defines an internal notch sized and shaped to receive the periphery of a radioembolization therapy administration set, the radioembolization therapy administration set including a vial at least partially filled with a radioactive therapeutic substance, and a container including a second compartment that defines a pocket configured to receive a tube, the tube being in fluid communication with and attached to the radioembolization therapy administration set. The tube is disposed within the pocket of the second compartment of the container and includes at least a first tube for administering the radioactive therapeutic substance from the vial. The radiation delivery determination system also includes a Geiger counter that is outside the container and configured to measure the total amount of radiation in the radioembolization therapy administration set and the tube.

[0006]

[0006] In yet another embodiment, a method of measuring the amount of radiation in a radioembolization therapy administration set and a tube in fluid communication therewith may include placing the radioembolization therapy administration set and the tube within a container. The container includes a first compartment that defines an internal notch sized and shaped to receive the periphery of the radioembolization therapy administration set, the radioembolization therapy administration set being disposed within the internal notch of the first compartment, and a second compartment that defines a pocket configured to receive the tube, the tube being disposed within the pocket of the second compartment. The method also includes measuring the amount of radiation in the radioembolization therapy administration set and the tube with a radiation measurement device disposed outside and spaced from the container.

[0007]

[0007] These and additional features provided by the embodiments described herein will be more fully understood in consideration of the following detailed description in conjunction with the drawings.

Brief Description of the Drawings

[0008]

Figure 1

Figure 2

[0009] Cross-sectional view of the radioembolization therapy administration set of FIG. 1, taken along line 2-2 of FIG. 1, according to one or more embodiments shown and described herein.

Figure 3

[0010] Perspective view of a vial assembly including an engagement head, according to one or more embodiments shown and described herein.

Figure 4

[0011] Perspective view of the radioembolization therapy administration set of FIG. 1, with the vial assembly of FIG. 3 received therein, with a series of delivery conduits coupled to the radioembolization therapy administration set, according to one or more embodiments shown and described herein.

Figure 5

[0012] Perspective view of a container for receiving the radioembolization therapy administration set of FIG. 4, with the front wall of the container removed for illustration, according to one or more embodiments shown and described herein.

Figure 6

[0013] Perspective view of the container of FIG. 5, with the radioembolization therapy administration set of FIG. 4 received therein, according to one or more embodiments shown and described herein.

Figure 7

[0014] Perspective view of the liner of the container of FIG. 5 for receiving the radioembolization therapy administration set of FIG. 4, according to one or more embodiments shown and described herein.

Figure 8

[0015] Top view of the container of FIG. 5, with the upper wall removed for illustration and including a front wall forming a protrusion, according to one or more embodiments shown and described herein.

Figure 9

[0016] Top view of another embodiment of the container of FIG. 5, with the upper wall removed for illustration and including a front wall forming a contour, according to one or more embodiments shown and described herein.

Figure 10

[0017] A perspective view of another container for receiving therein a radioembolization therapy delivery set of FIG. 4, with the front wall of the container removed for illustration purposes, according to one or more embodiments shown and described herein.

Figure 11

[0018] A cross-sectional view of the container of FIG. 10, taken along line 10-10 of FIG. 10, according to one or more embodiments shown and described herein.

Figure 12

[0019] A cross-sectional view of the container of FIG. 10, taken along line 11-11 of FIG. 10, according to one or more embodiments shown and described herein.

Figure 13

[0020] A perspective view of a housing for receiving a container for receiving therein a radioembolization therapy delivery set of FIG. 4, according to one or more embodiments shown and described herein.

Figure 14

[0021] A perspective view of the housing of FIG. 13 with the container of FIG. 6 received therein, according to one or more embodiments shown and described herein.

Figure 15

[0022] A flowchart for determining the amount of radiation within at least a portion of a medical treatment device, according to one or more embodiments shown and described herein.

DETAILED DESCRIPTION OF THE INVENTION

[0009]

[0023] Reference will now be made in detail to various embodiments of a delivery device for administering a radioactive compound to a patient, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts. As used herein, directional terms such as up, down, right, left, front, back, top, bottom, distal, and proximal are used only in relation to the figures as depicted and are not intended to imply absolute orientation.

[0010]

[0024] Ranges may 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 one particular value and / or to the other particular value. Similarly, it is to be understood that when a value is expressed as an approximation by use of the antecedent “about,” that particular value forms another embodiment. It is further to be understood that each endpoint of a range is significant both in relation to the other endpoint and independently of the other endpoint.

[0011]

[0025] Unless otherwise expressly stated, no method recited in this specification is intended to require that its steps be performed in a particular order or that any device-specific orientation be required. Accordingly, where a method claim does not actually recite the order to be followed by its steps, or where any apparatus claim does not actually recite an order or orientation to individual components, or where the steps are not otherwise specifically recited in the claims or description as being limited to a particular order, or where no specific order or orientation of components of an apparatus is recited, no order or orientation should be inferred in any way. This applies to any possible ambiguous bases for interpretation, including logical matters, grammatical mechanisms or punctuation derived from the arrangement of steps, operational flow, order of components, or orientation of components, the plain meaning derived therefrom, and the number or types of embodiments described in this specification.

[0012]

[0026] 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 this disclosure belongs. The terminology used in the description herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0013]

[0027] As used herein, the terms "horizontal," "vertical," "distal," and "proximal" are merely relative terms and merely indicate an overall relative orientation and do not necessarily indicate perpendicularity. These terms may also be used for convenience in referring to the orientation used within the figures, such orientation being used merely by convention and not being intended as a characteristic of the device shown. The present disclosure and its embodiments to be described herein may be used in any desired orientation. Further, horizontal and vertical walls generally need merely be intersecting walls and need not be at right angles. 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 dictates otherwise.

[0014]

[0028] In embodiments described herein, a particulate material delivery assembly, the amount of radiation of which can be determined as will be described in more detail below, may include a radioembolization administration set. The radioembolization administration set comprises a medical device such as a medical treatment device configured to deliver a radioactive compound to a treatment area within a patient's body in a procedure such as transarterial radioembolization. The radioactive compound may be a mixed solution of physiological saline and radioactive microspheres (i.e., microparticles) mixed within a vial of a vial assembly. The needle may include one or more ports as an outlet for injecting a fluid (i.e., physiological saline) into the vial containing the radioactive microspheres to produce the mixed solution, such as from a syringe or catheter line, and as an inlet for delivering the mixed solution to the patient.

[0015]

[0029] Also, in the embodiments described herein and further described in more detail below with respect to at least FIGS. 5-15, a radioembolization therapy administration set that may include a vial assembly received therein, and a radiation delivery determination system for determining the amount of radiation in a tube coupled to the radioembolization therapy administration set includes a container. The container includes a first compartment defining an internal notch sized and shaped to receive a periphery of the radioembolization therapy administration set, and a second compartment defining a pocket configured to receive a tube. In an embodiment, to normalize a reduction in the radiation emission intensity of the radiation included in the radioembolization therapy administration set and / or the vial assembly and the tube, a first rear surface of the first compartment disposed on an opposite side of a measurement facing surface of the front wall of the container is spaced from the measurement facing surface of the container by a first distance, and a second rear surface of the second compartment disposed on an opposite side of the measurement facing surface of the container is spaced from the measurement facing surface of the container by a second distance, the second distance being greater than the first distance. The measurement facing surface of the front wall of the container is closest to and faces the radioactive measurement device. In additional or alternative embodiments, to normalize a reduction in the radiation emission intensity of the radiation included in the radioembolization therapy administration set and / or the vial assembly and the tube, the container is placed within a housing that includes a radiation shield that extends partially along the housing and covers the second compartment of the container but not the first compartment of the container.

[0016]

[0030] The FIGS. 1-4 described below are directed to embodiments of a delivery device 500 for delivering microparticles, and the FIGS. 5-15 described in more detail below are directed to embodiments of one or more systems 1000 (see FIG. 14) for assisting in determining the amount of radiation within at least a portion of the delivery device 500. In some embodiments, as described in more detail below, the delivery device 500 is a radioembolization delivery device, the microparticles are a plurality of radioembolization beads, the fluid is a saline aqueous solution, and the resulting mixed fluid (e.g., mixed fluid solution) is a radioembolization bead-saline aqueous solution. The needle 559 can be configured to deliver the radioembolization bead-saline aqueous solution as a mixed fluid solution through the radioembolization delivery device, such as during the actuation of the vial engagement mechanism 520 in the positive pressure direction. In some embodiments, the fluid is a contrast agent-saline aqueous solution containing a contrast agent, and the resulting mixed fluid (e.g., mixed fluid solution) is a radioembolization bead-contrast agent-saline aqueous solution. The needle 559 can be configured to deliver the radioembolization bead-contrast agent-saline aqueous solution as a mixed fluid solution through the radioembolization delivery device. In some embodiments, the delivery device 500 is a chemoembolization delivery device, the microparticles are a plurality of chemoembolization beads, and the mixed fluid solution is a bead-saline aqueous solution or a bead-contrast agent-saline aqueous solution. I. Mechanical Delivery Device with Removable Radioembolization Administration Set

[0031] FIGS. 1 and 2 show embodiments of a delivery device 500 configured and operable to deliver radioactive material (e.g., radioembolization beads) while reducing radioactive emissions during use of the delivery device 500. The delivery device 500 can operate as described in International PCT Application No. PCT / 2019 / 033001, filed May 17, 2019, which is incorporated herein by reference in its entirety.

[0017]

[0032] Referring initially to FIG. 1, the delivery device 500 comprises a console assembly 510 including a console. The delivery device 500 may include a radiation embolization therapy administration set 540 operable to transition between a coupled state and a separated state relative to the console assembly 510. The console assembly 510 of the delivery device 500 comprises a base 512 defined by a proximal end 514 and a distal end 516 and extending therebetween. 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.

[0018]

[0033] The proximal end 514 of the base 512 further includes a mounting device 538 configured to securely hold an external device to the base 512 of the console assembly 510. The mounting device 538 is operable to facilitate the mounting of complementary devices to the console assembly 510 for use with the delivery device 500 during a procedure.

[0019]

[0034] Still referring to FIG. 1, the distal end 516 of the console assembly 510 defines a vial receiving region 518 sized and shaped to receive the console assembly 510 therein, as described in more detail herein. The console assembly 510 further includes a vial engagement mechanism 520 extending from the base 512 adjacent the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outwardly from the base 512 of the console assembly 510 towards the distal end 516. The vial engagement mechanism 520 is positioned within the vial receiving 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 receiving region 518 in response to actuation of the handle 528.

[0020]

[0035] The console assembly 510 includes a mechanical assembly disposed within the base 512 that is configured and operable to convert the manual movement of the handle 528 into a corresponding linear displacement of the vial engagement mechanism 520. In this 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 simultaneous actuation of the vial engagement mechanism 520 at the distal end 516.

[0021]

[0036] In an embodiment, and referring to FIG. 2, the flow sensor of the delivery device 500 can be positioned in-line with and configured to measure the amount of fluid (e.g., a suspension after therapeutic particles are effectively mixed with a fluid medium) passing through one or more of the tube sets of the delivery device 500 and, in particular, the needle 559, manifolds 555A, 555B, and / or ports 556. Referring back to FIG. 1, the vial engagement mechanism 520 includes a pair of lever arms 522 extending outwardly from the neck 524 of the vial engagement mechanism 520, which neck 524 extends laterally outwardly 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 extend through the protective cover 525. The protective cover 525 is operable to shield one or more internal components of the console assembly 510 from the outside of the console assembly 510 and, in particular, from the vial receiving region 518.

[0022]

[0037] A pair of lever arms 522 are movable simultaneously with the neck 524 of the vial engagement mechanism 520 in response to actuation of the handle 528 of the console assembly 510. Further, the pair of lever arms 522 are fixed relative to each other such that the space formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 are configured to firmly engage the vial assembly 580 therebetween and, in particular, within the space formed by the pair of lever arms 522. Thus, the vial engagement mechanism 520 is operable to firmly attach the vial assembly 580 to the console assembly 510 in the vial receiving region 518. The vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, but it should be understood that the vial engagement mechanism 520 can include various other structural configurations suitable for engaging the vial assembly 580, such as magnets on each component configured to engage with each other.

[0023]

[0038] Still referring to FIG. 1, the console assembly 510 further includes a safety shield 526 that is secured to the distal end 516 of the base 512 along the vial receiving region 518. In particular, the safety shield 526 is a protective cover sized and shaped to surround the vial receiving region 518 of the console assembly 510 when secured thereto. The safety shield 526 is selectively attachable to the distal end 516 of the base 512 and is formed of a material configured to inhibit radioactive emissions from one or more radiation doses stored within the vial receiving region 518, such as glass, polymer, or other plastic material.

[0024]

[0039] The distal end 516 of the console assembly 510 further includes an administration set space 532 sized and shaped to receive therein a radioembolization administration set 540. The administration set space 532 includes one or more, and in some embodiments a pair of, positioning portions 534 extending therein, the positioning portions 534 being sized and shaped to mate with complementary positioning portions (e.g., positioning ribs 554) of the radioembolization administration set 540, thereby facilitating coupling of the radioembolization administration set 540 with the base 512 of the console assembly 510 within the administration set space 532. As described in more detail herein, the radioembolization administration set 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, media) therethrough. In particular, the radioembolization administration set 540 is configured to partially receive therein a vial assembly 580 for administering therapeutic particles from the delivery device 500 to a patient during a procedure.

[0025]

[0040] Still referring to FIG. 1, the radioembolization administration set 540 is configured to partially receive the vial assembly 580 therein for administering therapeutic particles (e.g., radioactive fluid medium) from the delivery device 500 to the patient. In particular, the radioembolization administration set 540 includes a proximal end 544 and a distal end 542, with a pair of side walls 546 extending therebetween. The proximal end 544 of the radioembolization administration set 540 includes a handle 552 that extends proximally therefrom. The handle 552 is configured to facilitate the movement of the radioembolization administration set 540, particularly the insertion of the radioembolization administration set 540 into the administration set space 532 of the console assembly 510. The proximal end 544 further includes one or more ports 556 for coupling one or more delivery conduits (i.e., tubes) to the radioembolization administration set 540. Since one or more delivery conduits are further coupled to one or more external devices at the ends of the lines opposite the ports 556, the ports 556 effectively function to fluidly couple the radioembolization administration set 540 to one or more external devices via the delivery conduits connected thereto. The pair of side walls 546 of the radioembolization administration set 540 includes at least one positioning rib 554 that extends laterally outward therefrom, and the positioning rib 554 is sized and shaped to mate with and fit into a pair of positioning portions 534 of the console assembly 510. Accordingly, the pair of positioning ribs 554 is configured to facilitate the alignment and engagement of the radioembolization administration set 540 with the console assembly 510 when the distal end 542 is slidably received within the administration set space 532 of the base 512. 【002(6)】

[0041] It should be noted that the "【002(6)】" in the original text seems to be an incorrect format. I have translated it as "【002(6)】" as accurately as possible while maintaining the original form. If there is an error in the original content, it may need to be corrected according to the actual situation. Also, " ", " ", and "

[0041] " are preserved as they are according to the requirements.The radiation embolization therapy administration set 540 further includes an upper surface 548 extending from a proximal end 544 and a distal end 542 and positioned between a pair of side walls 546, and a lower surface 541 extending from the proximal end 544 and the distal end 542 and positioned between the pair of side walls 546. The upper surface 548 of the radiation embolization therapy administration set 540 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 upper surface 548, and this recessed region 549 can receive and / or collect various materials therein, including leakage of various fluid media during use of the delivery device 500, for example. The locking system 550 of the radiation embolization therapy administration set 540 forms an opening along the upper surface 548 that is sized and shaped to receive one or more devices, such as a priming assembly 560 and a vial assembly 580. In some embodiments, the radiation embolization therapy administration set 540 is pre-loaded with a priming assembly 560 disposed within the locking system 550. The priming assembly 560 includes a priming conduit 562 that extends outwardly from the locking system 550 of the radiation embolization therapy administration set 540. The priming assembly 560 connects the priming conduit 562 to a needle 559 and manifolds 555A and 555B and serves to purge air from the delivery device 500 including the manifolds 555A and 555B prior to utilization of the delivery device 500 in a procedure.

[0027]

[0042] Referring now to FIG. 2, the locking system 550 includes one or more protrusions 551 in an annular array extending outwardly therefrom, the protrusions 551 extending laterally into the aperture formed by the locking system 550, particularly along the upper surface 548. The annular array of protrusions 551 is formed within the inner circumference of the locking system 550 and extends along at least two continuously arranged rows. The annular array of protrusions 551 included in the locking system 550 engages corresponding locking features 586 (see FIG. 3) of the vial assembly 580, thereby configuring the vial assembly 580 to be securely fastened to the radioembolization therapy delivery set 540. The plurality of rows of protrusions 551 of the locking system 550 serve to provide a dual locking system to ensure that the radioembolization therapy delivery set 540, and particularly the needle 559 of the radioembolization therapy delivery set 540, is securely maintained through the septum 592 (see FIG. 3) of the vial assembly 580 during use of the delivery device 500 in the procedure.

[0028]

[0043] The radiation embolization therapy administration set 540 further includes a vial chamber 558 sized and shaped to receive therein a priming assembly 560 and a vial assembly 580, respectively. In other words, the vial chamber 558 is sized to receive both the priming assembly 560 and the vial assembly 580 separately from each other. The vial chamber 558 is enclosed within a protective chamber or shield 557 disposed around the vial chamber 558. The protective shield 557 is formed of a material configured to suppress, for example, metals, the radioactive emission from extending outwardly from the vial chamber 558. Additionally, the radiation embolization therapy administration set 540 includes a needle 559 along the lower end of the vial chamber 558 that extends through the protective shield 557 and into the vial chamber 558. The needle 559 is firmly fixed to the vial chamber 558 such that as a result, any device received through the aperture of the locking system 550 and into the vial chamber 558 will contact and interact with the needle 559 (e.g., the priming assembly 560, the vial assembly 580, and the like).

[0029]

[0044] Still referring to FIG. 2, the needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the radiation embolization therapy administration set 540. In particular, the manifolds 555A, 555B are positioned under 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 coupleable to one or more delivery conduits via one or more ports 556 of the radiation embolization therapy administration set 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A through a one-way check valve 553 disposed therebetween.

[0030]

[0045] Accordingly, the proximal manifold 555B is in fluid communication with one or more ports 556 via the distal manifold 555A, but the one or more ports 556 are not in fluid communication with the proximal manifold 555B due to the position of the one-way check valve 553 disposed between the manifolds 555A, 555B. Thus, the needle 559 is in fluid communication with one or more delivery conduits and / or devices coupled to the radioembolization administration set 540 at one or more ports 556 and the manifolds 555A, 555B secured therebetween. One or more ports 556 of the radioembolization administration set 540 may be coupled to a bag (e.g., a saline bag), syringe, catheter, and / or the like via one or more delivery conduits coupled thereto. In other embodiments, the needle 559 may be a cannula, catheter, or similar mechanism through which fluids and / or solutions are injected and received as described herein.

[0031]

[0046] Still referring to FIG. 2, the radioembolization administration set 540 includes a removable battery pack 570 coupled to the radioembolization administration set 540 along the distal end 542. The removable battery pack 570 includes 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 flow paths and the radiation source due to the location of the battery 572 within the removable battery pack 570.

[0032]

[0047] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to contact and interact with corresponding electrical contacts 511 (see FIG. 1) of the console assembly 510 when the radiation embolization therapy delivery set 540 is coupled to the base 512 in the delivery set space 532. Thus, the removable battery pack 570 is operable to provide power to the delivery device 500, and in particular, to the console assembly 510, when the radiation embolization therapy delivery set 540 is coupled to the console assembly 510.

[0033]

[0048] In addition, as will be described in more detail herein, in some embodiments, the locking system 550 may include at least one planar wall relative to the remaining circular orientation of the locking system 550. In this case, the aperture formed by the locking system 550 through the upper surface 548 of the radiation embolization therapy delivery set 540 is not of a circular shape as shown and described above, but of an irregular shape. In this case, the vial assembly 580 includes locking features 586 having a shape and size corresponding to the locking system 550, and in particular, to the at least one planar wall, such that the vial assembly 580 is received within the radiation embolization therapy delivery set 540 only when the orientation of the vial assembly 580 is adapted to the alignment of the locking features 586 and the locking system 550. In other words, the corresponding planar wall 586A (see FIG. 3) of the locking feature 586 must be aligned with the planar wall of the locking system 550 such that the vial assembly 580 can be received within the aperture formed by the locking system 550 of the radiation embolization therapy delivery set 540.

[0034]

[0049] Referring now to FIG. 3, the vial assembly 580 of the delivery device 500 is depicted. The vial assembly 580 includes 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 the end of the plunger 584 on the opposite side of the locking feature 586 and the vial body 589. The engagement head 582 includes a pair of arms 581 that extend laterally outwardly relative to the longitudinal length of the plunger 584 that extends downwardly therefrom. In this example, the engagement head 582 is formed integrally with the plunger 584, but it should be understood that in other embodiments, the engagement head 582 and the plunger 584 may be separate features that are fastened to each other. In any case, the engagement head 582 and the plunger 584 are 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 more detail herein, the plunger 584 is translatable in and out of the inner chamber 588 of the vial body 589 in response to the linear translational movement of the vial engagement mechanism 520 when the engagement head 582 is secured to the pair of lever arms 522.

[0035]

[0050] The plunger 584 includes a plurality of markings and / or graduations 583 positioned along the longitudinal length of the plunger 584. The plurality of graduations 583 indicate the relative extension of the engagement head 582 and the plunger 584 from the locking feature 586 and the vial body 589. As briefly described 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 engage a pair of lever arms 522 of the vial engagement mechanism 520 when the vial assembly 580 is received within the radiation embolization therapy delivery set 540 and the radiation embolization therapy delivery set 540 is inserted into the delivery set space 532 of the console assembly 510. As will be described in more 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 translational force applied to the vial engagement mechanism 520. The engagement head 582 and the plunger 584 can be formed of various materials including, but not limited to, metal, plastic, and / or the like.

[0036]

[0051] Still referring to FIG. 3, the vial assembly 580 further includes a safety tab 585 coupled to the plunger 584 relative to 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 can be formed of various materials such as, for example, plastic and is pre-assembled onto the vial assembly 580 prior to use of the delivery device 500. The safety tab 585 is removably fastened to the plunger 584 and inhibits translation of the plunger 584 relative to the vial body 589. In particular, the safety tab 585 abuts against the locking feature 586 in response to the application of a linear force to the plunger 584 to translate the plunger 584 relatively downward into the vial body 589. In this case, the safety tab 585 is configured to inhibit inadvertent movement of the plunger 584 and the corresponding inadvertent delivery of a fluid medium (e.g., therapeutic particles, radiation embolization beads) stored within the inner chamber 588 of the vial body 589. As will be described in more detail herein, the safety tab 585 is selectively removed from the plunger 584 in response to the coupling of the vial assembly 580 with the vial engagement mechanism 520 and in particular the engagement of the pair of lever arms 522 with the engagement head 582.

[0037]

[0052] Returning to FIG. 3 for reference, the locking feature 586 extends around the upper end of the vial body 589. In this example, the locking feature 586 of the vial assembly 580 includes a bushing that defines a side edge 587 that extends laterally outward along the outer periphery of the locking feature 586. The side edge 587 of the locking feature 586 is sized and shaped to engage the annular array of protrusions 551 of the locking system 550 when the vial assembly 580 is received within the vial chamber 558 of the radioembolization therapy delivery set 540. As will be described in more detail herein, the locking feature 586, and in particular the side edge 587 of the locking feature 586, is configured to securely attach the vial assembly 580 to the locking system 550 and prevent removal of the vial body 589 from the vial chamber 558 of the radioembolization therapy delivery set 540 during use of the delivery device 500 in the procedure. In some embodiments, as briefly described above, the locking feature 586 includes at least one planar wall 586A such that the locking feature 586 has an irregular shape. The at least one planar wall 586A is configured to correspond to the planar wall 550A of the locking system 550 such that alignment of the planar walls 550A and 586A requires that the vial assembly 580 be received through an aperture formed by the locking system 550.

[0038]

[0053] Still referring to FIG. 3, the vial body 589 extends relatively downwardly from the locking feature 586 and has a longitudinal length sized to receive at least a portion of the longitudinal length of the plunger 584 therein. By way of example only, the longitudinal length of the vial body 589 can be from about 8 millimeters to about 10 millimeters and, in this example, includes 9 millimeters, while the longitudinal length of the plunger 584 can be from about 9 millimeters to about 11 millimeters and, in this example, includes 10 millimeters. Thus, in some embodiments, the longitudinal length of the plunger 584 exceeds the longitudinal length of the vial body 589 such that translation of the plunger 584 into the internal chamber 588 of the vial body 589 causes the fluid medium stored therein to be sent out of the vial body 589. As will be described in more detail herein, translation of the plunger 584 through the internal chamber 588 of the vial body 589 results in administration of the fluid medium stored within the vial body 589 out of the vial assembly 580. The vial body 589 can be formed of a variety of materials including, for example, thermoplastic polymers, copolyesters, polycarbonates, biocompatible plastics, polysulfones, ceramics, metals, and / or the like.

[0039]

[0054] The vial body 589 of this example is formed of a material configured to suppress radioactive emissions from a fluid medium 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 has a width of approximately 9 millimeters (mm). The density and material composition of the vial body 589, together, may suppress beta radiation emissions from electron particles stored within the internal chamber 588. In this example, the plastic chemical composition of the vial body 589, in combination with a 9 mm wall thickness, results in a plurality of atoms disposed within the vial body 589, and such plurality of atoms can collide with electron particles that generate beta radiation, reducing the emission of the above radiation from the vial assembly 580. Thus, the vial assembly 580 enables an operator to handle radioactive substances stored within the vial body 589 without being exposed to beta radiation. It should be understood that in other embodiments, various other materials and / or wall regions may be incorporated within the vial body 589 of the vial assembly 580 without departing from the scope of the present disclosure.

[0040]

[0055] Still referring to FIG. 3, the vial body 589 of the vial assembly 580 is sealed at the first end by the locking feature 586. The vial assembly 580 further includes a cap 590 positioned at the opposite end of the vial body 589 from the locking feature 586, such that the cap 590 seals the second 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 the end of the vial body 589 opposite the locking feature 586. The septum 592 forms a seal against the end of the vial body 589 and the cap 590 holds the septum 592 therein. The septum 592 can be formed of various materials including, for example, elastomers, silicon, bromobutyl elastomers, rubber, urethane, and / or the like. The septum 592 provides an airtight seal for the vial body 589 and is configured to inhibit the release of a fluid medium (e.g., radioactive embolization beads) stored therein. As described in more detail herein, the septum 592 of the vial assembly 580 is configured to be punctured by the needle 559 of the radioactive embolization therapy administration set 540 when the vial assembly 580 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the radioactive embolization therapy administration set 540. In other embodiments, the septum 592 can be completely omitted in the case of alternative devices such as, for example, valve systems, needle injection ports, and / or the like.

[0041]

[0056] Referring now to FIG. 4, in response to determining that battery 572 contains a sufficient amount of power or that another power source provides the same, one or more delivery conduits are coupled to the radioembolization delivery set 540 via one or more ports 556. In particular, the dose delivery conduit 10A is coupled to the radioembolization delivery set 540 at the delivery port 556A, the contrast agent conduit 10B is coupled to the radioembolization delivery set 540 at the contrast agent port 556B, and the flushing conduit 10C is coupled to the radioembolization delivery set 540 at the flushing port 556C. The opposite end of the dose delivery conduit 10A is initially coupled to a fluid reservoir, such as a collection bowl for example. As will be described in more detail herein, once the radioembolization delivery set 540 is effectively primed with a fluid medium via the contrast agent conduit 10B, the dose delivery conduit 10A can subsequently be coupled to an external device, such as a catheter. The opposite end of the flushing conduit 10C is coupled to an external device, such as a syringe for example. With both the dose delivery conduit 10A and the flushing conduit 10C coupled to the radioembolization delivery set 540, the radioembolization delivery set 540 is flushed with a fluid medium (e.g., saline) from a syringe coupled to the flushing conduit 10C. In this case, the fluid medium is injected through the flushing conduit 10C into the distal manifold 555A of the radioembolization delivery set 540 and exits the radioembolization delivery set 540 through the dose delivery conduit 10A. Thus, the fluid medium is ultimately received and disposed of in the collection bowl by the dose delivery conduit 10A.

[0042]

[0057] Since the distal manifold 555A of the radiation embolization therapy administration set 540 is separated from the proximal manifold 555B by a one-way check valve 553 disposed therebetween, the fluid medium flushed from the syringe (via the flushing port 556C) through the distal manifold 555A is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. Rather, the fluid medium injected from the syringe through the flushing conduit 10C is received at the flushing port 556C, passed to the distal manifold 555A in fluid communication with the flushing port 556C, and redirected by the one-way check valve 553 toward the dose delivery port 556A coupled to the dose delivery line 10A. In this case, the dose delivery line 10A receives the fluid medium and sends it to the collection bowl coupled thereto, as a result of which the fluid medium is not directed beyond the one-way check valve 553 and into the proximal manifold 555B in fluid communication with the needle 559.

[0043]

[0058] The contrast agent catheter 10B is coupled to the radioembolization administration set 540 at the contrast agent port 556B. The opposite end of the contrast agent catheter 10B is coupled to a fluid media supply, such as a bag fixed to the console assembly 510 by a mounting device 538, for example. In this example, the bag is a saline bag, and thus the fluid media stored therein is saline. In this case, with the radioembolization administration set 540 including the priming assembly 560 positioned within the vial chamber 558 and the needle tip in fluid communication with the needle 559, the syringe is fluidly coupled to the priming conduit 562 of the priming assembly 560, and the plunger of the syringe is retracted to draw saline from the saline bag through the contrast agent catheter 10B, the contrast agent port 556B, the radioembolization administration set 540, and the priming conduit 562 and into the syringe. The plunger of the syringe is then pushed inward to send the extracted saline back through the priming conduit 562, the central body portion, the elongate shaft, and the needle tip of the priming assembly 560, such that the saline is received within the needle 559 of the radioembolization administration set 540. Thus, the manifolds 555A, 555B of the radioembolization administration set 540 are effectively primed with saline from the syringe because the needle 559 that has received saline from the priming assembly 560 is in fluid communication with the manifolds 555A, 555B. Since the manifolds 555A, 555B are in further fluid communication with the dose delivery conduit 10A via the delivery port 556A, the saline is effectively supplied to the collection bowl coupled to the dose delivery conduit 10A.

[0044]

[0059] Referring now to FIG. 4, the radioembolization administration set 540 is coupled to one or more external devices via one or more ports 556. In particular, the radioembolization administration set 540 is fluidly coupled to a catheter (e.g., a microcatheter) via a dosage delivery conduit 10A that is coupled to the delivery port 556A of the radioembolization administration set 540. In this case, the catheter is in fluid communication with the radioembolization administration set 540 via the dosage delivery conduit 10A. Further, the radioembolization administration set 540 is fluidly coupled to a contrast agent source, such as a saline bag, that is secured to the console assembly 510, e.g., via a mounting device 538 (see FIG. 1). The radioembolization administration set 540 is in fluid communication with the saline bag via a contrast agent conduit 10B that is coupled to the contrast agent port 556B of the radioembolization administration set 540. In this case, the saline bag is in fluid communication with the radioembolization administration set 540 via the contrast agent conduit 10B that is secured to the contrast agent port 556B.

[0045]

[0060] The contrast agent 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 more detail herein, since the contrast agent port 556B is coupled to the proximal manifold 555B rather than the distal manifold 555A that is separated from the proximal manifold 555B by a one-way check valve 553 disposed therebetween, saline from the saline bag can be drawn through the needle 559 of the radioembolization administration set 540 and into the vial body 589 of the vial assembly 580.

[0046]

[0061] Referring again to FIGS. 1 and 3, with the vial assembly 580 firmly coupled to the radioembolization therapy delivery set 540, the radioembolization therapy delivery set 540 is coupled to the console assembly 510 by translating the proximal end 544 of the radioembolization therapy delivery set 540 toward and into the distal end 516 of the console assembly 510. In particular, the proximal end 544 of the radioembolization therapy delivery set 540 is oriented into the delivery set space 532 of the console assembly 510 by aligning the positioning rib 554 of the radioembolization therapy delivery set 540 with the positioning portion 534 of the console assembly 510. Once the distal end 542 and the proximal end 544 of the radioembolization therapy delivery set 540 are fully enclosed within the delivery set space 532 of the console assembly 510, the electrical contacts 574 (FIG. 2) of the removable battery pack 570 interact with the corresponding electrical contacts 511 (FIG. 1) of the console assembly 510. In this case, 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 case, the interface display 530 of the console assembly 510 activates to display real-time information regarding the delivery device 500 to the patient during the procedure.

[0047]

[0062] Referring again to FIG. 4, when the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial receiving region 518, a negative pressure is generated within the internal chamber 588 of the vial body 589 due to the retraction of the stopper 594. In this case, since the saline bag is coupled to the radioembolization therapy delivery set 540 via the contrast agent conduit 10B and the contrast agent port 556B, the saline from the saline bag is drawn into the internal chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Thus, if the vial body 589 is pre-filled with a radioactive fluid medium (e.g., radioembolization microspheres), the saline is effectively mixed with the radioactive fluid medium within the vial body 589 when the plunger 584 is withdrawn from the internal chamber 588 and a negative pressure is generated through the delivery device 500.

[0048]

[0063] The radioembolization therapy delivery set 540 further includes a one-way check valve 553A along the contrast agent conduit 10B and the flushing conduit 10C. In particular, the one-way check valve 553A is configured to allow fluid communication from the contrast agent port 556B and the flushing port 556C into the manifolds 555A, 555B, and is further configured to prevent fluid communication from the manifolds 555A, 555B to the contrast agent port 556B and the flushing port 556C. Thus, it should be understood that directing the dose delivered from the vial body 589 to the manifolds 555A, 555B into the contrast agent conduit 10B or the flushing conduit 10C is not possible due to the one-way check valve 553A positioned therein. Thus, the dose is directed to the dose delivery port 556A and is received in a catheter fluidly coupled by the dose delivery conduit 10A thereto. In other words, the one-way check valve 553A prevents backflow of fluid into the radioembolization therapy delivery set 540 and / or the vial assembly 580 coupled thereto. II. Radiation Determination Embodiments

[0064] As briefly described above, FIGS. 5-15, discussed in more detail herein, generally relate to embodiments that assist the radiation delivery determination system 1000 in determining the amount of radiation within at least a portion of the delivery device 500. For example, the system 1000 discussed herein can be used to determine the amount of radiation in a fluid treatment operation from the delivery device 500 or the amount of radiation within at least a portion of the delivery device 500 after administration. More specifically, the system 1000 discussed herein includes a radiation embolization therapy administration set 540 that can be partially received within a vial assembly 580, and a tube 10 coupled to the radiation embolization therapy administration set 540 (i.e., the dose delivery conduit 10A, the contrast agent conduit 10B, and the flushing conduit 10C) and can be used to determine the amount of radiation therein. By determining the amount of radiation within at least a portion of the delivery device 500 after administration of the radiation dose and knowing a predetermined amount of radiation or radioactive fluid medium pre-loaded within the vial body 589, the amount of radiation administered to the patient can be determined and / or verified.

[0049]

[0065] Current systems and methods can involve roughly placing a radioembolization delivery set, vial assembly, and / or tube within a test container, and measuring the amount of radiation within the radioembolization delivery set, vial assembly, and / or tube within the test container using a radiation measurement device. However, the specific orientation and position of the radioembolization delivery set, vial assembly, and / or tube within the test container may not be known, and the distance from the radiation source and the radiation measurement device can affect the amount of radiation detected by the radiation measurement device. In particular, the intensity of the measured radiation is inversely proportional to the square of the distance between the radiation source and the radiation measurement device, and as a result, the intensity of the detected radiation decreases as the distance between the radiation source and the radiation measurement device increases. For example, the radioactivity measured by a radiation measurement device positioned 0.3 meters from a radiation source can be 10 millicuries (or an equivalent amount in becquerels), while the radioactivity measured by a radiation measurement device positioned 0.4 meters from the same radiation source can be 6.25 millicuries (or an equivalent amount in becquerels). Thus, users often have to take several readings at different locations around the test container and average the results of those several readings to accurately determine the amount of radiation within the radioembolization delivery set, vial assembly, and / or tube.

[0050]

[0066] Furthermore, different materials attenuate radiation to different degrees. Thus, due to differences in absorption, or radiation shielding characteristics, between the materials used to form the radioembolization delivery set, vial assembly, and / or tubing, for example, the same amount of radiation within the tubing and radioembolization delivery set can result in different readings by the radiation measurement device. That is, the radioembolization delivery set 540 may shield 50% of the radiation from within the radiation measurement device, and the tubing may shield nearly 0% of the radiation from within the radiation measurement device. Thus, a reading of 10 millicuries (or equivalent amount of becquerels) by the radiation measurement device can correspond to an actual radioactivity of 20 millicuries (or equivalent amount of becquerels) within the radioembolization delivery set, and 0 millicuries or becquerels within the tubing, or an actual radioactivity of 0 millicuries or becquerels within the radioembolization set and 10 millicuries (or equivalent amount of becquerels) within the tubing. Without normalization, or separately accounting for differences in radiation shielding of the various components of the delivery device, the true amount of radiation within the various components of the radioembolization delivery device (i.e., the radioembolization set, vial assembly, and / or tubing) may not be accurately determined overall. The systems described herein enable accurate and reproducible radiation measurements.

[0051]

[0067] Referring briefly to FIG. 14, a radiation delivery determination system 1000 (also referred to herein as system 1000) for determining the amount of radiation within at least a portion of a delivery device 500 is depicted. System 1000 includes a container 600 and a radiation measurement device 750 outside of container 600. Container 600 can receive a radiation embolization therapy administration set 540 and a tube 10 coupled to the radiation embolization therapy administration set 540, including a vial assembly 580 that can be partially received within the radiation embolization therapy administration set 540. In an embodiment, as described in more detail below, container 600 includes a first compartment 610 defining an internal notch 612 sized and shaped to receive a periphery of the radiation embolization therapy administration set 540, and a second compartment 620 defining a pocket 622 configured to receive tube 10. Tube 10, when received, is in fluid communication with and can be attached to the radiation embolization therapy administration set 540. The radiation embolization therapy administration set 540 can include a vial containing at least a partially administered radioactive therapeutic substance from the vial assembly 580, and tube 10 can include at least a first tube, such as a dose delivery conduit 10A, for administering the radioactive therapeutic substance from the vial of the vial assembly 580. A housing 800 can house container 600 therein. A radiation measurement device 750 outside of and spaced from housing 800 and container 600 is configured to measure the amount of radiation within the radiation embolization therapy administration set 540 and tube 10 coupled to the radiation embolization therapy administration set 540, including a vial assembly 580 that can be partially received within the radiation embolization therapy administration set 540.

[0052]

[0068] Referring now to FIG. 5, a container 600 is depicted. The container 600 includes a rear surface 601 of a rear wall 601', an upper surface 602 of an upper wall 602', a lower surface 603 of a lower wall 603', a first side surface 604 of a first side wall 604', and a second side surface 605 of a second side wall 605'. The container also includes a front wall 606 (see FIG. 8, not depicted in FIG. 5) that is mostly parallel to the rear surface 601 and orthogonal to the upper surface 602, the lower surface 603, the first side surface 604, and the second side surface 605. The container 600 is described and depicted herein as a six-sided structure, but it should be understood that the container 600 may include more or fewer surfaces as long as the container defines a volume configured to receive a radiation embolization therapy administration set 540 that includes a vial assembly 580 that can be partially received therein as described herein, and a tube 10 coupled to the radiation embolization therapy administration set 540.

[0053]

[0069] As described above, the container 600 includes a first compartment 610 and a second compartment 620. The first compartment 610 includes an internal notch 612 sized and shaped to receive a periphery of the radiation embolization therapy administration set 540 as shown in FIG. 6. As used herein, the periphery of the radiation embolization therapy administration set 540 may be defined by a proximal end 544, a distal end 542, a pair of side walls 546, an upper surface 548, a lower surface 541, a handle 552, and any protrusions, contours, or surface features therein. The internal notch 612 of the first compartment 610 is further sized and shaped to receive a periphery of the vial assembly 580 that can be partially received within the radiation embolization therapy administration set 540.

[0054]

[0070] Referring again to FIG. 5, the first compartment 610 can be partially defined by a rear face 601, an upper face 602, a lower face 603, a first side face 604, and a portion of a front face (not depicted). The first compartment 610 can be further defined by one or more internal protrusions 630A, 630B, 630C. The internal protrusions 630A, 630B, 630C can be integral with and extend inwardly from one or more of the rear face 601, upper face 602, lower face 603, first side face 604, second side face 605, and / or front face (not depicted) of the container 600. At least a portion of the internal protrusions 630A, 630B, 630C can, together with the rear face 601, upper face 602, lower face 603, first side face 604, and front face (not depicted), define an internal notch 612. The internal protrusions 630A, 630B, 630C can be at least partially shaped to correspond to at least a portion of the periphery of the radioembolization delivery set 540. By being shaped to receive the periphery of the radioembolization delivery set 540, the internal notch 612 secures the radioembolization delivery set 540 within the first compartment 610, and as a result, movement of the radioembolization delivery set 540 is restricted or eliminated. Further, the internal notch 612 can be sized and shaped such that the radioembolization delivery set 540 can be positioned therein in a single orientation.

[0055]

[0071] The second compartment 620 defines a pocket 622 configured to receive the tubes 10 (i.e., the dose delivery conduit 10A, the contrast agent conduit 10B, and the flushing conduit 10C) coupled to the radioembolization delivery set 540 as shown in FIG. 6. The second compartment 620 can be partially defined by a rear face 601, an upper face 602, a lower face 603, a second side face 605, and a portion of a front face (not depicted). The second compartment 620 can be further defined, for example, by portions of the internal protrusions 630B and 630C. That is, and with particular reference to the internal protrusion 630B, a first surface of the internal protrusion 630B can at least partially define the first compartment 610, and a second surface of the internal protrusion 630B can at least partially define the second compartment 620.

[0056]

[0072] The container 600 may include one or more adjustable walls to enable user access to the first compartment 610 and the second compartment 620. For example, and without limitation, the front wall 606 (see FIG. 8) may be hingedly attached to the first side wall 604' and selectively attached to the second side wall 605' by a fixing mechanism such as a latch, interference fit, snap-fit assembly, and / or other suitable fixing features. In an embodiment, one or more of the adjustable walls may be removable from the container 600. For example, and without limitation, the front wall 606 may be selectively attached to both the first side wall 604' and the second side wall 605' by a fixing mechanism such as a latch, interference fit, snap-fit assembly, and / or other suitable fixing features. The front wall 606 that defines the front face as the measurement opposing face 607 may be selectively attached to the walls 602', 603' that define the upper surface 602 and the lower surface 603, instead of or in addition to the walls 604', 605' that define the first side face 604 and the second side face 605. It should be further understood that the walls that define any of the rear face 601, the upper surface 602, the lower surface 603, the first side face 604, and the second side face 605 may be adjustable, such as through hinge attachment to another surface or wall, instead of or in addition to the front wall 606. Thus, in an embodiment, a user may access the first compartment 610 and the second compartment 620 from the upper, lower, front, rear, or side walls. When the container 600 is "closed", i.e., when one or more of the adjustable walls of the container 600 are attached to one or more other walls of the container 600 along all of their edges, the container 600 may be leak-proof. Thus, any liquid radioactive material within the container 600 may be maintained within the boundaries of the container 600.

[0057]

[0073] In an embodiment, the container 600 can be transparent such that the interior of the container 600 is visible through the walls of the container 600. In an embodiment, the container 600 can be made of polycarbonate, polymethyl methacrylate, polyethylene terephthalate, polyethylene terephthalate glycol, polyvinyl chloride, cyclic olefin copolymer, polyethylene, polypropylene, styrene methyl methacrylate, styrene acrylonitrile resin, polystyrene, and / or methyl methacrylate acrylonitrile butadiene styrene. The container 600 can be disposable. Thus, the container 600 can be discarded once it has been used to determine the radioactivity content of an individual radioembolization therapy administration set 540 (along with the tube 10 coupled thereto and the vial assembly 580 partially received therein). In other words, the container 600 can optionally not be reusable. This enables the user to safely discard the container 600 contaminated with radioactive material. This also further enables the user to select a clean, uncontaminated container 600 for each measurement of the radioactive material within the radioembolization therapy administration set 540 (along with the tube 10 coupled thereto and the vial assembly 580 partially received therein), ensuring that a container 600 that may have been radioactively contaminated does not compromise future radioactive measurements.

[0058]

[0074] Referring now to FIG. 6, there is depicted a container 600 that includes a radioembolization administration set 540 and a tube 10 coupled thereto (i.e., a dosage delivery conduit 10A, a contrast agent conduit 10B, and a flushing conduit 10C). The radioembolization administration set 540 and a vial assembly 580 partially received therein are disposed within an internal notch 612 of a first compartment 610 of the container 600. The tube 10 coupled to the radioembolization administration set 540 is disposed within a pocket 622 of a second compartment 620 of the container 600. As discussed above, the internal notch 612 restricts or removes movement of the radioembolization administration set 540 and receives the radioembolization administration set 540 in a single orientation by a tight fit. Thus, the container 600 enables a reproducible measurement procedure. That is, when the radioembolization administration set 540 and the vial assembly 580 partially received therein are disposed within the internal notch 612, a precise position of the radioembolization administration set 540 and the vial assembly 580 partially received therein relative to a measurement opposing surface 607 of the container 600 (see FIG. 8) and / or a radioactive measurement device can be determined. As used herein, the measurement opposing surface 607 of the container 600 refers to the surface of the container 600 that is closest to and opposite the radioactive measurement device. In other words, the amount of radiation within the container 600 is measured “through” the measurement opposing surface 607. The container 600, and the internal notch 612 of the first compartment 610, thus reduce the shape variability of the radioembolization administration set 540 and the vial assembly 580 partially received therein, as well as the effect of such variability on the readout from the radioactive measurement device.

[0059]

[0075] In some embodiments, the internal protrusions 630A, 630B, 630C within the container 600 may not be integral with one or more of the rear surface 601, upper surface 602, lower surface 603, first side surface 604, second side surface 605, and / or the front surface (not depicted) of the container 600. For example, and referring to FIG. 7, one or more of the internal protrusions 630A, 630B, 630C may be formed within the surface of the liner 650. The liner 650 may include a rear surface 661, upper surface 662, lower surface 663, first side surface 664, and second side surface 665, each configured to be disposed relative to the rear surface 601, upper surface 602, lower surface 603, first side surface 604, and second side surface 605 of the container 600, respectively. The liner 650 may not include a front surface in order to facilitate placement of the radiation embolization therapy delivery set 540, the tube 10 coupled thereto, and the vial assembly 580 at least partially received therein within the liner 650 of the container 600. In an embodiment, the liner 650 may include a front surface and may not include at least one of the rear surface 661, upper surface 662, lower surface 663, first side surface 664, and second side surface 665 in order to facilitate placement of the radiation embolization therapy delivery set 540, the tube 10 coupled thereto, and the vial assembly 580 at least partially received therein within the liner 650 of the container 600.

[0060]

[0076] The liner 650 is similar in function and is similarly configured to the first compartment 610 discussed with respect to FIG. 5 and is disposed within the first compartment 670, and is similar in function and is similarly configured to the second compartment 620 discussed with respect to FIG. 5 and at least partially defines a second compartment 680 disposed within the second compartment 620. The first compartment 670 at least partially defines an internal notch 672 that is similarly configured to the internal notch 612 discussed with respect to FIG. 6. The second compartment 680 at least partially defines a pocket 682 that is similarly configured to the pocket 622 discussed with respect to FIG. 5.

[0061]

[0077] Referring to FIG. 7 in combination with FIG. 5, the insert 650 can be selectively inserted and removed from the container 600. During operation, the user can place the radiation embolization therapy delivery set 540, the tube 10 coupled thereto, and the vial assembly 580 at least partially received therein within the insert 650. The user can then move one or more adjustable walls of the container 600 to access the interior of the container 600 and place the insert 650 therein. The user can then move (such as close) one or more adjustable walls of the container 600 to seal the container 600. As noted, when using the insert 650 including the internal protrusions 630A, 630B, 630C, the container 600 may not include any internal protrusions. The portions of the rear face 601, top face 602, bottom face 603, first side face 604, second side face 605, and front wall 606 of the container 600, together with the insert 650, may partially define a first compartment 670 and an internal notch 672 defined therein, as well as a second compartment 680 and a pocket 682 defined therein. For example, in an embodiment where the insert 650 does not include a front face, when the insert 650 is inserted into the container 600, the inward-facing front face of the front wall 606 of the container 600 may partially define the first compartment 670 and the second compartment 680.

[0062]

[0078] In an embodiment, the container 600 and / or the liner 650 can be shaped to maintain the tube 10 coupled to the radioembolization administration set 540 at a desired position within the pockets 622, 682 of the container 600 and / or the liner 650, respectively. For example, referring to FIG. 8 depicting a top view of the container 600 according to some embodiments, the container 600 can limit the volume of the pocket 622, or in other words, maintain the tube 10 coupled to the radioembolization administration set 540 at a designated position within the pocket 622. For example, the front wall 606 of the container 600 can include a protrusion 690 protruding inwardly from the front wall 606 towards the pocket 622. The protrusion 690 includes a first surface 692 and a second surface 694. The protrusion 690 can be defined by a portion of the front wall 606 of the container 600, the first surface 692 of the protrusion 690, the second surface 694 of the protrusion 690, and a portion of the second side surface 605 of the second side wall 605' of the container 600.

[0063]

[0079] The interior of the protrusion 690 can be solid. That is, the region surrounded by the front wall 606 of the container 600, the first surface 692 of the protrusion 690, the second surface 694 of the protrusion 690, and the second side surface 605 of the container 600 can be a solid material. In an embodiment, the first surface 692 of the protrusion 690, the second surface 694 of the protrusion 690, and the interior of the protrusion 690 can be the same material. In an embodiment, the first surface 692 of the protrusion 690, the second surface 694 of the protrusion 690, and the interior of the protrusion 690 can be formed of different materials. In an embodiment, the first surface 692 of the protrusion 690, the second surface 694 of the protrusion 690, and the interior of the protrusion 690 can be formed of the same material as the front wall 606 of the container 600 or other surfaces.

[0064]

[0080] Alternatively, the interior of the protrusion 690 can be hollow. That is, the region surrounded by the front wall 606 of the container 600, the first surface 692 of the protrusion 690, the second surface 694 of the protrusion 690, and the second side surface 605 of the container 600 can be empty. In an embodiment, the first surface 692 of the protrusion 690 and the second surface 694 of the protrusion 690 can be the same or different materials. In an embodiment, the first surface 692 of the protrusion 690 and the second surface 694 of the protrusion 690 can be formed of the same material as the front wall 606 or other surfaces of the container 600.

[0065]

[0081] In other embodiments, and referring to FIG. 9 depicting a top view of the container 600 of FIG. 5, the container 600 can include a contour 696 to maintain the tube 10 coupled to the radioembolization therapy delivery set 540 in a desired position within the pocket 622 of the container 600. The contour 696 can be formed within the front wall 606 of the container 600. For example, the front wall 606 can include a first portion 606A of the front wall 606, a second portion 606B of the front wall 606, and a third portion 606C of the front wall 606. The first portion 606A of the front wall 606 can at least partially define an internal notch 612. The third portion 606C of the front wall 606 can at least partially define the pocket 622. The second portion 606B of the front wall 606 can join the first portion 606A and the third portion 606C of the front wall 606. The third portion 606C of the front wall 606 can be offset, for example, in the direction of the y-axis of the coordinate axes of FIG. 9 from the first portion 606A of the front wall 606, thereby forming a portion of the contour 696. The contour 696, and more particularly, the third portion 606C of the front wall 606, limits the volume of the pocket 622 and, in other words, maintains the tube 10 coupled to the radioembolization therapy delivery set 540 in a designated position within the pocket 622.

[0066]

[0082] The protrusions 690 and the contours 696 discussed above have been described as being formed within or from the front wall 606 of the container 600, but the protrusions 690 and the contours 696 can similarly be formed within or from other surfaces or walls such as the rear wall 601' of the container 600. Forming the protrusions 690 and / or the contours 696 within the front wall 606 and / or the rear wall 601' can be particularly advantageous when the front wall 606 or the rear wall 601' includes the measurement opposing surface of the container 600. That is, when formed within or from the front wall 606 and / or the rear wall 601', the protrusions 690 and / or the contours 696 can maintain the tube 10 within the pocket 622 at a known distance from the radioactive measurement device in the direction of measurement when the front wall 606 or the rear wall 601' includes the measurement opposing surface.

[0067]

[0083] The protrusions 690 and / or the contours 696 can also be formed within the upper wall 602' (FIG. 5) and / or the lower wall 603' of the container 600. Forming the protrusions 690 and / or the contours 696 within the upper wall 602' (FIG. 5) or the lower wall 603' can be particularly advantageous when the upper wall 602' (FIG. 5) or the lower wall 603' includes the measurement opposing surface of the container 600. That is, when formed within or from the upper wall 602' (FIG. 5) or the lower wall 603', the protrusions 690 and / or the contours 696 can maintain the tube 10 within the pocket 622 at a known distance from the radioactive measurement device in the direction of measurement when the upper wall 602' (FIG. 5) or the lower wall 603' includes the measurement opposing surface. The protrusions 690 and / or the contours 696 can also be formed within the second side wall 605' of the container 600. Forming the protrusions 690 and / or the contours 696 within the second side wall 605' can be particularly advantageous when the second side wall 605' or the first side wall 604' includes the measurement opposing surface of the container 600. That is, when formed within or from the second side wall 605', the protrusions 690 and / or the contours 696 can maintain the tube 10 within the pocket 622 at a known distance from the radioactive measurement device in the direction of measurement when the first side wall 604' or the second side wall 605' includes the measurement opposing surface.

[0068]

[0084] Referring to FIGS. 5 and 7, pockets 622 and 682 are described herein as specifically including tubes that are coupled to the radioembolization therapy delivery set 540, but it should be understood that pockets 622 and 682 may include other objects instead of or in addition to the tubes. For example, after a treatment operation, the user may place gloves within pocket 622 or 682, which may or may not be contaminated with radioactive material. As another example, the user may place a towel that is used to absorb the outflow or leakage of radioactive material within pocket 622 or 682. Generally, after a treatment operation, any article that may contain or be contaminated with radioactive material and has little radioactive shielding properties may be placed within pocket 622 or 682 together with the tubes.

[0069]

[0085] Referring now to FIG. 10, another container 700 is depicted. Container 700 may be similar to container 600 discussed with respect to FIGS. 5 and 6, except as described herein with respect to offset surfaces 706, 707. Container 700 includes an upper surface 702, a lower surface 703, a first side surface 704, and a second side surface 705. The container also includes a first rear surface 706 and a second rear surface 707. The container also includes a front wall 708 (see FIG. 11) that is mostly parallel to the first rear surface 706 and the second rear surface 707 and may be orthogonal to the upper surface 702, the lower surface 703, the first side surface 704, and the second side surface 705.

[0070]

[0086] Container 700 includes a first compartment 710 and a second compartment 720. The first compartment 710 includes an internal notch 712 sized and shaped to receive the periphery of the radioembolization administration set 540. The internal notch 712 of the first compartment 710 is further sized and shaped to receive the periphery of the vial assembly 580 that can be partially received within the radioembolization administration set 540. The first compartment 710 can be partially defined by a first rear surface 706, an upper surface 702, a lower surface 703, a first side surface 704, and a front wall 708 (see FIG. 11). The first compartment 710 can be further defined by one or more internal protrusions 730A, 730B, 730C. The internal protrusions 730A, 730B, 730C, together with the first rear surface 706, the upper surface 702, the lower surface 703, the first side surface 704, and the front wall 708 (see FIG. 11), define the internal notch 712.

[0071]

[0087] The second compartment 720 defines a pocket 722 configured to receive the tubes 10 (i.e., the dose delivery conduit 10A, the contrast agent conduit 10B, and the flushing conduit 10C) coupled to the radioembolization administration set 540. The second compartment 720 and the pocket 722 can be partially defined by a second rear surface 707, an upper surface 702, a lower surface 703, a second side surface 705, and a front wall 708 (see FIG. 12). The second compartment 720 can be further defined by, for example, internal protrusions 730B and 730C. That is, and with particular reference to internal protrusion 730B, the first surface of the internal protrusion 730B can at least partially define the first compartment 710, and the second surface of the internal protrusion 730B can at least partially define the second compartment 720.

[0072]

[0088] Referring now to FIGS. 11 and 12, cross-sectional views of the container 700 around lines 11-11 and 12-12 of FIG. 10 are depicted. Specifically, FIG. 11 depicts a cross-sectional view of the internal notch 712 of the first compartment 710, and FIG. 12 depicts a cross-sectional view of the pocket 722 of the second compartment 720. The container 700 includes a measurement facing surface 607'. For example, the front wall 708 defines the measurement facing surface 607' of the container 700. Thus, the measurement facing surface 607' of the front wall 708 of the container 700 is closest to and opposite the radioactive measurement device 750, and the first rear surface 706 and the second rear surface 707 are disposed on the opposite side of the measurement facing surface 607'. The radioactive measurement device 750 is outside the container 700 and is configured to measure the amount of radiation in the radiation embolization therapy administration set 540, the vial assembly 580 that can be positioned therein, and the tube 10 coupled to the radiation embolization therapy administration set 540. In the front wall 708, and in the depicted embodiment, the measurement facing surface 607' is at a distance D3 from the radioactive measurement device 750. The first rear surface 706 that defines the internal notch 712 of the first compartment 710 is disposed on the opposite side of the measurement facing surface 607' of the container 700 and is spaced apart from the measurement facing surface 607' of the container 700 by a first distance D1. The second rear surface 707 that defines the pocket 722 of the second compartment 720 is disposed on the opposite side of the measurement facing surface 607' of the container 700 and is spaced apart from the measurement facing surface 607' of the container 700 by a second distance D2, and the second distance D2 is greater than the first distance D1. For example, the first rear surface 706 is at a distance D1 from the front wall 708. The second rear surface 707 is at a distance D2 from the front wall 708, which is greater than D1. In an embodiment, as depicted, the second rear surface 707 is the absolute rear surface of the container 700. In other embodiments, the second rear surface 707 can be offset by a distance from the absolute rear surface of the container 700. In such an embodiment, the first rear surface 706 is at a distance D1 from the front wall 708, the second rear surface 707 is at a distance D2 from the front wall 708, which is greater than D1, and the absolute rear surface of the container 700 is at a distance greater than D2 from the front wall 708.

[0073]

[0089] The fact that the first rear face 706 is closer to the front wall 708, and thus to the radioactive measurement device 750, than the second rear face 707 effectively positions the radioembolization therapy delivery set 540 closer to the radioactive measurement device 750 than the tube 10 coupled to the radioembolization therapy delivery set 540, including the vial assembly 580 that can be partially received therein. Notably, and as discussed above, the radioembolization therapy delivery set 540 and / or the vial assembly 580 that is partially received therein can include materials specifically selected to shield the user from the radioactive material therein. The tube 10 coupled to the radioembolization therapy delivery set 540 can exhibit a reduced amount of shielding when compared to the radioembolization therapy delivery set 540 and / or the vial assembly 580. Thus, components that exhibit increased absorption or shielding are positioned within the internal notch 712 and maintained at a distance closer to the radioactive measurement device 750 than components that exhibit a lesser amount of absorption (i.e., the tube 10) positioned within the pocket 722.

[0074]

[0090] As discussed above, the intensity of the radiation being measured, or the amount of radiation to which the radiation measurement device 750 is exposed, increases as the distance between the radiation source and the radiation measurement device 750 decreases. Thus, the reduction in the radiation emission intensity caused by the shielding properties of the materials of the radioembolization administration set 540 and / or the vial assembly 580, and the combination of the distance between the radioembolization administration set 540 and the vial assembly 580 that can be partially received therein and the radiation measurement device 750 may be equal to the reduction in the radiation emission intensity due to the shielding properties of the material of the tube 10, and the combination of the distance between the tube 10 and the radiation measurement device 750. In other words, the radiation emission intensity of all radioactive substances within the container 700 can be reduced to the same extent, regardless of whether they are included in the radioembolization administration set 540, the vial assembly 580, or the tube 10. That is, the difference in the emission intensity reduction caused by the material properties of the radioembolization administration set 540 and / or the vial assembly 580 and the tube 10 can be offset by the difference in the emission intensity reduction caused by the distance between the radioembolization administration set 540 and / or the vial assembly 580 and the radiation measurement device 750 and the distance between the tube 10 and the radiation measurement device 750.

[0075]

[0091] In an embodiment including an insert 650 that can be inserted into a container, such as the insert 650 of FIG. 7, it should be understood that the rear surface 661 of the insert 650 may include a first rear surface that partially defines a first compartment 670 and a second rear surface that partially defines a second compartment 680. The first rear surface of the insert 650 may be at a first distance from the measurement-facing surface of the container into which the insert 650 is inserted, and the second rear surface of the insert 650 may be at a second distance greater than the first distance from the measurement-facing surface of the container into which the insert 650 is inserted. In an embodiment, the measurement-facing surface of the container may be a part of the front wall, and as a result, the first rear surface of the insert 650 and the second rear surface of the insert 650 are disposed on the wall opposite to the wall of the measurement-facing surface of the container.

[0076]

[0092] Referring now to FIG. 13, there is depicted a housing 800 configured to receive either of the containers 600, 700 as described herein. The housing 800 may include a rear wall 801, an upper wall 802, a lower wall 803, a first side wall 804, a second side wall 805, and a front wall 806. Although the housing 800 is described and depicted herein as having a six-sided structure, it should be understood that the housing 800 may include more or fewer surfaces or walls so long as the housing defines a volume capable of receiving a container according to any of the above embodiments.

[0077]

[0093] The housing 800 may include one or more adjustable walls configured to open and close to allow user access to the interior of the housing 800. For example, and without limitation, the upper wall 802 may be hinged to the first side wall 804 and selectively secured to the second side wall 805 using a latch, interference fit, snap-fit assembly, and / or the like. In an embodiment, one or the adjustable walls may be removable from the housing 800. For example, and without limitation, the upper wall 802 may be selectively secured to both the first side wall 804' and the second side wall 805' using a securing mechanism such as a latch, interference fit, snap-fit assembly, and / or the like. The upper wall 802 may be selectively secured to the front wall 806 and the rear wall 801 instead of or in addition to the first side wall 804 and the second side wall 805. It should be further understood that any of the rear wall 801, the lower wall 803, the first side wall 804, the second side wall 805, and the front wall 806 may be adjustable, such as through hinge attachment to another surface or wall, instead of or in addition to the upper wall 802. Thus, in an embodiment, a user may access or close off the interior of the housing 800 from the top, bottom, front, rear, or side walls. More particularly, the user may place a container (e.g., container 600 depicted in FIG. 6) including a vial assembly 580 in which a radiation embolization therapy delivery set 540 may be partially received therein, and a tube 10 coupled to the radiation embolization therapy delivery set 540, within the housing 800.

[0078]

[0094] The housing 800 can be transparent so that the interior of the housing 800 can be seen through the walls of the housing 800. In an embodiment, the containers 600, 700 can be transparent. The housing 800 can be made of acrylic. The housing 800 can also be made of polycarbonate, polyethylene terephthalate, polyethylene terephthalate glycol, polyvinyl chloride, cyclic olefin copolymer, polyethylene, polypropylene, styrene methyl methacrylate, styrene acrylonitrile resin, polystyrene, and / or methyl methacrylate acrylonitrile butadiene styrene.

[0079]

[0095] The housing 800 can include a radiation shield 810 that extends partially along the housing 800. The radiation shield 810 is formed of a material configured to suppress radioactive emissions from radioactive substances within the housing 800 and, more particularly, within a container (e.g., container 600 of FIG. 6) contained therein. The radiation shield 810 can be a metal. The radiation shield 810 can include any of stainless steel, lead, tin, copper, pewter, and aluminum. The radiation shield 810 can extend along any of the rear wall 801, upper wall 802, lower wall 803, first side wall 804, second side wall 805, and front wall 806. Generally, the radiation shield 810 extends along the measurement facing surface of the housing 800. The measurement facing surface of the housing 800 is the surface of the housing 800 that is closest to and faces the radioactive measurement device. Thus, it can be said that the measurement of radiation within the housing 800 is performed “through” the measurement facing surface of the housing 800. In an embodiment, the radiation shield 810 can be integral with the housing 800 such that, as a result, the radiation shield 810 forms a part of the surface of the housing 800 along which the radiation shield 810 extends. In an embodiment, the radiation shield 810 can be fixed to the surface of the housing 800 along which the radiation shield 810 extends by any suitable adhesive or fixing means.

[0080]

[0096] Referring to FIGS. 5, 6, 13, and 14, the radiation shield 810 extends along the housing 800 such that the second compartment 620 of the container 600 is covered by the radiation shield 810 of the housing 800 and the first compartment 610 of the container 600 is not covered by the radiation shield 810 of the housing 800. Thus, the radiation shield 810 can be positioned such that radiation from the second compartment 620 to the radioactive measurement device passes through the radiation shield 810 of the housing 800 and radiation from the first compartment 610 of the container 600 to the radioactive measurement device does not pass through the radiation shield 810 of the housing 800. Therefore, as particularly depicted in FIGS. 13 and 14, the radioembolization administration set 540, including the vial assembly 580 that can be partially received therein, is not covered by the radiation shield 810, and the tube 10 coupled to the radioembolization administration set 540 is covered by the radiation shield 810. Notably, as discussed above, the radioembolization administration set 540 and / or the vial assembly 580 partially received therein can include materials specifically selected to shield the user from the radioactive substances therein. The tube 10 coupled to the radioembolization administration set 540 can exhibit a reduced amount of shielding when compared to the radioembolization administration set 540 and / or the vial assembly 580. Thus, components presenting increased absorption or shielding are not covered by the radiation shield 810, and components presenting a lesser amount of absorption are covered by the radiation shield 810. In particular, the radiation shield 810 can be selected such that the radiation emission intensity of all radioactive substances within the container 600 is shielded to the same extent regardless of whether it is included in the radioembolization administration set 540, the vial assembly 580, or the tube 10. That is, the difference in the reduction of radiation emission intensity caused by the material properties of the radioembolization administration set 540 and / or the vial assembly 580 and the material properties of the tube 10 can be offset by the radiation shield 810 covering the tube 10.In other words, the radiation emitted from the second compartment 620 to the radiation measurement device 750 must pass through the radiation shield 810 of the housing 800, while the radiation emitted from the first compartment 610 to the radiation measurement device 750 does not pass through the radiation shield 810 of the housing 800.

[0081]

[0097] Referring now to FIGS. 5, 6, 14, and 15, a method 900 for measuring the amount of radiation in a radiation embolization therapy delivery set 540 and in a tube 10 in fluid communication with the radiation embolization therapy delivery set 540 is described. In block 902 of method 900, the user removes a radiation embolization therapy delivery set 540, which may include a vial assembly 580 partially received therein, and a tube 10 coupled to the radiation embolization therapy delivery set 540 from a delivery device 500 (see FIG. 1). In particular, the radiation embolization therapy delivery set 540, which may include a vial assembly 580 partially received therein, and the tube 10 coupled to the radiation embolization therapy delivery set 540 are removed from the delivery device 500 after a treatment operation or after administration of at least a portion of an initial radiation dose pre-loaded into the vial assembly 580.

[0082]

[0098] In block 904 of method 900, the user places a radiation embolization therapy delivery set 540, which may include a vial assembly 580 partially received therein, and a tube 10 coupled to the radiation embolization therapy delivery set 540 within a container 600 (or other container described herein). More specifically, the radiation embolization therapy delivery set 540, which may include a vial assembly 580 partially received therein, is placed within an internal notch 612 of the first compartment 610, and the tube 10 coupled to the radiation embolization therapy delivery set 540 is placed within a pocket 622 of the second compartment 620. As discussed above, the internal notch 612 is sized and shaped to receive the periphery of the radiation embolization therapy delivery set 540 and the vial assembly 580 that may be partially received therein such that the radiation embolization therapy delivery set 540 and the vial assembly 580 that may be partially received therein can be reproducibly placed within the container 600.

[0083]

[0099] It should be understood that the radioembolization therapy administration set 540, which may include a vial assembly 580 that is partially received therein, and the tube 10 coupled to the radioembolization therapy administration set 540, can be placed within any of the containers described above. That is, in an embodiment, the container 600 may optionally include a protrusion 690 (see FIG. 8) or a contour 696 (see FIG. 9). Further still, in an embodiment, the radioembolization therapy administration set 540, which may include a vial assembly 580 that is partially received therein, and the tube 10 coupled to the radioembolization therapy administration set 540, can be placed within a container 700 (see FIGS. 10 - 12). In an embodiment, the user may first place the radioembolization therapy administration set 540, which may include a vial assembly 580 that is partially received therein, and the tube 10 coupled to the radioembolization therapy administration set 540, within the liner 650 (see FIG. 7), and then place the liner 650 within the container 600.

[0084]

[0100] In block 906 of method 900, the user may place the container 600 within the housing 800. As discussed above, the housing 800 may include a radiation shield 810 that extends partially along the housing 800 such that a second compartment 620 of the container 600 is covered by the radiation shield 810 and a first compartment 610 of the container 600 is not covered by the radiation shield 810.

[0085]

[0101] In block 908 of method 900, a user may measure, with a radiation measurement device 750, a radiation embolization therapy administration set 540 that may include a vial assembly 580 partially received therein, and the amount of radiation in a tube 10 coupled to the radiation embolization therapy administration set 540. The radiation measurement device 750 may be any device suitable for detecting and measuring radiation. The radiation measurement device 750 may be a Geiger counter, ionization chamber, proportional counter tube, gas-filled detector, scintillation counter, semiconductor detector, or other suitable device. The radiation measurement device 750 may be disposed outside or spaced apart from the container 600 and the housing 800. The radiation measurement device 750 is configured to measure, through the measurement facing surface of the container 600 and the housing 800, with the radiation measurement device 750, a radiation embolization therapy administration set 540 that may include a vial assembly 580 partially received therein, and the amount of radiation in a tube 10 coupled to the radiation embolization therapy administration set 540. The radiation measurement device 750 is particularly configured to determine a single measurement value of the total amount of radiation in a radiation embolization therapy administration set 540 that may include a vial assembly 580 partially received therein, and in a tube 10 coupled to the radiation embolization therapy administration set 540. The unit of the amount of radiation in a radiation embolization therapy administration set 540 that may include a vial assembly 580 partially received therein, and in a tube 10 coupled to the radiation embolization therapy administration set 540, measured by the radiation measurement device 750, may be curie, becquerel, counts per minute, rems per hour, sieverts per hour, etc., depending on the particular radiation measurement device 750 used.

[0086]

[0102] As described above, differences in the material properties of the radioembolization administration set 540 and / or the vial assembly 580 contained therein, as well as the material properties of the tube 10, can result in different degrees of shielding or attenuation of the radiation within the radioembolization administration set 540, and / or the vial assembly 580 contained therein, and the tube 10. Thus, in conventional systems and methods, the measurement of the total radiation within the radioembolization administration set 540, and the vial assembly 580 that may be contained therein, and the tube 10 can be inaccurate. Furthermore, as described above, in conventional systems and methods, the measurement of the total radiation within the radioembolization administration set 540, and the vial assembly 580 that may be contained therein, and the tube 10 can be inaccurate due to the variable placement of components within the measuring device and the different distances between the various components and the radioactive measurement device 750.

[0087]

[0103] The system 1000 and method 900 described herein solve the above problems and enable accurate measurement of the total amount of radiation in tube 10 coupled to radiation embolization therapy delivery set 540, which may include vial assembly 580 contained therein. In particular, the container (e.g., container 600) may enable precise and reproducible placement of radiation embolization therapy delivery set 540, which may include vial assembly 580 contained therein, and tube 10 coupled to radiation embolization therapy delivery set 540. Further, differences in the reduction of radiation emission intensity caused by the material properties of radiation embolization therapy delivery set 540 and / or vial assembly 580 contained therein and the material properties of tube 10 may be offset by the positioning of radiation shield 810 of tube 10 and / or housing 800. That is, in order to reduce the radiation emission intensity of the radiation in tube 10 to the same extent as the radiation in radiation embolization therapy delivery set 540, which may include vial assembly 580 partially received therein, tube 10 may be positioned within a container (e.g., container 600) at a known distance farther from radiation measurement device 750 than radiation embolization therapy delivery set 540, and / or radiation shield 810 may be positioned between tube 10 and radiation measurement device 750.

[0088]

[0104] That is, in some embodiments, the greater distance between tube 10 and radiation measurement device 750, and the shielding of tube 10 provided by radiation shield 810, when combined, may reduce the emission intensity of the radiation in tube 10 to the same extent as the radiation in radiation embolization therapy delivery set 540, which may include vial assembly 580 partially received therein.

[0089]

[0105] In other embodiments, compared to the radioembolization administration set 540 and the vial assembly 580 that can be positioned therein, a greater distance between the tube 10 and the radioactive measurement device 750, and the radioactive measurement device 750 alone may be sufficient to reduce the emission intensity of the radiation in the tube 10 to the same extent as the radiation in the radioembolization administration set 540 and the vial assembly 580 that can be partially received therein. In such embodiments, for example, the radioembolization administration set 540 including the vial assembly 580 that can be partially received therein, and the tube 10 can be placed within a container 700 (see FIGS. 10-12) and not placed within the housing 800 prior to measurement by the radioactive measurement device 750. Alternatively, in such embodiments, the radioembolization administration set 540 including the vial assembly 580 that can be partially received therein, and the tube 10 can be placed within a container 700 (see FIGS. 10-12) that can be placed within the housing 800 prior to measurement by the radioactive measurement device 750. However, in such cases, the housing 800 need not include a radiation shield 810 to further attenuate the radiation in the tube 10.

[0090]

[0106] In other embodiments, the shielding of the tube 10 provided by the radiation shield 810 alone may be sufficient to reduce the emission intensity of the radiation in the tube 10 to the same extent as the radiation in the radioembolization administration set 540 and the vial assembly 580 that can be partially received therein. In such embodiments, for example, the radioembolization administration set 540 including the vial assembly 580 that can be partially received therein, and the container (e.g., container 600) in which the tube 10 can be placed can maintain the radioembolization administration set 540 including the vial assembly 580 that can be partially received therein, and the tube 10 at approximately the same distance from the measurement facing surface of the container 600. The container 600 can then be placed within the housing 800 such that the radiation shield 810 extends partially along the housing 800 such that a second section 620 of the container 600 is covered by the radiation shield 810 and a first section 610 of the container 600 is not covered by the radiation shield 810.

[0091]

[0107] Since the systems 1000 and methods 900 within this specification enable an equal reduction in the emission intensity of radiation within the tube 10, as well as within the radiation embolization therapy delivery set 540 and the vial assembly 580 that can be partially received therein, a single correction factor can be applied to the raw measurements by the radiation measurement device 750 to obtain the amount of radiation within the tube 10, the radiation embolization therapy delivery set 540, and the vial assembly 580. After the treatment procedure, by determining the amount of radiation remaining within the radiation embolization therapy delivery set 540 that includes the vial assembly 580 that can be received therein, and within the tube 10 coupled to the radiation embolization therapy delivery set 540, the user can determine the percentage of the radiation dose pre-filled within the vial body 589 that was actually delivered to the patient. If less than 80% of the pre-filled dose was delivered to the patient, it can be determined that an error or misadministration event occurred during the treatment procedure.

[0092]

[0108] An embodiment is depicted in which measurement of the amount of radiation within the radioembolization therapy delivery set 540 and / or the vial assembly 580 partially received therein is performed “through” the sidewall 546 of the radioembolization therapy delivery set 540. That is, the measurement-facing surface of the radioembolization therapy delivery set 540, or the surface of the radioembolization therapy delivery set 540 closest to and facing the radioactive measurement device 750, is depicted herein as the sidewall 546. However, it should be understood that this is a non-limiting example. That is, the particular shape of the internal notch in either of the containers and / or liners described above (see, e.g., the internal notch 612 of the container 600 in FIG. 6), and / or the orientation of either of the containers described above (see, e.g., the container 600 in FIG. 6) when placed or otherwise positioned within the housing 800 for measurement from the radioactive measurement device 750, may be such that the measurement-facing surface of the radioembolization therapy delivery set 540 is the upper surface 548 of the radioembolization therapy delivery set 540. In such an embodiment, the effect of the material properties of the radioembolization therapy delivery set 540 on shielding of radiation within the vial assembly 580 can be reduced by measuring the amount of radiation within the vial assembly 580 through the opening of the vial chamber 558. III. LIST OF ASPECTS

[0109] Embodiments may be described with reference to the following numerical clauses.

[0093]

[0110] Aspect 1. A radiation delivery determination system comprising a container defining a first compartment defining an internal notch sized and shaped to receive a periphery of a radioembolization therapy delivery set, and a second compartment defining a pocket configured to receive a tube, the tube being in fluid communication with and adhered to the radioembolization therapy delivery set, and a radioactive measurement device located outside the container and configured to measure the amount of radiation within the radioembolization therapy delivery set and the tube.

[0094]

[0111] Aspect 2. A radiation delivery determination system according to Aspect 1, wherein the container receives the periphery of the radiation embolization therapy device, and the tube is disposed in a pocket of the second compartment of the container.

[0095]

[0112] Aspect 3. A radiation delivery determination system according to Aspect 1 or Aspect 2, wherein the radiation embolization therapy administration set is disposed in an internal notch of the first compartment of the container.

[0096]

[0113] Aspect 4. A radiation delivery determination system according to Aspect 1 to Aspect 3, wherein the container further includes a measurement facing surface, the first rear surface defining the internal notch of the first compartment is disposed on the opposite side of the measurement facing surface of the container, and is spaced from the measurement facing surface of the container by a first distance, the second rear surface defining the pocket of the second compartment is disposed on the opposite side of the measurement facing surface of the container, and is spaced from the measurement facing surface of the container by a second distance, and the second distance is greater than the first distance.

[0097]

[0114] Aspect 5. A radiation delivery determination system according to Aspect 1 to Aspect 4, wherein the measurement facing surface of the container is closest to and faces the radioactive measurement device.

[0098]

[0115] Aspect 6. A radiation delivery determination system according to Aspect 1 to Aspect 5, further including a housing, the housing being configured to house the container.

[0116] Aspect 7. A radiation delivery determination system according to Aspect 1 to Aspect 6, wherein the housing further includes a radiation shield that extends partially along the housing.

[0099]

[0117] Aspect 8. A radiation delivery determination system according to Aspect 1 to Aspect 7, wherein the radiation shield is positioned such that radiation from the second compartment to the radioactive measurement device passes through the radiation shield of the housing, and radiation from the first compartment to the radioactive measurement device does not pass through the radiation shield of the housing.

[0100]

[0118] Aspect 9. A radiation delivery determination system according to Aspect 1 to Aspect 8, wherein the housing is transparent such that the inside of the housing is visible through the wall of the housing, and the container is transparent such that the inside of the container is visible through the wall of the container.

[0101]

[0119] Aspect 10. A radiation delivery determination system according to Aspect 1 to Aspect 9, wherein the radioactive measurement device is a Geiger counter.

[0120] Aspect 11. A radiation delivery determination system comprising: a first compartment defining an internal notch sized and shaped to receive the periphery of a radioembolization therapy administration set, the radioembolization therapy administration set including a vial at least partially administered with a radioactive therapeutic substance; the first compartment; and a second compartment defining a pocket configured to receive a tube, the tube being in fluid communication with and attached to the radioembolization therapy administration set, the tube being disposed within the pocket of the second compartment of the container, the tube comprising at least a first tube for administering the radioactive therapeutic substance from the vial; a container; and a Geiger counter disposed outside the container and configured to measure the total amount of radiation in the radioembolization therapy administration set and the tube.

[0102]

[0121] Aspect 12. A radiation delivery determination system according to Aspect 11, wherein the container further comprises a measurement facing surface, the measurement facing surface of the container being closest to and facing the Geiger counter, a first rear surface defining the internal notch of the first compartment being disposed on the opposite side of the measurement facing surface of the container and spaced apart from the measurement facing surface of the container by a first distance, a second rear surface defining the pocket of the second compartment being disposed on the opposite side of the measurement facing surface of the container and spaced apart from the measurement facing surface of the container by a second distance, the second distance being greater than the first distance.

[0103]

[0122] Aspect 13. A radiation delivery determination system according to Aspect 11 or Aspect 12, wherein the container is transparent such that the inside of the container is visible through the wall of the container.

[0123] Aspect 14. A radiation delivery determination system according to Aspect 11 to Aspect 13, further comprising a housing configured to accommodate a container, the housing further comprising a radiation shield that extends partially along the housing, the radiation shield being positioned such that radiation from the second compartment to the Geiger counter passes through the radiation shield of the housing, and radiation from the first compartment to the Geiger counter does not pass through the radiation shield of the housing.

[0104]

[0124] Aspect 15. A radiation delivery determination system according to Aspect 11 to Aspect 14, wherein the housing is transparent such that the interior of the housing is visible through the wall of the housing.

[0125] Aspect 16. A method for measuring the amount of radiation in a radiation embolization therapy administration set and in a tube in fluid communication with the radiation embolization therapy administration set, the method comprising placing the radiation embolization therapy administration set and the tube in a container, the container being a first compartment defining an internal notch sized and shaped to receive the periphery of the radiation embolization therapy administration set, the radiation embolization therapy administration set being placed within the internal notch of the first compartment, the first compartment and a second compartment defining a pocket configured to receive the tube, the tube being placed within the pocket of the second compartment, and measuring the amount of radiation in the radiation embolization therapy administration set and the tube with a radiation measurement device disposed outside and spaced from the container.

[0105]

[0126] Aspect 17. The method according to Aspect 16, wherein the container further comprises a measurement facing surface, the measurement facing surface of the container being closest to and facing the radiation measurement device, a first rear surface defining the internal notch of the first compartment being disposed on the opposite side of the measurement facing surface of the container and spaced from the measurement facing surface of the container by a first distance, a second rear surface defining the pocket of the second compartment being disposed on the opposite side of the measurement facing surface of the container and spaced from the measurement facing surface of the container by a second distance, the second distance being greater than the first distance.

[0106]

[0127] Aspect 18. The method of Aspect 16 or Aspect 17, further comprising the step of placing the container within the housing, the housing comprising a radiation shield that extends partially along the housing, the radiation shield being positioned such that radiation from the second compartment to the radiation measurement device passes through the radiation shield of the housing, and radiation from the first compartment of the container to the radiation measurement device does not pass through the radiation shield of the housing.

[0107]

[0128] Aspect 19. The method of Aspects 16 - 18, wherein the radiation shield comprises at least one of stainless steel, aluminum, or pewter, and the housing comprises an acrylic resin material.

[0108]

[0129] Aspect 20. The method of Aspects 16 - 19, wherein the radiation measurement device is a Geiger counter.

[0130] It should be understood here that embodiments of the present disclosure are directed to a radioembolization therapy administration set including a vial assembly that can be received therein, and a radiation delivery determination system for determining the amount of radiation in a tube coupled to the radioembolization therapy administration set. The radiation delivery determination system includes a container. The container includes a first compartment defining an internal notch sized and shaped to receive a periphery of the radioembolization therapy administration set, and a second compartment defining a pocket configured to receive a tube. In an embodiment, to normalize a reduction in the radiation emission intensity of the radiation included in the radioembolization therapy administration set and / or the vial assembly and the tube, a first rear surface of the first compartment disposed on an opposite side of the measurement opposing surface of the container is spaced from the measurement opposing surface of the container by a first distance, and a second rear surface of the second compartment disposed on an opposite side of the measurement opposing surface of the container is spaced from the measurement opposing surface of the container by a second distance, and the second distance is greater than the first distance. The measurement opposing surface of the container is closest to and opposite the radioactive measurement device. In an embodiment, to normalize a reduction in the radiation emission intensity of the radiation included in the radioembolization therapy administration set and / or the vial assembly and the tube, the container is placed in a housing that includes a radiation shield that partially extends along the housing and covers the second compartment of the container but does not cover the first compartment of the container.

[0109]

[0131] Note that the terms "substantially" and "about" may be used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. These terms are also used herein to represent the degree to which a quantitative expression may vary from the stated reference without resulting in a change in the basic function of the subject matter in question.

[0110]

[0132] For purposes of explaining and defining the present disclosure, it should be noted that the term "substantially" is used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. The term "substantially" is also used herein to represent the degree to which a quantitative expression may vary from the stated reference without resulting in a change in the basic function of the subject matter in question. As such, it is used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation with respect to the arrangement of elements or features that, while expected to present a theoretically exact match or behavior, may in fact embody something that is slightly less than exactly so in practice.

[0111]

[0133] Although specific embodiments are 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. Furthermore, although various aspects of the claimed subject matter are described herein, such aspects need not be utilized in combination. Accordingly, the appended claims are intended to cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

1. A radiation delivery determination system, comprising: A container, wherein the container defines: A first compartment defining an internal notch sized and shaped to receive a periphery of a radioembolization therapy administration set; and A second compartment defining a pocket configured to receive a tube, the tube being in fluid communication with the radioembolization therapy administration set and attached to the radioembolization therapy administration set, the container; A radioactive measurement device disposed outside the container and configured to measure an amount of radiation in the radioembolization therapy administration set and the tube.

2. The radiation delivery determination system according to claim 1, wherein: The container receives the periphery of the radioembolization therapy device, and the tube is disposed within the pocket of the second compartment of the container.

3. The radiation delivery determination system according to claim 1, wherein: The radioembolization therapy administration set is disposed within the internal notch of the first compartment of the container.

4. The radiation delivery determination system according to claim 1, wherein: The container further comprises a measurement facing surface; A first rear surface defining the internal notch of the first compartment is disposed on the opposite side of the measurement facing surface of the container and is spaced apart from the measurement facing surface of the container by a first distance; A second rear surface defining the pocket of the second compartment is disposed on the opposite side of the measurement facing surface of the container and is spaced apart from the measurement facing surface of the container by a second distance, the second distance being greater than the first distance.

5. The radiation delivery determination system according to claim 4, wherein: The measurement facing surface of the container is closest to and faces the radioactive measurement device.

6. The radiation delivery determination system according to claim 1, further comprising: A housing configured to house the container.

7. The radiation delivery determination system according to claim 6, wherein: The housing further comprises a radiation shield extending partially along the housing.

8. The radiation delivery determination system according to claim 7, wherein the radiation shield: ​ Radiation from the second compartment to the radiation measurement device passes through the radiation shield of the housing, A radiation delivery determination system positioned such that radiation from the first compartment to the radiation measurement device does not pass through the radiation shield of the housing. **Claim 9** The radiation delivery determination system according to claim 6, The housing is transparent such that the interior of the housing is visible through the wall of the housing, and the container is transparent such that the interior of the container is visible through the wall of the container. A radiation delivery determination system. **Claim 10** The radiation delivery determination system according to claim 1, The radiation measurement device is a Geiger counter. A radiation delivery determination system. **Claim 11** A radiation delivery determination system, A container, where the container Defines a first compartment that defines an internal notch sized and shaped to receive the periphery of a radioembolization therapy administration set, The radioembolization therapy administration set includes a first compartment that includes a vial at least partially administered with a radioactive therapeutic substance, A second compartment that defines a pocket configured to receive a tube, and The tube is in fluid communication with the radioembolization therapy administration set and is attached to the radioembolization therapy administration set, The tube is disposed within the pocket of the second compartment of the container, The tube includes at least a first tube for administering a radioactive therapeutic substance from the vial. A container, A Geiger counter, which is outside the container and configured to measure the total amount of radiation in the radioembolization therapy administration set and the tube. A radiation delivery determination system. **Claim 12** The radiation delivery determination system according to claim 11, The container further includes a measurement facing surface, the measurement facing surface of the container is closest to and faces the Geiger counter, The first rear surface that defines the internal notch of the first compartment is disposed on the opposite side of the measurement facing surface of the container and is spaced apart from the measurement facing surface of the container by a first distance, The second rear surface that defines the pocket of the second compartment is disposed on the opposite side of the measurement facing surface of the container and is spaced apart from the measurement facing surface of the container by a second distance, and the second distance is greater than the first distance. A radiation delivery determination system. **Claim 13** The radiation delivery determination system according to claim 11, wherein the container is transparent such that the interior of the container is visible through the wall of the container, the radiation delivery determination system. **Claim 14** The radiation delivery determination system according to claim 11, wherein it further comprises a housing, the housing is configured to house the container, the housing further comprises a radiation shield that extends partially along the housing, and the radiation shield radiation from the second compartment to the Geiger counter passes through the radiation shield of the housing, is positioned such that radiation from the first compartment to the Geiger counter does not pass through the radiation shield of the housing, the radiation delivery determination system. **Claim 15** The radiation delivery determination system according to claim 14, wherein the housing is transparent such that the interior of the housing is visible through the wall of the housing, the radiation delivery determination system. **Claim 16** A method for measuring the amount of radiation in a radioembolization therapy administration set and in a tube in fluid communication with the radioembolization therapy administration set, the method comprising: placing the radioembolization therapy administration set and the tube within a container, the container comprising a first compartment defining an internal notch sized and shaped to receive the periphery of the radioembolization therapy administration set, the radioembolization therapy administration set being placed within the internal notch of the first compartment, the first compartment, and a second compartment defining a pocket configured to receive the tube, the tube being placed within the pocket of the second compartment, the step of: measuring the amount of radiation in the radioembolization therapy administration set and the tube with a radiation measurement device disposed outside and spaced from the container. **Claim 17** The method according to claim 16, wherein the container further comprises a measurement facing surface, the measurement facing surface of the container being closest to or facing the radiation measurement device, a first rear surface defining the internal notch of the first compartment is disposed on the opposite side of the measurement facing surface of the container and is spaced from the measurement facing surface of the container by a first distance. The second rear surface defining the pocket of the second compartment is disposed on the opposite side of the measurement facing surface of the container, is separated from the measurement facing surface of the container by a second distance, and the second distance is greater than the first distance, method. **Claim 18** The method according to claim 16, further comprising the step of placing the container in a housing, the housing comprising a radiation shield that extends partially along the housing, the radiation shield being positioned such that radiation from the second compartment to the radioactive measurement device passes through the radiation shield of the housing, and radiation from the first compartment of the container to the radioactive measurement device does not pass through the radiation shield of the housing. **Claim 19** The method according to claim 18, wherein the radiation shield includes at least one of stainless steel, aluminum, or pewter, and the housing includes an acrylic resin material. **Claim 20** The method according to claim 16, wherein the radioactive measurement device is a Geiger counter.

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