Vial geometries for optimal mixing

Abstract

To provide vial assembly components of medical devices configured to deliver radioactive compounds to a treatment area within a body.SOLUTION: A vial assembly includes a vial and a needle with at least one port. The vial includes a particulate material, a septum, a neck region including a first width, and a particulate region including a second width greater than the first width. The vial assembly is configured to move to a locked position. The needle may be configured to puncture the septum with the at least one port configured to be in the neck region when in the locked position. The at least one port may be configured to inject a fluid into the vial assembly to mix with the particulate material upon actuation of a vial engagement mechanism in a first direction and to receive a resulting mixed fluid from the vial assembly upon actuation of the vial engagement mechanism in a second direction opposite the first direction.SELECTED DRAWING: Figure 12A

Description

Technical Field

[0001]

[0001] This disclosure generally relates to components of medical devices for treating cancer, and more particularly to vial assembly components of medical devices configured and operable to deliver a radioactive compound to a treatment area within a patient's body in a procedure 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 patients or healthcare workers 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 transcatheter intra - arterial procedure performed under imaging, and is generally used for the treatment of malignant tumors. During this medical procedure, a microcatheter 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.

Summary of the Invention

Problems to be Solved by the Invention

[0004]

[0004] Generally, vial assembly components that operate with a syringe for manually administering a radioactive compound are prone to inconsistent flow rates and pressures resulting from mixing within the vial, allowing particles to remain and settle and not be fully mixed with the fluid within the vial. Such settling may require cleaning of the vial assembly components and / or connected components, which can cause insufficient injection rates and / or inefficient delivery, resulting in reduced bead dispersion. Such reduced bead dispersion can affect the efficacy of the treatment.

[0005]

[0005] Accordingly, there is a need for a vial assembly component of a medical device that is configured to and operable to perform radioembolization therapy that incorporates a simple design and consistent means for delivering a radioactive compound at a constant flow rate and pressure while preventing or reducing particle settling during such mixing and delivery to a patient's body.

Means for Solving the Problem

[0006]

[0006] According to an embodiment of the present disclosure, a vial assembly may include a vial and a needle. The vial may include a particulate material, a septum, a neck region including a first width, and a particulate region including a second width greater than the first width. The needle may include at least one port. The vial assembly may be configured to move to a locked position, and the needle is configured to pierce the septum of the vial assembly when the vial assembly is in the locked position. The at least one port is further configured to be within the neck region of the vial assembly when the vial assembly is in the locked position. The at least one port is configured to inject fluid into the vial assembly for mixing with the particulate material upon actuation of the vial engagement mechanism in a first direction and to receive the resulting mixed fluid from the vial assembly upon actuation of the vial engagement mechanism in a second direction opposite the first direction.

[0007]

[0007] In another embodiment, the vial may include a particulate material, a septum, a neck region, a particulate region, and an outer wall. The neck region may include a first width of the neck region. The neck region may be conical in shape. The particulate region may include a second width that is greater than the first width. The outer wall may include an outer wall width, a particulate region thickness between the outer wall and the particulate region, and a neck region thickness between the outer wall and the neck region. The neck region thickness may be greater than the particulate region thickness.

[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] A partial cross-sectional view of the vial assembly of FIG. 4 taken along line 4-4 of FIG. 3.

Figure 5

[0013] A perspective view of the vial slider of FIG. 1 with the vial assembly of FIG. 3 received therein with a series of delivery conduits coupled to the vial slider, according to one or more embodiments shown and described herein.

Figure 6

[0014] A perspective view of the vial slider of FIG. 1 with the vial assembly of FIG. 3 inserted therein, according to one or more embodiments shown and described herein.

Figure 7A

[0015] A partial cross-sectional view taken along line 7-7 of FIG. 6 of the vial assembly of FIG. 3 inserted into the vial sliding portion of FIG. 3 in the initial locking position.

Figure 7B

[0016] A partial cross-sectional view taken along line 7-7 of FIG. 5 of the vial assembly of FIG. 3 inserted into the vial sliding portion of FIG. 1 in the fully locked position.

Figure 8

[0017] A partial perspective view of the vial sliding portion coupled to the delivery device of FIG. 1 with the lever arm coupled to the vial assembly of FIG. 3 according to one or more embodiments shown and described in the present invention.

Figure 9

[0018] A perspective view of the vial sliding portion coupled to the delivery device of FIG. 1 with the lever arm coupled to the vial assembly of FIG. 3 and translated to the extended position according to one or more embodiments shown and described in the present invention.

Figure 10

[0019] A perspective view of the vial sliding portion coupled to the delivery device of FIG. 1 with the lever arm coupled to the vial assembly of FIG. 3 and translated to the lower position according to one or more embodiments shown and described in the present invention.

Figure 11A

[0020] A perspective view of the vial according to one or more embodiments shown and described in the present invention.

Figure 11B

[0021] A side view of the vial of FIG. 11A.

Figure 11C

[0022] A detailed view of the proximal edge of the proximal end of the vial of FIG. 11B.

Figure 11D

[0023] An upper distal view of the vial of FIG. 11A.

Figure 12A

[0024] A cross-sectional view of the vial of FIG. 11A taken along line 12A-12B of FIG. 11B.

Figure 12B

[0025] A detailed view of the neck region of the vial of FIG. 12A at the distal end.

Figure 12C

[0026] It is a proximal view near the bottom of the vial of FIG. 12A.

Figure 12D

[0027] It is an elevation view of a vial assembly including a vial of FIG. 12A, a needle disposed within the neck region of the vial, and a mixed fluid within the vial, with the needle in a first position, according to one or more embodiments shown and described in the present invention.

Figure 12E

[0028] It is a view showing the vial assembly of FIG. 12D with the needle in a second position.

Figure 12F

[0029] It is a view showing the vial assembly of FIG. 12D with the needle in a third position.

Figure 13A

[0030] It is a cross-sectional view taken along line 12A-12B of FIG. 11B of another embodiment of the vial of FIG. 11A, according to one or more embodiments shown and described in the present invention.

Figure 13B

[0031] It is a detailed view of the neck region of the vial of FIG. 13A at the distal end.

Figure 13C

[0032] It is a proximal view near the bottom of the vial of FIG. 13A.

Figure 13D

[0033] It is an elevation view of a vial assembly including a vial of FIG. 13A, a needle disposed within the neck region of the vial, and a mixed fluid within the vial, with the needle in a first position, according to one or more embodiments shown and described in the present invention.

Figure 14A

[0034] It is a cross-sectional view taken along line 12A-12B of FIG. 11B of another embodiment of the vial of FIG. 11A, according to one or more embodiments shown and described in the present invention.

Figure 14B

[0035] It is a detailed view of the neck region of the vial of FIG. 14A at the distal end.

Figure 14C

[0036] It is a proximal view near the bottom of the vial of FIG. 14A.

Figure 14D

[0037] An elevation view of a vial assembly according to one or more embodiments shown and described herein, including the vial of FIG. 14A, a needle disposed within the neck region of the vial, and a mixed fluid within the vial, with the needle in a first position.

Figure 14E

[0038] An elevation view of a vial assembly according to one or more embodiments shown and described herein, including another conical embodiment of the vial of FIG. 14A, a needle disposed within the neck region of the vial, and a mixed fluid within the vial, with the needle in a first position.

Figure 15A

[0039] A cross-sectional view taken along line 12A-12B of FIG. 11B of one other embodiment of the vial of FIG. 11A according to one or more embodiments shown and described herein.

Figure 15B

[0040] A detailed view of the neck region of the vial of FIG. 15A at the distal end.

Figure 15C

[0041] A lower proximal view of the vial of FIG. 15A.

Figure 16

[0042] A graph of the amount of remaining microspheres versus injection volume over time for the vial assemblies of FIGS. 12D, 13D, 14D, and 14E according to one or more embodiments shown and described herein.

Figure 17

[0043] A graph of the volume of remaining microspheres versus injection volume over time for the vial assemblies of FIGS. 12D, 13D, 14D, and 14E according to one or more embodiments shown and described herein.

Best Mode for Carrying Out the Invention

[0010]

[0044] With this, various embodiments of a delivery device for administering a radioactive compound to a patient are described in detail, examples of these embodiments being illustrated in the accompanying drawings. Where possible, the same reference numbers are used throughout the drawings to refer to the same or similar parts. As used herein, directional terms such as up, down, right, left, front, back, top, bottom, distal, and proximal are used only in relation to the figures as depicted and are not intended to imply an absolute orientation.

[0011]

[0045] 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, when values are expressed as approximations by use of the antecedent “about,” it is to be understood that the particular value forms another embodiment. It is further to be understood that each of the endpoints of a range is significant both in relation to the other endpoint and independently of the other endpoint. Unless otherwise expressly stated, no method described herein is intended to require that its steps be performed in a particular order or that any device-specific orientation be required. Thus, unless the method claims actually recite the order in which its steps are to be performed, or the apparatus claims actually recite an order or orientation for individual components, or the steps are otherwise specifically recited in the claims or description as being limited to a particular order, or the order or orientation of the components of the apparatus is otherwise recited, no order or orientation is to be inferred in any way. This applies to any possible ambiguity in interpretation, including logical matters, grammatical mechanisms or punctuation derived 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 herein.

[0012]

[0046] ​

[0013]

[0047] 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]

[0048] As used herein, the terms "horizontal", "vertical", "distal", and "proximal" are merely relative terms and merely indicate an overall relative orientation and do not necessarily indicate perpendicularity. These terms may also be used for convenience to refer to the orientation used in the figures, such orientation being used merely as a convention and not as an intended characteristic of the device shown. The present disclosure and its embodiments to be described herein may be used in any desired orientation. Further, horizontal and vertical walls generally merely need to 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 indicates otherwise. Thus, for example, reference to "a" component includes aspects having two or more such components unless the context clearly indicates otherwise.

[0015]

[0049] In the 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 area 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., microparticles) 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 the mixed solution, such as from a syringe or catheter line, and as an inlet for delivering the mixed solution to the patient.

[0016]

[0050] Figures 1-10 described below are directed to embodiments of a delivery device 500 for delivering microparticles 660, and Figures 11A-17 described in more detail below are directed to embodiments of one or more vials 600 that may be utilized, for example, with a delivery device 600 for delivering microparticles 660 as a vial containing microparticles 660. In some embodiments, as described in more detail below, the delivery device 500 is a radioembolization delivery device and the microparticles 660 are a plurality of radioembolization beads Further, the fluid is a physiological saline aqueous solution, and the resulting mixed fluid (e.g., mixed fluid solution) is a radioembolization bead - physiological saline aqueous solution. The needle 559 can be configured to deliver the radioembolization bead - physiological saline aqueous solution as a mixed fluid solution through the radioembolization delivery device, such as during the operation of the vial engagement mechanism 520 in the positive pressure direction. In some embodiments, the fluid is a contrast agent - physiological saline aqueous solution containing a contrast agent, and the resulting mixed fluid (e.g., mixed fluid solution) is a radioembolization bead - contrast agent - physiological saline aqueous solution. The needle 559 can be configured to deliver the radioembolization bead - contrast agent - physiological saline aqueous solution as a mixed fluid solution 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 fluid solution is a bead - physiological saline aqueous solution or a bead - contrast agent - physiological saline aqueous solution. I. Mechanical delivery device having a removable sliding portion assembly

[0051] Figures 1 - 10 illustrate embodiments of a delivery device 500 configured and operable to deliver radioactive material (e.g., radioembolization beads) while reducing radiation emission during use of the delivery device 500. The delivery device 500 operates as described in International PCT Application No. PCT / 2019 / 033001, filed May 17, 2019, which is incorporated herein by reference in its entirety, except with respect to the vial 600 utilized with the delivery device 500, and as described in more detail below with respect to Figures 11A - 17, and as may be described in one or more embodiments within this specification.

[0017]

[0052] Referring initially to FIG. 1, the delivery device 500 includes 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.

[0018]

[0053] 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.

[0019]

[0054] 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 the console assembly 510 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.

[0020]

[0055] The console assembly 510 includes a mechanical assembly disposed within the base 512 and configured and operable to convert the manual movement of the handle 528 into a 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 52 0 at the distal end 516.

[0021]

[0056] The sliding space 532 is sized and shaped to receive the sliding portion assembly 540 therein. As will be described in more detail herein, the sliding portion assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, media) therethrough. In particular, the sliding portion assembly 540 is configured to partially receive the vial assembly 580 therein for administering therapeutic particles from the delivery device 500 to the patient during a procedure.

[0022]

[0057] 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 and configured to measure the amount of fluid (e.g., a suspension after the therapeutic particles are effectively mixed with the 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 the outside of the console assembly 510 and, in particular, from the vial receiving region 518.

[0023]

[0058] A pair of lever arms 522 are movable simultaneously with the neck 524 of the vial engagement mechanism 520 in response to the 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.

[0024]

[0059] 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 thereto. 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 the emission of radiation from one or more radiation doses stored within the vial receiving region 518.

[0025]

[0060] 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 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.

[0026]

[0061] 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 media) from the delivery device 500 to the patient. In particular, the slider 540 includes a proximal end 542 and a distal end 544, and a pair of side walls 546 extend therebetween. The proximal 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 proximal 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 includes at least one positioning rib 554 extending laterally outward therefrom, and the positioning rib 554 is sized and shaped to fit and mate with the pair of positioning portions 534 of the console assembly 510. Thus, the pair of positioning ribs 554 is configured to facilitate the alignment and engagement of the slider 540 with the console assembly 510 when the distal end 544 is slidably received within the sliding space 532 of the base 512.

[0027]

[0062] The sliding body 540 further includes an upper surface 548 that extends from a proximal end 542 and a distal 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 540. The priming assembly 560 serves to purge air from the delivery device 500 prior to utilizing the delivery device 500 in a procedure.

[0028]

[0063] 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 an aperture formed by the locking system 550 along the upper surface 548, in particular. 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. The annular array of protrusions 551 included in the locking system 550 engages corresponding locking features 586 (see FIG. 3) of the vial assembly 580 and is thereby configured to securely hold the vial assembly 580 to the sliding body 540. It should be understood that the plurality of rows of protrusions 551 of the locking system 550 serve to provide a double locking system to ensure that the sliding assembly 540, and in particular the needle 559 of the sliding assembly 540, is securely maintained through the septum 592 (see FIG. 3) of the vial assembly 580 during use of the delivery device 500 in a procedure.

[0029]

[0064] Slide 540 further includes a vial chamber 558 that is sized and shaped to receive priming assembly 560 and vial assembly 580 therein, respectively. In other words, vial chamber 558 is sized to receive both priming assembly 560 and vial assembly 580 individually and separately from one another. Vial chamber 558 is enclosed in a protective chamber or shield 557 that is disposed around vial chamber 558. Protective shield 557 may be made of, for example, a material such as metal. Slide 540 is formed of a material configured to inhibit radiation emissions from escaping outward from vial chamber 558. Additionally, slide 540 includes a needle along the bottom end of vial chamber 558 that extends through protective shield 557 and into vial chamber 558. Needle 559 is securely secured to vial chamber 558 such that any device received through the aperture in locking system 550 and into vial chamber 558 will contact and interact with needle 559 (e.g., priming assembly 560, vial assembly 580, and the like).

[0030]

[0065] 2, needle 559 is coupled to distal manifold 555A and proximal manifold 555B disposed within slide 540; in particular, manifolds 555A, 555B are positioned below vial chamber 558 and protective shield 557. Proximal manifold 555B is fluidly coupled to needle 559, and distal manifold 555A is fluidly coupled to one or more ports 556 of slide 540. Proximal manifold 555B is in fluid communication with distal manifold 555A through one-way check valve 553 disposed therebetween.

[0031]

[0066] 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 one or more ports 556 and via the manifolds 555A, 555B fixed therebetween. One or more ports 556 of the slider assembly 540 can be coupled to a bag (e.g., a saline bag), syringe, catheter, and / or the like via one or more delivery conduits coupled thereto. In other embodiments, the needle 559 can be a cannula, catheter, or similar mechanism through which fluid and / or solution is injected and received as described herein.

[0032]

[0067] Still referring to FIG. 2, the slider 540 includes a removable battery pack 570 coupled to the slider 540 along the distal 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 one or more fluid channels and the radiation source due to the location of the battery 572 within the removable battery pack 570.

[0033]

[0068] 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 particularly to the console assembly 510, when the slider 540 is coupled to the console assembly 510.

[0034]

[0069] In addition, as will be described in more detail herein, in some embodiments, the locking system 550 can 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 rather 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 at least one planar wall, such that as a result, the vial assembly 580 is the vial assembly 58 0 is received within the slider 540 only when the orientation of 0 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.

[0035]

[0070] 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 are slidably translatable 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 internal 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.

[0036]

[0071] 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 locking feature 586 and the engagement head 582 and the plunger 584 from 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 will be 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.

[0037]

[0072] 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 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 the application of a linear force to the plunger 584 for translating the plunger 584 relatively downward into the vial body 589. In this case, the safety tab 585 is configured to inhibit 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 responsive to the coupling of the vial assembly 580 and the vial engagement mechanism 520 and, in particular, the engagement of the pair of lever arms 522 and the engagement head 582 and is selectively removed from the plunger 584 in response thereto.

[0038]

[0073] 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 includes a bushing (bearing cylinder) that defines a side edge 587 that extends laterally outward 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 attach 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 alignment of the planar walls 550A and 586A requires the vial assembly 580 to be received through an aperture formed by the locking system 550.

[0039]

[0074] 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 at least a portion of the longitudinal length of the plunger 584 therein. By way of example only, the longitudinal length of the vial body 589 can be from about 8 millimeters to about 10 millimeters, and in this example includes 9 millimeters, while the longitudinal length of the plunger 584 can be from about 9 millimeters to about 11 millimeters, and in this example includes 10 millimeters. Thus, in some embodiments, the longitudinal length of the plunger 584 exceeds the longitudinal length of the vial body 589, such that translation of the plunger 584 into the inner chamber 588 of the vial body 589 causes the fluid medium stored therein to be sent out of the vial body 589. As will be described in more detail herein, translation of the plunger 584 through the inner 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.

[0040]

[0075] The vial body 589 of this example is formed of a material configured to suppress radiation emission from a fluid medium stored in 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 may have a width of approximately 9 millimeters (mm). The combination of the density and material composition of the vial body 589 enables suppression of beta radiation emission from electron particles stored in 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 the radioactive material stored in the vial body 589 without being exposed to beta radiation. It should be understood that in other embodiments, various other materials and / or wall regions may be incorporated within the vial body 589 of the vial assembly 580 without departing from the scope of the present disclosure.

[0041]

[0076] Still referring to FIG. 3, the vial body 589 of the vial assembly 580 It is sealed at the first end 598 by the locking feature 586. The vial assembly 580 further includes a cap 590 positioned at the opposite end of the vial body 589 from the locking feature 586, such that the cap 590 seals the second end of the vial body 589 of the vial assembly 580. Additionally, the vial assembly 580 includes a septum 592, which is positioned adjacent to the cap 590 and in fluid communication with the end of the vial body 589 opposite the locking feature 586. The septum 592 forms a seal against the end 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 the release of a fluid medium (e.g., radiation embolization beads) stored therein. As 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 be used.

[0042]

[0077] 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.

[0043]

[0078] The stopper 594 is configured to form a liquid-tight seal with respect to the internal chamber 588 of the vial body 589 and is formed of various polymers having a predetermined viscoelasticity. For example, in some embodiments, the stopper 594 is formed of elastomers, silicones, rubbers, urethanes, plastics, 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 depressions 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 depressions 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.

[0044]

[0079] 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., towards the cap 590) within the vial body 589 in response to the translational movement of the plunger 584. The ribs 593 of the stopper 594 are in the internal cha of the vial body 589 With respect to the number 588 being pressed, the translational movement of the plunger 584 causes the translational movement of the rib 593 with respect to and along the internal chamber 588 of the vial body 589. As a result, 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, and this stopper 594 is fixed to the plunger 584 at the opposite end of the engagement head 582. Accordingly, 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.

[0045]

[0080] 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 dose 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 dose 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 dose 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 dose 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 dose delivery conduit 10A. Thus, the fluid medium is ultimately received and disposed (or processed therein) in the collection bowl by the dose delivery conduit 10A.

[0046]

[0081] Since the distal manifold 555A of the slider 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 to 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 conduit 10A. In this case, the dose delivery conduit 10A receives the fluid medium and transports it 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 in fluid communication with the needle 559.

[0047]

[0082] 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 medium supply, such as a bag secured 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 medium 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 retracted, whereby saline is drawn from the saline bag, through the contrast agent conduit 10B, the contrast agent Saline is drawn into the syringe through port 556B, slider 540, and priming conduit 562. The plunger of the syringe is then pushed inward to send the drawn saline in the opposite direction through priming conduit 562, central body portion 564, elongated shaft 566, and the needle tip of priming assembly 560. As a result, the saline is received into needle 559 of slider 540. Thus, manifolds 555A, 555B of slider 540 are effectively primed with saline from the syringe because needle 559, which has received saline from priming assembly 560, is in fluid communication with manifolds 555A, 555B. Since manifolds 555A, 555B are in further fluid communication with dose delivery line 10A via delivery port 556A, the saline is effectively supplied to the collection bowl coupled to dose delivery line 10A.

[0048]

[0083] Referring now to FIG. 5, slider 540 is coupled to one or more external devices through one or more ports 556. In particular, slider 540 is fluidly coupled to a catheter (e.g., a microcatheter) through dose delivery line 10A coupled to delivery port 556A of slider 540. In this case, the catheter is in fluid communication with slider 540 through dose delivery line 10A. Further, at step 718, slider 540 is fluidly coupled to a contrast agent source, such as a saline bag that is secured to console assembly 510 via, for example, mounting device 538 (see FIG. 1). Slider 540 is in fluid communication with the saline bag through contrast agent conduit 10B coupled to contrast agent port 556B of slider 540. In this case, the saline bag is in fluid communication with slider 540 through contrast agent conduit 10B secured to contrast agent port 556B.

[0049]

[0084] 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, the physiological saline from the physiological saline bag can be drawn into the vial body 589 of the vial assembly 580 through the needle 559 of the slider 540.

[0050]

[0085] Referring now to FIG. 6, the vial assembly 580 is slidably inserted into the slider assembly 540. The cap 590 of the vial assembly 580 is inserted through an aperture defined by a locking system 550 on the upper surface 548 of the slider 540, and the vial assembly 580 is gradually inserted therethrough until the locking feature 586 contacts the locking system 550.

[0051]

[0086] Referring now to FIG. 7A, the vial assembly 580 is shown as being disposed within the vial assembly 580. In particular, the vial body 589 is inserted into the vial chamber 558 together with the cap 590 positioned adjacent to the needle 559. In this case, the side edge 587 of the locking feature 586 contacts or abuts against the first row of annularly arranged protrusions 551 of the locking system 550. Continued advancement of the vial assembly 580 into the slider 540 bends the annularly arranged protrusions 551 positioned along the first row outward in response to the force generated thereon by the side edge 587. In other words, the side edge 587 of the locking feature 586 presses the annularly arranged protrusions 551 outward in response to the vial assembly 580 being received within the vial chamber 558.

[0052]

[0087] When the annularly arranged protrusions 551 of the locking system 550 bend outward with respect to the side edge 587 disposed therein, the continuous translational movement of the vial assembly 580 into the vial chamber 558 causes the side edge 587 of the locking feature 586 to advance beyond the first row of the annularly arranged protrusions 551, as a result of which the force applied thereto from the side edge 587 is removed. In this case, the annularly arranged protrusions 551 along the first row can bend inward and return to their initial positions, with the side edge 587 positioned below the first row of the protrusions 551. In some embodiments, when the side edge 587 extends through the annularly arranged protrusions 551, feedback is generated by the annularly arranged protrusions 551 (e.g., an audible click sound), thereby indicating to the operator that the vial assembly 580 is engaged with the locking system 550. Thus, with the first row of the protrusions 551 positioned to cover the side edge 587 of the locking feature 586, the locking system 550 prevents the vial assembly 580 from being pulled out of the vial chamber 558 of the slider 540 due to the obstacle formed by the first row of the protrusions 551. In this case, the needle 559 is positioned relative to and / or received through the cap 590, but does not contact the septum 592.

[0053]

[0088] Referring now to FIG. 7B, the continuous translational movement of the vial assembly 580 into the vial chamber 558 of the slider 540 will cause subsequent engagement between the side edge 587 of the locking feature 586 and the locking system 550. In particular, the side edge 587 engages the second row of the annularly arranged protrusions 551 of the locking system 550. The continuous advancement of the vial assembly 580 into the slider 540 causes the protrusions 551 positioned along the second row to bend outward in response to the application of the force generated thereon by the side edge 587. As the side edge 587 advances past the protrusions 551, the side edge 587 presses the protrusions 551 outward until the side edge 587 of the locking feature 586 advances beyond the second row of the protrusions 551 to reach the locking position L (FIG. 12D).

[0054]

[0089] In this case, the force applied from the side edge 587 is removed, and the annularly arranged protrusions 551 along the second row can bend inward and return to their initial positions, with the side edge 587 positioned below the second row of protrusions 551. Thus, since the second row of protrusions 551 is positioned to cover the side edge 587 of the locking feature 586, the locking system 550 prevents the vial assembly 580 from being pulled out of the vial chamber 558 of the slider 540 due to the obstacle formed by the second row of protrusions 551. In this case, at the locking position L, the needle 559 is positioned relative to and received through the cap 590 and the septum 592. More specifically, the needle 559 pierces the septum 592 of the vial assembly 580, and as a result, the slider 540 is in fluid communication with the vial body 589 of the vial assembly 580 through the needle 559.

[0055]

[0090] Referring now to FIGS. 1 and 8, with the vial assembly 580 firmly coupled to the slider 540, the slider 540 is coupled to the console assembly 510 by translating the proximal end 542 of the slider 540 toward and into the distal end 516 of the console assembly 510. In particular, the proximal 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 distal end 544 and the proximal end 542 of the slider 540 are completely sealed 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, whereby the console assembly 510 of the delivery device 500 is activated. 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.

[0056]

[0091] Referring back to FIG. 8, with the distal end 544 of the slider 540 being completely sealed within the sliding space 532 and the vial engagement mechanism 520 translated to the lower position, the pair of levers arm 522 engages the safety tab 585 of the vial assembly 580, thereby disengaging the safety tab 585 from the plunger 584. In other words, when the slider 540 is translated into the sliding space 532 in response to a force applied along the handle 552 at the proximal end 542, the position of the lever arm 522 of the vial engagement mechanism 520 is aligned with and joined to the safety tab 585 of the vial assembly 580. Thus, continued translational movement of the slider 540 into the sliding space 532 results in detachment of the safety tab 585 from the plunger 584 by the pair of lever arms 522. In this case, the plunger 584 of the vial assembly 580 is not prevented from translating into and / or out of the internal chamber 588 of the vial body 589 in response to actuation of the vial engagement mechanism 520 coupled thereto.

[0057]

[0092] Referring now to FIG. 9, the handle 528 of the console assembly 510 is actuated (e.g., translated relatively downward), thereby moving the vial engagement mechanism 520 within the vial receiving region 518 distally away from the sliding space 532 and the slider 540 received therein (e.g., translating linearly). In this case, since the pair of lever arms 522 of the vial engagement mechanism 520 are positioned around the plunger 584 of the vial assembly 580, the translational movement of the neck 524 and the pair of lever arms 522 causes the pair of lever arms 522 to engage the engagement head 582, and particularly the lower ends of the pair of arms 581. Removal of the safety tab 585 enables the plunger 584 to move upward and out of the vial body 589 of the vial assembly 580 in response to the translational movement of the vial engagement mechanism 520. Thus, the plunger 584 translates upward simultaneously with the translational movement of the vial engagement mechanism 520 due to the pair of arms 581 of the engagement head 582 being pulled upward by the pair of lever arms 522 in response to actuation of the handle 528.

[0058]

[0093] In this case, the pair of lever arms 522 of the vial engagement mechanism 520 are not firmly coupled to the pair of arms 581 of the engagement head 582. Rather, the pair of lever arms 522 are merely positioned below the pair of arms 581, such that as a result of the translational movement of the neck 524 of the vial engagement mechanism 520, the pair of lever arms 522 abut against and upwardly pull on the pair of arms 581. When the vial engagement mechanism 520 relatively upwardly pulls the plunger 584 of the vial assembly 580 within the vial receiving region 518, it should be understood that the annularly arranged protrusions 551 of the locking system 550 suppress the movement and / or upward translational movement of the vial assembly 580, and in particular the vial body 589, from the vial chamber 558 of the slider 540. Additionally, when the vial engagement mechanism 520 relatively upwardly pulls the vial assembly 580 stored within the slider 540 within the vial receiving region 518, it should be further understood that the positioning portion 534 of the console assembly 510 suppresses the movement and / or upward translational movement of the slider 540 from the sliding space 532 of the console assembly 510.

[0059]

[0094] Still referring to FIG. 9, continued operation of the handle 528 of the console assembly 510 causes continued translational movement of the vial engagement mechanism 520 and, as a result, the plunger 584 until the annular washer 596 comes to the position of the locking feature 586 (see FIG. 4). In this case, the annular washer 596 prevents further translation of the plunger 584 relative to the vial body 589 despite continued operation of the handle 528 of the console assembly 510. When the annular washer 596 of the vial assembly 580 abuts against the locking feature 586, thereby suppressing further translation of the plunger 584 out of the inner chamber 588 of the vial body 589 (and the aperture formed by the locking system 550), continued operation of the handle 528 causes the pair of arms 581 of the engagement head 582 to bend outward relative to the plunger 584. This is due to the upward force applied thereto by the pair of lever arms 522 in response to the vial engagement mechanism 520 translating upward and the plunger 584 being suppressed from moving further. This is the case.

[0060]

[0095] In other words, with the pair of lever arms 522 being pressed against the pair of arms 581 of the engagement head 582, continued translational movement of the neck 524 of the vial engagement mechanism 520 translates the pair of lever arms 522 upward, thereby applying a force to the pair of arms 581 of the engagement head 582. Since the engagement head 582 is integrally formed with the plunger 584 and the plunger 584 is suppressed from translating further relative to the vial body 589 due to an obstacle formed between the annular washer 596 and the locking feature 586, the pair of arms 581 of the engagement head 582 are flexibly deformed to expand outwardly so as to receive the upward translational movement of the pair of lever arms 522. As a result, the pair of lever arms 522 of the vial engagement mechanism 520 are firmly coupled to the pair of arms 581 of the engagement head 582 by snap engagement, thereby locking the vial engagement mechanism 520 to the vial assembly 580.

[0061]

[0096] 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, when the vial body 589 is pre-filled with a radioactive fluid medium (e.g., radiation embolization microspheres), the saline is drawn in by the plunger 584 from the internal chamber 588, and when a negative pressure is generated through the delivery device 500, it is effectively mixed with the radioactive fluid medium within the vial body 589.

[0062]

[0097] Referring now to FIG. 10, actuation of the handle 528 in the opposite direction (e.g., translated downwardly and / or pivoted relative to the base 512) results in simultaneous movement (e.g., linear translational movement) of the vial engagement mechanism 520. In this case, the neck 524 translates downwardly towards the sliding space 532, thereby translating the plunger 584 into the vial body 589 due to the firm engagement between the pair of arms 581 of the engagement head 582 and the pair of lever arms 522 of the vial engagement mechanism 520. Since the stopper 594 is movably disposed within the vial body 589, the translational movement of the plunger 584 causes a simultaneous translational movement of the stopper 594 through the vial body 589, thereby generating a positive pressure therein. As a result, the dose of the saline and radioactive fluid medium mixture stored within the internal chamber 588 is transported out of the vial body 589 through the needle 559 and into the proximal manifold 555B. Since the one-way check valve 553 is configured to allow fluid communication from the proximal manifold 555B to the distal manifold 555A, this dose is delivered therethrough and into the dose delivery conduit 10A via the dose delivery port 556A.

[0063]

[0098] Referring back to FIG. 5, the slider 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 located therein. Thus, the dose is directed to the dose delivery port 556A and is 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 slider 540 and / or the vial assembly 580 coupled thereto. Prevent backflow of fluid. II. Vial Assembly Embodiment

[0099] As briefly described above, the delivery device 500 described herein may include a vial assembly 580, embodiments of which are described in more detail below with respect to FIGS. 11A-17. Referring to FIG. 11A, a vial 600 is shown. The vial includes a vial body 602 disposed between a distal end 604 and a proximal end 606. The distal end 604 includes an upper distal surface 608 that defines an aperture 609.

[0064]

[0100] Referring to FIG. 11B, the proximal end 606 includes a lower proximal surface 610. The vial body 602 includes a length 612 disposed between the distal end 604 and the proximal end 606. In an embodiment, the length 612 is 8.3693 cm (3.295 inches).

[0065]

[0101] Furthermore, the distal end 604 includes a lip thickness 614 and an edge thickness 616 of the lip. As shown in the detailed view in FIG. 11C of the proximal edge of the distal end 604 having an edge thickness 616, a curved ledge below the proximal edge includes a radius of curvature 618. In an embodiment, the lip edge extending from the upper distal surface 608 may extend at a 45-degree angle to reach the lip, the lip thickness 614 may be 0.039 inches, and the curved ledge radius of curvature 618 may be 0.020 inches. Referring to FIG. 11D, the distal end 604, including the upper distal surface 608, includes a diameter 620. In an embodiment, the diameter 620 may be 1.299 inches.

[0066]

[0102] Referring to FIG. 12A, along line 12A-12A of vial 600 of FIG. 11B 11A , taken through a cross-sectional view of the embodiment of vial 600 is shown as vial 600A. Vial 600A includes a distal sidewall 622 along distal end 604 and a proximal sidewall 624 along proximal end 606. Proximal sidewall 624 defines an aperture, for example, one or more fastener features 626 configured to receive a fastener to retain septum 592 to vial 600A at proximal end 606. Distal sidewall 622 defines a particulate region 628 inside vial 600A. Proximal sidewall 624 defines a neck region 630A and a septum region 632 inside vial 600A. Septum region 632 is configured to retain septum 592.

[0067]

[0103] Particulate region 628 is co-aligned with longitudinal axis 636 of vial 600A. It has a microparticle region length 634. The microparticle region 628 and the neck region 630A are connected via a connecting wall angled at an angle 638 with respect to the longitudinal axis 636. The first distal portion of the connecting wall has a radius of curvature 640, and the second more distal portion of the connecting wall has a radius of curvature 642A. In an embodiment, the microparticle region length 634 is 7.33044 cm (2.886 inches), the angle 638 is 63 degrees, the radius of curvature 640 is 0.254 cm (0.10 inch), and the radius of curvature 642A is 0.2032 cm (0.08 inch). The aperture 609 of the upper distal surface 608 can have a diameter of 1.44272 cm (0.568 inch) in the range of plus or minus approximately 0.00508 cm (0.002 inch).

[0068]

[0104] In FIG. 12B, the neck region 630A of the vial 600A is shown in more detail thereof. The neck region 630A includes a diameter 644A. The septum region 632 includes an inner diameter 646A, an outer diameter 648, a septum region thickness 650, and a septum region radius of curvature 652. In an embodiment, the diameter 644A of the neck region 630A is 0.508 cm (0.200 inch), the inner diameter 646A of the septum region 632 is 0.67056 cm (0.264 inch), and the outer diameter 648 of the septum region 632 is 1.4224 cm (0.560 inch). The septum region thickness 650 can be 0.0889 cm (0.035 inch) in the range of plus or minus 0.00508 cm (0.002 inch). The radius of curvature 652 can be 0 .0254 cm (0.01 inch).

[0069]

[0105] A further detailed view of the septum region 632 in FIG. 12B shows a septum buffer region configured to provide cushioning to the septum 592 within the septum region 632 The septum buffer region includes a buffer thickness 654 of the connecting buffer wall between the first buffer wall and the second buffer wall, and a buffer angle 656 of the connecting buffer wall. In an embodiment, the buffer thickness 654 can be 0.0127 cm (0.005 inch), and the buffer angle 656 can be 30 degrees.

[0070]

[0106] Referring to FIG. 12C, the proximal end 606 of vial 600A including the proximal surface 610 is shown. A lower proximal view is shown. The proximal surface 610 defines a fastener spacing diameter 658. In an embodiment, the fastener spacing diameter 658 can be 2.38506 cm (0.939 inches), and the through hole defined by the proximal surface 610 is 0.508 cm (0.200 inches) to match the diameter 644A of the neck region 630A, and four of one or more fastener mechanisms 626 can be equally spaced around the proximal surface 610 and can be screws of the #6-32 UNC 2b type. In this and other embodiments herein, other types of fasteners for use or fastener mechanisms 626 as would be understood by one of ordinary skill in the art are contemplated to be within the scope of the present disclosure.

[0071]

[0107] Referring to FIG. 12D, an embodiment of vial assembly 580A is shown in FIG. 12A. Shown are vial 600A, needle 559 disposed within neck region 630A of vial 600A at first position P1, and mixed fluid 662 within vial 600A. Needle 559 in this and other embodiments of vial 600 described herein is configured to inject a fluid, such as saline, to mix with particulates 660 within vial 600A to create mixed fluid 662 within particulate region 628 and neck region 630A and includes at least one port 561. The particulate 660 shown in FIG. 12D and similar vial assembly embodiments shown herein with mixed fluid 662 represent the suspension of particulates 660 after mixing with an injection fluid to create mixed fluid 662. Particulates 660 can be used, for example, as radioactive spheres for radioembolization or chemoembolization spheres for chemoembolization. Although not shown with respect to vial 600D of FIGS. 15A-15C described below, any of the positions of needle 599 within vial 600, such as those shown in FIGS. 12D-12F, can be used with any of the vials 600 described herein, such as vial 600B of FIG. 13A, 600C of FIGS. 14A and 14D, 600C1 of FIG. 14E, and 600D of FIG. 15A. At least one port 561 is further configured to receive mixed fluid 662 to be delivered for treatment as described herein. At the first position P1, needle 559 is centrally disposed within neck region 630A with at least one needle port 561 facing the sidewall of neck region 630.

[0072]

[0108] FIG. 12E shows vial assembly 580A with needle 599 disposed within neck region 630A of vial 600A at second position P2. At the second position P2, needle 559 is biased toward the first side closer to the first sidewall of neck region 630 and away from the second sidewall with at least one port 561 facing the second sidewall away from needle 559. The gap distance between the first side, closer to the first sidewall defining the bias, and the needle can be, for example, 0.5 mm.

[0073]

[0109] Figure 12F shows the vial assembly 580A with the needle 599 disposed within the neck region 630 of the vial 600A in the third position P3. In the third position P3, the needle 559 is biased toward the first side closer to the first sidewall of the neck region 630 and away from the second sidewall, with at least one port 561 facing the first sidewall closer to the needle. The arrangement of at least one needle port 561 near the sidewall of the neck region 630 in any of the embodiments of the vial 600 as described herein is configured to allow for turbulent flow and efficient mixing. The gap distance between the first side near the first sidewall that defines the biasing and the needle can be, for example, 0.5 mm. The mixed fluid 662 within the vial 600A in each of FIGS. 12D - 12F can be the mixed fluid 662 at a time value of 3 seconds. Referring to FIG. 13A, a cross-sectional view of another embodiment of the vial 600 of FIG. 11A taken along line 12A - 12A of the vial 600 of FIG. 11B is shown as vial 600B. Vial 600B includes a distal sidewall 622 along the distal end 604 and a proximal sidewall 624 along the proximal end 606. The proximal sidewall 624 defines an aperture as one or more fastener mechanisms 626 configured to receive a fastener for holding the septum 592 to the vial 600B at the proximal end 606. The distal sidewall 622 defines a particulate region 628 inside the vial 600B. The proximal sidewall 624 defines a neck region 630B and a septum region 632 inside the vial 600B. The septum region 632 is configured to hold the septum 592.

[0075]

[0074]

[0110] The particulate region 628 is co - aligned with the longitudinal axis 636 of the vial 600B.

[0075]

[0111] ​It has a microparticle region length 634. The microparticle region 628 and the neck region 630B are connected via a connecting wall angled at an angle 638 with respect to the longitudinal axis 636. The first distal portion of the connecting wall has a radius of curvature 640, and the second more distal portion of the connecting wall has a radius of curvature 642B. In an embodiment, the microparticle region length 634 is 7.33044 cm (2.886 inches), the angle 638 is 63 degrees, the radius of curvature 640 is 0.254 cm (0.10 inches), and the radius of curvature 642A is 0.381 cm (0.15 inches). The aperture 609 of the upper distal surface 608 can have a diameter of 1.44272 cm (0.568 inches) in the range of plus or minus approximately 0.00508 cm (0.002 inches).

[0076]

[0112] In FIG. 13B, the neck region 630B of the vial 600B is shown in more detail thereof. The neck region 630B includes a diameter 644B. The septum region 632 includes an inner diameter 646B, an outer diameter 648, a septum region thickness 650, and a septum region radius of curvature 652. In an embodiment, the diameter 644B of the neck region 630B is 0.29972 cm (0.118 inches), the inner diameter 646B of the septum region 632 is 0.46228 cm (0.182 inches), and the outer diameter 648 of the septum region 632 is 1.4224 cm (0.560 inches). The septum region thickness 650 can be 0.0889 cm (0.035 inches) in the range of plus or minus 0.00508 cm (0.002 inches). The radius of curvature 652 can be 0.0254 cm (0.01 inches).

[0077]

[0113] A further detailed view of the septum region 632 within FIG. 13B shows a septum buffer region configured to provide buffering to the septum 592 within the septum region 632 which includes a buffer thickness 654 of the connecting buffer wall between the first buffer wall and the second buffer wall, and a buffer angle 656 of the connecting buffer wall. In an embodiment, the buffer thickness 654 can be 0.0127 cm (0.005 inches), and the buffer angle 656 can be 30 degrees.

[0078]

[0114] Referring to FIG. 13C, the proximal end 606 of the vial 600B including the proximal surface 610 is shown in a lower proximal view. The proximal surface 610 defines a fastener spacing diameter 658. In an embodiment, the fastener spacing diameter 658 can be 2.38506 cm (0.939 inches), the through hole defined by the proximal surface 610 is 0.29972 cm (0.118 inches) to match the diameter 644B of the neck region 630B, and four of the one or more fastener mechanisms 626 can be equally spaced around the proximal surface 610 and can be screws of the #6-32 UNC 2b type.

[0079]

[0115] Referring to FIG. 13D, an embodiment of the vial assembly 580 is shown including the vial 600B of FIG. 13A, the needle 559 disposed within the neck region 630B of the vial 600B at the first position P1, and the mixed fluid 662 within the vial 600B. In an embodiment, the cylindrical neck region 630B can be configured to have a diameter close to and slightly larger than the diameter of the needle 559. The mixed fluid 662 within the vial 600B can be the mixed fluid 662 at a time value of 3 seconds.

[0080]

[0116] Referring to FIG. 14A, a cross-sectional view of the embodiment of the vial 600 of FIG. 11A taken along line 12A-12A of the vial 600 of FIG. 11B is shown as the vial 600C. The vial 600C includes a distal sidewall 622 along the distal end 604 and a proximal sidewall 624 along the proximal end 606. The proximal sidewall 624 defines an aperture as one or more fastener mechanisms 626 configured to receive a fastener, for example, to hold the septum 592 to the vial 600C at the proximal end 606. The distal sidewall 622 defines a particulate region 628 inside the vial 600C. The proximal sidewall 624 defines a neck region 630D including a conical shape and a septum region 632 inside the vial 600C. The septum region 632 is configured to hold the septum 592.

[0081]

[0117] The particulate region 628 is co-aligned with the longitudinal axis 636 of the vial 600C and has a particulate region length 634. The particulate region 628 and the neck region 630C are connected via a connecting wall that is angled at an angle 638 with respect to the longitudinal axis 636. The first distal portion of the connecting wall has a radius of curvature 640 and the second, more distal portion of the connecting wall has a radius of curvature 642C. In an embodiment, the particulate region length 634 is 7.33044 cm (2.886 inches), the angle 638 is 63 degrees, the radius of curvature 640 is 0.254 cm (0.10 inches), and the radius of curvature 642C is 0.1524 cm (0.06 inches). The aperture 609 of the upper distal surface 608 can have a diameter of 1.44272 cm (0.568 inches) in the range of plus or minus approximately 0.00508 cm (0.002 inches).

[0082]

[0118] In FIG. 14B, the neck region 630C of the vial 600C is shown in more detail It results. The neck region 630C includes a diameter 644C and a distal conical diameter 670. From the distal conical diameter 670, a tapered (in other words, narrowing) transition (in other words, transition) wall 672 extends proximally so as to be tapered at an angle 674 with respect to the longitudinal axis 636. The septum region 632 includes an inner diameter 646C, an outer diameter 648, a septum region thickness 650, and a septum region radius of curvature 652. In an embodiment, the diameter 644C of the neck region 630C is 0.508 cm (0.200 inches), the inner diameter 646C of the septum region 632 is 0.82296 cm (0.324 inches), and the outer diameter 648 of the septum region 632 is 1.4224 cm (0.560 inches). The septum region thickness 650 can be 0.0889 cm (0.035 inches) in the range of plus or minus 0.00508 cm (0.002 inches). The radius of curvature 652 can be 0.0254 cm (0.01 inches). The distal conical diameter 670 can be 0.62992 cm (0.248 inches), the tapered transition wall 672 can have a distal radius of curvature of 0.0508 cm (0.02 inches), and the angle 674 can be 10 degrees. The length 676 between the distal portion and the proximal portion of the tapered transition wall 672 can be 0.67564 cm (0.266 inches).

[0083]

[0119] Referring to FIG. 14C, the proximal end 606 of the vial 600C including the proximal surface 610 is shown in a lower proximal view. The proximal surface 610 defines a fastener spacing diameter 658. In an embodiment, the fastener spacing diameter 658 can be 2.38506 cm (0.939 inches), and the through hole defined by the proximal surface 610 is 0.508 cm (0.200 inches) to match the diameter 644C of the neck region 630C, and one or more fastener mechanisms 6 Of the 26, 4 can be equally spaced around the proximal surface 610 and can be screws of the #6-32 UNC 2b type.

[0084]

[0120] Referring to FIG. 14D, an embodiment of the vial assembly 580 is shown in FIG. 12A Shown includes vial 600C, needle 559 disposed in neck region 630C of vial 600C at first position P1, and mixed fluid 662 within vial 600C, which may be mixed fluid 662 at a time value of 3 seconds.

[0085]

[0121] Referring to FIG. 14E, another embodiment of a vial assembly 580 includes a neck 6. Shown is vial 600C1 having a different conical shape for region 630C1. Needle 559 is disposed in neck region 630C1 of vial 600C1 at first position P1, and mixed fluid 662 is shown in vial 600C1. Mixed fluid 662 in vial 600C1 may be mixed fluid 662 at a time value of 3 seconds.

[0086]

[0122] Referring to FIG. 15A, along line 12A-12A of vial 600 of FIG. 11B 11A , taken through a cross-sectional view, is shown as vial 600D. Vial 600D includes a distal sidewall 622 along the distal end 604 and a proximal sidewall 624 along the proximal end 606. Proximal sidewall 624 defines an aperture, e.g., one or more fastener features 626 configured to receive a fastener to retain septum 592 to vial 600D at proximal end 606. Distal sidewall 622 defines an interior particulate region 628 of vial 600D. Proximal sidewall 624 defines an interior neck region 630D and septum region 632 of vial 600D. Septum region 632 is configured to retain septum 592.

[0087]

[0123] Particulate region 628 is co-aligned with longitudinal axis 636 of vial 600D. It has a microparticle region length of 634D. The microparticle region 628 and the neck region 630D are connected via a connecting wall having an inclination along an angle 638 with respect to the longitudinal axis 636. The distal portion of the connecting wall has a radius of curvature 642D. In an embodiment, the microparticle region length 634D is 7.89686 cm (3.109 inches), the angle 638 is 63 degrees, and the radius of curvature 642D is 0.2032 cm (0.08 inches). The aperture 609 of the upper distal surface 608 can have a diameter of 1.44272 cm (0.568 inches) in the range of plus or minus approximately 0.00508 cm (0.002 inches).

[0088]

[0124] In FIG. 15B, the neck region 630D of the vial 600D is shown in more detail Thereof. The neck region 630D includes a diameter 644D. The septum region 632 includes an inner diameter 646D, an outer diameter 648, a septum region thickness 650, and a septum region radius of curvature 652. In an embodiment, the diameter 644D of the neck region 630D is 0.50038 cm (0.197 inches), the inner diameter 646D of the septum region 632 is 0.66294 cm (0.261 inches), and the outer diameter 648 of the septum region 632 is 1.4224 cm (0.560 inches). The septum region thickness 650 can be 0.0889 cm (0.035 inches) in the range of plus or minus 0.00508 cm (0.002 inches). The radius of curvature 652 can be 0.0254 cm (0.01 inches).

[0089]

[0125] A further detailed view of the septum region 632 in FIG. 15B shows a septum buffer region configured to provide buffering to the septum 592 within the septum region 632 Thereof. The septum buffer region includes a buffer thickness 654 of the connecting buffer wall between the first buffer wall and the second buffer wall, and a buffer angle 656 of the connecting buffer wall. In an embodiment, the buffer thickness 654 can be 0.0127 cm (0.005 inches), and the buffer angle 656 can be 30 degrees.

[0090]

[0126] Referring to FIG. 15C, the proximal end 606 of the vial 600D including the proximal surface 610 A lower proximal view is shown. The proximal surface 610 defines a fastener spacing diameter 658. In an embodiment, the fastener spacing diameter 658 can be 2.38506 cm (0.939 inches), the through hole defined by the proximal surface 610 is 0.508 cm (0.200 inches) to match the diameter 644D of the neck region 630A, and four of the one or more fastener mechanisms 626 can be equally spaced around the proximal surface 610 and can be screws of the #6-32 UNC 2b type.

[0091]

[0127] The vial 600D of FIGS. 15A-15C can be configured as a flat-bottomed embodiment where the septum 592 is housed both within the septum region 6 32 and partially or completely within the neck region 630D. When the septum 592 is housed both within the septum region 632 and completely within the neck region 630D, at least one port 561 of the needle 559 can be disposed within the particulate region 628 in an embodiment. Alternatively, the septum 592 can be housed within the septum region 632 and not necessarily within the neck region 630D.

[0092]

[0128] In the embodiments described herein, the vial assemblies 580, 580 It includes vial 600 and needle 559. In non-limiting examples, vial assemblies 580, 580A may include vials 600A, 600B, 600C, and 600C1 at position P1 in FIGS. 12D, 13D, 14D, and 14E. Each vial 600 includes a neck region 630 (such as neck regions 630A, 630B, 630C, 630C1, and 630D in FIGS. 12A, 13A, 14A, 14E, and 15A) including particulate material (such as particulates 660), a septum 592, and a first width 644 (for example, a first width corresponding to diameters 644A, 644B, 644C, and 644D in FIGS. 12B, 13B, 14B, and 15B), and may include a particulate region 628 including a second width 609 (for example, a second width corresponding to the diameter associated with aperture 609 in FIGS. 12A, 13A, 14A, and 15A) that is greater than the first width 644.

[0093]

[0129] In an embodiment, the second width 609 may be at least twice as large as the first width 644. The septum 592 may be configured to be disposed proximally adjacent to the neck region 630, and the particulate region 628 may be disposed distally adjacent to the neck region 630. The septum 592 may be configured to be disposed within a septum region 632 of the vial 600. The septum region 632 may include a third width (for example, corresponding to the outer diameter 648 of the septum region 632 as described herein) that is greater than the first width 644 of the neck region 630, and the neck region 630 may be disposed between the septum region 632 and the particulate region 628. The septum 592 may be rectangular, and the septum region 632 may include a rectangular configuration sized and shaped to house the septum 592 within an airtight seal. At least a portion of the neck region 630 may be configured to house at least a portion of the septum 592.

[0094]

[0130] In an embodiment, the vial 600 may include an outer wall, and the outer wall is the vial Defined by the body 602, including an outer wall width (corresponding to, for example, the diameter 620 of the upper distal surface 608 of the vial 600 as shown in FIG. 11D), a particulate region thickness between the outer wall and the particulate region 628, and a neck region thickness between the outer wall and the neck region 630, where the neck region thickness is greater than the particulate region thickness. The neck region thickness may be at least 1.5 times or at least 2 times greater than the particulate region thickness. The vial assemblies 580, 580A may further include a particulate material assembly, which includes a console (corresponding to, for example, the console assembly 510 of FIG. 1) including a vial receiving region 518, and a vial engagement mechanism 520 extending from the console within the vial receiving region 518. The vial engagement mechanism 520 is configured to engage the vial assemblies 580, 580A and move the vial assemblies 580, 580A to the locking position L as described herein. It may be obtained.

[0095]

[0131] The connecting wall adjacent to the neck region 630 and the particulate region 628 may be angled with respect to the longitudinal axis 636 of the vial 60 0. The connecting wall may be angled at an angle of 63 degrees with respect to the longitudinal axis 636. In an embodiment, the connecting wall may be angled in the range of about 20 degrees to about 90 degrees with respect to the longitudinal axis 636. Alternatively, the connecting wall adjacent to the neck region 630 and the particulate region 628 may be sloped with respect to the longitudinal axis 636 of the vial 600 as shown in the vial 600D of FIG. 15A. In an embodiment, the connecting wall including the sloped configuration may prevent the particulates 660 from settling into the four corners and / or within the edges of the particulate region 628.

[0096]

[0132] In some embodiments, the neck region 630 is shown in FIGS. 12A, 13A, and It may include a cylindrical shape, such as that shown in the neck regions 630A, 630B, and 630D in FIG. 15A. The cylindrical shape may include a pair of side walls that are parallel to each other and spaced apart at a first width in cross-section. The septum width 648 (e.g., the septum width corresponding to the outer diameter 648 of the septum region 632) may be in the range of about 2.8 to 3.08 times the first width 644 of the neck region 630. In embodiments, the septum width 648 may be in the range of about 1.2 to 10.0 times the first width 644 of the neck region 630.

[0097]

[0133] In some embodiments, the neck region 630 is shown in FIGS. 14A, 14D, and It may include a conical shape, such as that shown in the neck regions 630C, 630C1 in FIG. 14E. The conical shape may include a pair of side walls that taper in proximal and outward directions relative to each other in cross section, such as that shown by the tapered transition wall 672 in FIG. 14B. As shown in the embodiments of FIGS. 14A-14E, the vials 600C, 600C1 include a neck region 630C that includes particulate material (e.g., particulates 660), a septum 592, a first width 644C, and includes a conical shape, a particulate region 628 that includes a second width 609 that is greater than the first width 644C, and an outer wall defined by the outer surface of the vial body 602. The outer wall may include an outer wall width (e.g., corresponding to the diameter of the aperture 609), a particulate region thickness between the outer wall and the particulate region 628, and a neck region thickness between the outer wall and the neck region 630C. The neck region thickness may be greater than the particulate region thickness. The vial 600C may further be attached to the vial assembly 580 and the particulate material assembly for delivering particulate material, e.g., via the delivery device 500 described herein. The vial assembly 580 may include the vial 600C and the needle 559 and may be configured to move the vial 600C to the locking position L. The needle 559 may include at least one port 561 configured to pierce the septum of the vial assembly 580 when the vial assembly 580 is in the locking position L. As shown in FIGS. 14D-14E, at least one port 561 may be further configured to be within the neck regions 630C, 630C1 of the vial assembly 580 when the vial assembly 580 is in the locking position L. The particulate material assembly may include a console (e.g., of the console assembly 510) that includes a vial receiving region 518, and a vial engagement mechanism 520 that extends from the console within the vial receiving region 518. The vial engagement mechanism 520 may engage a vial assembly 580 that includes the vial 600C and may be configured to move the vial assembly 580 that includes the vial 600C to the locking position L, as described herein.

[0098]

[0134] The needle is shown in FIGS. 12D-12F, 13D, and 14D-14E Vial assembly 580, 580A may include at least one port 561 such that vial assembly 580, 580A is configured to move to a locked position L (e.g., such as shown in positions P1, P2, and P3 in FIGS. 12D, 13D, 14D, and 14E in FIGS. 12E and 12F). Needle 559 is configured to pierce septum 592 of vial assembly 580, 580A when vial assembly 580, 580A is in locked position L. The at least one port 561 is further configured to be within the neck region 630 of the vial assembly 580, 580A when the vial assembly 580, 580A is in the locked position L. The at least one port 561 is configured to inject a fluid into the vial assembly 580, 580A for mixing with the particulate material upon actuation of the vial engagement feature (e.g., the vial engagement feature 520 of FIG. 1 ) in a first direction, and to receive a resulting mixed fluid 662 from the vial assembly 580, 580A upon actuation of the vial engagement feature 520 in a second direction opposite the first direction.

[0099]

[0135] Example

[0136] The birefringence of the birefringence described herein, such as those described with respect to FIGS. 11A-15C, Embodiments of vial 600 are configured to reduce and / or minimize the segregated volume of microspheres (e.g., microparticles 660) within the particulate region 628 and neck region 630 of vial 600, while preventing microsphere resuspension and improving flow rate and delivery performance. The flow rate for injecting fluid into vial 600 for mixing as described herein can be 1.0 mL / s for a time period such as 3 seconds (e.g., 1.0 mL / s for 3 seconds), or can be other flow rates deemed suitable for use with vial 600, such as 10.0 mL / s for 0.3 seconds, 5.0 mL / s for 0.6 seconds, or 2 mL / s for 1.5 seconds. Simulations of the examples of Figures 16 and 17 described below demonstrate a 1000 kg / m 3The physiological saline concentration as the injected fluid and a viscosity of 0.001 kg / m-s, and a density of 1100 kg / m 3 The parameters of the microspheres with a density of 0.0035 kg / m-s and a viscosity of 0.0035 kg / m-s were utilized.

[0100]

[0137] In an embodiment, the fluid domain of the vial 600 can be set to be filled with 74 % with microspheres, and the initial volume of the microspheres in the fluid domain can be 1.53 mL of the total fluid domain. Therefore, the current extrapolation ) of the fluid domain can be calculated as shown below. For the fluid domain to be set to be filled with 74% microspheres with respect to 100% of the fluid domain, when the initial volume of the microspheres is set to 1.53 mL, the volume of the microspheres can be 1.132 mL per the following formula, which is 74% × 1.53 mL.

[0101]

Equation

[0102]

[0138] In the 10 mL vial 600, the same volume of microspheres in the extrapolation is assumed to spread within the 10 mL vial volume such that the extrapolated volume fraction is 11.32% (1.132 mL divided by 10 mL). Therefore, in the case of homogeneous mixing on the 10 mL vial, the volume fraction of the microspheres is 11.32%. In the simulations of FIGS. 16 and 17, the fluid domain is 3 mL.

[0103]

[0139] Figure 16 shows, at position P1, FIGS. 12D, 13D, 14D, and 14 For vial assemblies 580, 580A including vials 600A, 600B, 600C, and 600C1 of E, a graph 700 of the simulation of the amount of residual microspheres versus injection volume over time is shown. The amount of microspheres (e.g., microparticles 660) remaining in each of vials 600A, 600B, 600C, and 600C1 for an injection volume of 1.0 mL / s over 3 seconds, which produces a mixed solution 662 when mixed with microparticles 660, is shown to decrease from 100% for each of these vials and end in the range of approximately 2% to approximately 10%. The equation that can be used to determine the amount of residual microspheres is specified below.

[0104]

Number

[0105]

[0140] For example, in Equation 2, time t can be set to 3.0 seconds as n, and the amount of microspheres and time = 0 seconds is divided by the microsphere volume at time = 3.0 seconds and multiplied by 100 to yield the % of microspheres remaining after 3.0 seconds.

[0106]

[0141] Figure 17 shows, at position P1, Figures 12D, 13D, 14D, and Figure 14 For vial assemblies 580, 580A including vials 600A, 600B, 600C, and 600C1 of E, a graph 800 of the simulation of the volume of residual microspheres versus injection volume over time is shown. The amount of microspheres (e.g., microparticles 660) remaining in each of vials 600A, 600B, 600C, and 600C1 for an injection volume of 1.0 mL / s over 3 seconds, which produces a mixed solution 662 when mixed with microparticles 660, is shown to decrease from an initial volume of approximately 52% within each respective vial and end in the range of approximately 22% to approximately 32%.

[0107]

[0142] The formula that can be used to determine the volume of the remaining microspheres is based on a volume integral as specified below. as follows.

[0108]

Number

[0109]

Number

[0110]

[0143] For example, Equation 3 determines the volume integral of the amount of microparticles 660 in vial 600 after mixing, and in Equation 4, it is divided by the total volume and compared with the total volume as a percentage of the total volume to reflect the residual volume of the microspheres after the mixing percentage. III. List of Aspects

[0144] Aspect 1. A vial assembly comprising a vial and a needle. The vial contains microparticles It comprises a material, a septum, a neck region including a first width, and a particulate region including a second width greater than the first width. The needle comprises at least one port. The vial assembly is configured to move to a locked position. The needle is configured to pierce the septum of the vial assembly when the vial assembly is in the locked position. The at least one port is further configured to be within the neck region of the vial assembly when the vial assembly is in the locked position. The at least one port is configured to inject fluid into the vial assembly for mixing with the particulate material upon actuation of the vial engagement mechanism in a first direction, and to receive the resulting mixed fluid from the vial assembly upon actuation of the vial engagement mechanism in a second direction opposite the first direction.

[0111]

[0145] Aspect 2. The vial assembly of Aspect 1, wherein the second width is at least twice as large as the first width. vial assembly.

[0146] Aspect 3. The vial assembly of Aspect 1 or Aspect 2, wherein the neck region includes a cylindrical shape. vial assembly.

[0112]

[0147] Aspect 4. The vial assembly of Aspect 3, wherein the cylindrical shape includes a pair of side walls that are parallel to each other in cross-section and spaced apart at the first width. vial assembly.

[0148] Aspect 5. The vial assembly of Aspect 4, wherein the septum width is in the range of about 1.2 times to 10.0 times the first width of the neck region. vial assembly.

[0113]

[0149] Aspect 6. The vial assembly of Aspect 1 or Aspect 2, wherein the neck region includes a conical shape. vial assembly.

[0150] Aspect 7. The vial assembly of Aspect 6, wherein the conical shape includes a pair of side walls that taper in a proximal and outward direction with respect to each other in cross-section. vial assembly.

[0114]

[0151] Aspect 8. The connection wall adjacent to the neck region and the particulate region is angled with respect to the longitudinal axis of the vial, and is a vial assembly according to any one of Aspects 1 to 7.

[0152] Aspect 9. The connection wall is angled in the range of about 20 degrees to about 90 degrees with respect to the longitudinal axis, and is a vial assembly of Aspect 8.

[0115]

[0153] Aspect 10. The connection wall adjacent to the neck region and the particulate region has an inclination with respect to the longitudinal axis of the vial, and is a vial assembly according to any one of Aspects 1 to 7.

[0154] Aspect 11. 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, and is a vial assembly according to any one of Aspects 1 to 10.

[0116]

[0155] Aspect 12. The septum is configured to be disposed within the septum region of the vial assembly, the septum region includes a third width greater than the first width, and the neck region is disposed between the septum region and the particulate region, and is a vial assembly of Aspect 11.

[0117]

[0156] Aspect 13. The septum is rectangular, and the septum region includes a rectangular configuration sized and shaped to house the septum within an airtight seal, and is a vial assembly of Aspect 12.

[0118]

[0157] Aspect 14. At least a portion of the neck region is configured to house at least a portion of the septum, and is a vial assembly according to any one of Aspects 1 to 13.

[0158] Aspect 15. The vial has an outer wall, an outer wall width, and a micro - between the outer wall and the particulate region A vial assembly according to any of aspects 1 to 14, comprising an outer wall and including a particle region thickness and a neck region thickness between the outer wall and the neck region, wherein the neck region thickness is greater than the particle region thickness.

[0119]

[0159] Aspect 16. The vial assembly according to aspect 15, wherein the neck region thickness is at least 1.5 times greater than the particle region thickness. The vial assembly of aspect 15.

[0160] Aspect 17. The vial assembly according to aspect 15, wherein the neck region thickness is at least 2 times greater than the particle region thickness. The vial assembly of aspect 15.

[0120]

[0161] Aspect 18. The vial assembly according to any of aspects 1 to 17, further comprising a particulate material assembly, the particulate material assembly comprising a console including a vial receiving region and a vial engagement mechanism extending from the console within the vial receiving region, the vial engagement mechanism being configured to engage the vial assembly and move the vial assembly to a locked position. The vial assembly of any of aspects 1 to 17, further comprising a particulate material assembly, the particulate material assembly comprising a console including a vial receiving region and a vial engagement mechanism extending from the console within the vial receiving region, the vial engagement mechanism being configured to engage the vial assembly and move the vial assembly to a locked position.

[0121]

[0162] Aspect 19. A vial comprising a particulate material, a septum, a neck region including a first width, a particulate region including a second width greater than the first width, and an outer wall. The neck region includes a conical shape. The outer wall includes an outer wall width, a particulate region thickness between the outer wall and the particulate region, and a neck region thickness between the outer wall and the neck region. The neck region thickness is greater than the particulate region thickness. The neck region includes a conical shape. The outer wall includes an outer wall width, a particulate region thickness between the outer wall and the particulate region, and a neck region thickness between the outer wall and the neck region. The neck region thickness is greater than the particulate region thickness.

[0122]

[0163] Aspect 20. Further comprising a vial assembly and a particulate material assembly. Vial of Aspect 19. The vial assembly comprises a vial and a needle. The vial assembly is configured to move the vial to a locked position. The needle comprises at least one port configured to pierce the septum of the vial assembly when the vial assembly is in the locked position. The at least one port is further configured to be within the neck region of the vial assembly when the vial assembly is in the locked position. The particulate material assembly comprises a console including a vial receiving region, and a vial engaging mechanism extending from the console within the vial receiving region. The vial engaging mechanism is configured to engage the vial assembly and move the vial assembly to the locked position.

[0123]

[0164] The terms “substantially” and “about” may be used herein to represent the inherent degree of uncertainty that may be attributable to any quantitative comparison, value, measurement, or other representation. It should be noted that 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 being addressed.

[0124]

[0165] For purposes of explaining and defining the present disclosure, the term “substantially” is used herein to represent the inherent degree of uncertainty that may be attributable to any quantitative comparison, value, measurement, or other representation. The term “substantially” is also 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 being addressed. As such, it is used herein to represent the inherent degree of uncertainty that may be attributable to any quantitative comparison, value, measurement, or other representation with respect to an arrangement of elements or features that is expected to present a theoretically exact match or behavior but that may actually embody something that is slightly less than exact in practice.

[0125]

[0166] ​While specific embodiments are illustrated and described herein, it is to be understood that various other changes and modifications can be made without departing from the spirit and scope of the claimed subject matter. Further, 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, the vial assembly comprising: a vial comprising a particulate material, a septum, a neck region including a first width, and a particulate region including a second width greater than the first width; a needle having at least one port; the vial assembly being configured to move to a locked position; the needle being configured to pierce the septum of the vial assembly when the vial assembly is in the locked position; the at least one port being further configured to be within the neck region of the vial assembly when the vial assembly is in the locked position; the at least one port being configured to inject fluid into the vial assembly for mixing with the particulate material upon actuation of a vial engagement mechanism in a first direction, and to receive the resulting mixed fluid from the vial assembly upon actuation of the vial engagement mechanism in a second direction opposite the first direction.

2. The vial assembly according to claim 1, wherein the second width is at least twice as large as the first width.

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

4. The vial assembly according to claim 3, wherein the cylindrical shape includes a pair of side walls that are parallel to each other in cross-section and spaced apart at the first width.

5. The vial assembly according to claim 4, wherein the septum width is in the range of about 1.2 times to 10.0 times the first width of the neck region.

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

7. The vial assembly according to claim 6, wherein the conical shape includes a pair of side walls that are tapered in proximal and outward directions with respect to each other in cross-section.

8. The vial assembly according to claim 1, wherein a connecting wall adjacent to the neck region and the particulate region is angled with respect to the longitudinal axis of the vial.

9. The vial assembly according to claim 8, wherein the connecting wall is angled in the range of about 20 degrees to about 90 degrees with respect to the longitudinal axis, the vial assembly.

10. The vial assembly according to claim 1, wherein the connecting wall adjacent to the neck region and the particulate region has an inclination with respect to the longitudinal axis of the vial, the vial assembly.

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

12. The vial assembly according to claim 11, wherein the septum is configured to be disposed within a septum region of the vial assembly, the septum region includes a third width greater than the first width, and the neck region is disposed between the septum region and the particulate region, the vial assembly.

13. The vial assembly according to claim 12, wherein the septum is rectangular, and the septum region includes a rectangular configuration sized and shaped to house the septum within an airtight seal, the vial assembly.

14. The vial assembly according to claim 1, wherein at least a portion of the neck region is configured to house at least a portion of the septum, the vial assembly.

15. The vial assembly according to claim 1, wherein the vial has an outer wall including an outer wall width, a particulate region thickness between the outer wall and the particulate region, and a neck region thickness between the outer wall and the neck region, and the neck region thickness is greater than the particulate region thickness, the vial assembly.

16. The vial assembly according to claim 15, wherein the neck region thickness is at least 1.5 times greater than the particulate region thickness, the vial assembly.

17. The vial assembly according to claim 15, wherein the neck region thickness is at least 2 times greater than the particulate region thickness, the vial assembly.

18. The vial assembly according to claim 1, further comprising a particulate material assembly, the particulate material assembly A console including a vial receiving region, A vial engaging mechanism extending from the console within the vial receiving region, the vial engaging mechanism being configured to engage the vial assembly and move the vial assembly to the locking position, a vial assembly comprising the vial engaging mechanism.

19. A vial, the vial comprising: a particulate material; a septum; a neck region including a first width, the neck region including a conical shape; a particulate region including a second width greater than the first width; an outer wall including an outer wall width, a particulate region thickness between the outer wall and the particulate region, and a neck region thickness between the outer wall and the neck region, the neck region thickness being greater than the particulate region thickness, a vial.

20. The vial according to claim 19, a vial assembly, the vial, the vial assembly being configured to move the vial to a locking position, and a needle having at least one port configured to pierce the septum of the vial assembly when the vial assembly is in the locking position, the at least one port being further configured to be within the neck region of the vial assembly when the vial assembly is in the locking position, a vial assembly comprising the needle. a particulate material assembly, a console including a vial receiving region, and a vial engaging mechanism extending from the console within the vial receiving region, the vial engaging mechanism being configured to engage the vial assembly and move the vial assembly to the locking position, a particulate material assembly further comprising the vial engaging mechanism. ​

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