Adapter Components and Methods of Use for a Microparticle Material Delivery Assembly

Abstract

A system and method for using an adapter component for a particulate material delivery assembly for delivering a mixed particulate solution to a patient, the adapter component including at least a pair of device connector ports, each device connector port configured to connect to a corresponding delivery line connector of a particulate delivery device to receive the mixed particulate solution. The adapter component further includes a guidewire connector port configured to connect to a containment bag unit including a guidewire disposed therein, and a catheter connector port configured to connect to a microcatheter for delivering the mixed particulate solution to the patient. The guidewire is configured to retract into and extend out of the containment bag unit to position the microcatheter within the patient without disconnecting at least one of the pair of device connector ports from the delivery line connector of the particulate delivery device.

Description

Technical Field

[0001]

[0001] This disclosure generally relates to components of medical devices for treating cancer, and more particularly to adapter components of medical devices configured and operable to connect to a specific material delivery assembly to deliver a radioactive compound 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 to patients or healthcare workers and can even be life-threatening. Therefore, medical devices for radiation therapy must be configured to protect other areas from unnecessary radiation exposure while delivering radioactive substances locally to specific areas of a patient's body.

[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 a patient's liver, where radiation embolization microspheres filled with a radioactive compound such as yttrium-90 ( 90 Y) are delivered to the target tumor. These microspheres occlude the blood vessels supplying the tumor while delivering radiation to kill tumor cells. Generally, clinicians or patients can be exposed to the risk of radiation emitted from this delivery.

Summary of the Invention

Problems to be Solved by the Invention

[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.

Means for Solving the Problems

[0005] According to an embodiment of the present disclosure, an adapter component for a particulate material delivery assembly for delivering a mixed particulate solution to a patient comprises at least a pair of device connector ports. Each device connector port is configured to connect to a corresponding delivery line connector of a particulate delivery device for receiving the mixed particulate solution. The adapter component is a guide wire connector port configured to connect to a confinement bag unit, the confinement bag unit including a guide wire disposed therein, the guide wire connector port, and further comprising a catheter connector port configured to connect to a microcatheter for delivering the mixed particulate solution to the patient. The guide wire is configured to retract into and extend from the confinement bag unit to position the microcatheter within the patient without disconnecting at least one of the pair of device connector ports from the delivery line connector of the particulate delivery device.

[0006] In another embodiment, an adapter component for a particulate material delivery assembly for delivering a mixed particulate solution to a patient comprises at least a pair of device connector ports, each device connector port being configured to connect to a corresponding delivery conduit connector of a particulate delivery device for receiving the mixed particulate solution. Each device connector port comprises a female luer connection portion configured to connect to a male luer connection portion of a corresponding delivery conduit connector of the particulate delivery device. The adapter component further comprises a guide wire connector port configured to connect to a confinement bag unit, the confinement bag unit including a guide wire disposed therein, the guide wire connector port comprising a hemostatic valve configured to connect to the confinement bag unit, and a catheter connector port configured to connect to a microcatheter for delivering the mixed particulate solution to the patient. The guide wire is configured to retract into and extend from the confinement bag unit through the hemostatic valve and through the catheter connector port for positioning the microcatheter within the patient without disconnecting at least one of the pair of device connector ports from the delivery conduit connector of the particulate delivery device.

[0007]

[0007] In yet another embodiment, a method of using an adapter component for a particulate material delivery assembly for delivering a mixed particulate solution to a patient includes attaching at least one of a pair of device connector ports to a corresponding delivery conduit connector of a particulate delivery device to receive the mixed particulate solution; attaching a guide wire connector port to a confinement bag unit, the confinement bag unit including a guide wire disposed therein; attaching a catheter connector port to a microcatheter to deliver the mixed particulate solution to the patient; and at least one of retracting and extending a guide wire relative to the confinement bag unit to position the microcatheter within the patient without disconnecting at least one of the pair of device connector ports from the delivery conduit connector of the particulate delivery device.

[0008]

[0008] These and additional features provided by the embodiments described herein will be more fully understood in consideration of the following detailed description, in conjunction with the drawings.

Brief Description of the Drawings

[0009]

Figure 1

[0009] A perspective view of a delivery device including a protective shield and a vial slider, according to one or more embodiments shown and described herein.

Figure 2

[0010] A cross-sectional view of the vial slider of FIG. 1 taken along line 2-2 of FIG. 1, according to one or more embodiments shown and described herein.

Figure 3

[0011] A perspective view of a vial assembly including an engagement head, according to one or more embodiments shown and described herein.

Figure 4

[0012] A partial cross-sectional view of the vial assembly of FIG. 4 taken along line 4-4 of FIG. 3.

Figure 5

[0013] FIG. 1 is a perspective view of the vial slider of FIG. 3 with a series of delivery conduits coupled to the vial slider and received therein, according to one or more embodiments shown and described in the present invention.

Figure 6

[0014] FIG. 4 is a partial cross-sectional side view of an adapter component for attachment to the delivery device of FIG. 1 via a series of delivery conduits of FIG. 5, according to one or more embodiments shown and described in the present invention.

Figure 7

[0015] FIG. 8 is a side view of a confinement bag unit configured to connect to the adapter component of FIG. 6, according to one or more embodiments shown and described in the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0010]

[0016] Reference will now be made in detail to various embodiments of a delivery device for administering a radioactive compound to a patient, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts. As used herein, directional terms such as above, below, right, left, front, rear, top, bottom, distal, and proximal are used only in relation to the figures as depicted and are not intended to imply absolute orientation.

[0011]

[0017] Ranges may be expressed herein as from “about” one particular value and / or to “about” another particular value. When such a range is expressed, another embodiment includes from one particular value and / or to another particular value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it should be understood that the particular value forms another embodiment. It should further be understood that each endpoint of a range is significant both in relation to the other endpoint and independently of the other endpoint.

[0012]

[0018] Unless otherwise expressly stated, no method recited in this specification is intended to be construed as requiring that its steps be performed in a specific order or that any device-specific orientation be required. Accordingly, where a method claim does not actually recite the order to be applied to its steps, or where any device claim does not actually recite an order or orientation with respect to individual components, or where the steps are not specifically recited in the claims or the description as being limited to a specific order, or where a specific order or orientation with respect to the components of a device is not recited, no order or orientation is intended to be inferred in any way. This applies to any possible ambiguous criteria for interpretation, including logical matters, grammatical mechanisms or punctuation, derived from the arrangement of steps, flow of operations, order of components, or orientation of components, the plain meaning derived from the number or type of embodiments described in this specification.

[0013]

[0019] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The technical terms used in the descriptions herein are for the purpose of describing particular embodiments only and are not intended to be limiting. As used in this specification and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0014]

[0020] As used herein, the terms “horizontal,” “vertical,” “distal,” and “proximal” are merely relative terms and merely indicate an overall relative orientation and do not necessarily indicate perpendicularity. These terms may also be used for convenience in referring to the orientation used in the figures, such orientation being used merely by convention and not being intended as a characteristic of the device shown. The present disclosure and its embodiments to be described herein may be used in any desired orientation. Further, horizontal and vertical walls generally merely need to be intersecting walls and do not need to be at right angles. As used herein, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components unless the context clearly dictates otherwise.

[0015]

[0021] In embodiments described herein, the particulate material delivery assembly may include a radioembolization delivery device. The radioembolization delivery device comprises a medical device configured to deliver a radioactive compound to a treatment area within a patient's body in a procedure such as transarterial radioembolization. The radioactive compound may be a mixed solution of saline and radioactive microspheres (i.e., microparticles) mixed within a vial of the vial assembly. The needle may include one or more ports as an outlet for injecting a fluid (i.e., saline) into the vial containing the radioactive microspheres to produce the mixed solution, such as from a syringe or catheter line, and as an inlet for delivering the mixed solution to the patient.

[0016]

[0022] The following FIGS. 1-5 are directed to embodiments of a delivery device 500 for delivering microparticles, and the following FIGS. 6-7, described in more detail below, are directed to embodiments of one or more components of the delivery device 500 as described herein that assist in shielding from radiation emitted from the microparticles. In some embodiments, as described in more detail below, the delivery device 500 is a radioembolization delivery device, the microparticles are a plurality of radioembolization beads, the fluid is a saline aqueous solution, and the resulting mixed fluid (e.g., mixed fluid solution) is a radioembolization bead-saline aqueous solution. The needle 559 can be configured to deliver the radioembolization bead-saline aqueous solution as a mixed fluid solution through the radioembolization delivery device, such as during actuation of the vial engagement mechanism 520 in the positive pressure direction. In some embodiments, the fluid is a contrast agent-saline aqueous solution containing a contrast agent, and the resulting mixed fluid (e.g., mixed fluid solution) is a radioembolization bead-contrast agent-saline aqueous solution. The needle 559 can be configured to deliver the radioembolization bead-contrast agent-saline aqueous solution as a mixed fluid solution through the radioembolization delivery device. In some embodiments, the delivery device 500 is a chemoembolization delivery device, the microparticles 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 Portion Assembly

[0023] FIGS. 1-10 illustrate embodiments of a delivery device 500 configured and operable to deliver radioactive material (e.g., radioembolization beads) while reducing radiation emission during use of the delivery device 500. The delivery device 500 can operate as described in International PCT Application No. PCT / 2019 / 033001, filed May 17, 2019, which is incorporated herein by reference in its entirety, except with respect to the radiation shielding components as described below with respect to FIGS. 6-7 and in one or more embodiments within this specification.

[0017]

[0024] Referring initially to FIG. 1, the delivery device 500 includes a console assembly 510 that includes a console. The delivery device 500 may include a sliding portion assembly 540 that is 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.

[0018]

[0025] The proximal end 514 of the base 512 further includes a mounting device 538 configured to securely hold an external device to the base 512 of the console assembly 510. The mounting device 538 is operable to facilitate the mounting of complementary devices to the console assembly 510 for use with the delivery device 500 during a procedure.

[0019]

[0026] Still referring to FIG. 1, the distal end 516 of the console assembly 510 defines a vial receiving region 518 sized and shaped to receive the console assembly 510 therein, as will be described in more detail herein. The console assembly 510 further includes a vial engagement mechanism 520 extending from the base 512 adjacent the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outwardly 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 region 518 of the console assembly 510 and is movably coupled to the handle 528. In particular, the handle 528 of the console assembly 510 is operable to move, and in particular, translate the vial engagement mechanism 520 within the vial receiving region 518 in response to actuation of the handle 528.

[0020]

[0027] 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 corresponding linear displacement of the vial engagement mechanism 520. In this example, the mechanical assembly is coupled to the handle 528 and the vial engagement mechanism 520 such that selective actuation of the handle 528 at the proximal end 514 causes simultaneous actuation of the vial engagement mechanism 520 at the distal end 516.

[0021]

[0028] In an embodiment, and referring to FIG. 2, the flow sensor of the delivery device 500 can be positioned in line with and configured to measure the amount of fluid (e.g., a suspension after therapeutic particles are effectively mixed with a fluid medium) passing through one or more of the tube sets of the delivery device 500, and in particular, the needle 559, manifolds 555A, 555B, and / or ports 556. Referring back to FIG. 1, the vial engagement mechanism 520 includes a pair of lever arms 522 extending outwardly from the neck 524 of the vial engagement mechanism 520, the neck 524 extending laterally outwardly from the base 512 of the console assembly 510. The neck 524 of the vial engagement mechanism 520 is disposed within 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 receiving region 518.

[0022]

[0029] A pair of lever arms 522 are movable simultaneously with the neck 524 of the vial engagement mechanism 520 in response to actuation of the handle 528 of the console assembly 510. Further, the pair of lever arms 522 are fixed relative to each other such that the space formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 are configured to firmly engage the vial assembly 580 therebetween and, in particular, within the space formed by the pair of lever arms 522. Thus, the vial engagement mechanism 520 is operable to firmly attach the vial assembly 580 to the console assembly 510 in the vial receiving region 518. The vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, but it should be understood that the vial engagement mechanism 520 can include various other structural configurations suitable for engaging the vial assembly 580.

[0023]

[0030] Still referring to FIG. 1, the console assembly 510 further includes a safety shield 526 that is secured to the distal end 516 of the base 512 along the vial receiving region 518. In particular, the safety shield 526 is a protective cover sized and shaped to surround the vial receiving region 518 of the console assembly 510 when secured to the console assembly 510. The safety shield 526 is selectively attachable to the distal end 516 of the base 512, and the safety shield 526 is formed of a material configured to suppress the emission of radiation from one or more radiation doses stored within the vial receiving region 518.

[0024]

[0031] The distal end 516 of the console assembly 510 further includes a sliding space 532 sized and shaped to receive the slider 540 therein. The sliding space 532 includes a pair of positioning portions 534 extending therein, and the positioning portions 534 are sized and shaped to fit corresponding positioning portions (e.g., positioning ribs 554) of the slider 540, thereby facilitating the coupling of the slider 540 and the base 512 of the console assembly 510 within the sliding space 532. As will be described in more detail herein, the sliding assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, media) therethrough. In particular, the sliding assembly 540 is configured to partially receive the vial assembly 580 therein for administering therapeutic particles from the delivery device 500 to the patient during the procedure.

[0025]

[0032] Still referring to FIG. 1, the slider 540 is configured to partially receive the vial assembly 580 therein for administering therapeutic particles (e.g., radioactive fluid medium) from the delivery device 500 to the patient. In particular, the slider 540 includes a proximal end 542 and a distal end 544, and a pair of side walls 546 extend therebetween. The proximal end 542 of the slider 540 includes a handle 552 that extends proximally therefrom. The handle 552 is configured to facilitate movement of the slider 540, particularly insertion of the slider 540 into the sliding space 532 of the console assembly 510. The proximal end 542 further includes one or more ports 556 for coupling one or more delivery conduits (i.e., tubes) to the slider 540. Since one or more delivery conduits are further coupled to one or more external devices at the ends of the line opposite the ports 556, the ports 556 effectively function to fluidly couple the slider 540 to one or more external devices via the delivery conduits connected thereto. The pair of side walls 546 of the slider 540 include at least one positioning rib 554 that extends laterally outward therefrom, and the positioning rib 554 is sized and shaped to mate with and fit into 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 slider 540 with the console assembly 510 when the distal end 544 is slidably received within the sliding space 532 of the base 512.

[0026]

[0033] The sliding body 540 further includes an upper surface 548 that extends from a proximal end 542 and a distal end 544 and is positioned between a pair of side walls 546. The upper surface 548 of the sliding body includes a recessed region 549 and a locking system 550. The recessed region 549 is sized and shaped to form a recess and / or cavity along the upper surface 548, and this recessed region 549 can receive and / or collect various materials therein, including leakage of various fluid media during the use of the delivery device 500, for example. The locking system 550 of the sliding body 540 forms an opening in the upper surface 548 that is sized and shaped to receive one or more devices, such as a priming assembly 560 and a vial assembly 580. In some embodiments, the sliding body 540 is pre-loaded with a priming assembly 560 disposed within the locking system 550. The priming assembly 560 includes a priming conduit 562 that extends outwardly from the locking system 550 of the sliding body 540. The priming assembly 560 serves to purge air from the delivery device 500 prior to utilizing the delivery device 500 in a procedure.

[0027]

[0034] Referring now to FIG. 2, the locking system 550 includes an annular array of protrusions 551 that extend outwardly therefrom, and the protrusions 551 extend laterally into an aperture formed by the locking system 550, particularly along the upper surface 548. The annularly arranged protrusions 551 are formed within the inner circumference of the locking system 550 and extend along at least two continuously arranged rows. The annular array of protrusions 551 included in the locking system 550 is configured to engage corresponding locking features 586 (see FIG. 3) of the vial assembly 580, thereby securely fastening the vial assembly 580 to the sliding body 540. It should be understood that the multiple rows of protrusions 551 of the locking system 550 serve to provide a double-locking system to ensure that the sliding assembly 540, and particularly the needle 559 of the sliding assembly 540, is securely maintained through the septum 592 (see FIG. 3) of the vial assembly 580 during the use of the delivery device 500 in a procedure.

[0028]

[0035] The sliding body 540 further includes a vial chamber 558 sized and shaped to receive therein a priming assembly 560 and a vial assembly 580, respectively. In other words, the vial chamber 558 is sized to receive both the priming assembly 560 and the vial assembly 580 separately from each other. The vial chamber 558 is enclosed within a protective chamber or shield 557 disposed around the vial chamber 558. The protective shield 557 is formed of a material configured to suppress, for example, radiation emission from the vial chamber 558 to the outside, such as metal. Additionally, the sliding body 540 includes a needle extending through the protective shield 557 and into the vial chamber 558 along the lower end of the vial chamber 558. The needle 559 is fixedly attached to the vial chamber 558 such that as a result, any device received through the aperture of the locking system 550 and into the vial chamber 558 will contact and interact with the needle 559 (e.g., the priming assembly 560, the vial assembly 580, and the like).

[0029]

[0036] Still referring to FIG. 2, the needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the sliding body 540. In particular, the manifolds 555A, 555B are positioned below the vial chamber 558 and the protective shield 557. The proximal manifold 555B is fluidly coupled to the needle 559, and the distal manifold 555A is fluidly coupled to one or more ports 556 of the sliding body 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A through a one-way check valve 553 disposed therebetween.

[0030]

[0037] Accordingly, the proximal manifold 555B is in fluid communication with one or more ports 556 via the distal manifold 555A, but the one or more ports 556 are not in fluid communication with the proximal manifold 555B due to the position of the one-way check valve 553 disposed between the manifolds 555A, 555B. Thus, the needle 559 is in fluid communication with one or more delivery conduits and / or devices coupled to the slider 540 at one or more ports 556 and via the manifolds 555A, 555B secured therebetween. The one or more ports 556 of the slider assembly 540 can be coupled to a bag (e.g., a saline bag), syringe, catheter, and / or the like via one or more delivery conduits coupled thereto. In other embodiments, the needle 559 can be a cannula, catheter, or similar mechanism through which fluid and / or solution is injected and received as described herein.

[0031]

[0038] Still referring to FIG. 2, the slider 540 includes a removable battery pack 570 coupled to the slider 540 along the distal end 544. The removable battery pack 570 includes a battery 572, electrical contacts 574, and a removable tab 576. The battery 572 of the delivery device 500 is isolated from one or more fluid channels and the radiation source due to the location of the battery 572 within the removable battery pack 570.

[0032]

[0039] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to contact and interact with corresponding electrical contacts 511 (see FIG. 1) of the console assembly 510 when the slider 540 is coupled to the base 512 in the sliding space 532. Accordingly, the removable battery pack 570 is operable to provide power to the delivery device 500, and particularly to the console assembly 510, when the slider 540 is coupled to the console assembly 510.

[0033]

[0040] In addition, as will be described in more detail herein, in some embodiments, the locking system 550 may include at least one planar wall relative to the other circular configurations of the locking system 550. In this case, the aperture formed by the locking system 550 through the upper surface 548 of the slider 540 is not of a circular shape as shown and described above, but of an irregular shape. In this case, the vial assembly 580 includes the locking system 550 and, in particular, a locking feature 586 having a shape and size corresponding to the at least one planar wall, such that the vial assembly 580 is received within the slider 540 only when the orientation of the vial assembly 580 corresponds to the orientation of the locking feature 586 and the locking system 550. In other words, the corresponding planar wall 586A (see FIG. 3) of the locking feature 586 must be aligned with the planar wall of the locking system 550 such that the vial assembly 580 can be received within the aperture formed by the locking system 550 of the slider 540.

[0034]

[0041] Referring now to FIG. 3, the vial assembly 580 of the delivery device 500 is depicted. The vial assembly 580 includes an engagement head 582, a plunger 584, a locking feature 586, and a vial body 589. In particular, the engagement head 582 of the vial assembly 580 is positioned at the end of the plunger 584 opposite the locking feature 586 and the vial body 589. The engagement head 582 includes a pair of arms 581 that extend laterally outwardly relative to the longitudinal length of the plunger 584 that extends downwardly therefrom. In this example, the engagement head 582 is formed integrally with the plunger 584, but it should be understood that in other embodiments, the engagement head 582 and the plunger 584 may be separate features that can be securely fixed to each other. In either case, the engagement head 582 and the plunger 584 are movable relative to the locking feature 586 and the vial body 589 such that the engagement head 582 and the plunger 584 can slideably translate through the locking feature 586 and the vial body 589. In particular, as will be described in more detail herein, the plunger 584 can translate in and out of the internal chamber 588 of the vial body 589 in response to the linear translational movement of the vial engagement mechanism 520 when the engagement head 582 is secured to the pair of lever arms 522.

[0035]

[0042] The plunger 584 includes a plurality of markings and / or graduations 583 positioned along the longitudinal length of the plunger 584. The plurality of graduations 583 indicate the relative extension of the engagement head 582 and the plunger 584 from the locking feature 586 and the vial body 589. As briefly described above, the engagement head 582 is configured to attach the vial assembly 580 to the vial engagement mechanism 520. In particular, the pair of arms 581 of the engagement head 582 are sized and shaped to engage with the pair of lever arms 522 of the vial engagement mechanism 520 when the vial assembly 580 is received within the slider 540 and the slider is inserted into the sliding space 532 of the console assembly 510. As will be described in more detail herein, the pair of lever arms 522 are received between the pair of arms 581 of the engagement head 582 and the plunger 584 in response to a predetermined translational force applied to the vial engagement mechanism 520. The engagement head 582 and the plunger 584 can be formed of a variety of materials including, but not limited to, metal, plastic, and / or the like.

[0036]

[0043] Still referring to FIG. 3, the vial assembly 580 further includes a safety tab 585 coupled to the plunger 584 relative to above the locking feature 586 and below the engagement head 582, such that the safety tab 585 is positioned along the longitudinal length of the plunger 584. The safety tab 585 can be formed of various materials such as, for example, plastic and is pre-assembled to the vial assembly 580 prior to use of the delivery device 500. The safety tab 585 is removably secured to the plunger 584 and inhibits translation of the plunger 584 relative to the vial body 589. In particular, the safety tab 585 abuts against the locking feature 586 in response to the application of a linear force to the plunger 584 to translate the plunger 584 relatively downward into the vial body 589. In this case, the safety tab 585 is configured to inhibit inadvertent movement of the plunger 584 and the corresponding inadvertent delivery of a fluid medium (e.g., therapeutic particles, radiation embolization beads) stored within the internal chamber 588 of the vial body 589. As described in more detail herein, the safety tab 585 is selectively removed from the plunger 584 in response to the coupling of the vial assembly 580 with the vial engagement mechanism 520 and, in particular, the engagement of the pair of lever arms 522 with the engagement head 582.

[0037]

[0044] Returning to FIG. 3 for reference, the locking feature 586 extends around the upper end of the vial body 589. In this example, the locking feature 586 of the vial assembly 580 includes a bushing (bearing cylinder) that defines a side edge 587 that extends laterally outward along the outer periphery of the locking feature 586. The side edge 587 of the locking feature 586 is sized and shaped to engage the annularly arranged protrusions 551 of the locking system 550 when the vial assembly 580 is received within the vial chamber 558 of the slider 540. As will be described in more detail herein, the locking feature 586, and in particular the side edge 587 of the locking feature 586, is configured to securely hold the vial assembly 580 to the locking system 550 and prevent removal of the vial body 589 from the vial chamber 558 of the slider 540 during use of the delivery device 500 in the procedure. In some embodiments, as briefly described above, the locking feature 586 includes at least one planar wall 586A such that the locking feature 586 has an irregular shape. The at least one planar wall 586A is configured to correspond to the planar wall 550A of the locking system 550 such that, as a result, alignment of the planar walls 550A and 586A requires the vial assembly 580 to be received through an aperture formed by the locking system 550.

[0038]

[0045] Still referring to FIG. 3, the vial body 589 extends relatively downward from the locking feature 586 and has a longitudinal length sized to receive at least a portion of the longitudinal length of the plunger 584 therein. By way of example only, the longitudinal length of the vial body 589 can be from about 8 millimeters to about 10 millimeters and, in this example, includes 9 millimeters, while the longitudinal length of the plunger 584 can be from about 9 millimeters to about 11 millimeters and, in this example, includes 10 millimeters. Thus, in some embodiments, the longitudinal length of the plunger 584 exceeds the longitudinal length of the vial body 589 such that, as a result of the translational movement of the plunger 584 into the internal chamber 588 of the vial body 589, the fluid medium stored therein is sent out of the vial body 589. As will be described in more detail herein, the translational movement of the plunger 584 through the internal chamber 588 of the vial body 589 enables the fluid medium stored within the vial body 589 to be administered out of the vial assembly 580. The vial body 589 can be formed of various materials including, for example, thermoplastic polymers, copolyesters, polycarbonates, biocompatible plastics, polysulfones, ceramics, metals, and / or the like.

[0039]

[0046] The vial body 589 of this example is formed of a material configured to suppress radiation emission from a fluid medium stored within the internal chamber 588 of the vial body 589. For example, the vial body 589 can be formed of a plastic such as polycarbonate and can have a width of approximately 9 millimeters (mm). The combination of the density and material composition of the vial body 589 enables suppression of beta radiation emission from electron particles stored within the internal chamber 588. In this example, the plastic chemical composition of the vial body 589, in combination with a wall thickness of 9 mm, provides a plurality of atoms disposed within the vial body 589, and such a plurality of atoms can address beta radiation that generates electrons and reduce the emission of the above radiation from the vial assembly 580. Accordingly, the vial assembly 580 enables an operator to handle radioactive substances stored 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 regions can be incorporated within the vial body 589 of the vial assembly 580 without departing from the scope of the present disclosure.

[0040]

[0047] Still referring to FIG. 3, the vial body 589 of the vial assembly 580 is sealed at the first end 598 by a locking feature 586. The vial assembly 580 further includes a cap 590 positioned at the opposite end of the vial body 589 opposite the locking feature 586, such that the cap 590 seals the second end of the vial body 589 of the vial assembly 580. Additionally, the vial assembly 580 includes a septum 592, the septum 592 being positioned adjacent to the cap 590 and in fluid communication with the end of the vial body 589 opposite the locking feature 586. The septum 592 forms a seal against the end of the vial body 589 and the cap 590 holds the septum 592 therein. The septum 592 can be formed of various materials including, for example, elastomers, silicones, bromobutyl elastomers, rubbers, urethanes, and / or the like. The septum 592 provides an airtight seal for the vial body 589 and is configured to inhibit the release of a fluid medium (e.g., radiation embolization beads) stored therein. As will be described in more detail herein, the septum 592 of the vial assembly 580 is configured to be pierced by the needle 559 of the slider 540 when the vial assembly 580 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the slider 540. In other embodiments, instead of the septum 592, alternative devices such as, for example, valve systems, needle injection ports, and / or the like can be used.

[0041]

[0048] Referring to FIG. 4, the vial assembly 580 further includes a stopper 594 fixedly coupled to the end of a plunger 584 opposite the engagement head 582. In this case, since the plunger 584 is coupled to and slidably translatable through an internal chamber 588 of the vial body 589, the stopper 594 is effectively disposed within the vial body 589. Thus, it should be understood that the stopper 594 is sized and shaped according to the size (e.g., diameter) of the internal chamber 588 of the vial body 589. The stopper 594 is fixed to the plunger 584, and the stopper 594 is slidably translatable through the vial body 589 in response to the translational movement of the plunger 584 through the vial body 589. The stopper 594 is defined by two or more ribs 593 extending laterally outwardly and one or more recesses 595 defined between at least two of the ribs 593.

[0042]

[0049] The stopper 594 is configured to form a liquid-tight seal against the internal chamber 588 of the vial body 589 and is formed of various polymers having a predetermined viscoelasticity. For example, in some embodiments, the stopper 594 is formed of elastomers, silicones, rubbers, urethanes, plastics, polyethylene, polypropylene, and / or the like. In this case, the stopper 594 is operable to prevent the fluid medium stored within the vial body 589 from diffusing (i.e., leaking) past the stopper 594 and out of the vial body 589. In particular, two or more ribs 593 of the stopper 594 abut against and form a seal along the internal chamber 588 of the vial body 589, thereby preventing the fluid medium from passing over the ribs 593. One or more depressions 595 formed between two or more ribs 593 of the stopper 594 are configured to receive, and more specifically capture, any fluid medium that may inadvertently diffuse (i.e., leak) past the ribs 593 of the stopper 594. Accordingly, the one or more depressions 595 serve as a safety mechanism for the vial assembly 580 to ensure that the fluid medium is maintained within the vial body 589 and not exposed beyond the vial assembly 580.

[0043]

[0050] Still referring to FIG. 4, two or more ribs 593 of the stopper 594 are additionally configured to press the fluid medium stored within the vial body 589 in one or more directions (e.g., towards the cap 590) within the vial body 589 in response to the translational movement of the plunger 584. With the ribs 593 of the stopper 594 pressed against the internal chamber 588 of the vial body 589, the translational movement of the plunger 584 results in a translational movement of the ribs 593 against and along the internal chamber 588 of the vial body 589, such that any fluid medium located in front of (i.e., below) the stopper 594 is effectively redirected within the vial body 589 in the direction of travel of the plunger 584 and the stopper 594. The vial assembly 580 further includes an annular washer 596 disposed within the vial body 589. In particular, the annular washer 596 is firmly fixed to the plunger 584 adjacent to the stopper 594, which is secured to the plunger 584 at the opposite end of the engagement head 582. Thus, the annular washer 596 is fixed to the plunger 584 and disposed within the vial body 589 adjacent to the stopper 594. Since the annular washer 596 is fixed to the plunger 584 adjacent to the stopper 594, the annular washer 596 is effectively disposed within the vial body 589.

[0044]

[0051] Referring now to FIG. 5, in response to determining that battery 572 contains a sufficient amount of power or that another power source provides the same, one or more delivery conduits are coupled to sliding assembly 540 via one or more ports 556. In particular, dosage delivery conduit 10A is coupled to slider 540 at delivery port 556A, contrast agent conduit 10B is coupled to slider 540 at contrast agent port 556B, and flushing conduit 10C is coupled to slider 540 at flushing port 556C. The opposite end of dosage delivery conduit 10A is initially coupled to a fluid reservoir, such as a collection bowl, for example. As will be described in more detail herein, once slider 540 is effectively primed by a fluid medium via contrast agent conduit 10B, dosage delivery conduit 10A can subsequently be coupled to an external device, such as a catheter. The opposite end of flushing conduit 10C is coupled to an external device, such as a syringe, for example. With both dosage delivery conduit 10A and flushing conduit 10C coupled to slider 540, slider 540 is flushed with a fluid medium (e.g., saline) from a syringe coupled to flushing conduit 10C. In this case, the fluid medium is injected through flushing conduit 10C into distal manifold 555A of slider 540 and exits slider 540 through dosage delivery conduit 10A. Thus, the fluid medium is ultimately received and disposed (or processed therein) by the collection bowl via dosage delivery conduit 10A.

[0045]

[0052] Since the distal manifold 555A of the sliding body 540 is separated from the proximal manifold 555B by a one-way valve 553 disposed therebetween, the fluid medium flushed from the syringe (through the flushing port 556C) through the distal manifold 555A is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. Rather, the fluid medium injected from the syringe through the flushing conduit 10C is received at the flushing port 556C, passed to the distal manifold 555A in fluid communication with the flushing port 556C, and redirected by the one-way valve 553 toward the dose delivery port 556A coupled to the dose delivery line 10A. In this case, the dose delivery line 10A receives the fluid medium and transports it to the collection bowl coupled thereto, and as a result, the fluid medium is not directed beyond the one-way valve 553 and into the proximal manifold 555B in fluid communication with the needle 559.

[0046]

[0053] The contrast agent conduit 10B is coupled to the slider 540 at the contrast agent port 556B. The opposite end of the contrast agent conduit 10B is coupled to a fluid medium supply, such as a bag that is secured to the console assembly 510 by, for example, a mounting device 538. In this example, the bag is a saline bag, and thus the fluid medium stored therein is saline. In this case, with the slider 540 including the priming assembly 560 positioned within the vial chamber 558 and the needle tip in fluid communication with the needle 559, the syringe is fluidly coupled to the priming conduit 562 of the priming assembly 560, and the plunger of the syringe is pulled back, thereby drawing saline from the saline bag into the syringe through the contrast agent conduit 10B, the contrast agent port 556B, the slider 540, and the priming conduit 562. The plunger of the syringe is then pushed inward to send the drawn saline in the opposite direction through the priming conduit 562, the central body portion, the elongate shaft, and the needle tip of the priming assembly 560, such that the saline is received into the needle 559 of the slider 540. Accordingly, the manifolds 555A, 555B of the slider 540 are effectively primed with saline from the syringe because the needle 559 that has received saline from the priming assembly 560 is in fluid communication with the manifolds 555A, 555B. Since the manifolds 555A, 555B are in further fluid communication with the dose delivery conduit 10A via the delivery port 556A, the saline is effectively supplied to the collection bowl coupled to the dose delivery conduit 10A.

[0047]

[0054] Referring now to FIG. 5, the slider 540 is coupled to one or more external devices via one or more ports 556. In particular, the slider 540 is fluidly coupled to a catheter (e.g., a microcatheter) via a dosage delivery conduit 10A coupled to the delivery port 556A of the slider 540. In this case, the catheter is in fluid communication with the slider 540 via the dosage delivery conduit 10A. Further, the slider 540 may be fluidly coupled to a contrast agent source, such as a saline bag, that is secured to the console assembly 510 via, for example, a mounting device 538 (see FIG. 1). The slider 540 is in fluid communication with the saline bag via a contrast agent conduit 10B coupled to the contrast agent port 556B of the slider 540. In this case, the saline bag is in fluid communication with the slider 540 via the contrast agent conduit 10B secured to the contrast agent port 556B.

[0048]

[0055] The contrast agent port 556B is in fluid communication with the proximal manifold 555B, while the delivery port 556A is in fluid communication with the distal manifold 555A. As will be described in more detail herein, since the contrast agent port 556B is coupled to the proximal manifold 555B rather than the distal manifold 555A that is separated from the proximal manifold 555B by a one-way check valve 553 disposed therebetween, saline from the saline bag can be drawn through the needle 559 of the slider 540 and into the vial body 589 of the vial assembly 580.

[0049]

[0056] Referring again to FIGS. 1 and 3, with the vial assembly 580 firmly coupled to the slider 540, the slider 540 is coupled to the console assembly 510 by translating the proximal end 542 of the slider 540 toward and into the distal end 516 of the console assembly 510. In particular, the proximal end 542 of the slider 540 is directed into the sliding space 532 of the console assembly 510 by aligning the positioning rib 554 of the slider 540 with the positioning portion 534 of the console assembly 510. Once the distal end 544 and the proximal end 542 of the slider 540 are fully enclosed within the sliding space 532 of the console assembly 510, the electrical contacts 574 (FIG. 2) of the removable battery pack 570 interact with the corresponding electrical contacts 511 (FIG. 1) of the console assembly 510. In this case, power from the battery 572 is transmitted to the console assembly 510 via the electrical contacts 574, thereby activating the console assembly 510 of the delivery device 500. In this case, the interface display 530 of the console assembly 510 is activated to display appropriate real-time information regarding the delivery device 500 during the procedure.

[0050]

[0057] Referring again to FIG. 5, when the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial receiving region 518, a negative pressure is generated within the internal chamber 588 of the vial body 589 due to the retraction of the stopper 594. In this case, with the saline bag coupled to the slider 540 via the contrast agent conduit 10B and the contrast agent port 556B, the saline from the saline bag is drawn into the internal chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Thus, if the vial body 589 is pre-filled with a radioactive fluid medium (e.g., radioactive microspheres for embolization), the saline is effectively mixed with the radioactive fluid medium within the vial body 589 when the plunger 584 is retracted from the internal chamber 588 and a negative pressure is generated through the delivery device 500.

[0051]

[0058] The sliding body 540 further includes a one-way check valve 553A along the contrast agent conduit 10B and the flushing conduit 10C. In particular, the one-way check valve 553A is configured to allow fluid communication from the contrast agent port 556B and the flushing port 556C into the manifolds 555A, 555B, and is further configured to prevent fluid communication from the manifolds 555A, 555B to the contrast agent port 556B and the flushing port 556C. Therefore, it should be understood that directing the dose delivered from the vial body 589 to the manifolds 555A, 555B into the contrast agent conduit 10B or the flushing conduit 10C is impossible because of the one-way check valve 553A positioned therein. Thus, the dose is directed to the dose delivery port 556A and received in a catheter fluidly coupled by the dose delivery conduit 10A. In other words, the one-way check valve 553A prevents backflow of fluid into the sliding body 540 and / or the vial assembly 580 coupled thereto. II. Radiation Containment Embodiments

[0059] As briefly described above, the delivery device 500 described herein may include an adapter component 600, and its embodiments and components are described in more detail below with respect to FIGS. 6-7. FIG. 6 depicts an adapter component 600 for attachment to the delivery device 500 of FIG. 1 via the delivery conduit of the delivery device 500. As a non-limiting example, the delivery conduit may be the dose delivery conduit 10A of FIG. 5. FIG. 7 depicts accessory components of the adapter component 600 as containment bag units 700, 700A. The containment bag units 700, 700A are configured to connect to the adapter component 600 of FIG. 6.

[0052]

[0060] The adapter component 600 is used with a particulate material delivery assembly, such as a delivery device 500 for delivering a mixed particulate solution to a patient. The adapter component 600 can include a connector port 602, a catheter connector port 604, and a guidewire connector port 606. In an embodiment, the adapter component 600 can include at least a pair of device connector ports 602A, 602B. One or more of the device connector ports 602, 602A, 602B can include a one-way valve, a needleless injection site, or other suitable components configured to prevent backflow. In an embodiment, the needleless injection site can be equipped with a luer-actuated valve component. The luer-actuated valve component can be, for example, a male luer lock connector. In such an aspect, the needleless injection site includes a luer-actuated valve opened by the shaft of the male luer, and once the shaft of the male luer is attached to the female luer lock, it allows fluid to flow through the opened valve. Each device connector port 602 can be configured to connect to a corresponding delivery line connector of a particulate delivery device, such as the dose delivery line 10A of the delivery device 500, to receive the mixed particulate solution. Each device connector port 602 of the adapter component 600 can include either a female luer connection or a male luer connection, and one of the female luer connection or the male luer connection is configured to connect to the male luer connection or the female luer connection of the corresponding delivery line connector of the particulate delivery device 500, which is the opposite of the female luer connection or the male luer connection of the other.

[0053]

[0061] The guide wire connector port 606 can be configured to connect to the confinement bag units 700, 700A. The confinement bag units 700, 700A can include a guide wire 702 (FIG. 7) disposed within the confinement bags 704, 704A as shown in FIGS. 6 - 7. The guide wire connector port 606 can include a hemostatic valve configured to connect to the confinement bag units 700, 700A. The hemostatic valve can be attached to a permanently or semi - permanently adhered capture bag as the confinement bags 704, 704A to capture the guide wire 702 while reducing the potential for radiation contamination when capturing and / or re - using the guide wire 702.

[0054]

[0062] The catheter connector port 604 can be configured to connect to a micro - catheter for delivering a mixed particulate solution to a patient via the dose delivery conduit 10A. The catheter connector port 604 includes one of a male Luer connector or a female Luer connector, and one of the male Luer connector or the female Luer connector is configured to connect to the opposite one of the female Luer connector or the male Luer connector of the micro - catheter.

[0055]

[0063] The guide wire 702 can be configured to retract into and extend from within the confinement bag units 700, 700A to position the micro - catheter within the patient without disconnecting from the delivery conduit connector (e.g., the dose delivery conduit 10A) of the particulate delivery device 500 of at least one of the pair of device connector ports 602A, 602B. In an embodiment, the guide wire 702 can be configured to retract into and extend from within the confinement bag units 700, 700A through the hemostatic valve of the guide wire connector port 606 and through the catheter connector port 604 to position the micro - catheter.

[0056]

[0064] Referring to FIG. 7, the confinement bag units 700, 700A may include a curled configuration in a naturally biased form. The confinement bag units 700, 700A may include a hoop shape that is another pre-formed biased shape, or may not be manufactured to include such a pre-formed shape.

[0057]

[0065] Referring again to FIG. 6, the adapter component 600 may further include one or more caps. One of the one or more caps may be configured to be disposed over the device connector port 602 when the device connector port 602 of the pair of device connector ports 602A, 602B is not connected to the delivery line connector of the particulate delivery device 500 (e.g., the dose delivery line 10A). When multiple dose vials are used in a procedure to deliver particulate material to a patient as described herein, the adapter component 600 may be used to connect the separate delivery lines 10A of the delivery device 500 to different connector ports 602 of the adapter component 600, respectively.

[0058]

[0066] The guide wire connector port 606 may be aligned with the catheter connector port 604 along the longitudinal axis. Each device connector port 600 may be angled with respect to the longitudinal axis. In an embodiment, the longitudinal axis may be disposed between the top portion and the bottom portion of the adapter component 600. One of the pair of device connector ports 602A, 602B, the device connector port 602A, may be angled in a first direction away from the longitudinal axis along the top portion. The other device connector port 602B of the pair of device connector ports 602A, 602B may be angled in a second direction away from the longitudinal axis along the bottom portion. The second direction may be a mirror angle of the first direction with respect to the longitudinal axis.

[0059]

[0067] In an embodiment, the adapter component 600 includes at least a pair of device connector ports 602A, 602B, a catheter connector port 604 configured to connect to a microcatheter for delivering a mixed particulate solution to a patient, and a guidewire connector port 606 configured to connect to a confinement bag unit 700, 700A in which a guidewire 702 is disposed. The guidewire connector port 606 includes a hemostatic valve configured to connect to the confinement bag unit 700, 700A.

[0060]

[0068] Each of the device connector ports 602A, 602B may be configured to connect to a corresponding delivery line connector (e.g., a corresponding dose delivery line 10A) of the particulate delivery device 500 for receiving a mixed particulate solution. Each of the device connector ports 602A, 602B may include a female Luer connection configured to connect to a male Luer connection of a corresponding delivery line connector of the particulate delivery device 500.

[0061]

[0069] The guidewire 702 is configured to retract into and extend from the confinement bag units 700, 700A through the hemostatic valve and through the catheter connector port 604 to position the microcatheter within the patient without disconnecting at least one of the pair of device connector ports 602A, 602B from a delivery line connector such as the dose delivery line 10A of the particulate delivery device 500.

[0062]

[0070] A method of using an adapter component 600 for a particulate material delivery assembly, such as a delivery device 500 as described herein for delivering a mixed particulate solution to a patient, may include attaching at least one connector port 602 of a pair of device connector ports 602A, 602B to a corresponding delivery line connector, such as a dose delivery line 10A of the particulate delivery device 500, to receive the mixed particulate solution. The method may further include attaching a guide wire connector port 606 of the adapter component 600 to a confinement bag unit 700, 700A that includes a guide wire 702 disposed therein. Additionally, the method may include attaching a catheter connector port 604 of the adapter component 600 to a microcatheter to deliver the mixed particulate solution to the patient through the attached dose delivery line 10A of the delivery device 500.

[0063]

[0071] During a procedure for delivering particulates from a delivery device 500 to a patient through a microcatheter positioned within the patient, the microcatheter may first be positioned within the patient through the use of a guide wire 702. The guide wire 702 is then removed prior to any fluid injection or radioembolization therapy, such as the delivery of particulates. Once a radioactive delivery line, such as a dose delivery line 10A, is directly connected to the microcatheter, the user typically does not disconnect it due to the risk of contamination. To treat multiple sites, the user removes the entire microcatheter (attached to the dose delivery line 10A) and regains access with a new catheter (attached to a new dose delivery line 10A), which increases the procedure cost and time.

[0064]

[0072] The adapter component 600 described herein enables such detachment of the microcatheter from the dose delivery conduit 10A of the delivery device 500 with a reduced risk of contamination even after the radioactive dose of the microparticles has been injected through the dose delivery conduit 10A and through the microcatheter into the patient, and / or enables repositioning of the microcatheter within the patient with or without such detachment. Thus, the adapter component 600 can ensure sterility and reduce biohazard during one or more guidewire exchange operations with respect to catheter placement during the procedure.

[0065]

[0073] In fact, the adapter component 600 enables reinsertion of the used guidewire 702 into the microcatheter, as well as repositioning of the microcatheter and / or tracking to a new treatment site. Once the microcatheter is in place, a user, such as a physician, can move the guidewire 702 into a containment bag unit 700, 700A, which can be, for example, a plastic sleeve. Such a sleeve is closed at the distal end and open at the proximal end to allow positioning of the guidewire 702 through the catheter connector port 604 and may be adhered to the guidewire 702 to allow easy movement and manipulation of the guidewire 702. Then, if the user intends to reuse the guidewire 702, the user can leave the guidewire 702 housed within a containment bag 704, 704A connected to a hemostatic valve (also referred to as a hemostatic valve), or the user can disconnect the containment bag 704, 704A from the hemostatic valve and seal the containment bag 704, 704A with its self-adhesive distal end. The user can then connect a new dose delivery conduit 10A to another connector port 602 on the adapter component 600 to enable delivery of a new dose to the new treatment site. III. List of Aspects

[0074] Aspect 1. The adapter component for a particulate material delivery assembly for delivering a mixed particulate solution to a patient may include at least a pair of device connector ports, each device connector port being configured to connect to a corresponding delivery line connector of a particulate delivery device for receiving the mixed particulate solution. The adapter component is a guide wire connector port configured to connect to a confinement bag unit, the confinement bag unit including a guide wire disposed therein, and may further include a catheter connector port configured to connect to a microcatheter for delivering the mixed particulate solution to the patient. The guide wire may be configured to retract into and extend from the confinement bag unit to position the microcatheter within the patient without disconnecting at least one of the pair of device connector ports from the delivery line connector of the particulate delivery device.

[0066]

[0075] Aspect 2. The adapter component of Aspect 1, further comprising a cap configured to be disposed over the device connector port when one of the pair of device connector ports is not connected to the delivery line connector of the particulate delivery device.

[0067]

[0076] Aspect 3. Each device connector port comprises one of a female Luer connection or a male Luer connection, and one of the female Luer connection or the male Luer connection is configured to connect to the male Luer connection or the female Luer connection of the corresponding delivery line connector of the particulate delivery device, which is the opposite of one of the female Luer connection or the male Luer connection, the adapter component of Aspect 1 or Aspect 2.

[0068]

[0077] Aspect 4. The catheter connector port includes one of a male Luer connector or a female Luer connector, and one of the male Luer connector or the female Luer connector is configured to connect to one of the female Luer connector or the male Luer connector of the micro catheter, which is opposite to the other of the male Luer connector or the female Luer connector. The adapter component of any one of Aspects 1 to 3.

[0069]

[0078] Aspect 5. The guide wire connector port includes a hemostatic valve configured to connect to the confinement bag unit. The adapter component of any one of Aspects 1 to 4.

[0079] Aspect 6. The guide wire is configured to retract into and extend from the confinement bag unit through the hemostatic valve and through the catheter connector port to position the micro catheter. The adapter component of Aspect 5.

[0070]

[0080] Aspect 7. The confinement bag unit has a rounded configuration in a naturally deflected form. The adapter component of any one of Aspects 1 to 6.

[0081] Aspect 8. The guide wire connector port is aligned with the catheter connector port along the longitudinal axis. The adapter component of any one of Aspects 1 to 7.

[0071]

[0082] Aspect 9. Each device connector port is angled with respect to the longitudinal axis. The adapter component of Aspect 8.

[0083] Aspect 10. The longitudinal axis is disposed between an upper portion and a lower portion. One of the pair of device connector ports is angled in a first direction away from the longitudinal axis along the upper portion, and the other of the pair of device connector ports is angled in a second direction away from the longitudinal axis along the lower portion. The adapter component of any one of Aspects 1 to 9.

[0072]

[0084] Aspect 11. The adapter component of Aspect 10, wherein the second direction is the reflection angle of the first direction with respect to the longitudinal axis.

[0085] Aspect 12. The adapter component for a particulate material delivery assembly for delivering a mixed particulate solution to a patient may include at least a pair of device connector ports, each device connector port being configured to connect to a corresponding delivery conduit connector of a particulate delivery device for receiving the mixed particulate solution, and each device connector port comprising a female Luer connector configured to connect to a male Luer connection of the corresponding delivery conduit connector of the particulate delivery device. The adapter component may further include a guide wire connector port configured to connect to a confinement bag unit, the confinement bag unit including a guide wire disposed therein, and the guide wire connector port comprising a hemostatic valve configured to connect to the confinement bag unit. The adapter component may further include a catheter connector port configured to connect to a microcatheter for delivering the mixed particulate solution to the patient. The guide wire may be configured to retract into and extend from the confinement bag unit through the hemostatic valve and through the catheter connector port to position the microcatheter within the patient without disconnecting at least one of the pair of device connector ports from the delivery conduit connector of the particulate delivery device.

[0073]

[0086] Aspect 13. The adapter component of Aspect 12, further comprising a cap configured to be disposed over the device connector port when one of the pair of device connector ports is not connected to the delivery conduit connector of the particulate delivery device.

[0074]

[0087] Aspect 14. The catheter connector port includes one of a male Luer connector or a female Luer connector, and one of the male Luer connector or the female Luer connector is configured to connect to one of the female Luer connector or the male Luer connector of the micro catheter, which is the opposite of one of the male Luer connector or the female Luer connector, and is an adapter component of any of Aspect 12 or Aspect 13.

[0075]

[0088] Aspect 15. The confinement bag unit has a rounded configuration in a naturally deflected form and is an adapter component of any of Aspect 12 to Aspect 14.

[0089] Aspect 16. The guide wire connector port is aligned with the catheter connector port along the longitudinal axis and is an adapter component of any of Aspect 12 to Aspect 15.

[0076]

[0090] Aspect 17. Each device connector port is angled with respect to the longitudinal axis and is an adapter component of Aspect 16.

[0091] Aspect 18. The longitudinal axis is disposed between an upper portion and a lower portion. One of the pair of device connector ports is angled in a first direction away from the longitudinal axis along the upper portion, and the other of the pair of device connector ports is angled in a second direction away from the longitudinal axis along the lower portion. It is an adapter component of Aspect 17.

[0077]

[0092] Aspect 19. The second direction is the reflection angle of the first direction with respect to the longitudinal axis and is an adapter component of Aspect 18.

[0093] Aspect 20. A method of using an adapter component for a particulate material delivery assembly for delivering a mixed particulate solution to a patient may include attaching at least one of a pair of device connector ports to a corresponding delivery conduit connector of a particulate delivery device to receive the mixed particulate solution; attaching a guide wire connector port to a confinement bag unit, the confinement bag unit including a guide wire disposed therein; and attaching a catheter connector port to a microcatheter to deliver the mixed particulate solution to the patient. The method may further include, without disconnecting at least one of the pair of device connector ports from the delivery conduit connector of the particulate delivery device, moving the guide wire relative to the confinement bag unit in one of a step of retracting and a step of extending the guide wire to position the microcatheter within the patient.

[0078]

[0094] Note that the terms "substantially" and "about" may be used herein to represent the essential degree of uncertainty that may arise from any quantitative comparison, value, measurement, or other representation. These terms are also used herein to represent the degree to which a quantitative expression may vary from the stated reference without resulting in a change in the basic function of the subject matter in question.

[0079]

[0095] Note that for the purposes of explaining and defining the present disclosure, the term "substantially" is used herein to represent the essential degree of uncertainty that may arise from any quantitative comparison, value, measurement, or other representation. The term "substantially" is also used herein to represent the degree to which a quantitative expression may vary from the stated reference without resulting in a change in the basic function of the subject matter in question. As such, it is used herein to represent the essential degree of uncertainty that may arise from any quantitative comparison, value, measurement, or other representation with respect to the arrangement of elements or features that may embody something that, while expected to present a theoretically exact match or behavior, actually falls slightly short of being exactly so.

[0080]

[0096] Although specific embodiments are illustrated and described herein, it should be understood that various other changes and modifications can be made without departing from the spirit and scope of the claimed subject matter. Further, while various aspects of the claimed subject matter are described herein, such aspects need not be utilized in combination. Accordingly, the appended claims are intended to cover all such changes and modifications that fall within the scope of the claimed subject matter.

Claims

An adapter component for a particulate material delivery assembly for delivering a mixed particulate solution of radioactive microparticles to a patient, the adapter component comprising: At least a pair of device connector ports, each device connector port being configured to connect to a corresponding delivery conduit connector of a particulate delivery device for receiving the mixed particulate solution; A guide wire connector port configured to connect to a self-sealing containment bag unit, the containment bag unit including a guide wire disposed therein; A catheter connector port configured to connect to a microcatheter for delivering the mixed particulate solution to the patient and configured to reposition the microcatheter after delivery of the mixed particulate solution; The guide wire is configured to retract into and extend from the containment bag unit to position the microcatheter within the patient without disconnecting at least one of the pair of device connector ports from the delivery conduit connector of the particulate delivery device, and the guide wire is reusable by the adapter component. An adapter component.

2. The adapter component according to claim 1, further comprising a cap configured to be disposed on one of the pair of device connector ports when the one device connector port of the pair of device connector ports is not connected to the delivery conduit connector of the particulate delivery device. An adapter component.

3. The adapter component according to claim 1, wherein each device connector port comprises one of a female Luer connection or a male Luer connection, and one of the female Luer connection or the male Luer connection is configured to connect to the male Luer connection or the female Luer connection of the corresponding delivery conduit connector of the particulate delivery device, which is opposite to one of the female Luer connection or the male Luer connection. An adapter component.

4. The adapter component according to claim 1, wherein the catheter connector port comprises one of a male Luer connector or a female Luer connector, and one of the male Luer connector or the female Luer connector is configured to connect to the opposite one of the female Luer connector or the male Luer connector of the microcatheter.

5. The adapter component according to claim 1, wherein the guide wire connector port comprises a hemostatic valve configured to connect to the confinement bag unit.

6. The adapter component according to claim 5, wherein the guide wire is configured to retract into and extend from the confinement bag unit through the hemostatic valve and through the catheter connector port to position the microcatheter.

7. The adapter component according to claim 1, wherein the confinement bag unit has a rounded configuration in a naturally deflected form.

8. The adapter component according to claim 1, wherein the guide wire connector port is aligned with the catheter connector port along a longitudinal axis.

9. The adapter component according to claim 8, wherein each device connector port is angled with respect to the longitudinal axis.

10. The adapter component according to claim 8, wherein the longitudinal axis is disposed between an upper portion and a lower portion, and one of the pair of device connector ports is angled in a first direction away from the longitudinal axis along the upper portion, and the other of the pair of device connector ports is angled in a second direction away from the longitudinal axis along the lower portion.

11. The adapter component according to claim 10, wherein the second direction is a reflection angle of the first direction with respect to the longitudinal axis.

12. An adapter component for a particulate material delivery assembly for delivering a mixed particulate solution of radioactive microparticles to a patient, the adapter component comprising At least a pair of device connector ports, each device connector port being configured to connect to a corresponding delivery line connector of a particulate delivery device for receiving the mixed particulate solution, each device connector port comprising a female Luer connection portion configured to connect to a male Luer connection portion of the corresponding delivery line connector of the particulate delivery device, the at least a pair of device connector ports, A guide wire connector port configured to connect to a self-sealing confinement bag unit, the confinement bag unit including a guide wire disposed therein, the guide wire connector port comprising a hemostatic valve configured to connect to the confinement bag unit, the guide wire connector port, A catheter connector port configured to connect to a microcatheter for delivering the mixed particulate solution to the patient and configured to reposition the microcatheter after delivery of the mixed particulate solution, and, The guide wire is configured to retract into and extend from the confinement bag unit through the hemostatic valve and through the catheter connector port to position the microcatheter within the patient without disconnecting at least one of the pair of device connector ports from the delivery line connector of the particulate delivery device, the guide wire being reusable by the adapter component, the adapter component.

13. The adapter component according to claim 12, further comprising a cap configured to be disposed on one of the pair of device connector ports when the one device connector port of the pair of device connector ports is not connected to the delivery line connector of the particulate delivery device, the adapter component.

14. The adapter component according to claim 12, wherein the catheter connector port comprises one of a male Luer connection portion or a female Luer connection portion, and one of the male Luer connection portion or the female Luer connection portion is configured to connect to the opposite of the male Luer connection portion or the female Luer connection portion of the female Luer connection portion or the male Luer connection portion of the microcatheter, the adapter component.

15. The adapter component according to claim 12, wherein the confinement bag unit has a rounded configuration in a naturally deflected form.

16. The adapter component according to claim 12, wherein the guide wire connector port is aligned with the catheter connector port along a longitudinal axis.

17. The adapter component according to claim 16, wherein each device connector port is angled with respect to the longitudinal axis.

18. The adapter component according to claim 17, wherein the longitudinal axis is disposed between an upper portion and a lower portion, and one of the pair of device connector ports is angled in a first direction away from the longitudinal axis along the upper portion, and the other of the pair of device connector ports is angled in a second direction away from the longitudinal axis along the lower portion.

19. The adapter component according to claim 18, wherein the second direction is a reflection angle of the first direction with respect to the longitudinal axis.

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