Radiation delivery determination assemblies, systems, and methods utilizing a radiation shield

Abstract

A radiation shield assembly includes a radioembolization delivery device and a radiation shield. The radioembolization delivery device includes a radiation sensor, a vial assembly, a radioembolization administration set containing the vial assembly, and delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set. The radiation shield includes a solid portion configured to block radiation. The solid portion includes an interior facing wall that defines an aperture. The solid portion and aperture of the radiation shield are sized such that, radiation emanating at a first angle from the radioembolization administration set and vial assembly passes through the aperture to the radiation sensor, and radiation emanating from a second angle from the delivery line tubing, the second angle distally below the first angle, is blocked by the solid portion of the radiation shield and does not pass through the aperture to the radiation sensor.

Description

RADIATION DELIVERY DETERMINATION ASSEMBLIES, SYSTEMS, AND METHODS UTILIZING A RADIATION SHIELDTECHNICAL FIELD

[0001] The present disclosure generally relates to components of medical devices for treating diseases such as cancer, and more particularly to assemblies, systems, and methods for determining an amount of radiation remaining in an administration set of a medical treatment device.BACKGROUND

[0002] A radioembolization delivery device is a medical device configured to deliver radioactive compounds to a treatment area within a patient’s body in procedures such as transarterial radioembolization. The radioactive compounds may be a solution of saline and radioactive microspheres (as particulate) mixed in a vial assembly delivered to the patient through a delivery line disposed between the delivery device and the patient. In treatments involving radiation therapy, such as cancer treatments, misadministration of a radioactive dose may compromise the efficacy of a treatment procedure. Therefore, in order to ensure that a predetermined amount of radiation has been administered to a patient, an amount of radiation still remaining in a medical treatment device may be measured following a treatment operation. However, due to the specific geometries of various components of the medical treatment device, particularly radiation measured from administered radioactive microspheres in the delivery line, it may be difficult to obtain accurate and repeatable measurements of the amount of radiation remaining in the vial of the medical treatment device following a treatment procedure.

[0003] Accordingly, a need exists for systems and methods for reproducibly and accurately determining an amount of radiation remaining in the administration set of a medical treatment device after at least a portion of the therapeutic has been delivered to the delivery line.SUMMARY

[0004] In accordance with an embodiment of the disclosure, a radiation shield assembly may include a radioembolization delivery device and a radiation shield. The radioembolization delivery device includes a radiation sensor, a vial assembly, a radioembolization administration set containing the vial assembly, and delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set. The radiation shield includes a solid portion configured to block radiation. The solid portion includes an exterior facing wall, an interior facing wall, a forward facing wall, and a rear facing wall. The exterior facing wall and the interior facing wall are disposed between the forward facing wall and the rear facing wall and the interior facing wall defines an aperture. The solid portion and the aperture of the radiation shield are sized such that, when the forward facing wall is directed toward the radioembolization administration set in a first position, and the rear facing wall is directed toward the radiation sensor that is disposed adjacent to the aperture in the first portion, the radiation emanating at a first angle from the radioembolization administration set and vial assembly passes through the aperture to the radiation sensor, and the radiation emanating from a second angle from the delivery line tubing, the second angle distally below the first angle, is blocked by the solid portion of the radiation shield and does not pass through the aperture to the radiation sensor.

[0005] In another embodiment, a delivery system may include a console assembly, a radioembolization administration set, a delivery line tubing, a radiation sensor, and a radiation shield. The console assembly includes a base and a vial containment region. The radioembolization administration set is removably couplable to the console assembly at the vial containment region and contains a vial assembly. The delivery line tubing is in fluid communication with and disposed distally below the radioembolization administration set. The delivery line tubing is configured for administering radioactive therapeutic material from the radioembolization administration set. The radiation sensor is coupled to the base. The radiation shield includes a solid portion configured to block radiation. The solid portion includes an exterior facing wall, an interior facing wall, a forward facing wall, and a rear facing wall. The exterior facing wall and the interior facing wall are disposed between the forward facing wall and the rear facing wall, and the interior facing wall defines an aperture. The solid portion and the aperture of the radiation shield are sized such that, when the forward facing wall is directed toward the radioembolization administration set in a first position, and the rear facing wall is directed towardthe radiation sensor that is disposed adjacent to the aperture in the first portion, the radiation emanating at a first angle from the radioembolization administration set and vial assembly passes through the aperture to the radiation sensor, and the radiation emanating from a second angle from the delivery line tubing, the second angle distally below the first angle, is blocked by the solid portion of the radiation shield and does not pass through the aperture to the radiation sensor.

[0006] In yet another embodiment, a method of measuring an amount of radiation within a radioembolization administration set may include detecting, with a radiation sensor and through a radiation shield, the amount of radiation within the radioembolization administration set. A vial assembly is contained within the radioembolization administration set. The method may also include blocking, with the radiation shield, radiation from a deliver line tubing in fluid communication with and disposed distally below the radioembolization administration set. The radiation shield is positioned between the radiation sensor and the radioembolization administration set. The radiation shield is positioned between the radiation sensor and the delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set. The radiation shield includes a solid portion configured to block radiation. The solid portion includes an exterior facing wall, an interior facing wall, a forward facing wall, and a rear facing wall. The exterior facing wall and the interior facing wall are disposed between the forward facing wall and the rear facing wall, and the interior facing wall defines an aperture. The solid portion and the aperture of the radiation shield are sized such that, when the forward facing wall is directed toward the radioembolization administration set in a first position and the rear facing wall is directed toward the radiation sensor that is disposed adjacent to the aperture in the first portion, the radiation emanating at a first angle from the radioembolization administration set and vial assembly passes through the aperture to the radiation sensor, and the radiation emanating from a second angle from the delivery line tubing, the second angle distally below the first angle, is blocked by the solid portion of the radiation shield and does not pass through the aperture to the radiation sensor.

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

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

[0009] FIG. 2 is a cross-sectional view of the radioembolization administration set of FIG. 1, according to one or more embodiments shown and described herein, the cross-section along line 2-2 of FIG. 1;

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

[0011] FIG. 4 is a perspective view of the radioembolization administration set of FIG. 1 with the vial assembly of FIG. 3 received therein, with a series of delivery lines coupled to the radioembolization administration set, according to one or more embodiments shown and described herein;

[0012] FIG. 5 is a partial perspective view of the delivery device of FIG. 1 including a mechanical assembly according to one or more embodiments shown and described herein;

[0013] FIG. 6 is a cross-sectional view of the delivery device of FIG. 1 with the radioembolization administration set of FIG. 4 received therein and including a radiation shield, according to one or more embodiments shown and described herein;

[0014] FIG. 7 is a partial perspective view of the radiation sensor, radiation shield and vial assembly in a first position, according to one or more embodiments shown and described herein;

[0015] FIG. 8 an isolated view of the radiation shield of FIG. 7, according to one or more embodiments shown and described herein; and

[0016] FIG. 9 is a flowchart for measuring an amount of radiation within a radioembolization administration set using a radiation sensor and radiation shield, according to one or more embodiments shown and described herein.DETAILED DESCRIPTION

[0017] Reference will now be made in detail to various embodiments of radiation shields for use in determining an amount of radiation remaining in the administration set of a medical treatment device after at least a portion of the therapeutic has been delivered to the delivery line, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts. Directional terms as used herein — for example up, down, right, left, front, back, top, bottom, distal, and proximal — are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

[0018] Ranges can be expressed herein as from “about” one particular value, and / or to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0019] Unless otherwise expressly stated, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred, in any respect. This holds for any possible non-express basis for interpretation, including: matters of logic with respect to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of embodiments described in the specification.

[0020] As used herein, the terms “horizontal,” “vertical,” “distal” and “proximal” are relative terms only, are indicative of a general relative orientation only, and do not necessarily indicate perpendicularity. These terms also may be used for convenience to refer to orientations used in the figures, which orientations are used as a matter of convention only and are not intended ascharacteristic of the devices shown. The present disclosure and the embodiments thereof to be described herein may be used in any desired orientation. Moreover, horizontal and vertical walls need generally only be intersecting walls, and need not be perpendicular. As used herein, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0021] In embodiments described herein, a particulate material delivery assembly for which an amount of radiation may be determined as described in greater detail further below may include a radioembolization administration set. A radioembolization administration set comprises a medical device such as a medical treatment device configured to deliver radioactive compounds to a treatment area within a patient’s body in procedures such as transarterial radioembolization. The radioactive compounds may be a mixed solution of saline and radioactive microspheres (i.e., a particulate) mixed in a vial of a vial assembly. The needle may include one or more ports as an outlet to inject fluid (i.e., saline), such as from a syringe or catheter line, into a vial including the radioactive microspheres to generate the mixed solution and as an inlet to deliver the mixed solution to the patient.

[0022] Also in embodiments described herein and described in greater detail further below with respect to at least FIGS. 6-9, a radiation delivery determination system for determining an amount of radiation within the radioembolization administration set after at least a portion of the therapeutic has been delivered may include the vial assembly received therein, tubing coupled to the radioembolization administration set, shielding for the radioactive therapeutic, a radiation sensor and a radiation shield. The shielding of the radioactive therapeutic may be reduced when the radioactive therapeutic leaves the administration set and enters the delivery line. In embodiments, the radiation shield includes a solid portion configured to block radiation such that radioactive emissions from the vial assembly and administration set, which emanate at a first angle, pass through an aperture of the shield to be measured by the radiation sensor, and radioactive emissions from the delivery line, which emanate at a second angle, are blocked by a solid portion of the shield and not registered by the sensor.

[0023] FIGS. 1-5 described below are directed to an embodiment of a delivery device to deliver a particulate, and FIGS. 6-9 described in greater detail further below are directed to embodiments of one or more systems and methods with a radiation shield to assist with determining an amount of radiation within at least a portion of the delivery device after at least a portion of the therapeutichas been delivered. In some embodiments, as described in greater detail below, the delivery device is a radioembolization delivery device, the particulate is a plurality of radioembolization beads, the fluid is a saline solution, and the resulting mixed fluid (e.g., the mixed fluid solution) is a radioembolization beads-saline solution. The needle may be configured to deliver the radioembolization beads-saline solution as the mixed fluid solution through the radioembolization delivery device, such as upon actuation of the vial engagement mechanism in the positive pressure direction. In some embodiments, the fluid is a contrast-saline solution including a contrast agent, and the resulting mixed fluid (e.g., the mixed fluid solution) is a radioembolization beads-contrast- saline solution. The needle may be configured to deliver the radioembolization beads-contrast- saline solution as the mixed fluid solution through the radioembolization delivery device. In some embodiments, the delivery device is a chemoembolization delivery device, the particulate is a plurality of chemoembolization beads, and the mixed fluid solution is a beads-saline solution or a beads-contrast-saline solution.I. Mechanical Delivery Device with Removable Radioembolization Administration Set

[0024] FIGS. 1 and 2 show an embodiment of a delivery device 500 that is configured and operable to deliver a radioactive material (e.g., radioembolizing beads) while reducing radioactive emissions during use of the delivery device 500. The delivery device 500 may operate as described in International PCT App. No. PCT / 2019 / 033001, filed May 17, 2019, the entirety of which is incorporated herein.

[0025] Referring initially to FIG. 1, the delivery device 500 comprises a console assembly 510, which includes a console. The delivery device 500 may include a radioembolization administration set 540 that is operable to transition between a coupled state and decoupled state relative to the console assembly 510. The console assembly 510 of the delivery device 500 comprises a base 512 defined by and extending between a proximal end 514 and a distal end 516. The proximal end 514 of the base 512 includes a handle (delivery handle) 528 movably coupled to the console assembly 510 and an interface display 530 positioned on the console assembly 510.

[0026] The proximal end 514 of the base 512 further includes an attachment device 538 that is configured to securely retain an external device to the base 512 of the console assembly 510. The attachment device 538 is operable to facilitate an attachment of a complimentary device to the console assembly 510 for use with the delivery device 500 during a procedure.

[0027] Still referring to FIG. 1, the distal end 516 of the console assembly 510 defines a vial containment region 518 that is sized and shaped to receive the console assembly 510 therein, aswill be described in greater detail herein. The console assembly 510 further includes a vial engagement mechanism 520 extending from the base 512 adjacent to the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outward from the base 512 of the console assembly 510 toward the distal end 516. The vial engagement mechanism 520 is positioned within the vial containment region 518 of the console assembly 510 and is movably coupled to the handle 528. In particular, the handle 528 of the console assembly 510 is operable to move, and in particular translate, the vial engagement mechanism 520 within the vial containment region 518 in response to an actuation of the handle 528.

[0028] The console assembly 510 includes a mechanical assembly 529 disposed within the base 512 that is configured and operable to convert a manual motion of the handle 528 to a corresponding linear displacement of the vial engagement mechanism 520. In the present example, the mechanical assembly 529 is coupled to the handle 528 and the vial engagement mechanism 520 such that selective actuation of the handle 528 at the proximal end 514 causes a simultaneous actuation of the vial engagement mechanism 520 at the distal end 516.

[0029] In embodiments, and referring to FIG. 2, a flow sensor of the delivery device 500 may be positioned in-line with the tubing set of the delivery device 500, and in particular the needle 559, the manifolds 555A, 555B, and / or one or more of the ports 556, and may be configured to measure an amount of fluid (e.g., suspension liquid after the therapeutic particles have effectively mixed with the fluid medium) that passes thereby. Referring back to FIG. 1, the vial engagement mechanism 520 comprises a pair of lever arms 522 extending outwardly from a neck 524 of the vial engagement mechanism 520, with the neck 524 extending laterally outward from the base 512 of the console assembly 510. The neck 524 of the vial engagement mechanism 520 is disposed within a protective cover 525 such that only the pair of lever arms 522 of the vial engagement mechanism 520 extends through the protective cover 525. The protective cover 525 is operable to shield one or more internal components of the console assembly 510 from an exterior of the console assembly 510, and in particular from the vial containment region 518.

[0030] The pair of lever arms 522 is simultaneously movable with the neck 524 of the vial engagement mechanism 520 in response to an actuation of the handle 528 of the console assembly 510. Further, the pair of lever arms 522 are fixed relative to one another such that a spacing formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 is configured to securely engage the vial assembly 580 therebetween, and in particular within the spacing formed by the pair of lever arms 522. Accordingly, the vialengagement mechanism 520 is operable to securely attach the vial assembly 580 to the console assembly 510 at the vial containment region 518. Although the vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, it should be understood that the vial engagement mechanism 520 may include various other structural configurations suitable for engaging the vial assembly 580, such as magnets on each component configured to engage with one another.

[0031] Still referring to FIG. 1, the console assembly 510 further includes a safety shield 526 secured to the distal end 516 of the base 512 along the vial containment region 518. In particular, the safety shield 526 is a protective covering that is sized and shaped to enclose the vial containment region 518 of the console assembly 510 when secured thereon. The safety shield 526 is selectively attachable to the distal end 516 of the base 512 and is formed of a material that is configured to inhibit radioactive emissions from one or more radioactive doses stored within the vial containment region 518, such as a glass, polymer, or other plastic material.

[0032] The distal end 516 of the console assembly 510 further includes an administration set cavity 532 that is sized and shaped to receive the radioembolization administration set 540 therein. The administration set cavity 532 includes one or more, and in some embodiments, a pair of alignment features 534 extending therein, with the alignment features 534 sized and shaped to correspond with complimentary alignment features of the radioembolization administration set 540 (e.g., alignment ribs 554) to thereby facilitate a coupling of the radioembolization administration set 540 with the base 512 of the console assembly 510 within the administration set cavity 532. As will be described in greater detail herein, the radioembolization administration set 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, medium) therethrough. In particular, the radioembolization administration set 540 is configured to partially receive a vial assembly 580 therein for administering the therapeutic particles from the delivery device 500 and to a patient during a procedure.

[0033] Still referring to FIG. 1, the radioembolization administration set 540 is configured to partially receive a vial assembly 580 therein for administering therapeutic particles (e.g., radioactive fluid medium) from the delivery device 500 and to a patient. In particular, the radioembolization administration set 540 comprises a proximal end 544 and a distal end 542 with a pair of sidewalls 546 extending therebetween. The proximal end 544 of the radioembolization administration set 540 includes a handle 552 extending proximally therefrom. The handle 552 is configured to facilitate movement of the radioembolization administration set 540, and inparticular, an insertion of the radioembolization administration set 540 into the administration set cavity 532 of the console assembly 510. The proximal end 544 further includes one or more ports 556 for coupling one or more delivery lines (i.e., tubing) to the radioembolization administration set 540. With the one or more delivery lines further be coupled to one or more external devices at an end of the line opposite of the ports 556, the ports 556 effectively serve to fluidly couple the radioembolization administration set 540 to the one or more external devices via the delivery lines connected thereto. The pair of sidewalls 546 of the radioembolization administration set 540 includes at least one alignment rib 554 extending laterally outward therefrom, where the alignment ribs 554 are sized and shaped to correspond with and mate to the pair of alignment features 534 of the console assembly 510. Accordingly, the pair of alignment ribs 554 are configured to facilitate an alignment and engagement of the radioembolization administration set 540 with the console assembly 510 when the distal end 542 is slidably received within the administration set cavity 532 of the base 512.

[0034] The radioembolization administration set 540 further includes a top surface 548 extending from the proximal end 544 and the distal end 542 and positioned between the pair of sidewalls 546, and a bottom surface 541 extending from the proximal end 544 and the distal end 542 and positioned between the pair of sidewalls 546. The top surface 548 of the radioembolization administration set 540 includes a recessed region 549 and a locking system 550. The recessed region 549 is sized and shaped to form a recess and / or cavity along the top surface 548, where the recessed region 549 is capable of receiving and / or collecting various materials therein, including, for example, leaks of various fluid media during use of the delivery device 500. The locking system 550 of the radioembolization administration set 540 forms an opening along the top surface 548 that is sized and shaped to receive one or more devices therein, such as a priming assembly 560 and a vial assembly 580. In some embodiments, the radioembolization administration set 540 comes preloaded with the priming assembly 560 disposed within the locking system 550. The priming assembly 560 includes a priming line 562 extending outwardly from the locking system 550 of the radioembolization administration set 540. The priming assembly 560 connects the priming line 562 to needle 559 and manifolds 555A and 555B and serves to purge the delivery device 500, including the manifolds 555A and 555B, of air prior to utilizing the delivery device 500 in a procedure.

[0035] Referring now to FIG. 2, the locking system 550 includes an annular array of one or more projections 551 extending outwardly therefrom, and in particular, extending laterally intothe aperture formed by the locking system 550 along the top surface 548. The annular array of projections 551 are formed within an inner perimeter of the locking system 550 and extend along at least two sequentially-arranged rows. The annular array of projections 551 included in the locking system 550 are configured to engage a corresponding locking feature 586 of the vial assembly 580 (See FIG. 3) to thereby securely fasten the vial assembly 580 to the radioembolization administration set 540. It should be understood that the multiple rows of projections 551 of the locking system 550 serve to provide a double-locking system to ensure the radioembolization administration set 540, and in particular a needle 559 of the radioembolization administration set 540, is securely maintained through a septum 592 of the vial assembly 580 See FIG. 3) during use of the delivery device 500 in a procedure.

[0036] The radioembolization administration set 540 further includes a vial chamber 558 that is sized and shaped to receive the priming assembly 560 and the vial assembly 580 therein, respectively. In other words, the vial chamber 558 is sized to individually receive both the priming assembly 560 and the vial assembly 580 separate from one another. The vial chamber 558 is encapsulated around a protective chamber or protective shield 557 disposed about the vial chamber 558. The protective shield 557 is formed of a material configured to inhibit radioactive emissions from extending outwardly from the vial chamber 558, such as, for example, a metal. Additionally, the radioembolization administration set 540 includes a needle 559 extending through the protective shield 557 and into the vial chamber 558 along a bottom end of the vial chamber 558. The needle 559 is fixedly secured relative to the vial chamber 558 such that any devices received through the aperture of the locking system 550 and into the vial chamber 558 are to encounter and interact with the needle 559 (e.g., the priming assembly 560, the vial assembly 580, and the like).

[0037] Still referring to FIG. 2, the needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the radioembolization administration set 540, and in particular the manifold 555A, 555B is positioned beneath the vial chamber 558 and the protective shield 557. The proximal manifold 555B is fluidly coupled to the needle 559 and the distal manifold 555A is fluidly couplable to one or more delivery lines via the one or more ports 556 of the radioembolization administration set 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A through a one-way check valve 553 disposed therebetween.

[0038] Accordingly, the proximal manifold 555B is in fluid communication with the one or more ports 556 via the distal manifold 555A, however, the one or more ports 556 are not in fluid communication with the proximal manifold 555B due to a position of the one-way check valve 553 disposed between the manifolds 555A, 555B. Thus, the needle 559 is in fluid communication with the one or more delivery lines and / or devices coupled to the radioembolization administration set 540 at the one or more ports 556 via the manifolds 555A, 555B secured therebetween. The one or more ports 556 of the radioembolization administration set 540 may be coupled to a bag (e.g., saline bag), a syringe, a catheter, and / or the like via one or more delivery lines coupled thereto. In other embodiments, the needle 559 may be a cannula, catheter, or similar mechanism through which to inject and receive fluid and / or a solution as described herein.

[0039] Still referring to FIG. 2, the radioembolization administration set 540 includes a removable battery pack 570 coupled to the radioembolization administration set 540 along the distal end 542. The removable battery pack 570 comprises a battery 572, electrical contacts 574, and a removable tab 576. The battery 572 of the delivery device 500 is isolated from one or more fluid paths and radiation sources due to a location of the battery 572 in the removable battery pack 570.

[0040] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to contact against and interact with corresponding electrical contacts 511 of the console assembly 510 (See FIG. 1) when the radioembolization administration set 540 is coupled to the base 512 at the administration set cavity 532. Accordingly, the removable battery pack 570 is operable to provide electrical power to the delivery device 500, and in particular the console assembly 510, when the radioembolization administration set 540 is coupled to the console assembly 510.

[0041] Additionally, as will be described in greater detail herein, in some embodiments the locking system 550 may include at least one planar wall relative to a remaining circular orientation of the locking system 550. In this instance, an aperture formed by the locking system 550 through the top surface 548 of the radioembolization administration set 540 is irregularly-shaped, rather than circularly-shaped as shown and described above. In this instance, the vial assembly 580 includes a locking feature 586 that has a shape and size that corresponds to the locking system 550, and in particular the at least one planar wall such that the vial assembly 580 is received within the radioembolization administration set 540 only when an orientation of the vial assembly 580 corresponds with an alignment of the locking feature 586 and the locking system 550. In otherwords, a corresponding planar wall 586A of the locking feature 586 (See FIG. 3) must be aligned with the planar wall of the locking system 550 for the vial assembly 580 to be receivable within an aperture formed by the locking system 550 of the radioembolization administration set 540.

[0042] Referring now to FIG. 3, the vial assembly 580 of the delivery device 500 is depicted. The vial assembly 580 comprises an engagement head 582, a plunger 584, a locking feature 586, and a vial body 589. In particular, the engagement head 582 of the vial assembly 580 is positioned at a terminal end of the plunger 584 opposite of the locking feature 586 and the vial body 589. The engagement head 582 includes a pair of arms 581 extending laterally outward relative to a longitudinal length of the plunger 584 extending downwardly therefrom. In the present example, the engagement head 582 is integrally formed with the plunger 584, however, it should be understood that in other embodiments the engagement head 582 and the plunger 584 may be separate features fastened thereto. In either instance, the engagement head 582 and the plunger 584 is movable relative to the locking feature 586 and the vial body 589 such that the engagement head 582 and the plunger 584 are slidably translatable through the locking feature 586 and the vial body 589. In particular, as will be described in greater detail herein, the plunger 584 may translate into and out of an internal chamber 588 of the vial body 589 in response to a linear translation of the vial engagement mechanism 520 when the engagement head 582 is secured to the pair of lever arms 522.

[0043] The plunger 584 includes a plurality of indicia and / or markings 583 positioned along a longitudinal length of the plunger 584. The plurality of markings 583 is indicative of a relative extension of the engagement head 582 and the plunger 584 from the locking feature 586 and the vial body 589. As briefly noted above, the engagement head 582 is configured to attach the vial assembly 580 to the vial engagement mechanism 520. In particular, the pair of arms 581 of the engagement head 582 are sized and shaped to couple with the pair of lever arms 522 of the vial engagement mechanism 520 when the vial assembly 580 is received within the radioembolization administration set 540 and the radioembolization administration set 540 is inserted into the administration set cavity 532 of the console assembly 510. As will be described in greater detail herein, the pair of lever arms 522 are received between the pair of arms 581 of the engagement head 582 and the plunger 584 in response to a predetermined translation force applied to the vial engagement mechanism 520. The engagement head 582 and the plunger 584 may be formed of various materials, including, but not limited to, a metal, plastic, and / or the like.

[0044] Still referring to FIG. 3, the vial assembly 580 further includes a safety tab 585 coupled to the plunger 584 relatively above the locking feature 586 and below the engagement head 582 such that the safety tab 585 is positioned along the longitudinal length of the plunger 584. The safety tab 585 may be formed of various materials, such as, for example, a plastic, and is preassembled onto the vial assembly 580 prior to a use of the delivery device 500. The safety tab 585 is removably fastened to the plunger 584 and inhibits the plunger 584 from translating relative to the vial body 589. In particular, the safety tab 585 abuts against the locking feature 586 in response to an application of linear force onto the plunger 584 to translate the plunger 584 relatively downward into the vial body 589. In this instance, the safety tab 585 is configured to inhibit an inadvertent movement of the plunger 584, and in response, an inadvertent delivery of a fluid media stored within the internal chamber 588 of the vial body 589 (e.g., therapeutic particles, radioembolizing beads). As will be described in greater detail herein, the safety tab 585 is selectively disengaged from the plunger 584 in response to a coupling of the vial assembly 580 with the vial engagement mechanism 520, and in particular an engagement of the pair of lever arms 522 with the engagement head 582.

[0045] Referring back to FIG. 3, the locking feature 586 extends about a top end of the vial body 589. In the present example, the locking feature 586 of the vial assembly 580 comprises a bushing that defines a lateral edge 587 extending laterally outward along an outer perimeter of the locking feature 586. The lateral edge 587 of the locking feature 586 is sized and shaped to engage the annular array of projections 551 of the locking system 550 when the vial assembly 580 is received within the vial chamber 558 of the radioembolization administration set 540. As will be described in greater detail herein, the locking feature 586, and in particular the lateral edge 587 of the locking feature 586, is configured to securely fasten the vial assembly 580 to the locking system 550 to inhibit removal of the vial body 589 from the vial chamber 558 of the radioembolization administration set 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 comprises an irregular-profile. The at least one planar wall 586A is configured to correspond to the locking system 550 such that an alignment of the planar walls 586A and the locking mechanism 550 is required for the vial assembly 580 to be received through an aperture formed by the locking system 550.

[0046] Still referring to FIG. 3, the vial body 589 extends downwardly relative from the locking feature 586 and has a longitudinal length that is sized to receive at least a portion of alongitudinal length of the plunger 584 therein. By way of example only, a longitudinal length of the vial body 589 may be about 8 millimeters to about 10 millimeters, and in the present example comprises 9 millimeters, while a longitudinal length of the plunger 584 may be about 9 millimeters to about 11 millimeters, and in the present example comprises 10 millimeters. Accordingly, in some embodiments a longitudinal length of the plunger 584 exceed a longitudinal length of the vial body 589 such that a translation of the plunger 584 into the internal chamber 588 of the vial body 589 causes a fluid media stored therein to be transferred outward from the vial body 589. As will be described in greater detail herein, a translation of the plunger 584 through the internal chamber 588 of the vial body 589 provides for an administration of a fluid media stored within the vial body 589 outward from the vial assembly 580. The vial body 589 may be formed of various materials, including, for example, a thermoplastic polymer, copolyester, polycarbonate, a biocompatible plastic, polysulfone, ceramics, metals, and / or the like.

[0047] The vial body 589 is of the present example is formed of a material that is configured to inhibit radioactive emissions from a fluid media stored within the internal chamber 588 of the vial body 589. For example, the vial body 589 may be formed of a plastic, such as polycarbonate, and have a width of approximately 9 millimeters (mm). A density and material composition of the vial body 589 may collectively inhibit beta radiation emission from electron particles stored within the internal chamber 588. In the present example, a chemical composition of the plastic of the vial body 589, along with the 9 mm wall thickness, provides a plurality of atoms disposed within the vial body 589 that are capable of encountering the electron particles generating beta radiation and reducing an emission of said radiation from the vial assembly 580. Accordingly, the vial assembly 580 allows an operator to handle the radioactive material stored within the vial body 589 without being exposed to beta radiation. It should be understood that various other materials and / or wall sections may be incorporated in the vial body 589 of the vial assembly 580 in other embodiments without departing from the scope of the present disclosure.

[0048] Still referring to FIG. 3, the vial body 589 of the vial assembly 580 is sealed at a first terminal end by the locking feature 586. The vial assembly 580 further includes a cap 590 positioned at an opposing, terminal end of the vial body 589 opposite of the locking feature 586, such that the cap 590 seals a second terminal end of the vial body 589 of the vial assembly 580. Additionally, the vial assembly 580 includes a septum 592 positioned adjacent to the cap 590 and in fluid communication with a terminal end of the vial body 589 opposite of the locking feature 586. The septum 592 forms a seal against a terminal end of the vial body 589 and the cap 590retains the septum 592 therein. The septum 592 may be formed of various materials, including, for example, an elastomer, silicon, bromobutyl elastomer, rubber, urethanes, and / or the like. The septum 592 is configured to provide an air-tight seal for the vial body 589 to thereby inhibit a release of a fluid media stored therein (e.g., radioembolizing beads). As will be described in greater detail herein, the septum 592 of the vial assembly 580 is configured to be punctured by the needle 559 of the radioembolization administration set 540 when the vial assembly 580 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the radioembolization administration set 540. In other embodiments, the septum 592 may be omitted entirely for an alternative device, such as, for example, a valve system, needle injection port, and / or the like.

[0049] Referring now to FIG. 4, in response to determining that the battery 572 contains or other power source provides a sufficient amount of power, one or more delivery lines are coupled to the radioembolization administration set 540 via the one or more ports 556. In particular, a dose delivery line 10A is coupled to the radioembolization administration set 540 at a delivery port 556A, a contrast line 10B is coupled to radioembolization administration set 540 at a contrast port 556B, and a flushing line 10C is coupled to the radioembolization administration set 540 at a flushing port 556C. An opposing end of the dose delivery line 10A is initially coupled to a fluid reservoir, such as, for example, a collection bowl. As will be described in greater detail herein, the dose delivery line 10A may be subsequently coupled to an external device, such as a catheter, once the radioembolization administration set 540 has been effectively primed by a fluid medium via the contrast line 10B. An opposing end of the flushing line 10C is coupled to an external device, such as, for example, a syringe. With both the dose delivery line 10A and the flushing line 10C coupled to the radioembolization administration set 540, the radioembolization administration set 540 is flushed with a fluid medium (e.g., saline) from the syringe coupled to the flushing line 10C. In this instance, the fluid medium is injected through the flushing line 10C, into the distal manifold 555A of the radioembolization administration set 540, and out of the radioembolization administration set 540 through the dose delivery line 10A. Accordingly, the fluid medium is ultimately received at the collection bowl and disposed thereat by the dose delivery line 10A.

[0050] With the distal manifold 555A of the radioembolization administration set 540 separated from the proximal manifold 555B by the one-way check valve 553 disposed therebetween, the fluid medium flushed through the distal manifold 555A from the syringe (viathe flushing port 556C) is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. Rather, the fluid medium injected from the syringe and through the flushing line IOC is received at the flushing port 556C, passed through the distal manifold 555A in fluid communication with the flushing port 556C, and redirected by the one-way check valve 553 towards the dose delivery port 556A that is coupled to the dose delivery line 10A. In this instance, the dose delivery line 10A receives and transfers the fluid medium to the collection bowl coupled thereto, such that the fluid medium is not directed beyond the one-way check valve 553 and into the proximal manifold 555B that is in fluid communication with the needle 559.

[0051] The contrast line 10B is coupled to the radioembolization administration set 540 at a contrast port 556B. An opposing end of the contrast line 10B is coupled to a fluid medium supply, such as, for example, a bag secured to the console assembly 510 via the attachment device 538. In the present example, the bag is a saline bag such that the fluid medium stored therein is saline. In this instance, with the radioembolization administration set 540 including the priming assembly 560 positioned within the vial chamber 558 and a needle end in fluid communication with the needle 559, a syringe is fluidly coupled to the priming line 562 of the priming assembly 560 and a plunger of the syringe is drawn back to pull saline through the contrast line 10B, the contrast port 556B, the radioembolization administration set 540, the priming line 562 and into the syringe from the saline bag. The plunger of the syringe is thereafter pushed inwards to transfer the extracted saline back through the priming line 562, a central body, an elongated shaft, and the needle end of the priming assembly 560 such that the saline is received into the needle 559 of the radioembolization administration set 540. Accordingly, the manifolds 555A, 555B of the radioembolization administration set 540 are effectively primed with the saline from the syringe as the needle 559 that received the saline from the priming assembly 560 is in fluid communication with the manifolds 555A, 555B. With the manifolds 555A, 555B in further fluid communication with the dose delivery line 10A via the delivery port 556A, the saline is effectively distributed to the collection bowl coupled thereto.

[0052] Referring now to FIG. 4, the radioembolization administration set 540 is coupled to one or more external devices via the one or more ports 556. In particular, the radioembolization administration set 540 is fluidly coupled to a catheter (e.g., microcatheter) via the dose delivery line 10A that is coupled to the delivery port 556A of the radioembolization administration set 540. In this instance, the catheter is in fluid communication with the radioembolization administration set 540 via the dose delivery line 10A. Further, the radioembolization administration set 540 maybe fluidly coupled to a contrast source, such as, for example, a saline bag secured to the console assembly 510 via the attachment device 538 (See FIG. 1). The radioembolization administration set 540 is in fluid communication with the saline bag via a contrast line 10B coupled to the contrast port 556B of the radioembolization administration set 540. In this instance, the saline bag is in fluid communication with the radioembolization administration set 540 via the contrast line 10B secured to the contrast port 556B.

[0053] The contrast port 556B is in fluid communication with the proximal manifold 555B while the delivery port 556A is in fluid communication with the distal manifold 555A. As will be described in greater detail herein, saline from the saline bag may be withdrawn through the needle 559 of the radioembolization administration set 540 and into the vial body 589 of the vial assembly 580 as the contrast port 556B is coupled to the proximal manifold 555B, rather than the distal manifold 555A which is separated from the proximal manifold 555B by the one-way check valve 553 disposed therebetween.

[0054] Referring again to FIGS. 1 and 3, with the vial assembly 580 securely coupled to the radioembolization administration set 540, the radioembolization administration set 540 is coupled to the console assembly 510 by translating the proximal end 544 of the radioembolization administration set 540 toward and into the distal end 516 of the console assembly 510. In particular, the proximal end 544 of the radioembolization administration set 540 is directed into the administration set cavity 532 of the console assembly 510 by aligning the alignment ribs 554 of the radioembolization administration set 540 with the alignment features 534 of the console assembly 510. Once the distal end 542 and the proximal end 544 of the radioembolization administration set 540 are fully seated within the administration set cavity 532 of the console assembly 510, the electrical contacts 574 (FIG. 2) of the removable battery pack 570 interact with corresponding electrical contacts 511 (FIG. 1) of the console assembly 510. In this instance, power from the battery 572 is transmitted to the console assembly 510 via the electrical contacts 574, thereby activating the console assembly 510 of the delivery device 500. In this instance, the interface display 530 of the console assembly 510 is activated to display pertinent, real-time information relating to the delivery device 500 during a procedure.

[0055] Referring again to FIG. 4, as the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial containment region 518, a negative pressure is generated within the internal chamber 588 of the vial body 589 due to a retraction of the stopper 594. In this instance, with the saline bag coupled to the radioembolization administration set 540via the contrast line 10B and the contrast port 556B, saline from the saline bag is pulled into the internal chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Accordingly, with the vial body 589 being preloaded with a radioactive fluid media (e.g., radioembolizing microspheres), the saline is effectively mixed with the radioactive fluid media within the vial body 589 as the plunger 584 is retracted from the internal chamber 588 and the negative pressure is generated through the delivery device 500.

[0056] The radioembolization administration set 540 further includes one-way check valves 553A in-line with the contrast line 10B and the flushing line 10C. In particular, the one-way check valves 553A are configured to permit fluid communication from the contrast port 556B and the flushing port 556C into the manifolds 555A, 555B, and further configured to prevent fluid communication from the manifolds 555A, 555B to the contrast port 556B and the flushing port 556C. Accordingly, it should be understood that the dose delivered from the vial body 589 to the manifold 555A, 555B is incapable of being directed into the contrast line 10B or the flushing line 10C due to the one-way check valves 553A positioned therein. Thus, the dose is directed to the dose delivery port 556A and received at the catheter fluidly coupled thereto by the dose delivery line 10A. In other words, the one-way check valves 553A prevent a backflow of fluid into the radioembolization administration set 540 and / or the vial assembly 580 coupled thereto.

[0057] Referring now to FIG. 5, the console assembly 510 includes a mechanical assembly 529 disposed within the base 512 that is configured and operable to convert a manual motion of the handle 528 to a corresponding linear displacement of the vial engagement mechanism 520. In the present example, the mechanical assembly 529 is coupled to the handle 528 and the vial engagement mechanism 520 such that selective actuation of the handle 528 at the proximal end 514 causes a simultaneous actuation of the vial engagement mechanism 520 at the distal end 516. As will be described in greater detail herein, the mechanical assembly 529 of the present example allows for fluid volume control and fluid flow volume control during a dose delivery with the delivery device 500. It should be understood that a mechanical configuration of the mechanical assembly 529 of the present example may comprise various linkages, gears, pullies, springs and / or the like that are specifically configured to amplify a force applied to the handle 528 with a corresponding displacement of the vial engagement mechanism 520. In some embodiments, the mechanical assembly 529 may comprise and / or be substituted by one or more electrically-driven systems, motors, and / or other devices operable to provide for a movement of the vial engagement mechanism 520 relative to the vial containment region 518 and / or provide a feedback to anoperator as the handle 528 is actuated. In other embodiments the mechanical assembly 529 may be configured such that the handle 528 may be actuated (i.e., moved) in various other arrangements or orientations than that shown and described herein to generate a corresponding linear displacement of the vial engagement mechanism 520. For example, the mechanical assembly 529 of the console assembly 510 may be configured to convert a linear, rotational, lateral and / or other various motions of the handle 528 to generate a disproportionate displacement of the vial engagement mechanism 520, with the displacement exceeding a force applied at the handle 528.

[0058] Still referring to FIG. 5, and as briefly described above, the console assembly 510 includes one or more sensors for monitoring and detecting certain conditions and / or materials stored in the console assembly 510 during use of the delivery device 500. In the present example, the console assembly 510 includes a linear displacement sensor 531 and a radiation sensor 533. The linear displacement sensor 531 is securely attached to the mechanical assembly 529 of the console assembly 510 such that the linear displacement sensor 531 is operable to move within the console assembly 510 in response to an actuation of the handle 528 and a corresponding movement of the vial engagement mechanism 520. The linear displacement sensor 531 is configured to detect and monitor a displacement distance, a velocity of displacement, and / or the like of the handle 528 and the vial engagement mechanism 520.

[0059] Still referring to FIG. 5, the radiation sensor 533 is securely attached to the base 512 of the console assembly 510 at a location adjacent to the vial containment region 518. In particular, the radiation sensor 533 is positioned proximate to the administration set cavity 532 that is sized and shaped to receive the radioembolization administration set 540 therein. As described in greater detail above, the radioembolization administration set 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, medium) therethrough such that the radiation sensor 533 is operable to detect and monitor a radiation level of the therapeutic particles due to a proximate location of the radiation sensor 533 with radioembolization administration set 540. In particular, the radioembolization administration set 540 is configured to partially receive a vial assembly 580 therein for administering the therapeutic particles from the delivery device 500 and to a patient.

[0060] As will further be described herein, by detecting a radiation level of the radioactive medium stored and transferred through the radioembolization administration set 540, computer readable and executable instructions of the delivery device 500, when executed by a processor ofthe delivery device 500, may determine a radiation dosage delivered from the delivery device 500. Additionally or alternatively, the computer readable and executable instructions executed by a processor of the delivery device 500 may further determine a remaining radiation dosage contained within the delivery device 500 during a procedure. As briefly noted above, the data detected by the radiation sensor 533 and the information determined by the processor of the delivery device 500 may be displayed at the interface display 530 for operator review. It should be understood that in other embodiments the delivery device 500 may include additional or fewer sensors than those shown and described herein (e.g., a dosimeter, a linear encoder, an optical sensor, a linear displacement sensor, a flow sensor, an ultrasonic sensor, a magnetic encoder, a laser distance sensor, an inductance sensor, a radial encoder, a volumetric sensor, mechanical transducers, etc.). A dosimeter and / or radiation sensor of the delivery device 500 may be configured to measure a remaining exposure to ionizing radiation stored within the delivery device 500, and in particularly the radioembolization administration set 540 and / or the vial assembly 580.

[0061] As merely illustrative examples only, a linear encoder may be paired with a scale that is configured to encode a position of a remaining dosage of therapeutic particles within the vial assembly 580 such that the linear encoder converts the encoded position into an analog or digital signal that may be decoded into a quantity. An optical sensor / encoder of the delivery device 500 may be configured to convert light rays from within the radioembolization administration set 540 and / or the vial assembly 580 into an electrical signal to measure a physical quantity of light that is thereby translated into a readable form for measuring a remaining radiation dosage contained within the delivery device 500. A magnetic encoder of the delivery device 500 may be configured and operable similar to the optical encoder to determine a remaining radiation dosage but utilizes magnetic fields in lieu of light. An inductive sensor encoder of the delivery device 500 may be configured to utilize electromagnetic induction to detect and measure a remaining dosage stored within the vial assembly 580 by developing a magnetic field therein in response to a current flowing therethrough. A laser distance sensor of the delivery device 500 may be configured to measure a remaining dosage within the vial assembly 580 through transmitting a laser to measure a distance within the vial body 589 to a top liquid surface of the therapeutic particles remaining therein.

[0062] By way of further examples, a flow sensor of the delivery device 500 may be positioned in-line with the tubing set of the delivery device 500, and in particular the needle 559, the manifolds 555A, 555B, and / or one or more of the ports 556, and may be configured to measurean amount of fluid (e.g., suspension liquid after the therapeutic particles have effectively mixed with the fluid medium) that passes thereby. An ultrasonic sensor of the delivery device 500 may comprise a transmitter, receiver, and / or transceiver configured to measure a distance to an object (e.g., remaining volume of dosage within the vial assembly 580) based on transmitting ultrasonic signals (i.e. sound waves) therein and measuring an elapsed time before receiving back the bounced sound waves. A radial encoder of the delivery device 500 may comprise an absolute encoder and / or an incremental encoder configured to convert an angular position or motion of the handle 528, the plunger 584, the mechanical assembly 529, and / or other components of the delivery device 500 to analog or digital ouput signals corresponding to a remaining dosage within the vial assembly 580.II. Radiation Determination Embodiments

[0063] As briefly noted above, FIGS. 6-9, discussed in more detail herein, generally relate to embodiments for radiation delivery determination systems including a radiation shieldto assist with determining an amount of radiation within at least a portion of the delivery device 500. For instance, the systems and methods discussed herein may be employed to determine an amount of radiation within at least a portion of the delivery device 500 following a treatment operation or administration of a radioactive dose of fluid from the delivery device 500. More particularly, the systems discussed herein may be employed to determine an amount of radiation within the radioembolization administration set 540, including the vial assembly 580 and not including an amount of radiation within the delivery line tubing 652 as shown in FIG. 4 (i.e. the dose delivery line 10A, the contrast line 10B, and the flushing line 10C) coupled to the radioembolization administration set 540. The shielding of the radioactive therapeutic may be reduced when the radioactive therapeutic leaves the radioembolization administration set 540 and enters the delivery line tubing 652. To ensure an accurate measurement of radioactive material remaining in the radioembolization administration set 540 after at least a portion of the therapeutic has been delivered to the delivery line tubing 652, a radiation shield 610 is positioned between a radiation sensor 533 and the radioembolization administration set 540. By determining an amount of radiation within at least a portion of the delivery device 500 following an administration of a radioactive dose, and knowing a predetermined amount of radiation, or radioactive fluid media, preloaded within the vial body 589, an amount of radiation administered to a patient can be determined and / or verified.

[0064] Some radiation systems and methods may involve placing a radioembolization administration set, vial assembly, and / or tubing loosely in a testing container separate and remote from a delivery device and measuring an amount of radiation in the radioembolization administration set, vial assembly, and / or tubing within the testing container with a radiation measurement device separate from the delivery device. However, the specific orientation and position of the radioembolization administration set, vial assembly, and / or tubing within the testing container may not be known, and the distance from the source of radiation and the radiation measurement device may affect the amount of radiation detected by the radiation measurement device. Particularly, the intensity of radiation measured is inversely proportional to the square of the distance between the source of radiation and the radioactive measurement device, such that the intensity of radiation detected decreases with increasing distance between the source of radiation and the radioactive measurement device. For instance, an activity of radiation measured with a radioactive measurement device positioned 0.3 meters from the source of radiation may be 10 millicurie (or an equivalent amount of Becquerel), while the activity of radiation measured with the radioactive measurement device positioned 0.4 meters from the same source of radiation may be 6.25 millicurie (or an equivalent amount of Becquerel). Therefore, users often must take several readings at different locations around the testing container and average the results of the several readings to accurately determine the amount of radiation within the radioembolization administration set, vial assembly, and / or tubing.

[0065] The systems described herein incorporate a radiation shield and radiation sensor into the delivery device to allow for accurate and reproducible real-time radiation measurements onboard the delivery device.

[0066] Referring to FIG. 6, a radioembolization delivery device 500 with a radiation shield assembly 600 is depicted. The delivery device 500 includes a console assembly 510 with the radioembolization administration set 540 coupled with the console assembly 510 in a first position 640 (FIG. 7). As shown in FIG. 6, the console assembly 510 has a proximal end 514 opposite a distal end 516. The radioembolization administration set 540 in the first position 640 (FIG. 7) is coupled within the console assembly 510 (FIG. 6) near the distal end 516 of the console assembly 510 and located in a position below the vial containment region 518. As described above, the handle 528 is movably coupled to the distal end 516 of the console assembly 510 and is operable to move the vial engagement mechanism 520 (FIG. 5), comprising a pair of lever arms 522 extending outwardly from a neck 524 within the vial containment region 518 in response to anactuation of the handle 528. The radiation sensor 533 is positioned proximate to the radioembolization administration set 540 such that the radiation sensor 533 is operable to detect and monitor a radiation level of the therapeutic particles due to the proximate location of the radiation sensor 533 with the radioembolization administration set 540. A radiation shield 610 is positioned between the radiation sensor 533 and the radioembolization administration set 540 in the first position 640 (FIG. 7).

[0067] Referring to FIGS. 6-7, the radioembolization administration set 540 may include a partially administered vial containing radioactive therapeutic material within the vial assembly 580 and the delivery line tubing 652 for administering radioactive therapeutic material from the vial assembly 580. In embodiments as described in greater detail below, the radiation sensor 533 is configured to measure an amount of radiation within the radioembolization administration set 540, including the vial assembly 580 that may be partially received therein, and, utilizing the radiation shield 610, excluding an amount of radiation within the delivery line tubing 652 coupled to the radioembolization administration set 540. As described in greater detail further below, radiation emissions from the outside the vial assembly 580 are blocked from reaching the radiation sensor 533 using the radiation shield 610.

[0068] Referring now to FIG. 7, the radiation sensor 533, the radiation shield 610, and the vial assembly 580 in the first position 640 are depicted. The vial assembly 580, located within the radioembolization administration set 540, includes a vial body 589 and a plunger 584 movable through the vial body 589. An engagement head 582 is coupled to the proximal end of the plunger 584. A protective shield 557 surrounds the vial body 589. The vial assembly 580 further includes a locking system 550 to secure the vial assembly 580 in the radioembolization administration set 540. A needle 559 enters the vial body 589 at the distal end and allows the radioactive therapeutic material to flow into the delivery line tubing 652, in fluid communication with the radioembolization administration set 540. The delivery device 500 may engage with the engagement head 582 to push the plunger 584 into the vial body 589 in order to displace the radioactive therapeutic material through the needle 559 and into the delivery line tubing 652.

[0069] The radiation sensor 533 and radiation shield 610 in the first position 640 are positioned proximate to the vial assembly 580 such that the radiation sensor 533 is operable to detect and monitor a radiation level of the therapeutic particles due to a proximate location of the radiation sensor 533. The radiation shield 610 has a forward facing wall 616 and an opposite rear facing wall 618. The forward facing wall 616 is directed towards the vial assembly 580 while the rearfacing wall 618 is adjacent to the radiation sensor 533. The radiation shield 610, described in greater detail below, includes a solid portion 620 made of any metallic, glass, polymer, other plastic material, any combination thereof, or the like, of a necessary thickness to at least partially or completely block radioactive emissions. A material thickness may depend on the material of the radiation shield 610 as well as the radioactive isotope to block by the solid portion 620. In embodiments, material thicknesses to block Y90 beta energy may include (1) poly sulfone at 8.8 mm thickness, (2) aluminum at 4.1 mm thickness, and (3) stainless steel at 1.4 mm thickness. Materials with lower atomic numbers minimize bremsstrahlung (e.g., deceleration electromagnetic radiation produced by the deceleration of a charged particle when deflected by another charged particle) when shielding beta energy. The radiation shield 610 further includes a central aperture 622 where radioactive emissions may pass. It is to be understood that the radiation shield 610 may be of any shape that includes an aperture 622 to allow radioactive emissions to pass through and a solid portion 620 to block radioactive emissions. Adjacent to the central aperture 622 of the radiation shield 610 is a measurement surface 642 of the radiation sensor 533 configured to receive radioactive emissions, which received emissions are measured with the radiation sensor 533.

[0070] In embodiments, emanating from the radioactive therapeutic within the vial assembly 580 are radioactive emissions that emanate at angles between a longitudinal axis LA running vertical through the center of the vial body 589 of the vial assembly 580 and the path between a point on the longitudinal axis LA and the measuring surface 642 of the radiation sensor 533. A range of radioactive emissions may emanate from the radioactive particulates in the radioactive therapeutic within the vial assembly 580 including from within the vial body 589 and the delivery line tubing 652. The solid portion 620 of the radiation shield 610 is configured to block a portion of the emanating radioactive emissions while the central aperture 622 of the radiation shield 610 allow the radioactive emissions to pass through, creating a pass through range 630 of radioactive emissions measured by the radiation sensor 533 and a blocked range 632 of radioactive emissions not measured by the radiation sensor 533. The pass through range 630 is disposed between (i) a first angle al defined between the measurement surface 642, the longitudinal axis LA of the vial body 589, and a bottom of the vial body 589 of the vial assembly 580 and (ii) a third angle a3 defined between the measurement surface 642, the longitudinal axis LA of the vial body 589, an a top of the vial body 589 of the vial assembly 580. The first angle al is an angle between the longitudinal axis LA and the path between the distal, bottom end of the vial body 589 and themeasuring surface 642 of the radiation sensor 533. The third angle a3 is an angle between the longitudinal axis LA and the path between the proximal, top end of the vial body 589, which may be representative of a bottom surface of a stopper located at the distal end of the plunger 584iand the measuring surface 642 of the radiation sensor 533. Therefore, the pass through range 630 is the range of radioactive emissions that emanate from the radioactive therapeutic remaining in the vial body 589 of the vial assembly 580 and reach the sensor 533, that is, the radiation emanating from the vial body 589 between the first angle al and the third angle a3. The radiation emanating in the pass through range 630 pass through the central aperture 622 to the measuring surface 642 of the radiation sensor 533.

[0071] The blocked range 632 is the range of emissions blocked by the radiation shield 610 and includes radiation emanating from a second angle a2 located distally below the first angle al. In embodiments, the second angle a2 is an angle between the longitudinal axis LA and the path between a portion of the underlying delivery line tubing 652 and the measuring surface 642 of the radiation sensor 533. However, it is to be understood that the second angle a2 can be from any point distally below the first angle al of which there is radioactive emissions or along any emission path from the delivery line tubing 652 to the sensor 533. The blocked range 632 is blocked by a solid portion 620 of the radiation shield 610 and does not pass through the central aperture 622 to the radiation sensor 533.

[0072] Now referring to FIG. 8, an isolated view of the radiation shield 610 according to some embodiments is depicted. The solid portion 620 of the radiation shield 610 includes an exterior facing wall 612 and an interior facing wall 614, which interior facing wall 614 defines the aperture 622. The radiation shield 610 further includes a forward facing wall 616, which may face the radioembolization administration set 540 in the first position 640, and a rear facing wall 618, which may be positioned adjacent to the radiation sensor 533 (FIG. 7). The exterior facing wall 612 and interior facing wall 614 are disposed between the forward facing wall 616 and the rear facing wall 618. The solid portion 620 and aperture 622 are sized such that (i) the radiation emanating at the first angle al (e.g., via the pass through range 630) from the radioembolization administration set 540 and the vial assembly 580 passes through the aperture 622 to the radiation sensor 533 and (ii) the radiation emanating from the second angle a2 (e.g., the blocked range 632) is blocked by the solid portion 620 of the radiation shield and does not pass through the aperture 622 to the radiation sensor 533. In embodiments, the solid portion 620 or the radiation shield 610may be stainless steel, lead, tin, copper, pewter, aluminum, plastic, any combination thereof, or the like.

[0073] In some embodiments, as seen in FIG. 8, the solid portion 620 of the radiation shield 610 includes a bottom portion 624, a_first vertical arm 625, and a second vertical arm 626. The first vertical arm 625 and the second vertical arm 626 extend in a vertical upward direction from the bottom portion 624 of the radiation shield 610. The first vertical arm 625 and second vertical arm 626 are spaced laterally apart such that the aperture 622 is defined between the first vertical arm 625, the second vertical arm 626, and the bottom portion 624. The bottom portion 624 is comprised of portions of the exterior facing wall 612, the forward facing wall 616, the rear facing wall 618, and a first surface 627 of the interior facing wall 614. The interior facing wall 614 may further include a second surface 628 and a third surface 629 vertically extending from ends of the first surface 627. The first vertical arm 625 is comprised of portions of the exterior facing wall 612, the forward facing wall 616, the rear facing wall 618, and the second surface 628 of the interior facing wall 614. The second vertical arm 626 is comprised of portions of the exterior facing wall 612, the forward facing wall 616, the rear facing wall 618, and the third surface 629 of the interior facing wall 614. The aperture 622 of the radiation shield 610 is defined by the first surface 627, the second surface 628, and the third surface 629 of the interior facing wall 614. However, it should be appreciated that the solid portion 620 and the central aperture 622 of the radiation shield 610 may be of any size and shape where the solid portion 620 blocks radiation emanating from second angle a2 from the delivery line tubing, the second angle a2 distally below the first angle al from the radioembolization administration set and vial assembly (e.g., the blocked range 632) and the aperture 622 allows radiation emanating at the first angle al (e.g., the pass through range 630) to hit the measuring surface 642 of the radiation sensor 533.

[0074] Referring now to FIG. 9, a method 700 for measuring the amount of radiation within a radioembolization administration set 540 will be described. At block 702 of the method 700, the radiation sensor 533 may detect through the aperture 622 of the radiation shield 610 the amount of radiation within a radioembolization administration set 540 and a vial assembly 580 contained within the radioembolization administration set 540. Particularly, the radiation therapeutic that is remaining in the vial assembly 580 after at least a portion of the therapeutic has been delivered through the delivery line tubing 652 may be detected. In embodiments, the radiation sensor 533 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 configured to measure theamount of radiation within the radioembolization administration set 540. In embodiments, the units of the amount of radiation within the radioembolization administration set 540 and vial assembly 580 measured by the radiation sensor 533 may be curie, Becquerel, counts per minute, rem per hour, Sieverts per hour, etc., depending on the radiation sensor 533 employed.

[0075] At block 704 of the method 700, the radiation shield 610 blocks the radiation from the delivery line tubing 652 in fluid communication with and disposed distally below the radioembolization administration set 540. As discussed above, the radiation shield 610 is positioned between the radiation sensor 533 and the radioembolization administration set 540 in the first position 640. The solid portion 620 and aperture 622 are sized such that the radiation emanating between a first angle al and a third angle a3 from the radioembolization administration set 540 and vial assembly 580 pass through the aperture 622 to the radiation sensor 533 via the pass through range 630, and the solid portion 620 blocks the radiation emanating from between a second angle a2 distally below the first angle al and the first angle al via the blocked range 632. Particularly, the radiation emanating from the delivery line tubing 652 is blocked with the solid portion 620 of the radiation shield 610, such that the radiation sensor 533 does not detect the radiation emanating from the delivery line tubing 652. In some embodiments, the interface display 530 is communicatively coupled to the radiation sensor 533 and displays the amount of radiation detected from within the radioembolization administration set 540.

[0076] Embodiments have been depicted to ensure an accurate measurement of radioactive material remaining in the radioembolization administration set 540 after at least a portion of the therapeutic has been delivered to the delivery line tubing 652. A radiation shield 610 is positioned between a radiation sensor 533 and the radioembolization administration set 540 to block radiation emanating from the radioactive therapeutic remaining within the radioembolization administration set 540 during and / or after delivery to the delivery line tubing 652. By determining an amount of radiation within at least a portion of the delivery device 500 following an administration of a radioactive dose, and knowing a predetermined amount of radiation, or radioactive fluid media, preloaded within the vial body 589, an amount of radiation administered to a patient can be determined and / or verified. Because the assemblies, systems, and methods herein allow for the blocking of radiation emanating from outside the vial assembly 580 of the radioembolization administration set 540, the radiation sensor 533 may obtain the amount of radiation within the vial assembly 580 and not yet administered to the patient. By determining an amount of radiation remaining in the vial assembly 580 of the radioembolization administration set 540, following atreatment procedure, a user can determine the percentage of the radioactive dose preloaded within the vial body 589 that was, in fact, delivered to the patient. If less than 80% of the preloaded dose was delivered to the patient, it may be determined that an error or misadministration occurred during the treatment procedure.III. Aspects Listing

[0077] Embodiments can be described with reference to the following numerical clauses:

[0078] Aspect 1. A radiation shield assembly, comprising: a radioembolization delivery device comprising a radiation sensor, a vial assembly, a radioembolization administration set containing the vial assembly, and a delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set; a radiation shield comprising a solid portion configured to block radiation, the solid portion comprising an exterior facing wall, an interior facing wall, a forward facing wall, and a rear facing wall, wherein the exterior facing wall and the interior facing wall are disposed between the forward facing wall and the rear facing wall, the interior facing wall defining an aperture; wherein: the solid portion and the aperture of the radiation shield are sized such that, when the forward facing wall is directed toward the radioembolization administration set in a first position and the rear facing wall is directed toward the radiation sensor that is disposed adjacent to the aperture in the first position: radiation emanating at a first angle from the radioembolization administration set and vial assembly passes through the aperture to the radiation sensor; and radiation emanating from a second angle from the delivery line tubing, the second angle distally below the first angle, is blocked by the solid portion of the radiation shield and does not pass through the aperture to the radiation sensor.

[0079] Aspect 2. The radiation shield assembly of Aspect 1, wherein the solid portion further comprises: a bottom portion; a first vertical arm extending from the bottom portion; and a second vertical arm extending from the bottom portion, wherein: the second vertical arm is laterally spaced from the first vertical arm; and the aperture is defined between the first vertical arm and the second vertical arm and the bottom portion.

[0080] Aspect 3. The radiation shield assembly of Aspect 2, wherein: the bottom portion is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a first surface of the interior facing wall; the first vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a second surface of the interior facing wall; and the second vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a third surface of the interior facing wall.

[0081] Aspect 4. The radiation shield assembly of Aspect 3, wherein: the aperture is defined by the first surface of the interior facing wall, the second surface of the interior facing wall, and the third surface of the interior facing wall.

[0082] Aspect 5. The radiation shield assembly of any of Aspect 1 to Aspect 4, wherein the rear facing wall of the radiation shield is positioned on a measuring surface of the radiation sensor in the first position.

[0083] Aspect 6. The radiation shield assembly of any of Aspect 1 to Aspect 5, wherein the radiation shield comprises stainless steel, lead, tin, copper, pewter, aluminum, plastic, or combinations thereof.

[0084] Aspect 7. A delivery system, comprising: a console assembly including a base and a vial containment region; a radioembolization administration set removably couplable to the console assembly at the vial containment region, wherein the radioembolization administration set contains a vial assembly; a delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set, wherein the delivery line tubing is configured for administering radioactive therapeutic material from the radioembolization administration set; a radiation sensor coupled to the base; and a radiation shield comprising a solid portion configured to block radiation, the solid portion comprising an exterior facing wall, an interior facing wall, a forward facing wall, and a rear facing wall, wherein the exterior facing wall and the interior facing wall are disposed between the forward facing wall and the rear facing wall, the interior facing wall defining an aperture; wherein: the solid portion and the aperture of the radiation shield are sized such that, when the forward facing wall is directed toward the radioembolization administration set in a first position and the rear facing wall is directed toward the radiation sensor that is disposed adjacent to the aperture in the first position: radiation emanating at a first angle from the radioembolization administration set and vial assembly passes through the aperture to the radiation sensor; and radiation emanating from a second angle from the delivery line tubing, the second angle distally below the first angle, is blocked by the solid portion of the radiation shield and does not pass through the aperture to the radiation sensor.

[0085] Aspect 8. The delivery system of Aspect 7, wherein the solid portion further comprises: a bottom portion; a first vertical arm extending from the bottom portion; and a second vertical arm extending from the bottom portion, wherein: the second vertical arm is laterally spaced from the first vertical arm; and the aperture is defined between the first vertical arm and the second vertical arm and the bottom portion.

[0086] Aspect 9. The delivery system of Aspect 8, wherein: the bottom portion is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a first surface of the interior facing wall; the first vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a second surface of the interior facing wall; and the second vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a third surface of the interior facing wall.

[0087] Aspect 10. The delivery system of Aspect 9, wherein: the aperture is defined by the first surface of the interior facing wall, the second surface of the interior facing wall, and the third surface of the interior facing wall.

[0088] Aspect 11. The delivery system of any of Aspect 7 to Aspect 10, wherein the rear facing wall of the radiation shield is positioned on a measuring surface of the radiation sensor in the first position.

[0089] Aspect 12. The delivery system of any of Aspect 7 to Aspect 11, wherein the radiation shield is spaced apart from the radioembolization administration set and the delivery line tubing.

[0090] Aspect 13. The delivery system of any of Aspect 7 to Aspect 12, wherein the vial assembly comprises a vial of radioactive therapeutic material.

[0091] Aspect 14. The delivery system of any of Aspect 7 to Aspect 13, wherein the radiation shield comprises stainless steel, lead, tin, copper, pewter, aluminum, plastic, or combinations thereof.

[0092] Aspect 15. The delivery system of any of Aspect 7 to Aspect 14, further comprising an interface display communicatively coupled to the radiation sensor.

[0093] Aspect 16. A method of measuring an amount of radiation within a radioembolization administration set, comprising: detecting, with a radiation sensor and through a radiation shield, the amount of radiation within the radioembolization administration set and a vial assembly contained within the radioembolization administration set, and blocking, with the radiation shield, radiation from a delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set, wherein: the radiation shield is positioned between the radiation sensor and the radioembolization administration set; the radiation shield is positioned between the radiation sensor and the delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set; and the radiation shield comprises a solid portion configured to block radiation, the solid portion comprising an exterior facing wall, an interior facing wall, a forward facing wall, and a rear facing wall, wherein theexterior facing wall and the interior facing wall are disposed between the forward facing wall and the rear facing wall, the interior facing wall defining an aperture, wherein: the solid portion and the aperture of the radiation shield are sized such that, when the forward facing wall is directed toward the radioembolization administration set in a first position and the rear facing wall is directed toward the radiation sensor that is disposed adjacent to the aperture in the first position: radiation emanating at a first angle from the radioembolization administration set and vial assembly passes through the aperture to the radiation sensor; and radiation emanating from a second angle from the delivery line tubing, the second angle distally below the first angle, is blocked by the solid portion of the radiation shield and does not pass through the aperture to the radiation sensor.

[0094] Aspect 17. The method of Aspect 16, further comprising: blocking the radiation emanating from the delivery line tubing with the solid portion of the radiation shield, such that the radiation sensor does not detect the radiation emanating from the delivery line tubing.

[0095] Aspect 18. The method of any of Aspect 16 to Aspect 17, further comprising: displaying the amount of radiation detected from within the radioembolization administration set on an interface display communicatively coupled to the radiation sensor.

[0096] Aspect 19. The method of any of Aspect 16 to Aspect 18, wherein the solid portion further comprises: a bottom portion; a first vertical arm extending from the bottom portion; and a second vertical arm extending from the bottom portion, wherein: the second vertical arm is laterally spaced from the first vertical arm; and the aperture is defined between the first vertical arm and the second vertical arm and the bottom portion.

[0097] Aspect 20. The method of Aspect 19, wherein: the bottom portion is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a first surface of the interior facing wall; the first vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a second surface of the interior facing wall; and the second vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a third surface of the interior facing wall.

[0098] It should now be understood that embodiments of the present disclosure are directed to a radiation delivery determination system for determining an amount of radiation within a radioembolization administration set, including a vial assembly that may be received therein, after at least a portion of the therapeutic has been delivered. The system further includes tubing coupled to the radioembolization administration set, shielding for the radioactive therapeutic, a radiationsensor and a radiation shield. In embodiments, the radiation shield includes a solid portion configured to block radiation while radioactive emissions from the vial assembly and administration set, which emanate at a first angle, pass through an aperture of the radiation shield to be measured by the radiation sensor. Radioactive emissions from the delivery line, which emanate at a second angle disposed below the first angle, are blocked by the solid portion of the radiation shield and not registered by the radiation sensor.

[0099] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

CLAIMS1. A radiation shield assembly, comprising: a radioembolization delivery device comprising a radiation sensor, a vial assembly, a radioembolization administration set containing the vial assembly, and a delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set; a radiation shield comprising a solid portion configured to block radiation, the solid portion comprising an exterior facing wall, an interior facing wall, a forward facing wall, and a rear facing wall, wherein the exterior facing wall and the interior facing wall are disposed between the forward facing wall and the rear facing wall, the interior facing wall defining an aperture; wherein: the solid portion and the aperture of the radiation shield are sized such that, when the forward facing wall is directed toward the radioembolization administration set in a first position and the rear facing wall is directed toward the radiation sensor that is disposed adjacent to the aperture in the first position: radiation emanating at a first angle from the radioembolization administration set and vial assembly passes through the aperture to the radiation sensor; and radiation emanating from a second angle from the delivery line tubing, the second angle distally below the first angle, is blocked by the solid portion of the radiation shield and does not pass through the aperture to the radiation sensor.

2. The radiation shield assembly of claim 1, wherein the solid portion further comprises: a bottom portion; a first vertical arm extending from the bottom portion; and a second vertical arm extending from the bottom portion, wherein: the second vertical arm is laterally spaced from the first vertical arm; and the aperture is defined between the first vertical arm and the second vertical arm and the bottom portion.

3. The radiation shield assembly of claim 2, wherein: the bottom portion is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a first surface of the interior facing wall;the first vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a second surface of the interior facing wall; and the second vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a third surface of the interior facing wall.

4. The radiation shield assembly of claim 3, wherein: the aperture is defined by the first surface of the interior facing wall, the second surface of the interior facing wall, and the third surface of the interior facing wall.

5. The radiation shield assembly of claim 1, wherein the rear facing wall of the radiation shield is positioned on a measuring surface of the radiation sensor in the first position.

6. The radiation shield assembly of claim 1, wherein the radiation shield comprises stainless steel, lead, tin, copper, pewter, aluminum, plastic, or combinations thereof.

7. A delivery system, comprising: a console assembly including a base and a vial containment region; a radioembolization administration set removably couplable to the console assembly at the vial containment region, wherein the radioembolization administration set contains a vial assembly; a delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set, wherein the delivery line tubing is configured for administering radioactive therapeutic material from the radioembolization administration set; a radiation sensor coupled to the base; and a radiation shield comprising a solid portion configured to block radiation, the solid portion comprising an exterior facing wall, an interior facing wall, a forward facing wall, and a rear facing wall, wherein the exterior facing wall and the interior facing wall are disposed between the forward facing wall and the rear facing wall, the interior facing wall defining an aperture; wherein: the solid portion and the aperture of the radiation shield are sized such that, when the forward facing wall is directed toward the radioembolization administration set in a first position and the rear facing wall is directed toward the radiation sensor that is disposed adjacent to the aperture in the first position:radiation emanating at a first angle from the radioembolization administration set and vial assembly passes through the aperture to the radiation sensor; and radiation emanating from a second angle from the delivery line tubing, the second angle distally below the first angle, is blocked by the solid portion of the radiation shield and does not pass through the aperture to the radiation sensor.

8. The delivery system of claim 7, wherein the solid portion further comprises: a bottom portion; a first vertical arm extending from the bottom portion; and a second vertical arm extending from the bottom portion, wherein: the second vertical arm is laterally spaced from the first vertical arm; and the aperture is defined between the first vertical arm and the second vertical arm and the bottom portion.

9. The delivery system of claim 8, wherein: the bottom portion is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a first surface of the interior facing wall; the first vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a second surface of the interior facing wall; and the second vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a third surface of the interior facing wall.

10. The delivery system of claim 9, wherein: the aperture is defined by the first surface of the interior facing wall, the second surface of the interior facing wall, and the third surface of the interior facing wall.

11. The delivery system of claim 7, wherein the rear facing wall of the radiation shield is positioned on a measuring surface of the radiation sensor in the first position.

12. The delivery system of claim 7, wherein the radiation shield is spaced apart from the radioembolization administration set and the delivery line tubing.

13. The delivery system of claim 7, wherein the vial assembly comprises a vial of radioactive therapeutic material.

14. The delivery system of claim 7, wherein the radiation shield comprises stainless steel, lead, tin, copper, pewter, aluminum, plastic, or combinations thereof.

15. The delivery system of claim 7, further comprising an interface display communicatively coupled to the radiation sensor.

16. A method of measuring an amount of radiation within a radioembolization administration set, comprising: detecting, with a radiation sensor and through a radiation shield, the amount of radiation within the radioembolization administration set and a vial assembly contained within the radioembolization administration set, and blocking, with the radiation shield, radiation from a delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set, wherein: the radiation shield is positioned between the radiation sensor and the radioembolization administration set; the radiation shield is positioned between the radiation sensor and the delivery line tubing in fluid communication with and disposed distally below the radioembolization administration set; and the radiation shield comprises a solid portion configured to block radiation, the solid portion comprising an exterior facing wall, an interior facing wall, a forward facing wall, and a rear facing wall, wherein the exterior facing wall and the interior facing wall are disposed between the forward facing wall and the rear facing wall, the interior facing wall defining an aperture, wherein: the solid portion and the aperture of the radiation shield are sized such that, when the forward facing wall is directed toward the radioembolization administration set in a first position and the rear facing wall is directed toward the radiation sensor that is disposed adjacent to the aperture in the first position:radiation emanating at a first angle from the radioembolization administration set and vial assembly passes through the aperture to the radiation sensor; and radiation emanating from a second angle from the delivery line tubing, the second angle distally below the first angle, is blocked by the solid portion of the radiation shield and does not pass through the aperture to the radiation sensor.

17. The method of claim 16, further comprising: blocking the radiation emanating from the delivery line tubing with the solid portion of the radiation shield, such that the radiation sensor does not detect the radiation emanating from the delivery line tubing.

18. The method of claim 16, further comprising: displaying the amount of radiation detected from within the radioembolization administration set on an interface display communicatively coupled to the radiation sensor.

19. The method of claim 16, wherein the solid portion further comprises: a bottom portion; a first vertical arm extending from the bottom portion; and a second vertical arm extending from the bottom portion, wherein: the second vertical arm is laterally spaced from the first vertical arm; and the aperture is defined between the first vertical arm and the second vertical arm and the bottom portion.

20. The method of claim 19, wherein: the bottom portion is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a first surface of the interior facing wall; the first vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a second surface of the interior facing wall; and the second vertical arm is defined by portions of the exterior facing wall, the forward facing wall, the rear facing wall, and a third surface of the interior facing wall.

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