Vial assembly systems and methods for optimal flow

Abstract

Systems and methods of the invention relate to a vial assembly system including a vial assembly and a needle. The vial assembly includes a diaphragm, a neck region including a top, a bottom, and a sidewall, and a particulate region including a bypass valve. The needle includes a port and a tip configured to pierce a septum configured to receive the needle such that the port is disposed in the neck region. A bypass path includes a first end and a second end, the bypass valve connected to the first end, the second end terminating at or within the sidewall, the bypass path configured to provide a fluid flow path to the needle in place of the first path upon pressure build-up of fluid flow in the vial assembly, the bypass path being configured to provide a fluid flow path to the needle in place of the second path upon pressure build-up of fluid flow in the vial assembly. And the first path is disposed in the vial assembly directly between the particulate region and the neck region.

Description

Technical Field

[0001] The present disclosure relates generally to components of medical devices for treating cancer and, more particularly, to a medical device vial assembly system configured and operable to deliver a radioactive compound to a treatment area within a patient's body during a procedure such as transarterial radioembolization. Background Art

[0002] In cancer treatment involving radiation therapy, unintentional or excessive exposure to radiation from the radiotherapeutic agent can be harmful and potentially fatal to the patient or medical personnel. Therefore, medical devices used for radiation therapy must be constructed to localize the delivery of radioactive materials to specific areas of the patient's body while protecting others from unnecessary radiation.

[0003] Transarterial radioembolization is a transcatheter intra-arterial procedure performed by interventional radiology and is commonly used to treat malignant tumors. In this medical procedure, a microcatheter is navigated into the patient's liver where it is loaded with a substance such as yttrium-90 ( 90 Radioembolic microspheres containing radioactive compounds (e.g., Y) are delivered to the target tumor. The microspheres embolize the blood vessels supplying the tumor while also delivering radiation to kill tumor cells. Generally speaking, the clinician or patient may be at risk of exposure to radiation emissions from the delivery.

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

[0005] According to one embodiment of the present disclosure, a vial assembly system includes a vial assembly and a needle. The vial assembly includes a diaphragm, a neck region, and a particle region for accommodating particles, the particle region includes a bypass valve, and the neck region includes a top, a bottom, and a side wall disposed between the top and the bottom. The needle includes a port and a tip located distal to the port, the tip being configured to pierce the diaphragm of the vial assembly disposed at the bottom of the neck region. The diaphragm is configured to receive the needle so that the port is disposed in the neck region of the vial assembly. A bypass path includes a first end and a second end. The bypass valve is connected to the first end of the bypass path, and the second end of the bypass path terminates at or within the side wall of the neck region. The bypass path is configured to provide the needle with a fluid flow path that replaces the first path when the pressure of the fluid flow in the vial assembly accumulates, and the first path is disposed in the vial assembly directly between the particle region and the neck region.

[0006] In another embodiment, a vial assembly system includes a vial assembly and a needle. The vial assembly includes a septum, a neck region, and a particle region for accommodating particles, the particle region including a bypass valve, the neck region including a top, a bottom, and a sidewall disposed between the top and the bottom, and the needle includes a port and a tip located distal to the port, the tip being configured to pierce the septum of the vial assembly disposed at the bottom of the neck region. The septum is configured to receive the needle so that the port is disposed in the neck region of the vial assembly. The bypass valve is connected to a bypass path including a first end and a second end. The bypass valve is connected to a first end of the bypass path, and the second end of the bypass path terminates at or within the sidewall of the neck region. The bypass path is configured to provide a fluid flow path to the needle that replaces a first path when pressure of the fluid flow in the vial assembly accumulates, and the first path is disposed in the vial assembly directly between the particle region and the neck region. The bypass path includes a conduit disposed between the bypass valve and a sidewall of the neck region, and the conduit of the bypass path is disposed radially relative to a longitudinal axis of the vial assembly.

[0007] In another embodiment, a method of operating a vial assembly system includes receiving a needle in a septum of a vial assembly of the vial assembly system such that a port of the needle is disposed in a neck region of the vial assembly. The vial assembly further includes a particle region, the particle region includes a bypass valve, the neck region includes a top, a bottom, and a sidewall disposed between the top and the bottom, the needle further includes a tip located distal to the port, the tip being configured to pierce a septum of the vial assembly disposed at the bottom of the neck region. The method further includes monitoring a pressure buildup in the vial assembly to determine whether the pressure buildup exceeds a threshold, and when the monitored pressure buildup exceeds the threshold, changing a fluid flow path from a first path to a bypass path. The bypass path includes a first end and a second end, the bypass valve is connected to the first end of the bypass path, the second end of the bypass path terminates at or within the sidewall of the neck region, and the first path is disposed in the vial assembly directly between the particle region and the neck region.

[0008] These and additional features provided by the embodiments described herein will be more fully understood from the following detailed description, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0010] Figure 2 for Figure 1 The vial slide according to one or more embodiments shown and described herein is arranged along Figure 1 A cross-sectional view of the section taken along line 2-2;

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

[0012] Figure 4 for Figure 4 The vial assembly is along Figure 3 A partial cross-sectional view of a section taken along line 4-4;

[0013] Figure 5 for Figure 1 A perspective view of a vial slide according to one or more embodiments shown and described herein, wherein a vial slide is received Figure 3 a vial assembly wherein a series of delivery lines are coupled to the vial slide;

[0014] Figure 6 is a schematic side view of a vial assembly system in a non-flow position, the vial assembly system pre-filled with microparticles for delivery, according to one or more embodiments shown and described herein;

[0015] Figure 7 for Figure 6 a side schematic view of a vial assembly system in a bypass path flow position in which a fluid containing particulates is directed along a bypass path to bypass a high concentration of underlying particulates in the vial assembly; and

[0016] Figure 8 for Figure 6 A side schematic diagram of a vial assembly system in a first path flow position in which a fluid containing particles is directed along a first path disposed between a particle region and a neck region of the vial assembly, wherein a high concentration of underlying particles is not present in the vial assembly. DETAILED DESCRIPTION

[0017] Reference will now be made in detail to various embodiments of a delivery device for administering a radioactive compound to a patient, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts. As used herein, directional terms—such as up, down, right, left, front, back, top, bottom, distal, and proximal—are made solely with reference to the drawings as drawn and do not imply absolute directions.

[0018] Ranges herein may be expressed as from "about" one particular value, and / or to "about" another particular value. When such ranges are expressed, another embodiment comprises from a particular value and / or to another particular value. Similarly, when values ​​are expressed as approximate values ​​by using the antecedent "about", it is understood that the particular values ​​form another embodiment. It is also understood that the endpoints of each range are important relative to the other endpoint and independently of the other endpoint.

[0019] Unless otherwise expressly stated, any method set forth herein should not be construed as requiring that its steps be performed in a specific order, or that any device have a specific orientation. Thus, in the absence of a method claim actually reciting the order in which its steps are to be followed, or any device claim actually reciting the order or orientation of the individual components, or in the absence of another specific statement in the claim or specification that the steps are limited to a specific order, or in the absence of a specific order or orientation of the components of the device, there is no intention to infer an order or orientation in any respect. The same is true for any possible non-explicitly stated basis for interpretation, including: logical matters regarding the arrangement of steps, operational flow, order of components, or orientation of components; straightforward meaning derived from grammatical organization or punctuation; the number or type of embodiments described in the specification.

[0020] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those of ordinary skill in the art to which the present disclosure belongs. The terms used in the description herein are only used to describe specific embodiments and are not intended to be limiting. As used in the specification and the appended claims, the singular forms "a", "an", and "the" are also intended to include plural forms unless the context clearly indicates otherwise.

[0021] As used herein, the terms "horizontal", "vertical", "distal" and "proximal" are relative terms only, indicating only a general relative orientation, not necessarily indicating verticality. For convenience, these terms may also be used to refer to the orientations used in the accompanying drawings, which are used only as a convention and are not intended to be features of the devices shown. The present disclosure and embodiments thereof to be described herein may be used in any desired orientation. In addition, horizontal and vertical walls generally only need to be intersecting walls, not vertical. As used herein, the singular forms "a", "a kind of", and "the" include plural references unless the context clearly indicates otherwise. Thus, for example, a reference to a "one" component includes aspects having two or more such components, unless the context clearly indicates otherwise.

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

[0023] Described below Figure 1-5 Embodiments of the delivery device 500 for delivering microparticles 660, described in more detail below, Figure 6-8 Embodiments of one or more vial assembly system components of a delivery device 500 as described herein facilitate delivery of microparticles 660 within a mixed solution 662 as described herein to a patient. As will be described in more detail below, Figure 6 An exemplary vial assembly system 600 includes a vial assembly 580', such as a syringe assembly prefilled with embolic particles as microparticles 660 to be delivered as a concentration of particles via a mixed solution 662 that is compatible with a fluid path through, for example, a needle, tubing, catheter, or similar delivery member, such as Figure 7-8 . The vial assembly 580' may include a concentration regulator 664, described in more detail below, which may allow an appropriate concentration of microparticles 660 to pass through the fluid path within and with the mixed solution 662. If the mass of microparticles 660 is too large for the fluid path and associated delivery components due to potential improper or insufficient mixing of the mixed solution 662 or sedimentation of the microparticles 660 due to gravity, the microparticles 660 may clog the microcatheter and prevent administration. Therefore, if the concentration of microparticles 660 is too high compared to a threshold value and may clog the fluid path delivery components, such as tubing, the concentration regulator 664 may restrict flow and allow the remaining low-concentration fluid as an upper layer of mixed solution 662 (above the bottom layer of suspended microparticles 660) to bypass the concentration regulator 664 via a pressure-sensitive one-way flow path, such as through a bypass valve 606 as described herein. The bypass valve 606 may be triggered by a pressure sensor component, or may be otherwise configured to open when the pressure applied to the bypass valve 606 exceeds a threshold value.

[0024] In some embodiments, as described in more detail below, the delivery device 500 is a radioembolic delivery device, the microparticles 660 are a plurality of radioembolic beads, the fluid is a saline solution, and the resulting mixed fluid (e.g., mixed solution 662) is a radioembolic bead-saline solution. The needle 559 can be configured to deliver the radioembolic bead-saline solution as a mixed fluid solution through the radioembolic delivery device, such as when the vial engagement mechanism 520 is actuated in a positive pressure direction. In some embodiments, the fluid is a contrast agent-saline solution containing a contrast agent, and the resulting mixed fluid (e.g., mixed solution 662) is a radioembolic bead-contrast agent-saline solution. The needle 559 can be configured to deliver the radioembolic bead-contrast agent-saline solution as a mixed solution 662 through the radioembolic delivery device. In some embodiments, the delivery device 500 is a chemoembolic delivery device, the microparticles 660 are a plurality of chemoembolic beads, and the mixed solution 662 is a bead-saline solution or a bead-contrast agent-saline solution.

[0025] I. Mechanical delivery device with removable slide assembly

[0026] Figure 1-5 One embodiment of a delivery device 500 is shown that is configured and operable to deliver radioactive material (e.g., radioembolic beads) while reducing radioactive emissions during use of the delivery device 500. The delivery device 500 can be operated as described in International PCT Application No. PCT / 2019 / 033001, filed May 17, 2019, the entire contents of which are incorporated herein, except for the delivery flow components of the vial assembly system, which contain a bypass path, as described below with respect to Figure 6 - 8 and described in more detail in one or more embodiments of the present invention.

[0027] First reference Figure 1 , the delivery device 500 includes a console assembly 510, which includes a console. The delivery device 500 may include a slide assembly 540, which is operable to transition between a coupled state and a decoupled state relative to the console assembly 510. The console assembly 510 of the delivery device 500 includes a base 512, which is defined by a proximal end 514 and a distal end 516 and extends between the proximal end and the distal end. The proximal end 514 of the base 512 includes a handle (delivery handle) 528 that is movably coupled to the console assembly 510 and an interface display 530 positioned on the console assembly 510.

[0028] The proximal end 514 of the base 512 further includes an attachment device 538 configured to securely hold an external device to the base 512 of the console assembly 510. The attachment device 538 is operable to facilitate attachment of a supplemental device to the console assembly 510 for use with the delivery device 500 during surgery.

[0029] Still reference Figure 1 , the distal end 516 of the console assembly 510 defines a vial receiving area 518, which is sized and shaped to receive a vial assembly 580 therein, as will be described in more detail herein. The console assembly 510 further includes a vial engagement mechanism 520 extending from the base 512 adjacent the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outward from the base 512 of the console assembly 510 toward the distal end 516. The vial engagement mechanism 520 is positioned within the vial receiving area 518 of the console assembly 510 and is movably coupled to a handle 528. In particular, the handle 528 of the console assembly 510 is operable to move, in particular translate, the vial engagement mechanism 520 within the vial receiving area 518 in response to actuation of the handle 528.

[0030] The console assembly 510 includes a mechanical assembly disposed within the base 512 that is configured and operable to translate 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.

[0031] Slide cavity 532 is sized and shaped to receive slide assembly 540 therein. As will be described in greater detail herein, slide assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, media) therethrough. In particular, slide assembly 540 is configured to partially receive vial assembly 580 therein for administering therapeutic particles from delivery device 500 to a patient during surgery.

[0032] In the embodiments, reference Figure 2 The flow sensor of the delivery device 500 can be positioned in series with the tubing set of the delivery device 500, particularly the needle 559, the manifolds 555A, 555B, and / or one or more ports 556, and can be configured to measure the amount of fluid (e.g., the suspension liquid after the therapeutic particles are effectively mixed with the fluid medium) passing therethrough. Return to Reference Figure 1, the vial engagement mechanism 520 includes a pair of lever arms 522 extending outwardly from a neck 524 of the vial engagement mechanism 520, wherein the neck 524 extends laterally outwardly from the base 512 of the console assembly 510. The neck 524 of the vial engagement mechanism 520 is disposed within a protective cap 525 such that only the pair of lever arms 522 of the vial engagement mechanism 520 extend through the protective cap 525. The protective cap 525 is operable to isolate one or more internal components of the console assembly 510 from the exterior of the console assembly 510, particularly from the vial receiving area 518.

[0033] The pair of lever arms 522 can move 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 so that the interval formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 is configured to securely engage the vial assembly 580 therebetween, particularly within the space formed by the pair of lever arms 522. Therefore, the vial engagement mechanism 520 is operable to securely attach the vial assembly 580 to the console assembly 510 at the vial receiving area 518. Although the vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, it should be understood that the vial engagement mechanism 520 can include various other structural configurations suitable for engaging the vial assembly 580. In a non-limiting example, the vial engagement mechanism 520 can include one or more magnets configured to engage with one or more corresponding magnets on the vial assembly.

[0034] Still reference Figure 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 area 518. In particular, the safety shield 526 is a protective covering that is sized and shaped to enclose the vial receiving area 518 of the console assembly 510 when secured to the console assembly 510. The safety shield 526 is selectively attachable to the distal end 516 of the base 512 and is formed of a material configured to inhibit radioactive emissions from one or more radioactive doses stored within the vial receiving area 518.

[0035] The distal end 516 of the console assembly 510 further includes a slide plate cavity 532 that is sized and shaped to receive a slide plate assembly 540 therein. The slide plate cavity 532 includes one or more or a pair of alignment features 534 extending therein, wherein the alignment features 534 are sized and shaped to correspond to complementary alignment features (e.g., alignment ribs 554) of the slide plate assembly 540, thereby facilitating coupling of the slide plate assembly 540 with the base 512 of the console assembly 510 within the slide plate cavity 532.

[0036] Still reference Figure 1 , the slide assembly 540 is configured to partially receive the vial assembly 580 therein for administering therapeutic particles (e.g., radioactive fluid medium) to the patient from the delivery device 500. In particular, the slide assembly 540 includes a distal end 542 and a proximal end 544 and a pair of sidewalls 546 extending between the distal end and the proximal end. The distal end 542 of the slide assembly 540 includes a handle 552 extending proximally therefrom. The handle 552 is configured to facilitate movement of the slide assembly 540, in particular, to facilitate insertion of the slide assembly 540 into the slide cavity 532 of the console assembly 510. The distal end 542 further includes one or more ports 556 for connecting one or more delivery lines (i.e., tubing) to the slide assembly 540. In the case where the one or more delivery lines are further connected to one or more external devices at the ends of the lines opposite to the ports 556, the ports 556 are effectively used to fluidically connect the slide assembly 540 to the one or more external devices via the delivery lines connected thereto. The pair of side walls 546 of the slide assembly 540 include at least one alignment rib 554 extending laterally outward therefrom, wherein the alignment rib 554 is sized and shaped to correspond to and cooperate with the pair of alignment features 534 of the console assembly 510. Thus, the pair of alignment ribs 554 are configured to facilitate alignment and engagement of the slide assembly 540 with the console assembly 510 when the proximal end 544 is slidably received in the slide cavity 532 of the base 512.

[0037] The slide assembly 540 further includes a top surface 548 extending from the distal end 542 and the proximal end 544 and positioned between the pair of sidewalls 546. The top surface 548 of the slide assembly includes a recessed area 549 and a locking system 550. The recessed area 549 is sized and shaped to form a groove and / or cavity along the top surface 548, wherein the recessed area 549 is capable of receiving and / or collecting various materials therein, including, for example, various fluid media leaked during use of the delivery device 500. The locking system 550 of the slide assembly 540 forms an opening along the top surface 548, which is sized and shaped to receive one or more devices, such as a perfusion assembly 560 and a vial assembly 580 therein. In some embodiments, the slide assembly 540 is preloaded with the perfusion assembly 560 disposed within the locking system 550. The perfusion assembly 560 includes a perfusion line 562 extending outwardly from the locking system 550 of the slide assembly 540. Irrigation assembly 560 connects irrigation line 562 to needle 559 and manifolds 555A and 555B, and is used to purge air from delivery device 500, including manifolds 555A and 555B, prior to using delivery device 500 in surgery.

[0038] Reference now Figure 2 , the locking system 550 includes an annular array of protrusions 551 that extend outwardly from the locking system 550, particularly laterally into a hole formed by the locking system 550 along the top surface 548. The annular array of protrusions 551 is formed within the inner periphery of the locking system 550 and extends along at least two sequentially arranged rows. In an embodiment, a single row may be used. The annular array of protrusions 551 included in the locking system 550 is configured to engage a corresponding locking feature 586 of the vial assembly 580 (see Figure 3 ), thereby securely securing the vial assembly 580 to the slide assembly 540. It should be appreciated that the multiple rows of protrusions 551 of the locking system 550 are used to provide a double locking system to ensure that the slide assembly 540, and in particular the needle 559 of the slide assembly 540, is securely held through the septum 592 of the vial assembly 580 during use of the delivery device 500 in a procedure (see Figure 3 ).

[0039] The slide assembly 540 further includes a vial chamber 558, which is sized and shaped to receive the perfusion assembly 560 and the vial assembly 580 therein, respectively. In other words, the vial chamber 558 is sized to receive the perfusion assembly 560 and the vial assembly 580 separately from each other. The vial chamber 558 is enclosed around a protective chamber or shield 557, which is disposed around the vial chamber 558. The protective shield 557 is formed of a material, such as metal or plastic, that is configured to suppress radioactive emissions and extends outward from the vial chamber 558. In addition, the slide assembly 540 includes a needle that extends through the protective shield 557 and extends into the vial chamber 558 along the bottom end of the vial chamber 558. Needle 559 is fixedly secured relative to vial chamber 558 such that any device received through the aperture of locking system 550 and into vial chamber 558 will encounter and interact with needle 559 (eg, priming assembly 560, vial assembly 580, and the like).

[0040] Still reference Figure 2 , needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the slide assembly 540, in particular the distal manifold 555A, the proximal manifold 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 may be fluidly coupled to one or more delivery lines via one or more ports 556 of the slide assembly 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A through a one-way check valve 553 disposed between the proximal and distal manifolds.

[0041] Thus, the proximal manifold 555B is in fluid communication with the one or more ports 556 via the distal manifold 555A, however, due to the position of the one-way check valve 553 disposed between the distal manifold 555A and the proximal manifold 555B, the one or more ports 556 are not in fluid communication with the proximal manifold 555B. Thus, the needle 559 is in fluid communication with one or more delivery lines and / or devices coupled to the slide assembly 540 at the one or more ports 556 via the manifolds 555A, 555B, which are fixed between the needle 559 and the one or more delivery lines and / or devices. The one or more ports 556 of the slide assembly 540 can be coupled to a bag (e.g., a saline bag), a syringe, a catheter, and / or the like via one or more delivery lines coupled thereto. In other embodiments, the needle 559 can be a cannula, a catheter, or a similar mechanism through which fluids and / or solutions as described herein are injected and received.

[0042] Still reference Figure 2 , the skateboard assembly 540 includes a removable battery pack 570 coupled to the skateboard assembly 540 along the proximal end 544. The removable battery pack 570 includes a battery 572, an electrical contact 574, and a removable tab 576. Because the battery 572 is located in the removable battery pack 570, the battery 572 of the delivery device 500 is isolated from one or more fluid paths and a radiation source.

[0043] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to mate with corresponding electrical contacts 511 (see FIG. 5A ) of the console assembly 510 when the slide assembly 540 is coupled to the base 512 at the slide cavity 532. Figure 1 ) contact and interact. Thus, the removable battery pack 570 is operable to provide power to the delivery device 500, particularly the console assembly 510, when the slide assembly 540 is coupled to the console assembly 510.

[0044] Additionally, as will be described in greater detail herein, in certain embodiments, the locking system 550 may include at least one planar wall that is associated with the remaining circular orientation of the locking system 550. In this case, the hole formed by the locking system 550 through the top surface 548 of the slide assembly 540 is irregularly shaped, rather than circular as shown and described above. In this case, the vial assembly 580 includes a locking feature 586 having a shape and size that corresponds to the locking system 550, and in particular to the at least one planar wall, such that the vial assembly 580 is received within the slide assembly 540 only when the orientation of the vial assembly 580 corresponds to the alignment of both the locking feature 586 and the locking system 550. In other words, the corresponding planar wall 586A of the locking feature 586 (see FIG. 5A ) is not necessarily aligned with the vial assembly 580. Figure 3 ) must be aligned with the planar wall of the locking system 550 so that the vial assembly 580 can be received in the hole formed by the locking system 550 of the slide assembly 540.

[0045] Reference now Figure 3 , depicting a vial assembly 580 of the delivery device 500. 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 an 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 extending downwardly therefrom, the pair of arms 581 extending laterally outward relative to the longitudinal length of the plunger 584. In this example, the engagement head 582 is integrally formed with the plunger 584, however, it should be understood that in other embodiments, the engagement head 582 and the plunger 584 can be independent features fastened thereto. In either case, the engagement head 582 and the plunger 584 can be moved relative to the locking feature 586 and the vial body 589 so that the engagement head 582 and the plunger 584 can be slidably translated through the locking feature 586 and the vial body 589. In particular, as will be described in greater detail herein, when the engagement head 582 is secured to a pair of lever arms 522 , the plunger 584 can translate into and out of the interior chamber 588 of the vial body 589 in response to linear translation of the vial engagement mechanism 520 .

[0046] The plunger 584 includes a plurality of markings and / or indicia 583 positioned along the longitudinal length of the plunger 584. The plurality of indicia 583 indicate the relative extensions of the engagement head 582 and the plunger 584 from the locking feature 586 and the vial body 589. As briefly mentioned 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 slide assembly 540 and the slide assembly is inserted into the slide cavity 532 of the console assembly 510. As will be described in greater detail herein, in response to a predetermined translational force applied to the vial engagement mechanism 520, the pair of lever arms 522 are received between the pair of arms 581 of the engagement head 582 and the plunger 584. Engagement head 582 and plunger 584 may be formed from a variety of materials including, but not limited to, metal, plastic, and / or the like.

[0047] Still reference Figure 3, the vial assembly 580 further includes a safety tab 585 coupled to the plunger 584 relatively above the locking feature 586 and below the engagement head 582, such that the safety tab 585 is positioned along the longitudinal length of the plunger 584. The safety tab 585 can be formed of a variety of materials, such as plastic, and preassembled to the vial assembly 580 prior to use of the delivery device 500. The safety tab 585 is removably secured to the plunger 584 and prevents the plunger 584 from translating relative to the vial body 589. In particular, in response to a linear force applied to the plunger 584 to relatively translate the plunger 584 downward into the vial body 589, the safety tab 585 abuts against the locking feature 586. In this case, the safety tab 585 is configured to prevent unintentional movement of the plunger 584, and in response, prevent unintentional delivery of a fluid medium (e.g., therapeutic particles, radioembolic beads) stored within the interior chamber 588 of the vial body 589. As will be described in greater detail herein, in response to coupling of the vial assembly 580 with the vial engagement mechanism 520 , and in particular engagement of the pair of lever arms 522 with the engagement head 582 , the safety tab 585 selectively disengages from the plunger 584 .

[0048] Return to reference Figure 3 , the locking feature 586 extends around the top end of the vial body 589. In the present example, the locking feature 586 of the vial assembly 580 includes a bushing that defines a lateral edge 587 that extends laterally outward along the outer periphery of the locking feature 586. The lateral edge 587 of the locking feature 586 is sized and shaped to engage the annular array of protrusions 551 of the locking system 550 when the vial assembly 580 is received within the vial chamber 558 of the slide assembly 540. As will be described in greater detail herein, the locking feature 586, and in particular the lateral edge 587 of the locking feature 586, is configured to securely secure the vial assembly 580 to the locking system 550 to inhibit the vial body 589 from being removed from the vial chamber 558 of the slide assembly 540 during use of the delivery device 500 in a procedure. In some embodiments, as briefly described above, the locking feature 586 includes at least one planar wall 586A such that the locking feature 586 includes an irregular profile. The at least one planar wall 586A is configured to correspond to the planar wall 550A of the locking system 550 such that the planar walls 550A, 586A need to be aligned in order for the vial assembly 580 to be received through the aperture formed by the locking system 550 .

[0049] Still reference Figure 3, the vial body 589 extends downward from the locking feature 586 and has a longitudinal length that is sized to receive at least a portion of the longitudinal length of the plunger 584 therein. Thus, in some embodiments, the longitudinal length of the plunger 584 exceeds the longitudinal length of the vial body 589 so that translation of the plunger 584 into the interior chamber 588 of the vial body 589 causes the fluid medium stored therein to be transferred outward from the vial body 589. As will be described in greater detail herein, translation of the plunger 584 in the interior chamber 588 of the vial body 589 applies the fluid medium stored in the vial body 589 outward from 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.

[0050] The vial body 589 of this example is formed of a material configured to suppress radioactive emissions from a fluid medium stored in the internal chamber 588 of the vial body 589. For example, the vial body 589 can be formed of a plastic such as polycarbonate and have a width. The density and material composition of the vial body 589 can jointly suppress beta radiation emissions from electron particles stored in the internal chamber 588. In this example, the chemical composition of the plastic of the vial body 589, together with the wall thickness of 9 mm, provides a plurality of atoms disposed in the vial body 589 that can encounter electron particles that generate beta radiation and reduce the emission of said radiation from the vial assembly 580. Therefore, the vial assembly 580 allows an operator to handle radioactive materials 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 segments can be incorporated into the vial body 589 of the vial assembly 580 without departing from the scope of the present disclosure.

[0051] Still reference Figure 3, the vial body 589 of the vial assembly 580 is sealed at a first end 598 by a locking feature 586. The vial assembly 580 further includes a cap 590 positioned at an opposite end of the vial body 589 opposite to the locking feature 586, so that the cap 590 seals the second end of the vial body 589 of the vial assembly 580. In addition, the vial assembly 580 includes a septum 592, which is positioned adjacent to the cap 590 and is in fluid communication with the end of the vial body 589 opposite to 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, silicon, bromobutyl elastomers, rubber, polyurethane rubber, and / or the like. The septum 592 is configured to provide an airtight seal for the vial body 589, thereby inhibiting the release of a fluid medium (e.g., radioembolic beads) stored therein. As will be described in greater detail herein, the septum 592 of the vial assembly 580 is configured to be pierced by the needle 559 of the slide assembly 540 when the vial assembly 580 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the slide assembly 540. In other embodiments, the septum 592 may be omitted entirely for alternative arrangements, such as valve systems, needle injection ports, and / or the like.

[0052] refer to Figure 4 , the vial assembly 580 further includes a plug 594 fixedly coupled to the end of the plunger 584 opposite the engagement head 582. In this case, the plug 594 is effectively disposed within the vial body 589 with the plunger 584 coupled to and slidably translatable through the interior chamber 588 of the vial body 589. Thus, it should be understood that the size and shape of the plug 594 is determined according to the size (e.g., diameter) of the interior chamber 588 of the vial body 589. The plug 594 is fixed to the plunger 584 so that the plug 594 can slidably translate through the vial body 589 in response to the plunger 584 translating through the vial body 589. The plug 594 is defined by two or more laterally outwardly extending ribs 593 and one or more grooves 595 defined between at least two of the ribs 593.

[0053] The stopper 594 is configured to form a liquid seal against the interior chamber 588 of the vial body 589 and can be formed of various polymers having a predetermined viscoelastic property. For example, in some embodiments, the stopper 594 is formed of an elastomer, silicone, rubber, polyurethane, plastic, polyethylene, polypropylene, and / or the like. In this case, the stopper 594 is operable to prevent the fluid medium stored in the vial body 589 from extending (i.e., leaking) beyond the stopper 594 and leaving the vial body 589. In particular, two or more ribs 593 of the stopper 594 abut against the interior chamber 588 of the vial body 589 and form a seal along the interior chamber, thereby preventing the fluid medium from exceeding the ribs 593. One or more grooves 595 formed between the two or more ribs 593 of the stopper 594 are configured to receive, more specifically, capture any fluid medium that may inadvertently extend (i.e., leak) beyond the ribs 593 of the stopper 594. Thus, the one or more grooves 595 serve as a safety mechanism for the vial assembly 580 to ensure that the fluid media is retained within the vial body 589 and is not exposed outside of the vial assembly 580 .

[0054] Still reference Figure 4 , the two or more ribs 593 of the plug 594 are additionally configured to push the fluid medium stored in the vial body 589 in one or more directions (e.g., toward the cap 590) in response to the translation of the plunger 584. With the ribs 593 of the plug 594 pressed against the interior chamber 588 of the vial body 589, the translation of the plunger 584 causes the ribs 593 to abut against and translate along the interior chamber 588 of the vial body 589 so that any fluid medium located in front of (i.e., below) the plug 594 is effectively redirected within the vial body 589 along the direction of travel of the plunger 584 and the plug 594. The vial assembly 580 further includes an annular gasket 596 disposed within the vial body 589. In particular, the annular gasket 596 is securely secured to the plunger 584 adjacent the plug 594, which is secured to the plunger 584 at the end opposite to the engagement head 582. Thus, the annular gasket 596 is secured to the plunger 584 and disposed within the vial body 589 adjacent the stopper 594. With the annular gasket 596 secured to the plunger 584 adjacent the stopper 594, the annular gasket 596 is effectively disposed within the vial body 589.

[0055] Reference now Figure 5In response to determining that the battery 572 contains or other power source provides a sufficient amount of power, one or more delivery lines are connected to the slide assembly 540 via one or more ports 556. In particular, the dose delivery line 10A is connected to the slide assembly 540 at the delivery port 556A, the contrast agent line 10B is connected to the slide assembly 540 at the contrast agent port 556B, and the flushing line 10C is connected to the slide assembly 540 at the flushing port 556C. The opposite end of the dose delivery line 10A is initially connected to a fluid reservoir, such as a collection bowl. As will be described in more detail herein, once the slide assembly 540 has been effectively perfused with a fluid medium via the contrast agent line 10B, the dose delivery line 10A can then be connected to an external device, such as a catheter. The opposite end of the flushing line 10C is connected to an external device, such as a syringe. In the case where both the dose delivery line 10A and the flushing line 10C are coupled to the sled assembly 540, the sled assembly 540 is flushed with a fluid medium (e.g., saline) from a syringe coupled to the flushing line 10C. In this case, the fluid medium is injected into the distal manifold 555A of the sled assembly 540 through the flushing line 10C, and exits the sled assembly 540 through the dose delivery line 10A. Thus, the fluid medium is ultimately received at the collection bowl through the dose delivery line 10A and is placed there.

[0056] In the case where the distal manifold 555A of the sled assembly 540 is separated from the proximal manifold 555B by the one-way valve 553 disposed between the distal manifold 555A and the proximal manifold 555B, the fluid medium flushed from the syringe (via the flush port 556C) through the distal manifold 555A is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. In contrast, the fluid medium injected from the syringe and passing through the flush line 10C is received at the flush port 556C, passes through the distal manifold 555A in fluid communication with the flush port 556C, and is 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 transfers it to the collection bowl coupled thereto so 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.

[0057] The contrast line 10B is coupled to the sled assembly 540 at the contrast port 556B. The opposite end of the contrast line 10B is coupled to a fluid medium supply source, such as a bag secured to the console assembly 510 via an attachment device 538. In this example, the bag is a saline bag so that the fluid medium stored therein is saline. In this case, with the sled assembly 540 including a perfusion assembly 560 positioned within the vial chamber 558 and a needle end 568 in fluid communication with the needle 559, a syringe is fluidly coupled to the perfusion line 562 of the perfusion assembly 560 and the plunger of the syringe is pulled back to pull saline from the saline bag through the contrast line 10B, the contrast port 556B, the sled assembly 540, the perfusion line 562 and into the syringe. Thereafter, the plunger of the syringe is pushed inwardly to transfer the drawn saline back through the priming line 562, the central body 564, the elongated shaft 566, and the needle end of the priming assembly 560 so that the saline is received into the needle 559 of the slide assembly 540. Thus, when the needle 559 receiving the saline from the priming assembly 560 is in fluid communication with the manifolds 555A, 555B, the manifolds 555A, 555B of the slide assembly 540 are effectively primed with saline from the syringe. With the manifolds 555A, 555B further in fluid communication with the dose delivery line 10A via the delivery port 556A, the saline is effectively distributed to the collection bowl coupled thereto.

[0058] Reference now Figure 5 , the sled assembly 540 is coupled to one or more external devices via one or more ports 556. In particular, the sled assembly 540 is fluidly coupled to a catheter (e.g., a microcatheter) via a dose delivery line 10A coupled to a delivery port 556A of the sled assembly 540. In this case, the catheter is in fluid communication with the sled assembly 540 via the dose delivery line 10A. Further, the sled assembly 540 is fluidly coupled to a contrast agent source, such as via an attachment device 538 (see Figure 1 ) is fixed to the saline bag of the console assembly 510. The sled assembly 540 is in fluid communication with the saline bag via a contrast agent line 10B coupled to the contrast agent port 556B of the sled assembly 540. In this case, the saline bag is in fluid communication with the sled assembly 540 via a contrast agent line 10B fixed to the contrast agent port 556B.

[0059] Contrast port 556B is in fluid communication with proximal manifold 555B, while delivery port 556A is in fluid communication with distal manifold 555A. As will be described in greater detail herein, when contrast port 556B is coupled to proximal manifold 555B rather than distal manifold 555A, saline from a saline bag can be drawn into vial body 589 of vial assembly 580 through needle 559 of sled assembly 540, the distal manifold being separated from proximal manifold 555B by one-way check valve 553 disposed therebetween.

[0060] Reference again Figure 1 and Figure 3 , with the vial assembly 580 securely coupled to the slide assembly 540, the slide assembly 540 is coupled to the console assembly 510 by translating the distal end 542 of the slide assembly 540 toward and into the distal end 516 of the console assembly 510. In particular, the distal end 542 of the slide assembly 540 is guided into the slide cavity 532 of the console assembly 510 by aligning the alignment ribs 554 of the slide assembly 540 with the alignment features 534 of the console assembly 510. Once the proximal and distal ends 544, 542 of the slide assembly 540 are fully seated in the slide cavity 532 of the console assembly 510, the electrical contacts 574 ( Figure 2 ) and corresponding electrical contacts 511 of the console assembly 510 ( Figure 1 ) interaction. In this case, power from battery 572 is transmitted to console assembly 510 via electrical contacts 574, thereby activating console assembly 510 of delivery device 500. In this case, interface display 530 of console assembly 510 is activated to display real-time information related to delivery device 500 during surgery.

[0061] Reference again Figure 5 , when the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial receiving area 518, a negative pressure is generated within the interior chamber 588 of the vial body 589 due to the withdrawal of the stopper 594. In this case, with a saline bag coupled to the sled assembly 540 via the contrast line 10B and the contrast port 556B, saline from the saline bag is drawn into the interior chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Therefore, with the vial body 589 preloaded with a radioactive fluid medium (e.g., radioembolic microspheres), when the plunger 584 is withdrawn from the interior chamber 588 and a negative pressure is generated by the delivery device 500, the saline is effectively mixed with the radioactive fluid medium within the vial body 589.

[0062] The sled assembly 540 further includes a one-way check valve 553A in series with the contrast agent line 10B and the flushing line 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 to the manifolds 555A, 555B, and is also 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 the dose delivered from the vial body 589 to the manifolds 555A, 555B cannot be directed to the contrast agent line 10B or the flushing line 10C due to the one-way check valve 553A positioned in the contrast agent line or the flushing line. Therefore, the dose is directed to the dose delivery port 556A and is received at the conduit that is fluidly connected to the delivery port 556A through the dose delivery line 10A. In other words, one-way check valve 553A prevents fluid from flowing back into slide assembly 540 and / or vial assembly 580 coupled thereto.

[0063] II. Embodiments of Vial Assembly Systems Having Bypass Paths

[0064] As briefly mentioned above, the delivery device 500 described herein can include a vial assembly system 680 that includes a bypass path that can be used to effectively deliver microparticles 660 via a mixed solution 662, an example of which will be described below with reference to Figure 6-8 In the examples, reference is made to Figure 6 , which illustrates a vial assembly system 680 pre-filled with microparticles 660 for delivery in a non-flow position 682, the vial assembly system 680 comprising a vial assembly 580' and a needle 559. The vial assembly 580' can include a vial body 589, which includes a septum 592, a neck region 602, and a microparticle region 604. The neck region 602 can include a cylindrical, conical, tapered, or other suitable shape. The microparticle region 604 can include a bypass valve 606. In an embodiment, the bypass valve 606 can include a one-way valve, a check valve, a pop-off valve, or other suitable valve configured for one-way directional flow. The bypass valve 606 disposed in the microparticle region 604 can be further disposed in a dead space region 628 of the microparticle region 604. The dead space region 628 is defined as an area in which the plunger 584 ( Figure 5 ) cannot be inserted further distally (ie, in a downward direction toward the septum 592) into the region and therefore cannot be inserted into the dead space region 628. In an embodiment, the vial assembly 580' can be a syringe assembly as described herein, the syringe assembly including a plunger 584 ( Figure 5), a barrel, a stopper, and a needle 559, a concentration regulator 664 as described in further detail below, a bypass valve 606 (e.g., a one-way valve that can be a pop-open valve, a duckbill valve, or the like), and a fluid path that connects the bypass valve 606 to the needle while bypassing the concentration regulator 664, such as through polyvinyl chloride (PVC) medical tubing.

[0065] The neck region 602 may include a top 610, a bottom 608, and a sidewall 612 disposed between the top and the bottom. The needle 559 may include a port 614 and a tip 616 located distal to the port 614. The port 614 of the needle 559 may be configured as an outlet for injecting a fluid into the vial assembly 580', and an inlet for delivering a mixed particle solution (e.g., a mixed solution 662) of the fluid and particles 660 from the vial assembly 580'. The tip 616 may be configured to pierce the septum 592 of the vial assembly 580' disposed at the bottom 608 of the neck region 602. The septum 592 may be configured to receive the needle 559 so that the port 614 is disposed in the neck region 602 of the vial assembly 580'. The size and shape of the neck region 602 may be configured to receive the tip 616 and the port 614 between the septum 592 and the concentration regulator 664, which will be described in more detail further below. The septum 592 can be configured to be disposed proximally (upwardly relative to the neck region) adjacent to the neck region 602 , and the microparticle region 604 can be disposed distally (downwardly relative to the neck region 602 ) adjacent to the neck region 602 .

[0066] As shown, bypass path 624 includes a first end 620 and a second end 622. Bypass valve 606 is connected to the first end 620 of bypass path 624. The second end 622 of bypass path 624 terminates at or within the sidewall 612 of neck region 602. Bypass path 624 is configured to provide a fluid flow path that replaces first path 626 to the needle via bypass path 624 when the pressure of the fluid flow in vial assembly 580 accumulates. As shown, first path 626 is directly arranged in vial assembly 580' between particle region 604 and neck region 602. In an embodiment, first path 626 is oriented along the longitudinal axis of vial assembly 580', and bypass path 624 is radially arranged relative to the longitudinal axis. Bypass path 624 may include a conduit 625 arranged between bypass valve 606 and sidewall 612 of neck region 602. In an embodiment, bypass path 624 may be a needle or an alternative metallic flow path instead of tubing 625 .

[0067] In an embodiment, the vial assembly system 680 can further include a concentration regulator 664 disposed between the neck region 602 and the particle region 604. The concentration regulator 664 can be configured to limit the concentration of the particles 660 sent to the needle 559 along the first path 626. The concentration regulator 664 can be a mesh component. Alternatively or additionally, the concentration regulator 664 can be a filter, a membrane, or other suitable regulator component configured to limit the flow of high concentration particles 660 above a concentration threshold.

[0068] As described herein, vial assembly 580' can be installed into delivery device 500, and plunger 584 ( Figure 5 ) can be pulled all the way up to draw fluid into the vial of vial assembly 580' and suspend the particles 660. Due to the presence of one-way bypass valve 606, fluid can be prevented from flowing upward along bypass path 624, and fluid can be drawn through concentration regulator 664 to suspend the particles 660 in mixed solution 662. If the user delays and the particles 660 settle out of suspension, such as Figure 6 As shown in , a large mass of particles 660 may gather at the top of the concentration regulator 664. In this state, the user can push the plunger 584 downward, and once sufficient pressure is reached, the one-way bypass valve 606 can open and allow the low-concentration fluid of the mixed solution 662 (containing a lower concentration of particles 660 and fluid) to flow along the bypass path 624 to the needle 559, as shown in FIG. Figure 7 Alternatively, in an embodiment, the concentration adjuster 664 may be used as a pressure sensor, or another pressure sensor may be used to trigger the bypass valve 606 upon detecting a pressure above a threshold. The user may continue to apply the mixed solution 662 until the plunger 584 blocks the one-way bypass valve 606. At this point, the user may again pull the plunger 584 upward to the maximum position and resuspend the spheres of microparticles 660 in the mixed solution 662 and apply the spheres of microparticles in the mixed solution as appropriate for the first path 626, as shown. Figure 8 as shown in .

[0069] Therefore, reference Figure 7 , showing bypass path flow position 684, wherein the fluid containing microparticles 660 as mixed solution 662 is directed along bypass paths 624A, 624 to bypass the high concentration of bottom microparticles 660 (which are shown as not suspended) below the suspended mixed solution 662 in vial assembly 580'. In an embodiment, bypass path 624 is configured to provide a fluid flow path to needle 559 that replaces first path 626 when the pressure of the fluid flow in vial assembly 580' accumulates due to the accumulation of microparticles 660 on concentration regulator 664.

[0070] In an embodiment, both the concentration adjuster 664 and the bypass valve 606 can be configured so that the particles 660 do not get stuck in a mesh, membrane, filter or the like, or in the valve features of the bypass valve 606. In addition, the size of the holes in the concentration adjuster 664 can be set to allow the particles 660 to pass through them, but spaced so that only an appropriate and predetermined amount can pass through each time without blocking the fluid path of the first path 626. The bypass valve 606 can be positioned above the position where the maximum concentration of particles 660 will occur and sufficiently below the top of the stroke of the plunger 584 to allow the particles 660 to be resuspended. The pressure required to open the bypass valve 606 can be such that the particles 660 and the concentration adjuster 664 are not damaged. The maximum operating pressure of the particles 660 and the concentration adjuster 664 can depend on the type of particles and concentration adjusters used, and can be determined by applying a controlled predetermined pressure to both to observe the maximum pressure that the particles and the concentration adjuster can withstand without being damaged. In an embodiment, a bypass fluid path as bypass path 624 may be overmolded or constructed as part of the syringe body of vial assembly 580 ′.

[0071] As mentioned above, Figure 8 The first path flow position 686 is illustrated, wherein the fluid containing the particles 660 as the mixed solution 662 is directed along the first path 626A, 626, which is disposed between the particle region 604 and the neck region 602 of the vial assembly 580', where there is no high concentration of bottom layer unsuspended particles 660. Therefore, when the bypass valve 606 is not triggered to flow along the first path 626A, 626, the first path is disposed between the particle region 604 and the neck region 602 of the vial assembly 580'. Figure 7 The bypass path 624 can be used to transfer the mixed solution 662 to prevent clogging. Figure 8 The first path 626A, 626.

[0072] In an embodiment, a method of operating a vial assembly system 680 may thus include receiving a needle 559 in a septum 592 of a vial assembly 580' of the vial assembly system 680 such that a port 614 of the needle 559 is disposed in a neck region 602 of the vial assembly 580'. Pressure buildup in the vial assembly 580' may be monitored to determine if the pressure buildup exceeds a threshold. When the monitored pressure buildup exceeds the threshold, the fluid flow path may be switched from the first path 626 to the bypass path 624, such as Figure 7 As described above, the bypass path 624 includes a first end 620 and a second end 622, the bypass valve 606 is connected to the first end 620 of the bypass path 624, the second end 622 of the bypass path 624 terminates at the sidewall 612 of the neck region 602, and the first path 626 is disposed in the vial assembly 580' directly between the particle region 604 and the neck region 602.

[0073] In embodiments, different numbers, sizes, and / or locations of concentration regulators 664 may be used in vial assembly 580'. Additionally or alternatively, a filter may be added before bypass valve 606. Bypass valve 606 may be a one-way valve or a pop-open valve or other suitable valve as described herein made of various materials, and concentration regulator 664 may be made of various metals, plastics, hydrogels, and the like.

[0074] III. List of aspects

[0075] Aspect 1. A vial assembly system includes a vial assembly and a needle. The vial assembly includes a septum, a neck region, and a particle region for containing particles, the particle region including a bypass valve, the neck region including a top, a bottom, and a sidewall disposed between the top and the bottom. The needle includes a port and a tip located distal to the port, the tip being configured to pierce the septum of the vial assembly disposed at the bottom of the neck region. The septum is configured to receive the needle so that the port is disposed in the neck region of the vial assembly. A bypass path includes a first end and a second end. The bypass valve is connected to the first end of the bypass path, and the second end of the bypass path terminates at or in the sidewall of the neck region. The bypass path is configured to provide a fluid flow path to the needle that replaces a first path when pressure of fluid flow in the vial assembly accumulates, and the first path is disposed in the vial assembly directly between the particle region and the neck region.

[0076] Aspect 2. The vial assembly system according to aspect 1, further comprising a concentration regulator disposed between the neck region and the particle region and configured to limit the concentration of particles sent to the needle along the first path.

[0077] Aspect 3. The vial assembly system according to aspect 2, wherein the concentration adjuster comprises a mesh member.

[0078] Aspect 4. The vial assembly system according to any one of aspects 1 to 3, wherein the bypass path is configured to provide a fluid flow path to the needle that replaces the first path when pressure of the fluid flow in the vial assembly accumulates due to accumulation of particles on the concentration regulator.

[0079] Aspect 5. The vial assembly system according to any one of aspects 1 to 4, wherein the neck region comprises a cylindrical shape.

[0080] Aspect 6. The vial assembly system according to any one of aspects 1 to 4, wherein the neck region comprises a conical shape.

[0081] Aspect 7. The vial assembly system according to any one of aspects 1 to 6, wherein the bypass valve disposed in the particle area is further disposed in a dead space area of ​​the particle area, the dead space area being defined as an area in which the plunger of the vial assembly cannot be inserted distally, so that the plunger cannot be inserted into the dead space area.

[0082] Aspect 8. The vial assembly system according to any one of aspects 1 to 7, wherein the port of the needle is configured as an outlet for injecting fluid into the vial assembly and an inlet for delivering the mixed particle solution from the vial assembly.

[0083] Aspect 9. The vial assembly system according to any one of aspects 1 to 8, wherein the first path is oriented along a longitudinal axis of the vial assembly and the bypass path is radial relative to the longitudinal axis.

[0084] Aspect 10. The vial assembly system according to any one of aspects 1 to 9, wherein the bypass path comprises a conduit disposed between the bypass valve and a side wall of the neck region.

[0085] Aspect 11. The vial assembly system according to any one of aspects 1 to 10, wherein the septum is configured to be disposed proximally adjacent to the neck region, and the microparticle region is disposed distally adjacent to the neck region.

[0086] Aspect 12. A vial assembly system, comprising a vial assembly and a needle. The vial assembly comprises a septum, a neck region, and a particle region for containing particles, the particle region comprising a bypass valve, the neck region comprising a top, a bottom, and a sidewall disposed between the top and the bottom, and the needle comprises a port and a tip located distal to the port, the tip being configured to pierce the septum of the vial assembly disposed at the bottom of the neck region. The septum is configured to receive the needle so that the port is disposed in the neck region of the vial assembly. The bypass valve is connected to a bypass path comprising a first end and a second end. The bypass valve is connected to a first end of the bypass path, the second end of the bypass path terminating at or within the sidewall of the neck region. The bypass path is configured to provide a fluid flow path to the needle that replaces a first path when pressure of fluid flow in the vial assembly accumulates, and the first path is disposed in the vial assembly directly between the particle region and the neck region. The bypass path includes a conduit disposed between the bypass valve and a sidewall of the neck region, and the conduit of the bypass path is disposed radially relative to a longitudinal axis of the vial assembly.

[0087] Aspect 13. The vial assembly system according to aspect 12, further comprising a concentration regulator disposed between the neck region and the particle region and configured to limit the concentration of particles sent to the needle along the first path.

[0088] Aspect 14. The vial assembly system according to aspect 13, wherein the concentration adjuster comprises a mesh member.

[0089] Aspect 15. The vial assembly system according to any one of aspects 12 to 14, wherein the bypass path is configured to provide a fluid flow path to the needle that replaces the first path when pressure of the fluid flow in the vial assembly accumulates due to accumulation of particles on the concentration regulator.

[0090] Aspect 16. The vial assembly system according to any one of aspects 12 to 15, wherein the neck region comprises a cylindrical shape.

[0091] Aspect 17. The vial assembly system according to any one of aspects 12 to 15, wherein the neck region comprises a conical shape.

[0092] Aspect 18. The vial assembly system according to any one of aspects 12 to 17, wherein the bypass valve is disposed in the particle area, and further disposed in a dead space area of ​​the particle area, wherein the dead space area is defined as an area in which a plunger of the vial assembly cannot be inserted distally, so that the plunger cannot be inserted into the dead space area.

[0093] Aspect 19. The vial assembly system according to any one of aspects 12 to 18, wherein the port of the needle is configured as an outlet for injecting fluid into the vial assembly and an inlet for delivering the mixed particle solution from the vial assembly.

[0094] Aspect 20. A method of operating a vial assembly system, the method comprising receiving a needle in a septum of a vial assembly of the vial assembly system such that a port of the needle is disposed in a neck region of the vial assembly. The vial assembly further comprises a particle region, the particle region comprising a bypass valve, the neck region comprising a top, a bottom, and a sidewall disposed between the top and the bottom, the needle further comprising a tip located distal to the port, the tip being configured to pierce a septum of the vial assembly disposed at the bottom of the neck region. The method further comprises monitoring a pressure buildup in the vial assembly to determine whether the pressure buildup exceeds a threshold, and when the monitored pressure buildup exceeds the threshold, changing a fluid flow path from a first path to a bypass path. The bypass path comprises a first end and a second end, the bypass valve being connected to the first end of the bypass path, the second end of the bypass path terminating at or within the sidewall of the neck region, and the first path being disposed in the vial assembly directly between the particle region and the neck region.

[0095] It should be noted that the terms "substantially" and "about" may be used herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0096] For purposes of describing and defining the present disclosure, it should be noted that the term "substantially" is used herein to represent the inherent degree of uncertainty 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 a stated reference without resulting in a change in the basic function of the subject matter in question. Thus, it is used to represent the inherent degree of uncertainty attributable to any quantitative comparison, value, measurement, or other representation, referring to an arrangement of elements or features that, while in theory would be expected to exhibit an exact correspondence or behavior, may in practice exhibit something slightly less exact.

[0097] Although specific embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. In addition, although various aspects of the claimed subject matter have been described herein, these aspects do not need to be used in combination. Therefore, the appended claims are intended to cover all such changes and modifications within the scope of the claimed subject matter.

Claims

1. A vial assembly system comprising: a vial assembly comprising a septum, a neck region, and a particle region for containing particles, the particle region comprising a bypass valve, the neck region comprising a top, a bottom, and a sidewall disposed between the top and the bottom; a needle including a port and a tip distal to the port, the tip being configured to pierce the septum disposed at a bottom of the neck region of the vial assembly; wherein the septum is configured to receive the needle such that the port is disposed in a neck region of the vial assembly; and wherein the bypass path comprises a first end and a second end, the bypass valve is connected to the first end of the bypass path, the second end of the bypass path terminates at or within the side wall of the neck region, the bypass path is configured to provide a fluid flow path to the needle that replaces the first path when pressure of the fluid flow in the vial assembly accumulates, and the first path is disposed in the vial assembly directly between the particle region and the neck region.

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

3. The vial assembly system according to claim 2, wherein: The concentration adjuster includes a mesh member.

4. The vial assembly system according to claim 2, wherein: The bypass path is configured to provide a fluid flow path to the needle in place of the first path when pressure of the fluid flow in the vial assembly accumulates due to accumulation of particles on the concentration regulator.

5. The vial assembly system of claim 1, wherein: The neck region comprises a cylindrical shape.

6. The vial assembly system of claim 1, wherein: The neck region includes a conical shape.

7. The vial assembly system of claim 1, wherein: The bypass valve disposed in the particle area is further disposed in a dead space area of ​​the particle area, the dead space area being defined as an area in which a plunger of the vial assembly cannot be inserted distally so that the plunger cannot be inserted into the dead space area.

8. The vial assembly system of claim 1, wherein: The needle port is configured as an outlet for injecting fluid into the vial assembly and an inlet for delivering a mixed particle solution from the vial assembly.

9. The vial assembly system of claim 1, wherein: The first path is oriented along a longitudinal axis of the vial assembly, and the bypass path is disposed radially relative to the longitudinal axis.

10. The vial assembly system of claim 1, wherein: The bypass path includes a conduit disposed between the bypass valve and a side wall of the neck region.

11. The vial assembly system of claim 1, wherein: The septum is configured to be disposed proximally adjacent to the neck region, and the microparticle region is disposed distally adjacent to the neck region.

12. A vial assembly system comprising: a vial assembly including a septum, a neck region, and a particle region for containing particles, the particle region including a bypass valve, the neck region including a top, a bottom, and a sidewall disposed between the top and the bottom; a needle including a port and a tip distal to the port, the tip being configured to pierce the septum disposed at a bottom of the neck region of the vial assembly; wherein the septum is configured to receive the needle such that the port is disposed in a neck region of the vial assembly; and wherein the bypass valve is connected to a bypass path including a first end and a second end, the bypass valve being connected to the first end of the bypass path, the second end of the bypass path terminating at or within the sidewall of the neck region, the bypass path being configured to provide a fluid flow path to the needle that replaces the first path when pressure of the fluid flow in the vial assembly accumulates, the first path being disposed in the vial assembly directly between the particle region and the neck region, the bypass path comprising a conduit disposed between the bypass valve and the sidewall of the neck region, and the conduit of the bypass path being disposed radially relative to the longitudinal axis of the vial assembly.

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

14. The vial assembly system of claim 13, wherein: The concentration adjuster includes a mesh member.

15. The vial assembly system of claim 13, wherein: The bypass path is configured to provide a fluid flow path to the needle in place of the first path when pressure of the fluid flow in the vial assembly accumulates due to accumulation of particles on the concentration regulator.

16. The vial assembly system of claim 12, wherein: The neck region comprises a cylindrical shape.

17. The vial assembly system of claim 12, wherein: The neck region includes a conical shape.

18. The vial assembly system of claim 12, wherein: The bypass valve disposed in the particle area is further disposed in a dead space area of ​​the particle area, the dead space area being defined as an area in which a plunger of the vial assembly cannot be inserted distally so that the plunger cannot be inserted into the dead space area.

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

20. A method of operating a vial assembly system, the method comprising: receiving a needle in a septum of a vial assembly of the vial assembly system such that a port of the needle is disposed in a neck region of the vial assembly, the vial assembly further comprising a particle region, the particle region comprising a bypass valve, the neck region comprising a top, a bottom, and a sidewall disposed between the top and the bottom, the needle further comprising a tip distal to the port, the tip being configured to pierce the septum of the vial assembly disposed at the bottom of the neck region; monitoring a pressure buildup in the vial assembly to determine if the pressure buildup exceeds a threshold; as well as When the monitored pressure accumulation exceeds the threshold, the fluid flow path is changed from the first path to a bypass path, wherein the bypass path includes a first end and a second end, the bypass valve is connected to the first end of the bypass path, the second end of the bypass path terminates at or in the sidewall of the neck region, and the first path is disposed in the vial assembly directly between the particle region and the neck region.

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