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 therapy.

Background Art

[0002]

[0002] In cancer treatment involving radiation therapy, inadvertent or excessive exposure to radiation from radioactive therapeutic agents can be harmful and potentially fatal to patients or healthcare workers. Thus, medical devices for radiation therapy must be configured to keep the delivery of radioactive substances to a specific area of the patient's body localized while protecting other areas from unnecessary radiation exposure.

[0003]

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

[0005] According to one embodiment of the present disclosure, a radiation containment component for sealing a microcatheter used to deliver mixed particles from a particulate delivery device for disposal comprises 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 a delivery conduit connector of a particulate delivery device, the delivery conduit connector is configured to receive mixed particles from the particulate delivery device. The distal end is configured to be disposed on and to contain a microcatheter that connects to the delivery conduit connector after use, and the distal end is configured to seal together to contain the microcatheter before disposal.

[0006]

[0006] In another embodiment, a radiation-sealed assembly for sealing and disposal comprises a particulate delivery device with a delivery conduit connector, a base connector, a microcatheter, and a radiation-sealed component. The microcatheter is used to deliver mixed particulate matter from the particulate delivery device, and the microcatheter is configured to connect to the base connector and the delivery conduit connector for delivering the mixed particulate matter, and the microcatheter is configured to be detached from the base connector and connected to the delivery conduit connector after use. The radiation-sealed component comprises 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 conduit connector of the particulate delivery device, and the delivery conduit connector is configured to receive mixed particulate matter from the particulate delivery device. The distal end is configured to be disposed on and to accommodate the microcatheter which is connected to the delivery conduit connector after use. The distal end is configured to seal together to accommodate the microcatheter before disposal.

[0007]

[0007] In yet another embodiment, a method for sealing and disposing of a microcatheter used to deliver mixed particles from a particulate delivery device includes the steps of connecting the delivery conduit connector of the particulate delivery device to the microcatheter, connecting the microcatheter to a base connector, delivering mixed particles from the particulate delivery device through the microcatheter and the base connector, and detaching the microcatheter from the base connector after use. The method further includes the steps of positioning the proximal end of a radiation containment component over the distal portion of the delivery conduit connector of the particulate delivery device so that the proximal end does not move distally, extending the distal end of the radiation containment component to cover and accommodate the microcatheter connected to the delivery conduit connector after use, and sealing the distal end to accommodate the microcatheter before disposal.

[0008]

[0008] These and additional features provided by the embodiments described herein will be better understood in conjunction with the drawings and the following detailed description. [Brief explanation of the drawing]

[0009] [Figure 1]

[0009] This is a perspective view of a delivery device including a protective shield and a vial sliding portion, according to one or more embodiments shown and described in the present invention. [Figure 2]

[0010] This is a cross-sectional view of the vial sliding portion of Figure 1, along line 2-2 in Figure 1, according to one or more embodiments shown and described in the present invention. [Figure 3]

[0011] This is a perspective view of a vial assembly including an engaging head, according to one or more embodiments shown and described in the present invention. [Figure 4]

[0012] This is a partial cross-sectional view of the vial assembly in Figure 4, taken along line 4-4 in Figure 3. [Figure 5]

[0013] This is a perspective view of the vial sliding part of Figure 1, in which the vial assembly of Figure 3 is received, with a series of delivery lines coupled to the vial sliding part according to one or more embodiments shown and described in the present invention. [Figure 6]

[0014] This is 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] This is a schematic side view of the radiation containment component shown in Figure 6, which is in a folded position and is positioned on the delivery conduit connector of the delivery device. [Figure 8]

[0016] This is a schematic side view of the radiation receiving component in Figure 7, which is deployed and being pulled distally over the microcatheter, approaching the base sheath that receives the distal end of the microcatheter. [Figure 9]

[0017] This is a schematic side view of the radiation receiving component in Figure 7, which is in its deployed position and is pulled further distally above the distal end that receives the microcatheter and the distal end of the microcatheter. [Figure 10]

[0018] Figure 9 is a schematic side view of the radiation containment component, which is deployed and sealed in a position for disposal and is positioned above and sealed over the distal end of the microcatheter after it has been removed from the base sheath. [Modes for carrying out the invention]

[0010]

[0019] Hereafter, various embodiments of delivery devices for administering radioactive compounds to patients will be described in detail, examples of these embodiments illustrated in the accompanying drawings. Where possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts. Directional terms as used herein, such as up, down, right, left, front, back, upper, lower, distal, and proximal, will be used only in relation to the drawings being depicted and are not intended to suggest any absolute orientation.

[0011]

[0020] A range may be expressed herein as “about” one particular value and / or “about” another particular value. When such a range is expressed, another embodiment includes one particular value and / or other particular values. Similarly, when a value is expressed as an approximation by the preceding use of “about,” it should be understood that the particular value forms another embodiment. It should be further understood that each endpoint of a range is significant in relation to and independently of the other endpoints.

[0012]

[0021] Unless otherwise expressly stated, no method described herein is intended in any way to be construed as requiring its steps to be performed in a specific order or requiring any apparatus-specific orientation. Therefore, if a method claim does not actually enumerate the order to which its steps should be applied, or if any apparatus claim does not actually enumerate the order or orientation to its individual components, or if it is not otherwise specifically stated in the claims or description that the steps should be limited to a specific order, or if no specific order or orientation to the components of the apparatus is enumerated, no order or orientation is intended to be inferred. This applies to all possible criteria of ambiguity regarding interpretation, including logical matters relating to the arrangement of steps, the flow of operation, the order of components, or the orientation of components, the obvious meaning derived from grammatical mechanisms or punctuation, 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 those commonly understood by those skilled in the art to which this disclosure belongs. The technical terms used in the descriptions herein are intended to describe only specific embodiments and are not intended to limit them. Where used herein and in the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context otherwise clearly indicates.

[0014]

[0023] Where used herein, the terms “horizontal,” “vertical,” “distal,” and “proximal” are merely relative terms, indicating only an overall relative orientation and not necessarily perpendicularity. These terms may also be used for convenience to refer to orientations used in figures, such orientations are used merely as convention and are not intended as characteristics of the devices shown. The disclosure and its embodiments described herein may be used in any desired orientation. Furthermore, horizontal and vertical walls generally need to be intersecting walls and do not need to be right angles. Where used herein, the singular forms “a,” “an,” and “the” include plural referents unless the context explicitly indicates otherwise. Thus, for example, a reference to one (a) component includes embodiments having two or more such components unless the context explicitly indicates otherwise.

[0015]

[0024] In embodiments described herein, a particulate material delivery assembly may include a radioembolization delivery device. The radioembolization delivery device comprises a medical device configured to deliver a radioactive compound to a treatment area within a patient's body in a procedure such as transarterial radioembolization. The radioactive compound may be a mixed solution of saline and radioactive microspheres (i.e., particulate matter) 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) 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] Figures 1 to 5, described below, illustrate embodiments of a delivery device 500 for delivering microparticles, and Figures 6 to 10, described in more detail below, illustrate embodiments of one or more components of the delivery device 500 as described herein, which serve as secondary radiation containment components 600 to help shield from radiation emitted from the microparticles. The radiation containment components 600, as described herein and in more detail below with respect to Figures 6 to 10, may further help prevent the release of biotoxic substances during the disposal of used delivery devices connected to microcatheters. Such biotoxic substances may include chemotherapeutic drugs, radioactive materials, blood, and / or other biotoxic substances that could cause health damage in the event of release into the surrounding environment. The radiation containment components 600 may be used to dispose of potentially contaminated accessory devices as described herein, which are used during radioembolization procedures, possibly the delivery of biotoxic drugs, or a combination thereof. For example, when removing the microcatheter 720 or delivery sheath from the patient after delivery, there may be leaks that could contaminate the environment and be biologically harmful to the user, such as the physician and / or surrounding users or healthcare personnel. The radiation containment component 600, which is described in more detail below with respect to this specification and Figures 6-10, may be placed on the delivery conduit connector 710 of the delivery device 500 before the delivery conduit connector 710 is connected to the hub of the microcatheter 720. After the final injection is performed, the user may slide the radiation containment component 600 toward the hub of the microcatheter 720 and then pull the delivery conduit connector 710 to further pull the microcatheter 720 and its base connector (such as the base sheath 730 as described herein) into the radiation containment component 600, after which the radiation containment component 600 may be sealed for disposal as described herein. The user may maintain the distal end 604 above the hub of the base connector to ensure that the microcatheter 720 of the radiation receiving component 600 is housed when it is removed 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 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 embodiments, the radiation containment component 600 may be placed on the delivery conduit connector 710 prior to the delivery of the mixed particles. In other embodiments, the radiation containment component 600 may be partitioned at 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 no pre-use installation is required.

[0017]

[0026] In some embodiments, as described in more detail below, the delivery device 500 is a radioembolization delivery device, the particles 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 the actuation of the vial engagement mechanism 520 in the positive pressure direction. In some embodiments, the fluid is a contrast agent-saline aqueous solution containing a contrast agent, and the resulting mixed fluid (e.g., mixed 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 particles 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 with Removable Sliding Assembly

[0027] Figures 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 may operate as described in International PCT Application No. PCT / 2019 / 033001, filed May 17, 2019, which is incorporated herein in its entirety, except for aspects related to radiation shielding components as described in more detail below with respect to Figures 6 - 10 and in one or more embodiments herein.

[0018]

[0028] Referring initially to Figure 1, the delivery device 500 includes a console assembly 510 that includes a console. The delivery device 500 may include a sliding assembly 540 operable to transition between a coupled state and a separated state with respect to the console assembly 510. The console assembly 510 of the delivery device 500 includes a base 512 defined by a proximal end 514 and a distal end 516 and extending therebetween. The proximal end 514 of the base 512 includes a handle (delivery handle) 528 movably coupled to the console assembly 510 and an interface display 530 positioned on the console assembly 510.

[0019]

[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 operable to facilitate the attachment of complementary devices to the console assembly 510 for use with the delivery device 500 during a procedure.

[0020]

[0030] Still referring to Figure 1, the distal end 516 of the console assembly 510 defines a vial housing area 518 which is sized and molded to receive a vial assembly 580, as will be described in more detail herein. The console assembly 510 further includes a vial engaging mechanism 520 extending from a base 512 adjacent to the distal end 516. In particular, the vial engaging mechanism 520 extends laterally outward from the base 512 of the console assembly 510 toward the distal end 516. The vial engaging mechanism 520 is positioned within the vial housing 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, and in particular, translate, the vial engaging mechanism 520 within the vial housing area 518 in response to the operation of the handle 528.

[0021]

[0031] The console assembly 510 includes a mechanical assembly disposed within the base 512, which is configured and capable of operating in such a way as to convert the manual movement of the handle 528 into a corresponding linear displacement of the vial engagement mechanism 520. In this example, the mechanical assembly is coupled to the handle 528 and the vial engagement mechanism 520, so that selective action of the handle 528 at the proximal end 514 causes simultaneous action of the vial engagement mechanism 520 at the distal end 516.

[0022]

[0032] The sliding space 532 is sized and molded to accommodate the sliding body 540. As described in more detail herein, the sliding assembly 540 is configured to contain and administer therapeutic particles (e.g., radioactive beads, microspheres, media) through it. In particular, the sliding assembly 540 is configured to partially accommodate the vial assembly 580 for administering therapeutic particles from the delivery device 500 to the patient during the procedure.

[0023]

[0033] In an embodiment, and referring to Figure 2, the flow sensor of the delivery device 500 may be positioned in line with the tube set of the delivery device 500, and in particular with one or more of the needle 559, manifolds 555A, 555B, and / or ports 556, and may be configured to measure the amount of fluid passing therethrough (e.g., a suspension after therapeutic particles have been effectively mixed with a fluid medium). Referring back to Figure 1, the vial engagement mechanism 520 comprises a pair of lever arms 522 extending outward from a neck 524 of the vial engagement mechanism 520, the neck 524 extending laterally outward from a base 512 of the console assembly 510. The neck 524 of the vial engagement mechanism 520 is disposed within a 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 housing area 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 the operation of the handle 528 of the console assembly 510. Furthermore, 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 fixed relative to each other. The pair of lever arms 522 of the vial engagement mechanism 520 are configured to firmly engage the vial assembly 580 between them and, in particular, within the space formed by the pair of lever arms 522. Thus, the vial engagement mechanism 520 is operable to firmly mount the vial assembly 580 to the console assembly 510 in the vial housing 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 may include a variety of other structural configurations suitable for engaging the vial assembly 580. In a non-limiting example, the vial engagement mechanism 520 may include one or more magnets configured to engage with one or more corresponding magnets on the vial assembly.

[0025]

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

[0026]

[0036] The distal end 516 of the console assembly 510 further includes a sliding space 532 which is sized and molded to accommodate a sliding body 540. The sliding space 532 includes one or more, or a pair of, positioning portions 534 extending therein, which are sized and molded to fit corresponding positioning portions of the sliding body 540 (e.g., positioning ribs 554), thereby facilitating the coupling of the sliding body 540 with the base 512 of the console assembly 510 within the sliding space 532.

[0027]

[0037] Still referring to Figure 1, the sliding body 540 is configured to partially receive a vial assembly 580 for administering therapeutic particles (e.g., a radioactive fluid medium) from the delivery device 500 to the patient. In particular, the sliding body 540 comprises a distal end 542 and a proximal end 544, with a pair of side walls 546 extending between them. The distal end 542 of the sliding body 540 includes a handle 552 extending proximal therefrom. The handle 552 is configured to facilitate the movement of the sliding body 540, in particular, the insertion of the sliding body 540 into the sliding space 532 of the console assembly 510. The distal end 542 further includes one or more ports 556 for connecting one or more delivery conduits (i.e., tubes) to the sliding body 540. Since one or more delivery conduits are further coupled to one or more external devices at the opposite end of the line from port 556, port 556 effectively functions to fluidly couple the sliding body 540 to one or more external devices via the delivery conduits to which it is connected. The pair of side walls 546 of the sliding body 540 include at least one positioning rib 554 extending laterally outward therefrom, the positioning rib 554 is sized and molded to fit and engage with a pair of positioning portions 534 of the console assembly 510. Thus, the pair of positioning ribs 554 are configured to facilitate alignment and engagement of the sliding body 540 with the console assembly 510 when the proximal ends 544 are slidably received within the sliding space 532 of the base 512.

[0028]

[0038] The sliding body 540 further includes an upper surface 548 extending from a distal end 542 and a proximal end 544 and 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 molded along the upper surface 548 to form a recess and / or cavity, and this recessed region 549 is capable of receiving and / or recovering various materials, including, for example, leakage of various fluid media during use of the delivery device 500. The locking system 550 of the sliding body 540 forms an opening in the upper surface 548, which is sized and molded 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 which is disposed within the locking system 550. The priming assembly 560 includes a priming conduit 562 extending outward from the locking system 550 of the sliding body 540. The priming assembly 560 connects the priming conduit 562 to the needle 559 and manifolds 555A and 555B, and serves to purge air from the delivery device 500, including manifolds 555A and 555B, before the delivery device 500 is utilized in the procedure.

[0029]

[0039] Referring now to Figure 2, the locking system 550 includes annularly arranged projections 551 extending outward therefrom, the projections 551 extending laterally in particular into an aperture formed by the locking system 550 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 consecutively arranged rows. In embodiments, a single row may be used. The annularly arranged projections 551 contained within the locking system 550 are configured to engage with the corresponding locking feature portion 586 of the vial assembly 580 (see Figure 3), thereby securely fastening the vial assembly 580 to the sliding body 540. It should be understood that the multiple rows of projections 551 of the locking system 550 serve to provide a double locking system to ensure that the sliding assembly 540, and in particular the needle 559 of the sliding assembly 540, are firmly held in place through the septum 592 of the vial assembly 580 (see Figure 3) during the use of the delivery device 500 in the procedure.

[0030]

[0040] The sliding body 540 further includes a vial chamber 558 which is sized and molded to receive 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 individually, separated from each other. The vial chamber 558 is enclosed in a protective chamber or shielding body 557 disposed around the vial chamber 558. The protective shielding body 557 is formed of a material configured to suppress radiation emissions from emitting outward from the vial chamber 558, such as metal or plastic. In addition, the sliding body 540 includes a needle that extends through the protective shielding body 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, and as a result, any device received through the aperture of the locking system 550 and into the vial chamber 558 will come into contact with and interact with the needle 559 (e.g., the priming assembly 560, the vial assembly 580, and similar devices).

[0031]

[0041] Still referring to Figure 2, the needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the sliding body 540, specifically the manifolds 555A and 555B positioned below the vial chamber 558 and the protective shield 557. The proximal manifold 555B is fluidically coupled to the needle 559, and the distal manifold 555A can be fluidly coupled to one or more delivery lines via one or more ports 556 of the sliding body 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A and through a one-way check valve 553 disposed between them.

[0032]

[0042] Therefore, the proximal manifold 555B is in fluid communication with one or more ports 556 via the distal manifold 555A, but one or more ports 556 are not in fluid communication with the proximal manifold 555B due to the location of a one-way check valve 553 disposed between the manifolds 555A, 555B. Thus, the needle 559 is in fluid communication with one or more delivery lines and / or devices coupled to the sliding body 540 at one or more ports 556, via the manifolds 555A, 555B fixed between them. One or more ports 556 of the sliding body assembly 540 may be coupled to a bag (e.g., a saline bag), a syringe, a catheter, and / or similar, via one or more delivery lines coupled to them. In other embodiments, the needle 559 may be a cannula, a catheter, or a similar mechanism through which fluids and / or solutions are injected and received as described herein.

[0033]

[0043] Still referring to Figure 2, the sliding body 540 includes a removable battery pack 570 coupled to the sliding body 540 along its proximal end 544. The removable battery pack 570 comprises 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 flow paths and radiation sources due to its location within the removable battery pack 570.

[0034]

[0044] The electrical contacts 574 of the removable battery pack 570 extend outward from the removable battery pack 570 and are operable to contact and interact with the corresponding electrical contacts 511 (see Figure 1) of the console assembly 510 when the sliding body 540 is coupled to the base 512 in the sliding space 532. Thus, the removable battery pack 570 is operable to supply power to the delivery device 500, and in particular to the console assembly 510, when the sliding body 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 configuration of the locking system 550. In this case, the aperture formed by the locking system 550 through the upper surface 548 of the sliding body 540 is irregular in shape rather than circular as shown and described above. In this case, the vial assembly 580 includes the locking system 550 and, in particular, a locking feature portion 586 having a shape and size corresponding to at least one planar wall, and as a result the vial assembly 580 is received in the sliding body 540 only when the orientation of the vial assembly 580 corresponds to the orientation of the locking feature portion 586 and the locking system 550. In other words, the corresponding planar wall 586A of the locking feature portion 586 (see Figure 3) must be aligned with the planar wall of the locking system 550 so that the vial assembly 580 can be received within the aperture formed by the locking system 550 of the sliding body 540.

[0036]

[0046] Referring now to Figure 3, the vial assembly 580 of the delivery device 500 is depicted. The vial assembly 580 comprises an engagement head 582, a plunger 584, a locking feature 586, and a vial body 589. In particular, the engagement head 582 of the vial assembly 580 is positioned at the end of the plunger 584 opposite the locking feature 586 and the vial body 589. The engagement head 582 includes a pair of arms 581 that extend laterally outward with respect to the longitudinal length of the plunger 584 extending downward from there. 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 feature parts that can be securely fixed to each other. In either case, the engaging head 582 and the plunger 584 are movable relative to the locking feature 586 and the vial body 589 so that the engaging head 582 and the plunger 584 can slide and translate through the locking feature 586 and the vial body 589. In particular, as will be described in more detail herein, when the engaging head 582 is fixed to a pair of lever arms 522, the plunger 584 may translate in and out of the internal chamber 588 of the vial body 589 in response to the linear translational motion of the vial engaging mechanism 520.

[0037]

[0047] The plunger 584 includes a plurality of markings and / or scales 583 positioned along the longitudinal length of the plunger 584. The plurality of scales 583 indicate the relative extensions of the engaging head 582 and the plunger 584 from the locking feature portion 586 and the vial body 589. As briefly described above, the engaging head 582 is configured to mount the vial assembly 580 onto the vial engaging mechanism 520. In particular, the pair of arms 581 of the engaging head 582 are sized and molded to engage with the pair of lever arms 522 of the vial engaging mechanism 520 when the vial assembly 580 is received within the sliding body 540 and the sliding body is inserted into the sliding space 532 of the console assembly 510. As described in more detail herein, the pair of lever arms 522 are received between the pair of arms 581 of the engaging head 582 and the plunger 584 in response to a predetermined translational force applied to the vial engaging mechanism 520. The engaging head 582 and plunger 584 may be formed from a variety of materials, including, but not limited to, metal, plastic, and / or similar materials.

[0038]

[0048] Still referring to 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 engaging head 582, so that the safety tab 585 is positioned along the longitudinal length of the plunger 584. The safety tab 585 may be formed from a variety of materials, such as plastic, and is pre-assembled to the vial assembly 580 before use of the delivery device 500. The safety tab 585 is removably attached to the plunger 584 and prevents the plunger 584 from translating relative to the vial body 589. In particular, the safety tab 585 abuts against the locking feature 586 in response to the application of a linear force to the plunger 584 to translate the plunger 584 relatively downward into the vial body 589. In this case, the safety tab 585 is configured to prevent unintentional movement of the plunger 584 and, accordingly, unintentional delivery of the fluid medium (e.g., therapeutic particles, radioembolic beads) contained within the internal chamber 588 of the vial body 589. As described in more detail herein, the safety tab 585 is selectively disengaged 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] Referring back to Figure 3, 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 bush (bearing cylinder) defining a side edge 587 that extends laterally outward along the outer circumference of the locking feature 586. The side edge 587 of the locking feature 586 is sized and molded to engage with the annularly arranged projection 551 of the locking system 550 when the vial assembly 580 is received in the vial chamber 558 of the sliding body 540. As will be described in more detail herein, the locking feature 586, in particular the side edge 587 of the locking feature 586, is configured to securely fasten the vial assembly 580 to the locking system 550, thereby preventing the vial body 589 from being removed from the vial chamber 558 of the sliding body 540 during use of the delivery device 500 in the procedure. In some embodiments, as briefly described above, the locking feature portion 586 includes at least one planar wall 586A such that the locking feature portion 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, and as a result, alignment between the planar wall 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 Figure 3, the vial body 589 extends relatively downward from the locking feature 586 and has a longitudinal length sized to accommodate 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, and as a result, the translational motion of the plunger 584 into the internal chamber 588 of the vial body 589 delivers the fluid medium contained therein out of the vial body 589. As will be described in more detail herein, the translational motion of the plunger 584 through the internal chamber 588 of the vial body 589 allows the fluid medium contained within the vial body 589 to be dispensed out of the vial assembly 580. The vial body 589 may be formed from a variety of materials, including, for example, thermoplastic polymers, copolyesters, polycarbonates, biocompatible plastics, polysulfones, ceramics, metals, and / or similar materials.

[0041]

[0051] The vial body 589 in this example is formed of a material configured to suppress radiation emission from the fluid medium contained within the internal chamber 588 of the vial body 589. For example, the vial body 589 may be made of a plastic such as polycarbonate and may have width. The combination of density and material composition of the vial body 589 is configured to suppress beta radiation emission from electron particles contained within the internal chamber 588. In this example, the chemical composition of the plastic of the vial body 589, in combination with a wall thickness of 9 mm, provides multiple atoms arranged within the vial body 589, which deal with electron-generating beta radiation and reduce the emission of the above radiation from the vial assembly 580. Thus, the vial assembly 580 allows the operator to handle the radioactive material contained within the vial body 589 without being exposed to beta radiation. It should be understood that in other embodiments, various other materials and / or wall areas may be incorporated into the vial body 589 of the vial assembly 580 without departing from the scope of this disclosure.

[0042]

[0052] Still referring to 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 the opposing end of the vial body 589 opposite the locking feature 586, so that the cap 590 seals a second end of the vial body 589 of the vial assembly 580. Additionally, the vial assembly 580 includes a septum 592, 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 with respect to the end of the vial body 589, and the cap 590 holds the septum 592 inside. The septum 592 may be formed from a variety of materials, including, for example, elastomers, silicones, bromobutyl elastomers, rubbers, urethanes, and / or similar materials. The septum 592 is configured to provide an airtight seal for the vial body 589, thereby preventing the release of the fluid medium contained therein (e.g., radioembolic beads). As described in more detail herein, the septum 592 of the vial assembly 580 is configured to be punctured by the needle 559 of the sliding body 540 when the vial assembly 580 is received in the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the sliding body 540. In other embodiments, alternative devices may be used instead of the septum 592, such as, for example, a valve system, a needle injection port, and / or similar materials.

[0043]

[0053] Referring to Figure 4, the vial assembly 580 further includes a stopper 594 fixedly coupled to the end of the plunger 584 opposite the engaging head 582. In this case, since the plunger 584 is coupled to and slidably translated through the internal chamber 588 of the vial body 589, the stopper 594 is effectively disposed within the vial body 589. It should be understood that the stopper 594 is thus sized and molded 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 is slidably translated through the vial body 589 in response to the translational motion of the plunger 584 through the vial body 589. The stopper 594 is defined by two or more ribs 593 extending laterally outward 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 to the internal chamber 588 of the vial body 589 and may be formed from a variety of polymers having a predetermined viscoelasticity. For example, in some embodiments, the stopper 594 may be formed from elastomer, silicone, rubber, urethane, plastic, polyethylene, polypropylene, and / or similar materials. In this case, the stopper 594 is operable to prevent the fluid medium contained within the vial body 589 from diffusing (i.e., leaking) past the stopper 594 to the outside of the vial body 589. In particular, two or more ribs 593 of the stopper 594 abut against and 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 the two or more ribs 593 of the stopper 594 are configured to receive, more specifically, capture any fluid medium that might inadvertently diffuse (i.e., leak) past the ribs 593 of the stopper 594. Therefore, one or more indentations 595 serve as a safety mechanism for the vial assembly 580 to ensure that the fluid medium is retained within the vial body 589 and not exposed beyond the vial assembly 580.

[0045]

[0055] Still referring to Figure 4, two or more ribs 593 of the stopper 594 are further configured to press the fluid medium contained within the vial body 589 in one or more directions (for example, toward the cap 590) in response to the translational motion of the plunger 584. With the ribs 593 of the stopper 594 pressed toward the internal chamber 588 of the vial body 589, the translational motion of the plunger 584 results in the translational motion of the ribs 593 toward and along the internal chamber 588 of the vial body 589, and as a result any fluid medium located in front of (i.e., below) the stopper 594 is effectively reoriented within the vial body 589 toward the direction of the plunger 584 and the movement of 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 fixed to the plunger 584 at the opposite end of the engaging head 582. Thus, the annular washer 596 is fixed to the plunger 584 and positioned within the vial body 589 adjacent to the stopper 594. Because the annular washer 596 is fixed to the plunger 584 adjacent to the stopper 594, the annular washer 596 is effectively positioned within the vial body 589.

[0046]

[0056] Referring now to Figure 5, in response to the battery 572 containing a sufficient amount of power or another power source deciding to provide it, one or more delivery conduits are coupled to the sliding assembly 540 via one or more ports 556. In particular, the dose delivery conduit 10A is coupled to the sliding body 540 at the delivery port 556A, the contrast agent conduit 10B is coupled to the sliding body 540 at the contrast agent port 556B, and the flushing conduit 10C is coupled to the sliding body 540 at the flushing port 556C. The opposite end of the dose delivery conduit 10A is initially coupled to a fluid reservoir, such as a recovery bowl. As will be described in more detail herein, once the sliding body 540 is effectively primed with a fluid medium via the contrast agent conduit 10B, the dose delivery conduit 10A may 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. With both the dose delivery line 10A and the flushing conduit 10C connected to the sliding body 540, the sliding body 540 is flushed with a fluid medium (e.g., saline solution) from a syringe connected 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 sliding body 540 and exits the sliding body 540 through the dose delivery line 10A. Thus, the fluid medium is ultimately received and placed (or processed) in a recovery bowl by the dose delivery line 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 between them, the fluid medium flushed from the syringe (through the flushing port 556C) through the distal manifold 555A is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. Rather, the fluid medium injected from the syringe through the flushing conduit 10C is received at the flushing port 556C, passed through the distal manifold 555A which is in fluid communication with the flushing port 556C, and then guided again by the one-way valve 553 toward the dose delivery port 556A which is coupled to the dose delivery conduit 10A. In this case, the dose delivery conduit 10A receives the fluid medium and transports it to a recovery bowl coupled thereto, and as a result, the fluid medium is not directed beyond the one-way valve 553 and into the proximal manifold 555B which is in fluid communication with the needle 559.

[0048]

[0058] The contrast agent conduit 10B is coupled to the sliding body 540 at the contrast agent port 556B. The opposite end of the contrast agent conduit 10B is coupled to a fluid medium supply unit, such as a bag fixed to the console assembly 510 by a mounting device 538. In this example, the bag is a saline bag, and therefore the fluid medium contained therein is saline. In this case, with the sliding body 540 including the priming assembly 560 positioned in the vial chamber 558 and the needle end 568 in fluid communication with the needle 559, the syringe is fluidly coupled to the priming conduit 562 of the priming assembly 560, 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 sliding body 540, and the priming conduit 562. The syringe plunger is then pushed inward, distributing the drawn-in saline solution in the opposite direction through the priming conduit 562, the central body 564, the elongated shaft 566, and the needle end of the priming assembly 560, as a result the saline solution is received into the needle 559 of the sliding body 540. Thus, the manifolds 555A and 555B of the sliding body 540 are effectively primed with saline solution from the syringe because the needle 559, which has received saline solution from the priming assembly 560, is in fluid communication with the manifolds 555A and 555B. Since the manifolds 555A and 555B are further in fluid communication with the dose delivery conduit 10A via the delivery port 556A, the saline solution is effectively supplied to the recovery bowl coupled to the dose delivery conduit 10A.

[0049]

[0059] Referring to Figure 5, the sliding body 540 is coupled to one or more external devices via one or more ports 556. In particular, the sliding body 540 is fluidically coupled to a catheter (e.g., a microcatheter) via a dose delivery conduit 10A coupled to a delivery port 556A of the sliding body 540. In this case, the catheter is in fluid communication with the sliding body 540 via the dose delivery conduit 10A. Furthermore, the sliding body 540 is fluidly coupled to a contrast agent source, such as a saline bag fixed to a console assembly 510 via a mounting device 538 (see Figure 1). The sliding body 540 is in fluid communication with the saline bag via a contrast agent conduit 10B coupled to a contrast agent port 556B of the sliding body 540. In this case, the saline bag is in fluid communication with the sliding body 540 via a contrast agent conduit 10B fixed 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, which is separated from the proximal manifold 555B by a one-way check valve 553 disposed between them, saline from the saline bag can be drawn through the needle 559 of the sliding body 540 into the vial body 589 of the vial assembly 580.

[0051]

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

[0052]

[0062] Referring again to Figure 5, when the vial engagement mechanism 520 and plunger 584 are simultaneously translated within the vial housing area 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 sliding body 540 via the contrast agent conduit 10B and contrast agent port 556B, saline from the saline bag is drawn into the internal chamber 588 of the vial body 589 through the proximal manifold 555B and needle 559. Therefore, if the vial body 589 is pre-filled with a radioactive fluid medium (e.g., radioembolic microspheres), the saline is effectively mixed with the radioactive fluid medium in the vial body 589 when the plunger 584 is retracted from the internal chamber 588 and a negative pressure is generated through the delivery device 500.

[0053]

[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 allow fluid communication from the contrast agent port 556B and the flushing port 556C into the manifolds 555A, 555B, and further configured to prevent fluid communication from the manifolds 555A, 555B to the contrast agent port 556B and the flushing port 556C. Therefore, it should be understood that directing the dose delivered from the vial body 589 to the manifolds 555A, 555B into the contrast agent conduit 10B or the flushing conduit 10C is impossible due to the one-way check valve 553A located therein. Thus, the dose is directed to the dose delivery port 556A and received in a catheter fluidically coupled by the dose delivery conduit 10A. In other words, the one-way check valve 553A prevents the backflow of fluid into the sliding body 540 and / or the vial assembly 580 to which it is coupled. E. Radiation containment mechanisms

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

[0054]

[0065] Referring to Figures 6 to 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 the 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 particulate matter from the particulate delivery device 500. Furthermore, as shown in Figure 10, which will be described in more detail below, the distal end 604 may be disposed on and accommodate a microcatheter 720 that will be connected to the delivery conduit connector 710 after use. Thus, the distal end 604 may be configured to seal together to accommodate the microcatheter 720 after use, in a non-limiting example, before disposal of the particulate delivery device 500.

[0055]

[0066] Referring to Figure 6, which shows the radiation-containing component 600 in the folded position 606, in an embodiment, the proximal end 602 includes a rigid material 608, and the distal end 604 includes a flexible material 610, the flexible material 610 being more elastic than the rigid material 608. The flexible material 610 may include a deformable plastic, a spring-loaded material, or other suitable flexible material configured to roll up, unfold, stretch, and / or return to a naturally biased position. The rigid material 608 may include cardboard, plastic, metal, or a combination 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 a thickness sufficient to help contain radiation, such as up to 9 mm, but not limited to, in the range of 1 mm to 10 mm, for blocking beta radiation, containing radiation, and therefore providing 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 fluids, cloth, or other suitable flexible material. In embodiments, the flexible material 610 includes an accordion rib structure in a relaxed state and is more elastic than the rigid material 608, and is configured to stretch into an extended state (e.g., an unfolded position 612 as shown in Figure 9 or a sealed position 614 for disposal as shown in Figure 10) to smooth the accordion rib structure, and to cover and accommodate the microcatheter 720 before sealing the distal end 604 of the radiation containment component 600. In embodiments, the flexible material 610 may be configured to unfold from a rolled state to cover and accommodate the microcatheter 720 before sealing the distal end 604 of the radiation containment component 600. The distal end 604 may include sealing by adhesive, a fastening mechanism, or a combination thereof to seal together to accommodate the microcatheter 720 before disposal as described herein.

[0056]

[0067] Referring to Figure 7, the radiation containment component 600 in the folded position 606 is shown disposed on the delivery conduit connector 710 of the particulate delivery device 500. The rigid material 608 of the proximal end 602 is configured to be disposed against the adjacent lip in 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 engaging features for engaging with one or more corresponding engaging features of the adjacent lip in the distal portion 712 of the delivery conduit connector 710, or other locking mechanisms, such as one or more projections and / or holes configured to engage with one or more other holes and / or projections, respectively. As shown in Figures 7 to 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 Figures 9 and 10, when the distal end 604 of the radiation containment component 600 is sealed to accommodate the microcatheter 720 (e.g., 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 Figure 7, the microcatheter 720 may include a proximal end 726 with a fastener 722, as shown. The fastener 722 may be a Luer connector or other fastening mechanism, as a non-limiting example, and may include a tip 723, a protrusion 724, and a base 725 having a width greater than the width of the tip 723, with the protrusion 724 defined between the tip 723 and the base 725. The distal end 728 of the microcatheter 720 is shown in Figure 8.

[0058]

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

[0059]

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

[0060]

[0071] Furthermore, the distal end 604 of the radiation-containing component 600 is pulled distally in the direction of arrow B toward the base sheath 730 receiving the distal end 728 of the microcatheter 720, for example, to deliver mixed microparticles from the microparticle delivery device 500 to the patient. The distal end 604 of the radiation-containing component 600 may continue to be pulled distally in the direction of arrow B toward the base sheath 730 receiving the distal end 728 of the microcatheter 720 to reach the position shown in Figure 9.

[0061]

[0072] Figure 9 illustrates a radiation-containing component 600 in a second deployed state, deployed position 612, which is pulled further distally over the base sheath 730 that receives the microcatheter 720 and the distal end 728 of the microcatheter 720. The distal end 604 of the radiation-containing component 600 can be sealed (and has a sealed end 732, for example, as also shown in Figure 10) before use of the connected microcatheter 720 and delivery conduit connector 710 to deliver mixed particles to the patient.

[0062]

[0073] Figure 10 illustrates a radiation containment component 600 that is positioned and sealed on the distal end 728 of a microcatheter 720 after it has been removed from the base sheath 730, and at the same time deployed and in a sealed position 614 for disposal (e.g., as biological hazardous waste). Such a seal is indicated as a sealed end 732. In the embodiment, after use, the distal end 728 of the microcatheter 720 may be removed from the base sheath 730, and the distal end 604 of the radiation containment component 600 may be sealed on the distal end 728 of the microcatheter 720 by the sealed end 732. The proximal end 726 of the microcatheter 720 may still be connected to the distal end 716 of the delivery conduit connector 710, and the proximal end 602 of the radiation containment component 600 may remain sealed on the distal portion 712 of the delivery conduit connector 710 by the sealed end 732. In one embodiment, the entire used particulate delivery device 500, including a radiation containment component 600 that is sealed by a sealed end 732 around the distal end 728 of the microcatheter 720 and the distal portion 712 of the delivery conduit connector 710, can then be disposed of (e.g., in hazardous waste disposal).

[0063]

[0074] In embodiments, a radiation-sealed assembly for sealing and disposal may include a particulate delivery device 500 including a delivery conduit 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 particulates from the particulate delivery device 500 and may be configured to connect to a base connector (e.g., a base sheath 730) and a delivery conduit connector 710 for delivering the mixed particulates. The microcatheter 720 may be configured to be detached from the base connector after use and connected to the delivery conduit connector 710.

[0064]

[0075] A method for sealing and disposing of a microcatheter 720 used to deliver mixed particles from a particulate delivery device 500 may include the step of connecting the delivery conduit connector 710 of the particulate delivery device 500 to the microcatheter 720, as shown, for example, in Figure 7. The microcatheter 720 may be connected to a base connector (such as a base sheath 730, as shown in Figures 8 and 9). Furthermore, 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 in Figure 9). The microcatheter 720 may be detached from the base connector after use, as shown in Figure 10. The proximal end 602 of the radiation containment component 600 may be positioned on the distal portion 712 of the delivery conduit connector 710 of the particulate delivery device 500 so that the proximal end 602 does not move distally toward the distal end 604. The distal end 604 of the radiation containment component 600 may extend to cover and accommodate the microcatheter 720 connected to the delivery conduit connector 710 after use. The distal end 604 of the radiation containment component 600 may be sealed together to accommodate the microcatheter 720 before disposal. In embodiments and as shown in Figure 10, the microcatheter 720 housed in the radiation containment component 600, the particulate delivery device 500 connected to the microcatheter 720, and the radiation containment component 600 may be disposed of in the disposal of hazardous biological waste. III. List of Modes

[0076] Embodiment 1. A radiation containment component for sealing a microcatheter used to deliver mixed particles from a particulate 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 conduit connector of the particulate delivery device, and the delivery conduit connector is configured to receive mixed particles from the particulate delivery device. The distal end is configured to be disposed on and contain the microcatheter that connects to the delivery conduit connector after use, and the distal end is configured to seal together to contain the microcatheter before disposal.

[0065]

[0077] Embodiment 2. A radiation containment component according to Embodiment 1, wherein the proximal end includes a rigid material, and the distal end includes a flexible material, the flexible material being more elastic than the rigid material.

[0066]

[0078] Embodiment 3. A radiation containment component according to Embodiment 2, wherein the rigid material at the proximal end is configured to be positioned relative to an adjacent lip in the distal portion of the delivery conduit connector in order to prevent the proximal end from moving in the distal direction.

[0067]

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

[0068]

[0080] Embodiment 5. A radiation containment component according to any of Embodiments 1 to 4, wherein the distal end of the radiation containment component is configured to cover the distal end of a delivery conduit connector when the distal end of the radiation containment component is sealed to contain a microcatheter, and the distal end of the delivery conduit connector is configured to connect to the proximal end of a microcatheter.

[0069]

[0081] Embodiment 6. A radiation containment component according to Embodiment 5, wherein the distal end of the delivery conduit connector is accessible when the distal end of the radiation containment component is not sealed.

[0070]

[0082] Embodiment 7. A radiation containment component according to any of Embodiments 1 to 6, wherein the proximal end comprises a rigid material and the distal end comprises a flexible material, the flexible material comprising an accordion rib structure in a relaxed state and elasticity greater than that of the rigid material, so as to stretch into an elongated state to smooth the accordion rib structure, and configured to cover and contain a microcatheter before sealing the distal end.

[0071]

[0083] Embodiment 8. A radiation containment component according to any of Embodiments 1 to 7, wherein the distal end includes an adhesive, a fastening mechanism, or a combination thereof for sealing together to accommodate a microcatheter before disposal.

[0072]

[0084] Embodiment 9. A radiation containment component according to any of Embodiments 1 to 8, wherein a microcatheter is configured to connect to a base connector for use in delivering mixed microparticles, and the microcatheter is configured to detach from the base connector after use and before the distal end containing the microcatheter is sealed.

[0073]

[0085] Embodiment 10. A radiation-sealed assembly for sealing and disposal, comprising a particulate delivery device with a delivery conduit connector, a base connector, a microcatheter, and a radiation-containing component. The microcatheter is used to deliver mixed particulate matter from the particulate delivery device, and the microcatheter is configured to connect to the base connector and the delivery conduit connector for delivering the mixed particulate matter, and the microcatheter is configured to be detached from the base connector and connected to the delivery conduit connector after use. The radiation-containing component comprises 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 conduit connector of the particulate delivery device, and the delivery conduit connector is configured to receive mixed particulate matter from the particulate delivery device. The distal end is configured to be disposed on and to contain the microcatheter that is connected to the delivery conduit connector after use. The distal end is configured to seal together to contain the microcatheter before disposal.

[0074]

[0086] Embodiment 11. A radiation-sealed assembly according to Embodiment 11, wherein the proximal end comprises a rigid material and the distal end comprises a flexible material, the flexible material being more elastic than the rigid material.

[0075]

[0087] Embodiment 12. A radiation-sealed assembly according to Embodiment 11, wherein the proximal end rigid material is configured to be positioned relative to an adjacent lip in the distal portion of the delivery conduit connector to prevent the proximal end from moving distally.

[0076]

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

[0077]

[0089] Embodiment 14. A radiation-sealed assembly according to any of Embodiments 10 to 13, wherein the distal end of a radiation-containing component is configured to cover the distal end of a delivery conduit connector when the distal end of the radiation-containing component is sealed to accommodate a microcatheter, and the distal end of the delivery conduit connector is configured to connect to the proximal end of the microcatheter.

[0078]

[0090] Embodiment 15. A radiation-sealed assembly according to Embodiment 14, wherein the distal end of a delivery conduit connector is accessible when the distal end of a radiation containment component is not sealed.

[0079]

[0091] Embodiment 16. A radiation-sealed assembly according to any of Embodiments 10 to 15, wherein the proximal end comprises a rigid material and the distal end comprises a flexible material, the flexible material comprising an accordion rib structure in a relaxed state and elasticity greater than that of the rigid material, to stretch into an elongated state to smooth the accordion rib structure, and configured to cover and accommodate a microcatheter before sealing the distal end.

[0080]

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

[0081]

[0093] Embodiment 18. A radiation-sealed assembly according to any of Embodiments 10 to 17, wherein a microcatheter is configured to connect to a base connector for use in delivering mixed microparticles, and the microcatheter is configured to detach from the base connector after use and before the distal end housing the microcatheter is sealed.

[0082]

[0094] Embodiment 19. A method for sealing and disposing of a microcatheter used to deliver mixed particles from a particulate delivery device, comprising the steps of: connecting a delivery conduit connector of a particulate delivery device to a microcatheter; connecting the microcatheter to a base connector; delivering mixed particles from the particulate delivery device through the microcatheter and the base connector; and detaching the microcatheter from the base connector after use. The method further comprises the steps of: positioning the proximal end of a radiation containment component on the distal portion of the delivery conduit connector of a particulate delivery device so that the proximal end does not move distally; extending the distal end of the radiation containment component to cover and accommodate a microcatheter connected to the delivery conduit connector after use; and sealing the distal end to accommodate the microcatheter before disposal.

[0083]

[0095] Embodiment 20. A method according to Embodiment 19, further comprising the steps of disposing of a microcatheter housed in a radiation containment component, a particulate delivery device connected to the microcatheter, and the radiation containment component in a biological hazardous waste disposal.

[0084]

[0096] It should be noted that the terms “substantially” and “about” may be used herein to express the inherent degree of uncertainty that may arise from any quantitative comparison, value, measurement, or other expression. These terms are also used herein to express the degree to which a quantitative expression may deviate from the given reference without resulting in a change in the fundamental function of the subject matter in question.

[0085]

[0097] For the purpose of describing and defining this disclosure, the term “substantially” is used herein to describe the inherent degree of uncertainty that may arise from any quantitative comparison, value, measurement, or other expression. The term “substantially” is also used herein to describe the degree to which a quantitative expression may deviate from the given reference without resulting in a change in the fundamental function of the subject matter in question. As such, it is used herein to describe the inherent degree of uncertainty that may arise from any quantitative comparison, value, measurement, or other expression with respect to the arrangement of elements or features that are expected to present an exact match or behavior in theory, but which in practice may embody something slightly less than that exact.

[0086]

[0098] While 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, while various aspects of the claimed subject matter are described herein, such aspects do not need to be used in combination. Accordingly, the attached claims are intended to cover all such changes and modifications that fall 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 of the microcatheter, wherein the radiation containment component is It comprises a proximal end portion and a distal end portion located opposite the proximal end portion, The proximal end portion is configured to connect to and cover the distal portion of the delivery conduit connector of the particle delivery device, and the delivery conduit connector is configured to receive the mixed particles from the particle delivery device. The distal end portion is positioned on the microcatheter connected to the delivery line connector after use, and is configured to accommodate it. The distal end portion is configured to be sealed together to accommodate the microcatheter before disposal, and is a radiation containment component.

2. A radiation containment component according to claim 1, A radiation containment component wherein the proximal end portion includes a rigid material, and the distal end portion includes a flexible material, the flexible material being more elastic than the rigid material.

3. A radiation containment component according to claim 2, A radiation containment component wherein the rigid material of the proximal end portion is configured to be positioned relative to the adjacent lip in the distal portion of the delivery conduit connector in order to prevent the proximal end portion from moving in the distal direction.

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

5. A radiation containment component according to claim 1, A radiation containment component wherein the distal end portion of the radiation containment component is configured to cover the distal end portion of the delivery conduit connector when the distal end portion of the radiation containment component is sealed to accommodate the microcatheter, and the distal end portion of the delivery conduit connector is configured to connect to the proximal end portion of the microcatheter.

6. A radiation containment component according to claim 5, The distal end portion of the delivery conduit connector is accessible when the distal end portion of the radiation containment component is not sealed, thereby providing a radiation containment component.

7. A radiation containment component according to claim 1, A radiation containment component comprising a proximal end portion comprising a rigid material, and a distal end portion comprising a flexible material, wherein the flexible material is configured to have an accordion rib structure in a relaxed state, and is more elastic than the rigid material and to stretch into an elongated state to smooth the accordion rib structure, and to cover and contain a microcatheter before sealing the distal end portion.

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

9. A radiation containment component according to claim 1, A radiation containment component comprising a microcatheter configured to connect to a base connector for the purpose of delivering the mixed microparticles, and the microcatheter configured to detach from the base connector after use and before the distal end portion housing the microcatheter is sealed.

10. A radiation-sealed assembly for sealing and disposing of a microcatheter, wherein the radiation-sealed assembly is A particulate delivery device equipped with a delivery conduit connector, Base connector and, A microcatheter used for delivering mixed microparticles from the microparticle delivery device, wherein the microcatheter is configured to be connected to the base connector and the delivery channel connector for delivering the mixed microparticles, and the microcatheter is configured to be detached from the base connector after use while connected to the delivery channel connector, A radiation containment component, It comprises a proximal end portion and a distal end portion located opposite the proximal end portion, The proximal end portion is configured to connect to and cover the distal portion of the delivery conduit connector of the particle delivery device, and the delivery conduit connector is configured to receive the mixed particles from the particle delivery device. The distal end portion is positioned on the microcatheter connected to the delivery line connector after use, and is configured to accommodate it. The distal end portion is configured to be sealed together to accommodate the microcatheter before disposal, and is a radiation containment component. A radiation-sealed assembly comprising:

11. A radiation-sealed assembly according to claim 10, A radiation-sealed assembly wherein the proximal end portion comprises a rigid material, and the distal end portion comprises a flexible material, the flexible material being more elastic than the rigid material.

12. A radiation-sealed assembly according to claim 11, A radiation-sealed assembly in which the rigid material of the proximal end portion is configured to be positioned relative to the adjacent lip of the distal portion of the delivery conduit connector in order to prevent the proximal end portion from moving in the distal direction.

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

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

15. A radiation-sealed assembly according to claim 14, The distal end portion of the delivery conduit connector is accessible when the distal end portion of the radiation containment component is not sealed, in a radiation-sealed assembly.

16. A radiation-sealed assembly according to claim 10, A radiation-sealed assembly comprising a proximal end portion comprising a rigid material, and a distal end portion comprising a flexible material, wherein the flexible material is configured to have an accordion rib structure in a relaxed state, and is more elastic than the rigid material and to stretch into an elongated state to smooth the accordion rib structure, and to cover and house the microcatheter before sealing the distal end portion.

17. A radiation-sealed assembly according to claim 10, The distal end portion is enclosed in a radiation-sealed assembly, including an adhesive, a fastening mechanism, or a combination thereof, to house the microcatheter before disposal.

18. A radiation-sealed assembly according to claim 10, A radiation-sealed assembly comprising a microcatheter configured to connect to the base connector for the purpose of delivering the mixed microparticles, and the microcatheter configured to detach from the base connector after use and before the distal end portion housing the microcatheter is sealed.

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