Septum with Multiple Ribs, Vial, and Vial Assembly for a Microparticle Delivery Device

Abstract

A septum for sealing a vial assembly having a vial including a neck region including a first width includes an upper surface, a lower surface disposed opposite the upper surface, a radially extending outer surface disposed between the upper surface and the lower surface, a plurality of ribs disposed on the upper surface, and a plurality of valleys. Each valley can be disposed between at least two of the plurality of ribs to separate the at least two of the plurality of ribs. The plurality of ribs can include at least an inner first rib, an intermediate rib, and an outer outer rib. The inner first rib can include an outer wall configured to radially compress against an inner wall of the neck region of the vial, and the outer wall includes a height greater than the heights of the intermediate rib and the outer outer rib.

Description

Technical Field

[0001]

[0001] The present 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 procedures such as transarterial radioembolization, for example, a septum with multiple ribs, and a vial containing a septum with multiple ribs.

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 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. Generally, clinicians or patients can be exposed to the risk of radiation emitted from this delivery.

[0004]

[0004] Therefore, there is a need for components of medical devices that are configured and operable to be sealed and shielded from such radiation when delivering radioactive compounds to a patient's body.

Summary of the Invention

Means for Solving the Problems

[0005]

[0005] According to an embodiment of the present disclosure, a septum for sealing a vial assembly having a vial including a neck region including a first width includes an upper surface, a lower surface disposed opposite the upper surface, a radially extending outer surface disposed between the upper surface and the lower surface, a plurality of ribs disposed on the upper surface, and a plurality of valleys. Each valley is disposed therebetween to separate at least two of the plurality of ribs. The plurality of ribs includes at least an inner first rib, an intermediate rib, and an outer outer rib (or an outer rib). The inner first rib includes an outer wall configured to radially compress against the inner wall of the neck region of the vial, and the outer wall includes a height greater than the heights of the intermediate rib and the outer outer rib.

[0006]

[0006] In another embodiment, the vial assembly includes a vial, a needle, and a septum. The vial may include a particulate material and a neck region including a first width. The needle includes at least one port and is configured for reception within the neck region. The septum is configured to receive the needle and to seal the vial assembly and the needle. The septum includes an upper surface, a lower surface disposed opposite the upper surface, a radially extending outer surface disposed between the upper surface and the lower surface, a plurality of ribs disposed on the upper surface, and a plurality of valleys. Each valley is disposed therebetween to separate at least two of the plurality of ribs. The plurality of ribs includes at least an inner first rib, an intermediate rib, and an outer outer rib. The inner first rib includes an outer wall configured to radially compress against the inner wall of the neck region of the vial, and the outer wall includes a height greater than the heights of the intermediate rib and the outer outer rib.

[0007]

[0007] In yet another embodiment, the vial comprises a particulate material, a neck region including a first width, and a septum. The septum includes an upper surface, a lower surface disposed opposite the upper surface, a radially extending outer surface disposed between the upper surface and the lower surface, a plurality of ribs disposed on the upper surface, and a plurality of valleys. Each valley is disposed therebetween to space apart at least two of the plurality of ribs. The plurality of ribs includes at least an inner first rib, an intermediate rib, and an outer outer rib. The inner first rib includes an outer wall configured to radially compress against the inner wall of the neck region of the vial, and the outer wall includes a height greater than the heights of the intermediate rib and the outer outer rib.

[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] Another cross-sectional view of the vial assembly of FIG. 3, in accordance with one or more embodiments shown and described herein, the vial assembly including a multi-ribbed septum.

Figure 7

[0015] Detailed cross-sectional view of the multi-ribbed septum of the vial assembly of FIG. 6.

Figure 8A

[0016] Upper side perspective view of the multi-ribbed septum of FIG. 7.

Figure 8B

[0017] Top plan view of the multi-ribbed septum of FIG. 7.

Figure 9

[0018] Cross-sectional view of the multi-ribbed septum of FIG. 8B, taken along line A-A of FIG. 8B.

Figure 10

[0019] Side plan view of the multi-ribbed septum of FIG. 7.

Figure 11

[0020] Side perspective view of another embodiment of the multi-ribbed septum for the vial assembly of FIG. 6, in accordance with one or more embodiments shown and described herein.

Figure 12

[0021] Lower side perspective view of the multi-ribbed septum of FIG. 11.

Figure 13

[0022] A diagram illustrating a first set of compression test data results for the multi-ribbed septum of FIG. 11.

Figure 14

[0023] A diagram illustrating a second set of compression test data results for the multi-ribbed septum of FIG. 11.

DETAILED DESCRIPTION OF THE INVENTION

[0010]

[0024] Reference will now be made in detail to various embodiments of a delivery device for administering a radiopharmaceutical to a patient, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts. As used herein, directional terms such as above, below, right, left, front, rear, top, bottom, distal, and proximal are used only in relation to the figures as depicted and are not intended to imply absolute orientation.

[0011]

[0025] 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 the other particular value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it should be understood that the particular value forms another embodiment. It should further be understood that each of the endpoints of each of these ranges is significant both in relation to the other endpoint and independently of the other endpoint.

[0012]

[0026] 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. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or where any device claim does not actually recite an order or orientation to individual components, or where the steps are not otherwise specifically recited in the claims or description as being limited to a particular order, or where no particular order or orientation of components of a device is recited, it is not intended that any order or orientation be inferred in any way. This applies to any possible ambiguity in interpretation, including logical matters, grammatical constructs or punctuation from the arrangement of steps, operational flow, order of components, or orientation of components, the plain meaning derived therefrom, and the number or type of embodiments described herein.

[0013]

[0027] 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 dictates otherwise.

[0014]

[0028] As used herein, the terms "horizontal", "vertical", "distal", and "proximal" are merely relative terms and simply indicate an overall relative orientation and do not necessarily indicate perpendicularity. These terms may also be used for convenience in referring to the orientation used in the figures, such orientation being used merely by convention and not intended as a characteristic of the device shown. The present disclosure and its embodiments described herein can be used in any desired orientation. Furthermore, horizontal and vertical walls generally need only be intersecting walls and need not be at right angles. As used herein, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a" component includes aspects having two or more such components unless the context clearly dictates otherwise.

[0015]

[0029] In the embodiments described in this specification, 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]

[0030] The figures 1-5 described below are directed to embodiments of a delivery device 500 for delivering microparticles 660, and the figures 6-14 described in more detail below are directed to embodiments of one or more septum components of the delivery device 500 as described herein to help shield from radiation emitted and delivered from the microparticles 660. In some embodiments, as described in more detail below, the delivery device 500 is a radioembolization delivery device, the microparticles 660 are a plurality of radioembolization beads, the fluid is a saline aqueous solution, and the resulting mixed fluid (e.g., mixed fluid solution) is a radioembolization bead-saline aqueous solution. The needle 559 can be configured to deliver the radioembolization bead-saline aqueous solution as a mixed fluid solution through the radioembolization delivery device, such as during actuation of the vial engagement mechanism 520 in the positive pressure direction. In some embodiments, the fluid is a contrast agent-saline aqueous solution containing a contrast agent, and the resulting mixed fluid (e.g., mixed fluid solution) is a radioembolization bead-contrast agent-saline aqueous solution. The needle 559 can be configured to deliver the radioembolization bead-contrast agent-saline aqueous solution as 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-saline aqueous solution or a bead-contrast agent-saline aqueous solution. I. Mechanical delivery device having a removable sliding portion assembly

[0031] 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 can operate as described in International PCT Application No. PCT / 2019 / 033001, filed May 17, 2019, which is incorporated herein by reference in its entirety, except with respect to septum components as described in more detail below with respect to Figures 6-14 and in one or more embodiments within this specification.

[0017]

[0032] 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 operable to transition between a coupled state and a separated state relative 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]

[0033] 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]

[0034] Still referring to FIG. 1, the distal end 516 of the console assembly 510 defines a vial receiving region 518 sized and shaped to receive a vial assembly 580 therein, as described in more detail herein. The console assembly 510 further includes a vial engagement mechanism 520 extending from the base 512 adjacent to the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outwardly from the base 512 of the console assembly 510 towards 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]

[0035] The console assembly 510 includes a mechanical assembly disposed within the base 512 that is 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 520 at the distal end 516.

[0021]

[0036] The sliding space 532 is sized and shaped to receive the slider 540 therein. As will be described in more detail herein, the sliding assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, media) therethrough. In particular, the sliding 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]

[0037] In an embodiment, and referring to FIG. 2, the flow sensor of the delivery device 500 can be positioned in-line with and configured to measure the amount of fluid (e.g., a suspension after the therapeutic particles are effectively mixed with the fluid medium) passing through 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 ports 556. 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]

[0038] A pair of lever arms 522 are movable simultaneously with the neck 524 of the vial engagement mechanism 520 in response to actuation of the handle 528 of the console assembly 510. Further, the pair of lever arms 522 are fixed relative to each other such that the space formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 are configured to firmly engage the vial assembly 580 therebetween and, in particular, within the space formed by the pair of lever arms 522. Thus, the vial engagement mechanism 520 is operable to firmly attach the vial assembly 580 to the console assembly 510 in the vial receiving region 518. The vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, but it should be understood that the vial engagement mechanism 520 may include various other structural configurations suitable for engaging the vial assembly 580. In non-limiting examples, the vial engagement mechanism 520 may include one or more magnets configured to engage one or more corresponding magnets on the vial assembly.

[0024]

[0039] Still referring to FIG. 1, the console assembly 510 further includes a safety shield 526 secured to the distal end 516 of the base 512 along the vial 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 inhibit radiation emission from one or more radiation doses stored within the vial receiving region 518.

[0025]

[0040] The distal end 516 of the console assembly 510 further includes a sliding space 532 sized and shaped to receive the slider 540 therein. The sliding space 532 includes one or more or a pair of positioning portions 534 extending therein, and the positioning portions 534 are sized and shaped to fit the corresponding positioning portions (e.g., positioning ribs 554) of the slider 540, thereby facilitating the coupling of the slider 540 and the base 512 of the console assembly 510 within the sliding space 532.

[0026]

[0041] Still referring to FIG. 1, the slider 540 is configured to partially receive the vial assembly 580 therein for administering therapeutic particles (e.g., radioactive fluid medium) from the delivery device 500 to the patient. In particular, the slider 540 includes a distal end 542 and a proximal end 544, and a pair of side walls 546 extend therebetween. The distal end 542 of the slider 540 includes a handle 552 extending proximally therefrom. The handle 552 is configured to facilitate the movement of the slider 540, particularly the insertion of the slider 540 into the sliding space 532 of the console assembly 510. The distal end 542 further includes one or more ports 556 for coupling one or more delivery conduits (i.e., tubes) to the slider 540. Since one or more delivery conduits are further coupled to one or more external devices at the ends of the lines on the opposite side of 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 engage with the pair of positioning portions 534 of the console assembly 510. Accordingly, 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 proximal end 544 is slidably received within the sliding space 532 of the base 512.

[0027]

[0042] The slider 540 further includes an upper surface 548 that extends from a distal end 542 and a proximal end 544 and is positioned between a pair of side walls 546. The upper surface 548 of the slider 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, for example, leakage of various fluid media during use of the delivery device 500. The locking system 550 of the slider 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 slider 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 slider 540. The priming assembly 560 connects the priming conduit 562 to the needle 559 and the manifolds 555A and 555B and serves to purge air from the delivery device 500, including the manifolds 555A and 555B, prior to utilizing the delivery device 500 in a procedure.

[0028]

[0043] 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, particularly along the upper surface 548. The annularly arranged protrusions 551 are formed within the inner circumference of the locking system 550 and extend along at least two continuously arranged rows. In embodiments, a single row may be used. The annular array of protrusions 551 included in the locking system 550 engages corresponding locking features 586 of the vial assembly 580 (see FIG. 3), thereby being configured to firmly secure the vial assembly 580 to the slider 540. The multiple rows of protrusions 551 of the locking system 550 serve to provide a dual locking system to ensure that the slider assembly 540, and particularly the pins 559 of the slider assembly 540, are firmly maintained through the septum 592 of the vial assembly 580 (see FIG. 3) during use of the delivery device 500 in the procedure.

[0029]

[0044] The slider 540 further includes a vial chamber 558 sized and shaped to receive therein a priming assembly 560 and a vial assembly 580, respectively. In other words, the vial chamber 558 is sized to receive both the priming assembly 560 and the vial assembly 580 separately from each other. The vial chamber 558 is enclosed within a protective chamber or shield 557 disposed around the vial chamber 558. The protective shield 557 is formed of a material configured to suppress emission of radiation, such as metal or plastic, from the vial chamber 558 to the outside. Additionally, the slider 540 includes a needle 559 extending along a lower end portion of the vial chamber 558 through the protective shield 557 and into the vial chamber 558. The needle 559 is firmly fixed to the vial chamber 558 such that any device received through the aperture of the locking system 550 and into the vial chamber 558 will contact and interact with the needle 559 (e.g., the priming assembly 560, the vial assembly 580, and the like).

[0030]

[0045] Still referring to FIG. 2, the needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the slider 540. In particular, the manifolds 555A, 555B are positioned below the vial chamber 558 and the protective shield 557. The proximal manifold 555B is fluidly coupled to the needle 559, and the distal manifold 555A is fluidly coupleable to one or more delivery conduits via one or more ports 556 of the slider 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A through a one-way check valve 553 disposed therebetween.

[0031]

[0046] Accordingly, the proximal manifold 555B is in fluid communication with one or more ports 556 via the distal manifold 555A, but the one or more ports 556 are not in fluid communication with the proximal manifold 555B due to the position of the one-way check valve 553 disposed between the manifolds 555A, 555B. Thus, the needle 559 is in fluid communication with one or more delivery conduits and / or devices coupled to the slider 540 at the one or more ports 556, and via the manifolds 555A, 555B fixed therebetween. The one or more ports 556 of the slider assembly 540 may 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 may be a cannula, catheter, or similar mechanism through which fluid and / or solution is injected and received as described herein.

[0032]

[0047] Still referring to FIG. 2, the slider 540 includes a removable battery pack 570 coupled to the slider 540 along the proximal end 544. The removable battery pack 570 includes a battery 572, electrical contacts 574, and a removable tab 576. The battery 572 of the delivery device 500 is isolated from the one or more flow paths and radiation sources due to the location of the battery 572 within the removable battery pack 570.

[0033]

[0048] 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]

[0049] In addition, as will be described in more detail herein, in some embodiments, the locking system 550 may include at least one planar wall relative to the other circular configurations of the locking system 550. In this case, the aperture formed by the locking system 550 through the upper surface 548 of the slider 540 is not circular in shape as shown and described above, but is irregular in shape. In this case, the vial assembly 580 includes the locking system 550 and, in particular, a locking feature 586 having a shape and size corresponding to the at least one planar wall, such that the vial assembly 580 is received within the slider 540 only when the orientation of the vial assembly 580 corresponds to the orientation of the locking feature 586 and the locking system 550. In other words, the corresponding planar wall 586A (see FIG. 3) of the locking feature 586 must be aligned with the planar wall of the locking system 550 such that the vial assembly 580 can be received within the aperture formed by the locking system 550 of the slider 540.

[0035]

[0050] 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 on the opposite side of 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 securely 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 inner chamber 588 of the vial body 589 in response to the linear translational movement of the vial engagement mechanism 520 when the engagement head 582 is secured to the pair of lever arms 522.

[0036]

[0051] The plunger 584 includes a plurality of markings and / or graduations 583 positioned along the longitudinal length of the plunger 584. The plurality of graduations 583 indicate the relative extension of the engagement head 582 and the plunger 584 from the locking feature 586 and the vial body 589. As briefly described above, the engagement head 582 is configured to attach the vial assembly 580 to the vial engagement mechanism 520. In particular, the pair of arms 581 of the engagement head 582 are sized and shaped to engage 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]

[0052] Still referring to FIG. 3, the vial assembly 580 further includes a safety tab 585 coupled to the plunger 584 over the relatively locking feature 586 and under the engagement head 582, such that the safety tab 585 is positioned along the longitudinal length of the plunger 584. The safety tab 585 can be formed of various materials such as, for example, plastic and is pre-assembled to the vial assembly 580 prior to use of the delivery device 500. The safety tab 585 is removably fastened to the plunger 584 and inhibits translation of the plunger 584 relative to the vial body 589. In particular, the safety tab 585 abuts against the locking feature 586 in response to the application of a linear force to the plunger 584 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 selectively removed from the plunger 584 in response to the coupling of the vial assembly 580 with the vial engagement mechanism 520 and, in particular, the engagement of the pair of lever arms 522 with the engagement head 582.

[0038]

[0053] 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, as a result, alignment of the planar walls 550A and 586A requires the vial assembly 580 to be received through the aperture formed by the locking system 550.

[0039]

[0054] Still referring to FIG. 3, the vial body 589 extends relatively downwardly from the locking feature 586 and has a longitudinal length sized to receive therein at least a portion of the longitudinal length of the plunger 584. Thus, in some embodiments, the longitudinal length of the plunger 584 exceeds the longitudinal length of the vial body 589, such that translational movement of the plunger 584 into the 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, translational movement 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]

[0055] The vial body 589 of this example is formed of a material configured to suppress radiation emission from a fluid medium stored within the internal chamber 588 of the vial body 589. For example, the vial body 589 may be formed of a plastic such as polycarbonate and may have a width. The combination of the density and material composition of the vial body 589 enables suppression of beta radiation emission from electron particles stored within the internal chamber 588. In this example, the chemical composition of the plastic of the vial body 589, in combination with a wall thickness of 9 mm, provides a plurality of atoms disposed within the vial body 589, and such a plurality of atoms can cope with beta radiation that generates electrons and reduce the emission of the above-described radiation from the vial assembly 580. Accordingly, the vial assembly 580 enables an operator to handle radioactive substances stored within the vial body 589 without being exposed to beta radiation. In other embodiments, it should be understood that 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]

[0056] Still referring to FIG. 3, the vial body 589 of the vial assembly 580 is sealed at the first end 598 by a 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, the septum 592 being 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 will be described in more detail herein, the septum 592 of the vial assembly 580 is configured to be pierced 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, alternative devices such as, for example, valve systems, needle injection ports, and / or the like can be used in place of the septum 592.

[0042]

[0057] 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 of the ribs 593.

[0043]

[0058] The stopper 594 is configured to form a liquid-tight seal with respect to the internal chamber 588 of the vial body 589 and can be formed of various polymers having a predetermined viscoelasticity. For example, in some embodiments, the stopper 594 is formed of elastomer, silicone, rubber, urethane, plastic, polyethylene, polypropylene, and / or the like. In this case, the stopper 594 is operable to prevent the fluid medium stored within the vial body 589 from diffusing (i.e., leaking) past the stopper 594 and out of the vial body 589. In particular, two or more ribs 593 of the stopper 594 abut against and form a seal along the internal chamber 588 of the vial body 589, thereby preventing the fluid medium from passing over the ribs 593. One or more recesses 595 formed between two or more ribs 593 of the stopper 594 are configured to receive, and more specifically capture, any fluid medium that may inadvertently diffuse (i.e., leak) past the ribs 593 of the stopper 594. Accordingly, the one or more recesses 595 serve as a safety mechanism for the vial assembly 580 to ensure that the fluid medium is maintained within the vial body 589 and not exposed beyond the vial assembly 580.

[0044]

[0059] 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. With the ribs 593 of the stopper 594 pressed against the internal chamber 588 of the vial body 589, the translational movement of the plunger 584 results in a translational movement of the ribs 593 relative to and along the internal chamber 588 of the vial body 589, such that any fluid medium located in front of (i.e., below) the stopper 594 is effectively redirected within the vial body 589 in the direction of travel of the plunger 584 and the stopper 594. The vial assembly 580 further includes an annular washer 596 disposed within the vial body 589. In particular, the annular washer 596 is firmly fixed to the plunger 584 adjacent to the stopper 594, which is secured to the plunger 584 at the opposite end of the engagement head 582. Thus, the annular washer 596 is fixed to the plunger 584 and disposed within the vial body 589 adjacent to the stopper 594. Since the annular washer 596 is fixed to the plunger 584 adjacent to the stopper 594, the annular washer 596 is effectively disposed within the vial body 589.

[0045]

[0060] Referring now to FIG. 5, in response to determining that battery 572 contains a sufficient amount of power or that another power source provides the same, one or more delivery conduits are coupled to the slider assembly 540 via one or more ports 556. In particular, the dosage delivery conduit 10A is coupled to the slider 540 at the delivery port 556A, the contrast agent conduit 10B is coupled to the slider 540 at the contrast agent port 556B, and the flushing conduit 10C is coupled to the slider 540 at the flushing port 556C. The opposite end of the dosage delivery conduit 10A is initially coupled to a fluid reservoir, such as a collection bowl, for example. As will be described in more detail herein, once the slider 540 is effectively primed by a fluid medium via the contrast agent conduit 10B, the dosage delivery conduit 10A can subsequently be coupled to an external device, such as a catheter. The opposite end of the flushing conduit 10C is coupled to an external device, such as a syringe, for example. With both the dosage delivery conduit 10A and the flushing conduit 10C coupled to the slider 540, the slider 540 is flushed with a fluid medium (e.g., saline) from a syringe coupled to the flushing conduit 10C. In this case, the fluid medium is injected through the flushing conduit 10C and into the distal manifold 555A of the slider 540 and out of the slider 540 through the dosage delivery conduit 10A. Thus, the fluid medium is ultimately received and disposed (or processed) therein by the collection bowl via the dosage delivery conduit 10A.

[0046]

[0061] Since the distal manifold 555A of the sliding body 540 is separated from the proximal manifold 555B by a one-way valve 553 disposed therebetween, the fluid medium flushed from the syringe (through the flushing port 556C) through the distal manifold 555A is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. Rather, the fluid medium injected from the syringe through the flushing conduit 10C is received at the flushing port 556C, passed 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 line 10A. In this case, the dose delivery line 10A receives the fluid medium and transports it to the collection bowl coupled thereto, as a result of which the fluid medium is not directed beyond the one-way valve 553 and into the proximal manifold 555B in fluid communication with the needle 559.

[0047]

[0062] 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 that is 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, thereby drawing saline from the saline bag into the syringe through the contrast agent conduit 10B, the contrast agent port 556B, the slider 540, and the priming conduit 562. The plunger of the syringe is then pushed inward to send the drawn saline in the opposite direction through the priming conduit 562, the central body portion 564, the elongated shaft 566, and the needle tip of the priming assembly 560, such that the saline is received into the needle 559 of the slider 540. Accordingly, the manifolds 555A, 555B of the slider 540 are effectively primed with saline from the syringe because the needle 559, which has received saline from the priming assembly 560, is in fluid communication with the manifolds 555A, 555B. Since the manifolds 555A, 555B are in further fluid communication with the dose delivery conduit 10A via the delivery port 556A, the saline is effectively supplied to a collection bowl coupled to the dose delivery conduit 10A.

[0048]

[0063] Referring now to FIG. 5, the slider 540 is coupled to one or more external devices via one or more ports 556. In particular, the slider 540 is fluidly coupled to a catheter (e.g., a microcatheter) via a dosage delivery conduit 10A coupled to the delivery port 556A of the slider 540. In this case, the catheter is in fluid communication with the slider 540 via the dosage delivery conduit 10A. Further, the slider 540 is fluidly coupled to a contrast agent source, such as a saline bag, which is fixed to the console assembly 510 via, for example, a mounting device 538 (see FIG. 1). The slider 540 is in fluid communication with the saline bag via a contrast agent conduit 10B coupled to the contrast agent port 556B of the slider 540. In this case, the saline bag is in fluid communication with the slider 540 via the contrast agent conduit 10B fixed to the contrast agent port 556B.

[0049]

[0064] The contrast agent port 556B is in fluid communication with the proximal manifold 555B, while the delivery port 556A is in fluid communication with the distal manifold 555A. As will be described in more detail herein, since the contrast agent port 556B is coupled to the proximal manifold 555B rather than the distal manifold 555A separated by a one-way check valve 553 disposed therebetween from the proximal manifold 555B, saline from the saline bag can be drawn through the needle 559 of the slider 540 into the vial body 589 of the vial assembly 580.

[0050]

[0065] Referring again to FIGS. 1 and 3, with the vial assembly 580 firmly coupled to the slider 540, the slider 540 is coupled to the console assembly 510 by translating the distal end 542 of the slider 540 toward and into the distal end 516 of the console assembly 510. In particular, the distal end 542 of the slider 540 is oriented into the sliding space 532 of the console assembly 510 by aligning the positioning rib 554 of the slider 540 with the positioning portion 534 of the console assembly 510. Once the proximal end 544 and the distal end 542 of the slider 540 are completely 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, thereby activating the console assembly 510 of the delivery device 500. In this case, the interface display 530 of the console assembly 510 is activated to display appropriate real-time information regarding the delivery device 500 during the procedure.

[0051]

[0066] Referring again to FIG. 5, when the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial receiving region 518, a negative pressure is generated within the internal chamber 588 of the vial body 589 due to the retraction of the stopper 594. In this case, with the saline bag coupled to the slider 540 via the contrast agent conduit 10B and the contrast agent port 556B, the saline from the saline bag is drawn into the internal chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Thus, if the vial body 589 is pre-filled with a radioactive fluid medium (e.g., radioactive embolization microspheres), the saline is effectively mixed with the radioactive fluid medium within the vial body 589 when the plunger 584 is retracted from the internal chamber 588 and a negative pressure is generated through the delivery device 500.

[0052]

[0067] The sliding body 540 further includes a one-way check valve 553A along the contrast agent conduit 10B and the flushing conduit 10C. In particular, the one-way check valve 553A is configured to allow fluid communication from the contrast agent port 556B and the flushing port 556C into the manifolds 555A, 555B, and is further configured to prevent fluid communication from the manifolds 555A, 555B to the contrast agent port 556B and the flushing port 556C. Therefore, it should be understood that directing the dose delivered from the vial body 589 to the manifolds 555A, 555B into the contrast agent conduit 10B or the flushing conduit 10C is impossible due to the one-way check valve 553A positioned 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 sliding body 540 and / or the vial assembly 580 coupled thereto. II. Multi-rib septum embodiments

[0068] As briefly described above, the delivery device 500 described herein may include multi-rib septa 692, 792, embodiments of which are described in more detail below with respect to FIGS. 6-14. FIGS. 6-10 illustrate an embodiment of a septum 692 as described herein, and FIGS. 11-14 illustrate an embodiment of another septum 792. Although an embodiment of a three-rib septum is illustrated, it is within the scope of the present disclosure and contemplated by the present disclosure that more or fewer ribs may be provided on the septa described herein.

[0053]

[0069] FIG. 6 illustrates a cross-sectional view of the vial assembly 580 of FIG. 3, and the vial assembly includes a septum 692 with a plurality of ribs. The vial assembly 580 is shown in FIG. 6 together with the vial body 589, the internal chamber 588 of the vial body 589, and the cap 590 as shown above. The vial body 589 is further shown to include a septum 692 disposed between the internal chamber 588 and the cap 590 of the vial assembly 580. FIG. 7 illustrates a detailed cross-sectional view of the septum 692 of the vial assembly 580 of FIG. 6, showing further details of the septum 692 disposed between the internal chamber 588 of the vial body 589 and the cap 590 of the vial assembly 580. The septum 692 is for sealing the vial assembly 580 having a vial body 589 of a vial including a neck region 591 including a first width as described in the embodiments within this specification.

[0054]

[0070] FIG. 8A is a top side perspective view of the septum 692. The septum 692 includes an upper surface 602, a lower surface 604 disposed opposite the upper surface 602, and a radially extending outer surface 606 disposed between the upper surface 602 and the lower surface 604.

[0055]

[0071] FIG. 8B is a top plan view of the septum 692. FIG. 9 is a cross-sectional view of the septum 692 taken along line A-A of FIG. 8B. As shown in FIG. 9, a plurality of ribs 608 are disposed on the upper surface 602. The septum 692 further includes a plurality of valleys 610, each valley 610 being disposed therebetween to radially separate at least two of the plurality of ribs 608. The plurality of ribs 608 include at least an inner first rib 612, an intermediate rib 614, and an outer outer rib 616, which are respectively an inner, intermediate, and outer rib in the radial direction to form a three-rib septum embodiment as a septum with a plurality of ribs, as shown in FIG. 9. The radius of curvature R1 of the valley 610 disposed between the inner first rib 612 and the intermediate rib 614 and the intermediate rib 612 can be 0.25 mm and can have a tolerance of plus or minus 0.13 mm such that the radius of curvature R1 is within the range of 0.12 mm to 0.38 mm. The radius of curvature R2 of the valley 610 disposed between the intermediate rib 614 and the outer outer rib 616 and the outer outer rib 616 can be about 0.13 mm and can have a tolerance of plus or minus 0.13 mm such that the radius of curvature R2 is within the range of 0 mm to 0.26 mm.

[0056]

[0072] The inner first rib 612 includes an outer wall 630 configured to radially compress against the inner wall of the neck region 591 of the vial as a radial outer wall 630. The outer wall 630 includes a height H2 that is greater than the height H1 of the intermediate rib 614 and the outer outer rib 616. In an embodiment, the height H2 can be 0.50 mm, the height H1 can be 0.25 mm, the height H2 can be within the range of about 0.37 mm to about 0.63 mm, and the height H1 can be within the range of about 0.12 mm to about 0.38 mm and can have a tolerance of plus or minus 0.13 mm.

[0057]

[0073] As further shown in FIG. 9, the bottom surface 604 includes a plurality of lower ribs 618. The plurality of ribs 608 of the septum 692 and the plurality of lower ribs 618 help provide an additional layer of seal to prevent leakage of fluid from the septum 692 from their respective upper or lower portions. The septum 692 further includes a plurality of lower valleys 620, and each valley 620 is disposed therebetween to radially separate at least two of the plurality of lower ribs 618 of the plurality of ribs 608. The plurality of valleys 610 and the plurality of lower valleys 620 help capture and hold any fluid that may leak past the ribs to prevent further leakage beyond the outer periphery of the septum 692. The plurality of lower ribs 618 may be positioned opposite to the plurality of ribs 608 of the upper surface 602 and may be aligned with the plurality of ribs 608 of the upper surface 602. The plurality of lower ribs 618 may include at least an inner first lower rib 622, an intermediate lower rib 624, and an outer outer lower rib 626. In an embodiment, the height of the inner first lower rib 622 may be equal to the height of the intermediate lower rib 624 and the outer outer lower rib 626. In another embodiment, as will be described in more detail below with respect to FIGS. 11-14, the inner first lower rib 722 may include a height H4 (FIG. 12) that is greater than the height H1 of the intermediate lower rib 624 and the outer outer lower rib 626. The inner first lower rib 722 having a height H4 greater than the height H1 of the intermediate lower rib 624 and the outer outer lower rib 626 helps provide an enhanced seal to prevent further compression against the vial assembly 580 and, thus, leakage through the septum 692.

[0058]

[0074] Referring again to FIG. 9, the septum 692 may include the diameter D1 of the intermediate rib 614 measured between the rib center points facing the 6.80 mm radial direction of the intermediate rib 614, with a tolerance of plus or minus 0.13 mm such that the diameter D1 may be in the range of about 6.67 mm to about 6.93 mm. The septum 692 may further include the diameter D2 of the outer outer rib 616 measured between the rib center points facing the 9.10 mm radial direction of the outer outer rib 616, with a tolerance of plus or minus 0.13 mm such that the diameter D2 may be in the range of about 8.57 mm to about 9.23. The lower diameter BD of the lower inner first rib 622 may be 4.72 mm, with a tolerance of plus or minus 0.13 mm such that the lower diameter BD may be in the range of about 4.59 mm to about 4.85 mm. The height H3 of the outer surface 606 disposed without including the plurality of ribs 608, 618 may be 1.00 mm, with a tolerance of plus or minus 0.13 mm such that the height H3 may be in the range of about 0.87 mm to about 1.13 mm.

[0059]

[0075] FIG. 10 is a side plan view of the septum 692. The outer diameter D3 of the outer surface 606 can be 9.60 mm, with a tolerance of plus or minus 0.13 mm such that the outer diameter D3 can be within the range of about 9.47 mm to about 9.73 mm. The radius of curvature R3 between the outer wall 630 and the upper surface 602 can be 0.13 mm, with a tolerance of plus or minus 0.13 mm such that the radius of curvature can be within the range of about 0 mm to about 0.26 mm. The radius of curvature R4 between the outer surface 606 and the upper surface 602 can be 0.25 mm, with a tolerance of plus or minus 0.13 mm such that the radius of curvature R4 can be within the range of about 0.12 mm to about 0.38 mm. The upper diameter TD of the inner first rib 612 can be 5.60 mm, with a tolerance of plus or minus 0.10 mm such that the upper diameter tD can be within the range of about 5.50 mm to about 5.70 mm. The lower diameter D3 of the outer surface 606 can be 9.60 mm, with a tolerance of plus or minus 0.10 mm such that the lower diameter D3 can be within the range of about 9.50 mm to about 9.70 mm. The first side depth SD1 of the outer surface 606 can be 1.50 mm, with a tolerance of plus or minus 0.13 mm such that the first side depth can be within the range of about 1.37 mm to about 1.63 mm. The second side depth SD2 of the outer wall 630 of the outer surface 606 and the inner first rib 612 can be 2.00 mm, with a tolerance of plus or minus 0.13 mm such that the second side depth SD2 can be within the range of about 1.87 mm to about 2.13 mm.

[0060]

[0076] As described above, FIGS. 11-14 illustrate another embodiment of a septum 792 with multiple ribs. FIG. 11 is a side perspective view of another embodiment of the septum 792 for the vial assembly 580 of FIG. 6. FIG. 12 is a lower side perspective view of the septum 792. The septum 792 is similar to the septum 692 except for the inner first rib 722 of the lower layer, which can include a height H4 (FIG. 12) greater than the height H1 of the intermediate rib 624 of the lower layer and the outer outer rib 626 of the lower layer, as described above. In an embodiment, the height H1 can be within the range of about 0.12 mm to 0.38 mm, such as 0.25 mm, and the height H4 can be within the range of about 0.37 mm to about 0.63 mm, such as 0.50 mm.

[0061]

[0077] FIG. 13 illustrates a first set of compression test data results of septum 792 after compression of outer wall 630 against the inner wall of neck region 591 of the vial to measure the contact pressure of septum 792 against needle 559. FIG. 14 illustrates a second set of compression test data results of septum 792 after compression of outer wall 630 against the inner wall of neck region 591 of the vial to measure the contact pressure of septum 792 against needle 559. With respect to the results of FIGS. 13-14, the radial compression target contact pressure between outer wall 630 of septum 792 and the inner wall of neck region 591 of the vial was greater than 1.03 MPa (150 psi (pounds per square inch)) to prevent leakage from pressure and vacuum cycles.

[0062]

[0078] In an embodiment, vial assembly 580 includes vial 597, needle 559, and septa 692, 792, as described herein. Vial 597 may include particulate material and a neck region 591 having a first width. Needle 559 may include at least one port and may be configured for receipt within neck region 591. Septa 692, 792 may be configured to receive needle 559 and to seal vial assembly 580 and needle 559.

[0063]

[0079] The needle 559 can be configured to pierce the septums 692, 792 of the vial assembly 580 when the vial assembly 580 is in the locked position. In an embodiment, the needle 559 can be included within the vial chamber and can be configured to pierce the septums 692, 792 of the vial assembly 580 when the vial assembly 580 is received within the vial chamber (i.e., when the vial assembly 580 is in the locked position). At least one port can be configured to be within the neck region 591 of the vial assembly 580 when the vial assembly 580 is in the locked position. At least one port can be further configured to inject fluid into the vial assembly 580 for mixing with the particulate material upon actuation of the vial engagement mechanism coupled to the vial assembly 580 in a first direction, and to receive the resulting mixed fluid from the vial assembly 580 upon actuation of the vial engagement mechanism 520 in a second direction opposite the first direction. In an embodiment, at least one port can be further configured to couple to a fluid source. When coupled, fluid from the fluid source can be injected into the vial assembly 580 via the at least one port for mixing with the particulate material upon actuation of the vial engagement mechanism 520 coupled to the vial assembly 580 in a first direction. The resulting mixed fluid can be discharged from the vial assembly 580 via the at least one port upon actuation of the vial engagement mechanism 520 in a second direction opposite the first direction.

[0064]

[0080] The vial assembly 580 can further include a particulate material assembly (such as a delivery device 500 as described herein) that can include a console (such as of the console assembly 510) that includes a vial receiving region 518. The vial engagement mechanism 520 can extend from the console within the vial receiving region 518, and the vial engagement mechanism 520 includes engagement features that can engage corresponding engagement features of the vial assembly 580 and can be configured to move the vial assembly 580 distally to a locked position (i.e., as noted above, the needle 559 can be configured to pierce the septums 692, 792 of the vial assembly 580 when the vial assembly 580 is in the locked position).

[0065]

[0081] In embodiments herein, septums 692, 792 can thus be used to create a seal over the piercing region of a syringe or container such as the vial assembly 580. The three - ribbed embodiments as described herein can provide a seven - fold improvement to the user over zero - rib septum safety in preventing fluid from leaking out of and escaping through the septum. The seal of the septums 692, 792 can be made of an elastomeric material such as rubber or silicone. The inner first rib 612 can be configured to create a radial seal with the mating surface of the vial 597, and the outer outer rib 616 can be configured to create a seal around the corresponding septum pocket of the vial assembly 580 that receives the septums 692, 792. The septums 692, 792 can be housed within a septum pocket having a sealing surface that can be adhered through fastening mechanisms such as ultrasonic bonding and / or screws, adhesives, crimp bonds, and / or the like. A user of the septums 692, 792 with the vial assembly 580 as described herein can be enabled to pressurize the vial assembly 580 to high pressures and can be capable of withstanding an internal pressure of up to 2.41 MPa (350 psi) without damage in the pierced state, as shown by the test results of FIGS. 13 - 14. III. List of Aspects

[0082] Aspect 1. A septum for sealing a vial assembly having a vial including a neck region having a first width includes an upper surface, a lower surface disposed opposite the upper surface, a radially extending outer surface disposed between the upper surface and the lower surface, a plurality of ribs disposed on the upper surface, and a plurality of valleys. Each valley may be disposed between at least two of the plurality of ribs to space them apart. The plurality of ribs may include at least an inner first rib, an intermediate rib, and an outer outer rib. The inner first rib may include an outer wall configured to radially compress against the inner wall of the neck region of the vial, and the outer wall includes a height greater than the heights of the intermediate rib and the outer outer rib.

[0066]

[0083] Aspect 2. The septum according to Aspect 1, wherein the lower surface comprises a plurality of lower ribs.

[0084] Aspect 3. The septum according to Aspect 2, wherein the plurality of lower ribs are positioned opposite and aligned with the plurality of ribs on the upper surface.

[0067]

[0085] Aspect 4. The septum according to Aspect 2 or Aspect 3, wherein the plurality of lower ribs comprise at least a lower inner first rib, a lower intermediate rib, and a lower outer outer rib.

[0068]

[0086] Aspect 5. The septum according to Aspect 4, wherein the lower inner first rib includes a height greater than the heights of the lower intermediate rib and the lower outer outer rib.

[0069]

[0087] Aspect 6. The vial assembly comprises a vial, a needle, and a septum. The vial may include a particulate material and a neck region, and the neck region includes a first width. The needle may include at least one port and may be configured for reception within the neck region. The septum may be configured to receive the needle and may be configured to seal the vial assembly and the needle. The septum may include an upper surface, a lower surface disposed opposite the upper surface, a radially extending outer surface disposed between the upper surface and the lower surface, a plurality of ribs disposed on the upper surface, and a plurality of valleys. Each valley may be disposed between at least two of the plurality of ribs to space the at least two of the plurality of ribs apart. The plurality of ribs may include at least an inner first rib, an intermediate rib, and an outer outer rib. The inner first rib may include an outer wall configured to radially compress against the inner wall of the neck region of the vial, and the outer wall includes a height greater than the heights of the intermediate rib and the outer outer rib.

[0070]

[0088] Aspect 7. A vial assembly according to aspect 6, wherein the needle may be configured to pierce the septum of the vial assembly when the vial assembly is in a locked position, and at least one port may be configured to be within the neck region of the vial assembly when the vial assembly is in a locked position.

[0071] At least one port may be further configured to inject fluid into the vial assembly for mixing with the particulate material upon actuation of a vial engagement mechanism coupled to the vial assembly 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.

[0072]

[0089] Aspect 8. A vial assembly according to aspect 7, further comprising a particulate material assembly. The microparticle material assembly may include a console that includes a vial receiving region. A vial engagement mechanism may extend from the console within the vial receiving region. The vial engagement mechanism includes engagement features configured to engage corresponding engagement features of a vial assembly and to move the vial assembly distally to a locked position configured such that a needle pierces a septum of the vial assembly.

[0073]

[0090] Aspect 9. A vial assembly according to any one of Aspects 6 to 8, wherein the lower surface comprises a plurality of lower ribs.

[0091] Aspect 10. The vial assembly of Aspect 9, wherein the plurality of lower ribs are positioned opposite and aligned with the plurality of upper ribs.

[0074]

[0092] Aspect 11. The vial assembly of Aspect 9 or Aspect 10, wherein the plurality of lower ribs comprise at least an inner first lower rib, an intermediate lower rib, and an outer outer lower rib.

[0075]

[0093] Aspect 12. The vial assembly of Aspect 11, wherein the inner first lower rib includes a height greater than the heights of the intermediate lower rib and the outer outer lower rib.

[0076]

[0094] Aspect 13. The vial comprises a particulate material, a neck region including a first width, and a septum. The septum may include an upper surface, a lower surface disposed opposite the upper surface, a radially extending outer surface disposed between the upper surface and the lower surface, a plurality of ribs disposed on the upper surface, and a plurality of valleys. Each valley may be disposed between at least two of the plurality of ribs to space the at least two of the plurality of ribs apart. The plurality of ribs may include at least an inner first rib, an intermediate rib, and an outer outer rib. The inner first rib may include an outer wall configured to radially compress against the inner wall of the neck region of the vial, and the outer wall includes a height greater than the height of the intermediate rib and the outer outer rib.

[0077]

[0095] Aspect 14. The vial according to aspect 13, further comprising a vial assembly. The vial assembly may include a vial and a needle. The vial assembly may be configured to move the vial to a locked position. The needle may include 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 may be further configured to be within the neck region of the vial assembly when the vial assembly is in the locked position.

[0078]

[0096] Aspect 15. The vial according to aspect 14, further comprising a particulate material assembly. The particulate material assembly may include a console and a vial engagement mechanism. The console may include a vial receiving region. The vial engagement mechanism may extend from the console within the vial receiving region. The vial engagement mechanism includes an engagement feature configured to engage a corresponding engagement feature of the vial assembly and to move the vial assembly distally to a locked position where the needle is configured to pierce the septum of the vial assembly.

[0079]

[0097] Aspect 16. The vial according to any one of aspects 13 to 15, The following is a vial having a plurality of lower ribs.

[0098] Aspect 17. The vial of Aspect 16, wherein the plurality of lower ribs are positioned opposite to and aligned with the plurality of upper ribs.

[0080]

[0099] Aspect 18. The vial of Aspect 16 or Aspect 17, wherein the plurality of lower ribs include at least an inner first rib of the lower layer, an intermediate rib of the lower layer, and an outer outer rib of the lower layer.

[0081]

[0100] Aspect 19. The vial of Aspect 18, wherein the inner first rib of the lower layer has a height greater than the heights of the intermediate rib of the lower layer and the outer outer rib of the lower layer.

[0082]

[0101] Aspect 20. The vial according to Aspect 18 or Aspect 19, wherein the height of the inner first rib is equal to the height of the inner first rib of the lower layer.

[0102] Note that the terms "substantially" and "about" may be used herein to represent the essential degree of uncertainty that may arise from any quantitative comparison, value, measurement, or other expression. These terms are also used herein to represent the degree to which a quantitative expression may vary from the recited reference without resulting in a change in the basic function of the subject matter in question.

[0083]

[0103] For the purpose of explaining and defining the present disclosure, it should be noted that the term "substantially" is used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other expression. The term "substantially" is also used herein to represent the degree to which a quantitative expression can vary from the stated reference without resulting in a change in the basic function of the subject matter in question. As such, it is used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other expression with respect to the arrangement of elements or features that, while theoretically expected to present an exact match or behavior, may in practice embody something that is slightly less than exact.

[0084]

[0104] Although specific embodiments are illustrated and described herein, it should be understood that various other changes and modifications can be made without departing from the spirit and scope of the claimed subject matter. Furthermore, although 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.

[0085]

[0105] Claims

Claims

1. A septum for sealing a vial assembly having a vial including a neck region including a first width, the septum comprising: an upper surface; a lower surface disposed opposite the upper surface; a radially extending outer surface disposed between the upper surface and the lower surface; a plurality of ribs disposed on the upper surface; a plurality of valleys, each valley disposed therebetween to space apart at least two of the plurality of ribs; the plurality of ribs comprising at least an inner first rib, an intermediate rib, and an outer outer rib; the inner first rib comprising an outer wall configured to radially compress against an inner wall of the neck region of the vial, the outer wall including a height greater than heights of the intermediate rib and the outer outer rib, the septum.

2. The septum according to claim 1, wherein the lower surface comprises a plurality of lower ribs.

3. The septum according to claim 2, wherein the plurality of lower ribs are positioned opposite and aligned with the plurality of ribs on the upper surface.

4. The septum according to claim 2, wherein the plurality of lower ribs comprise at least a lower inner first rib, a lower intermediate rib, and a lower outer outer rib.

5. The septum according to claim 4, wherein the lower inner first rib includes a height greater than heights of the lower intermediate rib and the lower outer outer rib.

6. A vial assembly, the vial assembly comprising: a vial comprising a particulate material and a neck region, the neck region including a first width; a needle comprising at least one port and configured for reception within the neck region; a septum configured to receive the needle and to seal the vial assembly and the needle, the septum comprising: an upper surface; a lower surface disposed opposite the upper surface; a radially extending outer surface disposed between the upper surface and the lower surface; a plurality of ribs disposed on the upper surface; a plurality of valleys, each valley disposed therebetween to space apart at least two of the plurality of ribs; the plurality of ribs comprising at least an inner first rib, an intermediate rib, and an outer outer rib; The inner first rib includes an outer wall, the outer wall is configured to compress radially against the inner wall of the neck region of the vial, and the outer wall includes a height greater than the heights of the intermediate rib and the outer outer rib, a vial assembly.

7. The vial assembly according to claim 6, wherein the needle is configured to pierce the septum of the vial assembly when the vial assembly is in the locked position, wherein the at least one port is 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 further configured to inject fluid into the vial assembly for mixing with particulate material upon actuation of a vial engagement mechanism coupled to the vial assembly 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 to the first direction, a vial assembly.

8. The vial assembly according to claim 7, further comprising a particulate material assembly, the particulate material assembly comprises a console including a vial receiving region, a vial engagement mechanism extending from the console within the vial receiving region, the vial engagement mechanism engaging corresponding engagement features of the vial assembly and comprising engagement features configured to move the vial assembly distally to a locked position where the needle is configured to pierce the septum of the vial assembly, a vial assembly.

9. The vial assembly according to claim 6, wherein the bottom surface comprises a plurality of lower ribs, a vial assembly.

10. The vial assembly according to claim 9, wherein the plurality of lower ribs are positioned opposite and aligned with the plurality of upper ribs, a vial assembly.

11. The vial assembly according to claim 9, wherein the plurality of lower ribs comprise at least an inner first rib of the lower layer, an intermediate rib of the lower layer, and an outer outer rib of the lower layer, a vial assembly.

12. The vial assembly according to claim 11, The inner first rib of the lower layer includes a height greater than the height of the intermediate rib of the lower layer and the outer outer rib of the lower layer, the vial assembly.

13. A vial, the vial comprising: a particulate material; a neck region including a first width; a septum, the septum comprising: an upper surface; a lower surface disposed opposite the upper surface; a radially extending outer surface disposed between the upper surface and the lower surface; a plurality of ribs disposed on the upper surface; a plurality of valleys, each valley being disposed therebetween to separate at least two of the plurality of ribs; the plurality of ribs comprising at least an inner first rib, an intermediate rib, and an outer outer rib; the inner first rib comprising an outer wall configured to radially compress against the inner wall of the neck region of the vial, the outer wall including a height greater than the height of the intermediate rib and the outer outer rib, the vial.

14. The vial according to claim 13, further comprising a vial assembly, the vial assembly comprising: the vial, the vial assembly being configured to move the vial to a locked position, the vial; a needle comprising 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 being further configured to be within the neck region of the vial assembly when the vial assembly is in the locked position, the needle.

15. The vial according to claim 14, further comprising a particulate material assembly, the particulate material assembly comprising: a console including a vial receiving region; a vial engagement mechanism extending from the console within the vial receiving region, the vial engagement mechanism comprising an engagement feature configured to engage a corresponding engagement feature of the vial assembly and configured to distally move the vial assembly to a locked position such that the needle pierces the septum of the vial assembly, the vial.

16. The vial according to claim 13, wherein the lower surface comprises a plurality of ribs of a lower layer, the vial.

17. The vial according to claim 16, The plurality of ribs in the lower layer are positioned opposite to the plurality of ribs on the upper surface and are aligned with the plurality of ribs on the upper surface, the vial.

18. The vial according to claim 16, wherein the plurality of ribs in the lower layer include at least an inner first rib in the lower layer, an intermediate rib in the lower layer, and an outer outer rib in the lower layer, the vial.

19. The vial according to claim 18, wherein the inner first rib in the lower layer has a height greater than the heights of the intermediate rib in the lower layer and the outer outer rib in the lower layer, the vial.

20. The vial according to claim 18, wherein the height of the inner first rib is equal to the height of the inner first rib in the lower layer, the vial.

Images