Radiation delivery determination system and method

Abstract

A radiation delivery determination system includes a container including a first compartment defining an internal cutout sized and shaped to receive an outer periphery of a radioembolic administration device and a second compartment defining a pocket configured to receive a conduit, where the conduit is configured to receive the radioembolic administration device. The conduit is in fluid communication with and attached to the radioembolic applicator. The radiation delivery determination system also includes a radioactivity measurement device external to the container and configured to measure an amount of radiation within the radioembolic applicator and the conduit.

Description

Technical Field

[0001] The present disclosure relates generally to components of medical devices used to treat 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] In treatments involving radiation therapy, such as cancer treatment, incorrect administration of a dose of radiation may compromise the effectiveness of the treatment procedure. Therefore, in order to ensure that a predetermined amount of radiation has been administered to a patient, the amount of radiation still remaining in a medical treatment device may be measured after a treatment procedure. However, due to the specific geometry of the various components of a medical treatment device and the different materials used for the different components of the medical treatment device, it may be difficult to accurately and reproducibly obtain a measurement of the amount of radiation remaining in a medical treatment device after a treatment procedure.

[0003] Therefore, there is a need for a system and method for repeatably and accurately determining the amount of radiation within at least a portion of a medical treatment device. Summary of the invention

[0004] According to an embodiment of the present disclosure, a radiation delivery determination system may include a container. The container includes: a first compartment, the first compartment defining an internal incision, the size and shape of the internal incision being configured to receive the periphery of a radioembolic administration device; a second compartment, the second compartment defining a bag-like member, the bag-like member being configured to receive a tube, wherein the tube is in fluid communication with the radioembolic administration device and is attached to the radioembolic administration device. The radiation delivery determination system also includes a radioactivity measurement device located outside the container, the radioactivity measurement device being configured to measure the amount of radiation within the radioembolic administration device and the tube.

[0005] In another embodiment, a radiation delivery determination system may include a container comprising: a first compartment defining an internal cutout sized and shaped to receive the periphery of a radioembolic administration device, wherein the radioembolic administration device includes a vial of at least a portion of the administration of a radiotherapeutic substance; and a second compartment defining a bag configured to receive a conduit, wherein the conduit is in fluid communication with and attached to the radioembolic administration device. The conduit is disposed within the bag in the second compartment of the container, and the conduit includes at least a first tube for administering the radiotherapeutic substance from the vial. The radiation delivery determination system also includes a Geiger counter located outside the container and configured to measure the total amount of radiation within the radioembolic administration device and the conduit.

[0006] In yet another embodiment, a method for measuring the amount of radiation within a radioembolic administration device and a conduit in fluid communication with the radioembolic administration device may include placing the radioembolic administration device and the conduit in a container. The container includes: a first compartment defining an internal incision sized and shaped to receive the periphery of the radioembolic administration device, wherein the radioembolic administration device is placed within the internal incision of the first compartment; and a second compartment defining a bag configured to receive the conduit, wherein the conduit is placed within the bag of the second compartment. The method also includes measuring the amount of radiation within the radioembolic administration device and the conduit using a radiation measurement device located outside the container and spaced apart from the container.

[0007] These and additional features provided by the embodiments described herein will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a perspective view of a delivery device including a protective shield and a radioembolization administration device according to one or more embodiments shown and described herein;

[0009] Figure 2 According to one or more embodiments shown and described herein Figure 1 A cross-sectional view of a radioembolization delivery device, the cross section being along Figure 1 The line 2-2 is intercepted;

[0010] Figure 3 is a perspective view of a vial assembly including an engagement head according to one or more embodiments shown and described herein;

[0011] Figure 4 According to one or more embodiments shown and described herein Figure 1 A perspective view of a radioembolization administration device, wherein a Figure 3 a vial assembly, and a series of delivery lines coupled to a radioembolization administration device;

[0012] Figure 5 is a method for receiving a Figure 4 A perspective view of a container of a radioembolization administration device, with the front wall of the container removed for ease of illustration;

[0013] Figure 6 According to one or more embodiments shown and described herein Figure 5 A perspective view of a container for receiving Figure 4 a radioembolization administration device;

[0014] Figure 7 is a method for receiving a Figure 4 Radioembolization delivery device Figure 5 A perspective view of a lining of a container;

[0015] Figure 8 According to one or more embodiments shown and described herein Figure 5 a top view of a container of with the top wall removed for illustration purposes and including a front wall forming a protrusion;

[0016] Fig. 9 According to one or more embodiments shown and described herein Figure 5 A top view of another embodiment of a container of wherein the top wall is removed for illustration and the container includes a contoured front wall;

[0017] Fig.10 is a method for receiving a Figure 4 A perspective view of another container of a radioembolization administration device, with the front wall of the container removed for ease of illustration;

[0018] Fig.11 According to one or more embodiments shown and described herein Fig.10 A cross-sectional view of a container, wherein the cross-section is along Fig.10 The line 10-10 is intercepted;

[0019] Fig.12 According to one or more embodiments shown and described herein Fig.10 A cross-sectional view of a container, wherein the cross-section is along Fig.10 The line 11-11 is intercepted;

[0020] Fig.13 is a perspective view of a housing for receiving a container according to one or more embodiments shown and described herein. Figure 4 a radioembolization administration device;

[0021] Fig.14 According to one or more embodiments shown and described herein Fig.13 A perspective view of a housing, wherein a Figure 6 Container;

[0022] Fig.15 is a flow chart for determining a radiation dose within at least a portion of a medical treatment device according to one or more embodiments shown and described herein. Specific embodiments

[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. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts. Directional terms (e.g., up, down, right, left, front, back, top, bottom, distal, and proximal) as used herein are made with reference only to the drawings as drawn and are not intended to imply an absolute orientation.

[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 the one particular value and / or to the other particular value. Similarly, when a value is expressed as an approximation by using the antecedent "about," it will be understood that the particular value forms another embodiment. It will also be understood that the endpoints of each of these ranges are important both relative to the other endpoint and independently of the other endpoint.

[0025] Unless otherwise expressly stated, it is not intended that any method set forth herein be interpreted as requiring that its steps be performed in a particular order, or as not requiring that its steps be performed in any particular orientation of the apparatus. Thus, in the absence of a method claim actually reciting an order to be followed by its steps, or in the absence of any apparatus claim actually reciting an order or orientation for individual components, or in the absence of otherwise specifically stating in the claims or specification that the steps are to be limited to a particular order, or in the absence of reciting a particular order or orientation for components of the apparatus, it is not intended that an order or orientation be inferred in any respect. This applies to any possible non-express basis for interpretation, including: matters of logic regarding arrangement of steps, operational flow, order of components, or orientation of components; ordinary meaning derived from grammatical organization or punctuation; and the number or type of embodiments described in this specification.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those of ordinary skill in the art to which the present disclosure belongs. The terms used in the description herein are only used to describe specific embodiments and are not intended to be limiting. As used in this specification and the appended claims, the singular forms "a", "an", and "the" are also intended to include the plural forms, unless the context clearly indicates otherwise.

[0027] As used herein, the terms "horizontal", "vertical", "distal" and "proximal" are relative terms only, indicating only a general relative orientation and not necessarily indicating verticality. For convenience, these terms may also be used to refer to the orientations used in the accompanying drawings, which are used only as a convention and are not intended to be used as characteristics of the devices shown. The present disclosure and embodiments thereof to be described herein may be used in any desired orientation. Moreover, horizontal walls and vertical walls generally only need to be intersecting walls, not necessarily perpendicular. As used herein, the singular forms of "a", "an", and "the" include plural referents unless the context clearly indicates otherwise. Thus, for example, reference to a "one" component includes aspects having two or more such components unless the context clearly indicates otherwise.

[0028] In embodiments described herein, a particulate matter delivery assembly, in which a dose of radiation may be determined as described in more detail below, may include a radioembolic administration device. The radioembolic administration device includes a medical device, such as a medical device configured to deliver a radioactive compound to a treatment area in a patient's body, such as in a procedure such as transarterial radioembolization. The radioactive compound may be a mixed solution of saline and radioactive microspheres (i.e., microspheres) mixed in a vial of a vial assembly. The needle may include one or more ports, the ports serving as an outlet to inject a fluid (i.e., saline), such as from a syringe or catheter line, into a vial including radioactive microspheres to produce a mixed solution, and the ports serving as an inlet to deliver the mixed solution to a patient.

[0029] Furthermore, in the present description and hereinafter with reference to at least Figure 5-15In a more detailed embodiment, a radiation delivery determination system for determining the amount of radiation within a radioembolic administration device (which may include a vial assembly received therein) and a tubing coupled to the radioembolic administration device includes a container. The container includes: a first compartment defining an internal cutout sized and shaped to receive the periphery of the radioembolic administration device; and a second compartment defining a pocket configured to receive the tubing. In an embodiment, to standardize the reduction in radiation emission intensity of radiation contained within the radioembolic administration device and / or the vial assembly and the tubing, a first rear surface of the first compartment disposed opposite to a measurement-facing surface of a front wall of the container is spaced apart from the measurement-facing surface of the container by a first distance, and a second rear surface of the second compartment disposed opposite to the measurement-facing surface of the container is spaced apart from the measurement-facing surface of the container by a second distance, wherein the second distance is greater than the first distance. The measurement-facing surface of the front wall of the container is closest to and faces the radiation measurement device. In additional or alternative embodiments, in order to standardize the reduction of the intensity of radiation emissions from radiation contained within the radioembolization administration device and / or vial assembly and tubing, 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 does not cover the first compartment of the container.

[0030] Described below Figure 1-4 The following is a more detailed description of an embodiment of a delivery device 500 for delivering microparticles. Figure 5-15 One or more systems 1000 for facilitating determination of the amount of radiation within at least a portion of a delivery device 500 (see Fig.14 ). In some embodiments, as described in more detail below, the delivery device 500 is a radioembolic delivery device, the microparticles are a plurality of radioembolic beads, the fluid is a saline solution, and the resulting mixed fluid (e.g., a mixed fluid solution) is a radioembolic bead-saline solution. The needle 559 can be configured to deliver the radioembolic bead-saline solution as a mixed fluid solution through the radioembolic delivery device, such as when the vial engagement mechanism 520 is actuated in a positive pressure direction. In some embodiments, the fluid is a contrast-saline solution including a contrast agent, and the resulting mixed fluid (e.g., a mixed fluid solution) is a radioembolic bead-contrast-saline solution. The needle 559 can be configured to deliver the radioembolic bead-contrast-saline solution as a mixed fluid solution through the radioembolic delivery device. In some embodiments, the delivery device 500 is a chemoembolic delivery device, the microparticles are a plurality of chemoembolic beads, and the mixed fluid solution is a bead-saline solution or a bead-contrast-saline solution.

[0031] I. Mechanical Delivery Device with Removable Radioembolic Administration Device

[0032] Figure 1 and Figure 2 An embodiment of a delivery device 500 is shown that is configured and operable to deliver radioactive material (e.g., radioembolic beads) while reducing radioactive emissions during use of the delivery device 500. The delivery device 500 can operate in the manner described in International PCT Application No. PCT / 2019 / 033001, filed May 17, 2019, the entire contents of which are incorporated herein.

[0033] First reference Figure 1 , the delivery device 500 includes a console assembly 510, which includes a console. The delivery device 500 may include a radioembolic administration device 540, which is operable to switch between a coupled state and a disengaged state relative to the console assembly 510. The console assembly 510 of the delivery device 500 includes a base 512, which is defined by a proximal end 514 and a distal end 516 and extends between the proximal end 514 and the distal end 516. The proximal end 514 of the base 512 includes a handle (delivery handle) 528 movably coupled to the console assembly 510 and an interface display 530 positioned on the console assembly 510.

[0034] The proximal end 514 of the base 512 also includes an attachment device 538 configured to securely retain an external device to the base 512 of the console assembly 510. The attachment device 538 is operable to facilitate attachment of a complementary device to the console assembly 510 for use with the delivery device 500 during a procedure.

[0035] Still refer to Figure 1 , the distal end 516 of the console assembly 510 defines a vial receiving area 518, which is sized and shaped to receive the console assembly 510 therein, as will be described in more detail herein. The console assembly 510 also includes a vial engagement mechanism 520 extending from the base 512 to near the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outward from the base 512 of the console assembly 510 toward the distal end 516. The vial engagement mechanism 520 is positioned within the vial receiving area 518 of the console assembly 510 and is movably coupled to a handle 528. In particular, the handle 528 of the console assembly 510 is operable to move (particularly translate) the vial engagement mechanism 520 within the vial receiving area 518 in response to actuation of the handle 528.

[0036] The console assembly 510 includes a mechanical assembly disposed within the base 512 that is configured and operable to translate manual movement of the handle 528 into a corresponding linear displacement of the vial engagement mechanism 520. In the present example, the mechanical assembly is coupled to the handle 528 and the vial engagement mechanism 520 such that selective actuation of the handle 528 at the proximal end 514 causes simultaneous actuation of the vial engagement mechanism 520 at the distal end 516.

[0037] In the examples and with reference to Figure 2 , the flow sensor of the delivery device 500 can be positioned in line with the tubing set of the delivery device 500 (particularly one or more of the needle 559, manifolds 555A, 555B, and / or port 556), and can be configured to measure the amount of fluid (e.g., a suspension of therapeutic particles effectively mixed with a fluid medium) passing therethrough. Referring again to Figure 1 , the vial engagement mechanism 520 includes a pair of lever arms 522 extending outwardly from a neck 524 of the vial engagement mechanism 520, wherein the 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 isolate one or more internal components of the console assembly 510 from the exterior of the console assembly 510, particularly the vial receiving area 518.

[0038] In response to actuation of the handle 528 of the console assembly 510, the pair of lever arms 522 can move simultaneously with the neck 524 of the vial engagement mechanism 520. In addition, the pair of lever arms 522 are fixed relative to each other so that the spacing formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 is configured to securely engage the vial assembly 580 therebetween, and in particular securely engage within the spacing formed by the pair of lever arms 522. Therefore, the vial engagement mechanism 520 is operable to securely attach the vial assembly 580 to the console assembly 510 at the vial receiving area 518. Although the vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, it should be understood that the vial engagement mechanism 520 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.

[0039] Still refer to Figure 1, the console assembly 510 also includes a safety shield 526 that is secured to the distal end 516 of the base 512 along the vial receiving area 518. In particular, the safety shield 526 is a protective cover that is sized and shaped to enclose the vial receiving area 518 of the console assembly 510 when secured to the vial receiving area 518 on the console assembly 510. 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 of one or more radioactive doses stored in the vial receiving area 518, such as glass, a polymer, or other plastic material.

[0040] The distal end 516 of the console assembly 510 also includes an applicator cavity 532 that is sized and shaped to receive a radioembolic applicator 540 therein. The applicator cavity 532 includes one or more (in some embodiments, a pair) alignment features 534 extending therein, wherein the alignment features 534 are sized and shaped to correspond to complementary alignment features (e.g., alignment ribs 554) of the radioembolic applicator 540, thereby facilitating the coupling of the radioembolic applicator 540 with the base 512 of the console assembly 510 within the applicator cavity 532. As will be described in greater detail herein, the radioembolic applicator 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, media) therethrough. In particular, the radioembolic applicator 540 is configured to partially receive a vial assembly 580 therein for administering therapeutic particles from the delivery device 500 to a patient during a procedure.

[0041] Still refer to Figure 1, the radioembolic administration device 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 radioembolic administration device 540 includes a proximal end 544 and a distal end 542, wherein a pair of side walls 546 extend between the proximal end and the distal end. The proximal end 544 of the radioembolic administration device 540 includes a handle 552 extending proximally therefrom. The handle 552 is configured to facilitate movement of the radioembolic administration device 540, and in particular, facilitate insertion of the radioembolic administration device 540 into the administration device cavity 532 of the console assembly 510. The proximal end 544 also includes one or more ports 556 for coupling one or more delivery lines (i.e., tubing) to the radioembolic administration device 540. In the event that the one or more delivery lines are further coupled to one or more external devices at the ends of the lines opposite the ports 556, the ports 556 are effective for fluidly coupling the radioembolic application device 540 to the one or more external devices via the delivery lines connected thereto. The pair of sidewalls 546 of the radioembolic application device 540 include at least one alignment rib 554 extending laterally outwardly therefrom, wherein the alignment rib 554 is sized and shaped to correspond to and mate with the pair of alignment features 534 of the console assembly 510. Thus, the pair of alignment ribs 554 are configured to facilitate alignment and engagement of the radioembolic application device 540 with the console assembly 510 when the distal end 542 is slidably received within the application device cavity 532 of the base 512.

[0042] The radioembolic administration device 540 also includes a top surface 548 extending from the proximal end 544 and the distal end 542 and positioned between a pair of side walls 546, and a bottom surface 541 extending from the proximal end 544 and the distal end 542 and positioned between the pair of side walls 546. The top surface 548 of the radioembolic administration device 540 includes a recessed area 549 and a locking system 550. The recessed area 549 is sized and shaped to form a recess and / or cavity along the top surface 548, wherein the recessed area 549 is capable of receiving and / or collecting various substances therein, including, for example, various fluid media leaked during use of the delivery device 500. The locking system 550 of the radioembolic administration device 540 forms an opening along the top surface 548, the opening being sized and shaped to receive one or more devices therein, such as a priming assembly 560 and a vial assembly 580. In some embodiments, the radioembolic administration device 540 is pre-loaded with the priming assembly 560 disposed within the locking system 550. Priming assembly 560 includes priming line 562 extending outwardly from locking system 550 of radioembolization administration device 540. Priming assembly 560 connects priming line 562 to needle 559 and manifolds 555A and 555B, and is used to purge air from delivery device 500 (including manifolds 555A and 555B) prior to using delivery device 500 in a procedure.

[0043] Reference now Figure 2 , the locking system 550 includes an annular array of one or more protrusions 551 extending outwardly from the locking system, and in particular, extending laterally along the top surface 548 into an aperture formed by the locking system 550. The annular array of protrusions 551 is formed within the inner periphery of the locking system 550 and extends along at least two sequentially arranged rows. The annular array of protrusions 551 included in the locking system 550 is configured to engage a corresponding locking feature 586 of the vial assembly 580 (see Figure 3 ), thereby securely securing the vial assembly 580 to the radioembolic administration device 540. It should be appreciated that the multiple rows of protrusions 551 of the locking system 550 are used to provide a double locking system to ensure that the radioembolic administration device 540, and in particular the needle 559 of the radioembolic administration device 540, is securely held through the septum 592 (see FIG. 5 ) of the vial assembly 580 during use of the delivery device 500 during a procedure. Figure 3 ).

[0044] The radioembolic administration device 540 also includes a vial chamber 558, which is sized and shaped to receive the pre-fill assembly 560 and the vial assembly 580 therein, respectively. In other words, the vial chamber 558 is sized to receive the pre-fill assembly 560 and the vial assembly 580, respectively, which are separated from each other. The periphery of the vial chamber 558 is enclosed by a protective chamber or shield 557 disposed around the vial chamber 558. The shield 557 is formed of a material configured to inhibit radioactive emissions from extending outward from the vial chamber 558, such as, for example, metal. In addition, the radioembolic administration device 540 includes a needle 559, which extends through the shield 557 and enters the vial chamber 558 along the bottom end of the vial chamber 558. The needle 559 is firmly fixed relative to the vial chamber 558 so that any device received into the vial chamber 558 through the aperture of the locking system 550 will encounter and interact with the needle 559 (e.g., the pre-fill assembly 560, the vial assembly 580, etc.).

[0045] Still refer to Figure 2 , needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the radioembolization administration device 540, and in particular, the manifolds 555A, 555B are positioned below the vial chamber 558 and the shield 557. The proximal manifold 555B is fluidly coupled to the needle 559, and the distal manifold 555A may be fluidly coupled to one or more delivery lines via one or more ports 556 of the radioembolization administration device 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A via a one-way check valve 553 disposed between the proximal manifold 555B and the distal manifold 555A.

[0046] Thus, the proximal manifold 555B is in fluid communication with the 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 lines and / or devices coupled to the radioembolization administration device 540 at the one or more ports 556 via the manifolds 555A, 555B fixed therebetween. The one or more ports 556 of the radioembolization administration device 540 can be coupled to a bag (e.g., a saline bag), a syringe, a catheter, and / or the like via one or more delivery lines coupled thereto. In other embodiments, the needle 559 can be a cannula, a catheter, or a similar mechanism through which fluids and / or solutions can be injected and received, as described herein.

[0047] Still refer to Figure 2, the radioembolic administration device 540 includes a removable battery pack 570 coupled to the radioembolic administration device 540 along the distal end 542. The removable battery pack 570 includes a battery 572, electrical contacts 574, and a removable tab 576. Due to the location of the battery 572 in the removable battery pack 570, the battery 572 of the delivery device 500 is isolated from one or more fluid paths and the radiation source.

[0048] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to contact corresponding electrical contacts 511 of the console assembly 510 when the radioembolization applicator 540 is coupled to the base 512 at the applicator cavity 532 (see Figure 1 Thus, when the radioembolization administration device 540 is coupled to the console assembly 510, the removable battery pack 570 is operable to provide power to the delivery device 500 and, in particular, the console assembly 510.

[0049] Additionally, as will be described in greater detail herein, in some embodiments, the locking system 550 may include at least one planar wall that is oriented relative to the rest of the circular shape of the locking system 550. In such cases, the aperture formed by the locking system 550 through the top surface 548 of the radioembolic administration device 540 is irregularly shaped, rather than circular as shown and described above. In such cases, the vial assembly 580 includes a locking feature 586 that corresponds in shape and size to the locking system 550 (particularly the at least one planar wall), such that the vial assembly 580 is received within the radioembolic administration device 540 only when the orientation of the vial assembly 580 corresponds to the alignment of the locking feature 586 and the locking system 550. In other words, the corresponding planar wall 586A of the locking feature 586 (see FIG. 5A ) is oriented relative to the rest of the circular shape of the locking system 550. Figure 3 ) must be aligned with the planar wall of the locking system 550 so that the vial assembly 580 can be received within the orifice formed by the locking system 550 of the radioembolization administration device 540.

[0050] Reference now Figure 3, depicting a vial assembly 580 of the delivery device 500. 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 opposite the locking feature 586 and the vial body 589. The engagement head 582 includes a pair of arms 581 that extend laterally outward relative to the longitudinal length of the plunger 584 extending downward therefrom. In this example, the engagement head 582 is integrally formed with the plunger 584, however, it should be understood that in other embodiments, the engagement head 582 and the plunger 584 can be independent features fastened thereto. In either case, the engagement head 582 and the plunger 584 can be movable relative to the locking feature 586 and the vial body 589 so that the engagement head 582 and the plunger 584 can be slidably translated through the locking feature 586 and the vial body 589. In particular, as will be described in greater detail herein, when the engagement head 582 is secured to a pair of lever arms 522 , the plunger 584 can translate into and out of the interior chamber 588 of the vial body 589 in response to linear translation of the vial engagement mechanism 520 .

[0051] The plunger 584 includes a plurality of markings and / or indicia 583 positioned along the longitudinal length of the plunger 584. The plurality of indicia 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, when the vial assembly 580 is received within the radioembolic device 540 and the radioembolic applicator 540 is inserted into the applicator cavity 532 of the console assembly 510, the pair of arms 581 of the engagement head 582 are sized and shaped to couple with the pair of lever arms 522 of the vial engagement mechanism 520. As will be described in more detail herein, in response to a predetermined translational force applied to the vial engagement mechanism 520, the pair of lever arms 522 are received between the pair of arms 581 of the engagement head 582 and the plunger 584. Engagement head 582 and plunger 584 may be formed from a variety of materials including, but not limited to, metal, plastic, and / or the like.

[0052] Still refer to Figure 3, the vial assembly 580 also includes a safety tab 585 coupled to the plunger 584 and relatively located 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 made of a variety of materials, such as plastic, and pre-assembled to the vial assembly 580 before using the delivery device 500. The safety tab 585 is removably fastened to the plunger 584 and prevents the plunger 584 from translating relative to the vial body 589. In particular, in response to applying a linear force on the plunger 584 to relatively translate the plunger 584 downward into the vial body 589, the safety tab 585 abuts the locking feature 586. In this case, the safety tab 585 is configured to prevent accidental movement of the plunger 584, and in response, prevent accidental delivery of the fluid medium (e.g., therapeutic microparticles, radioembolic beads) stored in the inner chamber 588 of the vial body 589. As will be described in greater detail herein, the safety tab 585 selectively disengages from the plunger 584 in response to coupling of the vial assembly 580 with the vial engagement mechanism 520 , and in particular in response to engagement of the pair of lever arms 522 with the engagement head 582 .

[0053] Reference again Figure 3 , the locking feature 586 extends around the top end of the vial body 589. In the present example, the locking feature 586 of the vial assembly 580 includes a liner that defines a side edge 587 that extends laterally outward along the 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 administration device 540. As will be described in greater detail herein, the locking feature 586, and in particular the side edge 587 of the locking feature 586, is configured to securely secure the vial assembly 580 to the locking system 550 to prevent the vial body 589 from being removed from the vial chamber 558 of the radioembolization administration device 540 during use of the delivery device 500 in a procedure. In some embodiments, as briefly described above, the locking feature 586 includes at least one planar wall 586A such that the locking feature 586 includes an irregular profile. The at least one planar wall 586A is configured to correspond with the planar wall 550A of the locking system 550 such that alignment of the planar walls 550A, 586A is required in order for the vial assembly 580 to be received through the aperture formed by the locking system 550 .

[0054] Still refer to Figure 3, the vial body 589 extends downward relative to the locking feature 586 and has a longitudinal length that is 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 mm to about 10 mm, including 9 mm in this example, while the longitudinal length of the plunger 584 can be from about 9 mm to about 11 mm, including 10 mm in this example. 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 interior chamber 588 of the vial body 589 causes the fluid medium stored therein to be transferred outward from the vial body 589. As will be described in more detail herein, translation of the plunger 584 through the interior chamber 588 of the vial body 589 enables the fluid medium stored in the vial body 589 to be applied outward from the vial assembly 580. The vial body 589 may be made from a variety of materials including, for example, thermoplastic polymers, copolyesters, polycarbonates, biocompatible plastics, polysulfones, ceramics, metals, and / or the like.

[0055] The vial body 589 of this example is formed of a material that is configured to suppress radioactive emissions from a fluid medium stored in the inner chamber 588 of the vial body 589. For example, the vial body 589 can be formed of plastic (e.g., polycarbonate) and have a width of approximately 9 millimeters (mm). The density and material composition of the vial body 589 will jointly suppress the emission of beta radiation from the electron particles stored in the inner chamber 588. In this example, the chemical composition of the plastic of the vial body 589 and the wall thickness of 9 millimeters allow a plurality of atoms to be disposed within the vial body 589 that are capable of encountering electron particles that produce beta radiation and reducing the emission of said radiation from the vial assembly 580. Therefore, the vial assembly 580 allows an operator to handle the radioactive material stored in the vial body 589 without being exposed to beta radiation. It should be understood that in other embodiments, various other materials and / or wall segments may be incorporated into the vial body 589 of the vial assembly 580 without departing from the scope of the present disclosure.

[0056] Still refer to Figure 3, the vial body 589 of the vial assembly 580 is sealed at a first end by a locking feature 586. The vial assembly 580 also includes a cap 590, which is located at an opposite end of the vial body 589 opposite to the locking feature 586, so that the cap 590 seals the second end of the vial body 589 of the vial assembly 580. In addition, the vial assembly 580 includes a septum 592, which is located near the cap 590 and is in fluid communication with the end of the vial body 589 opposite to the locking feature 586. The septum 592 forms a seal to the end of the vial body 589, and the cap 590 retains the septum 592 therein. The septum 592 can be formed of various materials, including, for example, elastomers, silicon, bromobutyl elastomers, rubber, polyurethane, and / or the like. The septum 592 is configured to provide an airtight seal to the vial body 589, thereby inhibiting the release of a fluid medium (e.g., radioembolic beads) stored therein. As will be described in greater detail herein, when the vial assembly 580 is received within the vial chamber 558, the septum 592 of the vial assembly 580 is configured to be pierced by the needle 559 of the radioembolic administration device 540, thereby establishing fluid communication between the vial body 589 and the radioembolic administration device 540. In other embodiments, the septum 592 may be omitted entirely, with alternative devices employed, such as a valve system, a needle injection port, and / or the like.

[0057] Reference now Figure 4In response to determining that the battery 572 contains sufficient charge or other power source provides sufficient charge, one or more delivery lines are coupled to the radioembolization administration device 540 via one or more ports 556. In particular, the dose delivery line 10A is coupled to the radioembolization administration device 540 at the delivery port 556A, the contrast agent line 10B is coupled to the radioembolization administration device 540 at the contrast agent port 556B, and the flush line 10C is coupled to the radioembolization administration device 540 at the flush port 556C. The opposite end of the dose delivery line 10A is initially coupled to a fluid reservoir (e.g., a collection bowl). As will be described in more detail herein, once the radioembolization administration device 540 has been effectively pre-filled with a fluid medium via the contrast agent line 10B, the dose delivery line 10A can then be coupled to an external device, such as a catheter. The opposite end of the flush line 10C is coupled to an external device, such as a syringe. In the case where both the dose delivery line 10A and the flushing line 10C are connected to the radioembolization administration device 540, the radioembolization administration device 540 is flushed with a fluid medium (e.g., saline) in a syringe connected to the flushing line 10C. In this case, the fluid medium is injected into the distal manifold 555A of the radioembolization administration device 540 through the flushing line 10C and flows out of the radioembolization administration device 540 through the dose delivery line 10A. Therefore, the fluid medium is finally received at the collection bowl and processed there through the dose delivery line 10A.

[0058] In the case where the distal manifold 555A of the radioembolization administration device 540 is isolated from the proximal manifold 555B by the one-way check valve 553 disposed between the distal manifold and the proximal manifold 555b, the fluid medium flushed from the syringe (via the flush port 556C) through the distal manifold 555A is blocked from passing through the proximal manifold 555B and the needle 559 coupled thereto. In contrast, the fluid medium injected from the syringe and passed through the flush line 10C is received at the flush port 556C, passes through the distal manifold 555A in fluid communication with the flush port 556C, and is redirected by the one-way check valve 553 to 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 transmits it to the collection bowl coupled thereto, so that the fluid medium is not guided beyond the one-way check valve 553 and enters the proximal manifold 555B in fluid communication with the needle 559.

[0059] The contrast agent line 10B is coupled to the radioembolization administration device 540 at the contrast agent tube port 556B. The opposite end of the contrast agent line 10B is coupled to a fluid medium supply device (e.g., a bag fixed to the console assembly 510 via the attachment device 538). In this example, the bag is a saline bag, so that the fluid medium stored therein is saline. In this case, where the radioembolization administration device 540 includes a prefill assembly 560 located in the vial chamber 558 and a needle end in fluid communication with the needle 559, the syringe is fluidly coupled to the prefill line 562 of the prefill assembly 560, and the plunger of the syringe is pulled back to pull saline from the saline bag through the contrast agent line 10B, the contrast agent port 556B, the radioembolization administration device 540, the prefill line 562 and into the syringe. Subsequently, the plunger of the syringe is pushed inward to transfer the extracted saline back through the priming line 562, the central body, the elongated shaft, and the needle end of the priming assembly 560, so that the saline is received into the needle 559 of the radioembolization administration device 540. Therefore, since the needle 559 receiving the saline from the priming assembly 560 is in fluid communication with the manifolds 555A, 555B, the manifolds 555A, 555B of the radioembolization administration device 540 can be effectively primed with saline from the syringe. With the manifolds 555A, 555B further in fluid communication with the dose delivery line 10A via the delivery port 556A, the saline can be effectively distributed to the collection bowl coupled thereto.

[0060] Reference now Figure 4 , the radioembolic administration device 540 is coupled to one or more external devices via the one or more ports 556. In particular, the radioembolic administration device 540 is fluidly coupled to a catheter (e.g., a microcatheter) via a dose delivery line 10A, which is coupled to a delivery port 556A of the radioembolic administration device 540. In this case, the catheter is in fluid communication with the radioembolic administration device 540 via the dose delivery line 10A. In addition, the radioembolic administration device 540 can be fluidly coupled to a contrast agent source, such as a saline bag secured to the console assembly 510 via an attachment device 538 (see Figure 1 ). The radioembolization administration device 540 is in fluid communication with the saline bag via a contrast agent line 10B coupled to a contrast agent port 556B of the radioembolization administration device 540. In this case, the saline bag is in fluid communication with the radioembolization administration device 540 via a contrast agent line 10B fixed to the contrast agent port 556B.

[0061] Contrast port 556B is in fluid communication with proximal manifold 555B, while delivery port 556A is in fluid communication with distal manifold 555A. As will be described in greater detail herein, because contrast port 556B is coupled to proximal manifold 555B, rather than to distal manifold 555A, which is isolated from proximal manifold 555B by one-way check valve 553 disposed between distal manifold 555A and proximal manifold 555B, saline from a saline bag can be drawn through needle 559 of radioembolization administration device 540 into vial body 589 of vial assembly 580.

[0062] Reference again Figure 1 and Figure 3 With the vial assembly 580 securely coupled to the radioembolic applicator 540, the radioembolic applicator 540 is coupled to the console assembly 510 by translating the proximal end 544 of the radioembolic applicator 540 toward and into the distal end 516 of the console assembly 510. In particular, the proximal end 544 of the radioembolic applicator 540 is guided into the applicator cavity 532 of the console assembly 510 by aligning the alignment ribs 554 of the radioembolic applicator 540 with the alignment features 534 of the console assembly 510. Once the distal end 542 and the proximal end 544 of the radioembolic applicator 540 are fully within the applicator cavity 532 of the console assembly 510, the electrical contacts 574 ( Figure 2 ) will contact the corresponding electrical contacts 511 ( Figure 1 ) interacts. In this case, power from battery 572 is transmitted to console assembly 510 through electrical contacts 574, thereby activating console assembly 510 of delivery device 500. In this case, interface display 530 of console assembly 510 is activated to display real-time information related to delivery device 500 during the procedure.

[0063] Reference again Figure 4 , when the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial receiving area 518, a negative pressure is generated within the interior chamber 588 of the vial body 589 due to the retraction of the stopper 594. In this example, in the case where a saline bag is coupled to the radioembolic administration device 540 via the contrast agent line 10B and the contrast agent port 556B, saline from the saline bag is drawn into the interior chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Therefore, in the case where the vial body 589 is pre-loaded with a radioactive fluid medium (e.g., radioembolic microspheres), when the plunger 584 is retracted from the interior chamber 588 and a negative pressure is generated by the delivery device 500, the saline is effectively mixed with the radioactive fluid medium within the vial body 589.

[0064] The radioembolization administration device 540 also includes a one-way check valve 553A in line with the contrast agent line 10B and the flush line 10C. In particular, the one-way check valve 553A is configured to allow fluid communication from the contrast agent port 556B and the flush port 556C to the manifolds 555A, 555B, and is also configured to prevent fluid communication from the manifolds 555A, 555B to the contrast agent port 556B and the flush port 556C. Therefore, it should be understood that due to the one-way check valve 553A located therein, the dose delivered from the vial body 589 to the manifolds 555A, 555B cannot be directed into the contrast agent line 10B or the flush line 10C. Therefore, the dose is directed to the dose delivery port 556A and received by the dose delivery line 10A in the catheter fluidly coupled thereto. In other words, the one-way check valve 553A prevents fluid from flowing back into the radioembolization administration device 540 and / or vial assembly 580 coupled thereto.

[0065] II. Emission Determination Example

[0066] As briefly described above, Figure 5-15 , as discussed in greater detail herein, generally relates to embodiments of a radiation delivery determination system 1000 to assist in determining the amount of radiation within at least a portion of a delivery device 500. For example, the system 1000 discussed herein can be used to determine the amount of radiation within at least a portion of a delivery device 500 after a therapeutic operation or administration of a fluid of a radioactive dose from the delivery device 500. More particularly, the system 1000 discussed herein can be used to determine the amount of radiation within a radioembolic administration device 540 (including a vial assembly 580 that can be partially received within the radioembolic administration device 540), and conduits 10 (i.e., a dose delivery line 10A, a contrast agent line 10B, and a flush line 10C) coupled to the radioembolic administration device 540. By determining the amount of radiation within at least a portion of the delivery device 500 after administration of a radioactive dose and knowing the 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.

[0067] The current system and method may involve placing the radioembolic administration device, vial assembly and / or tubing loosely in a test container, and using a radiation measuring device to measure the amount of radiation in the radioembolic administration device, vial assembly and / or tubing within the test container. However, the specific orientation and position of the radioembolic administration device, vial assembly and / or tubing within the test container may be unknown, and the distance between the radiation source and the radiation measuring device may affect the amount of radiation detected by the radiation measuring device. In particular, the measured radiation intensity is inversely proportional to the square of the distance between the radiation source and the radiation measuring device, so that the detected radiation intensity decreases as the distance between the radiation source and the radiation measuring device increases. For example, the radioactivity measured by the radiation measuring device at 0.3 meters from the radiation source may be 10 millicuries (or an equivalent amount of becquerels), while the radioactivity measured by the radiation measuring device at 0.4 meters from the same radiation source may be 6.25 millicuries (or an equivalent amount of becquerels). Therefore, the user must typically take multiple readings at different locations around the test container and then average the multiple readings to accurately determine the amount of radiation within the radioembolization administration device, vial assembly, and / or tubing.

[0068] In addition, different materials attenuate radiation to different degrees. Therefore, due to differences in absorption or radiation shielding properties of the materials used to form the radioembolic administration device, vial assembly, and / or tubing, for example, the same amount of radiation in the tubing and the radioembolic administration device may produce different readings by the radioactivity measuring device. That is, the radioembolic administration device 540 may shield 50% of the radiation from the radioactivity measuring device, while the tubing may shield almost 0% of the radiation from the radioactivity measuring device. Therefore, the 10 millicuries (or equivalent amount of becquerels) read by the radioactivity measuring device may be related to the actual radioactivity of 20 millicuries (or equivalent amount of becquerels) in the radioembolic administration device and 0 millicuries or becquerels in the tubing, or to the actual radioactivity of 0 millicuries or becquerels in the radioembolic administration device and 10 millicuries (or equivalent amount of becquerels) in the tubing. Without standardization, or without 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 radioembolic delivery device (i.e., the radioembolic device, vial assembly, and / or tubing) may not be accurately determined as a whole. The system described herein enables accurate and repeatable radiation measurements.

[0069] Brief reference Fig.14, depicts a radiation delivery determination system 1000 (also referred to herein as system 1000) for determining an amount of radiation within at least a portion of a delivery device 500. System 1000 includes a container 600 and a radioactivity measurement device 750 located outside of the container 600. The container 600 can receive a radioembolic administration device 540 (including a vial assembly 580 that can be partially received within the radioembolic administration device 540), and a conduit 10 coupled to the radioembolic administration device 540. In an embodiment, as described in more detail below, the container 600 includes a first compartment 610 defining an internal cutout 612 sized and shaped to receive the periphery of the radioembolic administration device 540, and a second compartment 620 defining a pocket 622 configured to receive the conduit 10. The conduit 10 can be in fluid communication with and attached to the radioembolic administration device 540 when received. The radioembolic administration device 540 may include a vial for administering at least a portion of the radioactive therapeutic substance from the vial assembly 580, and the tubing 10 may include at least a first tube, such as a dose delivery line 10A, for administering the radioactive therapeutic substance from the vial of the vial assembly 580. The housing 800 may house the container 600 therein. The radioactivity measurement device 750, which is located outside and spaced apart from the housing 800 and the container 600, is configured to measure the amount of radioactivity within the radioembolic administration device 540 (including the vial assembly 580 that may be partially received therein), and the tubing 10 coupled to the radioembolic administration device 540.

[0070] Reference now Figure 5 , showing a container 600. The container 600 includes a rear surface 601 of a rear wall 601', a top surface 602 of a top wall 602', a bottom surface 603 of a bottom 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 ( Figure 5 Not shown, see Figure 8 ), which may be primarily parallel to the rear surface 601 and orthogonal to the top surface 602, the bottom surface 603, the first side surface 604, and the second side surface 605. Although the container 600 is described and depicted herein as a six-sided structure, it should be understood that the container 600 may include more or fewer surfaces so long as the container defines a volume configured to receive the radioembolic administration device 540 (which may include a vial assembly 580 that may be partially received therein), and the conduit 10 coupled to the radioembolic administration device 540, as described herein.

[0071] As described above, container 600 includes a first compartment 610 and a second compartment 620. First compartment 610 includes an internal cutout 612 sized and shaped to receive the outer periphery of radioembolic administration device 540, such as Figure 6 As used herein, the periphery of the radioembolic administration device 540 can be defined by the proximal end 544, the distal end 542, the pair of sidewalls 546, the top surface 548, the bottom surface 541, the handle 552, and any protrusions, contours, or surface features therein. The internal cutout 612 of the first compartment 610 is further sized and shaped to receive the periphery of the vial assembly 580, which can be partially received in the radioembolic administration device 540.

[0072] Reference again Figure 5 , the first compartment 610 can be partially defined by the rear surface 601, the top surface 602, the bottom surface 603, the first side surface 604 and the portion of the front surface (not shown). The first compartment 610 can also be defined by one or more internal protrusions 630A, 630B, 630C. The internal protrusions 630A, 630B, 630C can be integrally formed with one or more of the rear surface 601, the top surface 602, the bottom surface 603, the first side surface 604, the second side surface 605 and / or the front surface (not shown) of the container 600 and extend inwardly therefrom. At least a portion of the internal protrusions 630A, 630B, 630C, together with the rear surface 601, the top surface 602, the bottom surface 603, the first side surface 604 and the front surface (not shown) can define an internal cutout 612. The internal protrusions 630A, 630B, 630C may be at least partially molded to correspond to at least a portion of the periphery of the radioembolic administration device 540. When shaped to receive the periphery of the radioembolic administration device 540, the internal cutout 612 secures the radioembolic administration device 540 within the first compartment 610 such that movement of the radioembolic administration device 540 is limited or eliminated. Furthermore, the internal cutout 612 may be sized and shaped such that the radioembolic administration device 540 can be positioned therein in a single orientation.

[0073] The second compartment 620 defines a bag 622 configured to receive the tubing 10 (ie, the dose delivery line 10A, the contrast agent line 10B, and the flushing line 10C) coupled to the radioembolization administration device 540, such as Figure 6As shown. The second compartment 620 can be partially defined by the rear surface 601, the top surface 602, the bottom surface 603, the second side surface 605, and a portion of the front surface (not shown). For example, the second compartment 620 can also be defined by portions of the internal protrusions 630B and 630C. That is, with specific reference to the internal protrusion 630B, the first surface of the internal protrusion 630B can at least partially define the first compartment 610, and the second surface of the internal protrusion 630B can at least partially define the second compartment 620.

[0074] The container 600 may include one or more adjustable walls to allow a user to access the first compartment 610 and the second compartment 620. For example, but not limited to, the front wall 606 (see Figure 8 ) may be an adjustable wall that is fixed to the first side wall 604' by a hinge and selectively fixed to the second side wall 605' by a fixing mechanism such as a latch, an interference fit, a snap-fit ​​assembly, and / or other suitable fixing features. In an embodiment, the one or more adjustable walls may be removable from the container 600. For example, but not limited to, the front wall 606 may be selectively fixed to both the first side wall 604' and the second side wall 605' by a fixing mechanism such as a latch, an interference fit, a snap-fit ​​assembly, and / or other suitable fixing features. The front wall 606, which defines a front surface as a measurement-facing surface 607, may be selectively fixed to the walls 602', 603' defining the top surface 602 and the bottom surface 603 as an alternative or additional solution to fixing to the walls 604', 605' defining the first side surface 604 and the second side surface 605. It should also be understood that any of the walls defining the rear surface 601, the top surface 602, the bottom surface 603, the first side surface 604, and the second side surface 605 can be adjustable, such as by being hingedly fixed to another surface or wall, as an alternative or in addition to the front wall 606. Thus, in an embodiment, a user can access the first compartment 610 and the second compartment 620 from the top wall, the bottom wall, the front wall, the rear wall, or the side wall. When the container 600 is "closed", that is, when one or more adjustable walls of the container 600 are fixed to one or more other walls of the container 600 along all of their edges, the container 600 can be sealed. Thus, any liquid radioactive material within the container 600 can be kept within the boundaries of the container 600.

[0075] In an embodiment, the container 600 may be transparent so that the interior of the container 600 can be seen through the wall of the container 600. In an embodiment, the container 600 may be made of polycarbonate, polymethyl methacrylate, polyethylene terephthalate, polyethylene terephthalate, polyvinyl chloride, cyclic olefin copolymer, polyethylene, polypropylene, styrene methyl methacrylate, styrene acrylonitrile resin, polystyrene and / or methyl methacrylate acrylonitrile butadiene styrene. The container 600 may be disposable. Thus, the container 600 may be used once to determine the radioactive content of a single radioembolization administration device 540 (together with the tubing 10 coupled thereto and the vial assembly 580 partially received therein) and then discarded. In other words, the container 600 may be optionally non-reusable. This allows the user to safely dispose of the container 600 contaminated with radioactive material. This further allows the user to select a clean, uncontaminated container 600 for each measurement of radioactive material in the radioembolic administration device 540 (along with the tubing 10 coupled thereto and the vial assembly 580 partially received therein), thereby ensuring that a container 600 that may be contaminated with radioactivity does not compromise future radioactivity measurements.

[0076] Reference now Figure 6 , a container 600 including a radioembolic administration device 540 and tubing 10 coupled thereto (i.e., a dose delivery line 10A, a contrast agent line 10B, and a flushing line 10C) is shown. The radioembolic administration device 540 and a vial assembly 580 partially received therein are disposed within an internal cutout 612 of a first compartment 610 of the container 600. The tubing 10 coupled to the radioembolic administration device 540 is disposed within a pocket 622 of a second compartment 620 of the container 600. As discussed above, the internal cutout 612 limits or eliminates movement of the radioembolic administration device 540 and receives the radioembolic administration device 540 in a fixed fit along a single orientation. Thus, the container 600 allows for repeatable measurement procedures. That is, when the radioembolic administration device 540 and the vial assembly 580 partially received therein are disposed within the internal cutout 612, the radioembolic administration device 540 and the vial assembly 580 partially received therein relative to the measurement-facing surface 607 (see Figure 8 ) and / or the precise position of the radioactive measuring device. As used herein, the measurement-facing surface 607 of the container 600 refers to the surface of the container 600 that is closest to and faces the radioactive measuring device. In other words, the amount of radioactivity within the container 600 is measured "through" the measurement-facing surface 607. Therefore, the internal cutout 612 of the container 600 and the first compartment 610 reduces the geometric variability of the radioembolization administration device 540 and the vial assembly 580 partially received therein and the effect of such variability on the reading of the radioactive measuring device.

[0077] In some embodiments, the internal protrusions 630A, 630B, 630C within the container 600 may not be integrally formed with one or more of the rear surface 601, top surface 602, bottom surface 603, first side surface 604, second side surface 605, and / or front surface (not shown) of the container 600. For example and with reference to Figure 7 , the one or more internal protrusions 630A, 630B, 630C may be formed in the surface of the liner 650. The liner 650 may include a rear surface 661, a top surface 662, a bottom surface 663, a first side surface 664, and a second side surface 665, each of which is respectively configured to be disposed against the rear surface 601, the top surface 602, the bottom surface 603, the first side surface 604, and the second side surface 605 of the container 600. The liner 650 may not include a front surface to allow the radioembolization administration device 540, the tubing 10 coupled thereto, and the vial assembly 580 at least partially received in the radioembolization administration device 540 to be easily placed in the liner 650. In an embodiment, the liner 650 may include a front surface and may not include at least one of the rear surface 661, the top surface 662, the bottom surface 663, the first side surface 664, and the second side surface 665 to allow the radioembolization application device 540, the tubing 10 connected thereto, and the vial assembly 580 at least partially received within the radioembolization application device 540 to be easily placed within the liner 650.

[0078] The liner 650 at least partially defines a first compartment 670 and a second compartment 680, the first compartment being associated with the Figure 5 The first compartment 610 discussed is similar and configured to be functionally similar to the Figure 5 The first compartment 610 discussed above is disposed in the first compartment 670, and the second compartment 680 is disposed in the first compartment 670. Figure 5 The second compartment 620 discussed is similar and configured to be functionally similar to the Figure 5 The second compartment 620 discussed above is provided within the second compartment 620. The first compartment 670 at least partially defines an internal cutout 672 configured to be functionally similar to the first compartment 670 described above. Figure 6 The second compartment 680 at least partially defines a pocket 682, which is configured similarly to the internal cutout 612 discussed above. Figure 5 The bag 622 discussed.

[0079] Combination Figure 5 refer to Figure 7, the liner 650 can be selectively inserted into or removed from the container 600. In operation, a user can place the radioembolic administration device 540, the tubing 10 coupled thereto, and the vial assembly 580 at least partially received in the radioembolic administration device 540 within the liner 650. The user can then move one or more adjustable walls of the container 600 to access the interior of the container 600 to place the liner 650 therein. The user can then move (e.g., close) the one or more adjustable walls of the container 600 to seal the container 600. As described above, when a liner 650 including internal protrusions 630A, 630B, 630C is used, the container 600 may not include any internal protrusions. Portions of the rear surface 601, top surface 602, bottom surface 603, first side surface 604, second side surface 605, and front wall 606 of the container 600 may partially define the first compartment 670 and the interior cutout 672 defined therein and the second compartment 680 and the pocket 682 defined therein together with the liner 650. For example, in embodiments where the liner 650 does not include a front surface, when the liner 650 is inserted into the container 600, the inwardly facing front surface of the front wall 606 of the container 600 may partially define the first compartment 670 and the second compartment 680.

[0080] In embodiments, the container 600 and / or liner 650 may be shaped to hold the tubing 10 coupled to the radioembolic administration device 540 in a desired position within the pockets 622, 682 of the container 600 and / or liner 650, respectively. Figure 8 , which shows that according to some embodiments Figure 5 6, which can limit the volume of the bag 622, or in other words, keep the tube 10 coupled to the radioembolic administration device 540 at a specific position within the bag 622. For example, the front wall 606 of the container 600 may include a protrusion 690 that protrudes inward from the front wall 606 toward the bag 622. The protrusion 690 includes a first surface 692 and a second surface 694. The protrusion 690 may 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.

[0081] The interior of the protrusion 690 may be solid. That is, the area defined 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 may be 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 may 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 may 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 may be formed of the same material as the front wall 606 or other surfaces of the container 600.

[0082] Alternatively, the interior of the protrusion 690 may be hollow. That is, the area defined 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 may be empty. In an embodiment, the first surface 692 of the protrusion 690 and the second surface 694 of the protrusion 690 may 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 may be formed of the same material as the front wall 606 or other surfaces of the container 600.

[0083] In other embodiments, reference Fig. 9 (It shows Figure 5 ), the container 600 may include a contour 696 to maintain the tubing 10 coupled to the radioembolic administration device 540 in a desired position within the pocket 622 of the container 600. The contour 696 may be formed in the front wall 606 of the container 600. For example, the front wall 606 may 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 may at least partially define the internal cutout 612. The third portion 606C of the front wall 606 may at least partially define the pocket 622. The second portion 606B of the front wall 606 may connect the first portion 606A and the third portion 606C of the front wall 606. The third portion 606C of the front wall 606 may, for example, be formed in Fig. 9 The third portion 606C of the front wall 606 is offset from the first portion 606A of the front wall 606 in the y-axis direction of the coordinate axis of the α-axis, thereby forming a portion of the profile 696. The profile 696, more specifically, the third portion 606C of the front wall 606 limits the volume of the bag 622, or in other words, holds the tube 10 coupled to the radioembolization administration device 540 at a specific position within the bag 622.

[0084] Although the protrusions 690 and profiles 696 discussed above have been described as being formed in or from the front wall 606 of the container 600, the protrusions 690 and profiles 696 may similarly be formed in or from other surfaces or walls, such as the rear wall 601' of the container 600. Forming the protrusions 690 and / or profiles 696 in the front wall 606 and / or rear wall 601' may be particularly advantageous when the front wall 606 or rear wall 601' comprises a measurement-facing surface of the container 600. That is, when the protrusions 690 and / or profiles 696 are formed in or from the front wall 606 and / or rear wall 601', if the front wall 606 or rear wall 601' comprises a measurement-facing surface, the protrusions 690 and / or profiles 696 may enable the conduit 10 in the pocket 622 to maintain a known distance from the radioactivity measurement device in the measurement direction.

[0085] The protrusion 690 and / or the profile 696 may also be formed on the top wall 602' ( Figure 5 ) and / or bottom wall 603'. When top wall 602' ( Figure 5 ) or bottom wall 603' comprises the surface of container 600 facing the measurement, the top wall 602' ( Figure 5 ) or the bottom wall 603 ', it may be particularly advantageous. That is, when the protrusion 690 and / or the contour 696 is formed in the top wall 602 '( Figure 5 ) and / or the bottom wall 603' or from the top wall 602' ( Figure 5 ) and / or bottom wall 603' is formed, if top wall 602' ( Figure 5 ) or the bottom wall 603' is the surface facing the measurement, the protrusion 690 and / or the profile 696 can keep the pipe 10 in the bag-like member 622 at a known distance from the radioactivity measuring device along the measurement direction. The protrusion 690 and / or the profile 696 can also be formed in the second side wall 605' of the container 600. When the second side wall 605' or the first side wall 604' comprises the surface facing the measurement of the container 600, it can be particularly advantageous to form the protrusion 690 and / or the profile 696 in the second side wall 605'. That is, when the protrusion 690 and / or the profile 696 is formed in or from the second side wall 605', if the first side wall 604' or the second side wall 605' comprises the surface facing the measurement of the container 600, the protrusion 690 and / or the profile 696 can keep the pipe 10 in the bag-like member 622 at a known distance from the radioactivity measuring device.

[0086] refer to Figure 5 and Figure 7Although the bags 622 and 682 are described herein as specifically housing a conduit coupled to the radioembolic administration device 540, it should be understood that the bags 622 and 682 may include other objects in place of or in addition to the conduit. For example, after a treatment procedure, a user may place their gloves in the bags 622 or 682, which may or may not be contaminated with radioactive material. As another example, a user may place a towel in the bags 622 or 682 for absorbing spilled or leaked radioactive material. In general, after a treatment procedure, any item that may include or be contaminated with radioactive material and has little to no radioactive shielding properties may be placed in the bags 622 or 682 along with the conduit.

[0087] Reference now Fig.10 , depicts another container 700. The container 700 may be similar to the reference Figure 5 and Figure 6 The container 600 is discussed, except as described herein, for example with respect to the offset surfaces 706, 707. The container 700 includes a top surface 702, a bottom 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 ), which may be primarily parallel to the first rear surface 706 and the second rear surface 707 and orthogonal to the top surface 702 , the bottom surface 703 , the first side surface 704 and the second side surface 705 .

[0088] The container 700 includes a first compartment 710 and a second compartment 720. The first compartment 710 includes an internal cutout 712 sized and shaped to receive the outer periphery of the radioembolic administration device 540. The internal cutout 712 of the first compartment 710 is further sized and shaped to receive the outer periphery of the vial assembly 580, which can be partially received in the radioembolic administration device 540. The first compartment 710 can be partially defined by a first rear surface 706, a top surface 702, a bottom 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 top surface 702, the bottom surface 703, the first side surface 704 and the front wall 708 (see Fig.11 ) together define internal cutout 712.

[0089] The second compartment 720 defines a pocket 722 configured to receive the tubing 10 (i.e., the dose delivery line 10A, the contrast line 10B, and the flush line 10C) coupled to the radioembolization administration device 540. The second compartment 720 and the pocket 722 may be partially defined by the second rear surface 707, the top surface 702, the bottom surface 703, the second side surface 705, and the front wall 708 (see Fig.12 ). For example, the second compartment 720 may also be defined by the inner protrusions 730B and 730C. That is, with particular reference to the inner protrusion 730B, the first surface of the inner protrusion 730B may at least partially define the first compartment 710, and the second surface of the inner protrusion 730B may at least partially define the second compartment 720.

[0090] Reference now Fig.11 and Fig.12 , respectively showing the container 700 along Fig.10 Specifically, Fig.11 A cross-sectional view of the interior cutout 712 of the first compartment 710 is shown, and Fig.12A cross-sectional view of the bag-like member 722 of the second compartment 720 is shown. The container 700 includes a surface 607' facing measurement. For example, the front wall 708 defines the surface 607' facing measurement of the container 700. Therefore, the surface 607' facing measurement of the front wall 708 of the container 700 is closest to and faces the radioactivity measurement device 750, and the first rear surface 706 and the second rear surface 707 are arranged to be opposite to the surface 607' facing measurement. The radioactivity measurement device 750 is located outside the container 700 and is configured to measure the amount of radiation in the radioembolic application device 540, the vial assembly 580 that can be located therein, and the pipeline 10 connected to the radioembolic application device 540. The distance D3 between the front wall 708 (the surface 607' facing measurement in the illustrated embodiment) and the radioactivity measurement device 750 is. The first rear surface 706 of the internal cutout 712 defining the first compartment 710 is disposed opposite to 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, and the second rear surface 707 of the pocket 722 defining the second compartment 720 is disposed opposite to 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, wherein the second distance D2 is greater than the first distance D1. For example, the first rear surface 706 is spaced apart from the front wall 708 by a distance D1. The second rear surface 707 is spaced apart from the front wall 708 by a distance D2, which is greater than D1. In an embodiment, as shown, the second rear surface 707 is the absolute rear surface of the container 700. In other embodiments, the second rear surface 707 may be offset from the absolute rear surface of the container 700 by a certain distance. 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, the distance D2 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.

[0091] The first rear surface 706 is closer to the front wall 708 than the second rear surface 707, and therefore closer to the radioactivity measurement device 750, which effectively positions the radioembolic administration device 540 (including the vial assembly 580 that may be partially received therein) closer to the radioactivity measurement device 750 than the conduit 10 coupled to the radioembolic administration device 540. Notably, as discussed above, the radioembolic administration device 540 and / or the vial assembly 580 partially received therein may include a specially selected material to protect the user from the radioactive material therein. The conduit 10 coupled to the radioembolic administration device 540 may exhibit a reduced amount of shielding compared to the radioembolic administration device 540 and / or the vial assembly 580. Thus, components that exhibit increased absorption or shielding are positioned within the internal cutout 712 and are maintained at a closer distance to the radioactivity measurement device 750 than components that exhibit less absorption (i.e., the conduit 10), which are positioned within the pocket 722.

[0092] As discussed above, the measured radiation intensity or the amount of radiation exposed to the radioactivity measuring device 750 increases as the distance between the radiation source and the radioactivity measuring device 750 decreases. Therefore, the combined reduction in radiation emission intensity caused by the shielding properties of the materials of the radioembolization administration device 540 and / or the vial assembly 580 and the distance between the radioembolization administration device 540 and the vial assembly 580 that may be partially received therein and the radioactivity measuring device 750 may be equal to the combined reduction in radiation emission intensity caused by the shielding properties of the materials of the pipe 10 and the distance between the pipe 10 and the radioactivity measuring device 750. In other words, the radiation emission intensity of all radioactive materials within the container 700 may be reduced to the same extent regardless of whether they are contained in the radioembolization administration device 540, the vial assembly 580, or the pipe 10. That is, the difference in emission intensity reduction caused by the material properties of the radioembolization application device 540 and / or the vial assembly 580 and the pipeline 10 can be offset by the difference in emission intensity reduction caused by the distance between the radioembolization application device 540 and / or the vial assembly 580 and the radioactivity measuring device 750 and the distance between the pipeline 10 and the radioactivity measuring device 750.

[0093] It should be understood that in embodiments including an insertable liner within the container, e.g. Figure 7The liner 650 of the embodiment of the present invention may include a first rear surface 661 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 liner 650 may be a first distance from a measurement-facing surface of a container into which the liner 650 is inserted, and the second rear surface of the liner 650 may be a second distance from a measurement-facing surface of the container into which the liner 650 is inserted, the second distance being greater than the first distance. In an embodiment, the measurement-facing surface of the container may be a portion of a front wall such that the first rear surface of the liner 650 and the second rear surface of the liner 650 are disposed on a wall opposite to the wall of the measurement-facing surface of the container.

[0094] Reference now Fig.13 , a housing 800 is shown, which is configured to accommodate any of the containers 600, 700 described herein. The housing 800 may include a rear wall 801, a top wall 802, a bottom 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 a six-sided structure, it should be understood that the housing 800 may include more or fewer surfaces or walls, as long as the housing defines a volume capable of receiving a container according to any of the above embodiments.

[0095] The housing 800 may include one or more adjustable walls that are configured to close or open to allow a user to access the interior of the housing 800. For example, but not limited to, the top wall 802 may be fixed to the first side wall 804 by a hinge and may be selectively fixed to the second side wall 805 by a latch, an interference fit, a snap-fit ​​assembly, and / or the like. In an embodiment, the one or more adjustable walls may be removable from the housing 800. For example, but not limited to, the top wall 802 may be selectively fixed to both the first side wall 804 and the second side wall 805 by a fixing mechanism such as a latch, an interference fit, a snap-fit ​​assembly, and / or the like. The top wall 802 may be selectively fixed to the front wall 806 and the rear wall 801 as an alternative to or in addition to being fixed to the first side wall 804 and the second side wall 805. It should also be understood that any of the rear wall 801, bottom wall 803, first side wall 804, second side wall 805, and front wall 806 may be adjustable, e.g., secured by hinges, to another surface or wall, instead of or in addition to being secured to the top wall 802. Thus, in embodiments, a user may gain or block access to the interior of the housing 800 from the top, bottom, front, rear, or side walls. More specifically, a user may place a container (e.g., Figure 6 The container 600 shown in FIG. 1 ), along with a vial assembly 580 that may be partially received therein, and tubing 10 coupled to the radioembolization administration device 540 are placed within the housing 800 .

[0096] The housing 800 may be transparent so that the interior of the housing 800 can be seen through the wall of the housing 800. In an embodiment, the containers 600, 700 may be transparent. The housing 800 may be made of acrylic. The housing 800 may also be made of polycarbonate, polyethylene terephthalate, polyethylene terephthalate, polyvinyl chloride, cyclic olefin copolymer, polyethylene, polypropylene, styrene methyl methacrylate, styrene acrylonitrile, polystyrene, and / or methyl methacrylate acrylonitrile butadiene styrene.

[0097] The housing 800 may include a radiation shield 810 that extends partially along the housing 800. The radiation shield 810 is formed of a material that is configured to suppress radioactive emissions from radioactive materials within the housing 800, and more particularly, to suppress the release of radioactive materials from containers (e.g., Figure 6 The radioactive discharge of radioactive materials in the container 600 of the housing 800 is prevented. The radioactive shield 810 may be metal. The radioactive shield 810 may include any one of stainless steel, lead, tin, copper, pewter, and aluminum. The radioactive shield 810 may extend along any one of the rear wall 801, the top wall 802, the bottom wall 803, the first side wall 804, the second side wall 805, and the front wall 806. Typically, the radioactive 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. Therefore, it can be said that the measurement of the radiation in the housing 800 is performed "through" the measurement-facing surface of the housing 800. In an embodiment, the radioactive shield 810 may be formed integrally with the housing 800 so that the radioactive shield 810 forms a portion of the surface of the housing 800 along which the radioactive shield 810 extends. In an embodiment, the radiation shield 810 may be secured to a surface of the housing 800 along which the radiation shield 810 extends by any suitable adhesive or securing element.

[0098] refer to Figure 5 , Figure 6 , Fig.13 and Fig.14 , the radiation shield 810 extends along the housing 800, so 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. Therefore, the radiation shield 810 can be positioned so that the radiation from the second compartment 620 to the radiation measuring device passes through the radiation shield 810 of the housing 800, and the radiation from the first compartment 610 of the container 600 to the radiation measuring device does not pass through the radiation shield 810 of the housing 800. Therefore, in particular, as Fig.14As shown, the radioembolic administration device 540 (including the vial assembly 580 that may be partially received therein) is not covered by the radiation shield 810, and the conduit 10 coupled to the radioembolic administration device 540 is covered by the radiation shield 810. It is noteworthy that, as described above, the radioembolic administration device 540 and / or the vial assembly 580 partially received therein may include a specially selected material to protect the user from the radioactive material therein. The conduit 10 coupled to the radioembolic administration device 540 may exhibit a reduced amount of shielding compared to the radioembolic administration device 540 and / or the vial assembly 580. Therefore, components that exhibit increased absorption or shielding are not covered by the radiation shield 810, while components that exhibit less absorption are covered by the radiation shield 810. In particular, the radiation shield 810 may be selected so that all radioactive materials within the container 600 (whether or not contained in the radioembolic administration device 540, the vial assembly 580, or the conduit 10) may be shielded to the same extent. That is, the difference in the reduction of the radiation emission intensity caused by the material properties of the radioembolization administration device 540 and / or the vial assembly 580 and the material properties of the pipeline 10 can be offset by the radiation shield 810 covering the pipeline 10. In other words, the radiation discharged from the second compartment 620 to the radiation measuring device 750 must pass through the radiation shield 810 of the housing 800, while the radiation discharged from the first compartment 610 to the radiation measuring device 750 does not pass through the radiation shield 810 of the housing 800.

[0099] Reference now Figure 5 , Figure 6 , Fig.14 and Fig.15 , a method 900 for measuring the amount of radiation within a radioembolic administration device 540 and a conduit 10 in fluid communication with the radioembolic administration device 540 will be described. At block 902 of the method 900, a user removes the radioembolic administration device 540 (which may include a vial assembly 580 partially received therein) and the conduit 10 coupled to the radioembolic administration device 540 (see FIG. 1 ). Figure 1 In particular, after a treatment procedure or after administration of at least some of the initial radioactive dose pre-loaded within vial assembly 580, radioembolic administration device 540 (which may include vial assembly 580 partially received therein) and tubing 10 coupled to radioembolic administration device 540 are removed from delivery device 500.

[0100] At block 904 of the method 900, the user places the radioembolic administration device 540 (which may include the vial assembly 580 partially received therein) and the tubing 10 coupled to the radioembolic administration device 540 in the container 600 (or other container described herein). More specifically, the radioembolic administration device 540 (which may include the vial assembly 580 partially received therein) is placed in the internal cutout 612 of the first compartment 610, and the tubing 10 coupled to the radioembolic administration device 540 is placed in the pocket 622 of the second compartment 620. As described above, the internal cutout 612 is sized and shaped to receive the outer periphery of the radioembolic administration device 540 and the vial assembly 580 that may be partially received therein, so that the radioembolic administration device 540 and the vial assembly 580 that may be partially received therein may be repeatedly placed within the container 600.

[0101] It should be understood that the radioembolic administration device 540 (which may include the vial assembly 580 partially received therein) and the tubing 10 coupled to the radioembolic administration device 540 may be placed in any of the above-described containers. That is, in an embodiment, the container 600 may optionally include a protrusion 690 (see Figure 8 ) or profile 696 (see Fig. 9 ). In addition, in an embodiment, the radioembolic administration device 540 (which may include the vial assembly 580 partially received therein) and the tubing 10 coupled to the radioembolic administration device 540 may be placed in the container 700 (see Figure 10-12 In an embodiment, a user may first place the radioembolic administration device 540 (which may include the vial assembly 580 partially received therein) and the tubing 10 coupled to the radioembolic administration device 540 in the liner 650 (see Figure 7 ), and then place the liner 650 in the container 600.

[0102] At block 906 of method 900, the user may place the container 600 in the housing 800. As described above, the housing 800 may include a radiation shield 810 extending partially along the housing 800 such that the second compartment 620 of the container 600 is covered by the radiation shield 810 and the first compartment 610 of the container 600 is not covered by the radiation shield 810.

[0103] At block 908 of method 900, a user may measure the amount of radiation within the radioembolic administration device 540 (which may include a vial assembly 580 partially received therein) and the tubing 10 coupled to the radioembolic administration device 540 using a radioactivity measurement device 750. The radioactivity measurement device 750 may be any device suitable for detecting and measuring radiation. The radioactivity measurement device 750 may be a Geiger counter, an ionization chamber, a proportional counter, a gas-filled detector, a scintillation counter, a semiconductor detector, or other suitable device. The radioactivity measurement device 750 may be disposed outside of the container 600 and the housing 800 and separated from the container 600 and the housing 800. The radioactivity measurement device 750 is configured to measure the amount of radiation within the radioembolic administration device 540 (which may include a vial assembly 580 partially received therein) and the tubing 10 coupled to the radioembolic administration device 540 using the radioactivity measurement device 750 to "penetrate" the measurement-facing surfaces of the container 600 and the housing 800. The radioactivity measurement device 750 is specifically configured to determine a single measurement of the total amount of radioactivity within the radioembolic administration device 540 (which may include a vial assembly 580 partially received therein) and the tubing 10 coupled to the radioembolic administration device 540. The units of the radioactivity measurement device 750 for the amount of radioactivity within the radioembolic administration device 540 (which may include a vial assembly 580 partially received therein) and the tubing 10 coupled to the radioembolic administration device 540 may be Curies, Becquerels, counts per minute, rems per hour, sieverts per hour, etc., depending on the specific radioactivity measurement device 750 employed.

[0104] As described above, the difference between the material properties of the radioembolic administration device 540 and / or the vial assembly 580 included therein and the material properties of the conduit 10 may result in different shielding or attenuation of the radiation within the radioembolic administration device 540 and / or the vial assembly 580 included therein and the conduit 10. Therefore, using conventional systems and methods, the measurement of the total radiation within the radioembolic administration device 540 and the vial assembly 580 that may be included therein and the conduit 10 may be inaccurate. In addition, as described above, using conventional systems and methods, the measurement of the total radiation within the radioembolic administration device 540, the vial assembly 580 that may be included therein and the conduit 10 may be inaccurate due to the different placement positions of the components within the measuring device and the different distances between the various components and the radiation measuring device 750.

[0105] The system 1000 and method 900 described herein address the above challenges and allow accurate measurement of the total amount of radiation within the radioembolic administration device 540 (including the vial assembly 580 that may be included therein) and the tubing 10 coupled to the radioembolic administration device 540. In particular, the above-described container (e.g., container 600) can allow for accurate and repeatable placement of the radioembolic administration device 540 (including the vial assembly 580 that may be included therein) and the tubing 10 coupled to the radioembolic administration device 540. In addition, differences in the reduction of radiation emission intensity caused by the material properties of the radioembolic administration device 540 and / or the vial assembly 580 included therein and the material properties of the tubing 10 can be offset by the positioning of the radioembolic administration device 540 (including the vial assembly 580 that may be included therein) and the tubing 10 coupled to the radioembolic administration device 540 and / or the radiation shield 810 of the housing 800. That is, in order to reduce the radiation emission intensity of radiation in the tubing 10 to the same extent as the radiation in the radioembolization administration device 540 (including the vial assembly 580 that may be partially received therein), the tubing 10 can be positioned within a container (e.g., container 600) and positioned at a known distance from the radioactivity measuring device 750 that is farther than the radioembolization administration device 540, and / or the radioactivity shield 810 can be located between the tubing 10 and the radioactivity measuring device 750.

[0106] That is, in some embodiments, the greater distance between the conduit 10 and the radioactivity measuring device 750 compared to the radioembolization administration device 540 and the vial assembly 580 that may be positioned therein, and the shielding of the conduit 10 provided by the radioactivity shield 810 may be combined to reduce the intensity of radiation emissions within the conduit 10 to the same extent as radiation within the radioembolization administration device 540 and the vial assembly 580 that may be partially received therein.

[0107] In other embodiments, the distance between tubing 10 and radioactivity measuring device 750 is greater than that between radioembolic administration device 540 and vial assembly 580 that may be positioned therein, and radioactivity measuring device 750 alone is sufficient to reduce the intensity of radiation emissions within tubing 10 to the same extent as that within radioembolic administration device 540 and vial assembly 580 that may be partially received therein. In such embodiments, for example, radioembolic administration device 540 (including vial assembly 580 that may be partially received therein) and tubing 10 may be placed in container 700 (see Figure 10-12), rather than being placed in housing 800 prior to measurement by radioactivity measuring device 750. Alternatively, in such an embodiment, radioembolic administration device 540 (including vial assembly 580 that may be partially received therein) and tubing 10 may be placed in container 700 (see Figure 10-12 ), the container can be placed in the housing 800 before being measured by the radiation measuring device 750. However, in these cases, the housing 800 does not need to include a radiation shield 810 to further attenuate the radiation within the pipeline 10.

[0108] In other embodiments, the shielding of the tubing 10 provided by the radiation shield 810 alone is sufficient to reduce the intensity of radiation emissions within the tubing 10 to the same extent as the radiation within the radioembolic administration device 540 and the vial assembly 580 that may be partially received therein. In such embodiments, for example, a container (e.g., container 600) in which the radioembolic administration device 540 (including the vial assembly 580 that may be partially received therein) and the tubing 10 may be placed may hold the radioembolic administration device 540 (including the vial assembly 580 that may be partially received therein) and the tubing 10 at approximately the same distance from the measurement-facing surface of the container 600. The container 600 may then be placed in the housing 800 (with the radiation shield 810 partially extending along the housing 800) such that the second compartment 620 of the container 600 is covered by the radiation shield 810 and the first compartment 610 of the container 600 is not covered by the radiation shield 810.

[0109] Since the systems 1000 and methods 900 herein allow for an equal reduction in radiation emission intensity within the tubing 10 and within the radioembolic administration device 540 and the vial assembly 580 that may be partially received therein, a single correction factor may be applied to the raw measurements by the radioactivity measurement device 750 to obtain the true amount of radiation within the tubing 10, the radioembolic administration device 540, and the vial assembly 580. By determining the amount of radiation remaining in the radioembolic administration device 540 (including the vial assembly 580 that may be received therein) and the tubing 10 coupled to the radioembolic administration device 540 after a treatment procedure, a user may determine the percentage of the preloaded radioactive dose within the vial body 589 that was actually delivered to the patient. If less than 80% of the preloaded dose is delivered to the patient, it may be determined that an error or misadministration event has occurred during the treatment procedure.

[0110] Some embodiments have been described in which the measurement of the amount of radiation in the radioembolic administration device 540 and / or the vial assembly 580 partially received therein is performed "through" the side wall 546 of the radioembolic administration device 540. That is, the surface of the radioembolic administration device 540 that faces the measurement, or the surface of the radioembolic administration device 540 that is closest to and faces the radioactivity measurement device 750 is depicted herein as the side wall 546. However, it should be recognized that this is a non-limiting example. That is, when placed in the housing 800 or otherwise positioned for measurement by the radioactivity measurement device 750, the specific shape of the internal cutout of any of the above-mentioned containers and / or liners (e.g., see Figure 6 The inner cutout 612 of the container 600) and / or any of the above containers (e.g., see Figure 6 The container 600 of the embodiment of the present invention can be oriented so that the surface of the radioembolic administration device 540 that faces the measurement is the top surface 548 of the radioembolic administration device 540. In such an embodiment, by measuring the amount of radiation in the vial assembly 580 that passes through the opening of the vial chamber 558, the effect of the material properties of the radioembolic administration device 540 on the shielding of radiation within the vial assembly 580 can be reduced.

[0111] III. List of aspects

[0112] The embodiments may be described with reference to the following numerical terms:

[0113] Aspect 1. A radiation delivery determination system, comprising: a container, the container comprising: a first compartment, the first compartment defining an internal incision, the size and shape of the internal incision being configured to receive the periphery of a radioembolic administration device; and a second compartment, the second compartment defining a bag-like member, the bag-like member being configured to receive a tube, wherein the tube is fluidically connected to the radioembolic administration device and attached to the radioembolic administration device; and a radioactivity measurement device, the radioactivity measurement device being located outside the container and configured to measure the amount of radiation within the radioembolic administration device and the tube.

[0114] Aspect 2. The radiation delivery determination system according to aspect 1, wherein the container receives the periphery of the radioembolization administration device and the conduit is disposed within the pocket of the second compartment of the container.

[0115] Aspect 3. The radiation delivery determination system according to any preceding aspect, wherein the radioembolization administration device is disposed within the internal cutout of the first compartment of the container.

[0116] Aspect 4. A radiation delivery determination system according to any of the preceding aspects, wherein: the container also includes a measurement-facing surface; the first rear surface of the internal incision defining the first compartment is arranged to be opposite to the measurement-facing surface of the container and spaced apart from the measurement-facing surface of the container by a first distance; and the second rear surface of the bag-like member defining the second compartment is arranged to be opposite to the measurement-facing surface of the container and spaced apart from the measurement-facing surface of the container by a second distance, wherein the second distance is greater than the first distance.

[0117] Aspect 5. The radiation delivery determination system according to any preceding aspect, wherein the measurement-facing surface of the container is closest to and faces the radioactivity measurement device.

[0118] Aspect 6. The radiation delivery determination system according to any preceding aspect, further comprising a housing, wherein the housing is configured to accommodate the container.

[0119] Aspect 7. The radiation delivery determination system according to any preceding aspect, wherein the housing further comprises a radiation shield extending partially along the housing.

[0120] Aspect 8. A radiation delivery determination system according to any of the preceding aspects, wherein the radiation shield is positioned so that: radiation from the second compartment to the radiation measuring device passes through the radiation shield of the shell; and radiation from the first compartment to the radiation measuring device does not pass through the radiation shield of the shell.

[0121] Aspect 9. A radiation delivery determination system according to any preceding aspect, wherein the shell is transparent so that the interior of the shell can be seen through the wall of the shell, and the container is transparent so that the interior of the container can be seen through the wall of the container.

[0122] Aspect 10. The radiation delivery determination system according to any preceding aspect, wherein the radioactivity measurement device is a Geiger counter.

[0123] Aspect 11. A radiation delivery determination system, the radiation delivery determination system comprising: a container, the container comprising: a first compartment, the first compartment defining an internal cutout, the size and shape of the internal cutout being configured to receive the periphery of a radioembolic administration device, wherein: the radioembolic administration device includes a vial for at least partial administration of a radioactive therapeutic substance; and a second compartment, the second compartment defining a bag-like member, the bag-like member being configured to receive a tube, wherein the tube is fluidically connected to and attached to the radioembolic administration device, wherein: the tube is disposed within the bag-like member of the second compartment of the container; and the tube includes at least a first tube for administering the radioactive therapeutic substance from the vial; and a Geiger counter, the Geiger counter being located outside the container and configured to measure the total amount of radiation within the radioembolic administration device and the tube.

[0124] Aspect 12. A radiation delivery determination system according to Aspect 11, wherein: the container also includes a measurement-facing surface, wherein the measurement-facing surface of the container is closest to and faces the Geiger counter; the first rear surface of the internal incision defining the first compartment is arranged to be opposite to the measurement-facing surface of the container and to be spaced apart from the measurement-facing surface of the container by a first distance; and the second rear surface of the bag-like member defining the second compartment is arranged to be opposite to the measurement-facing surface of the container and to be spaced apart from the measurement-facing surface of the container by a second distance, wherein the second distance is greater than the first distance.

[0125] Aspect 13. The radiation delivery determination system according to any preceding aspect, wherein the container is transparent such that the interior of the container can be seen through the wall of the container.

[0126] Aspect 14. A radiation delivery determination system according to any of the preceding aspects, wherein the radiation delivery determination system also includes a shell, wherein: the shell is configured to accommodate the container; the shell also includes a radiation shield extending partially along the shell, wherein the radiation shield is positioned so that: radiation from the second compartment to the Geiger counter passes through the radiation shield of the shell; and radiation from the first compartment to the Geiger counter does not pass through the radiation shield of the shell.

[0127] Aspect 15. The radiation delivery determination system according to any preceding aspect, wherein the housing is transparent such that the interior of the housing can be seen through the wall of the housing.

[0128] Aspect 16. A method for measuring the amount of radiation within a radioembolic application device and a tube in fluid communication with the radioembolic application device, the method comprising: placing the radioembolic application device and the tube into a container, the container comprising: a first compartment, the first compartment defining an internal incision, the size and shape of the internal incision being configured to receive the outer periphery of the radioembolic application device, wherein: the radioembolic application device is placed within the internal incision of the first compartment; a second compartment, the second compartment defining a bag-like member, the bag-like member being configured to receive the tube, wherein the tube is placed within the bag-like member of the second compartment; and measuring the amount of radiation within the radioembolic application device and the tube using a radiation measuring device disposed outside the container and separated from the container.

[0129] Aspect 17. A method according to Aspect 16, wherein: the container also includes a measurement-facing surface, wherein the measurement-facing surface of the container is closest to and faces the radioactivity measuring device; the first rear surface of the internal incision defining the first compartment is arranged to be opposite to the measurement-facing surface of the container and to be spaced apart from the measurement-facing surface of the container by a first distance; and the second rear surface of the bag-like member defining the second compartment is arranged to be opposite to the measurement-facing surface of the container and to be spaced apart from the measurement-facing surface of the container by a second distance, wherein the second distance is greater than the first distance.

[0130] Aspect 18. A method according to any of the preceding aspects, the method also includes placing the container in a shell, the shell including a radiation shield extending partially along the shell, wherein the radiation shield is positioned so that: radiation from the second compartment to the radiation measuring device passes through the radiation shield of the shell; and radiation from the first compartment of the container to the radiation measuring device does not pass through the radiation shield of the shell.

[0131] Aspect 19. The method of any preceding aspect, wherein the radiation shield comprises at least one of stainless steel, aluminum, or pewter, and the housing comprises an acrylic material.

[0132] Aspect 20. The method according to any preceding aspect, wherein the radioactivity measuring device is a Geiger counter.

[0133] It should now be understood that embodiments of the present disclosure relate to a radiation delivery determination system for determining the amount of radiation within a radioembolic administration device (including a vial assembly that can be received therein) and a tubing coupled to the radioembolic administration device. The radiation delivery determination system includes a container. The container includes: a first compartment, the first compartment defining an internal cutout, the internal cutout being sized and shaped to receive the periphery of the radioembolic administration device; a second compartment, the second compartment defining a pocket configured to receive the tubing. In an embodiment, in order to standardize the reduction of the radiation emission intensity of the radiation contained within the radioembolic administration device and / or the vial assembly and the tubing, a first rear surface of the first compartment disposed opposite to the measurement-facing surface of the container is spaced apart from the measurement-facing surface of the container by a first distance, and a second rear surface of the second compartment disposed opposite to the measurement-facing surface of the container is spaced apart from the measurement-facing surface of the container by a second distance, wherein the second distance is greater than the first distance. The measurement-facing surface of the container is closest to and faces the radioactivity measurement device. In an embodiment, in order to standardize the reduction of the radiation emission intensity of the radiation contained within the radioembolization administration device and / or vial assembly and tubing, 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 does not cover the first compartment of the container.

[0134] It should be noted that the terms "substantially" and "approximately" may be used herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0135] For purposes of describing and defining the present disclosure, it should be noted that the term "substantially" is used herein to indicate the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The term "substantially" is also used herein to indicate the degree to which a quantitative representation may be varied from a stated reference without resulting in a change in the basic function of the subject matter in question. Thus, the term is used to indicate the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation involving an arrangement of elements or features that, while in theory would be expected to exhibit an exact correspondence or behavior, may in practice manifest some less-than-exact correspondence or behavior.

[0136] Although specific embodiments have been shown and described herein, it will be appreciated that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. In addition, although various aspects of the claimed subject matter have been described herein, these aspects need not be used in combination. Therefore, it is intended that the appended claims cover all such changes and modifications that fall within the scope of the claimed subject matter.

Claims

1. A radiation delivery determination system, comprising: A container, comprising: a first compartment defining an interior cutout sized and shaped to receive an outer periphery of a radioembolic administration device; and a second compartment defining a pocket configured to receive a tubing, wherein the tubing is in fluid communication with and attached to the radioembolic administration device; and A radioactivity measuring device is located outside the container and is configured to measure the amount of radioactivity within the radioembolization administration device and the conduit.

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

3. The radiation delivery determination system of claim 1, wherein: The radioembolization administration device is disposed within the interior cutout of the first compartment of the container.

4. The radiation delivery determination system of claim 1, wherein: The container also includes a surface facing the measurement; a first rear surface of the interior cutout defining the first compartment disposed opposite the measurement-facing surface of the container and spaced a first distance from the measurement-facing surface of the container; and A second rear surface of the pocket defining the second compartment is disposed opposite the measurement-facing surface of the container and is spaced a second distance therefrom, wherein the second distance is greater than the first distance.

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

6. The radiation delivery determination system of claim 1, further comprising a housing, wherein: The housing is configured to accommodate the container.

7. The radiation delivery determination system of claim 6, wherein: The housing also includes a radiation shield extending partially along the housing.

8. The radiation delivery determination system of claim 7, wherein: The radiation shield is positioned such that: Radiation from the second compartment to the radioactivity measuring device passes through the radioactivity shield of the housing; and Radiation from the first compartment to the radioactivity measuring device does not pass through the radioactivity shield of the housing.

9. The radiation delivery determination system of claim 6, wherein: The housing is transparent so that the interior of the housing can be seen through the wall of the housing, and the container is transparent so that the interior of the container can be seen through the wall of the container.

10. The radiation delivery determination system of claim 1, wherein: The radioactivity measuring device is a Geiger counter.

11. A radiation delivery determination system comprising: A container, comprising: a first compartment defining an interior cutout sized and shaped to receive an outer periphery of a radioembolization administration device, wherein: The radioembolization administration device includes a vial of at least a portion of the administration of the radiotherapeutic substance; and a second compartment defining a pocket configured to receive a tube, wherein the tube is in fluid communication with and attached to the radioembolic administration device, wherein: The conduit is disposed within the pocket of the second compartment of the container; and The conduit comprises at least a first tube for administering a radioactive therapeutic substance from the vial; and A Geiger counter is located outside of the container and is configured to measure the total amount of radiation within the radioembolization administration device and the tubing.

12. The radiation delivery determination system of claim 11, wherein: The container further includes a measurement-facing surface, wherein the measurement-facing surface of the container is closest to the Geiger counter and faces the Geiger counter; a first rear surface defining the interior cutout of the first compartment disposed opposite and spaced a first distance from the measurement-facing surface of the container; and A second rear surface of the pocket defining the second compartment is disposed opposite the measurement-facing surface of the container and is spaced a second distance therefrom, wherein the second distance is greater than the first distance.

13. The radiation delivery determination system of claim 11, wherein: The container is transparent so that the interior of the container can be seen through the wall of the container.

14. The radiation delivery determination system of claim 11, further comprising a housing, wherein: The housing is configured to accommodate the container; The housing further comprises a radiation shield extending partially along the housing, wherein the radiation shield is 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.

15. The radiation delivery determination system of claim 14, wherein: The housing is transparent so that the interior of the housing can be seen through the wall of the housing.

16. A method of measuring the amount of radiation within a radioembolic administration device and a conduit in fluid communication with the radioembolic administration device, the method comprising: The radioembolization administration device and the tubing are placed in a container, the container comprising: a first compartment defining an interior cutout sized and shaped to receive an outer periphery of the radioembolization administration device, wherein: the radioembolization administration device is placed within the interior incision of the first compartment; a second compartment defining a pocket configured to receive the tubing, wherein the tubing is disposed within the pocket of the second compartment; and The amount of radiation within the radioembolization administration device and the conduit is measured using a radiation measuring device disposed outside of the container and spaced apart from the container.

17. The method of claim 16, wherein: The container further comprises a measurement-facing surface, wherein the measurement-facing surface of the container is closest to the radioactivity measuring device and faces the radioactivity measuring device; a first rear surface defining the interior cutout of the first compartment disposed opposite and spaced a first distance from the measurement-facing surface of the container; and A second rear surface of the pocket defining the second compartment is disposed opposite the measurement-facing surface of the container and is spaced a second distance therefrom, wherein the second distance is greater than the first distance.

18. The method of claim 16, further comprising placing the container in a housing including a radiation shield extending partially along the housing, wherein: The radiation shield is positioned such that: Radiation from the second compartment to the radioactivity measuring device passes through the radioactivity shield of the housing; and Radiation from the first compartment of the container to the radioactivity measuring device does not pass through the radioactivity shield of the housing.

19. The method according to claim 18, wherein: The radiation shield comprises at least one of stainless steel, aluminum, or pewter, and the housing comprises an acrylic material.

20. The method according to claim 16, wherein: The radioactivity measuring device is a Geiger counter.

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