WO2025159752A1

WO2025159752A1 - Radioembolization tubing set

Info

Publication number: WO2025159752A1
Application number: PCT/US2024/012944
Authority: WO
Inventors: Amanda THYSTRUP; Clint Solomon; Brandon Simmons; Terry A. Cruse; Ryan Thomas TOOLEY
Original assignee: Bard Peripheral Vascular Inc
Current assignee: Bard Peripheral Vascular Inc
Priority date: 2024-01-25
Filing date: 2024-01-25
Publication date: 2025-07-31
Anticipated expiration: 2026-07-25

Abstract

Assemblies and methods of use of a delivery assembly may include a console including a sled containment region, a sled assembly slidably couplable to the sled containment region of the console. The sled assembly may be configured to extend between an open position and a closed position. The sled assembly may be housed within the sled containment region in the closed position and the sled assembly extending from the sled containment region in the open position may be configured to receive a tubing set including one or more tubing in the open position. An aperture of a plurality of apertures of a front wall of the sled assembly may be configured to receive a tubing segment of the one or more tubing of the tubing set, the tubing segment configured to connect to a delivery line, the delivery line configured to deliver a particulate via the delivery assembly.

Description

RADIOEMBOLIZATION TUBING SET

TECHNICAL FIELD

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

BACKGROUND

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

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

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

SUMMARY

[0005] In accordance with an embodiment of the disclosure, a delivery assembly may include a console including a sled containment region, a sled assembly slidably couplable to the sled containment region of the console, the sled assembly including a front wall defining a plurality of apertures. The sled assembly may be configured to extend between an open position and a closed position. The sled assembly is housed within the sled containment region in the closed position, and the sled assembly extends from the sled containment region in the open position and may be configured to receive a tubing set including one or more tubing in the open position. An aperture of the plurality of apertures of the front wall of the sled assembly may be configured to receive a tubing segment of the one or more tubing of the tubing set, and the tubing segment may be configured to connect to a delivery line, the delivery line configured to deliver a particulate via the delivery assembly.

[0006] In another embodiment, a delivery assembly may include a console including a sled containment region, a sled assembly slidably couplable to the sled containment region of the console, and a tubing set. The sled assembly includes a front wall defining a plurality of apertures. The sled assembly may be configured to extend between an open position and a closed position, with the sled assembly housed within the sled containment region in the closed position, and the sled assembly extending from the sled containment region in the open position. The tubing set includes a tubing segment of one or more tubing, a vial assembly container, and a vial assembly. The sled assembly may be configured to receive the tubing set in the open position. The vial assembly container may be configured to receive the vial assembly, the vial assembly may be configured to contain a particulate, and the tubing segment of the one or more tubing of the tubing set may be configured to fluidly couple to the vial assembly. An aperture of the plurality of apertures of the front wall of the sled assembly may be configured to receive the tubing segment of the one or more tubing of the tubing set.

[0007] In yet another embodiment, a method of inserting a tubing set within a delivery assembly may include positioning a sled assembly slidably coupled to a sled containment region of a console of the delivery assembly into an open position, the sled assembly including a front wall defining a plurality of apertures. The method may further include receiving the tubing set within the sled assembly in the open position, receiving the tubing segment within an aperture of the plurality of apertures of the front wall of the sled assembly, and positioning the sled assembly into a closed position. The tubing set includes a tubing segment of one or more tubing, a vial assembly container, and a vial assembly disposed in the vial assembly container and containing a particulate, the tubing segment fluidly coupled to the vial assembly containing the particulate. The sled assembly is housed within the sled containment region in the closed position. [0008] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0011] FIG. 3 is a perspective view of a vial assembly including an engagement head according to one or more embodiments shown and described herein;

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

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

[0014] FIG. 6 is a schematic side view of an embodiment of the delivery device of FIGS. 1-5 as a delivery assembly with a sled assembly slidably couplable to a console, according to one or more embodiments shown and described herein; and

[0015] FIG. 7 is a flow chart of a process inserting a tubing set within the delivery assembly of FIG. 6, according to one or more embodiments shown and described herein.

DETAILED DESCRIPTION

[0016] Reference will now be made in detail to various embodiments of delivery devices for administering radioactive compounds to a patient, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts. Directional terms as used herein — for example up, down, right, left, front, back, top, bottom, distal, and proximal — are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

[0017] 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.

[0018] 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.

[0019] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs. The terminology used in the description herein is for describing particular embodiments only and is not intended to be limiting. As used in the specification and appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[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 as characteristic of the devices shown. The present disclosure and the embodiments thereof to be described herein may be used in any desired orientation. Moreover, horizontal and vertical walls need generally only be intersecting walls, and need not be perpendicular. As used herein, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0021] FIGS. 1-5 are directed to embodiments related to a delivery device 500, which may also be referred to herein as the “radioembolization delivery device” to deliver a material, such as radioactive mixed material. FIGS. 6-7, described in greater detail further below, are directed to embodiments of assemblies and methods for utilization of an embodiment of the delivery device 500 as a delivery assembly 600 to position components of the delivery assembly 600 to deliver the radioactive mixed material.

I. Mechanical Delivery Device with Removable Sled Assembly

[0022] FIGS. 1-5 show an embodiment of a delivery device 500 that is configured and operable to deliver a radioactive material (e.g., radioembolizing beads via a mixed particulate, such as of beads in a saline solution) while reducing radioactive emissions during use of the delivery device 500. The delivery device 500 may operate as described in International PCT App. No. PCT/2019/033001, filed May 17, 2019, the entirety of which is incorporated herein, except with respect to components as described in greater detail below with respect to FIGS. 6-7 and in one or more embodiments herein.

[0023] Referring initially to FIG. 1, the delivery device 500 comprises a console assembly 510, which includes a console. The delivery device 500 may include a sled assembly 540 that is operable to transition between a coupled state and decoupled state relative to the console assembly 510. The console assembly 510 of the delivery device 500 comprises a base 512 defined by and extending between a proximal end 514 and a distal end 516. The proximal end 514 of the base 512 includes a handle (delivery handle) 528 movably coupled to the console assembly 510 and an interface display 530 positioned on the console assembly 510.

[0024] 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 atachment device 538 is operable to facilitate an atachment of a complimentary device to the console assembly 510 for use with the delivery device 500 during a procedure.

[0025] Still referring to FIG. 1, the distal end 516 of the console assembly 510 defines a vial containment region 518 that is sized and shaped to receive a vial assembly 580 therein, as will be described in greater detail herein. The console assembly 510 further includes a vial engagement mechanism 520 extending from the base 512 adjacent to the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outward from the base 512 of the console assembly 510 toward the distal end 516. The vial engagement mechanism 520 is positioned within the vial containment region 518 of the console assembly 510 and is movably coupled to the handle 528. In particular, the handle 528 of the console assembly 510 is operable to move, and in particular translate, the vial engagement mechanism 520 within the vial containment region 518 in response to an actuation of the handle 528.

[0026] The console assembly 510 includes a mechanical assembly disposed within the base 512 that is configured and operable to convert a manual motion of the handle 528 to a corresponding linear displacement of the vial engagement mechanism 520. In the present example, the mechanical assembly is coupled to the handle 528 and the vial engagement mechanism 520 such that selective actuation of the handle 528 at the proximal end 514 causes a simultaneous actuation of the vial engagement mechanism 520 at the distal end 516.

[0027] The sled cavity 532 is sized and shaped to receive the sled assembly 540 therein. As will be described in greater detail herein, the sled assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, medium) therethrough. In particular, the sled assembly 540 is configured to partially receive a vial assembly 580 therein for administering the therapeutic particles from the delivery device 500 and to a patient during a procedure.

[0028] 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 555 A, 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.

[0029] The pair of lever arms 522 is simultaneously movable with the neck 524 of the vial engagement mechanism 520 in response to an actuation of the handle 528 of the console assembly 510. Further, the pair of lever arms 522 are fixed relative to one another such that a spacing formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 is configured to securely engage the vial assembly 580 therebetween, and in particular within the spacing formed by the pair of lever arms 522. Accordingly, the vial engagement mechanism 520 is operable to securely attach the vial assembly 580 to the console assembly 510 at the vial containment region 518. Although the vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, it should be understood that the vial engagement mechanism 520 may include various other structural configurations suitable for engaging the vial assembly 580. In a non-limiting example, the vial engagement mechanism 520 may include one or more magnets configured to engage with one or more corresponding magnets on the vial assembly.

[0030] 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.

[0031] The distal end 516 of the console assembly 510 further includes a sled cavity 532 that is sized and shaped to receive the sled assembly 540 therein. The sled cavity 532 includes one or more or a pair of alignment features 534 extending therein, with the alignment features 534 sized and shaped to correspond with complimentary alignment features of the sled assembly 540 (e.g., alignment ribs 554) to thereby facilitate a coupling of the sled assembly 540 with the base 512 of the console assembly 510 within the sled cavity 532.

[0032] Still referring to FIG. 1, the sled assembly 540 is configured to partially receive a vial assembly 580 therein for administering therapeutic particles (e.g., radioactive fluid medium) from the delivery device 500 and to a patient. In particular, the sled assembly 540 comprises a distal end 542 and a proximal end 544 with a pair of sidewalls 546 extending therebetween. The distal end 542 of the sled assembly 540 includes a handle 552 extending proximally therefrom. The handle 552 is configured to facilitate movement of the sled assembly 540, and in particular, an insertion of the sled assembly 540 into the sled cavity 532 of the console assembly 510. The distal end 542 further includes one or more ports 556 for coupling one or more delivery lines (i.e., tubing) to the sled assembly 540. With the one or more delivery lines further be coupled to one or more external devices at an end of the line opposite of the ports 556, the ports 556 effectively serve to fluidly couple the sled assembly 540 to the one or more external devices via the delivery lines connected thereto. The pair of sidewalls 546 of the sled assembly 540 includes at least one alignment rib 554 extending laterally outward therefrom, where the alignment ribs 554 are sized and shaped to correspond with and mate to the pair of alignment features 534 of the console assembly 510. Accordingly, the pair of alignment ribs 554 are configured to facilitate an alignment and engagement of the sled assembly 540 with the console assembly 510 when the proximal end 544 is slidably received within the sled cavity 532 of the base 512.

[0033] The sled assembly 540 further includes a top surface 548 extending from the distal end 542 and the proximal end 544 and positioned between the pair of sidewalls 546. The top surface 548 of the sled assembly includes a recessed region 549 and a locking system 550. The recessed region 549 is sized and shaped to form a recess and/or cavity along the top surface 548, where the recessed region 549 is capable of receiving and/or collecting various materials therein, including, for example, leaks of various fluid media during use of the delivery device 500. The locking system 550 of the sled assembly 540 forms an opening along the top surface 548 that is sized and shaped to receive one or more devices therein, such as a priming assembly 560 and a vial assembly 580. In some embodiments, the sled assembly 540 comes preloaded with the priming assembly 560 disposed within the locking system 550. The priming assembly 560 includes a priming line 562 extending outwardly from the locking system 550 of the sled assembly 540. The priming assembly 560 connects the priming line 562 to needle 559 and manifolds 555A and 555B and serves to purge the delivery device 500, including the manifolds 555A and 555B, of air prior to utilizing the delivery device 500 in a procedure.

[0034] Referring now to FIG. 2, the locking system 550 includes an annular array of projections 551 extending outwardly therefrom, and in particular, extending laterally into the aperture formed by the locking system 550 along the top surface 548. The annular array of projections 551 are formed within an inner perimeter of the locking system 550 and extend along at least two sequentially-arranged rows. In embodiments, a single row may be used. The annular array of projections 551 included in the locking system 550 are configured to engage a corresponding locking feature 586 of the vial assembly 580 See FIG. 3) to thereby securely fasten the vial assembly 580 to the sled assembly 540. It should be understood that the multiple rows of projections 551 of the locking system 550 serve to provide a double-locking system to ensure the sled assembly 540, and in particular a needle 559 of the sled assembly 540, is securely maintained through a septum 592 of the vial assembly 580 See FIG. 3) during use of the delivery device 500 in a procedure.

[0035] The sled assembly 540 further includes a vial chamber 558 that is sized and shaped to receive the priming assembly 560 and the vial assembly 580 therein, respectively. In other words, the vial chamber 558 is sized to individually receive both the priming assembly 560 and the vial assembly 580 separate from one another. The vial chamber 558 is encapsulated around a protective chamber or shield 557 disposed about the vial chamber 558. The protective shield 557 is formed of a material configured to inhibit radioactive emissions from extending outwardly from the vial chamber 558, such as, for example, a metal or plastic. Additionally, the sled assembly 540 includes a needle extending through the protective shield 557 and into the vial chamber 558 along a bottom end of the vial chamber 558. The needle 559 is fixedly secured relative to the vial chamber 558 such that any devices received through the aperture of the locking system 550 and into the vial chamber 558 are to encounter and interact with the needle 559 (e.g., the priming assembly 560, the vial assembly 580, and the like).

[0036] Still referring to FIG. 2, the needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the sled assembly 540, and in particular the manifold 555A, 555B is positioned beneath the vial chamber 558 and the protective shield 557. The proximal manifold 555B is fluidly coupled to the needle 559 and the distal manifold 555A is fluidly couplable to one or more delivery lines via the one or more ports 556 of the sled assembly 540. The proximal manifold 555B is in fluid communication with the distal manifold 555 A through a one-way check valve 553 disposed therebetween.

[0037] Accordingly, the proximal manifold 555B is in fluid communication with the one or more ports 556 via the distal manifold 555A, however, the one or more ports 556 are not in fluid communication with the proximal manifold 555B due to a position of the one-way check valve 553 disposed between the manifolds 555A, 555B. Thus, the needle 559 is in fluid communication with the one or more delivery lines and/or devices coupled to the sled assembly 540 at the one or more ports 556 via the manifolds 555A, 555B secured therebetween. The one or more ports 556 of the sled assembly 540 may be coupled to a bag (e.g., saline bag), a syringe, a catheter, and/or the like via one or more delivery lines coupled thereto. In other embodiments, the needle 559 may be a cannula, catheter, or similar mechanism through which to inject and receive fluid and/or a solution as described herein.

[0038] Still referring to FIG. 2, the sled assembly 540 includes a removable battery pack 570 coupled to the sled assembly 540 along the proximal end 544. The removable battery pack 570 comprises a battery 572, electrical contacts 574, and a removable tab 576. The battery 572 of the delivery device 500 is isolated from one or more fluid paths and radiation sources due to a location of the battery 572 in the removable battery pack 570.

[0039] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to contact against and interact with corresponding electrical contacts 511 of the console assembly 510 See FIG. 1) when the sled assembly 540 is coupled to the base 512 at the sled cavity 532. Accordingly, the removable battery pack 570 is operable to provide electrical power to the delivery device 500, and in particular the console assembly 510, when the sled assembly 540 is coupled to the console assembly 510.

[0040] Additionally, as will be described in greater detail herein, in some embodiments the locking system 550 may include at least one planar wall relative to a remaining circular orientation of the locking system 550. In this instance, an aperture formed by the locking system 550 through the top surface 548 of the sled assembly 540 is irregularly-shaped, rather than circularly-shaped as shown and described above. In this instance, the vial assembly 580 includes a locking feature 586 that has a shape and size that corresponds to the locking system 550, and in particular the at least one planar wall such that the vial assembly 580 is received within the sled assembly 540 only when an orientation of the vial assembly 580 corresponds with an alignment of the locking feature 586 and the locking system 550. In other words, a corresponding planar wall 586 A of the locking feature 586 See FIG. 3) must be aligned with the planar wall of the locking system 550 for the vial assembly 580 to be receivable within an aperture formed by the locking system 550 of the sled assembly 540.

[0041] 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.

[0042] The plunger 584 includes a plurality of indicia and/or markings 583 positioned along a longitudinal length of the plunger 584. The plurality of markings 583 is indicative of a relative extension of the engagement head 582 and the plunger 584 from the locking feature 586 and the vial body 589. As briefly noted above, the engagement head 582 is configured to attach the vial assembly 580 to the vial engagement mechanism 520. In particular, the pair of arms 581 of the engagement head 582 are sized and shaped to couple with the pair of lever arms 522 of the vial engagement mechanism 520 when the vial assembly 580 is received within the sled assembly 540 and the sled assembly is inserted into the sled cavity 532 of the console assembly 510. As will be described in greater detail herein, the pair of lever arms 522 are received between the pair of arms 581 of the engagement head 582 and the plunger 584 in response to a predetermined translation force applied to the vial engagement mechanism 520. The engagement head 582 and the plunger

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

[0043] 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.

[0044] Referring back to FIG. 3, the locking feature 586 extends about a top end of the vial body 589. In the present example, the locking feature 586 of the vial assembly 580 comprises a bushing that defines a lateral edge 587 extending laterally outward along an outer perimeter of the locking feature 586. The lateral edge 587 of the locking feature 586 is sized and shaped to engage the annular array of projections 551 of the locking system 550 when the vial assembly 580 is received within the vial chamber 558 of the sled assembly 540. As will be described in greater detail herein, the locking feature 586, and in particular the lateral edge 587 of the locking feature 586, is configured to securely fasten the vial assembly 580 to the locking system 550 to inhibit removal of the vial body 589 from the vial chamber 558 of the sled assembly 540 during use of the delivery device 500 in a procedure. In some embodiments, as briefly described above, the locking feature 586 includes at least one planar wall 586A such that the locking feature 586 comprises an irregular-profile. The at least one planar wall 586A is configured to correspond to the planar wall 550A of the locking system 550 such that an alignment of the planar walls 550A, 586A is required for the vial assembly 580 to be received through an aperture formed by the locking system 550.

[0045] Still referring to FIG. 3, the vial body 589 extends downwardly relative from the locking feature 586 and has a longitudinal length that is sized to receive at least a portion of a longitudinal length of the plunger 584 therein. Accordingly, in some embodiments a longitudinal length of the plunger 584 exceed a longitudinal length of the vial body 589 such that a translation of the plunger 584 into the internal chamber 588 of the vial body 589 causes a fluid media stored therein to be transferred outward from the vial body 589. As will be described in greater detail herein, a translation of the plunger 584 through the internal chamber 588 of the vial body 589 provides for an administration of a fluid media stored within the vial body 589 outward from the vial assembly 580. The vial body 589 may be formed of various materials, including, for example, a thermoplastic polymer, copolyester, polycarbonate, a biocompatible plastic, polysulfone, ceramics, metals, and/or the like.

[0046] The vial body 589 is of the present example is formed of a material that is configured to inhibit radioactive emissions from a fluid media stored within the internal chamber 588 of the vial body 589. For example, the vial body 589 may be formed of a plastic, such as polycarbonate, and have a width. A density and material composition of the vial body 589 may collectively inhibit beta radiation emission from electron particles stored within the internal chamber 588. In the present example, a chemical composition of the plastic of the vial body 589, along with the 9 mm wall thickness, provides a plurality of atoms disposed within the vial body 589 that are capable of encountering the electron particles generating beta radiation and reducing an emission of said radiation from the vial assembly 580. Accordingly, the vial assembly 580 allows an operator to handle the radioactive material stored within the vial body 589 without being exposed to beta radiation. It should be understood that various other materials and/or wall sections may be incorporated in the vial body 589 of the vial assembly 580 in other embodiments without departing from the scope of the present disclosure.

[0047] Still referring to FIG. 3, the vial body 589 of the vial assembly 580 is sealed at a first terminal end 598 by the locking feature 586. The vial assembly 580 further includes a cap 590 positioned at an opposing, terminal end of the vial body 589 opposite of the locking feature 586, such that the cap 590 seals a second terminal end of the vial body 589 of the vial assembly 580. Additionally, the vial assembly 580 includes a septum 592 positioned adjacent to the cap 590 and in fluid communication with a terminal end of the vial body 589 opposite of the locking feature 586. The septum 592 forms a seal against a terminal end of the vial body 589 and the cap 590 retains the septum 592 therein. The septum 592 may be formed of various materials, including, for example, an elastomer, silicon, bromobutyl elastomer, rubber, urethanes, and/or the like. The septum 592 is configured to provide an air-tight seal for the vial body 589 to thereby inhibit a release of a fluid media stored therein (e.g., radioembolizing beads). As will be described in greater detail herein, the septum 592 of the vial assembly 580 is configured to be punctured by the needle 559 of the sled assembly 540 when the vial assembly 580 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the sled assembly 540. In other embodiments, the septum 592 may be omitted entirely for an alternative device, such as, for example, a valve system, needle injection port, and/or the like.

[0048] Referring now to FIG. 4, in response to determining that the battery 572 contains or other power source provides a sufficient amount of power, one or more delivery lines are coupled to the sled assembly 540 via the one or more ports 556. In particular, a dose delivery line 10A is coupled to the sled assembly 540 at a delivery port 556A, a contrast line 10B is coupled to the sled assembly 540 at a contrast port 556B, and a flushing line 10C is coupled to the sled assembly 540 at a flushing port 556C. An opposing end of the dose delivery line 10A is initially coupled to a fluid reservoir, such as, for example, a collection bowl. As will be described in greater detail herein, the dose delivery line 10 A may be subsequently coupled to an external device, such as a catheter, once the sled assembly 540 has been effectively primed by a fluid medium via the contrast line 10B. An opposing end of the flushing line 10C is coupled to an external device, such as, for example, a syringe. With both the dose delivery line 10A and the flushing line 10C coupled to the sled assembly 540, the sled assembly 540 is flushed with a fluid medium (e.g., saline) from the syringe coupled to the flushing line 10C. In this instance, the fluid medium is injected through the flushing line 10C, into the distal manifold 555A of the sled assembly 540, and out of the sled assembly 540 through the dose delivery line 10A. Accordingly, the fluid medium is ultimately received at the collection bowl and disposed thereat by the dose delivery line 10A.

[0049] With the distal manifold 555A of the sled assembly 540 separated from the proximal manifold 555B by the one-way valve 553 disposed therebetween, the fluid medium flushed through the distal manifold 555A from the syringe (via the flushing port 556C) is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. Rather, the fluid medium injected from the syringe and through the flushing line 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 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 valve 553 and into the proximal manifold 555B that is in fluid communication with the needle 559.

[0050] The contrast line 10B is coupled to the sled assembly 540 at a contrast port 556B. An opposing end of the contrast line 10B is coupled to a fluid medium supply, such as, for example, a bag secured to the console assembly 510 via the attachment device 538. In the present example, the bag is a saline bag such that the fluid medium stored therein is saline. In this instance, with the sled assembly 540 including the priming assembly 560 positioned within the vial chamber 558 and the needle end 568 in fluid communication with the needle 559, a syringe is fluidly coupled to the priming line 562 of the priming assembly 560 and a plunger of the syringe is drawn back to pull saline through the contrast line 10B, the contrast port 556B, the sled assembly 540, the priming line 562 and into the syringe from the saline bag. The plunger of the syringe is thereafter pushed inwards to transfer the extracted saline back through the priming line 562, the central body 564, the elongated shaft 566, and the needle end of the priming assembly 560 such that the saline is received into the needle 559 of the sled assembly 540. Accordingly, the manifolds 555 A, 555B of the sled assembly 540 are effectively primed with the saline from the syringe as the needle 559 that received the saline from the priming assembly 560 is in fluid communication with the manifolds 555 A, 555B. With the manifolds 555 A, 555B in further fluid communication with the dose delivery line 10A via the delivery port 556A, the saline is effectively distributed to the collection bowl coupled thereto.

[0051] The sled assembly 540 is coupled to one or more external devices via the one or more ports 556. In particular, the sled assembly 540 is fluidly coupled to a catheter (e.g., microcatheter) via the dose delivery line 10 A that is coupled to the delivery port 556 A of the sled assembly 540. In this instance, the catheter is in fluid communication with the sled assembly 540 via the dose delivery line 10A. Further, the sled assembly 540 is fluidly coupled to a contrast source, such as, for example, a saline bag secured to the console assembly 510 via the attachment device 538 See FIG. 1). The sled assembly 540 is in fluid communication with the saline bag via a contrast line 10B coupled to the contrast port 556B of the sled assembly 540. In this instance, the saline bag is in fluid communication with the sled assembly 540 via the contrast line 10B secured to the contrast port 556B.

[0052] The contrast port 556B is in fluid communication with the proximal manifold 555B while the delivery port 556A is in fluid communication with the distal manifold 555A. As will be described in greater detail herein, saline from the saline bag may be withdrawn through the needle 559 of the sled assembly 540 and into the vial body 589 of the vial assembly 580 as the contrast port 556B is coupled to the proximal manifold 555B, rather than the distal manifold 555A which is separated from the proximal manifold 555B by the one-way check valve 553 disposed therebetween.

[0053] Referring again to FIGS. 1 and 3, with the vial assembly 580 securely coupled to the sled assembly 540, the sled assembly 540 is coupled to the console assembly 510 by translating the distal end 542 of the sled assembly 540 toward and into the distal end 516 of the console assembly 510. In particular, the distal end 542 of the sled assembly 540 is directed into the sled cavity 532 of the console assembly 510 by aligning the alignment ribs 554 of the sled assembly 540 with the alignment features 534 of the console assembly 510. Once the proximal end 544 and the distal end 542 of the sled assembly 540 are fully seated within the sled cavity 532 of the console assembly 510, the electrical contacts 574 (FIG. 2) of the removable battery pack 570 interact with corresponding electrical contacts 511 (FIG. 1) of the console assembly 510. In this instance, power from the battery 572 is transmitted to the console assembly 510 via the electrical contacts 574, thereby activating the console assembly 510 of the delivery device 500. In this instance, the interface display 530 of the console assembly 510 is activated to display pertinent, real-time information relating to the delivery device 500 during a procedure.

[0054] Referring again to FIG. 4, as the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial containment region 518, a negative pressure is generated within the internal chamber 588 of the vial body 589 due to a retraction of the stopper 594. In this instance, with the saline bag coupled to the sled assembly 540 via the contrast line 10B and the contrast port 556B, saline from the saline bag is pulled into the internal chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Accordingly, with the vial body 589 being preloaded with a radioactive fluid media (e.g., radioembolizing microspheres), the saline is effectively mixed with the radioactive fluid media within the vial body 589 as the plunger 584 is retracted from the internal chamber 588 and the negative pressure is generated through the delivery device 500.

[0055] The sled assembly 540 further includes one-way check valves 553A in-line with the contrast line 10B and the flushing line 10C. In particular, the one-way check valves 553A are configured to permit fluid communication from the contrast port 556B and the flushing port 556C into the manifolds 555A, 555B, and further configured to prevent fluid communication from the manifolds 555 A, 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 oneway check valves 553A positioned therein. Thus, the dose is directed to the dose delivery port 556 A and received at the catheter fluidly coupled thereto by the dose delivery line 10 A. In other words, the one-way check valves 553A prevent a backflow of fluid into the sled assembly 540 and/or the vial assembly 580 coupled thereto.

[0056] Referring to FIG. 5, an interface display communicatively coupled to the delivery device 500 may be operable to transmit information and/or data to an operator of the delivery device 500, and in particular data detected by an electrical system of the delivery device 500 which may comprise one or more sensors disposed within the delivery device 500, such as an onboard sensor (that may be, for example, radiation sensor 533 as described in greater detail further below). It should be understood that the delivery device 500 may include an electrical microprocessor that operates the interface display. In other embodiments, the interface display may comprise a remote smart device, a tablet, and/or the like.

[0057] 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 an operator as the handle 528 is actuated.

[0058] 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.

[0059] 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.

[0060] As will be described in greater detail herein, by measuring a displacement distance or velocity of the handle 528 and/or the vial engagement mechanism 520, computer readable and executable instructions of the delivery device 500, when executed by a processor of the delivery device 500, may determine a flow rate of a fluid media being delivered by the delivery device 500. Additionally or alternatively, the computer readable and executable instructions of the delivery device 500, when executed by a processor of the delivery device 500, may further determine a remaining volume of a fluid media stored within the delivery device 500. As briefly noted above, the data detected by the linear displacement sensor 531 and the information determined by the processor of the delivery device 500 may be displayed at the interface display 530 for operator review.

[0061] Still referring to FIG. 5, the radiation sensor 533 is securely attached to the base 512 of the console assembly 510 at a location adjacent to the vial containment region 518. In particular, the radiation sensor 533 is positioned proximate to the sled cavity 532 that is sized and shaped to receive the sled assembly 540 therein. As will be described in greater detail herein, the sled assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, medium) therethrough such that the radiation sensor 533 is operable to detect and monitor a radiation level of the therapeutic particles due to a proximate location of the radiation sensor 533 with the sled assembly 540. In particular, the sled assembly 540 is configured to partially receive a vial assembly 580 therein for administering the therapeutic particles from the delivery device 500 and to a patient.

[0062] As will further be described herein, by detecting a radiation level of the radioactive medium stored and transferred through the sled assembly 540, computer readable and executable instructions of the delivery device 500, when executed by a processor of the delivery device 500, may determine a radiation dosage delivered from the delivery device 500. Additionally or alternatively, the computer readable and executable instructions executed by a processor of the delivery device 500 may further determine a remaining radiation dosage contained within the delivery device 500 during a procedure. As briefly noted above, the data detected by the radiation sensor 533 and the information determined by the processor of the delivery device 500 may be displayed at the interface display for operator review. It should be understood that in other embodiments the delivery device 500 may include additional or fewer sensors than those shown and described herein (e.g., a dosimeter, a linear encoder, an optical sensor, a linear displacement sensor, a flow sensor, an ultrasonic sensor, a magnetic encoder, a laser distance sensor, an inductance sensor, a radial encoder, a volumetric sensor, mechanical transducers, etc.). A dosimeter and/or radiation sensor of the delivery device 500 may be configured to measure a remaining exposure to ionizing radiation stored within the delivery device 500, and in particularly the sled assembly 540 and/or the vial assembly 580.

[0063] By way of further examples, a flow sensor of the delivery device 500 may be positioned in-line with the tubing set of the delivery device 500, and in particular the needle 559, the manifolds 555A, 555B, and/or one or more of the ports 556, and may be configured to measure an amount of fluid (e.g., suspension liquid after the therapeutic particles have effectively mixed with the fluid medium) that passes thereby. An ultrasonic sensor of the delivery device 500 may comprise a transmitter, receiver, and/or transceiver configured to measure a distance to an object (e.g., remaining volume of dosage within the vial assembly 580) based on transmitting ultrasonic signals (i.e. sound waves) therein and measuring an elapsed time before receiving back the bounced sound waves. A radial encoder of the delivery device 500 may comprise an absolute encoder and/or an incremental encoder configured to convert an angular position or motion of the handle 528, the plunger 584, the mechanical assembly 529, and/or other components of the delivery device 500 to analog or digital ouput signals corresponding to a remaining dosage within the vial assembly 580.

II. Assemblies Utilizing the Delivery Device

[0064] Referring now to FIG. 6, embodiments herein are directed to a delivery assembly 600 as an embodiment of the delivery device 500. As described herein below, the delivery assembly 600 may include a console 610 (similar to the console assembly 510 of the delivery device 500 except as described below) and a sled assembly 640 (similar to the sled assembly 540 of the delivery device 500 except as described below). The sled assembly 640 of the delivery assembly 600 is slidably couplable to the sled assembly 640 such that a tubing set 643 may be inserted into the sled assembly 640, which may be a re-usable drawer able to be inserted into and removed from the console 610 of the delivery assembly 600 in a variety of manners as described herein. The delivery assembly 600 thus allows for reuse of components (e.g., reuse of a sled assembly 640, which is an embodiment of the sled assembly 540 of FIGS. 1-5) that may be connected to the tubing set 643. Once the radioembolization procedure has been completed using the delivery assembly 600, the tubing set 643 may be removed from the delivery assembly 600, and the delivery assembly 600 and sled assembly 640 may be reused by connecting another tubing set 643 to the delivery assembly 600. [0065] Referring now to FIG. 6, the delivery assembly 600 includes the console 610 including a sled containment region 632. The delivery assembly 600 further includes the sled assembly 640 slidably couplable to the sled containment region 632 of the console 610. The sled assembly 640 includes a front wall 642 defining a plurality of apertures 656. The sled assembly 640 is configured to slide between an open position OP and a closed position. The sled assembly 640 is housed within the sled containment region 632 in the closed position, while the sled assembly 640 extends from the sled containment region 632 in the open position OP as shown in FIG. 6. Moreover, in the open position OP, the sled assembly 640 is configured to receive the tubing set 643 (which includes one or more tubing 645). An aperture 656 of the plurality of apertures 656 is configured to receive a tubing segment 657 of the one or more tubing 645 of the tubing set 643. The tubing segment 657 is configured to connect to a delivery line 10 (such as the dose delivery line 10 A described above), which may be configured to deliver a particulate (e.g., the radioembolizing beads via the mixed particulate, as described hereinabove) to the patient during a procedure. In embodiments, the delivery assembly 600 may further include the tubing set 643.

[0066] In embodiments, the tubing set 643 may include a vial assembly 580, the vial assembly configured to contain the particulate. The tubing segment 657 of the one or more tubing 645 of the tubing set 643 may be configured to fluidly couple to the vial assembly 580. The tubing set 643 may further include a vial assembly container 680. The vial assembly container 680 may be configured to receive the vial assembly 580 containing the particulate. The tubing segment 657 of the one or more tubing 645 of the tubing set 643 may be configured to fluidly couple to the vial assembly 580.

[0067] As depicted in FIG. 6, dimensions of the sled containment region 632 may generally correspond to dimensions of the sled assembly 640, such that the entirety of the sled assembly 640 up to the front wall 642 is within the sled containment region 632 when the sled assembly 640 is in the closed position. As noted hereinabove, the sled assembly 640 may be slidably coupled to the sled containment region 632, such that the sled assembly 640 may slide between the open position OP and the closed position.

[0068] In embodiments, the sled assembly 640 may be slidably coupled to the sled containment region 632 through the use of a wheel and track system, such that wheels of the sled assembly 640 may slidably engage tracks of the sled containment region 632. The sled assembly 640 may be locked into the sled containment region 632, such that the sled assembly 640 only slides in and out of the sled containment region 632. In other embodiments, the sled assembly 640 may be removable from the sled containment region 632, such that the sled assembly 640 is detached from the sled containment region 632. Such removal of the sled assembly 640 from the sled containment region 632 may result in ease of loading the tubing set 643, as the sled assembly 640 may be more easily manipulated/moved to load the tubing set 643 into the sled assembly 640.

[0069] In embodiments, the sled assembly 640 may be locked into the closed position when the sled assembly 640 is inserted into the sled containment region 632. As such, the sled containment region 632 may further include a sled engagement feature 667. The sled engagement feature 667 may engage a region engagement feature 668 of the sled assembly 640 when the sled assembly 640 is in the closed position. When the sled engagement feature 667 is engaged to the region engagement feature 668, the sled assembly 640 may be locked to and within the sled containment region 632. The sled engagement feature 667 and region engagement feature 668 may automatically lock the sled assembly 640 within the sled containment region 632, or the sled assembly 640 may be locked into the sled containment region 632 through the use of a locking feature on the side of the console 610 or on the front wall 642 of the sled assembly 640. The sled assembly 640 may be unlocked from the sled containment region 632 through engagement of the locking feature. The sled assembly 640 may also be unlocked from the sled containment region 632 when a threshold force is applied to pull the sled assembly 640 out of the sled containment region 632.

[0070] The front wall 642 of the sled assembly 640 defining the plurality of apertures 646 may be made of a radiation shielding material 671, such that radiation does not escape the sled assembly 640. The radiation shielding material 671 may also define an entirety of the sled assembly 640, such that radiation does not escape the sled assembly 640 through any surface of the sled assembly 640. In embodiments, the radiation shielding material 671 may be made of plastic, lead, tungsten, or combinations thereof.

[0071] The sled assembly 640 may lock the tubing set 643 into place, such as through the use of a tubing locking mechanism 669. The sled assembly 640 may include the tubing locking mechanism 669. As such, when the tubing set 643 is placed within the sled assembly 640, the tubing locking mechanism 669 may receive the tubing segment 657 and lock the tubing segment 657 within the sled assembly 640. The tubing locking mechanism 669 may lock the tubing segment 657 into place through the use of a compression fit, snap fit, or any other suitable locking mechanism. The tubing segment 657 may be disengaged through enough force being applied to pull the tubing segment 657 out of the tubing locking mechanism 669. Alternatively, the tubing locking mechanism 669 may include a tube unlock feature that may be engaged to unlock the tubing segment 657.

[0072] As depicted in FIG. 6 and described above, the tubing set 643 may further include the vial assembly 580, which may be sized to fit within the vial assembly container 680 that is configured to receive the vial assembly 580. The vial assembly 580 may contain the particulate, and the tubing segment 657 of the one or more tubing 645 of the tubing set 643 may be configured to fluidly couple to the vial assembly 580 when the vial assembly 580 is placed within the vial assembly container 680. As such, the vial assembly 580 may deliver the particulate to the console 610 through the tubing segment 657.

[0073] The vial assembly container 680 may be sized such that the vial assembly 580 is held into place when the vial assembly 580 is inserted into the vial assembly container 680 (e.g., through press-fit or any other suitable means). The delivery assembly 600 may also include the vial engagement mechanism 520 (as described hereinabove). In embodiments, the vial engagement mechanism 520 may extend from the console 610 and engage the vial assembly 580 of the tubing set 643. The vial engagement mechanism 520 may move the vial assembly 580 into a locked position as described herein, such as through the use of the lever arms 522 to securely engage the vial assembly 580 with the lever arms 522, as described above and depicted in FIG. 2.

[0074] In embodiments, the vial assembly 580 may include an aperture on the underside of the vial assembly 580. A septum 592 may be included on the vial assembly 580 to prevent the particulate from escaping the vial assembly 580 before the vial assembly 580 is placed into the vial assembly container 680. The septum 592 may be any plastic or rubber material that prevents the particulate from escaping the vial assembly 580.

[0075] The delivery assembly 600 may further include a needle 599 in the vial assembly container 680. The needle 599 may be configured to puncture the septum 592 of the vial assembly 580 when the vial assembly 580 is in the locked position. The needle 599 may be fluidly coupled to the tubing segment 643 of the one or more tubing 645 of the tubing set 643, such that the particulate may be released from the vial assembly 580 through the needle 599 when the needle 599 punctures the septum 592 of the vial assembly 580. Thus, the particulate may be delivered to the patient during a procedure through the one or more tubing 645 of the tubing set 643.

[0076] In embodiments, the one or more tubing 645 of the tubing set 643 may include at least a supplemental tubing 665, which is fluidly coupled to the tubing segment 657 of the tubing set 643. The supplemental tubing 665 may include one, two (as depicted in FIG. 6), three, four or more supplemental tubes fluidly coupled to the tubing segment 657. The supplemental tubing 665 may be attached to additional vial assemblies or containers for gases or solutions other than the vial assembly 580. As such, the supplemental tubing 665 may allow for materials other than the particulate to be introduced into the tubing segment 657 of the tubing set 643, such as to be delivered to the patient through the delivery line 10. Other materials introduced into the tubing segment 657 through the supplemental tubing 665 may include saline to dilute the particulate, or any other material suitable to be delivered to a patient in a given procedure.

III. Methods of Use and Materials for Delivery Device

[0077] Now referring to FIG. 7, a process 700 is set forth for a method of inserting the tubing set 643 within the delivery assembly 600. The process 700 may include blocks 702, 704, 706, and 708 as described below.

[0078] In block 702, the sled assembly 640 slidably coupled to the sled containment region 632 of the delivery assembly console 610 is positioned into the open position OP. As described above, the sled assembly 640 includes a front wall 642 defining a plurality of apertures 656.

[0079] In block 704, the tubing set 643 is received within the sled assembly 640 in the open position OP. In embodiments, the tubing set 643 includes a tubing segment 657 of one or more tubing 645, a vial assembly container 680, and a vial assembly 580 disposed in the vial assembly container 680 and containing a particulate, the tubing segment fluidly coupled to the vial assembly 580 containing the particulate. [0080] In block 706, the tubing segment 657 of the tubing set 643 is received within an aperture

656 of the plurality of apertures 656 of the front wall 642 of the sled assembly 640. In block 708, the sled assembly 640 is positioned into the closed position, with the sled assembly 640 housed within the sled containment region 632 in the closed position.

[0081] In embodiments, the process 700 may further include connecting the tubing segment

657 to the delivery line 10. The particulate may be delivered from the vial assembly 580 through the tubing segment 657 through the delivery line 10 when the sled assembly 640 is positioned into the closed position in which the sled assembly 640 is housed within the sled containment region 632.

[0082] The process 700 may further include engaging the vial assembly 580 with the vial engagement mechanism 520 of the delivery assembly 600, the vial assembly mechanism 620 extending from the console 610 of the delivery assembly 600. The vial assembly 580 may be moved via the vial engagement mechanism 520 into a locked position. The process 700 may then include puncturing the septum 592 of the vial assembly 580 via the needle 599 of the delivery assembly 600 in the locked position as described herein and delivering the particulate from the vial assembly 580 through the needle 599 and through the tubing segment 657.

III. Aspects Listing

[0083] Aspect 1. A delivery assembly includes: a console including a sled containment region, a sled assembly slidably couplable to the sled containment region of the console, the sled assembly including a front wall defining a plurality of apertures, wherein the sled assembly is configured to extend between an open position and a closed position, the sled assembly housed within the sled containment region in the closed position, and the sled assembly extending from the sled containment region in the open position and configured to receive a tubing set including one or more tubing in the open position, and wherein an aperture of the plurality of apertures of the front wall of the sled assembly is configured to receive a tubing segment of the one or more tubing of the tubing set, the tubing segment configured to connect to a delivery line, the delivery line configured to deliver a particulate via the delivery assembly. [0084] Aspect 2. The delivery assembly of Aspect 1, wherein the tubing set further includes a vial assembly, the vial assembly configured to contain the particulate, wherein the tubing segment of the one or more tubing of the tubing set is configured to fluidly couple to the vial assembly.

[0085] Aspect 3. The delivery assembly of either of Aspect 1 or Aspect 2, wherein the tubing set further includes a vial assembly container, the vial assembly container configured to receive a vial assembly, the vial assembly configured to contain the particulate, wherein the tubing segment of the one or more tubing of the tubing set is configured to fluidly couple to the vial assembly.

[0086] Aspect 4. The delivery assembly of any of Aspect 1 to Aspect 3, further including a vial engagement mechanism extending from the console and configured to engage a vial assembly of the tubing set, the vial assembly including the particulate, the vial engagement mechanism configured to move the vial assembly to a locked position.

[0087] Aspect 5. The delivery assembly of Aspect 4, further including a needle configured to puncture a septum of the vial assembly when the vial assembly is in the locked position, the needle fluidly coupled to the tubing segment of the one or more tubing of the tubing set.

[0088] Aspect 6. The delivery assembly of any of Aspect 1 to Aspect 5, the one or more tubing further including at least a supplemental tubing, the supplemental tubing fluidly coupled to the tubing segment of the tubing set.

[0089] Aspect 7. The delivery assembly of any of Aspect 1 to Aspect 6, wherein the sled containment region further includes a sled engagement feature configured to engage a region engagement feature of the sled assembly in the closed position, such that when the sled engagement feature is engaged to the region engagement feature, the sled assembly is locked to and within the sled containment region.

[0090] Aspect 8. The delivery assembly of any of Aspect 1 to Aspect 7, the sled assembly further including a tubing locking mechanism, the tubing locking mechanism configured to receive the tubing segment and lock the tubing segment within the sled assembly.

[0091] Aspect 9. The delivery assembly of any of Aspect 1 to Aspect 8, wherein the front wall defining the plurality of apertures includes a radiation shielding material. 1

[0092] Aspect 10. The delivery assembly of Aspect 9, wherein the radiation shielding material includes of plastic, lead, tungsten, or combinations thereof.

[0093] Aspect 11. The delivery assembly of any of Aspect 1 to Aspect 10, wherein the sled assembly is removable from the sled containment region such that the sled assembly is configured to be detached from the sled containment region.

[0094] Aspect 12. The delivery assembly of any of Aspect 1 to Aspect 11, further including the tubing set.

[0095] Aspect 13. The delivery assembly of Aspect 12, wherein the tubing set further includes a vial assembly, the vial assembly configured to contain the particulate, the tubing segment configured to fluidly couple to the vial assembly.

[0096] Aspect 14. A delivery assembly includes: a console including a sled containment region, a sled assembly slidably couplable to the sled containment region of the console, the sled assembly including a front wall defining a plurality of apertures, wherein the sled assembly is configured to extend between an open position and a closed position, the sled assembly housed within the sled containment region in the closed position, and the sled assembly extending from the sled containment region in the open position. The delivery assembly further includes a tubing set including a tubing segment of one or more tubing, a vial assembly container, and a vial assembly, the sled assembly configured to receive the tubing set in the open position, wherein: the vial assembly container is configured to receive the vial assembly, the vial assembly is configured to contain a particulate, and the tubing segment of the one or more tubing of the tubing set is configured to fluidly couple to the vial assembly, and wherein an aperture of the plurality of apertures of the front wall of the sled assembly is configured to receive the tubing segment of the one or more tubing of the tubing set.

[0097] Aspect 15. The delivery assembly of Aspect 14, wherein the tubing segment is configured to connect to a delivery line, the delivery line is configured to deliver the particulate, and the one or more tubing further including at least a supplemental tubing, the supplemental tubing fluidly coupled to the tubing segment of the tubing set.

[0098] Aspect 16. The delivery assembly of either of Aspect 14 or Aspect 15, further including a vial engagement mechanism and a needle, the vial engagement mechanism extending from the console and configured to engage the vial assembly of the tubing set and configured to move the vial assembly to a locked position, the needle configured to puncture a septum of the vial assembly when the vial assembly is in the locked position, the needle fluidly coupled to the tubing segment of the one or more tubing of the tubing set.

[0099] Aspect 17. The delivery assembly of any of Aspect 14 to Aspect 16, wherein the sled containment region further includes a sled engagement feature configured to engage a region engagement feature of the sled assembly in the closed position, such that when the sled engagement feature is engaged to the region engagement feature, the sled assembly is locked to and within the sled containment region.

[00100] Aspect 18. A method of inserting a tubing set within a delivery assembly includes: positioning a sled assembly slidably coupled to a sled containment region of a console of the delivery assembly into an open position, the sled assembly including a front wall defining a plurality of apertures, receiving the tubing set within the sled assembly in the open position, the tubing set including a tubing segment of one or more tubing, a vial assembly container, and a vial assembly disposed in the vial assembly container and containing a particulate, the tubing segment fluidly coupled to the vial assembly containing the particulate. The method further includes receiving the tubing segment within an aperture of the plurality of apertures of the front wall of the sled assembly and positioning the sled assembly into a closed position, the sled assembly housed within the sled containment region in the closed position.

[00101] Aspect 19. The method of Aspect 18, further including: connecting the tubing segment to a delivery line and when the sled assembly is positioned into the closed position in which the sled assembly is housed within the sled containment region, delivering the particulate from the vial assembly through the tubing segment and through the delivery line.

[00102] Aspect 20. The method of either of Aspect 18 or Aspect 19, further including: engaging the vial assembly with a vial engagement mechanism of the delivery assembly, the vial engagement mechanism extending from the console of the delivery assembly, moving the vial assembly via the vial engagement mechanism into a locked position, puncturing a septum of the vial assembly via a needle of the delivery assembly in the locked position, the needle fluidly coupled to the tubing segment of the tubing set, and delivering the particulate from the vial assembly through the needle and through the tubing segment. [00103] It is noted that the terms “substantially” and “about” may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[00104] For the purposes of describing and defining the present disclosure it is noted that the term “substantially” is used herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The term “substantially” is used herein also to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. As such, it is used to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation, referring to an arrangement of elements or features that, while in theory would be expected to exhibit exact correspondence or behavior, may in practice embody something slightly less than exact.

[00105] 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.

[00106] What is claimed is:

Claims

1. A delivery assembly, comprising: a console comprising a sled containment region; a sled assembly slidably couplable to the sled containment region of the console, the sled assembly comprising a front wall defining a plurality of apertures, wherein the sled assembly is configured to extend between an open position and a closed position, the sled assembly housed within the sled containment region in the closed position, and the sled assembly extending from the sled containment region in the open position and configured to receive a tubing set comprising one or more tubing in the open position; and wherein an aperture of the plurality of apertures of the front wall of the sled assembly is configured to receive a tubing segment of the one or more tubing of the tubing set, the tubing segment configured to connect to a delivery line, the delivery line configured to deliver a particulate via the delivery assembly.

2. The delivery assembly of claim 1, wherein the tubing set further comprises a vial assembly, the vial assembly configured to contain the particulate, wherein the tubing segment of the one or more tubing of the tubing set is configured to fluidly couple to the vial assembly.

3. The delivery assembly of claim 1, wherein the tubing set further comprises a vial assembly container, the vial assembly container configured to receive a vial assembly, the vial assembly configured to contain the particulate, wherein the tubing segment of the one or more tubing of the tubing set is configured to fluidly couple to the vial assembly.

4. The delivery assembly of claim 1, further comprising a vial engagement mechanism extending from the console and configured to engage a vial assembly of the tubing set, the vial assembly comprising the particulate, the vial engagement mechanism configured to move the vial assembly to a locked position.

5. The delivery assembly of 4, further comprising a needle configured to puncture a septum of the vial assembly when the vial assembly is in the locked position, the needle fluidly coupled to the tubing segment of the one or more tubing of the tubing set.

6. The delivery assembly of claim 1, the one or more tubing further comprising at least a supplemental tubing, the supplemental tubing fluidly coupled to the tubing segment of the tubing set.

7. The delivery assembly of claim 1, wherein the sled containment region further comprises a sled engagement feature configured to engage a region engagement feature of the sled assembly in the closed position, such that when the sled engagement feature is engaged to the region engagement feature, the sled assembly is locked to and within the sled containment region.

8. The delivery assembly of claim 1, the sled assembly further comprising a tubing locking mechanism, the tubing locking mechanism configured to receive the tubing segment and lock the tubing segment within the sled assembly.

9. The delivery assembly of claim 1, wherein the front wall defining the plurality of apertures comprises a radiation shielding material.

10. The delivery assembly of claim 9, wherein the radiation shielding material is comprised of plastic, lead, tungsten, or combinations thereof.

11. The delivery assembly of claim 1, wherein the sled assembly is removable from the sled containment region such that the sled assembly is configured to be detached from the sled containment region.

12. The delivery assembly of claim 1, further comprising the tubing set.

13. The delivery assembly of claim 12, wherein the tubing set further comprises a vial assembly, the vial assembly configured to contain the particulate, the tubing segment configured to fluidly couple to the vial assembly.

14. A delivery assembly, comprising: a console comprising a sled containment region; a sled assembly slidably couplable to the sled containment region of the console, the sled assembly comprising a front wall defining a plurality of apertures, wherein the sled assembly is configured to extend between an open position and a closed position, the sled assembly housed within the sled containment region in the closed position, and the sled assembly extending from the sled containment region in the open position; a tubing set comprising a tubing segment of one or more tubing, a vial assembly container, and a vial assembly, the sled assembly configured to receive the tubing set in the open position, wherein: the vial assembly container is configured to receive the vial assembly, the vial assembly is configured to contain a particulate, and the tubing segment of the one or more tubing of the tubing set is configured to fluidly couple to the vial assembly; and wherein an aperture of the plurality of apertures of the front wall of the sled assembly is configured to receive the tubing segment of the one or more tubing of the tubing set.

15. The delivery assembly of claim 14, wherein the tubing segment is configured to connect to a delivery line, the delivery line is configured to deliver the particulate, and the one or more tubing further comprising at least a supplemental tubing, the supplemental tubing fluidly coupled to the tubing segment of the tubing set.

16. The delivery assembly of claim 14, further comprising a vial engagement mechanism and a needle, the vial engagement mechanism extending from the console and configured to engage the vial assembly of the tubing set and configured to move the vial assembly to a locked position, the needle configured to puncture a septum of the vial assembly when the vial assembly is in the locked position, the needle fluidly coupled to the tubing segment of the one or more tubing of the tubing set.

17. The delivery assembly of claim 14, wherein the sled containment region further comprises a sled engagement feature configured to engage a region engagement feature of the sled assembly in the closed position, such that when the sled engagement feature is engaged to the region engagement feature, the sled assembly is locked to and within the sled containment region.

18. A method of inserting a tubing set within a delivery assembly, the method comprising: positioning a sled assembly slidably coupled to a sled containment region of a console of the delivery assembly into an open position, the sled assembly comprising a front wall defining a plurality of apertures; receiving the tubing set within the sled assembly in the open position, the tubing set comprising a tubing segment of one or more tubing, a vial assembly container, and a vial assembly disposed in the vial assembly container and containing a particulate, the tubing segment fluidly coupled to the vial assembly containing the particulate; receiving the tubing segment within an aperture of the plurality of apertures of the front wall of the sled assembly; and positioning the sled assembly into a closed position, the sled assembly housed within the sled containment region in the closed position.

19. The method of claim 18, further comprising: connecting the tubing segment to a delivery line; and when the sled assembly is positioned into the closed position in which the sled assembly is housed within the sled containment region, delivering the particulate from the vial assembly through the tubing segment and through the delivery line.

20. The method of claim 18, further comprising: engaging the vial assembly with a vial engagement mechanism of the delivery assembly, the vial engagement mechanism extending from the console of the delivery assembly; moving the vial assembly via the vial engagement mechanism into a locked position; puncturing a septum of the vial assembly via a needle of the delivery assembly in the locked position, the needle fluidly coupled to the tubing segment of the tubing set; and delivering the particulate from the vial assembly through the needle and through the tubing segment.