WO2025221249A1

WO2025221249A1 - Vial assemblies for fluid delivery via a dead space port

Info

Publication number: WO2025221249A1
Application number: PCT/US2024/024886
Authority: WO
Inventors: Christian Andersen; Sherese L. Hill; Brandon Simmons; Amanda THYSTRUP; Ryan T. TOOLEY
Original assignee: Bard Peripheral Vascular Inc
Current assignee: Bard Peripheral Vascular Inc
Priority date: 2024-04-17
Filing date: 2024-04-17
Publication date: 2025-10-23
Anticipated expiration: 2026-10-17

Abstract

Delivery assemblies and methods of use for assemblies include engaging a vial engagement mechanism extending from a vial containment region of a console of the delivery assembly with a proximal end of a plunger of a vial assembly including a body comprising a sealed distal end and a side surface wall and at least one port on the side surface wall, the at least one port fully positioned within a dead space portion of the side surface wall disposed between a maximum stop point of the plunger and the sealed distal end. The plunger is moved in a proximal direction to pull a fluid into the body through the at least one port and moved in a distal direction to push the fluid out of the body of the vial assembly through the at least one port.

Description

VIAL ASSEMBLIES FOR FLUID DELIVERY VIA A DEAD SPACE PORT

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 via a dead space port 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 monitor radiation and 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, a vial assembly, and a vial engagement mechanism. The console includes a vial containment region. The vial assembly includes a body, a plunger, and at least one port. The body includes a sealed distal end and a side surface wall. The plunger includes a proximal end and a distal end, the proximal end disposed outside of the body, the distal end disposed within the body. The at least one port is on the side surface wall of the body. The plunger may be configured to move within the body until at a maximum stop point. The maximum stop point may be defined by a stop section on the side surface wall disposed a dead space distance away from the sealed distal end. A dead space portion of the body defines the dead space distance between the stop section and the sealed distal end. The at least one port is fully positioned within the dead space portion of the body. The vial engagement mechanism extends from the console within the vial containment region. The vial engagement mechanism may be configured to engage the proximal end of the plunger, move the plunger in a proximal direction to pull a fluid into the body of the vial assembly through the at least one port such that the fluid enters through the at least one port, and move the plunger in a distal direction to push the fluid out of the body of the vial assembly through the at least one port such that the fluid exits through the at least one port.

[0006] In another embodiment, a method of use of a delivery assembly may include engaging a vial engagement mechanism extending from a vial containment region of a console with a proximal end of a plunger of a vial assembly. The vial assembly may further include a body comprising a sealed distal end and a side surface wall and at least one port on the side surface wall. The at least one port may be fully positioned within a dead space portion of the side surface wall disposed between a maximum stop point of the plunger and the sealed distal end, the maximum stop point defined by a stop section on the side surface wall disposed a dead space distance away from the sealed distal end. The proximal end of the plunger may be disposed outside the body and a distal end of the plunger may be disposed within the body. The method may also include moving the plunger in a proximal direction to pull a fluid into the body of the vial assembly through the at least one port such that the fluid enters through the at least one port and moving the plunger in a distal direction to push the fluid out of the body of the vial assembly through the at least one port such that the fluid exits through the at least one port.

[0007] In yet another embodiment, a method of use of a delivery assembly may include engaging a vial engagement mechanism extending from a vial containment region of a console with a proximal end of a plunger of a vial assembly, the vial assembly further including a body including a sealed distal end and a side surface wall and a first port and a second port on the side surface wall, the first port and the second port fully positioned within a dead space portion of the side surface wall disposed between a maximum stop point of the plunger and the sealed distal end, the maximum stop point defined by a stop section on the side surface wall disposed a dead space distance away from the sealed distal end, the proximal end of the plunger disposed outside the body, and a distal end of the plunger disposed within the body, moving the plunger in a proximal direction to pull a fluid into the body of the vial assembly through the first port such that the fluid enters through the first port to mix with a particulate material within the body to form a mixed fluid, and moving the plunger in a distal direction to push the mixed fluid out of the body of the vial assembly through the second port such that the mixed fluid exits through the second port.

[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. l 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 cross-sectional view of an embodiment of a vial assembly including a pair of equidistant ports positioned in a dead space portion of a body of the vial assembly, the ports on opposite sides of the body and perpendicular to a central axis of the body, according to one or more embodiments shown and described herein;

[0015] FIG. 7 is a perspective view of another embodiment of a vial assembly including a pair of ports positioned in a dead space portion of a body of the vial assembly, the ports on a same side of the body with one port lower than the other and both perpendicular to a central axis of the body, according to one or more embodiments shown and described herein;

[0016] FIG. 8 is a perspective view of another embodiment of a vial assembly including a pair of ports positioned in a dead space portion of a body of the vial assembly, the ports on a same side of the body with one port lower than the other and both offset with respect to a central axis of the body, according to one or more embodiments shown and described herein; [0017] FIG. 9 is a perspective view of another embodiment of a vial assembly including a pair of ports positioned in a dead space portion of a body of the vial assembly, the ports on opposite sides of the body with one port lower than the other and both perpendicular to a central axis of the body, according to one or more embodiments shown and described herein;

[0018] FIG. 10 is a perspective view of another embodiment of a vial assembly including a pair of ports positioned in a dead space portion of a body of the vial assembly, the ports on opposite sides of the body with one port lower than the other and both offset with respect to a central axis of the body, according to one or more embodiments shown and described herein

[0019] FIG. 11 is a perspective view of another embodiment of a vial assembly including a pair of equidistant ports positioned in a dead space portion of a body of the vial assembly, the ports on opposite sides of the body and offset with respect to a central axis of the body, according to one or more embodiments shown and described herein;

[0020] FIG. 12 is a perspective view of an embodiment of a sled assembly containing the vial assembly of any of FIGS. 6-11 positioned within the sled assembly, according to one or more embodiments shown and described herein; and

[0021] FIG. 13 is a flow chart describing a method for using embodiments of the vial assembly of any of FIGS. 6-11 and/or the vial assembly of the sled assembly of FIG. 12 to deliver fluid through at least one port positioned in the dead space portion of the body of the vial assembly, according to one or more embodiments shown and described herein.

DETAILED DESCRIPTION

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] In embodiments described herein, a particulate material delivery assembly may include a radioembolization delivery device. A radioembolization delivery device comprises a medical device configured to deliver radioactive compounds to a treatment area within a patient’s body in procedures such as transarterial radioembolization. The radioactive compounds may be a mixed solution of saline and radioactive microspheres (i.e., a mixed particulate) mixed in a vial of a vial assembly. The needle may include one or more ports as an outlet to inject fluid (i.e., saline), such as from a syringe or catheter line, into a vial including the radioactive microspheres to generate the mixed solution 662 and as an inlet to deliver the mixed solution to the patient.

I. Mechanical Delivery Device with Removable Sled Assembly

[0028] 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. 6-12 and in one or more embodiments herein.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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).

[0042] Still referring to FIG. 2, the needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the sled assembly 540, and in particular the manifold 555A, 555B is positioned beneath the vial chamber 558 and the protective shield 557. The proximal manifold 555B is fluidly coupled to the needle 559 and the distal manifold 555A is fluidly couplable to one or more delivery lines via the one or more ports 556 of the sled assembly 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A through a one-way check valve 553 disposed therebetween.

[0043] 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. [0044] 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.

[0045] 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.

[0046] Additionally, as will be described in greater detail herein, in some embodiments the locking system 550 may include at least one planar wall relative to a remaining circular orientation of the locking system 550. In this instance, an aperture formed by the locking system 550 through the top surface 548 of the sled assembly 540 is irregularly-shaped, rather than circularly-shaped as shown and described above. In this instance, the vial assembly 580 includes a locking feature 586 that has a shape and size that corresponds to the locking system 550, and in particular the at least one planar wall such that the vial assembly 580 is received within the sled assembly 540 only when an orientation of the vial assembly 580 corresponds with an alignment of the locking feature 586 and the locking system 550. In other words, a corresponding planar wall 586A of the locking feature 586 See FIG. 3) must be aligned with the planar wall of the locking system 550 for the vial assembly 580 to be receivable within an aperture formed by the locking system 550 of the sled assembly 540.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] Referring now to FIG. 4, in response to determining that the battery 572 contains or other power source provides a sufficient amount of power, one or more delivery lines are coupled to the sled assembly 540 via the one or more ports 556. In particular, a dose delivery line 10A is coupled to the sled assembly 540 at a delivery port 556A, a contrast line 10B is coupled to the sled assembly 540 at a contrast port 556B, and a flushing line 10C is coupled to the sled assembly 540 at a flushing port 556C. An opposing end of the dose delivery line 10A is initially coupled to a fluid reservoir, such as, for example, a collection bowl. As will be described in greater detail herein, the dose delivery line 10A may be subsequently coupled to an external device, such as a catheter, once the sled assembly 540 has been effectively primed by a fluid medium via the contrast line 10B. An opposing end of the flushing line 10C is coupled to an external device, such as, for example, a syringe. With both the dose delivery line 10A and the flushing line 10C coupled to the sled assembly 540, the sled assembly 540 is flushed with a fluid medium (e.g., saline) from the syringe coupled to the flushing line 10C. In this instance, the fluid medium is injected through the flushing line 10C, into the distal manifold 555A of the sled assembly 540, and out of the sled assembly 540 through the dose delivery line 10A. Accordingly, the fluid medium is ultimately received at the collection bowl and disposed thereat by the dose delivery line 10A.

[0055] With the distal manifold 555A of the sled assembly 540 separated from the proximal manifold 555B by the one-way valve 553 disposed therebetween, the fluid medium flushed through the distal manifold 555A from the syringe (via the flushing port 556C) is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. Rather, the fluid medium injected from the syringe and through the flushing line 10C is received at the flushing port 556C, passed through the distal manifold 555A in fluid communication with the flushing port 556C, and redirected by the one-way valve 553 towards the dose delivery port 556 A that is coupled to the dose delivery line 10A. In this instance, the dose delivery line 10A receives and transfers the fluid medium to the collection bowl coupled thereto, such that the fluid medium is not directed beyond the one-way valve 553 and into the proximal manifold 555B that is in fluid communication with the needle 559.

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

[0057] The sled assembly 540 is coupled to one or more external devices via the one or more ports 556. In particular, the sled assembly 540 is fluidly coupled to a catheter (e.g., microcatheter) via the dose delivery line 10A that is coupled to the delivery port 556A of the sled assembly 540. In this instance, the catheter is in fluid communication with the sled assembly 540 via the dose delivery line 10A. Further, the sled assembly 540 is fluidly coupled to a contrast source, such as, for example, a saline bag secured to the console assembly 510 via the attachment device 538 (See FIG. 1). The sled assembly 540 is in fluid communication with the saline bag via a contrast line 10B coupled to the contrast port 556B of the sled assembly 540. In this instance, the saline bag is in fluid communication with the sled assembly 540 via the contrast line 10B secured to the contrast port 556B.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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 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 oneway check valves 553A positioned therein. Thus, the dose is directed to the dose delivery port 556A and received at the catheter fluidly coupled thereto by the dose delivery line 10A. In other words, the one-way check valves 553A prevent a backflow of fluid into the sled assembly 540 and/or the vial assembly 580 coupled thereto.

[0062] 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. [0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] By way of further examples, a flow sensor of the delivery device 500 may be positioned in-line with the tubing set of the delivery device 500, and in particular the needle 559, the manifolds 555A, 555B, and/or one or more of the ports 556, and may be configured to measure an amount of fluid (e.g., suspension liquid after the therapeutic particles have effectively mixed with the fluid medium) that passes thereby. An ultrasonic sensor of the delivery device 500 may comprise a transmitter, receiver, and/or transceiver configured to measure a distance to an object (e.g., remaining volume of dosage within the vial assembly 580) based on transmitting ultrasonic signals (i.e. sound waves) therein and measuring an elapsed time before receiving back the bounced sound waves. A radial encoder of the delivery device 500 may comprise an absolute encoder and/or an incremental encoder configured to convert an angular position or motion of the handle 528, the plunger 584, the mechanical assembly 529, and/or other components of the delivery device 500 to analog or digital output signals corresponding to a remaining dosage within the vial assembly 580.

II. Vial Assembly Embodiments

[0070] FIGS. 6-11 depict embodiments of vial assemblies 680, 780, 880, 980, 1080, and 1180 including at least one port 694 positioned in a dead space portion 698 of the vial assembly, as described in greater detail below. Each vial assembly 680, 780, 880, 980, 1080, and 1180 may be used with a delivery assembly including a console such as the delivery device 500 including the console assembly 510, the console assembly including a vial containment region 518. In embodiments, the delivery assembly comprises a radioembolization delivery device 500, and a fluid for delivery includes a contrast-saline solution configured to mix with a particulate material disposed in the body 689 of the vial assemblies described herein, the particulate material including a plurality of radioembolization beads, to form a mixed particulate fluid to deliver to a patient.

[0071] Referring to FIG. 6, an embodiment of a vial assembly 680 is shown including a pair of equidistant ports 694, 694A, 694B positioned in a dead space portion 698 of a body 689 of the vial assembly 680, with the ports 694, 694A, 694B on opposite sides of the body 689 and perpendicular to a central axis CA of the body 689. In embodiments, the first port 694A and the second port 694A may be positioned on the side surface wall 692 offset from (as shown in FIGS. 8-11) or perpendicular to (as shown in FIGS. 6-7) the central axis CA of the body 689. The body 689 of the vial assembly 680 includes a sealed distal end 696 and a side surface wall 692. The side surface wall 692 may comprise a first side SI and a second side S2 opposite of the first side SI. The body 689 of the vial assembly 680 includes a central axis CA, shown in FIG. 6 as a dashed longitudinal line drawn through the center of the body 689 of the vial assembly 680 perpendicular to the sealed distal end 696 of the vial assembly 680. In embodiments, one of the first port 694A or the second port 694B is positioned on the side surface wall 692 perpendicular to the central axis CA of the body 689, and the other of the first port 694A or the second port 694B is positioned on the side surface wall 692 offset from the central axis CA of the body 689.

[0072] The vial assembly 680 may also include a plunger 684 that has a proximal end 686 and a distal end 688. The proximal end 686 is disposed outside of the body 689, and the distal end 688 is disposed within the body. The plunger 684 is configured to move within the body 689 until at a maximum stop point 690. The maximum stop point may be defined by a stop section 702 on the side surface wall 692 disposed a dead space distance dd away from the sealed distal end 696. The plunger 684 cannot be further distally advanced past the maximum stop point 690, such that the distal end 688 of the plunger 684 cannot distally advance further past the dead space distance dd above the sealed distal end 696 that corresponds to the dead space portion 698 of the body 689. The dead space portion 698 of the body 689 of the vial assembly 680 defines the dead space distance dd between the stop section 702 on the side surface wall 692 and the sealed distal end 696 of the body 689. The dead space portion 698 can be understood to be the portion of the distal end of the body 689 of the vial assembly 680 in which the distal end 688 of the plunger 684 does not enter at a distal most position.

[0073] In one or more embodiments, the vial assembly 680 may include at least one port 694 fully positioned within the dead space portion 698 of the body 689 of the vial assembly 680. As shown in FIG. 6, the vial assembly may comprise a first port 694A and a second port 694B. In some embodiments the vial assembly 680 or any of the vial assemblies described herein may include only one port 694 as a single port or greater than two ports 694, such three or four ports 694. The at least one port 694 may be positioned fully within the dead space 698 such that the entirety of the port 694 is positioned distal to the maximum stop point 690 of the vial assembly 680

[0074] A vial engagement mechanism such as the vial engagement mechanism 520 of FIG. 1 may extend from the console (e.g., console assembly 510) within the vial containment region 518 and be configured to (i) engage a proximal end 686 of the plunger 684 of the vial assembly 680. The vial engagement mechanism 520 may further be configured to (ii) move the plunger 684 in a proximal direction to pull a fluid into the body 689 of the vial assembly 680 through the at least one port 694, 694A, 694B such that the fluid enters through the at least one port 694, 694A, 694B, and (iii) move the plunger 684 in a distal direction to push the fluid out of the body 689 of the vial assembly 680 through the at least one port 694, 694A, 694B such that the fluid exits through the at least one port 694, 694A, 694B. In an embodiment, the vial engagement mechanism 520 may be configured to (ii) move the plunger 684 in a proximal direction to pull a fluid into the body 689 of the vial assembly 680 through the first port 694A such that the fluid enters through the first port 694A, and (iii) move the plunger 684 in a distal direction to push the fluid out of the body 689 of the vial assembly 680 through the second port 694B such that the fluid exits through the second port 694B. Thus, the first port 694A may be configured to allow fluid to enter the vial assembly, and the second port 694B may be configured to allow fluid to exit the vial assembly.

[0075] The at least one port 694 may also comprise a one way valve 700 such that fluid can only pass through the port in one direction. As shown in FIG. 6, the first port 694A may include the one way valve 700. In other embodiments, the second port 694B may additionally or alternatively include the one way valve 700. In embodiments, where the first port 694A and the second port 694B both include a one way valve 700, the first port 694A may be configured with the one-way valve 700 to block fluid from exiting the body 689 of the vial assembly 680, and the second port 694B may be configured with the one-way valve 700 to block fluid from entering the the body 689 of vial assembly 680.

[0076] Still referring to FIG. 6, the first port 694A and the second port 694B may be equidistant from the sealed distal end 696 and coaxially positioned on a single plane Pl. The plane Pl is depicted as running through a center of the at least one port 694. In embodiments, the first port 694A and the second port 694A are positioned on the side surface wall 692 on a same plane Pl (as shown in FIG. 6) or on offset planes Pl, P2 bisecting the body 689.

[0077] A distance d is representative of a distance between the sealed distal end 696 and the plane corresponding to each port 694 (thus, between the sealed distal end 696 and the plane Pl in FIG. 6 for each port 694A, 694B). A distance dl is shown as the distance from the plane Pl of the first port 694A to the sealed distal end 696 while a distance d2 is shown as the distance from the plane Pl of the second port 694B to the sealed distal end 696. As shown in FIG. 6, the first port 694A and the second port 694B may be positioned on opposing sides SI, S2 of the side surface wall 692 with the first port 694A positioned on the first side SI and the second port 694B positioned on the second side S2. In the embodiment of FIG. 6, the first port 694A and the second port 694B are positioned equidistant from the sealed distal end 696 of the body 689 such that distance dl equals distance d2. In embodiments (as shown in FIGS. 7-10), one of the first port 694A or the second port 694B may be positioned closer to the sealed distal end 696 than the other of the first port 694A or the second port 694B.

[0078] In one or more embodiments at least one of the first port 694A or the second port 694B may be angled with respect to the side surface wall 692, such that a respective port longitudinal axis is angled with respect to a horizontal lateral axis of the body 689. In such embodiments, when a fluid enters through or exits from the angled port, the motion of the fluid may form a vortex pushing fluid around an interior perimeter of the vial assembly 680.

[0079] Now referring to FIG. 7, another embodiment as shown as vial assembly 780 including a pair of ports as a first port 794A and a second port 794B positioned in the dead space portion 698 of a body 689 of the vial assembly 780, the ports 794A, 794B on a same side of the side surface wall 692 of the body 689 of the vial assembly 780 with the first port 794A disposed lower than the other port 794B and both disposed perpendicular to the central axis CA of the body 689 of the vial assembly 780. . In one or more embodiments, and as shown in FIG. 7, the first port 794A may be positioned on a plane Pl that is distal to the second port 794B, and the second port 794B may be positioned on a plane P2 that is proximal to the first port 794A. The first port 794A may be spaced a distance dl away from the sealed distal end 696, and the second port 794B may be spaced a distance d2 away from the sealed distal end 696.

[0080] Now referring to FIG. 8, an embodiment of a vial assembly 880 is shown including a pair of ports 894A, 894B positioned in the dead space portion 698 of the body 689 of the vial assembly 880. The first and second ports 894A, 894B are on a same side of the body 689 with the first port 894A disposed lower than the other second port 894B and both ports 894A, 894B offset with respect to the central axis CA of the body 689 of the vial assembly 880.

[0081] Now referring to FIG. 9, an embodiment of a vial assembly 980 includes a pair of ports 994A, 994B positioned in the dead space portion 698 of the body 689 of the vial assembly 780 with the ports 994A, 994B on opposite sides of the body 689 with the first port 994A disposed lower than the other second port 994B and both ports 994A, 994B perpendicular to the central axis CA of the body 689 of the vial assembly 980.

[0082] Now referring to FIG. 10, an embodiment of a vial assembly 1080 includes a pair of ports 1094A, 1094B positioned in the dead space portion 698 of a body 689 of the vial assembly 680, the ports 1094A, 1094B disposed on opposite sides of the body 689 with the first port 1094A disposed lower than the other port 1094B and both ports 1094A, 1094B offset with respect to the central axis CA of the body 689 of the vial assembly 1080. As shown, the first port 1094A is disposed a distance dl away from the sealed distal end 696, while the first port 1094B is dispoed a distance d2 away from the sealed distance end 696, and the distance dl is less than the distance d2 such that the first port 1094A is disposed closer to the sealed distal end 696 and distally lower than the second port 1094B.

[0083] Now referring to FIG. 11, an embodiment of a vial assembly 1180 includes a pair of equidistant ports 1194A, 1194B positioned in the dead space portion 698 of the body 689 of the vial assembly 1180, the ports 1194A, 1194B on opposite sides of the body 689 and offset with respect to the central axis CA of the body 689 of the vial assembly 1180. The equidistant ports 1194A, 1194B are both disposed a same distance dl away from the sealed distal end 696.

[0084] Now referring to FIG. 12, in one or more embodiments, the vial assembly 1280 that may be any of the vial assemblies 680, 780, 880, 980, 1080, and 1180 described herein is secured and may be pre-assembled within a sled assembly 1240 such that the ports of the vial assembly (e.g., any of the at least one port 694, 784, 884, 984, 1084, and 1184 described herein) are fluidly coupled to ports 1256A and 1256B defined in a wall 1250 of the sled assembly 1240. The ports 1256A and 1256B are fluidly connected to the ports of the vial assembly 1280 via tubes 1295A and 1295B and may be connected to one or more delivery lines as described herein to receive fluid or deliver fluid (which delivered fluid may be a mixed fluid as described herein).

[0085] Now referring to FIG. 13, a process 1300 is set forth for a method of using a delivery assembly (e.g., the delivery device 500) with any of the embodiments of the vial assemblies 680, 780, 880, 980, 1080, 1180, and 1280 described herein to deliver fluid through at least one port 694, 784, 884, 984, 1084, and 1184 positioned in the dead space portion 698 of the body 689 of the respective vial assembly. The process 1300 may include blocks 1302, 1304, and 1306 as described below. [0086] In block 1302, the vial engagement mechanism 520 extending from the vial containment region 518 of a console (e.g., the console assembly 510) is engaged with the proximal end 686 of the plunger 684 of any of the vial assemblies 680, 780, 880, 980, 1080, and 1180. As described herein, the vial assembly 680, 780, 880, 980, 1080, 1180, and 1280 further includes a body 689 having a sealed distal end 696 and a side surface wall 692 and at least one port 694, 784, 884, 984, 1084, and 1184 on the side surface wall 692. The at least one port 694, 784, 884, 984, 1084, and 1184 is fully positioned within a dead space portion 698 of the side surface wall 692 disposed between a maximum stop point 690 of the plunger 694 and the sealed distal end 696. The maximum stop point 690 is defined by a stop section 702 on the side surface wall 692 disposed a dead space distance dd away from the sealed distal end 696. The proximal end 686 of the plunger 684 is disposed outside the body 689, and a distal end 688 of the plunger 684 is disposed within the body 689 of the respective vial assembly 680, 780, 880, 980, 1080, 1180, and 1280. [0087] In block 1304, the plunger 684 is moved in a proximal direction by the vial engagement mechanism 520 to pull a fluid into the body 689 of the respective vial assembly 680, 780, 880, 980, 1080, 1180, and 1280 through the at least one port 694, 784, 884, 984, 1084, and 1184. In embodiments, the fluid that enters the vial assembly 680 may mix with a particulate material within the body 689 of the respective vial assembly 680, 780, 880, 980, 1080, 1180, and 1280 to form a mixed fluid (e.g., a mixed particulate fluid).

[0088] In block 1306, the plunger 684 may be moved in a distal direction by the vial engagement mechanism 520 to push the fluid out of the body 689 of the respective vial assembly 680, 780, 880, 980, 1080, 1180, and 1280 through the at least one port 694, 784, 884, 984, 1084, and 1184 such that the fluid exits through the at least one port 694, 784, 884, 984, 1084, and 1184. In embodiments, the fluid that exits through the at least one port 694 may be the mixed fluid formed in the body 689 of the respective vial assembly 680, 780, 880, 980, 1080, 1180, and 1280. [0089] In embodiments, the at least one port 694, 784, 884, 984, 1084, and 1184 may comprise a first port 694A, 784A, 884A, 984A, 1084A, and 1184A and a second port 694B, 784B, 884B, 984B, 1084B, and 1184B. In such embodiments, in block 1204 the fluid may enter the vial assembly through the first port 694A, 784A, 884A, 984A, 1084A, and 1184A, and in block 1206 the fluid may exit the vial assembly through the second port 694B, 784B, 884B, 984B, 1084B, and 1184B. Thus, the plunger 684 is moved in a proximal direction to pull the fluid into the body 689 of the vial assembly 680, 780, 880, 980, 1080, and 1180 through the first port 694A, 784A, 884A, 984A, 1084A, and 1184A such that the fluid enters through the first port 694A, 784A, 884A, 984A, 1084A, and 1184A. Further, the plunger 684 is moved in the distal direction to push the fluid out of the body 689 of the vial assembly 680, 780, 880, 980, 1080, 1180, and 1280 through the second port 694B, 784B, 884B, 984B, 1084B, and 1184B such that the fluid exits through the second port 694B, 784B, 884B, 984B, 1084B, and 1184B.

[0090] The method may further include forming a vortex of the fluid within the dead space portion 698 after moving the plunger 684 in the proximal direction and the distal direction. The vortex may form from fluid entering the vial assembly 680, 780, 880, 980, 1080, 1180, and 1280 and fluid exiting the vial assembly 680, 780, 880, 980, 1080, 1180, and 1280 as the motion of the entering and existing fluid may create turbulence with respect to the fluid to mix with a particulate material within the dead space portion 698.

[0091] In one or more embodiments, the plunger 684 may be moved in a proximal direction to pull the fluid into the body 689 of the vial assembly 680, 780, 880, 980, 1080, 1180, and 1280 through the at least one port 694, 784, 884, 984, 1084, and 1184 such that the fluid enters through the at least one port 694, 784, 884, 984, 1084, and 1184 to mix with a particulate material within the body 689 to form a mixed fluid . The plunger 684 may then be moved in the distal direction to push the mixed fluid out of the body of the vial assembly 680, 780, 880, 980, 1080, 1180, and 1280 through the at least one port 694, 784, 884, 984, 1084, and 1184 such that the mixed fluid exits fluid exits through the at least one port 694, 784, 884, 984, 1084, and 1184.

III. Aspects Listing

[0092] Aspect 1. A delivery assembly includes: a console including a vial containment region, a vial assembly, and a vial engagement mechanism. The vial assembly includes a body comprising a sealed distal end and a side surface wall, a plunger including a proximal end and a distal end, the proximal end disposed outside of the body, the distal end disposed within the body, and at least one port on the side surface wall of the body. The plunger is configured to move within the body until at a maximum stop point, the maximum stop point defined by a stop section on the side surface wall disposed a dead space distance away from the sealed distal end, a dead space portion of the body defining the dead space distance between the stop section and the sealed distal end. The at least one port is fully positioned within the dead space portion of the body. The vial engagement mechanism extends from the console within the vial containment region. The vial engagement mechanism is configured to engage the proximal end of the plunger, move plunger in a proximal direction to pull a fluid into the body of the vial assembly through the at least one port such that the fluid enters through the at least one port, and move the plunger in a distal direction to push the fluid out of the body of the vial assembly through the at least one port such that the fluid exits through the at least one port.

[0093] Aspect 2. The delivery assembly of Aspect 1, wherein the at least one port includes a first port and a second port, wherein the first port is configured to allow fluid to enter the vial assembly, and the second port is configured to allow fluid to exit the vial assembly.

[0094] Aspect 3. The delivery assembly of Aspect 2, wherein the first port is positioned closer to the sealed distal end than the second port..

[0095] Aspect 4. The delivery assembly of Aspect 2, wherein the first port and the second port are positioned equidistant from the sealed distal end of the body.

[0096] Aspect 5. The delivery assembly of any of Aspect 2 to Aspect 4, wherein the first port and the second port are positioned on opposing sides of the side surface wall of the body.

[0097] Aspect 6. The delivery assembly of any of Aspect 2 to Aspect 4, wherein the first port and the second port are positioned on a same side of the side surface wall of the body

[0098] Aspect 7. The delivery assembly of any of Aspect 2 to Aspect 6, wherein each of the first port and the second port include a one-way valve, the one-way valve of the first port configured to block a flow of fluid exiting from the body, and the one-way valve of the second port configured to block the flow of fluid entering into the body.

[0099] Aspect 8. The delivery assembly of any of Aspect 2 to Aspect 7, wherein the first port and the second port are positioned on the side surface wall offset from or perpendicular to a central axis of the body.

[00100] Aspect 9. The deliver assembly of any of Aspect 2 to Aspect 8, wherein the first port and the second port are positioned on the side surface wall on a same plane or on offset planes bisecting the body.

[00101] Aspect 10. The deliver assembly of any of Aspect 2 to Aspect 9, wherein one of the first port or the second port is positioned on the side surface wall perpendicular to a central axis of the body and the other of the first port or the second port is positioned on the side surface wall offset from the central axis of the body.

[00102] Aspect 11. The delivery assembly of any of Aspect 2 to Aspect 10, wherein at least one of the first port or the second port is configured to be angled with respect to the side surface wall such that a respective port longitudinal axis is angled with respect to a horizontal lateral axis of the body. [00103] Aspect 12. The delivery assembly of any of Aspect 1 to Aspect 11, wherein the vial engagement mechanism is configured to (i) move the plunger in the proximal direction to pull the fluid into the body through the at least one port to mix with a particulate material within the body to form a mixed fluid, and (ii) move the plunger in the distal direction to push the mixed fluid out of the body.

[00104] Aspect 13. The delivery assembly of any of Aspect 1 to Aspect 12, wherein the vial assembly includes only one port.

[00105] Aspect 14. The delivery assembly of any of Aspect 1 Aspect 12, wherein the vial assembly includes greater than two ports.

[00106] Aspect 15. The delivery assembly of any of Aspect 1 to Aspect 14, wherein the delivery assembly comprises a radioembolization delivery device, and the fluid comprises a contrast-saline solution configured to mix with a particulate material disposed in the body and comprising a plurality of radioembolization beads.

[00107] Aspect 16. A method of use of a delivery assembly includes engaging a vial engagement mechanism extending from a vial containment region of a console with a proximal end of a plunger of a vial assembly, the vial assembly further including a body including a sealed distal end and a side surface wall and at least one port on the side surface wall, the at least one port fully positioned within a dead space portion of the side surface wall disposed between a maximum stop point of the plunger and the sealed distal end, the maximum stop point defined by a stop section on the side surface wall disposed a dead space distance away from the sealed distal end, the proximal end of the plunger disposed outside the body, and a distal end of the plunger disposed within the body. The method further include moving the plunger in a proximal direction to pull a fluid into the body of the vial assembly through the at least one port such that the fluid enters through the at least one port, and moving the plunger in a distal direction to push the fluid out of the body of the vial assembly through the at least one port such that the fluid exits through the at least one port.

[00108] Aspect 17. The method of Aspect 16, wherein the at least one port includes a first port and a second port, further including, moving the plunger in a proximal direction to pull the fluid into the body of the vial assembly through the first port such that the fluid enters through the first port, and moving the plunger in the distal direction to push the fluid out of the body of the vial assembly through the second port such that the fluid exits through the second port. [00109] Aspect 18. The method of any of Aspect 16 to Aspect 17, further including forming a vortex of the fluid within the dead space portion of the body after moving the plunger in the proximal direction and the distal direction.

[00110] Aspect 19. The method of any of Aspect 16 to Aspect 18, further including moving the plunger in a proximal direction to pull the fluid into the body of the vial assembly through the at least one port such that the fluid enters through the at least one port to mix with a particulate material within the body to form a mixed fluid and moving the plunger in the distal direction to push the mixed fluid out of the body of the vial assembly through the at least one port such that the mixed fluid exits fluid exits through the at least one port.

[00111] Aspect 20. A method of use of a delivery assembly including engaging a vial engagement mechanism extending from a vial containment region of a console with a proximal end of a plunger of a vial assembly, the vial assembly further including a body including a sealed distal end and a side surface wall and a first port and a second port on the side surface wall, the first port and the second port fully positioned within a dead space portion of the side surface wall disposed between a maximum stop point of the plunger and the sealed distal end, the maximum stop point defined by a stop section on the side surface wall disposed a dead space distance away from the sealed distal end, the proximal end of the plunger disposed outside the body, and a distal end of the plunger disposed within the body. The method further includes moving the plunger in a proximal direction to pull a fluid into the body of the vial assembly through the first port such that the fluid enters through the first port to mix with a particulate material within the body to form a mixed fluid, and moving the plunger in a distal direction to push the mixed fluid out of the body of the vial assembly through the second port such that the mixed fluid exits through the second port.

[00112] 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.

[00113] 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.

[00114] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

1. A delivery assembly, comprising: a console including a vial containment region; a vial assembly comprising: a body comprising a sealed distal end and a side surface wall; a plunger comprising a proximal end and a distal end, the proximal end disposed outside of the body, the distal end disposed within the body; and at least one port on the side surface wall of the body; wherein the plunger is configured to move within the body until at a maximum stop point, the maximum stop point defined by a stop section on the side surface wall disposed a dead space distance away from the sealed distal end, a dead space portion of the body defining the dead space distance between the stop section and the sealed distal end, and wherein the at least one port is fully positioned within the dead space portion of the body; and a vial engagement mechanism extending from the console within the vial containment region, wherein the vial engagement mechanism is configured to engage the proximal end of the plunger, move the plunger in a proximal direction to pull a fluid into the body of the vial assembly through the at least one port such that the fluid enters through the at least one port, and move the plunger in a distal direction to push the fluid out of the body of the vial assembly through the at least one port such that the fluid exits through the at least one port.

2. The delivery assembly of claim 1, wherein the at least one port comprises a first port and a second port, wherein the first port is configured to allow fluid to enter the vial assembly, and the second port is configured to allow fluid to exit the vial assembly.

3. The delivery assembly of claim 2, wherein the first port is positioned closer to the sealed distal end than the second port.

4. The delivery assembly of claim 2, wherein the first port and the second port are positioned equidistant from the sealed distal end of the body.

5. The delivery assembly of claim 2, wherein the first port and the second port are positioned on opposing sides of the side surface wall of the body.

6. The delivery assembly of claim 2, wherein the first port and the second port are positioned on a same side of the side surface wall of the body.

7. The delivery assembly of claim 2, wherein each of the first port and the second port comprise a one-way valve, the one-way valve of the first port configured to block a flow of fluid exiting from the body, and the one-way valve of the second port configured to block the flow of fluid entering into the body.

8. The delivery assembly of claim 2, wherein the first port and the second port are positioned on the side surface wall offset from or perpendicular to a central axis of the body.

9. The delivery assembly of claim 2, wherein the first port and the second port are positioned on the side surface wall on a same plane or on offset planes bisecting the body.

10. The deliver assembly of claim 2, wherein one of the first port or the second port is positioned on the side surface wall perpendicular to a central axis of the body and the other of the first port or the second port is positioned on the side surface wall offset from the central axis of the body.

11. The delivery assembly of claim 2, wherein at least one of the first port or the second port is configured to be angled with respect to the side surface wall such that a respective port longitudinal axis is angled with respect to a horizontal lateral axis of the body.

12. The delivery assembly of claim 1, wherein the vial engagement mechanism is configured to (i) move the plunger in the proximal direction to pull the fluid into the body through the at least one port to mix with a particulate material within the body to form a mixed fluid, and (ii) move the plunger in the distal direction to push the mixed fluid out of the body.

13. The delivery assembly of claim 1, wherein the vial assembly comprises only one port.

14. The delivery assembly of claim 1, wherein the vial assembly comprises greater than two ports.

15. The delivery assembly of claim 1, wherein the delivery assembly comprises a radioembolization delivery device, and the fluid comprises a contrast-saline solution configured to mix with a particulate material disposed in the body and comprising a plurality of radioembolization beads.

16. A method of use of a delivery assembly, comprising: engaging a vial engagement mechanism extending from a vial containment region of a console with a proximal end of a plunger of a vial assembly, the vial assembly further comprising a body comprising a sealed distal end and a side surface wall and at least one port on the side surface wall, the at least one port fully positioned within a dead space portion of the side surface wall disposed between a maximum stop point of the plunger and the sealed distal end, the maximum stop point defined by a stop section on the side surface wall disposed a dead space distance away from the sealed distal end, the proximal end of the plunger disposed outside the body, and a distal end of the plunger disposed within the body; moving the plunger in a proximal direction to pull a fluid into the body of the vial assembly through the at least one port such that the fluid enters through the at least one port; and moving the plunger in a distal direction to push the fluid out of the body of the vial assembly through the at least one port such that the fluid exits through the at least one port.

17. The method of claim 16, wherein the at least one port comprises a first port and a second port, further comprising: moving the plunger in a proximal direction to pull the fluid into the body of the vial assembly through the first port such that the fluid enters through the first port; and moving the plunger in the distal direction to push the fluid out of the body of the vial assembly through the second port such that the fluid exits through the second port.

18. The method of claim 16, further comprising forming a vortex of the fluid within the dead space portion of the body after moving the plunger in the proximal direction and the distal direction.

19. The method of claim 16, further comprising: moving the plunger in a proximal direction to pull the fluid into the body of the vial assembly through the at least one port such that the fluid enters through the at least one port to mix with a particulate material within the body to form a mixed fluid; and moving the plunger in the distal direction to push the mixed fluid out of the body of the vial assembly through the at least one port such that the mixed fluid exits fluid exits through the at least one port.

20. A method of use of a delivery assembly, comprising: engaging a vial engagement mechanism extending from a vial containment region of a console with a proximal end of a plunger of a vial assembly, the vial assembly further comprising a body comprising a sealed distal end and a side surface wall and a first port and a second port on the side surface wall, the first port and the second port fully positioned within a dead space portion of the side surface wall disposed between a maximum stop point of the plunger and the sealed distal end, the maximum stop point defined by a stop section on the side surface wall disposed a dead space distance away from the sealed distal end, the proximal end of the plunger disposed outside the body, and a distal end of the plunger disposed within the body; moving the plunger in a proximal direction to pull a fluid into the body of the vial assembly through the first port such that the fluid enters through the first port to mix with a particulate material within the body to form a mixed fluid; and moving the plunger in a distal direction to push the mixed fluid out of the body of the vial assembly through the second port such that the mixed fluid exits through the second port.