Radiation shielding component, sealing assembly, and method of use

Abstract

Radiation sealing assemblies and methods of sealing a microcatheter for delivery of mixed particles from a particle delivery device for treatment using a radiation shielding member that may include a proximal end and a distal end disposed opposite the proximal end. The proximal end is configured to be connected to and cover a distal portion of a delivery line connection of the particle delivery device, the delivery line connection configured to receive mixed particles from the particle delivery device. The distal ends are configured to be disposed over and receive a microcatheter connected to a delivery line connector after use, and the distal ends are configured to be sealed together to receive the microcatheter prior to treatment.

Description

Technical Field

[0001] The present disclosure relates generally to components of medical devices for treating cancer, and more particularly to radiation shielding components of medical devices that are configured and operable to assist in delivering radioactive compounds to a treatment region within a patient during procedures such as transarterial radioembolization. Background Art

[0002] In cancer treatment involving radiation therapy, unintentional or excessive exposure to radiation from the radiotherapeutic agent may be harmful to the patient or medical personnel, and may even be fatal. Therefore, medical equipment used for radiation therapy must be configured to deliver radioactive materials to specific parts of the patient's body while protecting others from unnecessary exposure to radiation.

[0003] Transarterial radioembolization is a transcatheter intra-arterial procedure performed by interventional radiology and is commonly used to treat malignant tumors. In this medical procedure, a microcatheter is navigated into the patient's liver where a radioactive compound (such as yttrium-90 ( 90 Y)) are delivered to a target tumor. The microspheres can embolize blood vessels supplying the tumor while also delivering radiation to kill tumor cells. Generally, clinicians or patients may be exposed to the risk of radiation emitted from this delivery.

[0004] Therefore, there is a need for a component of a medical device that is configured and operable to shield radioactive compounds from radiation when such radiation is delivered to a patient's body. Summary of the invention

[0005] According to one embodiment of the present disclosure, a radiation shielding component for sealing a microcatheter for treatment includes a proximal end and a distal end arranged opposite to the proximal end, wherein the microcatheter is used to deliver mixed particles from a particle delivery device. The proximal end is configured to be connected to and cover a distal portion of a delivery line connector of the particle delivery device, wherein the delivery line connector is configured to receive mixed particles from the particle delivery device. The distal end is configured to be arranged on a microcatheter connected to the delivery line connector after use and to accommodate the microcatheter, and the distal end is configured to be sealed together to accommodate the microcatheter before treatment.

[0006] In another embodiment, a radiation sealing assembly for sealing and disposal includes a particle delivery device, the particle delivery device including a delivery line connector, a base connector, a microcatheter and a radiation shielding component. The microcatheter is used to deliver mixed particles from the particle delivery device, the microcatheter is configured to be connected to the base connector and the delivery line connector to deliver the mixed particles, and the microcatheter is configured to be disconnected from the base connector after use and connected to the delivery line connector. The radiation shielding component includes a proximal end and a distal end arranged opposite to the proximal end. The proximal end is configured to be connected to and cover the distal portion of the delivery line connector of the particle delivery device, and the delivery line connector is configured to receive mixed particles from the particle delivery device. The distal end is configured to be arranged on the microcatheter connected to the delivery line connector after use and to accommodate the microcatheter. The distal end is configured to be sealed together so as to accommodate the microcatheter before disposal.

[0007] In yet another embodiment, a method for sealing and disposing a microcatheter for delivering mixed particles from a particle delivery device includes: connecting a delivery line connector of the particle delivery device to the microcatheter; connecting the microcatheter to a base connector; delivering mixed particles from the particle delivery device through the microcatheter and the base connector; and disconnecting the microcatheter from the base connector after use. The method also includes arranging a proximal end of a radiation shielding member on a distal portion of a delivery line connector of the particle delivery device so that the proximal end does not move in a distal direction, extending the distal end of the radiation shielding member until accommodating the microcatheter connected to the delivery line connector after use, and sealing the distal end together to accommodate the microcatheter before disposal.

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

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

[0010] Figure 2 According to one or more embodiments shown and described herein Figure 1 A cross-sectional view of a vial carriage, along Figure 1 The cross section is taken along line 2-2;

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

[0012] Figure 4 yes Figure 3 A partial cross-sectional view of a medicine bottle assembly, along Figure 3 The cross section is taken along line 4-4;

[0013] Figure 5 According to one or more embodiments shown and described herein Figure 1 The medicine bottle slide rack and the medicine bottle receiving Figure 3 A perspective view of a vial assembly of FIG. 1 , wherein a series of delivery lines are coupled to a vial carriage;

[0014] Figure 6 is a schematic side view of a radiation shield component in a folded position according to one or more embodiments shown and described herein;

[0015] Figure 7 is in a folded position and arranged on a delivery line connection of a delivery device Figure 6 A schematic side view of a radiation shielding component;

[0016] Figure 8 is in the expanded position Figure 7 A schematic side view of a radiation shielding member of the invention, the radiation shielding member being pulled distally through the microcatheter and proximate to a base sheath receiving the distal end of the microcatheter;

[0017] Fig. 9 is in the expanded position Figure 7 A schematic side view of a radiation shielding member further pulled distally through the microcatheter and a base sheath receiving the distal end of the microcatheter;

[0018] Fig.10 yes Fig. 9 Schematic side view of a radiation shield in a deployed and sealed position ready for disposal and deployed and sealed on the distal end of a microcatheter removed from a base sheath. DETAILED DESCRIPTION

[0019] Reference will now be made in detail to various embodiments of delivery devices for administering radioactive compounds to a patient, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts. Directional terms used herein (e.g., up, down, right, left, front, back, top, bottom, distal, and proximal) are made with reference only to the drawings as drawn and are not intended to represent absolute orientations.

[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 a particular value and / or to another particular value. Similarly, when a value is expressed as an approximation by using the antecedent "about," it will be understood that the particular value forms another embodiment. It will also be understood that the endpoints of each of these ranges are important both relative to the other endpoint and independently of the other endpoint.

[0021] Unless otherwise expressly stated, it is not intended that any method set forth herein be construed as requiring that its steps be performed in a particular order, or as not requiring that its steps be performed in any particular orientation of the apparatus. Thus, in the absence of a method claim actually reciting the order in which its steps are to be followed, or in the absence of any apparatus claim actually reciting an order or orientation for individual components, or in the absence of otherwise specifically stating in the claims or specification that the steps are to be limited to a particular order, or in the absence of reciting a particular order or orientation for components of the apparatus, then no order or orientation is intended to be inferred in any respect. This applies to any possible non-expressive basis for interpretation, including: problems of logic relating to the arrangement of steps, flow of operations, order of components, or orientation of components; ordinary meaning derived from grammatical organization or punctuation; and the number or type of embodiments described in this specification.

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those of ordinary skill in the art to which the present disclosure belongs. The terms used in the specification herein are only used to describe specific embodiments and are not intended to be limiting. As used in this specification and the appended claims, the singular forms of "a", "an" and "the" are also intended to include plural forms, unless the context clearly indicates otherwise.

[0023] As used herein, the terms "horizontal", "vertical", "distal" and "proximal" are relative terms only, indicating only a general relative orientation and not necessarily indicating verticality. For convenience, these terms may also be used to refer to the orientations used in the accompanying drawings, which are used only as a convention and are not intended to be used as characteristics of the devices shown. The present disclosure and its embodiments described herein can be used in any desired orientation. Moreover, horizontal walls and vertical walls generally only need to be intersecting walls and do not need to be perpendicular. As used herein, the singular forms of "a", "an", and "the" include plural referents unless the context clearly indicates otherwise. Thus, for example, unless the context clearly indicates otherwise, reference to a "one" component includes aspects having two or more such components.

[0024] In embodiments described herein, the particulate matter delivery assembly may include a radioembolic delivery device. The radioembolic delivery device includes a medical device configured to deliver a radioactive compound to a treatment area in a patient's body during a procedure such as transarterial radioembolization. The radioactive compound may be a mixed solution of saline and radioactive microspheres (i.e., particles) mixed in a vial of the vial assembly. The needle may include one or more ports as an outlet to inject a fluid (i.e., saline) from, for example, a syringe or catheter line into a vial including radioactive microspheres to produce a mixed solution, and as an inlet to deliver the mixed solution to the patient.

[0025] Described below Figure 1-5 The embodiment of the delivery device 500 for delivering particles is directed to, and will be described in more detail below. Figure 6-10 Embodiments of one or more components of a delivery device 500 as described herein are contemplated that act as secondary radiation shielding components 600 to help shield radiation emitted from particles. As described herein and further hereinafter with reference to Figure 6-10 The radiation shielding component 600, described in more detail, can further help prevent the release of hazardous materials when disposing of a used delivery device connected to a microcatheter. These hazardous materials may include chemotherapy drugs, radioactive materials, blood, and / or other biohazardous materials that may pose a health hazard if released into the surrounding environment. The radiation shielding component 600 can be used to dispose of potentially contaminated accessory devices used during radioembolization procedures, the delivery of potentially hazardous drugs, or a combination thereof (as described herein). For example, when the microcatheter 720 or delivery sheath is removed from the patient after delivery, there is a possibility of leakage, which may contaminate the environment and pose a danger to the user (e.g., a physician and / or surrounding users or medical staff). Described herein and further referred to below Figure 6-10The radiation shielding member 600 described in more detail can be placed on the delivery line connector 710 of the delivery device 500 before connecting the delivery line connector 710 to the seat of the microcatheter 720. After the last injection, the user can slide the radiation shielding member 600 toward the seat of the microcatheter 720, and then pull the delivery line connector 710 to further pull the microcatheter 720 from the base connector (such as the base sheath 730 described herein) into the radiation shielding member 600, and then the radiation shielding member can be sealed for disposal as described herein. The user can keep the distal end 604 of the radiation shielding member 600 on the seat of the base connector to ensure that the microcatheter 720 is contained when it is removed from the seat of the base connector. Once the entire microcatheter 720 is contained in the radiation shielding member 600, the user can use, for example, an adhesive on the distal end 604 of the radiation shielding member 600 to seal the corresponding end of the radiation shielding member 600. The user can then dispose of the particle delivery device 500 contained by the radiation shielding component 600 as described herein based on the hazardous disposal procedures. For example, the user can dispose of the contained particle delivery device 500 by wrapping a sterile towel around the contained particle delivery device 500, which towel can be further rolled up and placed in a waste container for disposal. In an embodiment, the radiation shielding component 600 can be placed on the delivery pipeline connector 710 before delivering the mixed particles. In other embodiments, the radiation shielding component 600 can be split out of an internal position (e.g., the center) to be wrapped around the particle delivery device 500 and the microcatheter 720 respectively, so that it does not need to be installed before use.

[0026] In some embodiments, as described in more detail below, the delivery device 500 is a radioembolic delivery device, the particles are a plurality of radioembolic beads, the fluid is a saline solution, and the resulting mixed fluid (e.g., a mixed fluid solution) is a radioembolic bead-saline solution. The needle 559 can be configured to deliver the radioembolic bead-saline solution as a mixed fluid solution through the radioembolic delivery device, such as when the vial engagement mechanism 520 is activated in the positive pressure direction. In some embodiments, the fluid is a contrast agent-saline solution including a contrast agent, and the resulting mixed fluid (e.g., a mixed fluid solution) is a radioembolic bead-contrast agent-saline solution. The needle 559 can be configured to deliver the radioembolic bead-contrast agent-saline solution as a mixed fluid solution through the radioembolic delivery device. In some embodiments, the delivery device 500 is a chemoembolic delivery device, the particles are a plurality of chemoembolic beads, and the mixed fluid solution is a bead-saline solution or a bead-contrast agent-saline solution.

[0027] I. Mechanical delivery device with removable carriage assembly

[0028] Figure 1-5 One embodiment of a delivery device 500 is shown that is configured and operable to deliver radioactive material (e.g., radioembolic beads) while reducing radioactive emissions during use of the delivery device 500. The delivery device 500 can be operated in the manner described in International PCT Application No. PCT / 2019 / 033001, filed May 17, 2019, the entire contents of which are incorporated herein, except as referenced below. Figure 6-10 Except for the radiation shielding components described in more detail and in one or more embodiments herein.

[0029] First reference Figure 1 , the delivery device 500 includes a console assembly 510, which includes a console. The delivery device 500 may include a carriage assembly 540, which is operable to transition between a coupled state and a decoupled state relative to the console assembly 510. The console assembly 510 of the delivery device 500 includes a base 512, which is defined by and extends between a proximal end 514 and a distal end 516. 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.

[0030] The proximal end 514 of the base 512 also includes an attachment device 538 configured to securely retain an external device to the base 512 of the console assembly 510. The attachment device 538 is operable to facilitate attachment of a complementary device to the console assembly 510 for use with the delivery device 500 during a surgical procedure.

[0031] Still refer to Figure 1 , the distal end 516 of the console assembly 510 defines a vial receiving area 518, which is sized and shaped to receive a vial assembly 580 therein, as will be described in more detail herein. The console assembly 510 also includes a vial engagement mechanism 520 extending from the base 512 and adjacent to the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outward from the base 512 of the console assembly 510 toward the distal end 516. The vial engagement mechanism 520 is positioned within the vial receiving area 518 of the console assembly 510 and is movably coupled to a handle 528. In particular, the handle 528 of the console assembly 510 is operable to move (particularly translate) the vial engagement mechanism 520 within the vial receiving area 518 in response to actuation of the handle 528.

[0032] 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 the present 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.

[0033] The carriage cavity 532 is sized and shaped to receive a carriage assembly 540 therein. As will be described in greater detail herein, the carriage assembly 540 is configured to store therapeutic particles (e.g., radioactive beads, microspheres, media) and administer the therapeutic particles therethrough. In particular, the carriage assembly 540 is configured to partially receive a vial assembly 580 therein for delivering the therapeutic particles from the delivery device 500 to the patient during a surgical procedure.

[0034] In the examples and with reference to Figure 2 , the flow sensor of the delivery device 500 can be positioned in line with the tubing of the delivery device 500 (particularly the needle 559, the manifolds 555A, 555B, and / or the one or more ports 556), and can be configured to measure the amount of fluid (e.g., a suspension of therapeutic particles effectively mixed with a fluid medium) passing therethrough. Referring again to Figure 1 , the vial engagement mechanism 520 includes a pair of lever arms 522 extending outwardly from a neck 524 of the vial engagement mechanism 520, wherein the neck 524 extends laterally outwardly from the base 512 of the console assembly 510. The neck 524 of the vial engagement mechanism 520 is disposed within a protective 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 exterior of the console assembly 510 (particularly from the vial receiving area 518).

[0035] The pair of lever arms 522 can move simultaneously with the neck 524 of the vial engagement mechanism 520 in response to the actuation of the handle 528 of the console assembly 510. In addition, the pair of lever arms 522 are fixed relative to each other so that the spacing formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 is configured to securely engage the vial assembly 580 therebetween, and in particular securely engage within the spacing formed by the pair of lever arms 522. Therefore, the vial engagement mechanism 520 is operable to securely attach the vial assembly 580 to the console assembly 510 at the vial receiving area 518. Although the vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, it should be understood that the vial engagement mechanism 520 may include various 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.

[0036] Still refer to Figure 1 , the console assembly 510 also includes a safety cover 526 that is fixed to the distal end 516 of the base 512 along the vial receiving area 518. In particular, the safety cover 26 is a protective cover that is sized and shaped to enclose the vial receiving area 518 of the console assembly 510 when the safety cover is fixed to the console assembly 510. The safety cover 526 is selectively attachable to the distal end 516 of the base 512 and is formed of a material configured to suppress radioactive emissions from one or more radioactive doses stored in the vial receiving area 518.

[0037] The distal end 516 of the console assembly 510 also includes a carriage cavity 532 that is sized and shaped to receive a carriage assembly 540 therein. The carriage cavity 532 includes one or more or a pair of alignment features 534 extending therein, wherein the alignment features 534 are sized and shaped to correspond with complementary alignment features (e.g., alignment ribs 554) of the carriage assembly 540 to facilitate coupling the carriage assembly 540 with the base 512 of the console assembly 510 within the carriage cavity 532.

[0038] Still refer to Figure 1, the carriage assembly 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 carriage assembly 540 includes a distal end 542 and a proximal end 544, and a pair of sidewalls 546 extending between the distal end and the proximal end. The distal end 542 of the carriage assembly 540 includes a handle 552 extending proximally from the distal end. The handle 552 is configured to facilitate movement of the carriage assembly 540, and in particular, to facilitate insertion of the carriage assembly 540 into the carriage cavity 532 of the console assembly 510. The distal end 542 also includes one or more ports 556 for coupling one or more delivery lines (i.e., tubing) to the carriage assembly 540. Since the one or more delivery lines are further coupled to one or more external devices at the ends of the lines opposite the ports 556, the ports 556 are effectively used to fluidly couple the carriage assembly 540 to the one or more external devices via the delivery lines connected thereto. The pair of side walls 546 of the carriage assembly 540 include at least one alignment rib 554 extending laterally outward from the pair of side walls, wherein the alignment rib 554 is sized and shaped to correspond to and mate with the pair of alignment features 534 of the console assembly 510. Thus, the pair of alignment ribs 554 are configured to facilitate alignment and engagement of the carriage assembly 540 with the console assembly 510 when the proximal end 544 is slidably received within the carriage cavity 532 of the base 512.

[0039] The carriage assembly 540 also includes a top surface 548 extending from the distal end 542 and the proximal end 544 and positioned between the pair of side walls 546. The top surface 548 of the carriage assembly includes a recessed area 549 and a locking system 550. The recessed area 549 is sized and shaped to form a recess and / or cavity along the top surface 548, wherein the recessed area 549 is capable of receiving and / or collecting various substances therein, including, for example, various fluid media leaked during use of the delivery device 500. The locking system 550 of the carriage assembly 540 forms an opening along the top surface 548, the opening being sized and shaped to receive one or more devices therein, such as a prefill assembly 560 and a vial assembly 580. In some embodiments, the carriage assembly 540 is preloaded with the prefill assembly 560 disposed within the locking system 550. The prefill assembly 560 includes a prefill line 562 extending outwardly from the locking system 550 of the carriage assembly 540. Priming assembly 560 connects priming line 562 to needle 559 and manifolds 555A and 555B, and is used to purge air from delivery device 500 (including manifolds 555A and 555B) prior to using delivery device 500 in a procedure.

[0040] Reference now Figure 2, the locking system 550 includes an annular array of protrusions 551 that extend outwardly from the locking system and, in particular, extend laterally along the top surface 548 into an aperture formed by the locking system 550. The annular array of protrusions 551 is formed within the inner periphery of the locking system 550 and extends along at least two sequentially arranged rows. In an embodiment, a single row may be used. The annular array of protrusions 551 included in the locking system 550 is configured to engage a corresponding locking feature 586 of the vial assembly 580 (see Figure 3 ), thereby securely securing the vial assembly 580 to the carriage assembly 540. It should be appreciated that the multiple rows of protrusions 551 of the locking system 550 are used to provide a double locking system to ensure that the carriage assembly 540, in particular the needle 559 of the carriage assembly 540, is locked by the septum 592 (see FIG. 5A ) of the vial assembly 580 during use of the delivery device 500 in a surgical procedure. Figure 3 ) Hold firmly.

[0041] The carriage assembly 540 also includes a vial chamber 558 that is sized and shaped to receive the prefill assembly 560 and the vial assembly 580 therein, respectively. In other words, the vial chamber 558 is sized to receive both the prefill assembly 560 and the vial assembly 580, respectively, separated from each other. The vial chamber 558 is enclosed around a protective chamber or protective cover 557 disposed around the vial chamber 558. The protective cover 557 is formed of a material (such as metal or plastic) configured to prevent radioactive emissions from expanding outward from the vial chamber 558. In addition, the carriage assembly 540 includes a needle that extends through the protective cover 557 and extends into the vial chamber 558 along the bottom end of the vial chamber 558. The needle 559 is firmly fixed relative to the vial chamber 558 so that any device (e.g., prefill assembly 560, vial assembly 580, etc.) received in the vial chamber 558 through the aperture of the locking system 550 will encounter and interact with the needle 559.

[0042] Still reference Figure 2 , needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the carriage assembly 540, and in particular, the manifolds 555A, 555B are positioned below the vial chamber 558 and the protective cover 557. The proximal manifold 555B is fluidly coupled to the needle 559, and the distal manifold 555A may be fluidly coupled to one or more delivery lines via one or more ports 556 of the carriage assembly 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A via a one-way check valve 553 disposed between the proximal manifold 555B and the distal manifold 555A.

[0043] Thus, the proximal manifold 555B is in fluid communication with the one or more ports 556 via the distal manifold 555A, but, due to the position of the one-way check valve 553 disposed between the manifolds 555A, 555B, the one or more ports 556 are not in fluid communication with the proximal manifold 555B. Thus, the needle 559 is in fluid communication with one or more delivery lines and / or devices coupled to the carriage assembly 540 at the one or more ports 556 via the manifolds 555A, 555B fixed therebetween. The one or more ports 556 of the carriage assembly 540 can be coupled to a bag (e.g., a saline bag), a syringe, a catheter, and / or the like via one or more delivery lines coupled thereto. In other embodiments, the needle 559 can be a cannula, a catheter, or a similar mechanism through which fluids and / or solutions as described herein are injected and received.

[0044] Still refer to Figure 2 , the carriage assembly 540 includes a removable battery pack 570 coupled to the carriage assembly 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 paths and the radiation source due to the position of the battery 572 in the removable battery pack 570.

[0045] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to contact corresponding electrical contacts 511 of the console assembly 510 when the carriage assembly 540 is coupled to the base 512 at the carriage cavity 532 (see Figure 1 Thus, the removable battery pack 570 is operable to provide power to the delivery device 500, and in particular the console assembly 510, when the carriage assembly 540 is coupled to the console assembly 510.

[0046] Additionally, as will be described in greater detail herein, in some embodiments, the locking system 550 can include at least one planar wall relative to the remaining circular orientation of the locking system 550. In this case, the aperture formed by the locking system 550 through the top surface 548 of the carriage assembly 540 is irregularly shaped, rather than circular as shown and described above. In this case, the vial assembly 580 includes a locking feature 586 having a shape and size corresponding to the locking system 550, and in particular to the at least one planar wall, such that the vial assembly 580 is received within the carriage assembly 540 only when the orientation of the vial assembly 580 corresponds to the alignment of the locking feature 586 and the locking system 550. In other words, the corresponding planar wall 586A of the locking feature 586 (see FIG. 5A ) is not necessarily the same as the planar wall 586A of the carriage assembly 540. 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 opening formed by the locking system 550 of the slide assembly 540.

[0047] Reference now Figure 3 , depicting a vial assembly 580 of a delivery device 500. The vial assembly 580 includes an engagement head 582, a plunger 584, a locking feature 586, and a vial body 589. In particular, the engagement head 582 of the vial assembly 580 is positioned at an end of the plunger 584 opposite the locking feature 586 and the vial body 589. The engagement head 582 includes a pair of arms 581 that extend laterally outward relative to the longitudinal length of the plunger 584 extending downward therefrom. In this example, the engagement head 582 is integrally formed with the plunger 584, however, it should be understood that in other embodiments, the engagement head 582 and the plunger 584 can be separate features that are securely connected. In either case, the engagement head 582 and the plunger 584 can be movable relative to the locking feature 586 and the vial body 589 so that the engagement head 582 and the plunger 584 can be slidably translated through the locking feature 586 and the vial body 589. In particular, as will be described in greater detail herein, when the engagement head 582 is secured to a pair of lever arms 522 , the plunger 584 can translate in and out of the interior chamber 588 of the vial body 589 in response to linear translation of the vial engagement mechanism 520 .

[0048] The plunger 584 includes a plurality of markings and / or indicia 583 positioned along the longitudinal length of the plunger 584. The plurality of markings 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, when the vial assembly 580 is received within the carriage assembly 540 and the carriage assembly is inserted into the carriage cavity 532 of the console assembly 510, the pair of arms 581 of the engagement head 582 are sized and shaped to couple with a pair of lever arms 522 of the vial engagement mechanism 520. As will be described in greater detail herein, in response to a predetermined translational force applied to the vial engagement mechanism 520, a pair of lever arms 522 are received between the pair of arms 581 of the engagement head 582 and the plunger 584. Engagement head 582 and plunger 584 may be formed from a variety of materials including, but not limited to, metal, plastic, and / or the like.

[0049] Still refer to Figure 3, the vial assembly 580 also includes a safety tab 585 coupled to the plunger 584 and relatively located 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 made of a variety of materials (e.g., plastic) and pre-assembled to the vial assembly 580 before using the delivery device 500. The safety tab 585 is removably fastened to the plunger 584 and prevents the plunger 584 from translating relative to the vial body 589. In particular, in response to applying a linear force on the plunger 584 to relatively translate the plunger 584 downward into the vial body 589, the safety tab 585 abuts the locking feature 586. In this case, the safety tab 585 is configured to prevent accidental movement of the plunger 584, and in response, prevent accidental delivery of a fluid medium (e.g., therapeutic particles, radioembolic beads) stored in the inner chamber 588 of the vial body 589. As will be described in greater detail herein, the safety tab 585 selectively disengages from the plunger 584 in response to coupling of the vial assembly 580 to the vial engagement mechanism 520 , and in particular in response to engagement of a pair of lever arms 522 to the engagement head 582 .

[0050] Reference again Figure 3 , the locking feature 586 extends around the top end of the vial body 589. In the present example, the locking feature 586 of the vial assembly 580 includes a bushing that defines a lateral edge 587 that extends laterally outward along the outer periphery of the locking feature 586. The lateral edge 587 of the locking feature 586 is sized and shaped to engage the annular array of protrusions 551 of the locking system 550 when the vial assembly 580 is received within the vial chamber 558 of the carriage assembly 540. As will be described in greater detail herein, the locking feature 586, and in particular the lateral edge 587 of the locking feature 586, is configured to securely secure the vial assembly 580 to the locking system 550 to prevent the vial body 589 from being removed from the vial chamber 558 of the carriage assembly 540 during use of the delivery device 500 in a procedure. In some embodiments, as briefly described above, the locking feature 586 includes at least one planar wall 586A such that the locking feature 586 includes an irregular profile. The at least one planar wall 586A is configured to correspond to the planar wall 550A of the locking system 550 such that alignment of the planar walls 550A, 586A is required in order for the vial assembly 580 to be received through the aperture formed by the locking system 550 .

[0051] Still refer to Figure 3, the vial body 589 extends downwardly relative to the locking feature 586 and has a longitudinal length that is sized to receive at least a portion of the longitudinal length of the plunger 584 therein. Thus, in some embodiments, the longitudinal length of the plunger 584 exceeds the longitudinal length of the vial body 589 such that translation of the plunger 584 into the interior chamber 588 of the vial body 589 causes the fluid medium stored therein to be transferred outwardly from the vial body 589. As will be described in more detail herein, translation of the plunger 584 through the interior chamber 588 of the vial body 589 provides for the application of the fluid medium stored within the vial body 589 outwardly from the vial assembly 580. The vial body 589 can be made of a variety of materials, including, for example, thermoplastic polymers, copolyesters, polycarbonates, biocompatible plastics, polysulfones, ceramics, metals, and / or the like.

[0052] The vial body 589 of this example is formed of a material that is configured to block radioactive emissions from a fluid medium stored in an inner chamber 588 of the vial body 589. For example, the vial body 589 can be formed of plastic (e.g., polycarbonate) and have a width. The density and material composition of the vial body 589 can work together to block beta radiation emissions from electron particles stored in the inner chamber 588. In this example, the chemical composition of the plastic of the vial body 589, together with the 9 mm wall thickness, provides a plurality of atoms arranged in the vial body 589 that are able to encounter electron particles that produce beta radiation and reduce the emission of said radiation from the vial assembly 580. Therefore, the vial assembly 580 allows an operator to handle radioactive materials stored in the vial body 589 without being exposed to beta radiation. It should be understood that, in other embodiments, various other materials and / or wall segments may be incorporated into the vial body 589 of the vial assembly 580 without departing from the scope of the present disclosure.

[0053] Still refer 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 also includes a cap 590 positioned at an opposite end of the vial body 589 opposite to the locking feature 586, so that the cap 590 seals the second end of the vial body 589 of the vial assembly 580. In addition, the vial assembly 580 includes a septum 592 positioned near the cap 590 and in fluid communication with the end of the vial body 589 opposite to the locking feature 586. The septum 592 forms a seal to the end of the vial body 589, and the cap 590 holds the septum 592 therein. The septum 592 can be formed of various materials, including, for example, elastomers, silicon, bromobutyl elastomers, rubber, polyurethane, and / or the like. The septum 592 is configured to provide an airtight seal for the vial body 589, thereby preventing the release of a fluid medium (e.g., radioembolic beads) stored therein. As will be described in greater detail herein, the septum 592 of the vial assembly 580 is configured to be pierced by the needle 559 of the carriage assembly 540 when the vial assembly 580 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the carriage assembly 540. In other embodiments, the septum 592 may be omitted entirely to employ alternative arrangements, such as a valve system, a needle injection port, and / or the like.

[0054] refer to Figure 4 , the vial assembly 580 also includes a stopper 594 fixedly coupled to the end of the plunger 584 opposite the engagement head 582. In this case, since the plunger 584 is coupled to the interior chamber 588 of the vial body 589 and slidably translates therethrough, the stopper 594 is effectively disposed within the vial body 589. Therefore, it should be understood that the size and shape of the stopper 594 are based on the size (e.g., diameter) of the interior chamber 588 of the vial body 589. The stopper 594 is fixed to the plunger 584 so that the stopper 594 can slidably translate through the vial body 589 in response to the translation 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 grooves 595 defined between at least two of the ribs 593.

[0055] The stopper 594 is configured to form a liquid seal with the inner chamber 588 of the vial body 589 and can be formed of various polymers having a predetermined viscoelastic property. For example, in some embodiments, the stopper 594 is formed of an elastomer, silicone, rubber, polyurethane, plastic, polyethylene, polypropylene, and / or the like. In this case, the stopper 594 is operable to prevent the fluid medium stored in the vial body 589 from extending (i.e., leaking) beyond the stopper 594 and flowing out of the vial body 589. In particular, two or more ribs 593 of the stopper abut against the inner chamber 588 of the vial body 589 and form a seal along the inner chamber 588, thereby preventing the fluid medium from passing over the ribs 593. One or more grooves 595 formed between the two or more ribs 593 of the stopper 594 are configured to receive and more specifically capture any fluid medium that may inadvertently extend (i.e., leak) beyond the ribs 593 of the stopper 594. Thus, one or more grooves 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 is not exposed outside the vial assembly 580.

[0056] Still refer to Figure 4 , the two or more ribs 593 of the stopper 594 are also configured to push the fluid medium stored in the vial body 589 in one or more directions therein (e.g., toward the cap 590) in response to the translation of the plunger 584. With the ribs 593 of the stopper 594 pressed against the interior chamber 588 of the vial body 589, the translation of the plunger 584 provides the ribs 593 to abut against and translate along the interior chamber 588 of the vial body 589, so that any fluid medium located in front of (i.e., below) the stopper 594 is effectively redirected within the vial body 589 along the direction of travel of the plunger 584 and the stopper 594. The vial assembly 580 also includes an annular gasket 596 disposed within the vial body 589. In particular, the annular gasket 596 is securely fixed to the plunger 584 adjacent to the stopper 594, which is fixed to the plunger 584 at the end opposite to the engagement head 582. Thus, the annular gasket 596 is fixed to the plunger 584 and disposed within the vial body 589 adjacent to the stopper 594. With the annular gasket 596 fixed to the plunger 584 adjacent to the stopper 594, the annular gasket 596 is effectively disposed within the vial body 589.

[0057] Reference now Figure 5In response to determining that the battery 572 contains sufficient charge or other power source provides sufficient charge, one or more delivery lines are coupled to the carriage assembly 540 via one or more ports 556. In particular, the dose delivery line 10A is coupled to the carriage assembly 540 at the delivery port 556A, the contrast agent line 10B is coupled to the carriage assembly 540 at the contrast agent port 556B, and the flush line 10C is coupled to the carriage assembly 540 at the flush port 556C. The opposite end of the dose delivery line 10A is initially coupled to a fluid reservoir (e.g., a collection bowl). As will be described in more detail herein, once the carriage assembly 540 has been effectively pre-filled with fluid medium via the contrast agent line 10B, the dose delivery line 10A can then be coupled to an external device, such as a catheter. The opposite end of the flush line 10C is coupled to an external device, such as a syringe. In the case where both the dose delivery line 10A and the flush line 10C have been coupled to the carriage assembly 540, the carriage assembly 540 is flushed with a fluid medium (e.g., saline) from a syringe coupled to the flush line 10c. In this case, the fluid medium is injected into the distal manifold 555A of the carriage assembly 540 through the flush line 10C and flows out of the carriage assembly 540 through the dose delivery line 10A. Thus, the fluid medium is ultimately received in a collection bowl and disposed at the collection bowl through the dose delivery line 10A.

[0058] In the case where the distal manifold 555A of the carriage assembly 540 is separated from the proximal manifold 555B by the one-way valve 553 disposed therebetween, the fluid medium flushed from the syringe (via the flush port 556C) through the distal manifold 555A is blocked from passing through the proximal manifold 555B and the needle 559 coupled thereto. In contrast, the fluid medium injected from the syringe and passed through the flush line 10C is received at the flush port 556C, passes through the distal manifold 555A in fluid communication with the flush port 556C, and is redirected by the one-way valve 553 to 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 transmits the fluid medium to the collection bowl coupled thereto, so that the fluid medium is not directed through the one-way valve 553 into the proximal manifold 555B in fluid communication with the needle 559.

[0059] Contrast line 10B is coupled to carriage assembly 540 at contrast port 556B. The opposite end of contrast line 10B is coupled to a fluid medium supply source (e.g., a bag secured to console assembly 510 via attachment 538). In this example, the bag is a saline bag, such that the fluid medium stored therein is saline. In this instance, where carriage assembly 540 includes a prefill assembly 560 positioned within vial chamber 558 and in fluid communication with needle 559 at needle end 568, a syringe is fluidly coupled to prefill line 562 of prefill assembly 560, and the plunger of the syringe is withdrawn to pull saline from the saline bag through contrast line 10B, contrast port 556B, carriage assembly 540, prefill line 562, and into the syringe. Subsequently, the plunger of the syringe is pushed inward to transfer the drawn saline back through the priming line 562, the central body 564, the elongated shaft 566 and the needle end of the priming assembly 560 so that the saline is received into the needle 559 of the carriage assembly 540. Thus, with the needle 559 receiving the saline from the priming assembly 560 in fluid communication with the manifolds 555A, 555B, the manifolds 555A, 555B of the carriage assembly 540 are used to effectively prime the syringe with saline. With the manifolds 555A, 555B further in fluid communication with the dose delivery line 10A via the delivery port 556A, the saline is effectively dispensed into the collection bowl coupled to the dose delivery line.

[0060] Reference now Figure 5 , the carriage assembly 540 is coupled to one or more external devices via one or more ports 556. In particular, the carriage assembly 540 is fluidly coupled to a catheter (e.g., a microcatheter) via a dose delivery line 10A coupled to a delivery port 556A of the carriage assembly 540. In this case, the catheter is in fluid communication with the carriage assembly 540 via the dose delivery line 10A. In addition, the carriage assembly 540 is fluidly coupled to a contrast medium source, such as a saline bag secured to the console assembly 510 via an attachment device 538 (see Figure 1 ). The carriage assembly 540 is in fluid communication with the saline bag via a contrast agent line 10B coupled to a contrast agent port 556B of the carriage assembly 540. In this case, the saline bag is in fluid communication with the carriage assembly 540 via a contrast agent line 10B fixed to the contrast agent port 556B.

[0061] Contrast port 556B is in fluid communication with proximal manifold 555B, while delivery port 556A is in fluid communication with distal manifold 555A. As will be described in greater detail herein, because contrast port 556B is coupled to proximal manifold 555B, rather than to distal manifold 555A, which is separated from proximal manifold 555B by one-way check valve 553 disposed between proximal manifold 555B and distal manifold 555B, saline from the saline bag can be drawn into vial body 589 of vial assembly 580 through needle 559 of carriage assembly 540.

[0062] Reference again Figure 1 and 3 With the vial assembly 580 securely coupled to the carriage assembly 540, the carriage assembly 540 is coupled to the console assembly 510 by translating the distal end 542 of the carriage assembly 540 toward and into the distal end 516 of the console assembly 510. In particular, the distal end 542 of the carriage assembly 540 is guided into the carriage cavity 532 of the console assembly 510 by aligning the alignment ribs 554 of the carriage assembly 540 with the alignment features 534 of the console assembly 510. Once the proximal and distal ends 544, 542 of the carriage assembly 540 are fully seated within the carriage cavity 532 of the console assembly 510, the electrical contacts 574 ( Figure 2 ) will mate with the corresponding electrical contact 511 ( Figure 1 ) interacts. In this example, power from battery 572 is transmitted to console assembly 510 via electrical contacts 574, thereby activating console assembly 510 of delivery device 500. In this example, interface display 530 of console assembly 510 is activated to display real-time information related to delivery device 500 during surgery.

[0063] Reference again Figure 5 As the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial receiving area 518, a negative pressure is generated within the interior chamber 588 of the vial body 589 due to the retraction of the stopper 594. In this example, with a saline bag coupled to the carriage assembly 540 via contrast line 10B and contrast port 556B, saline from the saline bag is drawn into the interior chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Thus, in the case where the vial body 589 is preloaded with a radioactive fluid medium (e.g., radioembolic microspheres), as the plunger 584 is retracted from the interior chamber 588 and negative pressure is generated by the delivery device 500, the saline is effectively mixed with the radioactive fluid medium within the vial body 589.

[0064] The carriage assembly 540 also includes a one-way check valve 553A in line with the contrast agent line 10B and the flushing line 10C. In particular, the one-way check valve 553A is configured to allow fluid communication from the contrast agent port 556B and the flushing port 556C to the manifolds 555A, 555B, and is also configured to prevent fluid communication from the manifolds 555A, 555B to the contrast agent port 556B and the flushing port 556C. Therefore, it should be understood that due to the one-way check valve 553A positioned therein, the dose delivered from the vial body 589 to the manifold 555A, 555B cannot be directed into the contrast agent line 10B or the flushing line 10C. Therefore, the dose is directed to the dose delivery port 556A and is received at the conduit coupled thereto through the dose delivery line 10A. In other words, the one-way check valve 553A prevents fluid from flowing back into the slide assembly 540 and / or the vial assembly 580 connected thereto. II. Radiation Shielding Embodiments

[0065] As briefly described above, the delivery device 500 described herein may include a radiation shielding component, an example of which will be described below with reference to Figure 6-10 Describe in more detail. Figure 6-10 An embodiment of a radiation shielding member 600 is shown for disposal or placement between a delivery line connection 710 (eg, a dose delivery line 10A) and a microcatheter 720 of a particle delivery device 500, as described in more detail below. Figure 6-10 Reflecting an embodiment of a radiation shielding component 600, such as a flexible bag sealed on a microcatheter 720 (the microcatheter is used to deliver mixed particles from a particle delivery device 500 to dispose of the mixed particles delivered from a delivery line connector 710 of the particle delivery device 500 to the microcatheter 720, particularly after use), the distal end 728 of the microcatheter 720 is sealed and the delivery line connector 710 connected to the microcatheter 720 is ready to be disposed of (e.g., thrown into a hazardous materials handling unit) after use.

[0066] refer to Figures 6 to 10 , the radiation shielding member 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 a delivery line connector 710 of the particle delivery device 500. The delivery line connector 710 may be configured to receive mixed particles from the particle delivery device 500. Fig.10As shown and described in more detail below, the distal end 604 can be configured to be disposed on a microcatheter 720 connected to a delivery line connector 710 after use and to house the microcatheter 720. Thus, the distal end 604 can be configured to seal together to house the microcatheter 720 after the particle delivery device 500 is used and before being disposed of (as a non-limiting example).

[0067] refer to Figure 6 , shows a radiation shielding component 600 in a folded position 606, wherein the proximal end 602 in the embodiment includes a rigid material 608, the distal end 604 includes a flexible material 610, and the flexible material 610 has greater elasticity 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 natural 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 have a thickness sufficient to help shield radiation, such as, but not limited to, in the range of 1 mm to 10 mm, such as up to 9 mm to block beta radiation, shield 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, water or other fluid-filled material, cloth, or other suitable flexible material. In an embodiment, the flexible material 610 includes an accordion-like rib structure in a relaxed form and having greater elasticity than the rigid material 608, and is configured to stretch to a stretched form (e.g., as Fig. 9 The expanded position 612 shown or Fig.10 The flexible material 610 may be configured to be unrolled from a rolled form to cover and contain the microcatheter 720 prior to sealing the distal end 604 of the radiation shielding member 600. The distal end 604 may include a seal via an adhesive, a fastening mechanism, or a combination thereof to seal together to contain the microcatheter 720 prior to treatment, as described herein.

[0068] refer to Figure 7, shows the radiation shielding component 600 in a folded position 606 arranged on a delivery line connector 710 of the particle delivery device 500. The rigid material 608 of the proximal end 602 is configured to be arranged against an adjacent lip on the distal portion 712 of the delivery line connector 710 to prevent the proximal end 602 from moving in a distal direction toward the distal end 604. In an embodiment, the rigid material 608 may include one or more engagement features to engage with one or more corresponding engagement features of the adjacent lip on the distal portion 712 of the delivery line connector 710, such as one or more protrusions and / or holes that are configured to engage with one or more corresponding other holes and / or protrusions or other locking mechanisms, respectively. Figure 7-10 As shown, the distal end 716 of the delivery line connector 710 can be configured to connect to the proximal end 726 of the microcatheter 720. When the distal end 604 of the radiation shielding component 600 is not sealed, the distal end 716 of the delivery line connector 710 can be accessible. In an embodiment, as described below with reference to at least Fig. 9 and Fig.10 As depicted, when the distal end 604 of the radiation shield 600 is sealed to receive the microcatheter 720 (eg, at the sealed end 732 ), the distal end 604 of the radiation shield 600 may be configured to cover the distal end 716 of the delivery line connector 710 .

[0069] Reference again Figure 7 , the microcatheter 720 may include a proximal end 726 as shown, which includes a fastener 722. As a non-limiting example, the fastener 722 may be a Luer connector or other fastening mechanism, and may include a terminal 723 as shown, a crosspiece 724, and a base 725, the width of the base being greater than the width of the terminal 723, and the crosspiece 724 being defined between the terminal 723 and the base 725. The distal end 728 of the microcatheter 720 is at Figure 8 Shown in.

[0070] Figure 8 The radiation shielding component 600 is shown in an expanded position 612, which can be in a first expanded state, pulled distally onto the microcatheter 720 and proximate to the base sheath 730 receiving the distal end 728 of the microcatheter 720. The microcatheter 720 can be configured to be connected to a base connector (e.g., the base sheath 730) for delivering mixed particles. In addition, the microcatheter 720 can be configured to be sealed (e.g., after use) at the distal end 604 of the radiation shielding component 600 containing the microcatheter 720. Fig.10 shown) is previously disconnected from a base connector such as a base cover 730.

[0071] Reference again Figure 8, in the first deployed state, the fastener 722 of the microcatheter 720 moves proximally in the direction of arrow A toward the proximal end 602 of the radiation shielding component 600 until the crosspiece 724 abuts against the rigid material 608 of the radiation shielding component 600. The abutment of the crosspiece 724 and the rigid material 608 helps prevent distal movement of the proximal end 602 of the radiation shielding component 600. Figure 8 The end 723 of the fastener 722 is shown when the crosspiece 724 abuts the rigid material 608 to extend through the hole in the rigid material 608 at the proximal end 602 of the radiation shielding device 600 .

[0072] In addition, the distal end 604 of the radiation shielding member 600 is pulled distally in the direction of arrow B toward the base sheath 730, which receives the distal end 728 of the microcatheter 720, for example, to deliver the mixed particles from the particle delivery device 500 to the patient. The distal end 604 of the radiation shielding member 600 can 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 Fig. 9 location.

[0073] Fig. 9 The radiation shield 600 is shown in the deployed position 612, which is in a second deployed state, being pulled further distally through the microcatheter 720 and the base sheath 730 receiving the distal end 728 of the microcatheter 720. Before delivering the mixed particles to a patient using the connected microcatheter 720 and delivery line connector 710, the distal end 604 of the radiation shield 600 (and having, for example, Fig.10 Sealed end 732 shown).

[0074] Fig.10 The radiation shielding member 600 is shown deployed and in a sealed position 614 for disposal (e.g., as hazardous waste) while being arranged and sealed on the distal end 728 of the microcatheter 720 removed from the base sheath 730. This seal is shown as a sealing end 732. In an embodiment, after use, the distal end 728 of the microcatheter 720 can be detached from the base sheath 730, and the distal end 604 of the radiation shielding member 600 can be sealed on the distal end 728 of the microcatheter 720 via a sealing end 732. 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 shielding member 600 can continue to be sealed on the distal portion 712 of the delivery line connector 710 via a sealing end 732. In embodiments, the entire used particle delivery device 500 may subsequently be disposed of (eg, in hazardous waste disposal), including the radiation shielding component 600 sealingly disposed about the distal end 728 of the microcatheter 720 and the distal portion 712 of the delivery line connector 710 via the sealing end 732 .

[0075] In an embodiment, a radiation sealing assembly for sealing and disposal may include a particle delivery device 500, the particle delivery device including a delivery line connector 710, a base connector (e.g., a base sheath 730), a microcatheter 720, and a radiation shielding component 600, as described herein. The microcatheter 720 may be used to deliver mixed particles from the particle delivery device 500 and is configured to be connected to the base connector (e.g., the base sheath 730) and the delivery line connector 710 to deliver the mixed particles. The microcatheter 720 may be configured to be disconnected from the base connector after use and connected to the delivery line connector 710.

[0076] A method for sealing and disposing a microcatheter 720 for delivering mixed particles from a particle delivery device 500 may include connecting a delivery line connector 710 of the particle delivery device 500 to the microcatheter 720, such as Figure 7 The microcatheter 720 can be connected to a base connector (e.g. Figure 8 and Fig. 9 In addition, the mixed particles can be passed through the micro-catheter 720 and the base connector (e.g., Fig. 9 The microcatheter 720 can be disconnected from the base connector after use, such as Fig.10 As shown. The proximal end 602 of the radiation shielding member 600 can be arranged on the distal portion 712 of the delivery line connector 710 of the particle delivery device 500 so that the proximal end 602 does not move in the distal direction toward the distal end 604. The distal end 604 of the radiation shielding member 600 can extend until it accommodates the microcatheter 720 connected to the delivery line connector 710 after use. The distal end 604 of the radiation shielding member 600 can be sealed together to accommodate the microcatheter 720 before disposal. In an embodiment, as shown in FIG. Fig.10 As shown, the micro-catheter 720 housed in the radiation shielding member 600 and the particle delivery device 500 connected to the micro-catheter 720 and the radiation shielding member 600 can be disposed of in a biohazard waste disposal.

[0077] III. List of aspects

[0078] Aspect 1. A radiation shielding component for sealing a microcatheter for treatment, the microcatheter being used to deliver mixed particles from a particle delivery device, the radiation shielding component comprising a proximal end and a distal end disposed opposite the proximal end. The proximal end is configured to be connected to and cover a distal portion of a delivery line connector of the particle delivery device, the delivery line connector being configured to receive the mixed particles from the particle delivery device. The distal end is configured to be disposed on and accommodate a microcatheter connected to the delivery line connector after use, and the distal end is configured to be sealed together to accommodate the microcatheter prior to treatment.

[0079] Aspect 2. The radiation shielding component according to aspect 1, wherein the proximal end comprises a rigid material, the distal end comprises a flexible material, and the flexible material has greater elasticity than the rigid material.

[0080] Aspect 3. The radiation shield component of aspect 2, wherein the rigid material of the proximal end is configured to be arranged against an adjacent lip on the distal portion of the delivery line connector to prevent movement of the proximal end in a distal direction.

[0081] Aspect 4. A radiation shielding component according to any one of Aspects 1 to 2, wherein the rigid material comprises cardboard, plastic, metal, or a combination thereof, and wherein the flexible material comprises a low-density material having a thickness of up to 9 mm to block beta radiation.

[0082] Aspect 5. A radiation shielding component according to any one of Aspects 1 to 4, wherein the distal end of the radiation shielding component is configured to cover the distal end of a delivery line connector when the distal end of the radiation shielding 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.

[0083] Aspect 6. The radiation shielding member according to Aspect 5, wherein the distal end of the delivery line connector is accessible when the distal end of the radiation shielding member is not sealed.

[0084] Aspect 7. A radiation shielding component according to any one of Aspects 1 to 6, wherein the proximal end comprises a rigid material, the distal end comprises a flexible material, and the flexible material comprises an accordion-type rib structure in a relaxed form and having greater elasticity than the rigid material and is configured to be stretched to a stretched form so that the accordion-type rib structure becomes smooth and covers and accommodates the microcatheter before sealing the distal end.

[0085] Aspect 8. The radiation shielding component according to aspects 1 to 7, wherein the distal end includes an adhesive, a fastening mechanism, or a combination thereof to seal together to accommodate the microcatheter prior to treatment.

[0086] Aspect 9. A radiation shielding component according to any one of Aspects 1 to 8, wherein the microcatheter is configured to be connected to a base connector for delivering the mixed particles, and the microcatheter is configured to be disconnected from the base connector after use and before the distal end accommodating the microcatheter is sealed.

[0087] Aspect 10. A radiation sealing assembly for sealing and disposal includes a particle delivery device, the particle delivery device including a delivery line connector, a base connector, a microcatheter and a radiation shielding component. The microcatheter is used to deliver mixed particles from the particle delivery device, the microcatheter is configured to be connected to the base connector and the delivery line connector to deliver the mixed particles, and the microcatheter is configured to be disconnected from the base connector and connected to the delivery line connector after use. The radiation shielding component includes a proximal end and a distal end arranged opposite to the proximal end. The proximal end is configured to be connected to and cover the distal portion of the delivery line connector of the particle delivery device, and the delivery line connector is configured to receive the mixed particles from the particle delivery device. The distal end is configured to be arranged on the microcatheter connected to the delivery line connector after use and to accommodate the microcatheter. The distal end is configured to be sealed together so as to accommodate the microcatheter before disposal.

[0088] Aspect 11. The radiation seal assembly of aspect 10, wherein the proximal end comprises a rigid material, the distal end comprises a flexible material, and the flexible material has greater elasticity than the rigid material.

[0089] Aspect 12. The radiation seal assembly of aspect 11, wherein the rigid material of the proximal end is configured to be arranged against an adjacent lip on the distal portion of the delivery line connector to prevent movement of the proximal end in a distal direction.

[0090] Aspect 13. The radiation seal assembly of any one of aspects 10 to 12, wherein the rigid material comprises cardboard, plastic, metal, or a combination thereof.

[0091] Aspect 14. A radiation sealing assembly according to any one of Aspects 10 to 13, wherein, when the distal end of the radiation shielding component is sealed to accommodate the microcatheter, the distal end of the radiation shielding component is configured to cover the distal end of the delivery line connector, and the distal end of the delivery line connector is configured to be connected to the proximal end of the microcatheter.

[0092] Aspect 15. The radiation seal assembly of aspect 14, wherein the distal end of the delivery line connector is accessible when the distal end of the radiation shielding member is unsealed.

[0093] Aspect 16. A radiation seal assembly according to any one of Aspects 10 to 15, wherein the proximal end comprises a rigid material, the distal end comprises a flexible material, and the flexible material comprises an accordion-like rib structure in a relaxed form and having greater elasticity than the rigid material and is configured to be stretched to a stretched form so as to smooth the accordion-like rib structure and cover and accommodate the microcatheter before sealing the distal end.

[0094] Aspect 17. The radiological seal assembly of any one of aspects 10 to 16, wherein the distal end comprises an adhesive, a fastening mechanism, or a combination thereof to seal together to house the microcatheter prior to disposal.

[0095] Aspect 18. A radiation seal assembly according to any one of Aspects 10 to 17, wherein the microcatheter is configured to be connected to the base connector for delivering the mixed particles, and the microcatheter is configured to be disconnected from the base connector after use and before the microcatheter is accommodated at the distal end and sealed.

[0096] Aspect 19. A method for sealing and disposing a microcatheter for delivering mixed particles from a particle delivery device, the method comprising: connecting a delivery line connector of the particle delivery device to the microcatheter; connecting the microcatheter to a base connector; delivering the mixed particles from the particle delivery device through the microcatheter and the base connector; and disconnecting the microcatheter from the base connector after use. The method also includes arranging the proximal end of the radiation shielding member on the distal portion of the delivery line connector of the particle delivery device so that the proximal end does not move in the distal direction; extending the distal end of the radiation shielding member until it accommodates the microcatheter connected to the delivery line connector after use; and sealing the distal end together to accommodate the microcatheter before disposal.

[0097] Aspect 20. The method according to aspect 19, further comprising disposing of the microcatheter housed in the radiation shielding member and the particle delivery device connected to the microcatheter and the radiation shielding member in biohazardous waste disposal.

[0098] It should be noted that the terms "substantially" and "approximately" may be used herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0099] For purposes of describing and defining the present disclosure, it should be noted that the term "substantially" is used herein to indicate the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The term "substantially" is also used herein to indicate the degree to which a quantitative representation may be varied from a stated reference without resulting in a change in the basic function of the subject matter in question. Thus, the term is used to indicate the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation involving an arrangement of elements or features that, while in theory would be expected to exhibit an exact correspondence or behavior, may in practice manifest some less-than-exact correspondence or behavior.

[0100] Although specific embodiments have been shown and described herein, it will be appreciated that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. In addition, although various aspects of the claimed subject matter have been described herein, these aspects need not be used in combination. Therefore, it is intended that the appended claims cover all such changes and modifications that fall within the scope of the claimed subject matter.

Claims

1. A radiation shielding component for sealing a microcatheter for treatment, the microcatheter being used to deliver mixed particles from a particle delivery device, the radiation shielding component comprising: a proximal end and a distal end disposed opposite to the proximal end; the proximal end is configured to connect to and cover a distal portion of a delivery line connector of the particle delivery device, the delivery line connector being configured to receive the mixed particles from the particle delivery device; The distal end is configured to be disposed on and accommodate the microcatheter connected to the delivery line connector after use; and The distal ends are configured to seal together to house the microcatheter prior to treatment.

2. The radiation shielding member according to claim 1, wherein: The proximal end includes a rigid material, the distal end includes a flexible material, and the flexible material has greater elasticity than the rigid material.

3. The radiation shielding member according to claim 2, wherein: The rigid material of the proximal end is configured to be disposed against an adjacent lip on the distal portion of the delivery line connector to prevent movement of the proximal end in a distal direction.

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

5. The radiation shielding member according to claim 1, wherein: The distal end of the radiation shielding member is configured to cover a distal end of the delivery line connector when the distal end of the radiation shielding member is sealed to accommodate the microcatheter, and the distal end of the delivery line connector is configured to be connected to a proximal end of the microcatheter.

6. The radiation shielding member according to claim 5, wherein: When the distal end of the radiation shield is unsealed, the distal end of the delivery line connector is accessible.

7. The radiation shielding member according to claim 1, wherein: The proximal end includes a rigid material, the distal end includes a flexible material, and the flexible material includes an accordion-like rib structure in a relaxed form and having greater elasticity than the rigid material, and the flexible material is configured to stretch to a stretched form to smooth the accordion-like rib structure and cover and contain the microcatheter before sealing the distal end.

8. The radiation shielding member according to claim 1, wherein: The distal end includes an adhesive, a fastening mechanism, or a combination thereof to seal together to house the microcatheter prior to disposal.

9. The radiation shielding member according to claim 1, wherein: The microcatheter is configured to be connected to a base connector for delivering the mixed particles, and the microcatheter is configured to be disconnected from the base connector after use and before the distal end housing the microcatheter is sealed.

10. A radiation seal assembly for sealing and disposal, the radiation seal assembly comprising: a particle delivery device, the particle delivery device comprising a delivery line connection; Base connector; a microcatheter for delivering mixed particles from the particle delivery device, the microcatheter being configured to be connected to the base connector and the delivery line connector to deliver the mixed particles, and the microcatheter being configured to be disconnected from the base connector and connected to the delivery line connector after use; and A radiation shielding component, the radiation shielding component comprising: a proximal end and a distal end disposed opposite to the proximal end; the proximal end being configured to connect to and cover a distal portion of the delivery line connector of the particle delivery device, the delivery line connector being configured to receive the mixed particles from the particle delivery device; The distal end is configured to be disposed on and accommodate the microcatheter connected to the delivery line connector after use; and The distal ends are configured to seal together to house the microcatheter prior to disposal.

11. The radiation seal assembly of claim 10, wherein: The proximal end includes a rigid material, the distal end includes a flexible material, and the flexible material has greater elasticity than the rigid material.

12. The radiation seal assembly of claim 11, wherein: The rigid material of the proximal end is configured to be disposed against an adjacent lip on the distal portion of the delivery line connector to prevent movement of the proximal end in a distal direction.

13. The radiation seal assembly of claim 11, wherein: The rigid material includes cardboard, plastic, metal, or a combination thereof.

14. The radiation seal assembly of claim 11, wherein: When the distal end of the radiation shielding member is sealed to accommodate the microcatheter, the distal end of the radiation shielding member is configured to cover the distal end of the delivery line connector, which is configured to be connected to the proximal end of the microcatheter.

15. The radiation seal assembly of claim 14, wherein: When the distal end of the radiation shield is unsealed, the distal end of the delivery line connector is accessible.

16. The radiation seal assembly of claim 10, wherein: The proximal end includes a rigid material, the distal end includes a flexible material, and the flexible material includes an accordion-like rib structure in a relaxed form and having greater elasticity than the rigid material, and the flexible material is configured to stretch to a stretched form to smooth the accordion-like rib structure and cover and contain the microcatheter before sealing the distal end.

17. The radiation seal assembly of claim 10, wherein: The distal end includes an adhesive, a fastening mechanism, or a combination thereof to seal together to house the microcatheter prior to disposal.

18. The radiation seal assembly of claim 10, wherein: The microcatheter is configured to be connected to the base connector for delivering the mixed particles, and the microcatheter is configured to be disconnected from the base connector after use and before the distal end receives the microcatheter and is sealed.

19. A method for sealing and disposing a microcatheter for delivering mixed particles from a particle delivery device, the method comprising: connecting a delivery line connector of the particle delivery device to the microcatheter; connecting the microcatheter to a base connector; delivering the mixed particles from the particle delivery device through the microcatheter and the base connector; disconnecting the microcatheter from the base connector after use; disposing a proximal end of a radiation shielding member on a distal portion of the delivery line connector of the particle delivery device such that the proximal end does not move in a distal direction; Extending the distal end of the radiation shielding member until it accommodates the microcatheter connected to the delivery line connector after use; as well as The distal ends are sealed together prior to disposal to house the microcatheter.

20. The method of claim 19, further comprising disposing of the microcatheter housed in the radiation shielding member and the particle delivery device connected to the microcatheter and the radiation shielding member in a biohazard waste disposal.

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