Radiation containment components, sealed assemblies, and methods of use

Abstract

A method of using a radiation containment component for sealing a radiation-sealed assembly and a microcatheter used for delivering mixed microparticles from a microparticle delivery device for disposal, which may include a proximal end and a distal end disposed opposite the proximal end. The proximal end is configured to connect to and cover a distal portion of a delivery conduit connector of the microparticle delivery device, and the delivery conduit connector is configured to receive mixed microparticles from the microparticle delivery device. The distal end is disposed on and configured to house a microcatheter that is connected to the delivery conduit connector after use, and the distal end is configured to seal together to house the microcatheter before disposal.

Description

Technical Field

[0001]

[0001] This disclosure generally relates to components of medical devices for treating cancer, and more particularly to radiation containment components of medical devices configured and operable to assist in the delivery of radioactive compounds to a treatment area within a patient's body in procedures such as transarterial radioembolization.

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 risks of radiation emitted from this delivery.

[0004]

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

Summary of the Invention

Means for Solving the Problems

[0005] According to one embodiment of the present disclosure, a radiation containment component for enclosing a microcatheter used to deliver mixed microparticles from a microparticle delivery device for disposal includes a proximal end and a distal end disposed opposite the proximal end. The proximal end is configured to connect to and cover a distal portion of a delivery conduit connector of the microparticle delivery device, and the delivery conduit connector is configured to receive mixed microparticles from the microparticle delivery device. The distal end is disposed over and configured to receive a microcatheter that is connected to the delivery conduit connector after use, and the distal end is configured to seal together to receive the microcatheter prior to disposal.

[0006] In another embodiment, a radiation-sealed assembly for sealing and disposal includes a microparticle delivery device with a delivery conduit connector, a base connector, a microcatheter, and a radiation containment component. The microcatheter is used to deliver mixed microparticles from the microparticle delivery device, and the microcatheter is configured to be connected to the base connector and the delivery conduit connector to deliver the mixed microparticles. The microcatheter is configured to be detached from the base connector after use and connected to the delivery conduit connector. The radiation containment component includes a proximal end and a distal end disposed opposite the proximal end. The proximal end is configured to connect to and cover a distal portion of a delivery conduit connector of the microparticle delivery device, and the delivery conduit connector is configured to receive mixed microparticles from the microparticle delivery device. The distal end is disposed over and configured to receive a microcatheter that is connected to the delivery conduit connector after use, and the distal end is configured to seal together to receive the microcatheter prior to disposal.

[0007]

[0007] In yet another embodiment, a method for sealing and discarding a microcatheter used to deliver mixed microparticles from a microparticle delivery device includes connecting a delivery conduit connector of the microparticle delivery device to the microcatheter, connecting the microcatheter to a base connector, delivering mixed microparticles from the microparticle delivery device through the microcatheter and the base connector, and detaching the microcatheter from the base connector after use. The method further includes disposing the proximal end of the radiation containment component on the distal portion of the delivery conduit connector of the microparticle delivery device such that the proximal end does not move distally, extending the distal end of the radiation containment component to cover the microcatheter connected to the delivery conduit connector after use, and sealing the distal ends together to contain the microcatheter before discarding.

[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 a series of delivery conduits coupled to the vial slider and the vial assembly of FIG. 3 received therein, according to one or more embodiments shown and described in the present invention.

Figure 6

[0014] A schematic side view of a radiation containment component in a folded position, according to one or more embodiments shown and described herein.

Figure 7

[0015] A schematic side view of the radiation containment component of FIG. 6 in a folded position disposed on the delivery conduit connector of the delivery device.

Figure 8

[0016] A schematic side view of the radiation containment component of FIG. 7 in a deployed position, pulled distally over the microcatheter and approaching the base sheath that receives the distal end of the microcatheter.

Figure 9

[0017] A schematic side view of the radiation containment component of FIG. 7 in a deployed position, further pulled distally over the microcatheter and the distal end that receives the distal end of the microcatheter.

Figure 10

[0018] A schematic side view of the radiation containment component of FIG. 9 in a deployed and sealed position for disposal, disposed and sealed over the distal end of the microcatheter removed from the base sheath.

DETAILED DESCRIPTION OF THE INVENTION

[0010]

[0019] 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. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts. Directional terms such as up, down, right, left, front, back, top, bottom, distal, and proximal as used herein are used only in relation to the figures as depicted and are not intended to imply an absolute orientation.

[0011]

[0020] 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, it should be understood that when a value is expressed as an approximation by use of the antecedent “about,” that particular value forms another embodiment. It should be further understood that each endpoint of a range is significant both in relation to the other endpoint and independently of the other endpoint.

[0012]

[0021] Unless otherwise expressly stated, no method recited herein is intended to be construed as requiring 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 specific order or orientation to the components of a device is recited, no order or orientation should be inferred in any way. This applies to any possible ambiguous criteria for interpretation, including logical matters, grammatical mechanisms or punctuation derived from the arrangement of steps, operational flow, order of components, or orientation of components, the plain meaning derived therefrom, and the number or type of embodiments described herein.

[0013]

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The terminology used in the description herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0014]

[0023] As used herein, the terms "horizontal," "vertical," "distal," and "proximal" are merely relative terms and simply indicate an overall relative orientation and do not necessarily indicate perpendicularity. These terms may also be used for convenience in referring to the orientations used within the figures, such orientations being used merely by convention and not being intended as characteristics of the devices shown. The present disclosure and its embodiments to be described herein may be used in any desired orientation. Further, horizontal and vertical walls generally need merely be intersecting walls and need not be at right angles. As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a" component includes aspects having two or more such components unless the context clearly dictates otherwise.

[0015]

[0024] In embodiments described herein, the particulate material delivery assembly may include a radioembolization delivery device. The radioembolization delivery device comprises a medical device configured to deliver a radioactive compound to a treatment region within a patient's body in a procedure such as transarterial radioembolization. The radioactive compound may be a mixed solution of saline and radioactive microspheres (i.e., 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]

[0025] The figures 1-5 described below are directed to embodiments of a delivery device 500 for delivering microparticles, and the figures 6-10 described in more detail below are directed to embodiments of one or more components of the delivery device 500 as a secondary radiation containment component 600 that helps shield from radiation emitted from the microparticles. The radiation containment component 600, as described in more detail below with respect to this specification and figures 6-10, can further help prevent the release of biohazardous substances upon disposal of a used delivery device connected to a microcatheter. Such biohazardous substances can include chemotherapeutic agents, radioactive substances, blood, and / or other biohazardous agents that can cause health damage in the case of release to the surrounding environment. The radiation containment component 600 can be utilized for disposing of perhaps contaminated accessory devices as described in this specification that are used during a radioembolization procedure, perhaps delivery of a biohazardous drug, or a combination thereof. For example, when removing the microcatheter 720 or delivery sheath from the patient after delivery, there can be a risk of contaminating the environment and there can be a leak that can be biohazardous to the user, such as a physician and / or surrounding user or healthcare worker. The radiation containment component 600, as described in more detail below with respect to this specification and figures 6-10, can be placed over the delivery line connector 710 of the delivery device 500 prior to connection of the delivery line connector 710 to the hub of the microcatheter 720. After the final injection has been made, the user can slide the radiation containment component 600 towards the hub of the microcatheter 720 and then pull on the delivery line connector 710 to further pull the microcatheter 720, such as a base sheath 730 described in this specification, into the radiation containment component 600, after which the radiation containment component 600 can be sealed for disposal as described in this specification. The user can maintain the distal end 604 over the hub of the base connector to ensure that the microcatheter 720 of the radiation containment component 600 is contained upon removal from the hub of the base connector.Once the entire microcatheter 720 is housed within the radiation containment component 600, the user may seal the corresponding end of the radiation containment component 600, for example, using an adhesive on the distal end 604 of the radiation containment component 600. The user may then discard the particulate delivery device 500 as housed by the radiation containment component 600 as described herein based on the biohazard disposal procedure. For example, the user may discard the housed particulate delivery device 500 using a sterilized towel wrapped around the housed particulate delivery device 500, which may further be wound up and placed into a waste container for disposal. In an embodiment, the radiation containment component 600 may be placed on the delivery line connector 710 prior to delivery of the mixed particulates. In other embodiments, the radiation containment component 600 may be partitioned in an inner location such as the center so as to be separately wound around the particulate delivery device 500 and the microcatheter 720 such that installation prior to use is not required.

[0017]

[0026] In some embodiments, as described in more detail below, the delivery device 500 is a radioembolization delivery device, the particulates 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 may 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 may 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 particulates 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 assembly

[0027] FIGS. 1-5 illustrate an embodiment of a delivery device 500 configured and operative to deliver radioactive material (e.g., radioactive embolization beads) while reducing radiation emission during use of the delivery device 500. The delivery device 500 operates as described in International PCT Application No. PCT / 2019 / 033001, filed May 17, 2019, which is incorporated herein by reference in its entirety, except with respect to radiation shielding components as described in more detail below with respect to FIGS. 6-10 and in one or more embodiments herein.

[0018]

[0028] 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 assembly 540 operative 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.

[0019]

[0029] 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 operative to facilitate mounting of a complementary device to the console assembly 510 for use with the delivery device 500 during a procedure.

[0020]

[0030] Still referring to FIG. 1, the distal end 516 of the console assembly 510 defines a vial receiving region 518 that is sized and shaped to receive the vial assembly 580 therein, as will be described in more detail herein. The console assembly 510 further includes a vial engagement mechanism 520 that extends from a base 512 adjacent the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outwardly from the base 512 of the console assembly 510 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 a handle 528. In particular, the handle 528 of the console assembly 510 is operable to move, and in particular translate, the vial engagement mechanism 520 within the vial receiving region 518 in response to actuation of the handle 528.

[0021]

[0031] The console assembly 510 includes a mechanical assembly disposed within the base 512 that is configured and operable to convert manual movement of the handle 528 into 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.

[0022]

[0032] The sliding space 532 is sized and shaped to receive a slider 540 therein. As will be described in more detail herein, the slider assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, media) therethrough. In particular, the slider assembly 540 is configured to partially receive the vial assembly 580 therein for administering therapeutic particles from the delivery device 500 to a patient during a procedure.

[0023]

[0033] In an embodiment, and referring to FIG. 2, the flow sensor of the delivery device 500 can be positioned in line with one or more of the tube set of the delivery device 500, and in particular, the needle 559, manifolds 555A, 555B, and / or ports 556, and can be configured to measure the amount of fluid (e.g., a suspension after therapeutic particles are effectively mixed with a fluid medium) passing therethrough. Referring back to FIG. 1, the vial engagement mechanism 520 includes a pair of lever arms 522 extending outwardly from the neck 524 of the vial engagement mechanism 520, and this 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 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.

[0024]

[0034] A pair of lever arms 522 are movable simultaneously with the neck 524 of the vial engagement mechanism 520 in response to actuation of the handle 528 of the console assembly 510. Further, the pair of lever arms 522 are fixed relative to each other such that the space formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 are configured to firmly engage the vial assembly 580 therebetween and, in particular, within the space formed by the pair of lever arms 522. Thus, the vial engagement mechanism 520 is operable to firmly attach the vial assembly 580 to the console assembly 510 in the vial receiving region 518. The vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, but it should be understood that the vial engagement mechanism 520 may include various other structural configurations suitable for engaging the vial assembly 580. In non-limiting examples, the vial engagement mechanism 520 may include one or more magnets configured to engage one or more corresponding magnets on the vial assembly.

[0025]

[0035] Still referring to FIG. 1, the console assembly 510 further includes a safety shield 526 that is secured to the distal end 516 of the base 512 along the vial receiving region 518. In particular, the safety shield 526 is a protective cover sized and shaped to surround the vial receiving region 518 of the console assembly 510 when secured to the console assembly 510. The safety shield 526 is selectively attachable to the distal end 516 of the base 512 and is formed of a material configured to suppress the emission of radiation from one or more radiation doses stored within the vial receiving region 518.

[0026]

[0036] 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 with the base 512 of the console assembly 510 within the sliding space 532.

[0027]

[0037] 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 include at least one positioning rib 554 extending laterally outward therefrom, and the positioning rib 554 is sized and shaped to fit and mate with the pair of positioning portions 534 of the console assembly 510. Accordingly, the pair of positioning ribs 554 are configured to facilitate the alignment and engagement of the slider 540 with the console assembly 510 when the proximal end 544 is slidably received within the sliding space 532 of the base 512.

[0028]

[0038] The sliding body 540 further includes an upper surface 548 that extends from a distal end 542 and a proximal end 544 and is positioned between a pair of side walls 546. The upper surface 548 of the sliding body includes a recessed region 549 and a locking system 550. The recessed region 549 is sized and shaped to form a recess and / or cavity along the upper surface 548, and this recessed region 549 can receive and / or collect various materials therein, including leakage of various fluid media during use of the delivery device 500, for example. The locking system 550 of the sliding body 540 forms an opening in the upper surface 548 that is sized and shaped to receive one or more devices, such as a priming assembly 560 and a vial assembly 580. In some embodiments, the sliding body 540 is pre-loaded with a priming assembly 560 disposed within the locking system 550. The priming assembly 560 includes a priming conduit 562 that extends outwardly from the locking system 550 of the sliding body 540. The priming assembly 560 connects the priming conduit 562 to a needle 559 and manifolds 555A and 555B and serves to purge air from the delivery device 500, including the manifolds 555A and 555B, before utilizing the delivery device 500 in a procedure.

[0029]

[0039] Referring now to FIG. 2, the locking system 550 includes an annular array of projections 551 extending outwardly therefrom, the projections 551 extending laterally into the aperture formed by the locking system 550, particularly along the upper surface 548. The annularly arranged projections 551 are formed within the inner circumference of the locking system 550 and extend along at least two continuously arranged rows. In an embodiment, a single row may be used. The annular array of projections 551 included in the locking system 550 engages corresponding locking features 586 (see FIG. 3) of the vial assembly 580, thereby configuring the vial assembly 580 to be securely fastened to the slider 540. The plurality of rows of projections 551 of the locking system 550 serve to provide a double locking system to ensure that the slider assembly 540, and particularly the pins 559 of the slider assembly 540, are securely maintained through the septum 592 (see FIG. 3) of the vial assembly 580 during use of the delivery device 500 in a procedure.

[0030]

[0040] The slider 540 further includes a vial chamber 558 sized and shaped to receive therein a priming assembly 560 and a vial assembly 580, respectively. In other words, the vial chamber 558 is sized to receive both the priming assembly 560 and the vial assembly 580 separately from each other. The vial chamber 558 is enclosed within a protective chamber or shield 557 disposed around the vial chamber 558. The protective shield 557 is formed of a material configured to suppress the emission of radiation, such as metal or plastic, from the vial chamber 558 to the outside. In addition, the slider 540 includes a needle 559 that extends through the protective shield 557 and into the vial chamber 558 along the lower end of 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).

[0031]

[0041] 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.

[0032]

[0042] Accordingly, the proximal manifold 555B is in fluid communication with one or more ports 556 via the distal manifold 555A, but the one or more ports 556 are not in fluid communication with the proximal manifold 555B due to the position of the one-way check valve 553 disposed between the manifolds 555A, 555B. Thus, the needle 559 is in fluid communication with one or more delivery conduits and / or devices coupled to the slider 540 at one or more ports 556 and via the manifolds 555A, 555B secured 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 fluids and / or solutions are injected and received as described herein.

[0033]

[0043] 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 one or more fluid channels and the radiation source due to the location of the battery 572 within the removable battery pack 570.

[0034]

[0044] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to contact and interact with corresponding electrical contacts 511 (see FIG. 1) of the console assembly 510 when the slider 540 is coupled to the base 512 in the sliding space 532. Accordingly, the removable battery pack 570 is operable to provide power to the delivery device 500, and in particular, the console assembly 510, when the slider 540 is coupled to the console assembly 510.

[0035]

[0045] In addition, as will be described in more detail herein, in some embodiments, the locking system 550 may include at least one planar wall relative to the other circular configurations of the locking system 550. In this case, the aperture formed by the locking system 550 through the upper surface 548 of the slider 540 is not of a circular shape as shown and described above, but is of an irregular shape. In this case, the vial assembly 580 includes the locking system 550 and, in particular, a locking feature 586 having a shape and size corresponding to at least one planar wall, such that the vial assembly 580 is received within the slider 540 only when the orientation of the vial assembly 580 corresponds to the orientation of the locking feature 586 and the locking system 550. In other words, the corresponding planar wall 586A (see FIG. 3) of the locking feature 586 must be aligned with the planar wall of the locking system 550 such that the vial assembly 580 can be received within the aperture formed by the locking system 550 of the slider 540.

[0036]

[0046] 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 outward with respect to the longitudinal length of the plunger 584 that extends downward 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 fixedly secured to each other. In either 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.

[0037]

[0047] The plunger 584 includes a plurality of markings and / or graduations 583 positioned along the longitudinal length of the plunger 584. The plurality of graduations 583 indicate the relative extension of the engagement head 582 and the plunger 584 from the locking feature 586 and the vial body 589. As briefly described above, the engagement head 582 is configured to attach the vial assembly 580 to the vial engagement mechanism 520. In particular, the pair of arms 581 of the engagement head 582 are sized and shaped to couple with the pair of lever arms 522 of the vial engagement mechanism 520 when the vial assembly 580 is received within the slider 540 and the slider is inserted into the sliding space 532 of the console assembly 510. As 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.

[0038]

[0048] Still referring to FIG. 3, the vial assembly 580 further includes a safety tab 585 coupled to the plunger 584 relative to above the locking feature 586 and below the engagement head 582, such that the safety tab 585 is positioned along the longitudinal length of the plunger 584. The safety tab 585 can be formed of various materials such as, for example, plastic and is pre-assembled to the vial assembly 580 prior to use of the delivery device 500. The safety tab 585 is removably secured to the plunger 584 and inhibits translation of the plunger 584 relative to the vial body 589. In particular, the safety tab 585 abuts against the locking feature 586 in response to the application of a linear force to the plunger 584 to translate the plunger 584 relatively downward into the vial body 589. In this case, the safety tab 585 is configured to 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 described in more detail herein, the safety tab 585 is selectively removed from the plunger 584 in response to the coupling of the vial assembly 580 with the vial engagement mechanism 520 and in particular, the engagement of the pair of lever arms 522 with the engagement head 582.

[0039]

[0049] Returning to FIG. 3 for reference, 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 arranged protrusions 551 of the locking system 550 when the vial assembly 580 is received within the vial chamber 558 of the slider 540. As will be described in more detail herein, the locking feature 586, and in particular the side edge 587 of the locking feature 586, is configured to securely hold the vial assembly 580 to the locking system 550 and prevent removal of the vial body 589 from the vial chamber 558 of the slider 540 during use of the delivery device 500 in the procedure. In some embodiments, as briefly described above, the locking feature 586 includes at least one planar wall 586A such that the locking feature 586 has an irregular shape. The at least one planar wall 586A is configured to correspond to the planar wall 550A of the locking system 550 such that, as a result, alignment of the planar walls 550A and 586A requires that the vial assembly 580 be received through an aperture formed by the locking system 550.

[0040]

[0050] Still referring to FIG. 3, the vial body 589 extends relatively downwardly from the locking feature 586 and has a longitudinal length sized to receive therein at least a portion of the longitudinal length of the plunger 584. Thus, in some embodiments, the longitudinal length of the plunger 584 exceeds the longitudinal length of the vial body 589, such that translational movement of the plunger 584 into the internal chamber 588 of the vial body 589 causes the fluid medium stored therein to be sent out of the vial body 589. As will be described in more detail herein, translational movement of the plunger 584 through the internal chamber 588 of the vial body 589 enables administration of the fluid medium stored within the vial body 589 out of the vial assembly 580. The vial body 589 can be formed of a variety of materials including, for example, thermoplastic polymers, copolyesters, polycarbonates, biocompatible plastics, polysulfones, ceramics, metals, and / or the like.

[0041]

[0051] The vial body 589 of this example is formed of a material configured to suppress radiation emission from the 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 can have a width. The combination of the density and material composition of the vial body 589 enables suppression of beta radiation emission from the electron particles stored in the internal chamber 588. In this example, the chemical composition of the plastic of the vial body 589, in combination with a wall thickness of 9 mm, provides a plurality of atoms disposed within the vial body 589, and such a plurality of atoms can cope with beta radiation that generates electrons and reduce the emission of the above radiation from the vial assembly 580. Accordingly, the vial assembly 580 enables an operator to handle the radioactive substance stored in the vial body 589 without being exposed to beta radiation. It should be understood that in other embodiments, various other materials and / or wall regions can be incorporated within the vial body 589 of the vial assembly 580 without departing from the scope of the present disclosure.

[0042]

[0052] Still referring to FIG. 3, the vial body 589 of the vial assembly 580 is sealed at the first end 598 by the locking feature 586. The vial assembly 580 further includes a cap 590 positioned at the opposite end of the vial body 589 from the locking feature 586, such that the cap 590 seals the second end of the vial body 589 of the vial assembly 580. Additionally, the vial assembly 580 includes a septum 592, which is positioned adjacent to the cap 590 and in fluid communication with the end of the vial body 589 opposite the locking feature 586. The septum 592 forms a seal against the end of the vial body 589, and the cap 590 holds the septum 592 therein. The septum 592 can be formed of various materials, including, for example, elastomers, silicones, bromobutyl elastomers, rubbers, urethanes, and / or the like. The septum 592 provides an airtight seal for the vial body 589 and is configured to inhibit the release of the fluid medium (e.g., radiation embolization beads) stored therein. As will be described in more detail herein, the septum 592 of the vial assembly 580 is configured to be punctured by the needle 559 of the slider 540 when the vial assembly 580 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the slider 540. In other embodiments, instead of the septum 592, alternative devices, such as, for example, valve systems, needle injection ports, and / or the like, can also be used.

[0043]

[0053] 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.

[0044]

[0054] The stopper 594 is configured to form a liquid-tight seal with respect to the internal chamber 588 of the vial body 589 and can be formed of various polymers having a predetermined viscoelasticity. For example, in some embodiments, the stopper 594 is formed of elastomer, silicone, rubber, urethane, plastic, polyethylene, polypropylene, and / or the like. In this case, the stopper 594 is operable to prevent the fluid medium stored within the vial body 589 from diffusing (i.e., leaking) past the stopper 594 and out of the vial body 589. In particular, two or more ribs 593 of the stopper 594 abut against and form a seal along the internal chamber 588 of the vial body 589, thereby preventing the fluid medium from passing over the ribs 593. One or more recesses 595 formed between two or more ribs 593 of the stopper 594 are configured to receive, and more specifically capture, any fluid medium that may inadvertently diffuse (i.e., leak) past the ribs 593 of the stopper 594. Thus, the one or more recesses 595 serve as a safety mechanism for the vial assembly 580 to ensure that the fluid medium is maintained within the vial body 589 and not exposed beyond the vial assembly 580.

[0045]

[0055] 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 against 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 again within the vial body 589 in the direction of travel of the plunger 584 and the stopper 594. The vial assembly 580 further includes an annular washer 596 disposed within the vial body 589. In particular, the annular washer 596 is firmly fixed to the plunger 584 adjacent to the stopper 594, which is secured to the plunger 584 at the opposite end of the engagement head 582. Thus, the annular washer 596 is fixed to the plunger 584 and disposed within the vial body 589 adjacent to the stopper 594. Since the annular washer 596 is fixed to the plunger 584 adjacent to the stopper 594, the annular washer 596 is effectively disposed within the vial body 589.

[0046]

[0056] 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 the fluid medium via the contrast agent conduit 10B, the dosage delivery conduit 10A can subsequently be coupled to an external device, such as a catheter. The opposite end of the flushing conduit 10C is coupled to an external device, such as a syringe, for example. With both the dosage delivery conduit 10A and the flushing conduit 10C coupled to the slider 540, the slider 540 is flushed with a fluid medium (e.g., saline) from a syringe coupled to the flushing conduit 10C. In this case, the fluid medium is injected through the flushing conduit 10C into the distal manifold 555A of the slider 540 and exits the slider 540 through the dosage delivery conduit 10A. Thus, the fluid medium is ultimately received and disposed (or processed therein) by the collection bowl via the dosage delivery conduit 10A.

[0047]

[0057] 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, such that as a result, the fluid medium is not directed beyond the one-way valve 553 and into the proximal manifold 555B in fluid communication with the needle 559.

[0048]

[0058] 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 fixed to the console assembly 510 by a mounting device 538, for example. In this example, the bag is a saline bag, and thus the fluid 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. As a result, 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 the collection bowl coupled to the dose delivery conduit 10A.

[0049]

[0059] 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, that is secured 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 secured to the contrast agent port 556B.

[0050]

[0060] 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 that is separated from the proximal manifold 555B by a one-way check valve 553 disposed therebetween, saline from the saline bag can be drawn through the needle 559 of the slider 540 and into the vial body 589 of the vial assembly 580.

[0051]

[0061] Referring again to FIGS. 1 and 3, with the vial assembly 580 firmly coupled to the slider 540, the slider 540 is coupled to the console assembly 510 by translating the distal end 542 of the slider 540 toward and into the distal end 516 of the console assembly 510. In particular, the distal end 542 of the slider 540 is directed into the sliding space 532 of the console assembly 510 by aligning the positioning rib 554 of the slider 540 with the positioning portion 534 of the console assembly 510. Once the proximal end 544 and the distal end 542 of the slider 540 are fully enclosed within the sliding space 532 of the console assembly 510, the electrical contacts 574 (FIG. 2) of the removable battery pack 570 interact with the corresponding electrical contacts 511 (FIG. 1) of the console assembly 510. In this case, power from the battery 572 is transmitted to the console assembly 510 via the electrical contacts 574, whereby the console assembly 510 of the delivery device 500 is activated. In this case, the interface display 530 of the console assembly 510 is activated to display appropriate real-time information regarding the delivery device 500 during the procedure.

[0052]

[0062] 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 microspheres for embolization), the saline is effectively mixed with the radioactive fluid medium within the vial body 589 when the plunger 584 is withdrawn from the internal chamber 588 and a negative pressure is generated through the delivery device 500.

[0053]

[0063] 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 enable 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 it is impossible to direct the dose delivered from the vial body 589 to the manifolds 555A, 555B into the contrast agent conduit 10B or the flushing conduit 10C because of the one-way check valve 553A located therein. Thus, the dose is directed to the dose delivery port 556A and is received in a catheter fluidly coupled by the dose delivery conduit 10A. In other words, the one-way check valve 553A prevents backflow of fluid into the sliding body 540 and / or the vial assembly 580 coupled thereto. II. Radiation containment embodiments

[0064] As briefly described above, the delivery device 500 described herein may include radiation containment components, embodiments of which are described in more detail below with respect to FIGS. 6-10. FIGS. 6-10 show embodiments of a radiation containment component 600 disposed between the delivery conduit connector 710 (e.g., the dose delivery conduit 10A) of the particulate delivery device 500 and the microcatheter 720 for disposal or for delivery between the delivery conduit connector 710 and the microcatheter 720 of the particulate delivery device 500, as described in more detail below. Thus, FIGS. 6-10 reflect embodiments of a radiation containment component 600, such as a flexible bag, for sealing over the microcatheter 720 used to deliver the mixed particulates from the delivery conduit connector 710 of the particulate delivery device 500 to the microcatheter 720 for disposal, particularly after use, such that the distal end 728 of the microcatheter 720 is sealed and the delivery conduit connector 710 connected to the used microcatheter 720 is ready for disposal (e.g., to be discarded into a biohazard treatment unit).

[0054]

[0065] Referring to FIGS. 6-10, the radiation containment component 600 may include a proximal end 602 and a distal end 604 disposed opposite the proximal end 602. The proximal end 602 may be configured to connect to and cover a distal portion 712 of the delivery conduit connector 710 of the particulate delivery device 500. The delivery conduit connector 710 may be configured to receive mixed particulates from the particulate delivery device 500. As shown in FIG. 10, which is described in more detail below, the distal end 604 may be disposed on and configured to receive a microcatheter 720 that is connected to the delivery conduit connector 710 after use. Thus, the distal end 604 may be configured to seal together, for example but not limited to, to receive the microcatheter 720 prior to discarding the particulate delivery device 500 after use.

[0055]

[0066] Referring to FIG. 6 showing the radiation containment component 600 in the folded position 606, in an embodiment, the proximal end 602 includes a rigid material 608, the distal end 604 includes a flexible material 610, and the flexible material 610 includes more elasticity than the rigid material 608. The flexible material 610 may include a deformable plastic, a spring-loaded material, or other suitable flexible materials configured to wind, deploy, extend, and / or return to a naturally biased position. The rigid material 608 may include cardboard, plastic, metal, or combinations thereof. The rigid material 608 may be square, circular, or other shapes from which the flexible material 610 extends. The flexible material 610 may be a low-density material and may include, but is not limited to, a thickness sufficient to assist in containing radiation, such as in the range of 1 mm to 10 mm, for example, up to 9 mm, to block beta radiation, contain the radiation, and thus provide additional shielding. The flexible material 610 may include a low-density material to block beta radiation, and the low-density material includes plastic, a material filled with water or other fluid, cloth, or other suitable flexible materials. In an embodiment, the flexible material 610 includes an accordion rib structure in a relaxed form and includes more elasticity than the rigid material 608 and is configured to extend to an extended form (e.g., the deployed position 612 as shown in FIG. 9 or the sealed position 614 for disposal as shown in FIG. 10) to smooth the accordion rib structure and to cover and contain the microcatheter 720 prior to sealing the distal end 604 of the radiation containment component 600. In an embodiment, the flexible material 610 may be configured to deploy from a wound form to cover and contain the microcatheter 720 prior to sealing the distal end 604 of the radiation containment component 600. The distal end 604 may include a seal by an adhesive, a fastening mechanism, or a combination thereof to seal together for containing the microcatheter 720 prior to disposal as described herein.

[0056]

[0067] Referring to FIG. 7, the radiation containment component 600 in the folded position 606 is shown disposed on the delivery conduit connector 710 of the microparticle delivery device 500. The rigid material 608 at the proximal end 602 is configured to be disposed against an adjacent lip at the distal portion 712 of the delivery conduit connector 710 to prevent the proximal end 602 from moving distally toward the distal end 604. In embodiments, the rigid material 608 may include one or more engagement features to engage one or more corresponding engagement features of the adjacent lips at the distal portion 712 of the delivery conduit connector 710, such as one or more other holes and / or protrusions that are each configured to engage one or more respective other holes and / or protrusions, or other locking mechanisms. As shown in FIGS. 7-10, the distal end 716 of the delivery conduit connector 710 may be configured to connect to the proximal end 726 of the microcatheter 720. The distal end 716 of the delivery conduit connector 710 may be accessible when the distal end 604 of the radiation containment component 600 is not sealed. In embodiments, and as described below with respect to at least FIGS. 9 and 10, when the distal end 604 of the radiation containment component 600 is sealed to contain the microcatheter 720 (such as at the sealed end 732), the distal end 604 of the radiation containment component 600 may be configured to cover the distal end 716 of the delivery conduit connector 710.

[0057]

[0068] Referring again to FIG. 7, the microcatheter 720 may include a proximal end 726 that includes a fastener 722 as shown. The fastener 722 may be, by way of non-limiting example, a luer connector or other fastening mechanism and may include, as shown, a tip 723, a flange 724, and a base 725 having a width greater than the width of the tip 723, with the flange 724 defined between the tip 723 and the base 725. The distal end 728 of the microcatheter 720 is shown in FIG. 8.

[0058]

[0069] FIG. 8 illustrates a radiation containment component 600 in a deployment position 612 that can be in a first deployed state, pulled distally over a microcatheter 720 and approaching a base sheath 730 that receives the distal end 728 of the microcatheter 720. The microcatheter 720 can be configured to connect to a base connector, such as base sheath 730, for use in delivering the mixed microparticles. Further, the microcatheter 720 can be configured to disconnect from a base connector, such as base sheath 730, after use and before the distal end 604 of the radiation containment component 600 that houses the microcatheter 720 is sealed (as shown in FIG. 10).

[0059]

[0070] Referring again to FIG. 8, in the first deployed state, the fastener 722 of the microcatheter 720 is moved proximally in the direction of arrow A toward the proximal end 602 of the radiation containment component 600 until the protrusion 724 abuts against the rigid material 608 of the radiation containment component 600. The abutment of the protrusion 724 and the rigid material 608 helps prevent distal movement of the proximal end 602 of the radiation containment component 600. Shown in FIG. 8 is the tip 723 of the fastener 722 when the protrusion 724 abuts against the rigid material 508 in order to extend through a hole in the rigid material 608 at the proximal end 602 of the radiation containment component 600.

[0060]

[0071] Further, the distal end 604 of the radiation containment component 600 is pulled distally in the direction of arrow B toward the base sheath 730 that receives the distal end 728 of the microcatheter 720, for example, for delivery of the mixed microparticles from the microparticle delivery device 500 to the patient. The distal end 604 of the radiation containment component 600 can continue to be pulled distally in the direction of arrow B toward the base sheath 730 that receives the distal end 728 of the microcatheter 720 in order to reach the position of FIG. 9.

[0061]

[0072] FIG. 9 illustrates the radiation containment component 600 in the deployed position 612 in a second deployed state, further pulled distally over the microcatheter 720 and the base sheath 730 that receives the distal end 728 of the microcatheter 720. The distal end 604 of the radiation containment component 600 can be sealed (and have a sealed end 732 as also shown, for example, in FIG. 10) prior to the use of the connected microcatheter 720 and delivery line connector 710 for delivering the mixed microparticles to a patient.

[0062]

[0073] FIG. 10 illustrates the radiation containment component 600 in the sealed position 614, deployed while disposed and sealed over the distal end 728 of the microcatheter 720 removed from the base sheath 730 and for disposal (e.g., as biohazardous waste). Such a seal is shown as the sealed end 732. In an embodiment, after use, the distal end 728 of the microcatheter 720 can be removed from the base sheath 730 and the distal end 604 of the radiation containment component 600 can be sealed by the sealed end 732 over the distal end 728 of the microcatheter 720. The proximal end 726 of the microcatheter 720 can still be connected to the distal end 716 of the delivery line connector 710, and the proximal end 602 of the radiation containment component 600 can continue to be sealed by the sealed end 732 over the distal portion 712 of the delivery line connector 710. In an embodiment, the entire used microparticle delivery device 500, including the radiation containment component 600 sealed and disposed by the sealed end 732 around the distal end 728 of the microcatheter 720 and the distal portion 712 of the delivery line connector 710, can then be discarded (such as in hazardous waste disposal).

[0063]

[0074] In an embodiment, a radiation-sealed assembly for sealing and disposal may include a particulate delivery device 500 including a delivery line connector 710, a base connector such as a base sheath 730, a microcatheter 720, and a radiation containment component 600 as described herein. The microcatheter 720 may be used to deliver mixed particles from the particulate delivery device 500 and may be configured to be connected to a base connector (e.g., the base sheath 730) and the delivery line connector 710 for delivering the mixed particles. The microcatheter 720 may be configured to be detached from the base connector after use and connected to the delivery line connector 710.

[0064]

[0075] A method for sealing and disposal of the microcatheter 720 used to deliver mixed particles from the particulate delivery device 500 may include, for example, as shown in FIG. 7, connecting the delivery line connector 710 of the particulate delivery device 500 to the microcatheter 720. The microcatheter 720 may be connected to a base connector (such as the base sheath 730 as shown in FIGS. 8 and 9). Further, the mixed particles may be delivered from the particulate delivery device 500 through the microcatheter 720 and the base connector (e.g., the base sheath 730 of FIG. 9). The microcatheter 720 may be detached from the base connector after use, as shown in FIG. 10. The proximal end 602 of the radiation containment component 600 may be disposed on the distal portion 712 of the delivery line connector 710 of the particulate delivery device 500 such that the proximal end 602 does not move distally towards the distal end 604. The distal end 604 of the radiation containment component 600 may extend to cover for accommodating the microcatheter 720 connected to the delivery line connector 710 after use. The distal end 604 of the radiation containment component 600 may be sealed together for accommodating the microcatheter 720 before disposal. In an embodiment, and as shown in FIG. 10, the microcatheter 720 accommodated in the radiation containment component 600, the particulate delivery device 500 connected to the microcatheter 720, and the radiation containment component 600 may be discarded in biomedical waste disposal. III. List of Aspects

[0076] Aspect 1. The radiation containment component used to seal the microcatheter for delivering mixed microparticles from the microparticle delivery device for disposal may include a proximal end and a distal end disposed opposite the proximal end. The proximal end is configured to connect to and cover the distal portion of the delivery line connector of the microparticle delivery device, and the delivery line connector is configured to receive the mixed microparticles from the microparticle delivery device. The distal end is disposed on and configured to accommodate the microcatheter connected to the delivery line connector after use, and the distal end is configured to seal together to accommodate the microcatheter before disposal.

[0065]

[0077] Aspect 2. The radiation containment component of Aspect 1, wherein the proximal end includes a rigid material and the distal end includes a flexible material, and the flexible material includes more elasticity than the rigid material.

[0066]

[0078] Aspect 3. The radiation containment component of Aspect 2, wherein the rigid material at the proximal end is configured to be disposed against the adjacent lip at the distal portion of the delivery line connector to prevent the proximal end from moving distally.

[0067]

[0079] Aspect 4. The radiation containment component of Aspect 1 or Aspect 2, wherein the rigid material includes cardboard, plastic, metal, or a combination thereof, and the flexible material includes a low-density material, and the low-density material includes a maximum thickness of 9 mm to block beta radiation.

[0068]

[0080] Aspect 5. The radiation containment component of any one of Aspects 1 to 4, wherein the distal end of the radiation containment component is configured to cover the distal end of the delivery line connector when the distal end of the radiation containment component is sealed to accommodate the microcatheter, and the distal end of the delivery line connector is configured to connect to the proximal end of the microcatheter.

[0069]

[0081] Aspect 6. A radiation containment component of Aspect 5, wherein the distal end of the delivery line connector is accessible when the distal end of the radiation containment component is not sealed.

[0070]

[0082] Aspect 7. A radiation containment component of any one of Aspects 1 - 6, wherein the proximal end comprises a rigid material, the distal end comprises a flexible material, the flexible material is in a relaxed form of an accordion rib structure and contains more elasticity than the rigid material, and is configured to extend to an extended form to smooth the accordion rib structure and to cover and contain a microcatheter before sealing of the distal end.

[0071]

[0083] Aspect 8. A radiation containment component of any one of Aspects 1 - 7, wherein the distal end comprises an adhesive, a fastening mechanism, or a combination thereof for sealing together to contain the microcatheter before disposal.

[0072]

[0084] Aspect 9. A radiation containment component of any one of Aspects 1 - 8, wherein the microcatheter is configured to connect to a base connector for the purpose of delivering mixed microparticles, and the microcatheter is configured to be detached from the base connector after use and before the distal end containing the microcatheter is sealed.

[0073]

[0085] Aspect 10. A radiation-sealed assembly for sealing and disposal, comprising a particulate delivery device with a delivery line connector, a base connector, a microcatheter, and a radiation containment component. The microcatheter is used to deliver mixed particulates from the particulate delivery device, and is configured to be connected to the base connector and the delivery line connector for delivering the mixed particulates. After use, the microcatheter is configured to be detached from the base connector and connected to the delivery line connector. The radiation containment component includes a proximal end and a distal end disposed opposite the proximal end. The proximal end is configured to connect to and cover the distal portion of the delivery line connector of the particulate delivery device, and the delivery line connector is configured to receive the mixed particulates from the particulate delivery device. The distal end is disposed on and configured to contain the microcatheter connected to the delivery line connector after use. The distal end is configured to be sealed together to contain the microcatheter before disposal.

[0074]

[0086] Aspect 11. The radiation-sealed assembly of Aspect 11, wherein the proximal end includes a rigid material and the distal end includes a flexible material, and the flexible material includes more elasticity than the rigid material.

[0075]

[0087] Aspect 12. The radiation-sealed assembly of Aspect 11, wherein the rigid material of the proximal end is configured to be disposed against an adjacent lip at the distal portion of the delivery line connector to prevent the proximal end from moving in the distal direction.

[0076]

[0088] Aspect 13. The radiation-sealed assembly according to any one of Aspects 10 to 12, wherein the rigid material includes cardboard, plastic, metal, or a combination thereof.

[0077]

[0089] Aspect 14. A radiation-sealed assembly according to any one of Aspects 10 to 13, wherein the distal end of the radiation-containing component is configured to cover the distal end of the delivery line connector when the distal end of the radiation-containing component is sealed to accommodate the microcatheter, and the distal end of the delivery line connector is configured to be connected to the proximal end of the microcatheter.

[0078]

[0090] Aspect 15. A radiation-sealed assembly according to Aspect 14, wherein the distal end of the delivery line connector is accessible when the distal end of the radiation-containing component is not sealed.

[0079]

[0091] Aspect 16. A radiation-sealed assembly according to any one of Aspects 10 to 15, wherein the proximal end includes a rigid material, the distal end includes a flexible material, the flexible material is in a relaxed form of an accordion rib structure, and includes more elasticity than the rigid material, and is configured to extend to an extended form to smooth the accordion rib structure, and to cover and accommodate the microcatheter before sealing the distal end.

[0080]

[0092] Aspect 17. A radiation-sealed assembly according to any one of Aspects 10 to 16, wherein the distal end includes an adhesive, a fastening mechanism, or a combination thereof for sealing together to accommodate the microcatheter before disposal.

[0081]

[0093] Aspect 18. A radiation-sealed assembly according to any one of Aspects 10 to 17, wherein the microcatheter is configured to be connected to a base connector for the purpose of delivering mixed microparticles, and the microcatheter is configured to be detached from the base connector after use and before the distal end that accommodates the microcatheter is sealed.

[0082]

[0094] Aspect 19. A method for sealing and discarding a microcatheter used to deliver mixed microparticles from a microparticle delivery device, the method comprising: connecting a delivery line connector of the microparticle delivery device to the microcatheter; connecting the microcatheter to a base connector; delivering mixed microparticles from the microparticle delivery device through the microcatheter and the base connector; and disconnecting the microcatheter from the base connector after use. The method further comprises disposing a proximal end of a radiation containment component on a distal portion of the delivery line connector of the microparticle delivery device such that the proximal end does not move distally; extending a distal end of the radiation containment component to cover the microcatheter received in the delivery line connector after use; and sealing the distal ends together to contain the microcatheter before discarding.

[0083]

[0095] Aspect 20. The method of aspect 19, further comprising discarding, in a biohazard waste disposal, the microcatheter received in the radiation containment component, the microparticle delivery device connected to the microcatheter, and the radiation containment component.

[0084]

[0096] Note that the terms “substantially” and “about” may be used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. These terms are also used herein to represent the degree to which a quantitative expression may vary from the stated reference without resulting in a change in the basic function of the subject matter in question.

[0085]

[0097] For purposes 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 representation. The term "substantially" is 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. As such, it is used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation with respect to the arrangement of elements or features that, while expected to present a theoretically exact match or behavior, may in practice embody something that is slightly less than exact.

[0086]

[0098] 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.

Claims

1. A radiation containment component for sealing a microcatheter used to deliver mixed microparticles from a microparticle delivery device for disposal, the radiation containment component comprising: a proximal end and a distal end disposed opposite the proximal end; the proximal end is configured to connect to and cover a distal portion of a delivery line connector of the microparticle delivery device, the delivery line connector being configured to receive the mixed microparticles from the microparticle delivery device; the distal end is disposed on and configured to receive the microcatheter that is connected to the delivery line connector after use; the distal end is configured to seal together to receive the microcatheter prior to disposal, the radiation containment component.

2. The radiation containment component according to claim 1, wherein: the proximal end includes a rigid material, the distal end includes a flexible material, and the flexible material includes more elasticity than the rigid material, the radiation containment component.

3. The radiation containment component according to claim 2, wherein: the rigid material of the proximal end is configured to be disposed against an adjacent lip at the distal portion of the delivery line connector to prevent the proximal end from moving in the distal direction, the radiation containment component.

4. The radiation containment component according to claim 2, wherein: the rigid material includes cardboard, plastic, metal, or a combination thereof, the flexible material includes a low-density material, and the low-density material includes a thickness of up to 9 mm to block beta radiation, the radiation containment component.

5. The radiation containment component according to claim 1, wherein: the distal end of the radiation containment component is configured to cover the distal end of the delivery line connector when the distal end of the radiation containment component is sealed to receive the microcatheter, and the distal end of the delivery line connector is configured to connect to the proximal end of the microcatheter, the radiation containment component.

6. The radiation containment component according to claim 5, wherein: the distal end of the delivery line connector is accessible when the distal end of the radiation containment component is not sealed, the radiation containment component.

7. The radiation containment component according to claim 1, wherein: The proximal end includes a rigid material, the distal end includes a flexible material, the flexible material includes an accordion rib structure in a relaxed form and has more elasticity than the rigid material, and is configured to extend to an extended form to smooth the accordion rib structure and to cover and accommodate the microcatheter before sealing of the distal end, a radiation containment component.

8. The radiation containment component according to claim 1, wherein the distal end includes an adhesive, a fastening mechanism, or a combination thereof for sealing together to accommodate the microcatheter before disposal, a radiation containment component.

9. The radiation containment component according to claim 1, wherein the microcatheter is configured to connect to a base connector for use in delivering the mixed microparticles, and the microcatheter is configured to disconnect from the base connector after use and before the distal end that accommodates the microcatheter is sealed, a radiation containment component.

10. A radiation-sealed assembly for sealing and disposal, the radiation-sealed assembly comprising: a microparticle delivery device comprising a delivery line connector; a base connector; a microcatheter used to deliver mixed microparticles from the microparticle delivery device, the microcatheter being configured to be connected to the base connector and the delivery line connector for delivering the mixed microparticles, the microcatheter being configured to be disconnected from the base connector after use and to be connected to the delivery line connector; a radiation containment component comprising: a proximal end and a distal end disposed opposite the proximal end; the proximal end being configured to connect to and cover a distal portion of the delivery line connector of the microparticle delivery device, the delivery line connector being configured to receive the mixed microparticles from the microparticle delivery device; the distal end being disposed on and configured to accommodate the microcatheter connected to the delivery line connector after use; the distal end being configured to be sealed together to accommodate the microcatheter before disposal; a radiation-sealed assembly comprising the radiation containment component.

11. The radiation-sealed assembly according to claim 10, The proximal end includes a rigid material, the distal end includes a flexible material, and the flexible material includes more elasticity than the rigid material, the described radiation-sealed assembly.

12. The radiation-sealed assembly according to claim 11, wherein the rigid material at the proximal end is configured to be disposed with respect to an adjacent lip at the distal portion of the delivery conduit connector so as to prevent the proximal end from moving in the distal direction, the radiation-sealed assembly.

13. The radiation-sealed assembly according to claim 11, wherein the rigid material includes cardboard, plastic, metal, or a combination thereof, the radiation-sealed assembly.

14. The radiation-sealed assembly according to claim 11, wherein the distal end of the radiation-containing component is configured to cover the distal end of the delivery conduit connector when the distal end of the radiation-containing component is sealed to accommodate the microcatheter, and the distal end of the delivery conduit connector is configured to be connected to the proximal end of the microcatheter, the radiation-sealed assembly.

15. The radiation-sealed assembly according to claim 14, wherein the distal end of the delivery conduit connector is accessible when the distal end of the radiation-containing component is not sealed, the radiation-sealed assembly.

16. The radiation-sealed assembly according to claim 10, wherein the proximal end includes a rigid material, the distal end includes a flexible material, the flexible material includes an accordion rib structure in a relaxed form, and more elasticity than the rigid material, and is configured to extend into an extended form to smooth the accordion rib structure and to cover and accommodate the microcatheter before sealing of the distal end, the radiation-sealed assembly.

17. The radiation-sealed assembly according to claim 10, wherein the distal end includes an adhesive, a fastening mechanism, or a combination thereof for sealing together to accommodate the microcatheter before disposal, the radiation-sealed assembly.

18. The radiation-sealed assembly according to claim 10, The microcatheter is configured to be connected to the base connector for the purpose of delivering the mixed microparticles, and the microcatheter is configured to be detached from the base connector after use and before the distal end containing the microcatheter is sealed, a radiation-sealed assembly.

19. A method for sealing and discarding a microcatheter used for delivering mixed microparticles from a microparticle delivery device, the method comprising: connecting a delivery line connector of the microparticle delivery device to the microcatheter; connecting the microcatheter to a base connector; delivering the mixed microparticles from the microparticle delivery device through the microcatheter and the base connector; detaching the microcatheter from the base connector after use; disposing the proximal end of the radiation containment component on the distal portion of the delivery line connector of the microparticle delivery device such that the proximal end does not move distally; extending the distal end of the radiation containment component to cover for containing the microcatheter connected to the delivery line connector after use; sealing by aligning the distal ends for containing the microcatheter before discarding, a method.

20. The method according to claim 19, further comprising discarding in biomedical hazardous waste disposal the microcatheter contained in the radiation containment component, and the microparticle delivery device connected to the microcatheter, and the radiation containment component.

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