Vial assembly system and method for optimal flow

Abstract

The system and method involve a vial assembly system comprising a vial assembly and a needle. The vial assembly includes a septum, a neck region, and a particulate region with a bypass valve, and the neck region has an upper portion, a lower portion, and a side wall. The needle has a tip configured to puncture a port and a septum configured to receive the needle such that the port is disposed in the neck region. A bypass path includes a first end and a second end, the bypass valve is connected to the first end, the second end terminates at or within the side wall, and the bypass path is configured to provide a fluid flow path to the needle in place of a first path upon an increase in the pressure of the fluid flow within the vial assembly. The first path is disposed directly within the vial assembly between the particulate region and the neck region.

Description

Technical Field

[0001]

[0001] This disclosure generally relates to components of a medical device for treating cancer, and more particularly to a vial assembly system of a medical device configured and operable to deliver a radioactive compound to a treatment area within a patient's body in procedures such as transarterial radioembolization therapy.

Background Art

[0002]

[0002] In cancer treatment involving radiation therapy, inadvertent or excessive exposure to radiation from radioactive therapeutic agents can be harmful to the patient or medical personnel and can even be life - threatening. Therefore, medical devices for radiation therapy must be configured to keep the delivery of radioactive substances to a specific area of the patient's body local while protecting other areas from unnecessary radiation exposure.

[0003]

[0003] Transarterial radioembolization therapy is a trans - catheter intra - arterial procedure performed under imaging, and is generally used for the treatment of malignant tumors. During this medical procedure, a micro - catheter is navigated into the patient's liver, where radiation - embolization microspheres filled with a radioactive compound such as yttrium - 90 ( 90 Y) are delivered to the target tumor. These microspheres occlude the blood vessels supplying the tumor while delivering radiation to kill tumor cells. Generally, the clinician or patient can be exposed to the risk of radiation emitted from this delivery.

[0004]

[0004] Therefore, there is a need for components of a medical device that are configured and operable to shield from such radiation and optimize the flow when delivering a radioactive compound to a patient's body.

Summary of the Invention

[0005] According to an embodiment of the present disclosure, a vial assembly system comprises a vial assembly and a needle. The vial assembly comprises a vial assembly comprising a septum, a neck region, and a particulate region for containing particulates and comprising a bypass valve, the neck region comprising an upper portion, a lower portion, and a side wall disposed therebetween. The needle comprises a port and a tip distal to the port, the tip being configured to pierce the septum of the vial assembly disposed at the lower portion of the neck region. The septum is configured to receive the needle such that the port is disposed in the neck region of the vial assembly. A bypass path includes a first end and a second end. The bypass valve is connected to the first end of the bypass path, and the second end of the bypass path terminates at or within the side wall of the neck region. The bypass path is configured to provide a fluid flow path to the needle as an alternative to a first path upon an increase in the pressure of the fluid flow within the vial assembly, the first path being disposed directly within the vial assembly between the particulate region and the neck region.

[0006]

[0006] In another embodiment, the vial assembly system comprises a vial assembly and a needle. The vial assembly comprises a septum, a neck region, and a particulate region for containing particulates, the neck region comprising an upper portion, a lower portion, and a side wall disposed therebetween, the needle comprising a port and a tip distal to the port, the tip being configured to pierce the septum of the vial assembly disposed at the lower portion of the neck region. The septum is configured to receive the needle such that the port is disposed in the neck region of the vial assembly. The bypass valve is connected to a bypass path that includes a first end and a second end. The bypass valve is connected to the first end of the bypass path, and the second end of the bypass path terminates at or within the side wall of the neck region. The bypass path is configured to provide a fluid flow path to the needle in place of a first path when the pressure of the fluid flow within the vial assembly increases, the first path being disposed directly within the vial assembly between the particulate region and the neck region. The bypass path comprises a tube disposed between the bypass valve and the side wall of the neck region, the tube of the bypass path being disposed radially with respect to the longitudinal axis of the vial assembly.

[0007]

[0007] In yet another embodiment, a method of operating a vial assembly system includes receiving a needle into a septum of a vial assembly of the vial assembly system such that a port of the needle is disposed in a neck region of the vial assembly. The vial assembly further includes a particulate region with a bypass valve, the neck region includes an upper portion, a lower portion, and a sidewall disposed therebetween, the needle further includes a tip distal to the port, and the tip is configured to pierce a septum of the vial assembly disposed at the lower portion of the neck region. The method further includes monitoring for a pressure increase within the vial assembly to determine whether the pressure increase exceeds a threshold value, and alternating a fluid flow path from a first path to a bypass path when the monitored pressure increase exceeds the threshold value. The bypass path includes a first end and a second end, the bypass valve is connected to the first end of the bypass path, the second end of the bypass path terminates at or within the sidewall of the neck region, and the first path is disposed directly within the vial assembly between the particulate region and the neck region.

[0008]

[0008] These and additional features provided by the embodiments described herein will be more fully understood in consideration of the following detailed description in conjunction with the drawings.

Brief Description of the Drawings

[0009]

Figure 1

[0009] A perspective view of a delivery device including a protective shield and a vial slider, according to one or more embodiments shown and described herein.

Figure 2

[0010] A cross-sectional view of the vial slider of FIG. 1 taken along line 2-2 of FIG. 1, according to one or more embodiments shown and described herein.

Figure 3

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

Figure 4

[0012] It is a partial cross-sectional view taken along line 4-4 of FIG. 3 of the vial assembly of FIG. 4.

Figure 5

[0013] A perspective view of the vial sliding part of FIG. 1 in which the vial assembly of FIG. 3 with a series of delivery conduits coupled to the vial sliding part is received therein, according to one or more embodiments shown and described in the present invention.

Figure 6

[0014] A schematic side view of a vial assembly system pre-filled with delivery microparticles in a non-flow position, according to one or more embodiments shown and described herein.

Figure 7

[0015] A schematic view of the vial assembly system of FIG. 6 in a bypass path flow position in which fluid containing microparticles is directed along a bypass path to bypass high-concentration lower-layer microparticles within the vial assembly.

Figure 8

[0016] A schematic view of the vial assembly system of FIG. 6 in a first path flow position in which fluid containing microparticles is directed along a first path disposed between the microparticle region and the neck region of the vial assembly because there are no high-concentration lower-layer microparticles within the vial assembly.

DETAILED DESCRIPTION OF THE INVENTION

[0010]

[0017] Hereinafter, various embodiments of a delivery device for administering a radioactive compound to a patient are described in detail, and examples of these embodiments are illustrated in the accompanying drawings. Where possible, the same reference numbers are used throughout the drawings to refer to the same or similar parts. Directional terms as used herein, such as up, down, right, left, front, back, upper, lower, distal, and proximal, are used only in relation to the figures as depicted and are not intended to imply an absolute orientation.

[0011]

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

[0012]

[0019] Unless otherwise expressly stated, no method recited in this specification is intended to require that its steps be performed in a particular order, or that any device-specific orientation be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or where any apparatus claim does not actually recite an order or orientation to individual components, or where the steps are not otherwise specifically recited in the claims or description as being limited to a particular order, or where no specific order or orientation of components of an apparatus is recited, no order or orientation should be inferred in any way. This applies to any possible ambiguity in interpretation, including logical matters, grammatical constructs or punctuation from the arrangement of steps, operational flow, order of components, or orientation of components, the plain meaning derived therefrom, and the number or type of embodiments described in this specification.

[0013]

[0020] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The terminology used in the description herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0014]

[0021] As used herein, the terms "horizontal," "vertical," "distal," and "proximal" are merely relative terms and simply indicate an overall relative orientation and do not necessarily indicate perpendicularity. These terms may also be used for convenience in referring to the orientations used within the figures, such orientations being used merely by convention and not being intended as characteristics of the devices shown. The present disclosure and its embodiments to be described herein may be used in any desired orientation. Further, horizontal and vertical walls generally need merely be intersecting walls and need not be at right angles. As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a" component includes aspects having two or more such components unless the context clearly dictates otherwise.

[0015]

[0022] In embodiments described herein, the particulate material delivery assembly may include a radioembolization delivery device. The radioembolization delivery device comprises a medical device configured to deliver a radioactive compound to a treatment region within a patient's body in a procedure such as transarterial radioembolization. The radioactive compound may be a mixed solution of saline and radioactive microspheres (i.e., particulate 660) mixed within a vial of the vial assembly. The needle may include one or more ports as an outlet for injecting a fluid (i.e., saline) into the vial containing the radioactive microspheres to produce a mixed solution 662, such as from a syringe or catheter line, and as an inlet for delivering the mixed solution to the patient.

[0016]

[0023] The FIGS. 1-5 described below are directed to embodiments of a delivery device 500 for delivering microparticles 660, and the FIGS. 6-8 described in more detail below are directed to embodiments of one or more vial assembly system components of a delivery device 500 as described herein that assist in the delivery of microparticles 660 within a mixed solution 662 as described herein to a patient. As described in more detail below, FIG. 6, as also shown in FIGS. 7-8, illustrates a vial assembly system 600 that includes a vial assembly 580', such as a syringe assembly pre-filled with embolic particles as microparticles 660 to be delivered as concentrated particles through a flow path compatible with, for example, a needle, tube, catheter, or similar delivery component, via a mixed solution 662. The vial assembly 580' can include a concentration regulator 664, described in more detail below, that can allow an appropriate concentration of microparticles 660 to pass therethrough with the mixed solution 662 into the flow path. If a bolus of microparticles 660 is too large for the flow path and associated delivery components, due to either potential improper or insufficient mixing of the mixed solution 662 or sedimentation of the microparticles 660 due to gravity, the microparticles 660 can occlude a microcatheter and prevent administration. Thus, if the concentration of microparticles 660 is too high compared to a threshold and is likely to occlude a flow path delivery component such as a tube, the concentration regulator 664 can restrict the flow and allow the remaining low-concentration fluid as the upper mixed solution 662 (above the lower suspended microparticles 660) to bypass the concentration regulator 664 via a pressure-sensitive one-way flow path, such as through a bypass valve 606 as described herein. The bypass valve 606 can be triggered by a pressure sensor component or can be otherwise configured to open when the pressure applied to the bypass valve 606 exceeds a threshold value.

[0017]

[0024] In some embodiments, as described in more detail below, the delivery device 500 is a radioembolization delivery device, the microparticles 660 are a plurality of radioembolization beads, the fluid is a saline aqueous solution, and the resulting mixed fluid (e.g., mixed solution 662) is a radioembolization bead-saline aqueous solution. The needle 559 can be configured to deliver the radioembolization bead-saline aqueous solution as a mixed fluid solution through the radioembolization delivery device, such as during the actuation of the vial engagement mechanism 520 in the positive pressure direction. In some embodiments, the fluid is a contrast agent-saline aqueous solution containing a contrast agent, and the resulting mixed fluid (e.g., mixed solution 662) is a radioembolization bead-contrast agent-saline aqueous solution. The needle 559 can be configured to deliver the radioembolization bead-contrast agent-saline aqueous solution as the mixed solution 662 through the radioembolization delivery device. In some embodiments, the delivery device 500 is a chemoembolization delivery device, the microparticles 660 are a plurality of chemoembolization beads, and the mixed solution 662 is a bead-saline aqueous solution or a bead-contrast agent-saline aqueous solution. I. Mechanical Delivery Device with Removable Sliding Assembly

[0025] Figures 1-5 illustrate embodiments of a delivery device 500 configured and operable to deliver radioactive substances (e.g., radioembolization beads) while reducing radiation emission during use of the delivery device 500. The delivery device 500 can operate as described in International PCT Application No. PCT / 2019 / 033001, filed May 17, 2019, which is incorporated herein by reference in its entirety, except for the vial assembly system delivery flow components including a bypass path as described in more detail below with respect to Figures 6-8 and in one or more embodiments herein.

[0018]

[0026] Referring initially to FIG. 1, the delivery device 500 comprises a console assembly 510 that includes a console. The delivery device 500 may include a sliding portion assembly 540 that is operable to transition between a coupled state and a separated state with respect to the console assembly 510. The console assembly 510 of the delivery device 500 includes a base 512 defined by a proximal end 514 and a distal end 516 and extending therebetween. The proximal end 514 of the base 512 includes a handle (delivery handle) 528 movably coupled to the console assembly 510 and an interface display 530 positioned on the console assembly 510.

[0019]

[0027] The proximal end 514 of the base 512 further includes a mounting device 538 configured to securely hold an external device to the base 512 of the console assembly 510. The mounting device 538 is operable to facilitate the mounting of complementary devices to the console assembly 510 for use with the delivery device 500 during a procedure.

[0020]

[0028] Still referring to FIG. 1, the distal end 516 of the console assembly 510 defines a vial receiving region 518 sized and shaped to receive a vial assembly 580 therein, as will be described in more detail herein. The console assembly 510 further includes a vial engagement mechanism 520 extending from the base 512 adjacent the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outwardly from the base 512 of the console assembly 510 toward the distal end 516. The vial engagement mechanism 520 is positioned within the vial receiving region 518 of the console assembly 510 and is movably coupled to the handle 528. In particular, the handle 528 of the console assembly 510 is operable to move, and in particular translate, the vial engagement mechanism 520 within the vial receiving region 518 in response to actuation of the handle 528.

[0021]

[0029] The console assembly 510 includes a mechanical assembly disposed within the base 512 that is configured and operable to convert manual movement of the handle 528 into corresponding linear displacement of the vial engagement mechanism 520. In this example, the mechanical assembly is coupled to the handle 528 and the vial engagement mechanism 520 such that selective actuation of the handle 528 at the proximal end 514 causes simultaneous actuation of the vial engagement mechanism 520 at the distal end 516.

[0022]

[0030] The sliding space 532 is sized and shaped to receive a slider assembly 540 therein. As will be described in more detail herein, the slider assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, media) therethrough. In particular, the slider assembly 540 is configured to partially receive the vial assembly 580 therein for administering therapeutic particles from the delivery device 500 to a patient during a procedure.

[0023]

[0031] In an embodiment, and referring to FIG. 2, the flow sensor of the delivery device 500 can be positioned in-line with one or more of the tubing sets of the delivery device 500, and in particular, the needle 559, the manifolds 555A, 555B, and / or the port 556, to measure the amount of fluid (e.g., a suspension after therapeutic particles are effectively mixed with a fluid medium) passing therethrough. Referring back to FIG. 1, the vial engagement mechanism 520 includes a pair of lever arms 522 extending outwardly from the neck 524 of the vial engagement mechanism 520, the neck 524 extending laterally outwardly from the base 512 of the console assembly 510. The neck 524 of the vial engagement mechanism 520 is disposed within the protective cover 525 such that only the pair of lever arms 522 of the vial engagement mechanism 520 extend through the protective cover 525. The protective cover 525 is operable to shield one or more internal components of the console assembly 510 from outside the console assembly 510, and in particular, from the vial receiving region 518.

[0024]

[0032] A pair of lever arms 522 are movable simultaneously with the neck 524 of the vial engagement mechanism 520 in response to actuation of the handle 528 of the console assembly 510. Further, the pair of lever arms 522 are fixed relative to each other such that the space formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 are configured to firmly engage the vial assembly 580 therebetween and, in particular, within the space formed by the pair of lever arms 522. Thus, the vial engagement mechanism 520 is operable to firmly attach the vial assembly 580 to the console assembly 510 in the vial receiving region 518. The vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, but it should be understood that the vial engagement mechanism 520 may include various other structural configurations suitable for engaging the vial assembly 580. In non-limiting examples, the vial engagement mechanism 520 may include one or more magnets configured to engage one or more corresponding magnets on the vial assembly.

[0025]

[0033] Still referring to FIG. 1, the console assembly 510 further includes a safety shield 526 that is secured to the distal end 516 of the base 512 along the vial receiving region 518. In particular, the safety shield 526 is a protective cover sized and shaped to surround the vial receiving region 518 of the console assembly 510 when secured to the console assembly 510. The safety shield 526 is selectively attachable to the distal end 516 of the base 512 and is formed of a material configured to suppress radiation emission from one or more radiation doses stored within the vial receiving region 518.

[0026]

[0034] The distal end 516 of the console assembly 510 further includes a sliding space 532 sized and shaped to receive the slider 540 therein. The sliding space 532 includes one or more or a pair of positioning portions 534 extending therein, and the positioning portions 534 are sized and shaped to fit the corresponding positioning portions (e.g., positioning ribs 554) of the slider 540, thereby facilitating the coupling of the slider 540 and the base 512 of the console assembly 510 within the sliding space 532.

[0027]

[0035] Still referring to FIG. 1, the slider 540 is configured to partially receive the vial assembly 580 therein for administering therapeutic particles (e.g., radioactive fluid medium) from the delivery device 500 to the patient. In particular, the slider 540 includes a distal end 542 and a proximal end 544, and a pair of side walls 546 extend therebetween. The distal end 542 of the slider 540 includes a handle 552 extending proximally therefrom. The handle 552 is configured to facilitate the movement of the slider 540, particularly the insertion of the slider 540 into the sliding space 532 of the console assembly 510. The distal end 542 further includes one or more ports 556 for coupling one or more delivery conduits (i.e., tubes) to the slider 540. Since one or more delivery conduits are further coupled to one or more external devices at the ends of the line opposite the ports 556, the ports 556 effectively function to fluidly couple the slider 540 to one or more external devices via the delivery conduits connected thereto. The pair of side walls 546 of the slider 540 include at least one positioning rib 554 extending laterally outward therefrom, and the positioning rib 554 is sized and shaped to fit and engage with the pair of positioning portions 534 of the console assembly 510. Accordingly, the pair of positioning ribs 554 are configured to facilitate the alignment and engagement of the slider 540 with the console assembly 510 when the proximal end 544 is slidably received within the sliding space 532 of the base 512.

[0028]

[0036] The sliding body 540 further includes an upper surface 548 that extends from a distal end 542 and a proximal end 544 and is positioned between a pair of side walls 546. The upper surface 548 of the sliding body includes a recessed region 549 and a locking system 550. The recessed region 549 is sized and shaped to form a recess and / or cavity along the upper surface 548, and this recessed region 549 can receive and / or collect various materials therein, including leakage of various fluid media during use of the delivery device 500, for example. The locking system 550 of the sliding body 540 forms an opening in the upper surface 548 that is sized and shaped to receive one or more devices, such as a priming assembly 560 and a vial assembly 580. In some embodiments, the sliding body 540 is pre-loaded with a priming assembly 560 disposed within the locking system 550. The priming assembly 560 includes a priming conduit 562 that extends outwardly from the locking system 550 of the sliding body assembly 540. The priming assembly 560 connects the priming conduit 562 to the needle 559 and the manifolds 555A and 555B and serves to purge air from the delivery device 500, including the manifolds 555A and 555B, before utilizing the delivery device 500 in a procedure.

[0029]

[0037] Referring now to FIG. 2, the locking system 550 includes an annular array of protrusions 551 that extend outwardly therefrom, and the protrusions 551 extend laterally into the aperture formed by the locking system 550, particularly along the upper surface 548. The annularly arranged protrusions 551 are formed within the inner circumference of the locking system 550 and extend along at least two continuously arranged rows. In an embodiment, a single row may be used. The annular array of protrusions 551 included in the locking system 550 engages corresponding locking features 586 of the vial assembly 580 (see FIG. 3), thereby being configured to firmly secure the vial assembly 580 to the slider 540. It should be understood that the multiple rows of protrusions 551 of the locking system 550 serve to provide a dual locking system to ensure that the slider assembly 540, and particularly the pins 559 of the slider assembly 540, are firmly maintained through the septum 592 of the vial assembly 580 (see FIG. 3) during use of the delivery device 500 in a procedure.

[0030]

[0038] The slider 540 further includes a vial chamber 558 sized and shaped to receive therein a priming assembly 560 and a vial assembly 580, respectively. In other words, the vial chamber 558 is sized to receive both the priming assembly 560 and the vial assembly 580 separately from each other. The vial chamber 558 is enclosed within a protective chamber or shield 557 disposed around the vial chamber 558. The protective shield 557 is formed of a material configured to suppress the emission of radiation from the vial chamber 558 to the outside, such as, for example, metal or plastic. Additionally, the slider 540 includes a needle 559 extending along the lower end of the vial chamber 558 through the protective shield 557 and into the vial chamber 558. The needle 559 is fixedly secured to the vial chamber 558 such that any device received through the aperture of the locking system 550 and into the vial chamber 558 will contact and interact with the needle 559 (e.g., the priming assembly 560, the vial assembly 580, and the like).

[0031]

[0039] Still referring to FIG. 2, the needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the slider 540. In particular, the manifolds 555A, 555B are positioned below the vial chamber 558 and the protective shield 557. The proximal manifold 555B is fluidly coupled to the needle 559, and the distal manifold 555A is fluidly coupleable to one or more delivery conduits via one or more ports 556 of the slider assembly 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A through a one-way check valve 553 disposed therebetween.

[0032]

[0040] Accordingly, the proximal manifold 555B is in fluid communication with one or more ports 556 via the distal manifold 555A, but the one or more ports 556 are not in fluid communication with the proximal manifold 555B due to the position of the one-way check valve 553 disposed between the manifolds 555A, 555B. Thus, the needle 559 is in fluid communication with one or more delivery conduits and / or devices coupled to the slider 540 at the one or more ports 556, and via the manifolds 555A, 555B fixed therebetween. The one or more ports 556 of the slider assembly 540 can be coupled to a bag (e.g., a saline bag), a syringe, a catheter, and / or the like via one or more delivery conduits coupled thereto. In other embodiments, the needle 559 can be a cannula, a catheter, or a similar mechanism through which fluid and / or solution is injected and received as described herein.

[0033]

[0041] Still referring to FIG. 2, the slider 540 includes a removable battery pack 570 coupled to the slider 540 along the proximal end 544. The removable battery pack 570 includes a battery 572, electrical contacts 574, and a removable tab 576. The battery 572 of the delivery device 500 is isolated from the one or more fluid channels and the radiation source due to the location of the battery 572 within the removable battery pack 570.

[0034]

[0042] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to contact and interact with corresponding electrical contacts 511 (see FIG. 1) of the console assembly 510 when the slider 540 is coupled to the base 512 in the sliding space 532. Accordingly, the removable battery pack 570 is operable to provide power to the delivery device 500, and in particular, to the console assembly 510 when the slider 540 is coupled to the console assembly 510.

[0035]

[0043] In addition, as will be described in more detail herein, in some embodiments, the locking system 550 may include at least one planar wall relative to the other circular configurations of the locking system 550. In this case, the aperture formed by the locking system 550 through the upper surface 548 of the slider 540 is not of a circular shape as shown and described above, but of an irregular shape. In this case, the vial assembly 580 includes the locking system 550 and, in particular, a locking feature 586 having a shape and size corresponding to the at least one planar wall, such that the vial assembly 580 is received within the slider 540 only when the orientation of the vial assembly 580 corresponds to the orientation of the locking feature 586 and the locking system 550. In other words, the corresponding planar wall 586A (see FIG. 3) of the locking feature 586 must be aligned with the planar wall of the locking system 550 such that the vial assembly 580 can be received within the aperture formed by the locking system 550 of the slider 540.

[0036]

[0044] Referring now to FIG. 3, the vial assembly 580 of the delivery device 500 is depicted. The vial assembly 580 includes an engagement head 582, a plunger 584, a locking feature 586, and a vial body 589. In particular, the engagement head 582 of the vial assembly 580 is positioned at the end of the plunger 584 opposite the locking feature 586 and the vial body 589. The engagement head 582 includes a pair of arms 581 that extend laterally outwardly relative to the longitudinal length of the plunger 584 that extends downwardly therefrom. In this example, the engagement head 582 is formed integrally with the plunger 584, but it should be understood that in other embodiments, the engagement head 582 and the plunger 584 may be separate features that can be firmly fixed to each other. In any case, the engagement head 582 and the plunger 584 are movable relative to the locking feature 586 and the vial body 589 such that the engagement head 582 and the plunger 584 can slideably translate through the locking feature 586 and the vial body 589. In particular, as will be described in more detail herein, the plunger 584 can translate in and out of the inner chamber 588 of the vial body 589 in response to the linear translational movement of the vial engagement mechanism 520 when the engagement head 582 is secured to the pair of lever arms 522.

[0037]

[0045] The plunger 584 includes a plurality of markings and / or graduations 583 positioned along the longitudinal length of the plunger 584. The plurality of graduations 583 indicate the relative extension of the engagement head 582 and the plunger 584 from the locking feature 586 and the vial body 589. As briefly described above, the engagement head 582 is configured to attach the vial assembly 580 to the vial engagement mechanism 520. In particular, the pair of arms 581 of the engagement head 582 are sized and shaped to couple with the pair of lever arms 522 of the vial engagement mechanism 520 when the vial assembly 580 is received within the slider 540 and the slider is inserted into the sliding space 532 of the console assembly 510. As described in more detail herein, the pair of lever arms 522 are received between the pair of arms 581 of the engagement head 582 and the plunger 584 in response to a predetermined translational force applied to the vial engagement mechanism 520. The engagement head 582 and the plunger 584 can be formed of various materials including, but not limited to, metal, plastic, and / or the like.

[0038]

[0046] Still referring to FIG. 3, the vial assembly 580 further includes a safety tab 585 coupled to the plunger 584 relative to above the locking feature 586 and below the engagement head 582, such that the safety tab 585 is positioned along the longitudinal length of the plunger 584. The safety tab 585 can be formed of various materials such as, for example, plastic and is pre-assembled to the vial assembly 580 prior to use of the delivery device 500. The safety tab 585 is removably fastened to the plunger 584 and inhibits translation of the plunger 584 relative to the vial body 589. In particular, the safety tab 585 abuts against the locking feature 586 in response to the application of a linear force to the plunger 584 to translate the plunger 584 relatively downward into the vial body 589. In this case, the safety tab 585 is configured to prevent inadvertent movement of the plunger 584 and the corresponding inadvertent delivery of a fluid medium (e.g., therapeutic particles, radiation embolization beads) stored within the internal chamber 588 of the vial body 589. As will be described in more detail herein, the safety tab 585 is selectively removed from the plunger 584 in response to the coupling of the vial assembly 580 with the vial engagement mechanism 520 and in particular the engagement of the pair of lever arms 522 with the engagement head 582.

[0039]

[0047] Returning to FIG. 3 and referring thereto, the locking feature 586 extends around the upper end of the vial body 589. In this example, the locking feature 586 of the vial assembly 580 comprises a bushing (bearing cylinder) that defines a side edge 587 that extends laterally outwardly along the outer periphery of the locking feature 586. The side edge 587 of the locking feature 586 is sized and shaped to engage the annularly disposed protrusions 551 of the locking system 550 when the vial assembly 580 is received within the vial chamber 558 of the slider 540. As will be described in more detail herein, the locking feature 586, and in particular the side edge 587 of the locking feature 586, is configured to securely hold the vial assembly 580 to the locking system 550 and prevent removal of the vial body 589 from the vial chamber 558 of the slider 540 during use of the delivery device 500 in the procedure. In some embodiments, as briefly described above, the locking feature 586 includes at least one planar wall 586A such that the locking feature 586 has an irregular shape. The at least one planar wall 586A is configured to correspond to the planar wall 550A of the locking system 550, such that in order to align the planar walls 550A and 586A, it is necessary for the vial assembly 580 to be received through an aperture formed by the locking system 550.

[0040]

[0048] Still referring to FIG. 3, the vial body 589 extends relatively downwardly from the locking feature 586 and has a longitudinal length sized to receive therein at least a portion of the longitudinal length of the plunger 584. Thus, in some embodiments, the longitudinal length of the plunger 584 exceeds the longitudinal length of the vial body 589, such that translational movement of the plunger 584 into the internal chamber 588 of the vial body 589 causes the fluid medium stored therein to be forced out of the vial body 589. As will be described in more detail herein, translational movement of the plunger 584 through the internal chamber 588 of the vial body 589 enables administration of the fluid medium stored within the vial body 589 out of the vial assembly 580. The vial body 589 can be formed of a variety of materials including, for example, thermoplastic polymers, copolyesters, polycarbonates, biocompatible plastics, polysulfones, ceramics, metals, and / or the like.

[0041]

[0049] The vial body 589 of this example is formed of a material configured to suppress radiation emission from a fluid medium stored within the internal chamber 588 of the vial body 589. For example, the vial body 589 can be formed of a plastic such as polycarbonate and can have a width. The combination of the density and material composition of the vial body 589 enables suppression of beta radiation emission from electron particles stored within the internal chamber 588. In this example, the chemical composition of the plastic of the vial body 589, in combination with a wall thickness of 9 mm, provides a plurality of atoms disposed within the vial body 589, and such a plurality of atoms can cope with beta radiation that generates electrons and reduce the emission of the above-described radiation from the vial assembly 580. Accordingly, the vial assembly 580 enables an operator to handle radioactive substances stored within the vial body 589 without being exposed to beta radiation. It should be understood that in other embodiments, various other materials and / or wall regions can be incorporated within the vial body 589 of the vial assembly 580 without departing from the scope of the present disclosure.

[0042]

[0050] Still referring to FIG. 3, the vial body 589 of the vial assembly 580 is sealed at the first terminus 598 by a locking feature 586. The vial assembly 580 further includes a cap 590 positioned at the opposing terminus of the vial body 589 opposite the locking feature 586, such that the cap 590 seals the second terminus of the vial body 589 of the vial assembly 580. Additionally, the vial assembly 580 includes a septum 592, the septum 592 being positioned adjacent to the cap 590 and in fluid communication with the terminus of the vial body 589 opposite the locking feature 586. The septum 592 forms a seal against the terminus of the vial body 589 and the cap 590 holds the septum 592 therein. The septum 592 can be formed of various materials including, for example, elastomers, silicones, bromobutyl elastomers, rubbers, urethanes, and / or the like. The septum 592 provides an airtight seal for the vial body 589 and is configured to inhibit release of a fluid medium (e.g., radiation embolization beads) stored therein. As will be described in more detail herein, the septum 592 of the vial assembly 580 is configured to be punctured by the needle 559 of the slider 540 when the vial assembly 580 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the slider 540. In other embodiments, instead of the septum 592, alternative devices such as, for example, valve systems, needle injection ports, and / or the like can also be used.

[0043]

[0051] Referring to FIG. 4, the vial assembly 580 further includes a stopper 594 fixedly coupled to the end of a plunger 584 opposite the engagement head 582. In this case, since the plunger 584 is coupled to and slidably translatable through an internal chamber 588 of the vial body 589, the stopper 594 is effectively disposed within the vial body 589. Thus, it should be understood that the stopper 594 is sized and shaped according to the size (e.g., diameter) of the internal chamber 588 of the vial body 589. The stopper 594 is fixed to the plunger 584, and the stopper 594 is slidably translatable through the vial body 589 in response to the translational movement of the plunger 584 through the vial body 589. The stopper 594 is defined by two or more ribs 593 extending laterally outwardly and one or more recesses 595 defined between at least two ribs 593.

[0044]

[0052] The stopper 594 is configured to form a liquid-tight seal with respect to the internal chamber 588 of the vial body 589 and can be formed of various polymers having a predetermined viscoelasticity. For example, in some embodiments, the stopper 594 is formed of elastomer, silicone, rubber, urethane, plastic, polyethylene, polypropylene, and / or the like. In this case, the stopper 594 is operable to prevent the fluid medium stored within the vial body 589 from diffusing (i.e., leaking) past the stopper 594 and out of the vial body 589. In particular, two or more ribs 593 of the stopper 594 abut against and form a seal along the internal chamber 588 of the vial body 589, thereby preventing the fluid medium from passing over the ribs 593. One or more recesses 595 formed between two or more ribs 593 of the stopper 594 are configured to receive, and more specifically, capture any fluid medium that may inadvertently diffuse (i.e., leak) past the ribs 593 of the stopper 594. Thus, the one or more recesses 595 serve as a safety mechanism for the vial assembly 580 to ensure that the fluid medium is maintained within the vial body 589 and not exposed beyond the vial assembly 580.

[0045]

[0053] Still referring to FIG. 4, two or more ribs 593 of the stopper 594 are additionally configured to press the fluid medium stored within the vial body 589 in one or more directions (e.g., toward the cap 590) within the vial body 589 in response to the translational movement of the plunger 584. With the ribs 593 of the stopper 594 pressed against the inner chamber 588 of the vial body 589, the translational movement of the plunger 584 results in a translational movement of the ribs 593 relative to and along the inner chamber 588 of the vial body 589, such that any fluid medium located in front of (i.e., below) the stopper 594 is effectively redirected within the vial body 589 in the direction of travel of the plunger 584 and the stopper 594. The vial assembly 580 further includes an annular washer 596 disposed within the vial body 589. In particular, the annular washer 596 is firmly fixed to the plunger 584 adjacent to the stopper 594, which is secured to the plunger 584 at the opposite end of the engagement head 582. Thus, the annular washer 596 is fixed to the plunger 584 and disposed within the vial body 589 adjacent to the stopper 594. Since the annular washer 596 is fixed to the plunger 584 adjacent to the stopper 594, the annular washer 596 is effectively disposed within the vial body 589.

[0046]

[0054] Referring now to FIG. 5, in response to determining that the battery 572 contains a sufficient amount of power or that another power source provides the same, one or more delivery conduits are coupled to the slider assembly 540 via one or more ports 556. In particular, the dosage delivery conduit 10A is coupled to the slider 540 at the delivery port 556A, the contrast agent conduit 10B is coupled to the slider 540 at the contrast agent port 556B, and the flushing conduit 10C is coupled to the slider 540 at the flushing port 556C. The opposite end of the dosage delivery conduit 10A is initially coupled to a fluid reservoir, such as a collection bowl, for example. As will be described in more detail herein, once the slider 540 is effectively primed by the fluid medium via the contrast agent conduit 10B, the dosage delivery conduit 10A can subsequently be coupled to an external device, such as a catheter. The opposite end of the flushing conduit 10C is coupled to an external device, such as a syringe, for example. With both the dosage delivery conduit 10A and the flushing conduit 10C coupled to the slider 540, the slider 540 is flushed with a fluid medium (e.g., saline) from a syringe coupled to the flushing conduit 10C. In this case, the fluid medium is injected through the flushing conduit 10C into the distal manifold 555A of the slider 540 and exits the slider 540 through the dosage delivery conduit 10A. Thus, the fluid medium is ultimately received and disposed (or processed therein) in the collection bowl by the dosage delivery conduit 10A.

[0047]

[0055] Since the distal manifold 555A of the sliding body 540 is separated from the proximal manifold 555B by a one-way valve 553 disposed therebetween, the fluid medium flushed from the syringe (through the flushing port 556C) through the distal manifold 555A is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. Rather, the fluid medium injected from the syringe through the flushing conduit 10C is received at the flushing port 556C, passed through the distal manifold 555A in fluid communication with the flushing port 556C, and redirected by the one-way valve 553 toward the dose delivery port 556A coupled to the dose delivery line 10A. In this case, the dose delivery line 10A receives the fluid medium and transports it to the collection bowl coupled thereto, as a result of which the fluid medium is not directed beyond the one-way valve 553 and into the proximal manifold 555B in fluid communication with the needle 559.

[0048]

[0056] The contrast agent conduit 10B is coupled to the slider 540 at the contrast agent port 556B. The opposite end of the contrast agent conduit 10B is coupled to a fluid media supply, such as a bag fixed to the console assembly 510 by a mounting device 538, for example. In this example, the bag is a saline bag, and thus the fluid media stored therein is saline. In this case, with the slider 540 including the priming assembly 560 positioned within the vial chamber 558 and the needle tip 568 in fluid communication with the needle 559, the syringe is fluidly coupled to the priming conduit 562 of the priming assembly 560, and the plunger of the syringe is pulled back, thereby drawing saline from the saline bag into the syringe through the contrast agent conduit 10B, the contrast agent port 556B, the slider 540, and the priming conduit 562. The plunger of the syringe is then pushed inward to send the drawn saline in the opposite direction through the priming conduit 562, the central body portion 564, the elongated shaft 566, and the needle tip of the priming assembly 560, such that the saline is received within the needle 559 of the slider 540. Accordingly, the manifolds 555A, 555B of the slider 540 are effectively primed with saline from the syringe since the needle 559, which has received saline from the priming assembly 560, is in fluid communication with the manifolds 555A, 555B. Since the manifolds 555A, 555B are in further fluid communication with the dose delivery conduit 10A via the delivery port 556A, the saline is effectively supplied to the collection bowl coupled to the dose delivery conduit 10A.

[0049]

[0057] Referring now to FIG. 5, the slider 540 is coupled to one or more external devices via one or more ports 556. In particular, the slider 540 is fluidly coupled to a catheter (e.g., a microcatheter) via a dose delivery conduit 10A coupled to the delivery port 556A of the slider 540. In this case, the catheter is in fluid communication with the slider 540 via the dose delivery conduit 10A. Further, the slider 540 is fluidly coupled to a contrast agent source, such as a saline bag, which is secured to the console assembly 510, for example, via a mounting device 538 (see FIG. 1). The slider 540 is in fluid communication with the saline bag via a contrast agent conduit 10B coupled to the contrast agent port 556B of the slider 540. In this case, the saline bag is in fluid communication with the slider 540 via the contrast agent conduit 10B secured to the contrast agent port 556B.

[0050]

[0058] The contrast agent port 556B is in fluid communication with the proximal manifold 555B, while the delivery port 556A is in fluid communication with the distal manifold 555A. As will be described in more detail herein, since the contrast agent port 556B is coupled to the proximal manifold 555B rather than the distal manifold 555A separated by a one-way check valve 553 disposed therebetween from the proximal manifold 555B, saline from the saline bag can be drawn through the needle 559 of the slider 540 into the vial body 589 of the vial assembly 580.

[0051]

[0059] Referring again to FIGS. 1 and 3, with the vial assembly 580 firmly coupled to the slider 540, the slider 540 is coupled to the console assembly 510 by translating the distal end 542 of the slider 540 toward and into the distal end 516 of the console assembly 510. In particular, the distal end 542 of the slider 540 is directed into the sliding space 532 of the console assembly 510 by aligning the positioning rib 554 of the slider 540 with the positioning portion 534 of the console assembly 510. Once the proximal end 544 and the distal end 542 of the slider 540 are completely enclosed within the sliding space 532 of the console assembly 510, the electrical contacts 574 (FIG. 2) of the removable battery pack 570 interact with the corresponding electrical contacts 511 (FIG. 1) of the console assembly 510. In this case, power from the battery 572 is transmitted to the console assembly 510 via the electrical contacts 574, thereby activating the console assembly 510 of the delivery device 500. In this case, the interface display 530 of the console assembly 510 is activated to display appropriate real-time information regarding the delivery device 500 during the procedure.

[0052]

[0060] Referring again to FIG. 5, when the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial receiving region 518, a negative pressure is generated within the internal chamber 588 of the vial body 589 due to the retraction of the stopper 594. In this case, with the saline bag coupled to the slider 540 via the contrast agent conduit 10B and the contrast agent port 556B, the saline from the saline bag is drawn into the internal chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Thus, if the vial body 589 is pre-filled with a radioactive fluid medium (e.g., radioactive embolization microspheres), the saline is effectively mixed with the radioactive fluid medium within the vial body 589 when the plunger 584 is retracted from the internal chamber 588 and a negative pressure is generated through the delivery device 500.

[0053]

[0061] The sliding body 540 further includes a one-way check valve 553A along the contrast agent conduit 10B and the flushing conduit 10C. In particular, the one-way check valve 553A is configured to allow fluid communication from the contrast agent port 556B and the flushing port 556C into the manifolds 555A, 555B, and is further configured to prevent fluid communication from the manifolds 555A, 555B to the contrast agent port 556B and the flushing port 556C. Therefore, it should be understood that directing the dose delivered from the vial body 589 to the manifolds 555A, 555B into the contrast agent conduit 10B or the flushing conduit 10C is impossible because of the one-way check valve 553A positioned therein. Thus, the dose is directed to the dose delivery port 556A and received in a catheter fluidly coupled by the dose delivery conduit 10A. In other words, the one-way check valve 553A prevents backflow of fluid into the sliding body 540 and / or the vial assembly 580 coupled thereto. II. Vial Assembly System with Bypass Path Embodiment

[0062] As briefly described above, the delivery device 500 described herein may include a vial assembly system 680 that includes a bypass pathway for effectively delivering the microparticles 660 via the mixed solution 662, embodiments of which are described in more detail below with respect to FIGS. 6-8. Referring to FIG. 6, which illustrates a vial assembly system 680 pre-filled with microparticles 660 for delivery and in a non-flow position 682, the vial assembly system 680 includes a vial assembly 580' and a needle 559. The vial assembly 580' may include a vial body 589 that includes a septum 592, a neck region 602, and a microparticle region 604. The neck region 602 may include a cylindrical shape, a conical shape, a tapered shape, or other suitable shape. The microparticle region 604 may include a bypass valve 606. In an embodiment, the bypass valve 606 may include a one-way valve, a check valve, a safety valve, or other suitable valve configured for one-way directed flow. The bypass valve 606 disposed in the microparticle region 604 may further be disposed in the dead space region 628 of the microparticle region 604. The dead space region 628 is defined as the region into which the plunger 584 (FIG. 5) of the vial assembly 580' cannot be further pushed distally (i.e., downwardly toward the septum 592) within that region, and thus, cannot be pushed into the dead space region 628. In an embodiment, the vial assembly 580' is a syringe assembly as described herein that includes a plunger 584 (FIG. 5), a barrel, a stopper, and a needle 559, as well as a concentration regulator 664, a bypass valve 606 (such as a one-way valve, a safety valve, a duckbill valve, or the like), and a flow path such as through a polyvinyl chloride (PVC) medical tube that connects the bypass valve 606 to the needle while bypassing the concentration regulator 664.

[0054]

[0063] The neck region 602 may include an upper portion 610, a lower portion 608, and side walls 612 disposed therebetween. The needle 559 may include a port 614 and a tip 616 distal to the port 614. The port 614 of the needle 559 may be configured as an outlet for injecting fluid into the vial assembly 580' and as an inlet for delivering a mixed particulate solution (e.g., mixed solution 662) of fluid and particulate 660 from the vial assembly 580'. The tip 616 may be configured to pierce the septum 592 of the vial assembly 580' disposed at the lower portion 608 of the neck region 602. The septum 592 is configured to receive the needle 559 such that the port 614 is disposed in the neck region 602 of the vial assembly 580'. The neck region 602 may be sized and shaped to receive both the tip 616 and the port 614 between the septum 592 and the concentration regulator 664, which will be described in more detail below. The septum 592 may be configured to be disposed proximally adjacent to (and above) the neck region 602, and the particulate region 604 may be disposed distally adjacent to (and below) the neck region 602.

[0055]

[0064] The bypass path 624, as shown, includes a first end 620 and a second end 622. A bypass valve 606 is connected to the first end 620 of the bypass path 624. The second end 622 of the bypass path 624 terminates at or within the side wall 612 of the neck region 602. The bypass path 624 is configured to provide a fluid flow path to the needle via the bypass path 624 as an alternative to the first path 626 upon a pressure increase in the fluid flow within the vial assembly 580. As shown, the first path 626 is disposed directly within the vial assembly 580' between the particulate region 604 and the neck region 602. In an embodiment, the first path 626 is oriented along the longitudinal axis of the vial assembly 580', and the bypass path 624 is disposed radially with respect to the longitudinal axis. The bypass path 624 may include a tube 625 disposed between the bypass valve 606 and the side wall 612 of the neck region 602. In an embodiment, rather than the tube 625, the bypass path 624 may be a needle or an alternative metal flow path.

[0056]

[0065] In an embodiment, the vial assembly system 680 may further include a concentration regulator 664 disposed between the neck region 602 and the particulate region 604. The concentration regulator 664 may be configured to limit the concentration of the particulates 660 to be sent to the needle 559 along the first path 626. The concentrator regulator 664 may be a mesh component. Alternatively or additionally, the concentrator regulator 664 may be a filter, membrane, or other suitable regulator component configured to limit the flow of high-concentration particulates 660 above a concentration threshold.

[0057]

[0066] The vial assembly 580' may be installed within the delivery device 500 as described herein, and the plunger 584 (FIG. 5) may be pulled all the way up to draw fluid into the vial of the vial assembly 580' and suspend the particulates 660. The fluid may be prevented from traveling through the bypass path 624 due to the one-way bypass valve 606, and the fluid may be drawn into the concentration regulator 664 to suspend the particulates 660 within the mixed solution 662. If the user is late and the particulates 660 settle out of suspension as shown in FIG. 6, a large bolus of the particulates 660 may accumulate on top of the concentration regulator 664. In this state, the user may depress the plunger 584, and when sufficient pressure is achieved, the one-way bypass valve 606 opens and the low-concentration fluid of the mixed solution 662 (including a lower particulates 660 concentration together with the fluid) may flow out of the needle 559 along the bypass path 624 as shown in FIG. 7. Alternatively, in an embodiment, the concentration regulator 664 may be used as a pressure sensor, or another pressure sensor may be used to trigger the bypass valve 606 upon detection of a pressure above a threshold. The user may continue to administer the mixed solution 662 until the plunger 584 blocks the one-way bypass valve 606. At this point, the user may pull the plunger 584 back up to the maximum position and resuspend and administer the particulates 660 within the mixed solution 662 at a suitable concentration suitable for the first path 626 as shown in FIG. 8.

[0058]

[0067] Thus, referring to FIG. 7, a bypass path flow position 684 is shown where fluid containing particles 660 as the mixed solution 662 is directed along bypass paths 624A, 624 to bypass the high concentration lower layer particles 660 shown as non-suspended below the suspended mixed solution 662 within the vial assembly 580'. In an embodiment, bypass path 624 is configured to provide a fluid flow path to needle 559 in place of first path 626 upon an increase in the pressure of the fluid flow within vial assembly 580' when accumulation of particles 660 occurs at concentration regulator 664.

[0059]

[0068] In an embodiment, both concentration regulator 664 and bypass valve 606 can be configured such that particles 660 do not clog a net, membrane, filter, or the like, or the valve features of bypass valve 606. Additionally, the holes within concentration regulator 664 can be sized to allow particles 660 to pass therethrough, but spaced such that only an appropriate and predetermined amount can pass through at one time without clogging the flow path of first path 626. Bypass valve 606 can be positioned well above where the maximum concentration of particles 660 occurs and well below the upper portion of the plunger 584 stroke to allow particles 660 to be resuspended. The pressure required to open bypass valve 606 can be such that particles 660 and concentration regulator 664 are not damaged. The maximum operating pressure of particles 660 and concentration regulator 664 can depend on the type of particles and concentration regulator used, and the maximum operating pressure can be determined by an applied and controlled predetermined pressure to both to observe the maximum pressure that the particles and concentration regulator can withstand without being damaged. In an embodiment, the bypass flow path as bypass path 624 can be overmolded or made as part of the syringe body of vial assembly 580'.

[0060]

[0069] As described above, FIG. 8 illustrates a first path flow position 686 where the fluid containing the particles 660 as the mixed solution 662 is directed along the first paths 626A, 626 disposed between the particle region 604 and the neck region 602 of the vial assembly 580' because there is no high-concentration lower layer and undispersed particles 660 within the vial assembly 580'. Thus, the first paths 626A, 626 of FIG. 8 can be used when the bypass valve 606 is not triggered to divert the mixed solution 662 along the bypass path 624 of FIG. 7 to prevent blockage.

[0061]

[0070] In an embodiment, the method of operating the vial assembly system 680 can thus include receiving the needle 559 within the septum 592 of the vial assembly 580' of the vial assembly system 680 such that the port 614 of the needle 559 is disposed in the neck region 602 of the vial assembly 580'. The pressure rise within the vial assembly 580' can be monitored to determine whether the pressure rise exceeds a threshold value. When the pressure rise exceeds the threshold value, the fluid flow path can be alternated from the first path 626 to the bypass path 624, such as that shown in FIG. 7. As described above, the bypass path 624 includes a first end 620 and a second end 622, the bypass valve 606 is connected to the first end 620 of the bypass path 624, the second end 622 of the bypass path 624 terminates at the side wall 612 of the neck region 602, and the first path 626 is disposed directly within the vial assembly 580' between the particle region 604 and the neck region 602.

[0062]

[0071] In an embodiment, concentration regulators 664 of different numbers, sizes, and / or locations can be used with the vial assembly 580'. Additionally or alternatively, a filter can be added and positioned in front of the bypass valve 606. The bypass valve 606 can be a one-way or safety valve made of various materials or other suitable valves as described herein, and the concentration regulator 664 can be made of various metals, plastics, hydrogels, and the like. III. List of Aspects

[0072] Aspect 1. The vial assembly system includes a vial assembly and a needle. The vial assembly includes a vial assembly having a septum, a neck region, and a particulate region for containing particulates and having a bypass valve. The neck region includes an upper portion, a lower portion, and a side wall disposed therebetween. The needle includes a port and a tip distal to the port, and the tip is configured to pierce the septum of the vial assembly disposed at the lower portion of the neck region. The septum is configured to receive the needle such that the port is disposed in the neck region of the vial assembly. The bypass path includes a first end and a second end. The bypass valve is connected to the first end of the bypass path, and the second end of the bypass path terminates at or within the side wall of the neck region. The bypass path is configured to provide a fluid flow path to the needle in place of the first path when the pressure of the fluid flow within the vial assembly increases, and the first path is directly disposed within the vial assembly between the particulate region and the neck region.

[0063]

[0073] Aspect 2. The vial assembly system according to Aspect 1, further comprising a concentration regulator disposed between the neck region and the particulate region and configured to limit the concentration of particulates to be sent to the needle along the first path.

[0064]

[0064]

[0074] Aspect 3. The vial assembly system according to Aspect 2, wherein the concentration regulator comprises a mesh component.

[0075] Aspect 4. The vial assembly system according to any one of Aspects 1 to 3, wherein the bypass path is configured to provide a fluid flow path to the needle in place of the first path when the pressure of the fluid flow within the vial assembly increases when particulate accumulation occurs in the concentration regulator.

[0065]

[0065]

[0076] Aspect 5. The vial assembly system according to any one of Aspects 1 to 4, The neck region is a vial assembly system including a cylindrical shape.

[0066]

[0077] Aspect 6. A vial assembly system according to any one of Aspects 1 to 4, The neck region is a vial assembly system including a conical shape.

[0067]

[0078] Aspect 7. A vial assembly system according to any one of Aspects 1 to 6, The bypass valve disposed in the particulate region is further disposed in the dead space region of the particulate region, and the dead space region is defined as a region where the plunger of the vial assembly cannot be pushed distally, and as a result, the plunger cannot be pushed into the dead space region. A vial assembly system.

[0068]

[0079] Aspect 8. A vial assembly system according to any one of Aspects 1 to 7, The port of the needle is configured as an outlet for injecting fluid into the vial assembly and an inlet for delivering the mixed particulate solution from the vial assembly. A vial assembly system.

[0069]

[0080] Aspect 9. A vial assembly system according to any one of Aspects 1 to 8, The first path is directed along the longitudinal axis of the vial assembly, and the bypass path is disposed radially with respect to the longitudinal axis. A vial assembly system.

[0070]

[0081] Aspect 10. A vial assembly system according to any one of Aspects 1 to 9, The bypass path includes a tube disposed between the bypass valve and the side wall of the neck region. A vial assembly system.

[0071]

[0082] Aspect 11. A vial assembly system according to any one of Aspects 1 to 10, The septum is configured to be disposed proximally adjacent to the neck region, and the particulate region is disposed distally adjacent to the neck region, a vial assembly system.

[0072]

[0083] Aspect 12. The vial assembly system includes a vial assembly and a needle. The vial assembly includes a septum, a neck region, and a particulate region for containing particulates, the neck region includes an upper portion, a lower portion, and a side wall disposed therebetween, the needle includes a port and a tip distal to the port, and the tip is configured to pierce the septum of the vial assembly disposed at the lower portion of the neck region. The septum is configured to receive the needle such that the port is disposed in the neck region of the vial assembly. The bypass valve is connected to a bypass path including a first end and a second end. The bypass valve is connected to the first end of the bypass path, and the second end of the bypass path terminates at or within the side wall of the neck region. The bypass path is configured to provide a fluid flow path to the needle in place of a first path when the pressure of the fluid flow within the vial assembly increases, and the first path is disposed directly within the vial assembly between the particulate region and the neck region. The bypass path includes a tube disposed between the bypass valve and the side wall of the neck region, and the tube of the bypass path is disposed radially with respect to the longitudinal axis of the vial assembly.

[0073]

[0084] Aspect 13. The vial assembly system according to Aspect 12, further comprising a concentration regulator disposed between the neck region and the particulate region and configured to limit the concentration of particulates to be sent to the needle along the first path.

[0074]

[0085] Aspect 14. The vial assembly system according to Aspect 13, wherein the concentration regulator comprises a mesh component.

[0086] Aspect 15. The vial assembly system according to any one of Aspects 12 to 14, The bypass path is configured to provide a fluid flow path to the needle as an alternative to the first path when particulate accumulation occurs in the concentration regulator and when the pressure of the fluid flow within the vial assembly increases, a vial assembly system.

[0075]

[0087] Aspect 16. A vial assembly system according to any one of Aspects 12 to 15, The neck region includes a cylindrical shape, a vial assembly system.

[0076]

[0088] Aspect 17. A vial assembly system according to any one of Aspects 12 to 15, The neck region includes a frustoconical shape, a vial assembly system.

[0077]

[0089] Aspect 18. A vial assembly system according to any one of Aspects 12 to 17, The bypass valve disposed in the particulate region is further disposed in the dead space region of the particulate region, and the dead space region is defined as a region where the plunger of the vial assembly cannot be pushed distally, and as a result, the plunger cannot be pushed into the dead space region, a vial assembly system.

[0078]

[0090] Aspect 19. A vial assembly system according to any one of Aspects 12 to 18, The port of the needle is configured as an outlet for injecting fluid into the vial assembly and an inlet for delivering the mixed particulate solution from the vial assembly, a vial assembly system.

[0079]

[0091] Aspect 20. A method of operating a vial assembly system includes receiving a needle within a septum of a vial assembly of the vial assembly system such that a port of the needle is disposed in a neck region of the vial assembly. The vial assembly further includes a particulate region with a bypass valve, the neck region includes an upper portion, a lower portion, and a side wall disposed therebetween, the needle further includes a tip distal to the port, and the tip is configured to pierce a septum of the vial assembly disposed in the lower portion of the neck region. The method further includes monitoring a pressure increase within the vial assembly to determine whether the pressure increase exceeds a threshold value, and alternating a fluid flow path from a first path to a bypass path when the monitored pressure increase exceeds the threshold value. The bypass path includes a first end and a second end, the bypass valve is connected to the first end of the bypass path, the second end of the bypass path ends at or within the side wall of the neck region, and the first path is disposed directly within the vial assembly between the particulate region and the neck region.

[0080]

[0092] Note that the terms “substantially” and “about” may be used herein to represent the inherent degree of uncertainty that may arise from any quantitative comparison, value, measurement, or other representation. These terms may also be used herein to represent the degree to which a quantitative representation may vary from the stated reference without resulting in a change in the basic function of the subject matter in question.

[0081]

[0093] For purposes of explaining and defining the present disclosure, note that the term "substantially" is used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. The term "substantially" is also used herein to represent the degree to which a quantitative expression may vary from the stated reference without resulting in a change in the basic function of the subject matter in question. As such, it is used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation with respect to the arrangement of elements or features that, while theoretically expected to present an exact match or behavior, may in practice embody something that is slightly less than exact.

[0082]

[0094] It is to be understood that while specific embodiments are illustrated and described herein, various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, while various aspects of the claimed subject matter are described herein, such aspects need not be utilized in combination. Accordingly, the appended claims are intended to cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

1. A vial assembly system comprising a vial assembly comprising a septum, a neck region, and a particulate region for containing particulates, the neck region comprising an upper portion, a lower portion, and sidewalls disposed therebetween, and a needle comprising a port and a tip distal to the port, the tip configured to pierce the septum of the vial assembly disposed in the lower portion of the neck region, wherein the septum is configured to receive the needle such that the port is disposed in the neck region of the vial assembly, a bypass path includes a first end and a second end, the bypass valve is connected to the first end of the bypass path, the second end of the bypass path terminates at or within the sidewall of the neck region, and the bypass path is configured to provide a fluid flow path to the needle in place of a first path when the pressure of the fluid flow within the vial assembly increases, the first path being disposed directly within the vial assembly between the particulate region and the neck region, a vial assembly system.

2. The vial assembly system according to claim 1, further comprising a concentration regulator disposed between the neck region and the particulate region and configured to limit the concentration of particulates to be sent to the needle along the first path.

3. The vial assembly system according to claim 2, wherein the concentration regulator comprises a mesh component.

4. The vial assembly system according to claim 2, wherein the bypass path is configured to provide the fluid flow path to the needle in place of the first path when the pressure of the fluid flow within the vial assembly increases when particulate accumulation occurs at the concentration regulator.

5. The vial assembly system according to claim 1, wherein the neck region includes a cylindrical shape.

6. The vial assembly system according to claim 1, wherein the neck region includes a conical shape.

7. The vial assembly system according to claim 1, wherein The bypass valve disposed in the particulate region is further disposed in the dead space region of the particulate region, and the dead space region is defined as a region where the plunger of the vial assembly cannot be pushed distally, and as a result, the plunger cannot be pushed into the dead space region, vial assembly system.

8. A vial assembly system according to claim 1, wherein the port of the needle is configured as an outlet for injecting fluid into the vial assembly and an inlet for delivering the mixed particulate solution from the vial assembly, vial assembly system.

9. A vial assembly system according to claim 1, wherein the first path is directed along the longitudinal axis of the vial assembly, and the bypass path is disposed radially with respect to the longitudinal axis, vial assembly system.

10. A vial assembly system according to claim 1, wherein the bypass path comprises a tube disposed between the bypass valve and the side wall of the neck region, vial assembly system.

11. A vial assembly system according to claim 1, wherein the septum is configured to be disposed proximally adjacent to the neck region, and the particulate region is disposed distally adjacent to the neck region, vial assembly system.

12. A vial assembly system, comprising a vial assembly for containing particulate matter, the vial assembly comprising a septum, a neck region, and a particulate region comprising a bypass valve, the neck region comprising an upper portion, a lower portion, and a side wall disposed therebetween, vial assembly, and a needle comprising a port and a tip distal to the port, the tip being configured to pierce the septum of the vial assembly disposed in the lower portion of the neck region, comprising, wherein the septum is configured to receive the needle such that the port is disposed in the neck region of the vial assembly, The bypass valve is connected to a bypass path including a first end and a second end, the bypass valve is connected to the first end of the bypass path, the second end of the bypass path ends at or within the side wall of the neck region, the bypass path is configured to provide a fluid flow path to the needle as an alternative to a first path when the pressure of the fluid flow within the vial assembly increases, the first path is disposed directly within the vial assembly between the particulate region and the neck region, the bypass path includes a tube disposed between the bypass valve and the side wall of the neck region, and the tube of the bypass path is disposed radially with respect to the longitudinal axis of the vial assembly, vial assembly system.

13. The vial assembly system according to claim 12, further comprising a concentration regulator disposed between the neck region and the particulate region and configured to limit the concentration of the particulate to be sent to the needle along the first path, vial assembly system.

14. The vial assembly system according to claim 13, wherein the concentration regulator includes a mesh component, vial assembly system.

15. The vial assembly system according to claim 13, wherein the bypass path is configured to provide the fluid flow path to the needle as an alternative to the first path when the pressure of the fluid flow within the vial assembly increases when particulate accumulation occurs in the concentration regulator, vial assembly system.

16. The vial assembly system according to claim 12, wherein the neck region includes a cylindrical shape, vial assembly system.

17. The vial assembly system according to claim 12, wherein the neck region includes a frustoconical shape, vial assembly system.

18. The vial assembly system according to claim 12, wherein the bypass valve disposed in the particulate region is further disposed in a dead space region of the particulate region, and the dead space region is defined as a region into which the plunger of the vial assembly cannot be pushed distally, and as a result, the plunger cannot be pushed into the dead space region, vial assembly system.

19. The vial assembly system according to claim 12, wherein the port of the needle is configured as an outlet for injecting fluid into the vial assembly and an inlet for delivering the mixed particulate solution from the vial assembly, a vial assembly system.

20. A method of operating a vial assembly system, receiving a needle into a septum of a vial assembly of the vial assembly system such that a port of the needle is disposed in a neck region of the vial assembly, wherein the vial assembly further comprises a particulate region with a bypass valve, the neck region comprises an upper portion, a lower portion, and a side wall disposed therebetween, the needle further comprises a tip distal to the port, and the tip is configured to pierce the septum of the vial assembly disposed in the lower portion of the neck region; monitoring an increase in pressure within the vial assembly to determine whether the increase in pressure exceeds a threshold value; alternating a fluid flow path from a first path to a bypass path when the monitored increase in pressure exceeds the threshold value, the bypass path including a first end and a second end, the bypass valve being connected to the first end of the bypass path, the second end of the bypass path terminating at or within the side wall of the neck region, and the first path being disposed directly within the vial assembly between the particulate region and the neck region; A method comprising.

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