Radioembolization delivery device

Abstract

To provide a simplified radioembolization device.SOLUTION: A delivery assembly includes a console including a vial containment region 518, and a vial engagement mechanism 520 extending from the console within the vial containment region. The engagement mechanism is configured to engage a vial assembly. The delivery assembly further includes a sled 540 removably coupled to the console at the vial containment region, and a safety shield removably coupled to the console over the vial containment region such that the vial engagement mechanism and the sled are encapsulated within the safety shield when the safety shield is coupled to the console. The sled, the vial assembly, and the safety shield are configured to inhibit radioactive emissions from within the vial containment region.SELECTED DRAWING: Figure 13

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] This application claims the benefit of priority of U.S. Provisional Application No. 62 / 673,632, entitled "Radioembolization Delivery Device," filed on May 18, 2018, and U.S. Provisional Application No. 62 / 673,628, entitled "Dual Stage Syringe," filed on May 18, 2018, the disclosures of which are incorporated herein by reference.

[0002]

[0002] The present invention generally relates to medical devices for treating cancer, and more particularly to medical devices configured and operable to deliver a radioactive compound to a treatment area within a patient's body in procedures such as transarterial radioembolization.

Background Art

[0003]

[0003] In cancer treatment involving radiation therapy, inadvertent or excessive exposure to radiation from radioactive therapeutic agents can be harmful and potentially fatal to patients or medical personnel. 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 the patient's body.

[0004]

[0004] Transarterial radioembolization is a transcatheter intra - arterial procedure performed under imaging, and is generally used for the treatment of malignant tumors. During this medical procedure, a microcatheter is navigated into the patient's liver, where radiation - embolization microspheres filled with a radioactive compound such as yttrium - 90 ( 90 Y) are delivered to the target tumor. These microspheres occlude the blood vessels supplying the tumor while delivering radiation to kill tumor cells.

[0005]

[0005] Generally, medical devices for performing radioembolization procedures include multiple syringes, external tubing, vials containing radioactive compounds, and radioactive vials, and also require a large shielding assembly for shielding them. Such devices typically involve time-consuming and labor-intensive setup procedures. Complex devices are generally stationary, and thus limit the mobility of the physician in the operating room to a location somewhat close to the device.

[0006]

[0006] During radioembolization procedures, the routine handling of the product container storing the radioactive substance generally requires a nuclear medicine technician to handle the substance with forceps or tweezers. This process further involves the possibility of exposing additional medical personnel to radiation and contaminating the operating room. Syringes for manually administering radioactive compounds are prone to inconsistent flow rates and pressures. Insufficient injection rates result in a reduction in bead dispersion, which can affect the effectiveness of the treatment.

Summary of the Invention

Problems to be Solved by the Invention

[0007]

[0007] Accordingly, there is a need for a medical device configured and operable to perform radioembolization incorporating a very simple design and consistent means for administering a radioactive compound at a constant flow rate and pressure to a patient's body. The simplified device provides the physician with improved operability in the operating room during the medical procedure, including the ability to reposition the device around the patient as desired. Additionally, a device with improved shielding of the radioactive substance enables greater protection for the physician using the medical device while treating the patient.

Brief Description of the Drawings

[0008]

Figure 1

Figure 2

[0009] Cross-sectional view taken along line 2-2 of FIG. 1 of the delivery device of FIG. 1, with a handle assembly coupled to the protective shield by a plunger, according to one or more embodiments shown and described herein.

Figure 3

[0010] Perspective view of the delivery device of FIG. 1, connected to a syringe and a microcatheter, according to one or more embodiments shown and described herein.

Figure 4A

[0011] Partial cross-sectional view taken along line 4A-4A of FIG. 2 of the handle assembly of FIG. 1 in its initial position, according to one or more embodiments shown and described herein.

Figure 4B

[0012] Partial cross-sectional view taken along line 4B-4B of FIG. 2 of the handle assembly of FIG. 1 in its actuated position, according to one or more embodiments shown and described herein.

Figure 5

[0013] Perspective view of a hand-held delivery device, according to one or more embodiments shown and described herein.

Figure 6

[0014] Partially exploded perspective view of the hand-held delivery device of FIG. 5, including a syringe assembly, according to one or more embodiments shown and described herein.

Figure 7

[0015] Cross-sectional view of the hand-held delivery device of FIG. 5, according to one or more embodiments shown and described herein.

Figure 8

[0016] Perspective view of a flushing syringe to be coupled to the hand-held delivery device of FIG. 5, according to one or more embodiments shown and described herein.

Figure 9

[0017] A perspective view of another handheld delivery device in accordance with one or more embodiments shown and described herein.

Figure 10

[0018] A cross-sectional view taken along line 10-10 of FIG. 9 of the handheld delivery device of FIG. 9 with a plurality of manually and electrically actuated syringes received therein.

Figure 11

[0019] A perspective view of another handheld delivery device in accordance with one or more embodiments shown and described herein.

Figure 12

[0020] A cross-sectional view taken along line 12-12 of FIG. 11 of the handheld delivery device of FIG. 11 with a plurality of electrically actuated syringes received therein.

Figure 13

[0021] A perspective view of a delivery device including a protective shield and a vial slider in accordance with one or more embodiments shown and described herein.

Figure 14

[0022] A partial perspective view of the delivery device of FIG. 13 including a mechanical assembly in accordance with one or more embodiments shown and described herein.

Figure 15

[0023] A cross-sectional view taken along line 15-15 of FIG. 13 of the vial slider of FIG. 13 in accordance with one or more embodiments shown and described herein.

Figure 16

[0024] A perspective view of the vial slider of FIG. 13 with the battery pack removed in accordance with one or more embodiments shown and described herein.

Figure 17

[0025] A perspective view of the priming assembly of the vial slider of FIG. 13 in accordance with one or more embodiments shown and described herein.

Figure 18

[0026] A perspective view of a vial assembly including an engagement head in accordance with one or more embodiments shown and described herein.

Figure 19A

[0027] A perspective view of an alternative engagement head of the vial assembly of FIG. 18, according to one or more embodiments shown and described herein.

Figure 19B

[0028] A perspective view of an alternative engagement head of the vial assembly of FIG. 18, according to one or more embodiments shown and described herein.

Figure 19C

[0029] A perspective view of an alternative engagement head of the vial assembly of FIG. 18, according to one or more embodiments shown and described herein.

Figure 20

[0030] A partial cross-sectional view of the vial assembly of FIG. 18, taken along line 20-20 of FIG. 18.

Figure 21

[0031] A perspective view of a sterile container assembly, according to one or more embodiments shown and described herein.

Figure 22

[0032] A cross-sectional view of the sterile container assembly of FIG. 21, taken along line 22-22 of FIG. 21, with the vial assembly of FIG. 18 housed therein, according to one or more embodiments shown and described herein.

Figure 23

[0033] A perspective view of the delivery device of FIG. 13, with the protective shield removed and the lever arm of the delivery device actuated, according to one or more embodiments shown and described herein.

Figure 24

[0034] A perspective view of the vial sliding portion of FIG. 13, with the priming assembly of FIG. 17 removed, according to one or more embodiments shown and described herein.

Figure 25

[0035] A perspective view of the vial sliding portion of FIG. 13, with the vial assembly of FIG. 18 inserted therein, according to one or more embodiments shown and described herein.

Figure 26A

[0036] A partial cross-sectional view taken along line 26-26 of FIG. 25 of the vial assembly of FIG. 18 inserted into the vial sliding portion of FIG. 13 in the initial locking position.

Figure 26B

[0037] A partial cross-sectional view taken along line 26-26 of FIG. 25 of the vial assembly of FIG. 18 inserted into the vial sliding portion of FIG. 13 in the fully locked position.

Figure 27

[0038] A partial perspective view of the vial sliding portion coupled to the delivery device of FIG. 13 with the lever arm coupled to the vial assembly of FIG. 18 according to one or more embodiments shown and described herein.

Figure 28A

[0039] A schematic view of the display interface of the delivery device of FIG. 13 according to one or more embodiments shown and described herein.

Figure 28B

[0040] Another schematic view of the display interface of the delivery device of FIG. 13 according to one or more embodiments shown and described herein.

Figure 29

[0041] A perspective view of the vial sliding portion coupled to the delivery device of FIG. 13 with the lever arm coupled to the vial assembly of FIG. 18 and translated to the extended position according to one or more embodiments shown and described herein.

Figure 30

[0042] A perspective view of the vial sliding portion of FIG. 13 in which the vial assembly of FIG. 18 is received with a series of delivery conduits coupled to the vial sliding portion according to one or more embodiments shown and described herein.

Figure 31

[0043] A perspective view of the vial sliding portion coupled to the delivery device of FIG. 13 with the lever arm coupled to the vial assembly of FIG. 18 and translated to the lower position according to one or more embodiments shown and described herein.

Figure 32

[0044] A perspective view of the delivery device of FIG. 13 with the protective shield and the vial slider removed, according to one or more embodiments shown and described herein.

Figure 33

[0045] A flowchart of an exemplary method of delivering a radiation dose using the delivery device of FIG. 13.

Figure 34

[0046] A perspective view of an alternative plunger for use with the vial assembly of FIG. 18, according to one or more embodiments shown and described herein.

Figure 35

[0047] A cross-sectional view of an alternative plunger for use with the vial assembly of FIG. 18, according to one or more embodiments shown and described herein.

Figure 36A

[0048] A cross-sectional view of the plunger of FIG. 35 in a partially extended position relative to the vial assembly of FIG. 18, according to one or more embodiments shown and described herein.

Figure 36B

[0049] A cross-sectional view of the plunger of FIG. 35 in a fully extended position relative to the vial assembly of FIG. 18, according to one or more embodiments shown and described herein.

Figure 37

[0050] A perspective view of an alternative plunger for use with the vial assembly of FIG. 18, according to one or more embodiments shown and described herein.

Figure 38A

[0051] A perspective view of the plunger of FIG. 37 in a first orientation, according to one or more embodiments shown and described herein.

Figure 38B

[0052] A perspective view of the plunger of FIG. 37 in a second orientation, according to one or more embodiments shown and described herein.

Figure 39A

[0053] A cross-sectional view of an alternative vial assembly in a first configuration, according to one or more embodiments shown and described herein.

Figure 39B

[0054] A cross-sectional view of the vial assembly of FIG. 39A in a second configuration, according to one or more embodiments shown and described herein.

DETAILED DESCRIPTION OF THE INVENTION

[0009]

[0055] Various embodiments of a delivery device for administering a radioactive compound to a patient will now be described in detail, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts. Directional terms such as up, down, right, left, front, back, top, bottom, distal, and proximal as used herein are used only in relation to the figures as depicted and are not intended to imply absolute orientation.

[0010]

[0056] 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 preceding “about”, it is to be understood that the particular value forms another embodiment. It is further to be understood that each endpoint of a range is significant both in relation to the other endpoint and independently of the other endpoint.

[0011]

[0057] Unless expressly stated otherwise, it is not intended in any way that any method set forth herein be construed as requiring that its steps be performed in a particular order or that any specific orientation of any apparatus is required. Thus, if a method claim does not actually recite an order in which its steps are to be applied, or if any apparatus claim does not actually recite an order or orientation for individual components, or if the claim or description does not otherwise specifically state that the steps are to be limited to a particular order, or if no particular order or orientation for the apparatus components is recited, no order or orientation is intended to be inferred in any way. This applies to all potentially indefinite criteria for interpretation, including logical considerations regarding the placement of steps, operational flow, component order, or component orientation, obvious meaning derived from grammatical mechanisms or punctuation, and the number or type of embodiments described herein.

[0012]

[0058] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in this specification and the appended claims, the singular forms "a," "an," and "the" may be used interchangeably unless the context clearly indicates otherwise. Number forms are intended to be included as well.

[0013]

[0059] 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 within the figures, such orientation being used merely by convention and not intended as a characteristic of the device shown. The invention and its embodiments to be described herein may be used in any desired orientation. Further, horizontal and vertical walls generally need merely be intersecting walls and need not be at right angles. As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a" component includes aspects having two or more such components unless the context clearly dictates otherwise. I. Mechanical Delivery Device

[0060] Referring now to FIGS. 1-4, one embodiment of a delivery device 100 is depicted, which is configured and operative to deliver radioactive material (e.g., radiation embolization beads) while reducing radiation emission during use of the delivery device 100. Referring particularly to FIG. 1, the delivery device 100 includes a base (substrate) 102, a main housing 110, and a handle assembly 120. The base 102 includes a pair of handles 104 configured to facilitate selective positioning of the delivery device 100 during a medical procedure. The base 102 is formed of a radiation shielding material, whereby any radioactive fluid medium stored within the delivery device 100 is efficiently shielded from any object positioned relatively below the base 102, thereby minimizing exposure of the radioactive material contained within the delivery device 100. By way of example only, the radiation shielding material of the base 102 can be formed of any combination of plastic, metal, and / or the like. By way of illustrative example only, the base 102 can be formed of acrylonitrile butadiene styrene (ABS), tungsten, barium, lead, tin, and various other suitable materials configured to suppress radiation emission. The base 102 further includes an elongate member 106 configured to provide a mechanical connection point for holding a replenisher or mixed fluid. By way of example, the elongate member 106 is configured to hold a storage-type device such as a bag and / or syringe filled with one or more fluid media (e.g., saline, contrast agent, etc.).

[0014]

[0061] The base 102 of the delivery device 100 has a square and / or rectangular shape and is shown and described herein as defining a planar surface, but in other embodiments, the base 102 can include a variety of other shapes, sizes, and / or profiles. Additionally, in some embodiments, the base 102 can be completely omitted from the delivery device 100 without departing from the scope of the present disclosure. The main housing 110 is integral with the base 102 and is configured such that the main housing 110 is firmly fixed to the base 102. Similar to the base 102, the main housing 110 can be formed of a radiation shielding material configured and operable to suppress radiation emission therethrough. As will be described in more detail below, the main housing 110 is sized and shaped to house radiation plug beads and / or particles within a central chamber (reservoir) 112 of the main housing 110. In some examples, the main housing 110 can be formed of a transparent material, and the transparent material is operable to provide a magnifying function for improved visualization of the radiation plug beads contained therein. The material of the main housing 110 can also be a shield against radiation such as beta particles, X-rays, gamma particles, and / or the like. By way of example only, the main housing 110 can be formed of polycarbonate. In some embodiments, the main housing 110 can include an observation window, and such an observation window is formed of a transparent material to facilitate visualization of the contents disposed within the main housing 110. The transparent material is further configured and operable to suppress radiation emission therethrough. It can be further formed of a radiation shielding material.

[0015]

[0062] The handle assembly 120 is configured to provide a mechanical system for delivering radioactive embolization beads from the delivery device 100 to a patient. In particular, the handle assembly 120 provides a greater range of movement of the syringe handle proportional to the amount of radioactive material to be delivered to the patient, thereby providing the operator with a more accurate detection of the dose (or dosage) of radioactive material being delivered from the delivery device 100. The configuration and length of the handle assembly 120 provide an additional distance between the operator's hand and the radioactive material contained within the main housing 110, thereby reducing the radiation exposure to the operator of the delivery device 100.

[0016]

[0063] The handle assembly 120 includes a vertical column 122 integral with the base 102. The vertical column 122 extends vertically from the base 102 such that the vertical column 122 is oriented perpendicular to the base 102. The handle assembly 120 further includes an elongate lever 124 having a proximal end 125 and a distal end 126. The elongate lever 124 is pivotally coupled to the vertical column 122 at the distal end 126 such that the proximal end 125 of the elongate lever 124 is configured to pivot relative to the base 102 about the distal end 126 as a fulcrum. The elongate lever 124 includes a plunger 128 that extends from an intermediate connection portion 130 of the elongate lever 124 positioned between the proximal end 125 and the distal end 126 toward the base 102. The plunger 128 is configured to translate relative to the base 102 when the elongate lever 124 pivots about the distal end 126 as a fulcrum. As will be described in more detail below, the plunger 128 is slidably received within the central chamber 112 of the main housing 110 such that the plunger 128 is configured to access the radioactive material contained within the central chamber 112.

[0017]

[0064] The handle assembly 120 further includes a handle (actuator) 132 that is pivotally coupled to the elongated lever 124 at the proximal end 125. The handle 132 is sized and shaped to be selectively operable about the proximal end 125 of the elongated lever 124 as a fulcrum. In this case, the movement of the handle 132 relative to the proximal end 125 is operable to simultaneously pivot the handle 132 about the elongated lever 124 as a fulcrum and pivot the elongated lever 124 about the distal end 126 as a fulcrum. Thus, the plunger 128 is configured to translate relative to the main housing 110 and the base 102 in response to pivoting of the elongated lever 124 about the distal end 126 as a fulcrum. Thus, actuation of the handle 132 is operable to translate the plunger 128 into the main housing 110. Although not shown, the plunger 128 can include a plurality of markings (or graduations) along the longitudinal length of the plunger 128 and is adapted to provide visual feedback of the displacement of the plunger 128 relative to the main housing 110. Additionally or alternatively, in some embodiments, the delivery device 100 can include a sensor (e.g., a linear encoder) that detects or measures the linear movement of the plunger 128 into the central chamber 112. In some embodiments, the delivery device 100 includes a locking mechanism that engages the plunger 128 and is configured to releasably fix the plunger 128 in position relative to the main housing 110.

[0018]

[0065] In some embodiments, the handle assembly 120 is automatically moved by a stepper or motor (not shown) so that flow rate, volume, or other process parameters can be easily reproduced. Since the handle assembly 120 is automatically moved, the operator can operate the delivery device 100 hands-free, thereby further reducing the potential for radiation exposure and human error.

[0019]

[0066] Still referring to FIG. 1, the elongated lever 124 is attached to the handle 132 a marker 134 and an interface display 136 mounted on an elongated lever 124 adjacent to the distal end 126. The marker 134 and the interface display 136 are cooperatively configured to generate visual feedback to the operator indicating real-time information regarding the flow rate administered by the delivery device 100. In the embodiment of FIG. 1, the interface display 136 includes a series of indicators configured to correlate the deflection of the handle 132 to either an amount of force or a range of the delivery flow rate of the radioactive material. As is apparent from viewing FIG. 2, with the handle 132 oriented parallel to the elongated lever 124, the interface display 136 extends towards the lower portion of the marker 134, and as a result, the interface display 136 is positioned adjacent to the portion of the interface display 136 representing the acceptable degree of deflection of the handle 132 and thus the acceptable flow rate. In other embodiments, the interface display 136 may comprise a scale, a ruler, a digital display, a remote smart device, a tablet, and / or the like.

[0020]

[0067] In contrast, referring back to FIG. 1, when the handle 132 is oriented transversely with respect to the elongated lever 124, the interface display 136 extends towards the upper portion of the marker 134, and as a result, the interface display 136 can be positioned adjacent to the portion of the interface display 136 that represents an excessive degree of deflection of the handle 132, i.e., an unacceptable flow rate. Merely by way of illustrative example, a series of indicators on the interface display 136 can include markings such as a plurality of colors (e.g., green, yellow, orange, red, etc.), a plurality of numbers (e.g., 1 to 5), or other measurable markings that would be apparent to those skilled in the art. Alternatively, in other embodiments, the delivery device 100 includes, instead of or in addition to the marker 134 and the interface display 136, an accelerometer or a displacement sensor, and the accelerometer or the displacement sensor is configured to correlate the deflection of the handle 132 to either an amount of force or a range of delivery flow rates of the radioactive material.

[0021]

[0068] In the delivery device 100 of FIG. 2, the main housing 110 includes a central chamber 112 sized and shaped to slidably receive a plunger 128 therein. As briefly described above, the plunger 128 is configured to translate through the central chamber 112 of the main housing 110 in response to actuation (i.e., pivoting) of a handle 132 about a distal end 126 of an elongate lever 124. The plunger 128 includes a needle 129 disposed therein. The needle 129 is configured to translate slidably within the central chamber 112 as the plunger 128 translates relative to the main housing 110. As further seen in FIG. 2, the main housing 110 includes a vial compartment 114 at a lower end of the central chamber 112. The vial compartment 114 is sized and shaped to store therapeutic particles (e.g., radioactive embolization beads, radioactive seeds, microspheres, etc.) therein. The vial compartment 114 is isolated from the remainder of the central chamber 112 by a protective seal 116 disposed between the vial compartment 114 and the remainder of the central chamber 112. Thus, the therapeutic particles disposed within the vial compartment 114 are not in fluid communication with the remainder of the main housing 110. This is because the protective seal 116 is configured to create a protective barrier between the central chamber 112 and the vial compartment 114.

[0022]

[0069] Although not shown, it should be understood that the base 102 may further include a quick release mechanism positioned below the main housing 110. In particular, the quick release mechanism may be sized and shaped to remove the vial compartment 114 from within the central chamber 112 of the main housing 110.

[0023]

[0070] The needle 129 in response to the translational movement of the plunger 128 through the central chamber 112 , it is configured to pierce the protective seal 116. In this case, access to the therapeutic particles within the vial compartment 114 becomes possible when the handle 132 of the elongate lever 124 pivots about the distal end 126 to a position corresponding to the displacement between the needle 129 and the protective seal 116. Additionally, although not shown, the plunger 128 can also include a sterile barrier mechanism proximate to the needle 129, and it should be understood that the sterile barrier mechanism is configured to sterilize the contact area between the needle 129 and the protective seal 116. In this case, the sterile barrier mechanism is operable to minimize the potential contamination of the protective seal 116 when the needle 129 contacts the protective seal 116 for accessing the therapeutic particles within the vial compartment 114.

[0024]

[0071] By way of example only, the sterile barrier mechanism can comprise a removable Tyvek® disk. Since the sterile barrier mechanism is positioned proximate to the protective seal 116, there is no need to wipe the needle 129 with alcohol before it advances into the vial compartment 114. The needle 129 includes a plurality of side holes (not shown) along the longitudinal length of the needle 129. The side holes (not shown) are configured to generate a turbulent flow within the vial compartment 114 when the needle 129 extends into the vial compartment 114, thereby mixing the therapeutic particles contained therein. The side holes of the needle 129 provide access to the central lumen 127 of the needle 129 that extends along the longitudinal length of the needle 129. As described in more detail herein, the central lumen 127 of the needle 129 is configured to receive a fluid medium (e.g., saline) from a fluid reservoir fluidly coupled thereto, and as a result, in response to a positive pressure being generated within the main housing 110, when the needle 129 translates downwardly into the central chamber 112 of the main housing 110, the fluid medium is transported into the vial compartment 114 through the plurality of side holes.

[0025]

[0072] Although not shown, the vial compartment 114, the plunger 128, and / or the needle 129 may include a plurality of outwardly projecting flaps, outwardly projecting ribs, or other outwardly projecting features, and it should be understood that such flaps or the like are configured to further promote the mixing of the radiation embolization beads and the fluid medium when the needle 129 and the plunger 128 are advanced into the vial compartment 114. Additionally or alternatively, the delivery device 100 may further include a stir bar (not shown), and such a stir bar is operable to improve the mixing of the radiation embolization beads and the fluid medium within the vial compartment 114.

[0026]

[0073] In some embodiments, the delivery device 100 may include a plurality of abutments (not shown) within the central chamber 112 of the main housing 110. The plurality of abutments may extend into the central chamber 112 and may be configured to releasably engage the plunger 128 as the plunger 128 is translated through the central chamber 112, thereby creating a plurality of stopping points. In this case, the plurality of abutments temporarily inhibit the advancement of the plunger 128 into the main housing 110, thereby providing tactile feedback to the operator for managing dose control. The tactile feedback experienced at the plurality of stopping points indicates to the operator the displacement of the plunger 128 relative to the main housing 110, thereby informing the operator of the sphere concentration, flow rate, and / or the torque or pressure that will be delivered by the delivery device 100. In other examples, the delivery device 100 includes a stir bar (not shown) within the vial compartment 114 and / or the central chamber 112 and is adapted to facilitate the mixing of the radiation embolization beads and the fluid medium received therein.

[0027]

[0074] Still referring to FIG. 2, the elongated lever 124 includes a torque coupling member 138 within the elongated lever 124 and the handle 132, and the torque coupling member 138 is configured to extend between the elongated lever 124 and the handle 132. In other words, the torque coupling member 138 is configured to couple the proximal end 125 of the elongated lever 124 to the handle 132 In this example, the torque coupling member 138 is an elastically biased spring, and as is apparent in FIG. 2, such a spring is configured to bias the handle 132 into an orientation substantially parallel to the longitudinal length of the elongated lever 124. In this case, by releasing the handle 132, the handle 132 is returned to its initial position in an orientation parallel to the elongated lever 124, and as a result, the torque coupling member 138 is operable to temporarily stop the plunger 128 in the retracted position relative to the central chamber 112 and withdraw the needle 129 from contact with the protective seal 116. As will be described in more detail below, the torque coupling member 138 is configured to resist lateral movement of the handle 132 toward the base 102 and is such that a predetermined force is required to operate the handle 132

[0028]

[0075] The torque coupling member 138 provides volumetric flow rate, or alternatively volumetric velocity control during delivery of the radioactive material from the delivery device 100 to the patient. In particular, the torque coupling member 138 correlates the deflection of the handle 132 to the flow rate generated by the delivery device 100. In other aspects, it should be understood that, as seen in FIG. 1, the torque coupling member 138 can be configured to bias the handle 132 into an orientation substantially transverse to the longitudinal length of the elongated lever 124. In this case, by releasing the handle 132, the handle 132 is returned to its initial position in an orientation transverse to the elongated lever 124, and as a result, the torque coupling member 138 is operable to advance the plunger 128 to the extended position relative to the central chamber 112 with the needle 129 piercing the protective seal 116

[0029]

[0076] The operation of the delivery device 100 will be described hereinafter with reference to FIG. 3. In particular, the operator selectively positions the delivery device 100 adjacent to the patient in the operating room by operating the base 102 via the handle 104. With the delivery device 100 positioned in the desired location, the operator couples the contrast agent syringe 150, and optionally the catheter 160, to the delivery device 100 via the first connector valve 108. In particular, the first connector valve 108 is a three-way check valve (also known as a T-valve connector), and the contrast agent line 152 is connected to the contrast agent syringe 150 at one end and to the first connector valve 108 at the opposite end. In this example, the contrast agent syringe 150 contains the contrast medium stored therein, although the contrast agent syringe 150 may contain various other fluid media as may be apparent to those skilled in the art. The contrast agent syringe 150 further comprises a plurality of markings 154 along the body of the contrast agent syringe 150, thereby indicating to the operator the current volume of the contrast medium stored therein. Although not shown, it should be understood that the contrast agent syringe 150 may be coupled to a syringe pump or an automatic injector configured to automate the operation of the contrast agent syringe 150. In this case, the delivery of the contrast medium stored in the contrast agent syringe 150 can be performed with a high degree of reliability and a consistent flow rate.

[0030]

[0077] Catheter 160 is similarly coupled to the first connector valve 108 such that the contrast agent syringe 150 is in fluid communication with the catheter 160. In this case, the delivery device 100 is coupled to the first connector valve 108 by a delivery conduit (also referred to as a transport conduit) 107, and the delivery conduit 107 is connected to the first connector valve 108 at one end and to a second connector valve 109 at the opposite end. In this example, the catheter 160 is a microcatheter, and the microcatheter is sized and shaped to establish fluid communication between the target treatment site and the delivery device 100 via a vein. Similar to the first connector valve 108, the second connector valve 109 is a three-way check valve (also known as a T-valve connector), and the delivery conduit 107 from the first connector valve 108 is coupled to the second connector valve 109 at the first end, and the fluid reservoir line 105 is adapted to be attached to the second connector valve 109 at the other end.

[0031]

[0078] The fluid reservoir line 105 is coupled to a bag configured to store a fluid medium therein or alternatively to a fluid reservoir (not shown) that may comprise a chamber. In this example, the fluid reservoir contains saline or a contrast medium therein. By way of example only, the fluid reservoir is configured to store an intravenous sugar solution such as dextrose solution (D5W). It should be understood that the delivery conduit 107 and the connector valves 108, 109 are sized and shaped to include a smooth diameter transition or interface at their intersection, thereby minimizing dead volume and the potential for sphere settlement within the tubing.

[0032]

[0079] The needle 129 is similarly coupled to the second connector valve 109 via another delivery line 107 (see FIG. 3), such that the needle 129 of the delivery device 100 establishes fluid communication with the contrast agent syringe 150, the catheter 160, and the fluid reservoir line 105. The central lumen 127 of the needle 129 can be coupled to the delivery line 107, such that the needle 129 is in fluid communication with the second connector valve 109. In this case, the fluid reservoir line 105 communicates with the central lumen 127 of the needle 129 via the second connector valve 109, such that the central lumen 127 is operable to receive a fluid medium from a fluid reservoir (not shown) attached to the fluid reservoir line 105.

[0033]

[0080] As described in more detail below, the downward advancement of the needle 129 through the central chamber 112 of the main housing 110 generates a negative pressure through the central lumen 127 due to the downward translation of the needle 129. In this case, the delivery line 107 that is fluidly coupled to the central lumen 127, providing fluid communication between the central lumen 127 and the fluid reservoir line 105 via the second connector valve 109 therebetween, similarly generates a negative pressure within the delivery line 107 and the second connector valve 109. The fluid medium stored within a fluid reservoir (not shown) coupled to the fluid reservoir line 105 is drawn from the fluid reservoir through the fluid reservoir line 105 as a result of the negative pressure generated by the needle 129 and transported to the fluid reservoir by the lines 105, 107, and the second connector valve 109 that is fluidly coupled therebetween. Thus, the fluid medium is transported into the central lumen 127 via the second connector valve 109 and the delivery line 107. It should be understood that the delivery line 107 extending from the second connector valve 109 extends through the upper end of the plunger 128 and into the upper end of the central lumen 127 of the needle 129. With the needle 129 slidably received within the central chamber 112 of the main housing 110 and the delivery line 105 fluidly coupled to the central lumen 127 of the needle 129, the delivery line 105 is effectively in fluid communication with the central chamber 112 of the main housing 110.

[0034]

[0081] In an exemplary treatment technique for discharging radioactive embolization beads, the operator can apply a downward force to the handle 132 with respect to the base 102, thereby pivoting the handle 132 about the proximal end 125 and pivoting the elongated lever 124 about the distal end 126 to activate the delivery device 100. As briefly described above, the torque coupling member 138 is elastically biased to suppress the downward movement of the handle 132 toward the base 102, and as a result, the handle 132 is biased toward a parallel configuration with the elongated lever 124, as best seen in FIG. 4A. In this case, the operator can apply a predetermined force to the handle 132 to overcome the elastic biasing of the torque coupling member 138, as seen in FIG. 4B, thereby activating the elongated lever 124. Applying a constant force to the handle 132 can overcome the elastic biasing of the torque coupling member 138, thereby translating the plunger 128 slidably downward through the central chamber 112 of the main housing 110.

[0035]

[0082] The needle 129 has already been punctured through the protective seal 116 and is in fluid communication with the radioactive embolization beads contained in the vial compartment 114. As a result, the downward translational movement of the plunger 128 advances the needle 129 toward the bottom surface of the vial compartment 114. As briefly described above, the needle 129 is advanced upward with respect to the vial compartment 114 before the fluid medium is drawn into the central lumen 127, and thereby generating a negative pressure within the vial compartment 114 by the actuation of the handle 132. In this case, when the needle 129 translates upward with respect to the bottom surface of the vial compartment 114, the fluid medium is effectively dispersed from the fluid reservoir and into the central lumen 127 of the needle 129. The bottom surface of the vial compartment 114 effectively serves as a refill start point for the delivery device 100.

[0036]

[0083] A plurality of side holes along the needle 129 are adapted to mix the fluid medium received within the central lumen 127 into the therapeutic particles (e.g., radioembolization beads) stored within the vial compartment 114. By applying a downward force, here the vial compartment 114 is in fluid communication with the central lumen 127 of the needle 129, so that as the needle 129 translates relatively downward through the central chamber 112, in response to the generation of a negative pressure within the vial compartment 114, the fluid medium is effectively discharged from the central lumen 127 of the needle 129 and into the vial compartment 114. The radioembolization bead concentration per delivery cycle can be defined according to the selected refill volume. In this case, the plunger 128 is lowered with the needle 129 into the vial compartment 114 through the central chamber 112. Thereby, a mixture of therapeutic particles (e.g., radioembolization beads) and a fluid medium, collectively referred to as a suspension fluid or liquid, is injected through the central lumen 127 and toward the first connector valve 108 via the interconnecting system of the second connector valve 109 and the delivery conduit 107.

[0037]

[0084] When the needle 129 is fully advanced into the vial compartment 114 (i.e., the refill starting point), the handle 132 is ready to refill the delivery device 100. The handle 132 is lifted relative to the base 102 and remains in its initial orientation, in which the handle 132 is substantially parallel to the longitudinal length of the elongated lever 124 due to a stop (not shown) present in the pivoting region between the handle 132 and the elongated lever 124. In this case, the function of the torque coupling member 138 is disabled. Alternatively, the handle 132 can simply be released so that the downward force applied to the handle 132 is removed. In this case, due to the elastic biasing of the torque coupling member 138, the handle 132 returns to its initial orientation in which the handle 132 is substantially parallel to the longitudinal length of the elongated lever 124. In this case, the plunger 128 is drawn through the central chamber 112, thereby pulling the needle 129 out of the vial compartment 114. The drawing in of the plunger 128 and the needle 129 creates a negative pressure within the vial compartment 114, as a result of which a mixture of radioactive embolization beads and the fluid medium is withdrawn towards the first connector valve 108 through the central lumen 127 and via the interconnecting system of the second connector valve 109 and the delivery conduit 107.

[0038]

[0085] While the mixed medium is being transported towards the first connector valve 108, the operator actuates the contrast agent syringe 150, thereby transporting the contrast medium towards the first connector valve 108 through the contrast agent line 152, so that the various media can be mixed together at the first connector valve 108 prior to delivery to the catheter 160. The operator can repeatedly actuate the handle 132 in order to continue filling and flushing the catheter 160 with a mixture of radioactive embolization beads, fluid medium, and / or contrast medium by means of the pressurizing means described above. II. Manual Hand-Held Delivery Device

[0086] Figures 5-7 illustrate another embodiment of a delivery device 200 configured and operative to deliver a radioactive material (e.g., radioactive embolization beads) while reducing radiation emission during use of the delivery device 200. Referring specifically to FIG. 5, the delivery device 200 includes a housing 202 extending between a proximal end 204 and a distal end 206. The housing 202 includes a pair of chambers 202A, 202B disposed therein, specifically, at least one chamber 202A defining a lumen 220A (see FIG. 6) sized and shaped to receive a device therein, and at least one chamber 202B defining another lumen 220B (see FIG. 7) for storing a fluidic substance (e.g., saline). In some embodiments, chamber 202B may be formed of a translucent material such that the fluidic substance stored within lumen 220B is visible from outside the delivery device 200. In other embodiments, lumen 220B of the second chamber 202B is sized and shaped to receive a device such as, for example, an external fluid reservoir. Specifically, lumen 220A of chamber 202A is sized and shaped to receive a vial assembly 250 within the delivery device 200. Lumen 220A of chamber 202A includes one or more retention mechanisms configured to selectively lock the vial assembly 250 to the delivery device 200, and it should be understood that the vial assembly 250 is to be securely held within lumen 220A during use of the delivery device 200. Actuation of the retention mechanism allows for selective removal of the vial assembly 250 from lumen 220A of chamber 202A such that the vial assembly 250 can be discarded separately from the delivery device 200 after use of the delivery device 200.

[0039]

[0087]

[0040]

[0088] In this example, the holding mechanism of the delivery device 200 includes an aperture 209, which is positioned along the housing 202 and, in particular, is disposed through the chamber 202A. The aperture 209 of the delivery device 200 is sized and shaped to receive the corresponding holding mechanism of the vial assembly 250. In particular, the corresponding holding mechanism of the vial assembly 250 includes a pushable button 258 such that when the vial assembly 250 is slidably received through the lumen 220A of the chamber 202A, the aperture 209 is adapted to receive the pushable button 258. As will be described in more detail herein, the pushable button 258 is configured to elastically expand outwardly from the vial assembly 250 in response to alignment of the pushable button 258 with the aperture 209 when the vial assembly 250 is translated through the chamber 202A. In other embodiments, the holding mechanism of the lumen 220A is configured to permanently affix the vial assembly 250 to the delivery device 200 such that the vial assembly 250 cannot be removed later from the lumen 220A of the chamber 202A. In this case, the delivery device 200 is disposable together with the vial assembly 250.

[0041]

[0089] Still referring to FIG. 5, with the vial assembly 250 fully positioned within the lumen 220A of the chamber 202A, the handle 252 of the vial assembly 250 extends proximally from the housing 202 at the proximal end 204 such that the vial assembly 250 is not fully contained within the lumen 220A of the chamber 202A. In this case, the handle 252 of the vial assembly 250 is accessible to the operator of the delivery device 200 when the vial assembly 250 is fully assembled within the delivery device 200. As will be described in more detail below, with the handle 252 of the vial assembly 250 extending outwardly from the proximal end 204 of the delivery device 200 and being accessible thereat, the vial assembly 250 can be actuated by the operator while remaining firmly received within the lumen 220A of the chamber 202A. The housing 202 further includes a distal head 208 that is integrally formed with the pair of chambers 202A, 202B of the housing 202. The distal head 208 includes a tapered profile relative to the elongate profiles of the pair of chambers 202A, 202B. In particular, the distal head 208 tapers distally to the catheter hub 210 of the delivery device 200 toward the distal end 206 of the delivery device 200. Alternatively, in other embodiments, the catheter hub 210 may include tubes and / or standard connectors configured to couple the delivery device 200 to various devices.

[0042]

[0090] The catheter hub 210 is configured to couple the delivery device 200 to a device, such as a catheter (not shown), for example, thereby facilitating fluid communication between the delivery device 200 and the device. For example, the catheter hub 210 may comprise a luer fitting that is selectively engageable with a corresponding luer fitting of the device (e.g., a catheter), thereby coupling the delivery device 200 to the device at the catheter hub 210. The lumens 220A, 220B of the chambers 202A, 202B of the delivery device 200 may include a variety of other sizes and shapes other than those shown and described herein for receiving additional devices (e.g., vial assembly 250) and / or fluid media without departing from the scope of the present disclosure.

[0043]

[0091] Still referring to FIG. 5, the housing 202 is further sized and shaped to receive the operability of the delivery device 200 and is adapted to be gripped by an operator. Additionally and / or alternatively, the housing 202 of the delivery device 200 may be sized and shaped to receive a corresponding dock and / or retention fixture. The housing 202 of the delivery device 200 may be overmolded with various materials, such as, for example, silicone, thermoplastic elastomer, thermoplastic vulcanizate, and the like. In some embodiments, the housing 202 may include or be constructed of a radiation shielding material so as to encapsulate any radioactive material contained within the delivery device 200 therein, such that exposure to radiation emissions from any radioactive material stored in the delivery device 200 is limited to the housing 202. By way of example only, the radiation shielding material of the housing 202 may include any combination of plastic and metal. By way of illustrative example only, the housing 202 may be formed of acrylonitrile butadiene styrene (ABS), lead, tungsten, tin, bismuth, or other suitable materials configured and operable to suppress radiation emissions.

[0044]

[0092] Instead, it should be understood that the housing 202 can be formed of other materials that are not configured to shield against radiation emission. In this case, the delivery device 200 can include additional features configured to suppress radiation emission from within the housing 202 of the delivery device 200. For example, the delivery device 200 can include one or more radiation shielding inserts positioned within the lumens 220A, 220B of a pair of chambers 202A, 202B and / or within the distal head 208, thereby reducing radiation exposure from within the housing 202. By way of example only, the one or more radiation shielding inserts can be formed of acrylonitrile butadiene styrene (ABS), lead, tungsten, tin, barium, or other suitable materials configured and operable to suppress radiation emission. Additionally or alternatively, in some aspects, the delivery device 200 can be overmolded with a radiation shielding material. By way of illustrative example only, this material can include silicone, thermoplastic elastomer, thermoplastic vulcanizate, or other suitable materials configured and operable to suppress radiation emission.

[0045]

[0093] The vial assembly 250 can be formed of materials including plastic, thermoplastic polymer, polycarbonate, polyethylene, polyethylene terephthalate, and the like. As will be described in more detail herein, in some embodiments, at least a portion of the vial assembly 250 removably received within the housing 202 of the delivery device 200 can be formed of a material and / or include such features (e.g., protective shield 253, see FIG. 7) configured and operable to suppress radiation exposure from the substance stored therein. In this case, the housing 202 of the delivery device 200 can be formed of plastic and can be formed of plastic.

[0046]

[0094] Referring now to FIG. 6, the delivery device 200 is depicted with the vial assembly 250 removed from within the lumen 220A of the chamber 202A. In particular, the housing 202 of the delivery device 200 includes an opening 205A at the proximal end 204 of the chamber 202A through which the vial assembly 250 is received. In this case, the opening 205A is sized and shaped to receive the vial assembly 250 such that the vial assembly 250 surrounds the lumen 220A of the chamber 202A when received therein. The vial assembly 250 includes a handle 252, a plunger 254, and an elongate body 256 and a depressible button 258 that extends laterally outwardly from the elongate body 256. As briefly described above, the depressible button 258 is elastically biased to an extended position and is selectively depressible in response to compression of the depressible button 258 by a predetermined force. In other words, actuation of the depressible button 258 results in depression of the depressible button 258 into the elongate body 256 of the vial assembly 250. Accordingly, the depressible button 258 is configured to elastically expand outwardly from the elongate body 256 of the vial assembly 250 upon termination of the application of the predetermined force thereto.

[0047]

[0095] The depressible button 258 is sized and shaped to be received through the aperture 209 of the housing 202 such that, in response to alignment of the depressible button 258 with the aperture 209, the depressible button 258 extends outwardly from the elongated body 256 and extends through the aperture 209. In this case, the vial assembly 250 is effectively coupled to the housing 202 of the delivery device 200 and is firmly disposed within the lumen 220A of the chamber 202A. In other embodiments, it should be understood that the vial assembly 250 may include additional depressible buttons 258 along the elongated body 256 to secure the vial assembly 250 to the housing 202 of the delivery device 200. Alternatively, in other embodiments, the vial assembly 250 includes other suitable retention mechanisms, such retention mechanisms being configured and operable to attach the vial assembly 250 to the delivery device 200. As will be described in more detail herein, in some embodiments, the actuation of the depressible button 258, and / or other buttons or mechanisms, can facilitate the actuation of the handle 252 and plunger 254 for administering a dose from the delivery device 200. In this case, the depressible button 258 serves as an additional safety feature in addition to the retention mechanism. As will be described in more detail herein, in some embodiments, the delivery device 200 may include one or more sensors disposed therein, such as, for example, a linear encoder. In this case, the linear encoder is disposed on and / or coupled to the plunger 254 such that the plunger 254 extends through the linear encoder and the linear encoder is configured to translate in parallel with the plunger 254.

[0048]

[0096] Still referring to FIG. 6, chamber 202B of housing 202 is sized and shaped to receive a fluid medium therein, and in particular, chamber 202B serves as a fluid reservoir for storing a fluid medium (e.g., saline) within lumen 220B. In particular, lumen 220B of chamber 202B may be sized to receive and store a predetermined volume of fluid medium therein, such as that transferred to chamber 202B from an external device (e.g., a syringe). By way of example, the predetermined volume of chamber 202B may range from about 80 milliliters (mL) to about 120 milliliters (mL), and more specifically, may be 100 milliliters (mL).

[0049]

[0097] The fluid reservoir formed by the chamber 202B of the housing 202 may store a variety of fluid media therein, such as, for example, saline, intravenous sugar solution, dextrose solution (D5W), and / or contrast media. The delivery device 200 may be configured to receive a fluid reservoir device within the lumen 220B, such as a syringe, a bag, and / or the like. In this case, the fluid reservoir device may be pre-assembled into the chamber 202B of the housing 202, or alternatively, separate from the delivery device 200, such that an operator of the delivery device 200 must couple the fluid reservoir device with the housing 202. The housing 202 further includes a proximal wall 205B at the proximal end 204 of the chamber 202B to enclose the lumen 220B. The proximal wall 205B includes a port 207 extending proximally therefrom, which is configured and operable to couple the lumen 220B of the chamber 202B to a corresponding device, such as a syringe (not shown), or the like. In this example, proximal wall 205B includes a number of vents and / or holes disposed therethrough to facilitate movement of a floating septum disposed within chamber 202B (see FIG. 7) without creating a vacuum (i.e., negative pressure) within chamber 202B.

[0050]

[0098] Still referring to FIG. 6, the chamber 202A of the housing 202 may further include one or more positioning portions 203 disposed within the inner cavity 220A. The positioning portion 203 may extend from the chamber 202A into the inner cavity 220A so as to interface with the outer surface of the elongated body 256 of the vial assembly 250, thereby aligning the vial assembly 250 with the chamber 202A. In this case, the positioning portion 203 includes an annularly arranged groove extending inwardly from the chamber 202A into the inner cavity 220A. It should be understood that the chamber 202A may include various suitable positioning portions other than those shown and described herein without departing from the scope of the present disclosure.

[0051]

[0099] The handle 252 of the vial assembly 250 is integrally fixed to the plunger 254, and the plunger 254 extends into the elongated body 256. As will be described in more detail herein, the plunger 254 is configured to move, particularly rotate and translate, relative to the elongated body 256 of the vial assembly 250 in response to actuation of the handle 252. The vial assembly 250 includes a protective shield 253 disposed around at least a portion of the elongated body 256. In this example, the protective shield 253 extends around the distal portion of the elongated body 256 of the vial assembly 250, but it should be understood that the protective shield 253 may extend along additional and / or fewer portions of the elongated body 256 without departing from the scope of the present disclosure. Additionally, in some embodiments, the protective shield 253 of the vial assembly 250 may include a plurality of marks and / or labels disposed along its outer surface. As will be described in more detail herein, the material constituting the protective shield 253 is configured to suppress and can act to suppress radiation emission from the material stored within the elongated body 256 of the vial assembly 250.

[0052]

[0100] Still referring to FIG. 6, the vial assembly further includes a safety tab 259 The containment, safety tab 259 is coupled to the plunger 254, and in particular along an intermediate portion of the longitudinal length of the plunger 254, in proximity to the elongated body 256. The safety tab 259 is affixed to the plunger 254 and abuts against the proximal end of the elongated body 256. The safety tab 259 is configured to inhibit movement of the plunger 254, and in particular the linear translational movement of the plunger 254 into the elongated body 256, by engaging the elongated body 256. The safety tab 259 is selectively removable from the vial assembly 250 in response to applying a force to the safety tab 259 on the opposite side of the plunger 254, thereby extracting the safety tab 259 from engagement with the plunger 254 and the elongated body 256. Thus, removal of the safety tab 259 results in translational movement of the plunger 254 into the elongated body 256. In other embodiments, the safety lock may comprise a depressible handle coupled to the handle 252, or alternatively, an electrical switch that removes a physical obstruction that inhibits the handle 252 and the plunger 254 from translating relative to the elongated body 256.

[0053]

[0101] Referring now to FIG. 7, the chamber 202B is disposed within the lumen 220B It includes a floating septum 221, and the floating septum 221 extends between ports 207 and 211 and is movably coupled to an internal pipeline 223 that is coupled thereto. Thus, the floating septum 221 is translatable within the lumen 220B and along the internal pipeline 223. As will be described in more detail herein, the floating septum 221 is configured to translate within the lumen 220B of the chamber 202B and along the internal pipeline 223 in response to the port 207 receiving a fluid medium therethrough into the chamber 202B and / or the port 211 discharging a fluid medium therethrough out of the chamber 202B. The vial assembly 250 is a single-chamber syringe having an internal chamber 251 disposed within an elongated body 256. The vial assembly 250 is configured to selectively deliver the fluid medium contained within the elongated body 256 of the vial assembly 250, particularly within the internal chamber 251. In other words, the elongated body 256 is sized to store a fluid medium within the internal chamber 251 for delivery to a patient when the vial assembly 250 is assembled to the delivery device 200 in response to actuation of the handle 252. In this example, the fluid medium stored within the internal chamber 251 of the elongated body 256 contains a radioactive substance such as, for example, radioactive embolization beads, radioactive microspheres, and the like. As will be described in more detail herein, the fluid medium stored within the internal chamber 251 of the elongated body 256 can be pre-filled within the internal chamber 251 prior to use of the vial assembly 250 by an operator. The internal chamber 251 can be formed of various materials and / or can include various wall thicknesses. In this example, the internal chamber 251 is formed of plastic and includes a wall thickness of approximately 9 millimeters (mm).

[0054]

[0102] The vial assembly 250 is, for example, polycarbonate, polyethylene, poly It is formed of a plastic material, such as polyethylene terephthalate or various other plastics. The internal chamber 251 of the vial assembly 250 is disposed within the elongated body 256 and encapsulated within a protective shield 253 that extends around the internal chamber 251. The protective shield 253 can be formed of a plastic, such as acrylonitrile butadiene styrene (ABS), lead, tungsten, tin, white eye, and / or other suitable materials for preventing exposure to radioactive substances from within the internal chamber 251. It should be understood that the internal chamber 251 of the vial assembly 250 can be pre-filled with a radioactive substance prior to the assembly of the vial assembly 250 and the delivery device 200. In this case, the radioactive substance is disposed within the protective shield 253 of the vial assembly 250, and as a result, the radiation emission generated by the radioactive substance is suppressed by the protective shield 253 prior to the use of the vial assembly 250 and the insertion of the vial assembly 250 into the delivery device 200.

[0055]

[0103] In other embodiments, the vial assembly 250 is a dual chamber syringe and includes at least two internal chambers 251. In this case, the vial assembly 250 is configured to separately maintain a fluid medium within each of the chambers 251, and as a result, the fluid media within the chambers 251 are not exposed to each other and can be delivered separately from the vial assembly 250 relative to each other. By way of example only, the vial assembly 250 can be configured and operable in accordance with at least some of the teachings of U.S. Application No. 62 / 673628, entitled "Dual Stage Syringe," filed on the same date as this specification, the disclosure of which is incorporated herein by reference.

[0056]

[0104] Still referring to FIG. 7, the plunger 254 of the vial assembly 250 extends through elongated body 256 and is, among other things, coupled to interior chamber 251 of vial assembly 250 opposite handle 252. In particular, plunger 254 is coupled to interior chamber 251 such that movement of plunger 254 creates pressure within interior chamber 251 to deliver material stored in interior chamber 251 out of interior chamber 251. The plunger 254 is a threaded plunger and includes a threaded portion 257A extending along the longitudinal length of the plunger 254. The threaded portion 257A of the plunger 254 is configured to mate with a corresponding threaded portion 201 of the vial assembly 250 disposed within the elongated body 256 to facilitate rotation of the plunger 254 therein. In this case, rotation of the handle 252 results in simultaneous rotational and linear translational movement of the plunger 254 through the elongated body 256 and relative to the internal chamber 251.

[0057]

[0105] In particular, the handle 252 is adapted to allow for rotational forces to the handle (i.e., the 252 relative to the elongated body 256. In this case, rotating the handle 252 threads the plunger 254 further along the corresponding threaded portion 201, thereby dispensing material stored within the internal chamber 251 from the delivery device 200 as the plunger 254 applies continued pressure to the internal chamber 251. Rotation of the handle 252 in conjunction with translational movement of the handle 252 results in a slow and controlled rate of fluid deposition from the internal chamber 251.

[0058]

[0106] Still referring to FIG. 7, plunger 254 separates from threaded portion 257A. It includes a non-threaded portion 257B that extends along the longitudinal length of the plunger 254 that is separated. The non-threaded portion 257B of the plunger 254 is configured to facilitate and is operable to facilitate the sliding translation of the plunger 254 within the elongated body 256, and is configured to slidably engage one or more mechanisms 212 (e.g., ball bearings) disposed within the elongated body 256. In this case, the linear motion of the handle 252 results in a simultaneous linear translational motion of the plunger 254 through the elongated body 256 and relative to the internal chamber 251. In particular, the handle 252 is configured such that the application of a linear force to the handle (i.e., pushing the handle 252 relative to the elongated body 256) results in a linear translational motion of the plunger 254 into the elongated body 256. In this case, pushing the handle 252 towards the elongated body 256 further translates the plunger 254 into the elongated body 256 and towards the internal chamber 251, whereby, when the plunger 254 applies a continuous pressure to the internal chamber 251, the material stored in the internal chamber 251 is dispensed from the delivery device 200. The translational motion of the handle 252 enables a faster and controlled rate of fluid supply from the internal chamber 251 compared to the rotation of the handle 252. It should be understood that the translational motion of the plunger 254 results in a simultaneous translational motion of the threaded portion 257A relative to the chamber 202A. With the threaded portion 257A engaged and coupled to the corresponding threaded portion 201 of the vial assembly 250, the plunger 254 is further configured to translate the threaded portion 201 within the chamber 202A and relative to the internal chamber 251 of the vial assembly 250.

[0059]

[0107] The delivery device 200 includes a fluid reservoir 216 disposed within the housing 202 and further includes, in particular, a distal head 208. In this example, the fluid reservoir 216 may comprise a manifold (e.g., a Y-shaped manifold), a connector valve (e.g., a three-way connector and / or a T-valve connector), or various other connector mechanisms. In some embodiments, the fluid reservoir 216 may include one or more check valves to prevent fluid media flow in a particular direction. As will be described in more detail herein, the fluid reservoir 216 is configured to provide fluid communication between the vial assembly 250 and the lumen 220B of the chamber 202B. In addition, the fluid reservoir 216 is coupled to the catheter hub 210 such that the vial assembly 250 and the lumen 220B of the chamber 202B are in fluid communication with the catheter hub 210..

[0060]

[0108] Still referring to FIG. 7, the fluid reservoir 216 includes a series of delivery conduits 214 ( i.e., inner tubes), and the series of delivery conduits 214 extends between the vial assembly 250 and the lumen 220B of the chamber 202B, fluidly coupling the fluid reservoir 216 to each of the vial assembly 250 and the lumen 220B of the chamber 202B. In particular, at least one of the series of delivery conduits 214 is coupled to a port 211 in the lumen 220B of the chamber 202B on the opposite side of the port 207, such that the fluid reservoir 216 is in fluid communication with a fluid media (e.g., saline) stored within the lumen 220B. Further, at least one of the series of delivery conduits 214 is coupled to a needle 222 positioned at the end of a delivery conduit 214 that is in line and on the opposite side of the fluid reservoir 216. In this case, the needle 222 is positioned within the distal head 208 of the housing 202 such that the needle 222 extends into the lumen 220A of the chamber 202A.

[0061]

[0109] Since the needle 222 extends into the lumen 220A of the chamber 202A, the needle 222 It should be understood that when the vial assembly 250 is slidably received into the inner cavity 220A through the opening 205A, it is operable to couple and engage with the elongated body 256. In this example, the vial assembly 250 includes a septum 255 disposed around the distal end of the elongated body 256, and this septum 255 is configured to receive the needle 222 passing through the septum when the elongated body 256 is received into the inner cavity 220A of the chamber 202A. The septum 255 is formed of an elastomer and is operable to be punctured by the needle 222, thereby enabling fluid communication between the inner chamber 251 of the vial assembly 250 and the fluid reservoir 216 via the delivery conduit 214 coupled to the needle 222. It should be understood that the septum 255 can be formed of various other suitable materials that are configured to tightly seal the inner chamber 251 of the vial assembly 250 within the elongated body 256 while also being further operable to receive the needle 222 passing through the septum. Although not shown, it should be understood that the fluid reservoir 216 can be fluidly coupled to the catheter hub 210 via a delivery conduit 214 that is coupled to the fluid reservoir 216 and extends between the fluid reservoir 216 and the catheter hub 210. In other embodiments, it should be further understood that the vial assembly 250 can include various other needle connection ports other than the septum 255 shown and described above.

[0062]

[0110] Although not shown, in some embodiments, the housing 202 is a delivery de To provide real-time feedback on the contents, quantity, and operability of the delivery device 200 to the operator of the vice 200, it should be understood that an interface surface having one or more displays (e.g., a dosimeter display, a sensor output display, an observation window, etc.) may be included. Additionally or alternatively, the delivery device 200 may be communicatively coupled to one or more remote displays (e.g., a smart device, a tablet, etc.). In an embodiment, the delivery device 200 may further include one or more sensors operable to measure the rate of delivery of a fluid medium from the delivery device 200, such as, for example, a mixture of a fluid medium contained within the chamber 202B and a radioactive substance (e.g., a radiation embolization bead) stored within the internal chamber 251 of the vial assembly 250. By way of example only, one or more sensors (e.g., a dosimeter, a linear encoder, an optical sensor, a linear displacement sensor, a flow sensor, an ultrasonic sensor, a magnetic encoder, a laser distance sensor, an inductance sensor, a radial encoder, a volume measurement sensor, a mechanical transducer, etc.) may be configured to measure the velocity, pressure, force, displacement, flow, capacitance, radiation, and / or the like of the fluid medium delivered from the delivery device 200.

[0063]

[0111] The sensor output display provides real-time monitoring of measurements such as those calculated by one or more sensors and is viewable by the operator during the medical procedure. In particular, such sensors assist the operator in adjusting the fluid delivery, for example, after considering the measurement output from the device's display. By way of example, the sensor output display may be positioned along the housing 202 of the delivery device 200 and / or in wireless communication with the delivery device 200 and may comprise an LCD screen, a mechanical output section, a smart device, a remote tablet, or various other display output sections. As briefly described above, the delivery device provides real-time feedback on the contents of the delivery device 200, the quantity, and the operability to the operator of the vice 200.

[0064]

[0112] As briefly described above, the delivery device provides real-time feedback on the contents may include one or more sensors for monitoring the radiation level of. By way of example only, such sensors may be highly sensitive radiation sensors (e.g., ultra-small circuits, Geiger counters, etc.) configured to detect radiation and measure the absorbed dose of radiation (TID). Such sensors may be positioned at various locations within the delivery device 200 and, in particular, along the path of travel of the radioactive material stored within the delivery device 200 to determine the radioactivity rate of the above material. The sensor output display may provide a real-time monitoring display of these measurements and may include various devices such as, for example, an LCD screen, a mechanical output unit, a smart device, a remote tablet, or other various display output units. In other embodiments, the data and information described above may be transmitted (e.g., wirelessly or wired) to a remote device, and as a result, it should be understood that the display of the remote device provides the above output to the operator on the display.

[0065]

[0113] In some embodiments, an observation window may be positioned in the housing 202, particularly in the chamber 2 02A, the vial assembly 250 is received within the chamber 202A, and the vial assembly 250 can be visually recognized. The observation window can be formed of a radiation shielding material, similar to the protective shield 253 of the vial assembly 250, thereby sealing any radioactive material contained within the delivery device 200 therein, and thereby minimizing the exposure of radioactive material through the observation window. By way of example only, the radiation shielding material of the observation window can be formed of plastic such as acrylonitrile-butadiene-styrene (ABS), lead glass, or other suitable materials for preventing exposure to radioactive substances. Alternatively, the observation window may include a video monitor operable to display the visual condition within the chamber 202A.

[0066]

[0114] Referring now to FIG. 8, the chamber 202A of the housing 202 is the delivery de The vial assembly 250 may further include a purging syringe 280 stored therein for the purpose of flushing the delivery line 214 and the fluid reservoir 216 of the delivery device 200 prior to loading the vial assembly 250 for use with the vice 200. It should be appreciated that in some embodiments, the purging syringe 280 may be pre-assembled within the lumen 220A of the chamber 202A. The purging syringe 280 includes a proximal end 282 and a distal end 284, between which an elongated body 286 extends. The elongated body 286 of the purging syringe 280 is sized and shaped to be received within the chamber 202A of the housing 202, and in particular to create a press fit against the lumen 220A of the chamber 202A. The elongated body 286 may further include a plurality of markings and / or indicia 285 thereon for the purpose of measuring and / or identifying a volume of the fluid medium stored therein.

[0067]

[0115] The proximal end 282 secures the purging syringe 280 to the chamber 202A. 2. In addition, the purging syringe 280 includes at least one depressible button 288 extending laterally outwardly from the elongated body 286, which is sized and shaped to be received within the aperture 209 of the housing 202. It should be understood that the depressible button 288 of the purging syringe 280 is configured and operable similarly to the depressible button 258 of the vial assembly 250 described above. The distal end 284 of the purging syringe 280 includes a port 283 sized and shaped to receive the needle 222 therethrough, thereby providing a connection between the purging syringe 280 and the delivery device. Fluid communication between the fluid reservoir 216 of the needle 222 and the delivery line 214 is established via the needle 222 and the delivery line 214 positioned therebetween.

[0068]

[0116] Exemplary modes of operation of the delivery device 200 are described below. This and the following related description are not intended to limit the subject matter described herein, nor are they intended to be an exact description of how a fluid medium may be delivered using delivery device 200, but rather to provide a simple overview to illustrate the general administration of a radioactive medium from delivery device 200 as described herein.

[0069]

[0117] 7-8, in the delivery conduit 214 and fluid reservoir 216, First, air is purged using a purging syringe 280. In particular, an external syringe containing a fluid medium (e.g., saline) is coupled to chamber 202B via a connection at port 207. The lumen 220B of chamber 202B is filled to a desired volume with fluid medium from this syringe, and once chamber 202B is filled, the syringe is disconnected from port 207. In this case, floating septum 221 is translated within lumen 220B as chamber 202B is filled with fluid medium via port 207, thereby translating septum 221 along an internal tubing 223 coupled to and extending between ports 207, 211. In particular, floating septum 221 is translated distally from port 207 and proximal to port 211 as chamber 202B is filled with fluid medium. The delivery device 200 is oriented vertically and the purging syringe 280 is retracted, thereby drawing a volume of fluid medium from the lumen 220B of the chamber 202B through the delivery line 214. The purging syringe 280 is then pushed forward toward the catheter hub 210 to prime (fill) the delivery line 214 and fluid reservoir 216 with saline. The delivery line may be coupled to the catheter hub 210 of the delivery device 200, and the opposite end of the delivery line may be positioned in a collection bowl for receiving the flushed medium therein. These steps may be repeated as necessary to remove air from the delivery line 214 and fluid reservoir 216, effectively preparing the delivery device 200 for use during the procedure.

[0070]

[0118] With the delivery line 214 of the delivery device 200 purged of air, 2A, the purging syringe 280 is removed from the lumen 220A of the chamber 202A through the opening 205A, and the vial assembly 250 is inserted through the opening 205A. In particular, the purging syringe 280 is removed by depressing the depressible button 288 at the aperture 209 and extracting the elongated body 286 by pulling the collar 281 at the proximal end 282 proximally out of the opening 205A. In addition, the vial assembly 250 is received through the opening 205A and inserted into the housing 202 by depressing the depressible button 258 and slidably translating the elongated body 256 into the lumen 220A.

[0071]

[0119] Referring again to FIG. 6, chamber 202A is pressed against depressible button 258. With continued application of the predetermined force, thereby maintaining the depressible button 258 in a contracted state, the vial assembly 250 is advanced through the chamber 202A until the depressible button 258 is located at the aperture 209 of the housing 202. At this stage, since the predetermined force is no longer being applied to the depressible button, the resilient bias of the depressible button 258 causes it to extend outwardly from the elongated body 256. Upon receipt of the depressible button 258 within the aperture 209, the septum 255 of the vial assembly 250 contacts the needle 222 within the lumen 220A of the chamber 202A. Thus, the septum 255 is punctured and the needle 222 is in fluid communication with the interior chamber 251 of the vial assembly 250.

[0072]

[0120] In other words, the vial assembly 250 is moved distally forward into the chamber 202A. Advancement of the handle 252 provides a series of feedback (e.g., visual, auditory, tactile, and / or mechanical feedback) to confirm coupling of the vial assembly 250 with the delivery device 200. In particular, receipt of the depressible button 258 within the aperture 209 may provide visual, auditory, tactile, and mechanical feedback to the operator that the vial assembly 250 is coupled to the delivery device 200. Additionally, puncture of the septum 255 by the needle 222 may provide auditory, tactile, and mechanical feedback to the operator that the vial assembly 250 is in fluid communication with the delivery device 200. In this case, any advancement of the handle 252 delivers radioembolic beads stored within the internal chamber 251 of the vial assembly 250, since the internal chamber 251 is in fluid communication with the delivery device 200.

[0073]

[0121] Referring to FIG. 7, the catheter hub 210 of the delivery device 200 is 2A of the delivery device 200. In other embodiments, the catheter hub 210 may be coupled to a catheter (e.g., a microcatheter) with a delivery line extending therebetween. It should be appreciated that in other embodiments, the catheter hub 210 may be coupled to a catheter prior to assembly of the vial assembly 250 into the chamber 202A of the delivery device 200. Because the vial assembly 250 contains the radioembolic beads within the internal chamber 251 with the protective shield 253 disposed thereon, the operator is not required to manipulate any vials containing radioactive material while performing the medical procedure. Rather, once the vial assembly 250 is assembled within the housing 202 of the delivery device 200, the operator is not required to directly handle the radioembolic beads, thereby reducing the risk of radioactive or biological contamination due to human error during the procedure.

[0074]

[0122] The lumen 220B of the chamber 202B is filled with a fluid medium, and the vial assembly With the 250 fully assembled within the delivery device 200, the operator can selectively activate the delivery device 200 to deliver a controlled mixture of therapeutic particles (e.g., radioactive embolization beads) from the vial assembly 250 and a fluid medium from the chamber 202B during the procedure. As briefly described above, the delivery device 200 can be communicatively coupled to a remote device such as, for example, a tablet, computer, mobile device, and / or the like. When the delivery device 200 is being used during the procedure, the remote device can receive and display delivery information for the operator of the delivery device 200 to observe via the interface display of the remote device. For example, the delivery information displayed via the remote device can include, but is not limited to, flow rate (ml / min), current volume of the medium within chambers 202A, 202B, injected volume of the medium from chambers 202A, 202B, residual rate of radioactivity stored within the delivery device 200, and / or the like.

[0075]

[0123] Referring back to FIG. 5, to administer a dose of radioactive material using the delivery device 200, the handle 252 of the vial assembly 250 is actuated to proximally translate the plunger 254 away from the elongate body 256. In this case, a negative pressure is generated between the internal chamber 251 of the vial assembly 250 and the lumen 220B of the chamber 202B that are in communication with each other through the air-purged delivery conduit 214. Thus, by pulling the plunger 254 proximally, the fluid medium (e.g., saline) stored within the lumen 220B can be withdrawn through the delivery conduit 214 and through the needle 222 into the internal chamber 251 of the vial assembly 250. In particular, as the fluid medium within the chamber 202B is depleted, the floating septum 221 translates proximally towards the port 207 and distally away from the port 211. Such suction of the fluid medium into the internal chamber 251 where the therapeutic particles are stored causes mixing of the two substances within the internal chamber to form a suspension fluid.

[0076] ​

[0124] When the handle 252 and plunger 254 are fully pulled proximally, The handle 252 may be actuated to translate the plunger 254 distally towards the elongated body 256 to generate positive pressure. The handle 252 may be actuated either by rotating the handle 252 to deliver a slow and controlled dose of the radioactive mixture, or by translating the handle 252 to deliver a fast and controlled dose. In some embodiments, depressing the depressible button 258 towards the elongated body 256 is required to translate the handle 252 and plunger 254 to deliver a fast and controlled dose of the mixture. In this case, the depressible button 258 may serve as a secondary safety mechanism for the delivery device 200 when administering a fast dose of the mixture.

[0077]

[0125] Referring back to FIG. 7, within the interior chamber 251 of the vial assembly 250 The dosage of the mixture formed is effectively transported through the needle 222 and into the fluid reservoir 216, and this dosage is thereby delivered out from the delivery device 200 through the catheter hub 210. Since the delivery device 200 is coupled to the catheter via the catheter hub 210, the mixture can be delivered intravenously to the patient by positioning the catheter at the target treatment site within the patient. The operation of the handle 252 described above is repeated to refill and purge the mixture of the fluid medium until any one of the following occurs: a sufficient dosage has been administered to the patient (e.g., the sensor output read from the dosimeter sensor has dropped to a predetermined level), the internal chamber 251 has been depleted, and / or stasis has occurred. Additional dosages can be delivered by the delivery device 200. The sensor output display can provide the operator with real-time information feedback on the force, pressure, and / or flow of the mixture delivered from the delivery device 200 to the catheter via one or more sensors included within the delivery device 200. By monitoring (observing) the sensor output display, the operator can adjust the delivery of the radiation embolization beads to the patient and stop the delivery when desired.

[0078]

[0126] If the fluid medium stored within the lumen 220B of the chamber 202B is depleted before the completion of the procedure, additional fluid medium (e.g., saline) can be refilled into the chamber 202B during the procedure via the port 207. At the end of the procedure, the delivery device 200 can be discarded. In some embodiments, the delivery device 200 can include a transducer therein such that it can be possible to operate the delivery device 200 from a remote location, and as a result, the operator can be located at a location away from the radioactive substance included within the delivery device 200.

[0079]

[0079]

[0127] Although not shown, the delivery device 200 can be removable It should be appreciated that the delivery device 200 may further include a device stand sized and shaped to receive the delivery device 200. The device stand may be configured and operable to temporarily maintain the delivery device 200 during a medical procedure. Thus, the device stand may facilitate sterilization or maintain sterility of the delivery device 200 before, during, and after use of the delivery device 200 for a procedure. III. SEMI-AUTOMATED HANDHELD DELIVERY DEVICE

[0128] 9-10 show a method for distributing radiation while reducing radiation emissions during use of the delivery device 300. 1 illustrates another embodiment of a delivery device 300 configured and operable to deliver a radioactive material (e.g., radioembolic beads). Since the delivery device 300 of this example is substantially similar to the delivery device 200 except for the differences explicitly noted herein, it should be understood that the delivery device 300 may be configured and operable similarly to the delivery device 200 described above.

[0080]

[0129] With particular reference to FIG. 9 , the delivery device 300 includes a proximal end 304 and a distal end 305. includes a housing 302 extending between 6, the distal end 306 of the housing 302 includes an elongated housing 308 extending distally therefrom. The elongated housing 308 of the delivery device 300 includes a distal tip 310 having a catheter hub for coupling the delivery device 300 to an external device such as, for example, a catheter. The housing 302 of the delivery device 300 defines a lumen 320 disposed therein (see FIG. 10). As described in more detail herein, the lumen 320 defined by the housing 302 houses one or more devices (eg, syringes, fluid reservoirs, valves, and the like) within the delivery device 300. The housing 302 further includes an interface surface 312 positioned between the proximal end 304 and the distal end 306 of the delivery device 300, the interface surface 312 including one or more switches for actuating one or more devices, the one or more devices being housed within and coupled to the delivery device 300. The interface surface 312 further includes one or more displays for providing output and / or operational feedback (eg, visual) of one or more devices housed within the delivery device 300.

[0081]

[0130] In this example, the interface surface 312 of the delivery device 300 is at least , a dose meter display 314, a sensor output display 316, a contrast agent switch 333, a flushing switch 334, and a saline switch 335. The positions of the displays 314, 316 and switches 333, 334, 335 shown and described herein are for illustrative purposes only, and thus it should be understood that the locations of the displays 314, 316 and switches 333, 334, 335 can vary without departing from the scope of the present disclosure. As will be described in more detail below, each switch 333, 335 is communicatively coupled to and configured to operate a respective device (e.g., a contrast agent syringe 323, a saline syringe 325) contained within the lumen 320 of the housing 302. Thus, operating switches 333, 335 via the interface surface 312 of the housing 302 can result in the automatic delivery of the fluid media contained within syringes 323, 325, respectively.

[0082]

[0131] Referring now to FIG. 10, the lumen 320 of the housing 302 is at least , including a pair of connector valves 321, 322, a contrast agent syringe 323, a fluid reservoir 324, a saline syringe 325, and a syringe 350. Various devices disposed within the lumen 320 of the housing 302 are disposed within the lumen 320 of the housing 302 and are fluidly coupled to each other via a series of delivery conduits 326 extending therebetween. In particular, the syringe 350 is fluidly coupled to the first connector valve 322 via a delivery conduit 326 extending therebetween. The syringe 350 includes an external chamber 354, an internal chamber 356 disposed within the external chamber 354, and an internal needle 358 disposed within the external chamber 354. The internal chamber 356 is sized and shaped to be received within the external chamber 354. In other words, the syringe 350 is a dual-chamber syringe capable of storing a plurality of fluid media therein, and as a result, the fluid media stored in each of the respective chambers 354, 356 are separated from each other. In this example, the fluid media stored in the external chamber 354 of the syringe 350 includes a saline media, and the fluid media stored in the internal chamber 356 of the syringe includes a radioactive media, such as, for example, radioactive beads. In other embodiments, it should be understood that the pair of connector valves 321, 322 may comprise various other devices, such as, for example, a manifold.

[0083]

[0132] The syringe 350 further includes a handle 352 coupled to the internal chamber 356 such that the internal chamber 356, in response to actuation (e.g., linear translational movement) of the handle 352 relative to the housing 302 of the delivery device 300, within the lumen 320, and and is movable, particularly within the outer chamber 354. It should be understood that the outer chamber 354 of the syringe 350 is firmly fixed within the lumen 320 of the housing 302, such that as a result, the outer chamber 354 cannot move in response to actuation of the handle 352. The handle 352 extends proximally outwardly from the housing 302 at the proximal end 304, such that as a result, even though the syringe 350 is disposed within the lumen 320 of the housing 302, the handle 352 of the syringe 350 is accessible to an operator of the delivery device 300. The handle 352 of the syringe 350 extends distally from the lumen 320 through a syringe opening 305 located at the proximal end 304 of the housing 302.

[0084]

[0133] The inner needle 358 of the syringe 350 is firmly fixed within the outer chamber 354 at the opposite end of the inner chamber 356 of the syringe 350. With the inner chamber 356 movably coupled to the handle 352 within the outer chamber 354 and the inner needle 358 fixedly disposed within the outer chamber 354, translational movement of the handle 352 can result in an interaction between the inner chamber 356 and the inner needle 358. More specifically, and as described in more detail herein, actuation of the handle 352 (e.g., translating the handle 352 distally toward the distal end 306 of the delivery device 300) generates pressure within the outer chamber 354 of the syringe 350 as the inner chamber 356 moves within the outer chamber 354.

[0085]

[0134] Still referring to FIG. 10, upon initial actuation of the handle 352, the outer cha The fluid medium (e.g., saline) stored within the handle 352 is effectively transferred from the outer chamber 354 to the first connector valve 322 via the delivery line 326 coupled therebetween. In this case, continued translational movement of the handle 352 towards the distal end 306 of the delivery device 300 causes the inner chamber 356 to abut against the inner needle 358 within the outer chamber 354. In this case, when the inner needle 358 punctures the inner chamber 356, the handle 352 is operable to establish fluid communication between the inner chamber 356 and the outer chamber 354. Thus, the fluid medium (e.g., radioembolic beads) stored within the inner chamber 356 can thereby be transported to the outer chamber 354, and with the outer chamber 354 being emptied of fluid medium by the initial actuation of the handle 352, the radioembolic beads stored in the inner chamber 356 can be effectively delivered to the first connector valve 322 via the delivery line 326 coupled therebetween.

[0086]

[0135] A first connector valve 322 disposed within the lumen 320 of the housing 302 is 3, the first connector valve 322 is similar to the fluid reservoir 216 of the delivery device 200 described in , and as a result, the first connector valve 322 may comprise a Y-manifold, a three-way check valve assembly, and / or the like. The first connector valve 322 provides fluid communication between the syringe 350 and the fluid reservoir 324 via a series of delivery lines 326. Additionally, the first connector valve 322 is in fluid communication with a second connector valve 321, which is positioned adjacent the distal end 306 of the housing 302 and disposed within the elongated housing 308. A contrast syringe 323 and a saline syringe 325 are fluidly coupled to the second connector valve 321.

[0087]

[0136] Still referring to FIG. 10, the contrast syringe 323 contains a fluid medium therein. configured to, and in this example, the contrast agent syringe 323 contains a contrast medium stored therein. The saline syringe 325 is similarly configured to store a fluid medium therein, and in this example, the saline syringe 325 contains a saline medium stored therein. It should be understood that the syringes 323, 325 can contain various other suitable fluid media and in some cases can contain the same substance stored therein. Although not shown, it should be understood that additional or fewer syringes 323, 325, 350 can be included within the lumen 320 of the delivery device 300. Further, the syringes 323, 325 are shown as being of a different size and shape than the syringe 350, but it should be understood that the syringes 323, 325, 350 can include various suitable shapes and sizes that can be stored within the lumen 320 of the housing 302 without departing from the scope of the present disclosure. Additionally, the positions of the syringes 323, 325, 350 shown and described herein are for illustrative purposes only, and thus, it should be further understood that the locations of the syringes 323, 325, 350 can vary without departing from the scope of the present disclosure.

[0088]

[0137] The contrast agent syringe 323 is in fluid communication with the second connector valve 321 via the delivery line 326 is in fluid communication, and the saline syringe 325 is in fluid communication with the second connector valve 321 via a separate delivery line 326. In this case, the fluid media contained within syringes 323, 325, 350 are separated and isolated from each other within the lumen 320 of the housing 302 until they reach the second connector valve 321. In other words, the second connector valve 321 serves as the location where the fluid media contained within syringes 323, 325, 350 are integrated. In some embodiments, it should be understood that syringes 323, 325, 350 may be removably received within the lumen 320 and, in particular, may not be pre-assembled within the delivery device 300. Thus, the operator can determine which of syringes 323, 325, 350 should be loaded into the delivery device 300 based on the particular medical procedure to be performed using the delivery device 300. Alternatively, in some cases, syringes 323, 325, 350 may be pre-loaded into the delivery device 300, such that as a result, the operator need not insert one or more of syringes 323, 325, 350 into the lumen 320 during the medical procedure.

[0089]

[0138] Still referring to FIG. 10, in this example, switches 333, 334, 335 is electrically actuated to thereby actuate syringes 323, 325, 350, respectively. In other embodiments, one or more of the switches may be configured to be actuated hydraulically, mechanically, and / or pneumatically to actuate syringes 323, 325, 350. In particular, contrast agent switch 333 is configured to and is operable to actuate contrast agent syringe 323 such that upon actuation of contrast agent switch 333, a fluid medium (e.g., contrast medium) stored within contrast agent syringe 323 is sent via a series of delivery conduits 326 into second connector valve 321. Saline switch 335 is configured to and is operable to actuate saline syringe 325 such that upon actuation of saline switch 335, a fluid medium (e.g., contrast medium) stored within saline syringe 325 is sent via a series of delivery conduits 326 into second connector valve 321. Flushing switch 334 serves as a safety lock and is configured to allow delivery of a first fluid medium (e.g., saline) from outer chamber 354 of syringe 350. Thus, actuation of handle 352 of syringe 350 is disabled from delivering the first fluid medium stored within outer chamber 354 until flushing switch 334 is actuated.

[0090]

[0139] Referring back to FIG. 9, actuation of switches 333, 334, 335 involves, the s It should be appreciated that the actuation of the switches 333, 334, 335 may include interacting with the interface surface 312 of the housing 302 of the delivery device 300 by contacting the switches 333, 334, 335 (i.e., one click actuation), sequentially engaging the switches 333, 334, 335, and the like. It should be appreciated that in other embodiments, the switches 333, 334, 335 may be located remotely from the housing 302 such that the delivery device 300 may be activated wirelessly via a remote device. In either case, activation of the switches 333, 335 of the delivery device 300 automatically delivers the respective fluid medium within the delivery device 300. The pressure, flow, and / or fill rate through the syringes 323, 325 in response to actuation of the switches 333, 335 may be adjusted. It should be appreciated that the rate may be pre-programmed such that activation of switches 333, 335 automatically delivers fluid media at a predetermined rate.

[0091]

[0140] For example, the desired pressure, flow, and / or fill rate of the delivery device 300 may be , may be selectively input at interface surface 312 and / or via a remote device communicatively coupled to delivery device 300 prior to initiating a procedure with delivery device 300. It should be understood, however, that the syringe 350, and in particular the delivery of the fluid medium (e.g., radioembolic beads) stored within the internal chamber 356 of syringe 350, remains entirely manual via handle 352. Thus, the effective flow rate and pressure rise rate for delivering the syringe 350's one or more media stored within chambers 354, 356 are mechanically determined based on the application of force to handle 352.

[0092]

[0141] Referring back to FIG. 10 , the delivery device 300 includes a lumen 302 of a housing 302. It may include one or more sensors disposed within 320. As described in more detail above with respect to the delivery device 200, one or more sensors (e.g., dosimeters, linear encoders, optical sensors, linear displacement sensors, flow sensors, ultrasonic sensors, magnetic encoders, laser distance sensors, inductance sensors, radial encoders, volume measurement sensors, mechanical transducers, etc.) are housed within the delivery device 300 and are configured and operable to measure the flow, capacitance, radiation, volume, and / or the like of various fluid media administered thereby. In this example, the delivery device 300 includes a dosimeter sensor 328 and a displacement sensor 330. In particular, the dosimeter sensor 328 is disposed within the housing 302 and, in particular, within the elongated housing 308 of the delivery device 300. The dosimeter sensor 328 is fluidly coupled to the second connector valve 321 via a delivery conduit 326 extending therebetween and is operable to measure the radiation level of the fluid media administered from the second connector valve 321 through the dosimeter sensor 328 to the catheter hub at the distal tip 310 of the delivery device 300. The dosimeter sensor 328 is communicatively coupled to a dosimeter display 314 positioned on the interface surface 312 so that an operator of the delivery device 300 can monitor the data detected by the dosimeter sensor 328 on the delivery device.

[0093]

[0142] The displacement sensor 330 is positioned on the handle 352 of the syringe 350, and its connection As a result, the displacement sensor 330 is positioned outside the inner cavity 320 of the housing 302. The displacement sensor 330 is operable to measure the linear displacement of the handle 352 relative to the housing 302 to determine the force, pressure, and / or flow of a fluid medium administered from the syringe 350 to the catheter hub at the distal tip 310. The displacement sensor 330 is communicatively coupled to a sensor output display 316 positioned on the interface surface 312 so that an operator of the delivery device 300 can observe the data detected by the displacement sensor 330 on the delivery device. It should be understood that additional and / or fewer sensors, displays, switches, and / or syringes can be disposed within the delivery device 300 without departing from the scope of the present disclosure.

[0094]

[0143] Still referring to FIG. 10, in an exemplary mode of operation of the delivery device 300 the operator can use the delivery device 300 in a manner substantially similar to that of the delivery device 200 described above. For example, with the syringes 323, 325, 350 assembled within the inner cavity 320 of the housing 302, the delivery device 300 is coupled to an external catheter via a catheter hub positioned at the distal tip 310. In this case, the flushing switch 334 is actuated by pressing the flushing switch 334 downward, thereby unconstraining the movement of the handle 352 of the syringe 350. Accordingly, the operator applies a predetermined force to the handle 352 and, more specifically may push the handle 352 distally towards the housing 302 to initiate flushing of the syringe 350, the connector valves 321, 322, and the catheter hub at the distal tip 310 via the delivery line 326 disposed therebetween. By actuating the handle 352, the delivery device 300 is flushed with a fluid medium stored in the outer chamber 354 of the syringe 350. The fluid medium stored in the outer chamber 354 may include, for example, a saline medium. Thus, the saline is transported through the catheter hub at the distal tip 310 and into the outer catheter coupled to the delivery device 300, thereby removing any air contained therein from the corresponding catheter system.

[0095]

[0144] The flashing switch 334 is continuously pressed against the interface surface 312. A first feedback is provided to an operator of the delivery device 300 upon continued distal translation of the handle 352 distally into the housing 302 while remaining in the housing 302. By way of example only, the delivery device 300 may be configured to generate feedback (e.g., visual, auditory, tactile, mechanical, etc.) when the fluid medium (e.g., saline) stored within the outer chamber 354 of the syringe 350 is depleted. When the outer chamber 354 is empty, the operator actuates one or more of the switches 333, 335 to transfer the fluid medium stored within the outer chamber, respectively. A second feedback is generated when continued translation of the handle 352 distally into the housing 302 of the delivery device 300 causes the inner needle 358 to puncture the inner chamber 356 of the syringe 350. In this case, fluid communication is established between the inner chamber 356 and the outer chamber 354 such that the fluid medium (e.g., radioembolic beads) stored within the inner chamber 356 may be effectively transported therefrom.

[0096]

[0145] Still referring to FIG. 10, in this case, the handle 352 is attached to the housing 3 It is manually retracted proximally relative to 02, which requires continuous operation of the flushing switch 334 along the interface surface 312. Accordingly, a negative pressure is generated within the syringe 350, and as a result, the negative pressure causes the fluid medium stored within the fluid reservoir 324 to be transported through the first connector valve 322, through the external chamber 354, and into the internal chamber 356. Thus, the fluid medium stored within the fluid reservoir 324 is mixed with the fluid medium contained within the internal chamber 356. Subsequent distal translational movement of the handle 352 towards the housing 302 transports the fluid medium mixture from the syringe 350 through the first connector valve 322 and into the second connector valve 321. In this case, the operator may further activate either switch 333 or 335, thereby transporting the contrast medium and / or the saline medium from the contrast agent syringe 323 and / or the saline syringe 325, respectively, to the second connector valve 321.

[0097]

[0146] Accordingly, a further mixture of media is formed at the second connector valve 321 from one or more fluid media contained within the syringes 323, 325, 350. Thus, prior to the fluid medium mixture being delivered through the catheter hub at the distal tip 310 of the delivery device 300 and into the external catheter coupled thereto, the delivery device 300 is operable to mix the plurality of fluid media within the delivery device for delivery to the patient. The sensor output display 316 on the interface surface 312 provides real-time information feedback on the force, pressure, and / or flow of the mixture delivered from the delivery device 300 to the catheter via the displacement sensor 330. The displacement sensor 330 enables the operator to adjust the delivery of the radioactive embolization beads to the patient and to stop the delivery if desired. The operator can continue to deliver the radioactive embolization beads from the delivery device 300 until the dosimeter display 314 indicates that the radiation exposure level measured by the dosimeter sensor 328 has decreased to an acceptable level (e.g., approximately zero radioactive material remains within the delivery device 300). ​IV. Automatic Handheld Delivery Device

[0147] Figures 11-12 show another embodiment of a delivery device 400 configured and operable to deliver radioactive material (e.g., radiation embolization beads) while reducing radiation emission during use of the delivery device 400. It should be understood that the delivery device 400 of this example may be configured and operable in a manner similar to the delivery devices 200, 300 described above, since the delivery device 400 is substantially similar to the delivery devices 200, 300 except for the differences explicitly described herein.

[0098]

[0098]

[0148] Referring to FIG. 11 in detail, the delivery device 400 includes a housing 402 extending between a proximal end 404 and a distal end 406, and the distal end 406 of the housing 402 includes an elongate housing 408 extending distally therefrom. The elongate housing 408 of the delivery device 400 includes a catheter hub 410 for coupling the delivery device 400 to an external device such as, for example, a catheter. The housing 402 of the delivery device 400 defines a lumen 420 disposed therein (see FIG. 12). Similar to the delivery device 300 described above, the lumen 420 defined by the housing 402 of the delivery device 400 houses one or more devices (e.g., syringes, fluid reservoirs, valves, manifolds, and the like) within the delivery device 400, such as a pair of connector valves 421, 422, a contrast agent syringe 423, a manifold and / or fluid reservoir 424, a saline syringe 425, and a syringe 450. It should be understood that the connector valves 421, 422, syringes 423, 425, 450, and fluid reservoir 424 of the delivery device 400 are configured and operable in a manner substantially similar to those described above with respect to the delivery device 300. In some embodiments, it should be understood that the pair of connector valves 421, 422 may comprise various other devices such as, for example, a manifold. 06 and includes a housing 402 extending between a proximal end 404 and a distal end 4

[0099]

[0149] Still referring to FIG. 11, the housing 402 further includes an interface surface 412 positioned between the proximal end 404 and the distal end 406 of the delivery device 400, and this interface surface 412 includes one or more switches for actuating one or more devices stored within and coupled to the delivery device 400. The interface surface 412 further includes one or more displays for providing output and / or operational feedback (e.g., visual) of one or more devices stored within the delivery device 400. The delivery device 400 includes contrast agent switches 433, flushing switches 434, and saline switches 435 positioned along the interface surface 412, which are substantially similar to the switches 333, 334, 335 of the delivery device 300 described above. However, unlike the delivery device 300, the delivery device 400 does not include a dosimeter display or a sensor output display on the interface surface 412. Rather, the delivery device 400 includes a first engagement switch 440 and a first dispensing switch 442 positioned along the interface surface 412. Further, the elongated housing 408 includes a second engagement switch 444 and a second dispensing switch 446 positioned proximate to the switches 440, 442. Although not shown, it should be understood that the switches 444, 446 may alternatively be positioned along the interface surface 412. The position of the switches along the interface surface 412 of the delivery device 400 is for illustrative purposes only, and thus, it should be further understood that the switches may be positioned along various other surfaces of the delivery device 400 without departing from the scope of the present disclosure.

[0100]

[0150] Rather, the delivery device 400 includes a first engagement switch 440 and a first dispensing switch 442 positioned along the interface surface 412. Further, the elongated housing 408 includes a second engagement switch 444 and a second dispensing switch 446 positioned proximate to the switches 440, 442. Although not shown, it should be understood that the switches 444, 446 may alternatively be positioned along the interface surface 412. The position of the switches along the interface surface 412 of the delivery device 400 is for illustrative purposes only, and thus, it should be further understood that the switches may be positioned along various other surfaces of the delivery device 400 without departing from the scope of the present disclosure.

[0101]

[0151] Still referring to FIG. 11, the delivery device 400 has respective syringes 4 The fluid medium stored within 23, 425, 450 is configured to be delivered in response to actuation (e.g., pressing) of the corresponding switches 433, 434, 435. In other words, as will be described in more detail below, unlike the flushing switch 334 of the delivery device 300 described above, actuation of the flushing switch 434 of the delivery device 400 results in an auto-translational movement of the handle 452 of the syringe 450. In this example, the switches 433, 434, 435 are configured to be electrically actuated to flush the syringes 423, 425, 450, respectively. In other embodiments, the switches 433, 434, 435 may be configured to be actuated hydraulically, mechanically, and / or pneumatically to flush the syringes 423, 425, 450.

[0102]

[0152] Referring to FIG. 12, the handle 452 of the syringe 450 is disposed within the housing 402 of the delivery device 400, and the delivery device 400 does not include a syringe opening at the proximal end 404 of the housing 402. Thus, actuation of the handle 452 is at least partially controlled by the flushing switch 434 on the interface surface 412, rather than by the manual actuation required of the handle 352 of the delivery device 300 as described in more detail above.

[0103]

[0103]

[0153] In an exemplary mode of operation, the delivery device 400 is the delivery de It is used in a manner substantially similar to the vise 300. For example, with the syringes 423, 425, 450 assembled within the lumen 420 of the housing 402, the delivery device 400 is coupled to a catheter via the catheter hub 410 of the housing 402. With the catheter positioned within the target treatment site of a patient's body, the flushing switch 434 is actuated to automatically translate the handle 452 distally, whereby a fluid medium (e.g., saline) stored within the outer chamber 454 of the syringe is flushed therefrom, through a series of delivery conduits 426, into the connector valves 421, 422 and the catheter hub 410, respectively. Accordingly, saline is transported through the catheter hub 410 and into the catheter coupled thereto, thereby removing any air contained therein from the catheter system.

[0104]

[0154] Referring back to FIG. 11, continued actuation of the flushing switch 434 results in continued translational movement of the handle 452 in the distal direction until a first feedback (e.g., visual, auditory, tactile, mechanical, etc.) is generated. The first feedback may indicate that the fluid medium (e.g., saline) stored within the outer chamber 454 of the syringe 450 has been emptied. In this case, the operator stops actuating (e.g., pressing) the flushing switch 434 and actuates either the contrast agent switch 433 and / or the saline switch 435, whereby a contrast medium or saline medium, respectively, may be transmitted from either of the syringes 423, 425 to the second connector valve 421.

[0105]

[0155] Actuating the first and second engagement switches 440, 444 simultaneously injects The delivery device 400 includes an outer chamber 454 and an inner chamber 456 of the injector 450, and an engagement switch 440, 444 are actuated to engage the inner needle 458. The engagement switch 440, 444 is actuated to engage the inner chamber 456 of the injector 450, resulting in translational movement of the inner needle 458 within the outer chamber 454 and toward the inner chamber 456. Thus, unlike the delivery device 300 described above, the inner needle 458 of the delivery device 400 is movable within the outer chamber 454 in response to actuation of the engagement switches 440, 444. The inner needle 458 is translated within the outer chamber 454 until the inner needle 458 contacts the inner chamber 456 within the outer chamber 454. In this case, the inner chamber 456 is punctured by the inner needle 458, thereby establishing access to the fluid medium (e.g., radioembolic beads) stored within the inner chamber 456. A second feedback (e.g., visual, audio, tactile, mechanical, etc.) is generated to indicate that fluid communication to the inner chamber 456 has been established.

[0106]

[0156] Referring back to FIG. 12, proximal to the proximal end 404 of the delivery device 400 Manual retraction of the handle 452 in the direction activates the fill switch 436. 4. Proximal retraction of handle 452 generates a negative pressure within syringe 450, causing fluid medium stored within fluid reservoir 424 to be drawn into internal chamber 456 via a series of delivery conduits 426 and first connector valve 422 coupled therebetween. As internal chamber 456 receives therein the fluid medium of fluid reservoir 424, a mixture of media is formed within internal chamber 456. The operator can cease actuating (e.g., pressing) fill switch 436, thereby terminating the proximal translation of handle 452.

[0107]

[0157] In this case, the fluid media from the fluid reservoir 424 and the internal chamber 456 are mixed. With the compound formed within the internal chamber 456, actuating both dispensing switches 442, 446 results in a translational movement of the handle 452 in the distal direction towards the distal end 406 of the delivery device 400, thereby generating a positive pressure to deliver the mixture from the syringe 450, through the first connector valve 422, and into the second connector valve 421. In this case, either of the switches 433, 435 can be actuated, thereby transporting contrast agent and / or saline from the contrast agent syringe 423 and / or saline syringe 425, respectively. Thus, an additional mixture can be formed in the second connector valve 421 having a fluid medium transported from the syringes 423, 425, 450 prior to being delivered through the catheter hub 410 and into the connecting catheter. As described in more detail above with respect to the delivery devices 100, 200, 300, the delivery device 400 of the present example can include one or more sensors (e.g., dosimeters, linear encoders, optical sensors, linear displacement sensors, flow sensors, ultrasonic sensors, magnetic encoders, laser distance sensors, inductance sensors, radial encoders, volume measurement sensors, mechanical transducers, etc.) for detecting, measuring, and outputting data regarding the therapeutic particles administered to the patient by the delivery device 400. V. Mechanical delivery device having a removable slider (sliding assembly)

[0158] Figures 13 - 29 illustrate another embodiment of a delivery device 500 configured and operable to deliver radioactive material (e.g., radioactive embolization beads) while reducing radiation emission during use of the delivery device 500. It should be understood that the delivery device 500 of the present example can be configured and operable in a manner similar to the delivery device 100 described above, since the delivery device 500 is substantially similar to the delivery device 100 except for the differences explicitly noted herein.

[0108]

[0159] Referring initially to Figure 13, the delivery device 500 is in a coupled state with respect to each other and The delivery device 500 includes a console assembly 510 and a slider 540 that are operable to transition between a deployed and a retracted state. 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. As will be described in more detail herein, the interface display 530 is operable to transmit information and / or data to an operator of the delivery device 500 and, in particular, data detected by an electrical system of the delivery device 500 that may include one or more sensors disposed within the delivery device 500 (see FIG. 14). It should be understood that the delivery device 500 may include an electrical microprocessor that operates the interface display 530. In other embodiments, the interface display 530 may include a remote smart device, a tablet, and / or the like.

[0109]

[0160] The proximal end 514 of the base 512 further includes a mounting device 538 configured to securely hold an external device to the base 512 of the console assembly 510. The mounting device 538 is operable to facilitate the attachment of complementary devices to the console assembly 510 for use with the delivery device 500 during a procedure. In this example, the mounting device 538 is a hook assembly extending outwardly from a side of the base 512 sized and shaped to attach a saline bag (i.e., a complementary device) to the console assembly 510. In other embodiments, the engagement mechanism may include various other forms or configurations for securing the complementary device to the console assembly 510.

[0110]

[0161] Still referring to FIG. 13, the distal end 516 of the console assembly 510 As will be described in more detail herein, it defines a vial receiving region 518 sized and shaped to receive the console assembly 510 therein. The console assembly 510 further includes a vial engaging mechanism 520 extending from a base 512 adjacent to the distal end 516. In particular, the vial engaging mechanism 520 extends laterally outwardly from the base 512 of the console assembly 510 towards the distal end 516. The vial engaging mechanism 520 is positioned within the vial receiving region 518 of the console assembly 510 and is movably coupled to a handle 528. In particular, the handle 528 of the console assembly 510 is operable to move, and in particular, translate the vial engaging mechanism 520 within the vial receiving region 518 in response to actuation of the handle 528. The ergonomic design of the handle 528 serves to facilitate the delivery of a dose from the delivery device 500 through a range of various operator angles with respect to the base 512, thereby improving the maneuverability in performing a procedure using the delivery device 500.

[0111]

[0162] Referring now to FIG. 14, the console assembly 510 includes a handle 52 5 includes a mechanical assembly 529 disposed within base 512 configured and operable to translate a manual movement of handle 528 into a corresponding linear displacement of vial engagement mechanism 520. In this example, mechanical assembly 529 is coupled to handle 528 and vial engagement mechanism 520 such that selective actuation of handle 528 at proximal end 514 causes simultaneous actuation of vial engagement mechanism 520 at distal end 516. As described in more detail herein, mechanical assembly 529 of this example enables fluid volume control and fluid flow rate control during dose delivery with delivery device 500. It should be appreciated that the mechanical configuration of mechanical assembly 529 of this example may include various linkages, gears, pulleys, springs, and / or the like that are specifically configured to amplify a force applied to handle 528 with a corresponding displacement of vial engagement mechanism 520. In some embodiments, the mechanical assembly 529 may include and / or be replaced by one or more electrically driven systems, motors, and / or other devices operable to effect movement of the vial engagement mechanism 520 relative to the vial receiving area 518 and / or to provide feedback to an operator when the handle 528 is actuated.

[0112]

[0163] In other embodiments, the mechanical assembly 529 may be configured such that the handle 528 is 528 to generate a corresponding linear displacement of the vial engagement mechanism 520. For example, the mechanical assembly 529 of the console assembly 510 may be configured to translate various linear, rotational, lateral and / or other movements of the handle 528 to generate a disproportionate displacement of the vial engagement mechanism 520 that exceeds a force applied to the handle 528.

[0113]

[0164] Still referring to FIG. 14, and as briefly described above, The console assembly 510 includes one or more sensors for monitoring and detecting certain conditions and / or materials stored in the console assembly 510 during use of the delivery device 500. In this example, the console assembly 510 includes a linear displacement sensor 531 and a radiation sensor 533. The linear displacement sensor 531 detects the position of the console assembly 510 relative to the radiation sensor 533. 0 mechanical assembly 529 such that linear displacement sensor 531 is operable to move within console assembly 510 in response to actuation of handle 528 and corresponding movement of vial engagement mechanism 520. Linear displacement sensor 531 is configured to detect and monitor the displacement distance, rate of displacement, and / or the like, of handle 528 and vial engagement mechanism 520.

[0114]

[0165] As described in more detail herein, the handle 528 and / or the bi- By measuring the displacement distance or speed of the linear engagement mechanism 520, the computer readable and executable instructions of the delivery device 500, when executed by the processor of the delivery device 500, may determine the flow rate of the fluid medium being delivered by the delivery device 500. Additionally or alternatively, the computer readable and executable instructions of the delivery device 500, when executed by the processor of the delivery device 500, may further determine the remaining volume of the fluid medium stored within the delivery device 500. As briefly described above, data detected by the linear displacement sensor 531 and information determined by the processor of the delivery device 500 may be displayed on the interface display 530 for operator review.

[0115]

[0166] Still referring to FIG. 14, the radiation sensor 533 is located in the vial receiving area 5. It is firmly attached to the base 512 of the console assembly 510 at a location adjacent to 18. In particular, the radiation sensor 533 is positioned proximate to a sliding space 532 that is sized and shaped to receive a slider 540 therein. As will be described in more detail herein, the slider 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, media) therethrough, and as a result, the radiation sensor 533 is operable to detect and monitor the radiation level of the therapeutic particles due to its proximity to the slider 540. In particular, the slider 540 is configured to partially receive a vial assembly 580 therein for administering therapeutic particles from the delivery device 500 to a patient.

[0116]

[0167] As further described herein, stored in and passing through the slider 540 By detecting the radiation level of the radioactive medium being transported, the computer-readable and executable instructions of the delivery device 500 can determine the radiation dose delivered from the delivery device 500 when executed by a processor of the delivery device 500. Additionally or alternatively, the computer-readable and executable instructions executed by a processor of the delivery device 500 can further determine the residual radiation dose contained within the delivery device 500 during the procedure. As briefly described above, the data detected by the radiation sensor 533 and the information determined by a processor of the delivery device 500 can be displayed on the interface display 530 for operator review. In other embodiments, the delivery device 500 may include additional or fewer sensors compared to those shown and described herein (e.g., dosimeters, linear encoders, optical sensors, linear displacement sensors, flow sensors, ultrasonic sensors, magnetic encoders, laser distance sensors, inductance sensors, radial encoders, volume measurement sensors, mechanical transducers, etc.). It should be understood that the dosimeter and / or radiation sensor of the delivery device 500 can be configured to measure the residual exposure to ionizing radiation within the delivery device 500, and in particular, within the slider 540 and / or the vial assembly 580.

[0117]

[0168] Merely as an illustrative example, a linear encoder can be paired with a scale configured to encode the position of the residual dose of therapeutic particles within the vial assembly 580, such that as a result, the linear encoder can convert the encoded position into an analog or digital signal that can be decoded into a quantity. The optical sensor / encoder of the delivery device 500 converts a light beam from within the slider 540 and / or the vial assembly 580 into an electrical signal to The magnetic encoder of the delivery device 500 may be configured to measure a physical quantity of light that is converted into a readable format to measure the amount of residual radiation contained within the delivery device 500. The magnetic encoder of the delivery device 500 may be configured and operable similarly to an optical encoder to determine the amount of residual radiation, but utilizes a magnetic field instead of light. The inductive sensor encoder of the delivery device 500 may be configured to utilize electromagnetic induction to detect and measure the residual dose stored within the vial assembly 580 by generating a magnetic field therein in response to a current flowing through the vial assembly 580. The laser distance sensor of the delivery device 500 may be configured to measure the residual dose within the vial assembly 580 by transmitting a laser to measure the distance within the vial body 589 to the upper liquid surface of the therapeutic particles remaining within the vial body 589.

[0118]

[0169] As a further example, a flow sensor of the delivery device 500 The ultrasonic sensor of the delivery device 500 may be positioned in line with the tubing set, and in particular one or more of the needle 559, the manifold 555A, 555B, and / or the port 556, and may be configured to measure the amount of fluid (e.g., suspension after therapeutic particles have been effectively mixed with the fluid medium) passing therethrough. The ultrasonic sensor of the delivery device 500 may comprise a transmitter, receiver, and / or transceiver configured to measure the distance to an object (e.g., the remaining dose in the vial assembly 580) based on transmitting an ultrasonic signal (i.e., sound waves) in the vial assembly 580 and measuring the elapsed time to receive the returning sound waves. The radial encoder of the delivery device 500 may comprise an absolute encoder and / or a relative encoder, such encoder configured to convert the angular position or movement of the handle 528, the plunger 584, the mechanical assembly 529, and / or other components of the delivery device 500 into an analog or digital output signal corresponding to the remaining dose in the vial assembly 580.

[0119]

[0170] Referring back to FIG. 13, the vial engagement feature 520 is 20, which laterally extend outwardly from a neck 524 of the console assembly 510. The neck 524 of the vial engagement mechanism 520 is disposed within the protective cover 525 such that only the pair of lever arms 522 of the vial engagement mechanism 520 extend through the protective cover 525. The protective cover 525 is operable to shield one or more internal components of the console assembly 510 from the exterior of the console assembly 510, and in particular, from the vial receiving area 518. As described in more detail herein, the vial receiving area 518 of the console assembly 510 is sized and configured to receive one or more radioactive materials therein. In some embodiments, the protective cover 525 of the console assembly 510 may be formed of a variety of materials, including, for example, silicone.

[0120]

[0171] The pair of lever arms 522 are connected to a handle 528 of the console assembly 510. 5. The pair of lever arms 522 are simultaneously movable with the neck 524 of the vial engagement mechanism 520 in response to actuation of the pair of lever arms 522. Furthermore, the pair of lever arms 522 are fixed relative to one another such that a 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 securely engage the vial assembly 580 therebetween, and particularly within the space formed by the pair of lever arms 522. Thus, 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 a variety of other structural configurations suitable for engaging the vial assembly 580.

[0121]

[0172] Still referring to FIG. 13, 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. By way of example only, the safety shield 526 may be formed of acrylonitrile butadiene styrene (ABS), lead, tungsten, tin, barium, or other suitable materials configured and operable to suppress the emission of radiation. In this example, the safety shield 526 includes a wall thickness of approximately 9.525 millimeters (3 / 8 inch). In addition to suppressing radiation exposure, the safety shield 526 serves to prevent and contain any effluent and / or leakage of radioactive media. Such effluent and leakage can occur within the vial receiving region 518 and at one or more luer connections included between the console assembly 510, the slider 540, and the vial assembly 580. As will be described in more detail herein, since the safety shield 526 is selectively attachable to the console assembly 510, the safety shield 526 can be separately cleaned after use of the delivery device 500 during a procedure.

[0122]

[0173] In other embodiments, the delivery device 500 includes, in addition to the safety shield 526, And / or, instead thereof, a splash guard may be included. The splash guard may be formed of an opaque housing that surrounds the vial receiving region 518, similar to the safety shield 526, and may be selectively opened and closed by various mechanisms. For example, in some embodiments, the splash guard may include a sliding window, a hinge coupled to the console assembly 510 such that the splash guard is pivotable, and / or the like. The splash guard may be formed of various polymers, including but not limited to polycarbonate. It should be understood that the splash guard serves to provide a protective shield against effluents and / or leaks during preparation of the delivery device 500 for use in a procedure and during loading of the slider 540 and / or the vial assembly 580 onto the console assembly 510.

[0123]

[0174] 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 with the base 512 of the console assembly 510 within the sliding space 532. In this example, the pair of positioning portions 534 includes longitudinal recesses extending laterally along the sliding space 532, but it should be understood that the pair of positioning portions 534 may take various other forms and configurations other than those shown and described herein without departing from the scope of the present disclosure. For example, the positioning portions of the console assembly 510 may include one or more magnets configured to mate with corresponding magnets of the slider 540.

[0124]

[0175] Still referring to FIG. 13, the slider 540 is for therapeutic particles (e.g., radiation configured to partially receive the vial assembly 580 therein for administering the viscous fluid medium) from the delivery device 500 to a 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 lines 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 includes 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 is 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. As will be described in more detail herein, the pair of positioning portions 534 and the pair of positioning ribs 554 are operable to suppress vertical deflection (or misalignment) and / or movement of the slider 540 during use of the delivery device 500, and more specifically, during vertical translation of the vial engagement mechanism 520 and the accompanying vertical retraction of the vial assembly 580 received within the slider 540. One or more ports 556 for coupling one or more delivery conduits (i.e., tubes) to the slider 540 are further included. Since one or more delivery conduits are further coupled to one or more external devices at the ends of the lines 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 includes 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 is 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. As will be described in more detail herein, the pair of positioning portions 534 and the pair of positioning ribs 554 are operable to suppress vertical deflection (or misalignment) and / or movement of the slider 540 during use of the delivery device 500, and more specifically, during vertical translation of the vial engagement mechanism 520 and the accompanying vertical retraction of the vial assembly 580 received within the slider 540.

[0125]

[0176] The slider 540 extends from the proximal end 542 and the distal end 544, and a pair of sides It further includes an upper surface 548 positioned between the walls 546. The upper surface 548 of the slider 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 slider 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 (see FIG. 17). In some embodiments, the slider 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 slider 540. As described in more detail herein, the priming assembly 560 serves to purge air from the delivery device 500 prior to using the delivery device 500 in a procedure.

[0126]

[0177] Referring now to FIG. 15, the locking system 550 extends outwardly therefrom It includes the protruding portions 551 of the annular array, and the protruding portions 551 extend horizontally into the aperture formed by the locking system 550, particularly along the upper surface 548. The annularly arranged protruding portions 551 are formed within the inner circumference of the locking system 550 and extend along at least two continuously arranged rows. As will be described in more detail herein, the annularly arranged protruding portions 551 included in the locking system 550 engage with the corresponding locking features 586 of the vial assembly 580 (see FIG. 18), thereby being configured to firmly fix the vial assembly 580 to the slider 540. The multiple rows of the protruding portions 551 of the locking system 550 are adapted to provide a double locking system for the slider 540, and particularly for the needles 559 of the slider 540, thereby ensuring that it is firmly maintained through the septum 592 of the vial assembly 580 (see FIG. 18) during the use of the delivery device 500 in the procedure. Thus, the double locking system formed by the locking system 550 reduces the occurrence of unintended delivery of the dose during the preparation of the delivery device 500 for the procedure. It should be understood that additional and / or fewer protruding portions 551 may be included along the locking system 550 other than those shown and described herein without departing from the scope of the present disclosure. Alternatively, in other embodiments, the locking system 550 may include various other suitable engaging features configured to snap-engage with and operable in the manner of the vial assembly 580 in addition to the annularly arranged protruding portions 551 shown and described herein. For example, in other embodiments, the locking system 550 may include a threaded portion, one or more magnets, one or more crush ribs, and / or the like.

[0127]

[0178] The slider 540 includes a priming assembly 560 and a vial assembly 5 80 therein. In other words, vial chamber 558 is sized to individually receive both priming assembly 560 and vial assembly 580, separate from one another. Vial chamber 558 is enclosed in a protective chamber or shield 557 disposed about vial chamber 558. Protective shield 557 is formed of a material, such as, for example, a metal, that is configured to inhibit radiation emissions from escaping outwardly from vial chamber 558. In addition, slide 540 includes a needle along a bottom end of vial chamber 558 that extends through protective shield 557 and into vial chamber 558. Needle 559 is securely secured to vial chamber 558 such that any device received through the aperture of locking system 550 and into vial chamber 558 will contact and interact with needle 559 (e.g., priming assembly 560, vial assembly 580, and the like).

[0128]

[0179] Still referring to FIG. 15, needle 559 is a distal end disposed within slider 540. 5B. In particular, manifolds 555A, 555B are positioned below vial chamber 558 and protective shield 557. Proximal manifold 555B is fluidly coupled to needle 559, and distal manifold 555A is fluidly coupled to one or more ports 556 of slide 540. Proximal manifold 555B is in fluid communication with distal manifold 555A through a one-way check valve 553 disposed therebetween. It should be appreciated that one-way check valve 553 is configured to facilitate fluid communication from proximal manifold 555B to distal manifold 555A and prevent fluid communication from distal manifold 555A to proximal manifold 555B. In other words, one-way check valve 553 prevents the backflow of fluid into slide 540 and / or vial assembly 580 coupled thereto.

[0129]

[0180] Thus, 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. As will be described in more detail herein, the one or more ports 556 of the slider 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 omitted and an alternative device can be used, such devices being, for example, valve systems, needleless injection ports, and / or the like.

[0130]

[0181] Still referring to FIG. 15, 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. In some embodiments, the removable battery pack 570 can be pre-loaded onto the slider 540, but in other embodiments, the removable battery pack 570 is separate from the slider 540, such that as a result, it should be understood that the operator needs to couple the removable battery pack 570 to the slider 540 along the distal end 544. In any case, 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.

[0131]

[0182] ​​​The battery 572 can comprise various amounts and types of batteries, such as, for example, four disposable double A (AA) batteries, alkaline batteries, Li-ion batteries, mini-coin batteries, single form dry cells, and / or the like, to power the delivery device 500. In some embodiments, the battery 572 can be encapsulated within a polymer or wax material. As described in more detail herein, 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. 13) of the console assembly 510 when the slider 540 is coupled to the base 512 in the sliding space 532. Thus, the removable battery pack 570 is operable to provide power to the delivery device 500, and in particular, to the console assembly 510, when the slider 540 is coupled to the console assembly 510.

[0132]

[0183] Still referring to FIG. 15, the removal ​The removable tab 576 is selectively removable from the removable battery pack 570. The removable tab 576 is operable to check the battery state of the removable battery pack 570 upon removal of the removable tab 576. As will be described in more detail herein, removal of the removable tab 576 prior to initiation of a procedure using the delivery device 500 provides an indication to the operator of the delivery device 500 as to whether the removable battery pack 570 contains sufficient power stored therein to perform the procedure. The removable battery pack 570 generates feedback indicative of the charge level of the battery 572 in response to removal of the removable tab 576. For example, in some embodiments, the removable battery pack 570 includes an LED status indicator 578 (see FIG. 24) that visually displays a color (e.g., green, yellow, red) indicative of the remaining battery level of the battery 572. In other embodiments, the removable battery pack 570 may include a speaker that generates an audible alarm indicative of the remaining battery level of the battery 572. In other embodiments, it should be understood that the slider 540 and / or the console assembly 510 may be electrically powered by various other suitable power sources without departing from the scope of the present disclosure. For example, one or more of the slider 540 and / or the console assembly 510 may be directly coupled to an external power source, the console assembly 510 may include one or more batteries stored therein, and / or the like may be possible.

[0133]

[0184] Referring now to FIG. 16, the slider 540 is a removable battery pa To attach the battery pack 570 thereto, it includes one or more retention features 547 disposed along the distal end 544 of the slider 540. In particular, the retention feature 547 of the slider 540 comprises a protrusion extending outwardly from the distal end 544. The removable battery pack 570 includes one or more corresponding retention features 577 disposed along the surface of the removable battery pack 570 opposite the electrical contacts 574, and the corresponding retention feature 577 of the removable battery pack 570 is configured to engage the retention feature 547 of the slider 540. In particular, the retention feature 577 of the removable battery pack 570 comprises a recess extending inwardly into the removable battery pack 570 to receive the retention feature 547 of the slider 540 therein, thereby securely coupling the removable battery pack 570 to the slider 540 at the distal end 544. It should be understood that various other retention features 547, 577, in addition to those shown and described herein, may be included in the slider 540 and the removable battery pack 570 without departing from the scope of the present disclosure. For example, the corresponding retention features may include magnets, snaps, screws, and / or may comprise similar ones.

[0134]

[0185] In addition, as will be described in more detail herein, in some embodiments Further, the locking system 550 may include at least one planar wall 550A relative to the other circular configurations of the locking system 550. In this case, the aperture formed by the locking system 550 through the upper surface 548 of the slider 540 is not of a circular shape as shown and described above, but is of an irregular shape. In this case, the vial assembly 580 includes 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 550A. As a result, 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. 18) of the locking feature 586 must be aligned with the planar wall 550A 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.

[0135]

[0186] Referring now to FIG. 17, the priming assembly 560 of the delivery device 500 is depicted. The priming assembly 560 includes a priming conduit 562, a handle 563, a central body portion 564, an elongate shaft 566, and a needle tip 568. The central body portion 564 is sized and shaped to be slidably received within the vial chamber 558 of the slider 540 and, in particular, includes a diameter that is substantially the same as the diameter of the vial chamber 558. As a result, when the priming assembly 560 is received within the slider 540, a press fit occurs between the central body portion 564 and the vial chamber 558. The handle 563 and the elongate shaft 566 are formed integrally with the central body portion 564 with the handle 563 extending perpendicularly outward from the central body portion 564 at an opposite end of the elongate shaft 566.

[0136]

[0187] In other words, the handle 563 extends relatively upwardly from the central body portion 564 However, elongated shaft 566 extends relatively downward from central body portion 564 in a direction opposite to handle 563. Thus, when priming assembly 560 is slidably received within vial chamber 558 of slide 540, handle 563 is positioned adjacent upper surface 548 of slide 540, and elongated shaft 566 is disposed within slide 540. Handle 563 is configured to facilitate grasping and manipulating priming assembly 560 for insertion into and extraction from slide 540. It should be appreciated that in other embodiments, handle 563, central body portion 564, and / or elongated shaft 566 may be separate components that are assembled together to form priming assembly 560.

[0137]

[0188] Still referring to FIG. 17, the elongated shaft 566 is sized to have a predetermined length. 13, the handle 563 may be readily accessible to an operator of the delivery device 500 through the aperture formed by the locking system 550. It should be understood that the overall longitudinal length of the handle 563, central body portion 564, and elongated shaft 566 is substantially similar to the longitudinal length of the vial chamber 558 of the slide 540, such that the handle 563 is partially disposed within and / or partially exposed from the vial chamber 558 (see FIG. 13).

[0138]

[0189] The elongated shaft 566 of the priming assembly 560 is It further includes a needle end 568 positioned along the opposite end of the elongated shaft 566 . The needle tip 568 is formed of a material operable to receive the needle 559 of the slider 540 through the needle tip in response to the priming assembly 560 being received within the vial chamber 558 of the slider 540. For example, the needle tip 568 of the priming assembly 560 can be formed of an elastomeric material configured to be punctured by the needle 559 when the needle tip 568 is slidably inserted through the vial chamber 558 and positioned relative to the needle 559. In this example, the priming assembly 560 further includes one or more positioning portions 565A, 565B positioned along a central body portion 564 configured to maintain the priming assembly 560 within the vial chamber 558 of the slider 540.

[0139]

[0190] Referring now to FIG. 18, the vial assembly 58 0 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 any case, the engagement head 582 and the plunger 584 are movable relative to the locking feature 586 and the vial body 589 such that the engagement head 582 and the plunger 584 are slidably translatable through the locking feature 586 and the vial body 589. In particular, as will be described in more detail herein, the plunger 584 can translate in and out of an 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.

[0140]

[0191] 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 various materials including, but not limited to, metal, plastic, and / or the like.

[0141]

[0192] Still referring to FIG. 18, the vial assembly 580 further includes a safety tab 585 coupled to the plunger 584 above the relatively 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 fastened 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 prevents inadvertent movement of the plunger 584 and the corresponding ​​It is configured to suppress the inadvertent delivery of a fluid medium (e.g., therapeutic particles, radioactive embolization beads) stored within the internal chamber 588 of the vial body 589. As will be 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 and the vial engagement mechanism 520, and in particular, the engagement of a pair of lever arms 522 and the engagement head 582.

[0142]

[0193] The engagement head 582 of the vial assembly 580 is shown and described herein as including a pair of arms 581 that extend laterally outward from the plunger 584. It should be understood, however, that the engagement head 582 may include various other structural configurations suitable for engaging a pair of lever arms 522 of the vial engagement mechanism 520. For example, referring now to FIGS. 19A-19C, alternative embodiments of the engagement head of the vial assembly 580 are depicted. It should be understood that the engagement head shown and described herein may be incorporated into the vial assembly 580 in the same manner as the engagement head 582 described above.

[0143]

[0194] Referring now to FIG. 19A, an alternative embodiment of the engagement head 582A is depicted. It is written. The engagement head 852A includes a ring 583A that defines an aperture together with the upper plane 584A of the plunger 584. The ring 583A includes at least a pair of flexible tabs (elastic arms) 581A that extend laterally inward from the ring 583A and into the aperture formed within the ring 583A. In particular, the pair of flexible tabs 581A are separated from each other on opposite side surfaces of the ring 583A and are angled relatively inwardly toward each other. In this case, the pair of flexible tabs 581A are transverse to the longitudinal length of the plunger 584. In this example, the pair of flexible tabs 581A can be bent by hand, and as a result, the pair of flexible tabs 581A can be selectively pressed outwardly away from each other when an inward force is applied thereto (e.g., from a pair of lever arms 522 received through the ring 583A). The pair of flexible tabs 581A are elastically biased in an initial state to expand outwardly relative to each other and into the aperture defined by the ring 583A.

[0144]

[0195] In this example, the pair of lever arms 522 of the vial engagement mechanism 520 can be received through the aperture formed by the ring 5 83A, and as a result, the pair of lever arms 522 are positioned between and engaged with the pair of flexible tabs 581A. In this case, the engagement head 582A is firmly attached to the vial engagement mechanism 520. It should be understood that the engagement head 582A of this example can be configured and operable to correspond to an alternative embodiment of a vial engagement mechanism that includes features different from the pair of lever arms 522 of the vial engagement mechanism 520 shown and described above.

[0145]

[0196] Referring now to FIG. 19B, an alternative engagement head 582B is depicted. The engagement head 582B includes a plurality of flexible fingers 581B extending vertically upward from the plunger 584. In particular, the plurality of flexible fingers 581B extend parallel to and coaxially aligned with the longitudinal length of the plunger 584. An end of each of the plurality of flexible fingers 581B is positioned relatively above the upper planar surface 584B of the plunger 584. In this example, the plurality of flexible fingers 581B are manually bendable such that the plurality of flexible fingers 581B can be selectively pressed inwardly toward one another when an outward force is applied thereto. The plurality of flexible fingers 581B are elastically biased in an initial state to spread outwardly away from one another.

[0146]

[0197] Thus, engagement head 582B is inserted into vial engagement feature 520 and particularly In addition, the insertion between the pair of lever arms 522 of the vial engagement mechanism 520 This causes the flexible fingers 581B to be compressed inwardly, thereby engaging a pair of lever arms 522 disposed about the flexible fingers 581B. In this case, the flexible fingers 581B are secured to the vial engagement mechanism 520 by the flexible fingers 851B expanding outwardly relative to the pair of lever arms 522. It should be understood that the engagement head 582B of this example may be configured and operable to correspond to alternative embodiments of the vial engagement mechanism including different features than the pair of lever arms 522 of the vial engagement mechanism 520 shown and described above.

[0147]

[0198] Referring now to FIG. 19C, another alternative engagement head 582C is depicted. The engagement head 582C includes a pair of flexible clamps 581C disposed on the plunger 584'. The plunger 584' of this embodiment differs from the plunger 584 of the previous embodiment in that the plunger 584' is bifurcated along the longitudinal length of the plunger 584'. This bifurcated portion extends from the pair of flexible clamps 581C of the engagement head 582C to a terminal end 584C. The pair of flexible clamps 581C extend parallel to and coaxially aligned with the longitudinal length of the plunger 584. In this example, the pair of flexible clamps 581C can be manually bent such that the pair of flexible clamps 581C can be selectively compressed inwardly toward one another when an external force is applied thereto. The pair of flexible clamps 581C are elastically biased in an initial state to spread outwardly away from one another.

[0148]

[0199] Therefore, the engagement head 582C is inserted into the vial engagement mechanism 520, specifically, Inserting the vial engagement head 582C between the pair of lever arms 522 of the vial engagement mechanism 520 causes the pair of flexible clamps 581C to be compressed inwardly, thereby engaging the pair of lever arms 522 disposed around the pair of flexible clamps 581C. In this case, the pair of flexible clamps 581C is secured to the vial engagement mechanism 520 by the pair of flexible clamps 581C expanding outwardly relative to the pair of lever arms 522. It should be understood that the engagement head 582C of the present example may be configured and operable to correspond to alternative embodiments of the vial engagement mechanism including different features than the pair of lever arms 522 of the vial engagement mechanism 520 shown and described above. It should be further understood that engagement heads of various other configurations and geometries may be incorporated with the vial assembly 580 without departing from the scope of the present disclosure. For example, in other embodiments, the engagement head of the vial assembly 580 may comprise one or more magnets, screws, cams, and / or the like.

[0149]

[0200] Referring back to FIG. 18, 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 outwardly 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 disposed 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 attach 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 alignment of the planar walls 550A and 586A requires that the vial assembly 580 be received through an aperture formed by the locking system 550.

[0150]

[0201] The planar walls 550A, 550B are such that the safety tab 585 of the vial assembly 580 It should be appreciated that the pair of lever arms 522 of the vial engagement mechanism 520 serve to ensure that the safety tab 585 is coupled to the plunger 584 in a manner that allows for removal of the safety tab 585 by the vial engagement mechanism 520. In particular, the pair of lever arms 522 of the vial engagement mechanism 520 are configured to exert a lateral force on the safety tab 585 in response to the slide 540 being slidably received within the slide space 532. Thus, by requiring the vial assembly 580 to be properly aligned with the locking system 550 when the vial assembly is coupled to the slide 540, orientation of the safety tab 585 relative to the pair of lever arms 522 can be easily achieved, thereby facilitating removal of the safety tab 585 when the slide 540 is coupled to the console assembly 510.

[0151]

[0202] Still referring to FIG. 18, the vial body 589 is secured to the locking feature 586. 580。580 may include a longitudinal length extending relatively downwardly from the vial body 589 and 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 may be from about 8 millimeters to about 10 millimeters, and in this example, includes 9 millimeters, while the longitudinal length of the plunger 584 may 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 translational movement of the plunger 584 into the internal chamber 588 of the vial body 589 causes the fluid medium stored therein to be delivered out of the vial body 589. As described in more detail herein, translational movement of the plunger 584 through the internal chamber 588 of the vial body 589 allows the fluid medium stored within the vial body 589 to be dispensed out of the vial assembly 580. The vial body 589 may be formed from a variety of materials, including, for example, thermoplastic polymers, copolyesters, polycarbonates, biocompatible plastics, polysulfones, ceramics, metals, and / or the like.

[0152]

[0203] In this example, the vial body 589 has an internal chamber 588 of the vial body 589. The vial body 589 is formed of a material configured to suppress radiation emissions from the stored fluid medium. For example, the vial body 589 may be formed of a plastic such as polycarbonate and may have a width of approximately 9 millimeters (mm). The density and material composition of the vial body 589 combine to suppress gamma radiation emissions from electron particles stored within the internal chamber 588. In this example, the chemical composition of the plastic of the vial body 589, in combination with a wall thickness of 9 mm, provides a plurality of atoms disposed within the vial body 589 that can handle beta radiation that generates electrons and reduce the emission of said radiation from the vial assembly 580. Thus, the vial assembly 580 allows an operator to handle the radioactive material 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 sections may be incorporated within the vial body 589 of the vial assembly 580 without departing from the scope of the present disclosure.

[0153]

[0204] Still referring to FIG. 18, the vial body 5 of the vial assembly 580 89 is sealed at a first end by locking feature 586. Vial assembly 580 further includes a cap 590 positioned at an opposing end of vial body 589 opposite locking feature 586 such that cap 590 seals a second end of vial body 589 of vial assembly 580. Additionally, vial assembly 580 includes a septum 592 positioned adjacent to cap 590 and in fluid communication with the end of vial body 589 opposite locking feature 586. Septum 592 forms a seal against the end of vial body 589, and cap 590 holds septum 592 therein. Septum 592 can be formed of various materials including, for example, elastomers, silicones, bromobutyl elastomers, rubbers, urethanes, and / or the like. Septum 592 provides an airtight seal for vial body 589 and is configured to thereby suppress release of a fluid medium (e.g., radiation embolization beads) stored therein. As described in more detail herein, septum 592 of vial assembly 580 is configured to be pierced by needle 559 of slider 540 when vial assembly 580 is received within vial chamber 558, thereby establishing fluid communication between vial body 589 and slider 540. In other embodiments, instead of septum 592, alternative devices such as, for example, valve systems, needle injection ports, and / or the like can be used.

[0154]

[0205] Referring to FIG. 20, vial assembly 580 is opposite the engagement head 582 It further includes a stopper 594 fixedly coupled to the end of the plunger 584 on the side. In this case, since the plunger 584 is coupled to and slidably translatable through the 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 depressions 595 defined between at least two ribs 593. In this example, the stopper 594 includes six ribs 593 and two cavities formed therebetween, but it should be understood that in other embodiments, additional and / or fewer ribs 593 and depressions 595 may be included in the stopper 594.

[0155]

[0206] The stopper 594 is a liquid-tight seal for the internal chamber 588 of the vial body 589 It is formed of various polymers configured to form a stopper and 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 suppress 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 inner chamber 588 of the vial body 589, thereby suppressing the fluid medium from crossing 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 to capture, any fluid medium that may inadvertently diffuse (i.e., leak) past the ribs 593 of the stopper 594. Thus, 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.

[0156]

[0207] Still referring to FIG. 20, two or more ribs 593 of the stopper 594 are Additionally, in response to the translational movement of the plunger 584, it is 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. With the ribs 593 of the stopper 594 pressed against the inner 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 inner chamber 588 of the vial body 589, such that any fluid The media is also effectively redirected again within the vial body 589 in the direction of travel of the plunger 584 and the stopper 594. The vial assembly 580 further includes an annular washer 596 disposed within the vial body 589. In particular, the annular washer 596 is firmly fixed to the plunger 584 adjacent to the stopper 594, and this stopper 594 is fixed 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.

[0157]

[0208] The annular washer 596 is, for example, plastic, metal, and / or the like It can be formed of various materials, such as. The annular washer 596 can be fixedly attached to the plunger 584 by various suitable means, including, for example, an adhesive. It should be understood that the annular washer 596 is sized and shaped according to the size (e.g., diameter) of the inner chamber 588 of the vial body 589 such that the annular washer 596 can slideably translate within the inner chamber 588 of the vial body 589 simultaneously with the plunger 584 and the stopper 594. The annular washer 596 is configured to prevent the plunger 584 from detaching from the vial body 589 by abutting against the lower end of the locking feature 586 when the plunger 584 is translated maximally relatively outwardly (i.e., upwardly). In other words, since the annular washer 596 is firmly fixed to the end of the plunger 584 disposed within the vial body 589 and the plunger 584 has a size smaller than the vial body 589 to allow translational movement of the plunger 584 through the vial body 589, the annular washer 596 serves as an obstacle to prevent the plunger 584 from translating outside the vial body 589. The annular washer 596 is configured to engage the lower end of the locking feature 586 in response to retraction of the plunger 584 from the vial body 589 at a predetermined distance (i.e., the predetermined length of the plunger 584).

[0158]

[0209] Referring now to FIG. 21, a sterile container assembly 600 is depicted. Sterile Container assembly 600 is sized and shaped to receive vial assembly 580 therein for storing and transporting vial assembly 580 prior to use of vial assembly 580 while maintaining the sterility of vial assembly 580. The sterile container assembly 600 includes an upper housing 602 having a closed end 604 and an open end 606, and a lower housing 612 having a closed end 614 and an open end 616. The closed ends 604, 614 of both housings 602, 612 of the sterile container assembly 600 include materials operable to form a liquid seal, such as, for example, synthetic materials, polyethylene fibers, and / or the like. The seals formed at the closed ends 604, 614 of both housings 602, 612 are configured to allow water vapor permeation therethrough for sterilization of the contents of housings 602, 612.

[0159]

[0210] The open ends 606, 616 of both housings 602, 612 include mating systems 608, 618 that are configured to couple the housings 602, 612 to each other. In this example, the mating systems 608, 618 of the sterile container assembly 600 are threaded portions positioned along each of the open ends 606, 616 of the housings 602, 612 and configured to engage with each other such that the threaded portions are configured to engage with each other to secure the upper housing 602 to the lower housing 612. It should be understood that various other mating systems 608, 618, such as, for example, magnets, rubber bands, snaps, and / or the like, can be incorporated with the sterile container assembly 600 without departing from the scope of the present disclosure. The sterile container assembly 600 can be formed of various materials including, but not limited to, metals, plastics, and / or the like. The sterile container assembly 600 includes a liquid seal formed along the closed ends 604, 614 and a gasket seal formed between the open ends 606, 616 ​Due to 90 , when the upper housing 602 is coupled to the lower housing 612, it is configured and operable to suppress leakage of therapeutic particles from the sterile container assembly 600 to the outside.

[0160]

[0211] Referring now to FIG. 22, the vial assembly 580 is depicted as being received within the sterile container assembly 600. In particular, the cap 590 of the vial assembly 580 is received at and positioned adjacent to the closed end 614 of the lower housing 612 of the sterile container assembly 600. Further, the engagement head 582 of the vial assembly 580 is received at and positioned adjacent to the closed end 604 of the upper housing 602 of the sterile container assembly 600. In this case, the open ends 606, 616 of the housings 602, 612 of the sterile container assembly 600 are secured to each other via the respective mating systems 608, 618 of the housings 602, 612. In some embodiments, at least one of the upper housing 602 and / or the lower housing 612 includes a gasket seal adjacent the open ends 606, 616 such that a seal is formed proximate the mating systems 608, 618 when the upper housing 602 is coupled to the lower housing 612. In the present example, the upper housing 602 includes an annular gasket seal 610 that extends within the upper housing 602 adjacent the open end 606 and, in particular, along the mating system 608 of the upper housing 602. The gasket seal 610 is configured to form an airtight seal between the housings 602, 612 of the sterile container assembly 600 when the mating systems 608, 618 are coupled to the housings 602, 612.

[0161]

[0212] In other embodiments, the vial assembly 580 is a loading system (shown ​​It can be stored and transported to the delivery device 500 by (not present). The loading system may include a radiation shield and is configured to hold the vial assembly 580 therein. The loading system may include a removable sliding portion that can be aligned with the vial engagement mechanism 520 of the console assembly 510, and this sliding portion includes one or more plates formed of various materials, including lead, tungsten, and / or various other polymers, to provide a radiation shield. The lead plate can be formed with various wall thicknesses, including, for example, 9.525 millimeters (3 / 8 inch). In some embodiments, the loading system may be an extendable tray, and such a tray can be selectively retracted and / or pivoted back to a predetermined location for use with the delivery device 500. The sliding portion of the loading system may include a groove along a portion of the loading system where the vial assembly 580 is stored, such that the groove receives and holds any effluent and / or leakage of the fluid medium from the vial body 589.

[0162]

[0213] Referring now to FIGS. 23 - 32 in conjunction with the flowchart of FIG. 33, an exemplary method 700 of operating the delivery device 500 is schematically depicted. The depictions of FIGS. 23 - 33 and the following accompanying description are not intended to limit the subject matter described herein or to represent an exact description of how a fluid medium can be delivered using the delivery device 500. Rather, it is intended to provide a simple schematic appearance for illustrative purposes of the general administration of a radioactive medium from the delivery device 500 described herein.

[0163]

[0214] In step 702 of FIG. 33, the removal The removable tab 576 is operative to determine the amount of power contained within the battery 572 of the removable battery pack 570. In particular, the removable tab 576 is removed from the removable battery pack 570, and a feedback output is generated to identify the state of the battery 572 of the removable battery pack 570. At step 706, the operator of the delivery device 500 determines whether the battery 572 of the removable battery pack 570 contains a sufficient amount of power to perform the procedure by observing the feedback output generated by the removable battery pack 570. In this example, the removable battery pack 570 includes an LED status indicator 578 (see FIG. 24) that displays a green light when the battery 572 contains a sufficient amount of power to perform the procedure and a red light when the battery 572 contains an insufficient amount of power to perform the procedure. In response to determining at step 704 that the battery 572 contains an insufficient amount of power, the operator, at step 706, replaces the slider 540 with a new slider 540 for use with the console assembly 510 to perform the procedure. Alternatively, in other embodiments, rather than replacing the slider 540 entirely, the operator may disconnect the removable battery pack 570 from the slider 540 and attach a new removable battery pack 570 to the original slider 540. In either case, the exemplary method 700 returns to step 702 where the removable tab 576 of the new removable battery pack 570 is operative to determine whether a sufficient amount of power is present within the battery 572 to perform the procedure.

[0164]

[0215] Determining at step 704 that the battery 572 contains an insufficient amount of power

[0165]

[0216] Referring now to FIG. 30, at step 702 when the battery 572 is sufficient ​In response to determining that an amount of power is included, one or more delivery conduits are coupled to the slider 540 via one or more ports 556 in step 708. In particular, the dosage delivery conduit 10A is coupled to the slider 540 at the delivery port 556A, the contrast agent conduit 10B is coupled to the slider 540 at the contrast agent port 556B, and the flushing conduit 10C is coupled to the slider 540 at the flushing port 556C. The opposite end of the dosage delivery conduit 10A is initially coupled to a fluid reservoir, such as a collection bowl, for example. As will be described in more detail herein, once the slider 540 is effectively primed by the fluid medium via the contrast agent conduit 10B, the dosage delivery conduit 10A can subsequently be coupled to an external device, such as a catheter. The opposite end of the flushing conduit 10C is coupled to an external device, such as a syringe, for example. With both the dosage delivery conduit 10A and the flushing conduit 10C coupled to the slider 540, in step 710, the slider 540 is flushed with a fluid medium (e.g., saline) from a syringe coupled to the flushing conduit 10C. In this case, the fluid medium is injected through the flushing conduit 10C into the distal manifold 555A of the slider 540 and exits the slider 540 through the dosage delivery conduit 10A. Thus, the fluid medium is ultimately received and disposed (or processed therein) by the collection bowl via the dosage delivery conduit 10A. In other embodiments where the console assembly 510 and / or the slider 540 are electrically coupled to an external power source instead of the removable battery pack 570 described above, it should be understood that the corresponding steps 702, 704, 706 of the exemplary method 700 described above can be replaced and / or completely omitted without departing from the scope of the present disclosure.

[0166]

[0217] The distal manifold 555A of the slider 540 is from the proximal manifold 555B , since they are separated 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. Instead, 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, as a result of which 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. Step 710 may be repeated as necessary to effectively flush the slider 540 and the dose delivery line 10A coupled thereto. It should be understood that this may be repeated as necessary to effectively flush the slider 540 and the dose delivery line 10A coupled thereto.

[0167]

[0218] Referring back to FIG. 24, in step 712, the contrast agent conduit 10B It is coupled to the slider 540 at the contrast agent port 556B. The opposite end of the contrast agent conduit 10B is coupled to a fluid medium supply, such as a bag fixed to the console assembly 510 by, 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 568 in fluid communication with the needle 559, the syringe is fluidly coupled to the priming conduit 562 of the priming assembly 560, and the plunger of the syringe is retracted, thereby drawing saline from the saline bag into the syringe through the contrast agent conduit 10B, the contrast agent port 556B, the slider 540, and the priming conduit 562. The plunger of the syringe is then pushed inward to send the drawn saline in the opposite direction through the priming conduit 562, the central body portion 564, the elongated shaft 566, and the needle tip 568 of the priming assembly 560, and as a result, the saline is received into the needle 559 of the slider 540. Accordingly, the manifolds 555A, 555B of the slider 540 are effectively primed with saline from the syringe since 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. It should be understood that step 712 can be repeated as necessary to remove all air from the slider 540 and the collection line coupled thereto.

[0168]

[0219] Referring now to FIG. 23, and also in step 714, the console asse The safety shield 526 of the console 510 is detached from the base 512 such that the vial receiving region 518 is exposed. The vial engaging mechanism 520 is positioned within the vial receiving region 518 and is readily accessible to the operator of the delivery device 500 with the safety shield 526 removed from the base 512 of the console assembly 510. At step 716, the handle 528 of the console assembly 510 is actuated, thereby moving the vial engaging mechanism 520 along with the vial receiving region 518. More particularly, the handle 528 is translated and / or pivoted upwardly relative to the base 512, thereby translating the pair of lever arms 522 and the neck 524 of the vial engaging mechanism 520 downwardly relative to the base 512, such that as a result, the vial engaging mechanism 520 is positioned proximate to the sliding space 532.

[0169]

[0220] Referring now to FIG. 30 and also at step 718, 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 dose 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 dose delivery conduit 10A. Further, at step 718, the slider 540 is fluidly coupled to a contrast agent source, such as a saline bag, secured to the console assembly 510 via, for example, a mounting device 538 (see FIG. 13). 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.

[0170]

[0221] 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, 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, so that the saline from the saline bag can be drawn through the needle 559 of the slider 540 into the vial body 589 of the vial assembly 580.

[0171]

[0222] Referring now to FIG. 24, also in step 720, the priming assembly 560 is removed from the slider 540 by gripping the handle 563 and pulling the priming assembly 560 outwardly from the vial chamber 558. When the handle 563 is pulled out from the slider 540 through an aperture formed by the locking system 550, the needle end 568 of the priming assembly 560 is disengaged from the needle 559 of the slider 540. In some embodiments, feedback (e.g., mechanical, tactile, etc.) indicating the detachment of the needle end 568 from the needle 559 is generated so that the operator receives an indication of the cut.

[0172]

[0223] Referring now to FIG. 25, in step 722, the vial assembly 580 is slidably inserted into the slide 540. In particular, the vial assembly 580 is removed from the sterile container assembly 600 in which it is initially stored. The vial assembly 580 is removed from the sterile container assembly 600 by separating the housings 602, 612 of the sterile container assembly 600 in response to the decoupling of the corresponding mating systems 608, 618 of the housings 602, 612. Because the sterile container assembly 600 includes a gasket seal 610 and liquid seals along the closed ends 604, 614 of both housings 602, 612, the sterile container assembly 600 effectively maintains the radioactive medium stored within the vial assembly 580 during storage and transport of the vial assembly 580 for use in a procedure. It should be appreciated that in some embodiments, the sterile container assembly 600 containing the vial assembly 580 therein may be stored within a lead pod until it is desired to use the vial assembly 580. The cap 590 of the vial assembly 580 is inserted through an aperture defined by the locking system 550 in the upper surface 548 of the slide 540, and the vial assembly 580 is gradually inserted therethrough until the locking feature 586 contacts the locking system 550.

[0173]

[0224] Referring now to FIG. 26A, the vial assembly 580 includes a vial assembly 5. In particular, the vial body 589 is inserted into the vial chamber 558 with the cap 590 positioned proximate to the needle 559. In this case, the side edges 587 of the locking features 586 contact or abut the first row of the annularly arranged projections 551 of the locking system 550. Continued advancement of the vial assembly 580 into the slide 540 bends the annularly arranged projections 551 positioned along the first row outwardly in response to the application of a force thereto generated by the side edges 587. In other words, the side edges 587 of the locking features 586 urge the annularly arranged projections 551 outwardly in response to the vial assembly 580 being received within the vial chamber 558.

[0174]

[0225] When the annularly arranged protrusions 551 of the locking system 550 bend outwardly relative to the side edge 587 disposed therein 7, the continued translational movement of the vial assembly 580 into the vial chamber 558 causes the side edge 587 of the locking feature 586 to advance beyond the first row of the annularly arranged protrusions 551, as a result of which the force applied thereto from the side edge 587 is removed. In this case, the annularly arranged protrusions 551 along the first row can bend inwardly and return to their initial position, with the side edge 587 positioned below the first row of the protrusions 551. In some embodiments, when the side edge 587 extends through the annularly arranged protrusions 551 feedback is generated by the annularly arranged protrusions 551 (e.g., an audible click sound), thereby indicating to the operator that the vial assembly 580 is engaged with the locking system 550. Thus, with the first row of the protrusions 551 positioned to cover the side edge 587 of the locking feature 586, the locking system 550 prevents the vial assembly 580 from being pulled out of the vial chamber 558 of the slider 540 due to the obstacle formed by the first row of the protrusions 551. In this case, the needle 559 is positioned relative to and / or received through the cap 590, but does not contact the septum 592.

[0175]

[0226] Referring now to FIG. 26B, the continued translational movement of the vial assembly 580 into the vial chamber 558 of the slider 540 will then result in subsequent engagement between the side edge 587 of the locking feature 586 and the locking system 550. In particular, the side edge 587 engages the second row of the annularly arranged protrusions 551 of the locking system 550. The continued advancement of the vial assembly 580 into the slider 540 causes the protrusions 551 positioned along the second row to bend outwardly in response to the application of the force generated thereon by the side edge 587. As the side edge 587 advances past the protrusions 551, the side edge 587 presses the protrusions 551 outwardly until the side edge 587 of the locking feature 586 advances beyond the second row of the protrusions 551.

[0176]

[0227] In this case, the applied force from side edge 587 is removed, and the annular The projections 551 of the arrangement are allowed to bend inwardly back to their initial position with the side edges 587 positioned under the second row of projections 551. Thus, because the second row of projections 551 is positioned over the side edges 587 of the locking features 586, the locking system 550 prevents the vial assembly 580 from being withdrawn from the vial chamber 558 of the slide 540 due to the obstruction formed by the second row of projections 551. In this case, the needle 559 is positioned against and received through the cap 590 and the septum 592. More specifically, the needle 559 pierces the septum 592 of the vial assembly 580, such that the slide 540 is in fluid communication with the vial body 589 of the vial assembly 580 through the needle 559.

[0177]

[0228] Referring now to FIG. 27, and again in step 724, the vial assembly With the bridge 580 securely coupled to the slide 540, the slide 540 is coupled to the console assembly 510 by translating the proximal end 542 of the slide 540 toward and into the distal end 516 of the console assembly 510. In particular, the proximal end 542 of the slide 540 is directed into the sliding space 532 of the console assembly 510 by aligning the positioning rib 554 of the slide 540 with the positioning portion 534 of the console assembly 510. Once the distal end 544 and the proximal end 542 of the slide 540 are fully sealed within the sliding space 532 of the console assembly 510, the electrical contacts 574 of the removable battery pack 570 interact with corresponding electrical contacts 511 of the console assembly 510 (see FIG. 23 ). In this case, power from the battery 572 is transmitted via electrical contacts 574 to the console assembly 510, thereby operating the console assembly 510 of the delivery device 500. In this case, the interface display 530 of the console assembly 510 is operated to display appropriate real-time information regarding the delivery device 500 during the procedure.

[0178]

[0229] Referring to FIG. 28A, a schematic diagram of an interface display 530 is shown. In turn, the interface display 530 of the console assembly 510 provides a wealth of data regarding the delivery device 500. By way of merely illustrative example, the interface display 530 of this example displays at least the total duration 530A of dose delivery, the life 530B of the battery 572, the volume 530C of fluid medium stored in the vial assembly 580, the current state 530D of the delivery device 500, the volume 530C of fluid medium being injected by the delivery device 500, and the amount of fluid medium being delivered. Data relating to the total body volume 530E, the radiation fraction 530F of the fluid medium contained within the vial assembly 580, and / or the volumetric injection / dilution flow rate 530G of the fluid medium delivered and / or withdrawn by the delivery device 500 are displayed.

[0179]

[0230] In step 724, the slide 540 is coupled to the console assembly 510. In the engaged state, the interface display 530 indicates the initiation of a procedure with the delivery device 500, and the data displayed thereon will be indicative of such. As use of the delivery device 500 progresses, the data displayed along the interface display 530 may progressively update to reflect the current status and characteristics of the delivery device 500. It should be understood that the various information items 530A-530G shown and described herein are for illustrative purposes only, and that more and / or less data may be detected, monitored, and displayed by the delivery device 500 in the interface display 530.

[0180]

[0231] Referring back to FIG. 27, the distal end 544 of the slider 540 is inserted into the sliding space 532. 5. With the vial engagement mechanism 520 fully sealed in place and translated to the lower position in step 716, the pair of lever arms 522 engage the safety tab 585 of the vial assembly 580, thereby disengaging the safety tab 585 from the plunger 584. In other words, as the slide 540 is translated into the slide space 532 in response to a force applied along the handle 552 at the proximal end 542, the position of the lever arm 522 of the vial engagement mechanism 520 aligns with and engages the safety tab 585 of the vial assembly 580. Thus, continued translation of the slide 540 into the slide space 532 results in the disengagement of the safety tab 585 from the plunger 584 by the pair of lever arms 522. In this case, plunger 584 of vial assembly 580 is not prevented from translating into and / or out of interior chamber 588 of vial body 589 in response to actuation of vial engagement mechanism 520 coupled thereto.

[0181]

[0232] Additionally, in step 724, the safety shield 526 is 5. In this case, the safety shield 526 is attached to the base 512 of the console assembly 510 over the vial receiving area 518, such that the safety shield 526 contains the vial engagement mechanism 520, the vial assembly 580, and the slide 540 within the vial receiving area 518. Thus, during a procedure with the delivery device 500, the safety shield 526 maintains one or more components of the delivery device 500 described herein contained within the vial receiving area 518, thereby shielding the operator and / or patient from one or more fluid media (e.g., radioembolic microspheres) being transported between the console assembly 510, the slide 540, and / or the vial assembly 580.

[0182]

[0233] 29, and again in step 726, the console assembly The handle 528 of the assembly 510 is actuated (e.g., translated relatively downward), thereby moving the vial engagement mechanism 520 in the vial receiving area 518 distally (e.g., translated linearly) away from the slide space 532 and the slide 540 received therein. In this case, because the pair of lever arms 522 of the vial engagement mechanism 520 are positioned about the plunger 584 of the vial assembly 580, the translational movement of the neck 524 and the pair of lever arms 522 engages the pair of lever arms 522 with the engagement head 582, and in particular the lower ends of the pair of arms 581. With the safety tab 585 removed, the plunger 584 is operable to translate upward and out of the vial body 589 of the vial assembly 580 in response to the translational movement of the vial engagement mechanism 520. Thus, in response to the actuation of the handle 528 in step 726, the plunger 584 is moved upward by the pair of arms 581 of the engagement head 582 through the pair of lever arms 522. Due to being pulled toward the vial engaging mechanism 520, it translates upward simultaneously with the translational movement of the vial engaging mechanism 520.

[0183]

[0234] In this case, the pair of lever arms 522 of the vial engagement mechanism 520 are not firmly coupled to the pair of arms 581 of the engagement head 582. Rather, the pair of lever arms 522 are merely positioned under the pair of arms 581, such that as a result of the translational movement of the neck 524 of the vial engagement mechanism 520, the pair of lever arms 522 abut against and upwardly pull on the pair of arms 581. When the vial engagement mechanism 520 pulls the plunger 584 of the vial assembly 580 relatively upward within the vial receiving region 518, it should be understood that the annularly arranged protrusions 551 of the locking system 550 inhibit the movement and / or upward translational movement of the vial assembly 580, and particularly the vial body 589, from the vial chamber 558 of the slider 540. Additionally, when the vial engagement mechanism 520 pulls the vial assembly 580 stored within the slider 540 relatively upward within the vial receiving region 518, it should be further understood that the positioning portion 534 of the console assembly 510 inhibits the movement and / or upward translational movement of the slider 540 from the sliding space 532 of the console assembly 510.

[0184]

[0235] Still referring to FIG. 29, the handle 52 of the console assembly 510 ​Due to the continued operation of 8, the continued translational movement of the vial engagement mechanism 520, and as a result the plunger 584, is brought about until the annular washer 596 comes to the position of the locking feature 586 (see FIG. 20). In this case, the annular washer 596 prevents the plunger 584 from further translating relative to the vial body 589 despite the continued operation of the handle 528 of the console assembly 510. With the annular washer 596 of the vial assembly 580 abutting against the locking feature 586, thereby suppressing further translation of the plunger 584 out of the inner chamber 588 of the vial body 589 (and the aperture formed by the locking system 550), when the handle 528 is continuously operated, the pair of arms 581 of the engagement head 582 bend outward relative to the plunger 584. This is due to the upward force applied there by the pair of lever arms 522 in response to the vial engagement mechanism 520 translating upward and the plunger 584 being suppressed from moving further.

[0185]

[0236] In other words, with the pair of lever arms 522 pressed against the pair of arms 581 of the engagement head 582, the continued translational movement of the neck 524 of the vial engagement mechanism 520 translates the pair of lever arms 522 upward, thereby applying a force to the pair of arms 581 of the engagement head 582. The engagement head 582 is integrally formed with the plunger 584, and since the plunger 584 is suppressed from further translating relative to the vial body 589 due to the obstacle formed between the annular washer 596 and the locking feature 586, the pair of arms 581 of the engagement head 582 are flexibly deformed to expand outward so as to receive the upward translational movement of the pair of lever arms 522. As a result, the pair of lever arms 522 of the vial engagement mechanism 520 are firmly coupled to the pair of arms 581 of the engagement head 582 by snap - type engagement, thereby locking the vial engagement mechanism 520 to the vial assembly 580.

[0186]

[0237] Referring now to FIG. 30, the vial engagement mechanism 520 and the plunger 58 When 4 are simultaneously translated within the vial accommodation region 518, due to the retraction of the stopper 594, a negative pressure is generated within the internal chamber 588 of the vial body 589. In this case, with the physiological saline bag coupled to the slider 540 via the contrast agent conduit 10B and the contrast agent port 556B, the physiological saline from the physiological saline bag is drawn into the internal chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Therefore, when the vial body 589 is pre-filled with a radioactive fluid medium (e.g., radiation embolization microspheres), the physiological saline is effectively mixed with the radioactive fluid medium within the vial body 589 when the plunger 584 is drawn from the internal chamber 588 and a negative pressure is generated through the delivery device 500. Referring now to FIG. 31, also at step 728, the actuation of the handle 528 in the opposite direction (e.g., translated downwardly and / or pivoted with respect to the base 512) results in the simultaneous movement (e.g., linear translation movement) of the vial engagement mechanism 520. In this case, the neck 524 translates downwardly towards the sliding space 532, thereby translating the plunger 584 into the vial body 589 due to the firm engagement between the pair of arms 581 of the engagement head 582 and the pair of lever arms 522 of the vial engagement mechanism 520. Since the stopper 594 is movably disposed within the vial body 589, the translational movement of the plunger 584 causes a simultaneous translational movement of the stopper 594 through the vial body 589, thereby generating a positive pressure therein. As a result, the dose of the physiological saline and radioactive fluid medium mixture stored within the internal chamber 588 is transported out of the vial body 589 through the needle 559 and into the proximal manifold 555B. Since the one-way check valve 553 is configured to allow fluid communication from the proximal manifold 555B to the distal manifold 555A, this dose is delivered therethrough and into the dose delivery conduit 10A via the dose delivery port 556A.

[0187]

[0238] Referring now to FIG. 31, also at step 728, the actuation of the handle 528 in the opposite direction (e.g., translated downwardly and / or pivoted with respect to the base 512) results in the simultaneous movement (e.g., linear translation movement) of the vial engagement mechanism 520. In this case, the neck 524 translates downwardly towards the sliding space 532, thereby translating the plunger 584 into the vial body 589 due to the firm engagement between the pair of arms 581 of the engagement head 582 and the pair of lever arms 522 of the vial engagement mechanism 520. Since the stopper 594 is movably disposed within the vial body 589, the translational movement of the plunger 584 causes a simultaneous translational movement of the stopper 594 through the vial body 589, thereby generating a positive pressure therein. As a result, the dose of the physiological saline and radioactive fluid medium mixture stored within the internal chamber 588 is transported out of the vial body 589 through the needle 559 and into the proximal manifold 555B. Since the one-way check valve 553 is configured to allow fluid communication from the proximal manifold 555B to the distal manifold 555A, this dose is delivered therethrough and into the dose delivery conduit 10A via the dose delivery port 556A.

[0188]

[0239] Referring back to FIG. 30, the slider 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 it is impossible to direct the dose delivered from the vial body 589 to the manifolds 555A, 555B into the contrast agent conduit 10B or the flushing conduit 10C because of the one-way check valve 553A located therein. Thus, the dose is directed to the dose delivery port 556A and is received in a catheter fluidly coupled by the dose delivery conduit 10A. In other words, the one-way check valve 553A prevents backflow of fluid into the slider 540 and / or the vial assembly 580 coupled thereto.

[0189]

[0189]

[0240] Referring now to FIG. 33, in step 730, the operator determines whether an additional dose delivery from the delivery device 500 to the catheter is required during the procedure. In response to determining that an additional dose for delivery is required in step 730, steps 726 and 728 are repeated as necessary to effectively deliver the required volume of the dose. The operator can monitor the interface display 530 of the console assembly 510, view the various information presented therein, and determine in step 730 whether additional dose delivery is required. As described in more detail above, one or more sensors of the delivery device 500, and in particular, at least the linear displacement sensor 531 and the radiation sensor 533, are configured to detect and measure various characteristics of the delivery device 500 and / or the medium stored therein for display on the interface display 530.

[0190]

[0190]

[0241] Referring now to FIG. 28B, another example of the interface display 530 is shown in FIG. Schematically, the interface display 530 of the console assembly 510 provides various data regarding the delivery device 500, as described in more detail above. In particular, in steps 726, 728, and 730, the interface display 530 continues to indicate the progress of the delivery device 500 during the procedure. As use of the delivery device 500 progresses in steps 726, 728, and 730, the interface The data displayed on the display 530 updates progressively to reflect the current status and characteristics of the delivery device 500 .

[0191]

[0242] Referring to FIG. 32, in step 730, if an additional dose is required for delivery, In response to determining that the removable battery pack 570 is not to be removed, the safety shield 526 is decoupled from the base 512 of the console assembly 510, at step 732, thereby exposing the vial receiving area 518 enclosed therein. Additionally, the slide 540 is decoupled from the slide space 532 of the console assembly 510, at step 732, thereby removing the slide 540 from the vial receiving area 518. Upon separation of the distal end 544 of the slide 540 from the base 512 of the console assembly 510, the electrical contacts 574 of the removable battery pack 570 and the corresponding electrical contacts 511 of the console assembly 510 become disengaged, thereby terminating the supply of power to the console assembly 510. Thus, one or more components of the delivery device 500 that require power, such as, for example, the interface display 530, are no longer operable. In this case, slide 540 and vial assembly 580 are discarded together since locking feature 586 and locking system 550 are fixedly assembled. In other cases, removable battery pack 570 is detached from slide 540 prior to discarding slide 540 and vial assembly 580. In this case, removable battery pack 570, including battery 572, is discarded separately from slide 540. VI. Electric Delivery Device with Sliding Body

[0243] As briefly described above, in some embodiments, the delivery device 50 0 may include an electric system instead of the mechanical assembly 529 shown and described herein. For example, the handle 528 may be communicatively coupled to the vial engagement mechanism 520 by an electrical coupling with at least one motor coupled therebetween. In this embodiment, the operation of the handle 528 to draw a fluid medium from the vial assembly 580 and subsequently deliver the fluid medium from the delivery device 500 is electrically performed at a predetermined flow rate by computer-readable and executable instructions executed by a processor. In other embodiments, the handle 528 is communicatively coupled to the vial engagement mechanism 520 by an electrical coupling with at least one motor coupled to each of the handle 528 and the vial engagement mechanism 520. In this embodiment, the operation of the handle 528 to draw a fluid medium may be mechanically performed as shown and described above, where the handle 528 is translated relatively downward by an operator to translate the vial engagement mechanism 520 linearly upward relative to the vial receiving region 518. It should be understood that the processor and the memory storing the computer-readable and executable instructions can be provided in the delivery device 500, the remote device, and / or both.

[0192]

[0244] In any embodiment, the vial body 58 of the vial assembly 580 Manual actuation of the handle 528 to inject a dose of the fluid medium stored in the delivery device 500 activates a drive motor communicatively coupled to the handle 528. The drive motor is configured to generate a resistance force on the handle 528 that is proportional to and opposite to the manual force applied to the handle 528 by the operator. In this case, tactile feedback is generated by the motor at the handle 528 in response to physical manipulation of the handle 528 during delivery of the medium from the delivery device 500. The degree of resistance force generated by the motor at the handle 528 corresponds to a pre-defined volumetric injection flow rate, pre-programmed and / or determined by computer readable and executable instructions executed by the processor. Thus, manual manipulation of the handle 528 during the injection process of the delivery device 500 causes the motor to generate resistance on the handle 528 to the extent that it changes the current injection flow rate from the pre-defined injection flow rate.

[0193]

[0245] A motor communicatively coupled to the handle 528 controls manual actuation of the handle 528. It should be appreciated that the actuator inhibits but does not prevent manual actuation such that the degree of resistance and tactile feedback generated at the handle 528 corresponds to and increases with the difference between the current injection rate from the default injection rate. In this example, continued manual actuation of the handle 528 to an extent that increases the difference between the current injection rate and the default injection rate causes the motor communicatively coupled to the handle 528 to generate a progressively increased resistance force on the handle 528, thereby providing greater tactile feedback to the operator indicating an increased threshold. It should be appreciated that if another motor is coupled to the vial engagement mechanism 520, the drive motor coupled to the handle 528 is in communication with the motor coupled to the vial engagement mechanism 520 such that manual actuation at the handle 528 is transmitted to the vial engagement mechanism 520. In this case, an input by the operator at the handle 528 that overcomes the resistance force applied to the handle 528 proportionally applies linear translational motion to the vial engagement mechanism 520.

[0194]

[0246] In another embodiment, a computer readable and The read and executable instructions include a maximum discrepancy threshold such that manual actuation of handle 528 by an operator of delivery device 500 is prevented to a degree that exceeds the maximum discrepancy threshold. Delivery device 500 may include one or more sensors coupled to handle 528, plunger 584, vial engagement mechanism 520, manifolds 555A, 555B, and / or other components of delivery device 500 to detect and monitor various characteristics of delivery device 500. For example, the one or more sensors may be configured to measure a manual force applied to handle 528 by an operator, a linear displacement of vial engagement mechanism 520, a current injection flow rate of delivery device 500, a torque of a drive motor coupled to handle 528 and / or vial engagement mechanism 520, and / or the like. By way of example, the one or more drive motors may include, but are not limited to, a linear stage actuator. Additionally, the one or more sensors may include, for example, a current sensor, a torque sensor, a pressure sensor, a flow sensor, and / or the like. Although not shown, it should be understood that in other embodiments, the handle 528 of the delivery device 500 may be located remotely from the console assembly 510, and as a result, the motor communicatively coupled to the handle 528 is likewise remote with respect to the console assembly 510.

[0195]

[0247] In some embodiments, the manual actuation sensitivity of the handle 528 is It can be selectively programmed and adjusted before use of the delivery device 500. For example, the computer-readable and executable instructions executed by the processor can include various settings for correlating the relative order of movement at the handle 528 with the linear displacement of the vial engagement mechanism 520. In this case, the coarse and / or fine operation of the handle 528 can initiate various torques in the drive motor communicatively coupled to the vial engagement mechanism 520 to translate the vial engagement mechanism 520 within the vial receiving region 518. The operator of the delivery device 500 can identify the default infusion flow rate, the current infusion flow rate, and / or other data and characteristics regarding the resistance force generated by one or more drive motors along the interface display 530 of the console assembly 510. VII. Dual Component Plunger

[0248] Referring now to FIG. 34, an alternative plunger assembly 800 is depicted Therein. In the example shown and described herein, it should be understood that the plunger assembly 800 is configured and operable in substantially the same manner as the plunger 584 described above, except for the differences explicitly set forth herein. Thus, the plunger assembly 800 of this example can be readily incorporated into the vial assembly 580 described above. The plunger assembly 800 functions in many respects substantially the same as the plunger 584 described above, and thus, the configuration of the vial assembly 580 comprising the plunger assembly 800 of this example is the same as and operable in the same manner as the vial assembly 580 described above having the plunger 584, except for the differences described below. It should be understood that.

[0196]

[0249] The plunger assembly 800 includes an inner member 810 and an outer member 820 , the outer member 820 is sized and shaped to slidably receive the inner member 810 therethrough. In particular, the inner member 810 includes upper and lower ends 812, 814 that define an elongated body 816 extending therebetween, such that the ends 812, 814 define a longitudinal length of the elongated body 816. It should be appreciated that the upper end 812 includes an upper aperture 811 extending therethrough. The elongated body 816 defines a lumen that extends through the inner member 810 from the upper end 812 to the lower end 814, such that the upper aperture 811 is in fluid communication with the lumen of the elongated body 816. In this example, the elongated body 816 of the inner member 810 is cylindrical in shape, similar to the shape of the vial body 589 in which the plunger assembly 800 is slidably received.

[0197]

[0250] Still referring to FIG. 34, the inner member 810 has a top end 812 adjacent thereto. The inner member 810 further includes a pair of pins 818 extending laterally outwardly from the elongated body 816 adjacent the lower end 814. The pair of flexible latches 813 are resiliently biased to extend laterally outwardly from the elongated body 816. As described in more detail herein, application of a laterally inward force to the pair of flexible latches 813 (i.e., toward the elongated body 816) causes the pair of flexible latches 813 to flexibly deform inwardly into a lumen defined by the elongated body 816. The inner member 810 further includes a pair of pins 818 extending laterally outwardly from the elongated body 816 adjacent the lower end 814. As described in more detail herein, the pair of pins 818 are sized and shaped to be slidably received within a longitudinal slot 826 of the outer member 820.

[0198]

[0251] The outer member 820 of the plunger assembly 800 defines an elongated body extending therebetween. It has a defined upper end portion 822 and a lower end portion 824, such that the end portions 822, 824 define the longitudinal length of the elongated body. The upper end portion 822 includes an upper aperture 821 extending therethrough. The elongated body defines a lumen extending through the outer member 820 from the upper end portion 822 to the lower end portion 824, such that it should be understood that the upper aperture 821 is in fluid communication with the lumen of the outer member 820. The elongated body of the outer member 820 is shaped substantially similarly to the inner member 810 such that the outer member 820 is sized and shaped to slidably receive the inner member 810 through the lumen defined by the elongated body. Thus, the elongated body of the outer member 820 is cylindrical in shape similar to the shape of the vial body 589 in which the plunger assembly 800 is slidably received.

[0199]

[0252] Still referring to FIG. 34, the outer member 820 includes an engagement head 823 extending around the elongated body adjacent to the upper aperture 821. In particular, the engagement head 823 extends around the elongated body in its transverse length, such that the engagement head 823 includes a diameter larger than that of the elongated body. As described herein, the size of the bottom surface of the engagement head 823 is set to such an extent that the pair of lever arms 522 of the vial engagement mechanism 520 are received on this bottom surface in response to the vertical translational movement of the neck 524 and the corresponding linear displacement of the plunger assembly 800 relative to the vial body 589. Thus, it should be understood that the engagement head 823 of the outer member 820 and the pair of flexible latches 813 of the inner member 810 together are a structural equivalent substitute for the pair of arms 581 of the engagement head 582 of the plunger 584.

[0200]

[0253] The outer member 820 further includes a pair of windows 828 disposed through the elongated body adjacent to the upper end portion 822 of the outer member 820. The pair of windows 828 extend into the lumen defined by the elongated body and are sized according to the size and shape of the pair of flexible latches 813. And are formed. As will be described in more detail herein, a pair of windows 828 are configured to receive a pair of flexible latches 813 therethrough to securely fasten the inner member 810 to the outer member 820. As briefly described above, the outer member 820 includes a pair of longitudinal slots 826 that extend through the elongated body adjacent the lower end 824. In particular, the longitudinal slots 826 extend along opposite side surfaces of the elongated body and are defined between an upper region 825 and a lower region 827. The longitudinal slots 826 are sized and formed to slidably receive at least one of a pair of pins 818 of the inner member 810 therethrough. Additionally, the outer member 820 includes a stopper 829 that is substantially similar to the stopper 594 described above, such that the stopper 829 is configured and operable just like the stopper 594.

[0201]

[0254] Still referring to FIG. 34, in an exemplary mode of operation of the plunger assembly 800 having the vial assembly 580 described above, the inner member 810 is initially received within the lumen of the outer member 820, with the upper ends 812, 822 being coplanar with each other and a pair of flexible latches 813 being disposed within the lumen of the outer member 820. In particular, the pair of flexible latches 813 are positioned within the lumen of the outer member 820 between the upper aperture 821 and the pair of windows 828. In this case, the inner surface of the elongated body of the outer member 820 applies a laterally inward force to the pair of flexible latches 813, as a result of which the pair of flexible latches 813 are deformed inwardly into the lumen of the inner member 810.

[0202]

[0202]

[0255] The elastic biasing of the flexible latch 813 is generated by the laterally inward 8, the plunger assembly 800 exerts an outward force against the force of the vial engagement mechanism 520, resulting in a frictional interference between the pair of flexible latches 813 and the inner surface of the elongate body against the inner member 810 and the outer member 820. Thus, the inner member 810 is securely secured within and against the outer member 820 prior to actuation of the plunger assembly 800 in response to linear translational movement of the vial engagement mechanism 520.

[0203]

[0256] Still referring to FIG. 34, a pair of flexible latches 813 are in an initial position. In the initial position, the pair of pins 818 of the inner member 810 are received in the longitudinal slot 826 while being disposed in the lumen of the elongated body and positioned between the upper aperture 821 and the pair of windows 828. In particular, the pair of pins 818 are positioned along the upper section 825 of the longitudinal slot 826 when the plunger assembly 800 is in the initial position. When the plunger assembly 800 is installed in the vial assembly 580 and the vial assembly 580 is assembled with the slide 540, the coupling of the slide 540 and the console assembly 510 results in the engagement of the pair of lever arms 522 with the bottom surface of the engagement head 823. Thus, the upward translational movement of the vial engagement mechanism 520 results in the engagement of the bottom surface of the engagement head 823, thereby translating the plunger assembly 800 vertically upward relative to the vial body 589 of the vial assembly 580.

[0204]

[0257] Still referring to FIG. 34, in this example, a vial body 589 and / or The locking feature 586 of the vial assembly 580 includes a retaining feature that is sized and configured to engage a pair of pins 818 disposed within the vial body 589 during a predetermined translational movement of the plunger assembly 800 relative to the vial body 589. In other words, the retaining feature is positioned within the vial body 589 and / or the locking feature 586 at a location such that the retaining feature engages the pair of pins 818 after the plunger assembly 800 has been translated vertically a predetermined distance relative to the vial body 589. The location of the retaining feature and the predetermined translational movement distance described above correspond to a minimum threshold volume of a fluid medium (e.g., saline) that is to be drawn into the inner chamber 588 in response to a linear displacement of the plunger assembly 800 within the inner chamber 588. It should be understood that it is configured to do so.

[0205]

[0258] Thus, by positioning the retaining feature at a predetermined distance, prior to dose delivery by the delivery device, it is possible to facilitate the withdrawal of a predetermined minimum volume threshold of the fluid medium into the inner chamber 588. The predetermined minimum volume threshold can include various suitable amounts for creating a suitable mixture of therapeutic particles and the fluid medium (e.g., saline), such that the resulting suspension fluid to be delivered is sufficient or appropriate for administration to a patient. For example, in some embodiments, the predetermined minimum volume threshold may be equal to about 9 milliliters to 11 milliliters, and more particularly, 10 milliliters.

[0206]

[0259] Still referring to FIG. 34, once the plunger assembly 800 has reached a predetermined distance When only translated in the translational direction, the pair of pins 818 reach and engage the retention feature, thereby locking the vertical position of the pair of pins 818 thereat relative to the vial body 589. Continued operation of the vial engagement mechanism 520 results in continued translational movement of the pair of lever arms 522 and the outer member 820 due to the engagement of the bottom surface of the engagement head 823 with the pair of lever arms 522. In this case, the outer member 820 translates upward relative to the inner member 810, and its vertical position is firmly fixed due to the engagement of the pair of pins 818 and the retention feature, as a result of which the pair of pins 818 translate along the longitudinal slot 826 from the upper region 825 to the lower region 827. In addition, the pair of flexible latches 813 of the inner member 810 translate within the lumen of the outer member 820 until they reach the pair of windows 828. In this case, the pair of flexible latches 813 extend outwardly and through the pair of windows 828 because no inward lateral force is generated on the pair of flexible latches 813 by the inner surface of the outer member 820. Thus, the pair of flexible latches 813 return to their initial configuration by extending laterally outwardly from the lumen of the elongated body 816 of the inner member 810 and through the pair of windows 828.

[0207]

[0260] It should be understood that when the pair of flexible latches 813 come to and are received by the positions of the pair of windows 828, the pair of pins 818 of the inner member 810 are positioned in the lower region 827 of the longitudinal slot 826. In this case, the inner member 810 is firmly fixed to the outer member 820, as a result of which the relative vertical positions of the members 810, 820 are fixed. It should be further understood that the pair of flexible latches 813 project outwardly from the pair of windows 828 with a predetermined length that effectively increases the lateral width of the outer member 820 at the location along the pair of windows 828. In this case, the downward translational movement of the neck 524 of the vial engagement mechanism 520 disengages the pair of lever arms 522 from the bottom surface of the engagement head 823 and engages the pair of flexible latches 813 positioned below, as a result of which the members 810, 820 of the plunger assembly 800 are effectively translated downward into the internal chamber 588 from which the dose is delivered. VIII. Two-wing plunger

[0261] 35-36, an alternative vial assembly 830 is illustrated. It should be understood that in the example shown and described herein, vial assembly 830 is configured and operable exactly like vial assembly 580 described above, except for the differences explicitly noted herein. Thus, vial assembly 830 of the present example may be readily incorporated into slide 540 described above. It should be understood that vial assembly 830 functions in many respects substantially similarly to vial assembly 580 described above, and thus slide 540 comprising vial assembly 830 of the present example may be configured and operable similarly to slide 540 described above with vial assembly 580 received therein, except for the differences described below.

[0208]

[0262] In particular, referring to FIG. 35, the vial assembly 830 includes an engagement head 83 1. It includes a locking feature portion 832, a plunger 835, a vial body 836, and a stopper 839. The engaging head 831 and the stopper 839 define the longitudinal length of the plunger 835. In other words, the engaging head 831 and the stopper 839 are positioned along the opposite ends of the plunger 835. The elongated head 831 of this example includes a bottom surface 833 that faces towards the locking feature portion 832 including a side edge 838 that extends around the upper region of the vial body 836. The stopper 839 is coupled to the lower region of the plunger 835 and is configured and operable in the same manner as the stopper 594 of the vial assembly 580 described above. The cap 834 of the vial assembly 830 includes an aperture 837 at the end of the vial body 836 that is sized and shaped to receive the needle 559 of the slider 540 when the vial assembly 830 is coupled thereto. In some embodiments, it should be understood that the aperture 837 may include one or more features for receiving the needle 559, such as an elastomer similar to the septum 592 of the vial assembly 580 described above, for example.

[0209]

[0263] The vial assembly 830 is a pair of movables to which the plunger 835 is coupled The vial assembly 830 differs from the vial assembly 580 in that it includes a pair of flexible wings 840. In particular, the pair of flexible wings 840 are movably coupled to an outer surface of the plunger 835 and extend along the longitudinal length of the plunger 835. The pair of flexible wings 840 has a longitudinal length extending between a pivotable blade 842 and a rotatable coupler 844, each of which is coupled to the outer surface of the plunger 835. In this example, the pair of flexible wings 840 is shown in an initial orientation with the pivotable blade 842 in a vertical configuration. With the pair of flexible wings 840 in the initial orientation, the longitudinal length of the pair of flexible wings 840 is disposed entirely within the vial body 836 of the vial assembly 830. As described in more detail herein, the pivotable blades 842 of the pair of flexible wings 840 are configured to pivot laterally outwardly, away from the plunger 835 of the vial assembly 830 in response to vertical translational movement of the plunger 835 out of the vial body 836.

[0210]

[0264] Referring now to FIG. 36A, an exemplary operational model of the vial assembly 830 is shown. In the actuation mode, the vial engagement mechanism 520 engages the engagement head 831, and in particular, the pair of lever arms 522 engages the bottom surface 833 of the engagement head 831. In this case, actuation of the handle 528 results in upward translational movement of the neck 524, which in turn translates the pair of lever arms 522 vertically upward. With the pair of lever arms 522 engaged against the bottom surface 833 of the engagement head 831, the engagement head 831 and the plunger 835 are linearly displaced relative to the vial body 836 of the vial assembly 830. The upward translational movement of the plunger 835 transitions the pair of flexible wings 840 from an initial orientation to a partially actuated position. In particular, the pair of flexible wings 840 rotates about the rotatable coupler 844, and as a result, the longitudinal length of the pair of flexible wings 840 is deflected outwardly from the vial body 836. In other words, the pair of flexible wings 840 are configured to flexibly deform such that the longitudinal length of the pair of flexible wings 840 is curved outward from the vial body 836 .

[0211]

[0265] Pivotable blades 842 of a pair of flexible wings 840 extend from the plunger 835. 8. The pivotable blade 842 pivots outwardly, thereby forming an engagement surface 843 on the blade 842. In other words, the pivotable blade 842 is configured to snap out and form the engagement surface 843 in response to translational movement of the plunger 835 and simultaneous rotation of the flexible wings 840 about the rotatable coupler 844. The length of the engagement surface 843 formed by the pivotable blade 842 is configured to engage the pair of lever arms 522 when the plunger 835 translates a predetermined distance, which is determined by the length of the plunger 835 translating outwardly, thereby forming an engagement surface 843 on the blade 842. It should be appreciated that this corresponds to a minimum threshold volume of fluid medium (eg, saline) that will be drawn into vial body 836 in response to linear displacement of vial 835.

[0212]

[0266] Still referring to FIG. 36A, plunger 835 is a portion of a predetermined distance. 8, such that the length of the engagement surface 843 formed by the pivotable blades 842 of each of the flexible wings 840 is such that it is not operable to engage the pair of lever arms 522 during downward translation of the neck 524 of the vial engagement mechanism 520. Rather, the engagement surface 843 is partially formed in this case, such that the opposite translation of the vial engagement mechanism 520 causes the pair of lever arms 522 to be translated linearly by the pair of pivotable blades 842 and therefore does not interact with and / or engage corresponding features of the vial assembly 830. In this case, the plunger 835 is not pushed into the vial body 836, thereby not dispensing a dose for delivery.

[0213]

[0267] Continued upward translational motion of plunger 835 due to engagement with lever arm 522 It should be understood that by further extending the pivotable blade 842 outwardly in response to movement, the withdrawal of a predetermined minimum volume threshold of the fluid medium into the vial body 836 can be easily performed prior to dose delivery by the delivery device. The predetermined minimum volume threshold can include various suitable amounts for creating a suitable mixture of therapeutic particles and a fluid medium (e.g., saline solution), such that the resulting suspension fluid to be delivered is suitable for administration to a patient. For example, in some embodiments, the predetermined minimum volume threshold can be equal to about 9 milliliters to 11 milliliters, and more particularly, 10 milliliters.

[0214]

[0268] Referring now to FIG. 36B, as the plunger 835 translates a predetermined distance the pair of pivotable blades 842 extend outwardly from the plunger 835 at a greater length due to increased deformation of the flexible wings 840. Continued operation of the vial engagement mechanism 520 results in continued translational movement of the pair of lever arms 522 and the plunger 835 due to the engagement of the bottom surface 833 of the engagement head 831 with the pair of lever arms 522. In this case, the plunger 835 translates upward relative to the vial body 836, and as a result, the pair of flexible wings 840 deflect further outward from the longitudinal length of the plunger 835. As a result, the pair of pivotable blades 842 extend laterally outwardly, thereby forming the engagement surface 843 at a greater length. In this case, the pair of pivotable blades 842 extend outwardly in a horizontal configuration.

[0215]

[0269] The pair of engagement surfaces 843 are located along the pair of pivotable blades 842 It is further to be understood that the plunger 835 projects outwardly from the plunger 835 by a predetermined length that effectively increases the lateral width thereof. In this case, the downward translation of the neck 524 of the vial engagement mechanism 520 disengages a pair of lever arms 522 from the bottom surface 833 of the engagement head 831 and engages the engagement surface 843 of a pair of pivotable blades 842 positioned therebelow, such that the plunger 835 is effectively translated downwardly into the vial body 836 from which the dose is delivered. IX. Rotatable Plunger

[0270] Referring now to FIGS. 37-38, an alternative plunger assembly 850 is depicted. In the example shown and described herein, it is to be understood that the plunger assembly 850 is configured and operable in substantially the same manner as the plunger 584 described above, except for the differences explicitly set forth herein. Accordingly, the plunger assembly 850 of this example can be readily incorporated into the vial assembly 580 described above. The plunger assembly 850 functions in many respects substantially the same as the plunger 584 described above, and thus, the vial assembly 580 comprising the plunger assembly 850 of this example can be configured and operable in the same manner as the vial assembly 580 described above having the plunger 584, except for the differences described below. It is to be understood that.

[0216]

[0271] Referring specifically to FIG. 37, the plunger assembly 850 includes an upper end 852 and It includes a call lower end portion 854, and a pair of engaging heads 851, 856 are positioned along the upper end portion 852. In particular, with the bottom surface 853 of the upper engaging head 851 positioned relatively above the upper surface 855 of the lower engaging head 856, the plunger assembly 850 includes the upper engaging head 851 and the lower engaging head 856. The plunger assembly 850 further includes a curved path 857 disposed along and extending around the outer surface of the plunger assembly 850. Since the plunger assembly 850 of the present invention has a cylindrical profile, the curved path 857 is formed thereon, and as a result, the curved path 857 extends around the cylindrical shape of the plunger assembly 850. Although not shown, it should be understood that the curved path 857 is sized and shaped to slidably receive therein pins from the vial body 589 and / or the locking feature 586. In this case, the translational movement of the plunger assembly 850 with the pins received within the curved path 857 results in the translational movement of the plunger assembly 850 relative to the vial body 589 due to the curved configuration of the curved path 857. As will be described in more detail herein, the plunger assembly 850 further includes a straight path 858 disposed along and extending to the outer surface of the plunger assembly 850 (see FIG. 38B), and this straight path 858 is parallel to the longitudinal length of the plunger assembly 850.

[0217]

[0272] The plunger assembly 850 is a stopper for the plunger 584 described above. 594. The size and shape of the upper engagement head 851 differs from the size and shape of the lower engagement head 856, such that the pair of engagement heads 851, 856 have different profiles relative to one another. In this example, the upper engagement head 851 includes a circular shaped profile and the lower engagement head 856 includes an oval and / or rectangular shaped profile. It should be understood that the engagement heads 851, 856 may include various other shapes and / or sizes other than those shown and described herein without departing from the scope of the present disclosure. As described in more detail herein, the shapes of the engagement heads 851, 856 are configured to vary relative to one another to facilitate delivery of a predetermined minimum threshold of fluid medium from the vial body 589.

[0218]

[0273] Now referring to FIG. 38A, the plunger assembly 850 is 38B. In the first orientation, the upper engagement head 851 has a circular shape, and therefore, in the first orientation, the upper engagement head 851 has a similar profile to a plurality of other orientations, including, for example, the second rotatable orientation shown in FIG. 38B. In contrast, the lower engagement head 856 has an oval and / or rectangular shape, and therefore, in the plurality of orientations, the lower engagement head 856 has a different profile. For example, in the first orientation, the width of the lower engagement head 856 is smaller than the width of the lower engagement head 856 in the second orientation shown in FIG. 38B.

[0219]

[0274] In an exemplary mode of operation of the plunger assembly 850, a vial engager The structure 520 is coupled to the plunger assembly 850 by receiving a pair of lever arms 522 between the upper engagement head 851 and the lower engagement head 856. In particular, the pair of lever arms 522 of the vial engagement mechanism 520 are slidably positioned between the pair of engagement heads 851, 856, and as a result, the neck 524 of the vial engagement mechanism 520 The vertical translational movement causes engagement of the bottom surface 853 of the upper engagement head 851 by the pair of lever arms 522 positioned thereunder. As briefly described above, with the plunger assembly 850 received within the vial body 589 of the vial assembly 580, pins extending from the vial body 589 and / or the locking feature 586 are slidably received within the curved path 857 of the plunger assembly 850.

[0220]

[0275] Still referring to FIG. 38A, the translational movement of the vial engagement mechanism 520 with the pair of lever arms 522 engaged with the bottom surface 853 of the upper engagement head 851 results in upward translational movement of the plunger assembly 850 relative to the vial body 589. With the fixed pin of the vial body 589 slidably coupled to the plunger assembly 850 within the curved path 857, the translational movement of the vial engagement mechanism 520 further results in rotation of the plunger assembly 850 in a direction corresponding to the path of travel of the fixed pin within the curved path 857. It should be understood that in the initial initial position, the fixed pin of the vial assembly 580 is received along the upper portion of the curved path 857. The curved path 857 of the plunger assembly 850 extends relatively downward from the upper portion toward the lower end portion 854 and surrounds the plunger assembly 850, so that the curved path 857 is configured to facilitate rotation of the plunger assembly 850 together with simultaneous upward translational movement relative to the vial body 589.

[0221]

[0276] In this case, the fixed pin passes from the upper portion through the curved path 857 and through the lower end 85 Proceed towards the lower part of the curved path 857 adjacent to 4. Since the curved path 857 extends around the cylindrical shape of the plunger assembly 850, the plunger assembly 850 is oriented in a direction (e.g., counterclockwise, clockwise, etc.) rotatable from the first orientation to the second orientation (see FIG. 38B). It should be understood that the configuration and length of the curved path 857 correspond to a predetermined translational movement distance that the plunger assembly 850 travels relative to the vial body 589. The predetermined translational movement distance further corresponds to a minimum threshold volume of a fluid medium (e.g., physiological saline) that will be drawn into the internal chamber 588 in response to the linear displacement of the plunger assembly 850 within the internal chamber 588.

[0222]

[0277] Therefore, translating the fixed pin from the upper part to the lower part of the curved path 857 enables the extraction of a predetermined minimum volume threshold of the fluid medium into the internal chamber 588 prior to dose delivery by the delivery device when the plunger assembly 850 translates upward. The predetermined minimum volume threshold may include various suitable amounts (e.g., 10 milliliters) for creating a suitable mixture of therapeutic particles and the fluid medium (e.g., physiological saline) to ensure that the resulting suspension fluid to be delivered is appropriate for administration to the patient.

[0223]

[0278] Referring now to FIG. 38B, the fixed pin slidably reaches the end of the curved path 857 When moved and the plunger assembly 850 translates upward relative to the vial body 589 by a predetermined distance, the fixed pin is slidably received within the linear path 858 of the plunger assembly 850. The linear path 858 is in communication with the curved path 857 and extends parallel to the longitudinal length of the plunger assembly 850. In addition to the transfer of the fixed pin within the linear path 858, moving the fixed pin through the curved path 857 results in a rotation of the lower engagement head 856 into a second orientation due to the simultaneous rotation of the plunger assembly 850. In this case, due to the shape of the lower engagement head 856, the lower engagement head 856 provides a greater lateral width that is positioned under the pair of lever arms 522. Thus, actuation of the vial engagement mechanism 520 in the downward direction causes a separation of the pair of lever arms 522 from the bottom surface 853 of the upper engagement head 851 and a subsequent engagement with the upper surface 855 of the lower engagement head 856.

[0224]

[0279] It should be understood that actuation of the vial engagement mechanism 520 in the downward direction prior to rotating the lower engagement head 856 into the second orientation does not result in a corresponding downward translation of the plunger assembly 850. In particular, the lateral width formed under the pair of lever arms 522 by the upper surface 855 of the lower engagement head 856 is smaller than the width of the pair of lever arms 522, and as a result, the downward translation of the vial engagement mechanism 520 causes the pair of lever arms 522 to pass over the lower engagement head 856.

[0225]

[0225]

[0280] Still referring to FIG. 38B, when the plunger assembly 850 is in the second orientation When rotated to, the continuous operation of the vial engagement mechanism 520 results in the translational movement of the pair of lever arms 522 and the plunger assembly 850 due to the engagement between the upper surface 855 of the lower engagement head 856 and the pair of lever arms 522. In this case, the fixed pin of the vial body 589 translates downward through the straight path 858, and its vertical position is fixed to the vial body 589. As a result, the plunger assembly 850 moves relative to the vial body 589 and delivers a dose therefrom. It should be understood that the plunger assembly 850 maintains a fixed orientation relative to the vial body 589 when the fixed pin of the vial body 589 translates downward through the straight path 858.

[0226]

[0281] In other embodiments, the curved path 857 and the straight path 858 can be formed within the locking feature 586 of the vial body 5 89 and / or the vial assembly 580. As a result, the plunger assembly 850 includes a fixed pin that extends laterally outward therefrom. In this case, the plunger assembly 850 translates and rotates in a manner substantially similar to that shown and described herein when the fixed pin of the plunger assembly 850 travels along the travel path formed by the curved path of the vial assembly 580 before reaching the connection with the straight path of the vial assembly 580. In this embodiment, the length and geometry of the curved path and / or the straight path of the vial assembly 580 can be substantially similar to the configuration of the paths 857, 858 shown and described herein. IIX. Suspension Chamber Vial Assembly

[0282] Referring now to FIGS. 39A-39B, an alternative vial assembly 900 is depicted. In the examples shown and described herein, it should be understood that the vial assembly 900 is configured and operable in exactly the same manner as the vial assembly 580 described above, except for the differences explicitly set forth herein. Thus, the vial assembly 900 of this example can be readily incorporated into the slider 540 described above. The vial assembly 900 functions substantially the same as the vial assembly 580 described above in many respects, and thus, it should be understood that the slider 540 comprising the vial assembly 900 of this example can be configured and operable in the same manner as the slider 540 described above with the vial assembly 580 received therein, except for the differences described below.

[0227]

[0283] Although not shown, it should be understood that the vial assembly 900 can include locking features disposed along the upper end of the vial assembly 900 that are substantially the same as the locking features 586 of the vial assembly 580 shown and described above. Thus, the vial assembly 900 of this example is configured to be received within and securely coupled to the slider 540 by the connection engagement of the locking features of the vial assembly 900 and the locking system 550 of the slider 540.

[0228]

[0228]

[0284] Referring to FIG. 39A in detail, the vial assembly 900 includes a vial body 902 that defines an internal chamber 904 in which a pair of stoppers 908 and a floating septum 910 are positioned. In particular, the pair of stoppers 908 and the floating septum 910 are disposed within the vial body 902 and are translatable with the internal chamber 904 in response to the vial assembly 900 receiving one or more fluid media therein. A pair of stoppers 908 are formed integrally with the floating septum 910 and, more particularly, extend laterally outward therefrom at opposite ends of the floating septum 910. The pair of stoppers 908 are movably coupled to the edge of the vial body 902 such that the pair of stoppers 908 are translatable on the vial body 902. Since the floating septum 910 is secured to the pair of stoppers 908, the translational movement of the pair of stoppers 908 within the vial body 902 results in a simultaneous translational movement of the floating septum 910 within the internal chamber 904.

[0229]

[0285] The pair of stoppers 908 are of the vial assembly 580 shown and described above It should be understood that the pair of stoppers 908 is configured and operable in the same manner as the stopper 594. Thus, the pair of stoppers 908 is configured to form a liquid seal for the vial body 902 and is formed of various polymers having a predetermined viscoelasticity. For example, in some embodiments, the stopper 908 is formed of elastomers, silicones, rubbers, urethanes, plastics, polyethylene, polypropylene, and / or the like. In this case, the stopper 908 is operable to prevent the fluid medium stored within the vial body 902 from diffusing (i.e., leaking) past the stopper 908 and out of the vial body 902. Further, the floating septum 910 is configured and operable in the same manner as the septum 592 of the vial assembly 580 shown and described above. The septum 910 forms a seal against the terminus of the vial body 902. The septum 910 may be formed of various materials including, for example, elastomers, silicones, bromobutyl elastomers, rubbers, urethanes, and / or the like. The septum 910 is configured to provide an airtight seal for the vial body 902 and thereby prevent the release of the fluid medium (e.g., radiation embolization beads) stored therein. As will be described in more detail herein, the septum 910 of the vial assembly 900 is configured to be pierced by the needle 559 of the slider 540 when the vial assembly 900 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 902 and the slider 540.

[0230]

[0286] Still referring to FIG. 39A, a vial assembly having a slider 540 In an exemplary mode of operation of the vial assembly 900, the vial body 902 of the vial assembly 900 is slidably received within the vial chamber 558 of the slider 540, and a locking feature (not shown) of the vial assembly 900 securely holds the vial body 902 therein in response to engaging the locking system 550 of the slider 540. As briefly described above, it should be understood that the locking feature of the vial assembly 900 is configured and operable in substantially the same manner as the locking feature 586 of the vial assembly 580 shown and described above.

[0231]

[0287] The delivery conduit 901A is fluidly coupled to an external device such as a syringe, for example. Another delivery conduit 901B is fluidly coupled to the delivery conduit 901A via a one-way check valve 918 and to another external device such as a bag containing a fluid medium (e.g., saline) therein. It should be understood that the one-way check valve 918 is configured to permit fluid communication from the delivery conduit 901B to the delivery conduit 901A and to simultaneously inhibit fluid communication from the delivery conduit 901A to the delivery conduit 901B. In this case, the syringe is actuated to draw the fluid medium from the bag by the connection between the pair of delivery conduits 901A, 901B and through the one-way check valve 918. With the syringe filled with the fluid medium therein, subsequent actuation of the syringe results in delivery of the fluid medium to the vial assembly 900 via a delivery conduit 901C that is fluidly coupled to the syringe via a one-way check valve 916. Similar to the valve 918 described above, the one-way check valve 916 is configured to permit fluid communication from the delivery conduit 901A to the delivery conduit 901C and to simultaneously inhibit fluid communication from the delivery conduit 901C to the delivery conduit 901A.

[0232]

[0288] Still referring to FIG. 39A, a pair of stoppers 908 and a floating septum It should be appreciated that, in an initial position, the stopper 908 and the floating septum 910 are positioned along an upper region of the internal chamber 904 of the vial body 902 before the syringe delivers the fluid medium thereto via the delivery line 901C. In this case, the internal chamber 904 of the vial body 902 contains therapeutic particles pre-loaded therein, and such volume of the therapeutic particles determines the relative positions of the pair of stoppers 908 and the floating septum 910 within the vial body 902. When the syringe is actuated and the fluid medium stored therein is delivered through the delivery lines 901A, 901C, the fluid medium is received within the internal chamber 904 of the vial body 902 via an inlet port 905 disposed within the internal chamber 904. In particular, the inlet port 905 is positioned relatively higher than the location of a pair of stoppers 908 and a floating septum 910, with the stoppers 908 and the floating septum 910 positioned therebetween such that the inlet port 905 is isolated from fluid communication with the needle 559 of the slider 540.

[0233]

[0289] 39B, a fluid medium is introduced into the internal chamber of the vial body 902. When the fluid is received within the vial body 902 and mixed with the therapeutic particles preloaded in the vial body 902, the volume of fluid within the internal chamber 904 is increased. In this case, the pressure within the vial body 902 is increased, and a force is generated against the pair of stopper 908 and floating septum 910, causing the stopper 908 and floating septum 910 to translate within the vial body 902. In particular, the stopper 908 and floating septum 910 are linearly displaced away from the inlet port 905, such that the pair of stopper 908 and floating septum 910 translates toward the needle 559 as the fluid volume within the internal chamber 904 increases. When the vial body 902 receives a predetermined volume of fluid therein, the floating septum 910 translates a corresponding linear distance within the internal chamber 904, thereby joining the needle 559. In this case, the needle 559 pierces the floating septum 910 and the proximal manifold 555 B of the slide 540 establishes fluid communication with the fluid stored within the vial body 902 through the needle 559 .

[0234]

[0290] The terms "substantially" and "about" may be used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. It should be noted that these terms may also be used herein to represent the degree to which a quantitative expression may vary from the recited reference without resulting in a change in the basic function of the subject matter in question.

[0235]

[0291] For the purposes of explaining and defining the present invention, the term "substantially" is used herein to represent the essential degree of uncertainty that may result from any quantitative ratio comparison, value, measurement, or other representation. The term "substantially" may also be used herein to represent the degree to which a quantitative expression may vary from the recited reference without resulting in a change in the basic function of the subject matter in question. As such, it is used herein to represent the essential degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation with respect to the arrangement of elements or features that may embody something that, while theoretically expected to present an exact match or behavior, actually falls slightly short of being exactly so.

[0236]

[0292] While specific embodiments are illustrated and described herein, it is to be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Furthermore, while various aspects of the claimed subject matter are described herein, such aspects need not be utilized in combination. Accordingly, the appended claims are intended to cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

**Claim 1** A delivery assembly, the delivery assembly comprising: A console including a vial receiving area; A vial engagement mechanism extending from the console within the vial receiving area, the engagement mechanism being configured to engage a vial assembly; A slider removably attachable to the console in the vial receiving area; A safety shield removably attachable to the console across the vial receiving area, the vial engagement mechanism and the slider being enclosed within the safety shield when the safety shield is attached to the console; and The delivery assembly, wherein the slider, the vial assembly, and the safety shield are configured to suppress radiation emission from within the vial receiving area. **Claim 2** The delivery assembly according to claim 1, wherein The vial assembly comprises A vial body formed of a material that suppresses radiation emission from within the vial body; A locking feature coupled to the vial body, the locking feature being configured to securely engage the vial assembly with the slider when the vial body is received within the slider; and A plunger slidably translatable relative to the locking feature and through the vial body in response to the vial engagement mechanism engaging the vial assembly. **Claim 3** The delivery assembly according to claim 2, wherein The plunger includes an engagement head having a pair of resilient arms sized and shaped to couple with a pair of lever arms of the vial engagement mechanism. **Claim 4** The delivery assembly according to claim 2, wherein The vial assembly includes a septum disposed within a distal end of the vial body, the septum being configured to seal the vial body. **Claim 5** The delivery assembly according to any one of claims 1 to 4, wherein The delivery assembly, wherein the console comprises an interface display and one or more of a dosimeter, linear encoder, optical sensor, linear displacement sensor, flow sensor, ultrasonic sensor, magnetic encoder, laser distance sensor, inductance sensor, radial encoder, volume measurement sensor, radiation sensor, and mechanical transducer.

6. The delivery assembly according to claim 5, wherein the interface display is communicatively coupled to one or more of a dosimeter, linear encoder, optical sensor, linear displacement sensor, flow sensor, ultrasonic sensor, magnetic encoder, laser distance sensor, inductance sensor, radial encoder, volume measurement sensor, radiation sensor, and mechanical transducer.

7. The delivery assembly according to any one of claims 1 to 6, wherein when the slider is coupled to the console, the vial engagement mechanism is disposed within the vial receiving region and proximate to the slider.

8. The delivery assembly according to claim 7, wherein the delivery assembly further comprises a delivery handle, the delivery handle being coupled to the vial engagement mechanism and configured to move the vial engagement mechanism within the vial receiving region.

9. The delivery assembly according to claim 8, wherein the delivery handle is configured to move the vial assembly relative to the slider in response to actuation of the delivery handle.

10. The delivery assembly according to any one of claims 1 to 9, wherein the slider comprises a locking system and a vial chamber, the locking system forming an aperture sized and shaped to receive the vial assembly therethrough into the vial chamber.

11. The delivery assembly according to claim 10, wherein the locking system comprises an annular protrusion extending laterally into the aperture, the annular protrusion sized and shaped to engage a locking feature of the vial assembly when the vial assembly is received through the aperture into the vial chamber.

12. The delivery assembly according to claim 10, wherein the vial chamber is enclosed within a protective shield formed of a material that suppresses radiation emission from within the vial chamber, the delivery assembly. **Claim 13** The delivery assembly according to claim 10, wherein the slider comprises a needle extending into the vial chamber, the needle being configured to pierce the septum of the vial assembly when the vial assembly is received into the vial chamber through the aperture, the delivery assembly. **Claim 14** The delivery assembly according to claim 13, wherein the slider comprises a manifold fluidly coupled to the needle, such that as a result, the manifold is in fluid communication with the vial chamber via the needle, the delivery assembly. **Claim 15** The delivery assembly according to claim 14, wherein the slider comprises one or more ports in fluid communication with the vial chamber through the manifold, and one or more delivery conduits are operable to couple to the manifold via the one or more ports, the delivery assembly. **Claim 16** The delivery assembly according to any one of claims 1 to 15, wherein the slider, the vial assembly, and the safety shield are formed of a material that suppresses radiation emission from within the vial containment region, the delivery assembly. **Claim 17** The delivery assembly according to claim 2, wherein the plunger includes an engagement head having a bottom surface sized and shaped to couple with a pair of lever arms of the vial engagement mechanism, the delivery assembly. **Claim 18** The delivery assembly according to claim 17, wherein the vial assembly further includes a pair of flexible wings, the pair of flexible wings being rotatably coupled to the plunger, and the pair of flexible wings being configured to flexibly deform in response to the outward translational movement of the plunger from the vial body so as to be so configured, the delivery assembly. **Claim 19** The delivery assembly according to claim 18, wherein The pair of flexible wings is configured to form an engagement surface, and the engagement surface is sized and shaped to connect with the pair of lever arms in response to deformation of the pair of flexible wings when the plunger translates outward from the vial body. Delivery assembly.

20. The delivery assembly according to claim 2, wherein the plunger includes an upper engagement head and a lower engagement head positioned relative to below the upper engagement head along the longitudinal length of the plunger. Delivery assembly.

21. The delivery assembly according to claim 20, wherein the upper engagement head includes a bottom surface, and the bottom surface is sized and shaped to connect with a pair of lever arms of the vial engagement mechanism in response to an upward translational movement of the vial engagement mechanism. Delivery assembly.

22. The delivery assembly according to claim 21, wherein the lower engagement head includes an upper surface, and the upper surface is sized and shaped to connect with a pair of lever arms of the vial engagement mechanism in response to a downward translational movement of the vial engagement mechanism. Delivery assembly.

23. The delivery assembly according to claim 22, wherein the plunger further includes at least a curved path and a straight path disposed along the outer surface of the plunger, and the curved path and the straight path are sized and shaped to slidably receive a fixed pin of the vial body therein. Delivery assembly.

24. The delivery assembly according to claim 23, wherein the curved path extends around the outer surface of the plunger, and the straight path extends along the outer surface and parallel to the longitudinal length of the plunger. Delivery assembly.

25. The delivery assembly according to claim 24, wherein the plunger is configured to rotate within the vial body and translate outward from the vial body in response to the pair of lever arms connecting the bottom surface of the upper engagement head when the vial engagement mechanism translates upward due to the fixed pin being received within the curved path. Delivery assembly.

26. The delivery assembly according to claim 24, The plunger is configured to translate into the vial body in a fixed orientation with respect to the plunger in response to the pair of lever arms that couple the upper surface of the lower engagement head when the vial engagement mechanism translates downward due to the fixed pin being received within the linear path, delivery assembly. [

27. ] A delivery assembly according to any one of claims 1 to 26, The vial assembly includes an internal chamber and a floating septum movably disposed therein, delivery assembly. [

28. ] A delivery assembly according to claim 27, The floating septum is configured to translate within the vial body in response to the internal chamber receiving a fluid medium therein, delivery assembly. [

29. ] A delivery assembly according to claim 28, The floating septum translates within the vial body, and as the fluid medium within the internal chamber increases, the floating septum engages the needle of the slider positioned at the lower end of the internal chamber, delivery assembly. [

30. ] A delivery device according to any one of claims 1 to 29, The vial engagement mechanism is coupled to an electrical system such that translational movement of the vial engagement mechanism within the vial receiving region is electrically driven, delivery device. [

31. ] A delivery device according to any one of claims 1 to 30, The slider includes a battery, and the battery is configured to supply power to the slider and the console in response to the slider coupling with the console in the vial receiving region, delivery device. [

32. ] A delivery device according to claim 31, The slider includes a battery status indicator communicatively coupled to the battery and configured to display data indicative of the charge of the battery, delivery device. [

33. ] A delivery device according to any one of claims 1 to 32, The slider is configured to maintain fluid leakage of the therapeutic particles therein, and as a result, the slider is operable to suppress radiation emission and fluid leakage from the therapeutic particles stored therein, delivery device. [

34. ] A treatment delivery device, the treatment delivery device comprising: A housing having a protective shielding material, the housing sized and shaped to couple to a device; A vial compartment disposed within the housing, the vial compartment configured to receive a treatment medium therein, the protective shielding material suppressing exposure of the treatment medium from the housing to the outside; A fluid reservoir disposed within the housing, the fluid reservoir configured to receive a fluid medium therein, the fluid reservoir in fluid communication with the vial compartment; An actuator movably coupled to the housing such that movement of the actuator delivers the fluid medium to the vial compartment; and The treatment delivery device, wherein the actuator is configured to deliver a mixture of the fluid medium and the treatment medium to the device. **Claim 35** A treatment delivery device, the treatment delivery device comprising: A substrate; A housing coupled to the substrate, the housing defining a compartment for storing a treatment substance, the housing formed of a material configured to suppress radiation emission from the compartment; A reservoir coupled to the substrate, the reservoir defining a storage portion for storing a flowing substance; A handle assembly coupled to the substrate, the handle assembly movably coupled to the housing, the handle assembly configured to generate a negative pressure within the housing and the reservoir such that movement of the handle assembly draws the flowing substance from the reservoir and the treatment substance from the housing. **Claim 36** A hand-held delivery device, the hand-held delivery device comprising: A first chamber sized and shaped to receive a first device containing treatment particles stored therein; A second chamber sized and shaped to receive a second device containing a fluid medium stored therein; ​ A distal end including a manifold and a needle disposed therein, the distal end being coupled to the first chamber and the second chamber such that the manifold is in fluid communication with the first device and the second device, the needle extending into the first chamber and being coupled to the first device received within the first chamber, the distal end comprising: A handheld delivery device in which the therapeutic particles stored in the first device and the fluid medium stored in the second device are received in the manifold, thereby forming a mixture therein.

37. The handheld delivery device according to claim 36, The handheld delivery device, wherein the first device is punctured by the needle when received within the first chamber.

38. The handheld delivery device according to claim 36 or 37, The handheld delivery device, wherein the first device is a vial assembly, the vial assembly including an internal chamber for storing the therapeutic particles therein and a protective shield disposed around the internal chamber for suppressing the radiation emission generated by the therapeutic particles.

39. The handheld delivery device according to claim 38, The handheld delivery device, wherein the vial assembly includes a handle and a plunger, the plunger being coupled to the internal chamber, and in response to the actuation of the handle, the translational movement of the plunger into the internal chamber causes the therapeutic particles to be delivered into the manifold through the needle.

40. The handheld delivery device according to claim 39, The handheld delivery device, wherein the handle is configured to translate the plunger in response to the rotation of the handle.

41. The handheld delivery device according to claim 39, The handheld delivery device, wherein the handle is configured to translate the plunger in response to the translational movement of the handle.

42. The handheld delivery device according to claim 39, the handheld delivery device being A handheld delivery device further comprising a safety tab, the safety tab being removably coupled to the vial assembly and configured to inhibit translational movement of the plunger, thereby preventing delivery of the therapeutic particles into the manifold. **Claim 43** The handheld delivery device according to claim 39, wherein the safety tab is configured to be detached from the vial assembly in response to applying a force to the plunger to enable translational movement of the plunger. **Claim 44** The handheld delivery device according to any one of claims 36 to 43, wherein the first device includes a retaining mechanism, and the first chamber includes a corresponding retaining mechanism, such that the first device is securely retained in the first chamber in response to the retaining mechanism of the first device engaging the corresponding retaining mechanism of the first chamber. **Claim 45** The handheld delivery device according to claim 44, wherein the retaining mechanism of the first device includes a pushable button, and the corresponding retaining mechanism of the first chamber includes an aperture sized and shaped to receive the pushable button therethrough. **Claim 46** The handheld delivery device according to any one of claims 36 to 45, the handheld delivery device further comprising a catheter hub disposed within the distal end and in fluid communication with the manifold, the catheter hub being configured to couple the manifold to an external device such that the external device is in fluid communication with the mixture. **Claim 47** The handheld delivery device according to any one of claims 36 to 46, wherein the second device is a fluid reservoir, and the fluid medium stored therein is saline or a mixture of saline and a contrast agent. **Claim 48** The handheld delivery device according to any one of claims 36 to 47, the handheld delivery device further comprising A handheld delivery device further comprising one or more of a dosimeter, a linear encoder, an optical sensor, a linear displacement sensor, a flow sensor, an ultrasonic sensor, a magnetic encoder, a laser distance sensor, an inductance sensor, a radial encoder, a volume measurement sensor, and a mechanical transducer.

49. The handheld delivery device according to claim 48, wherein the handheld delivery device further comprises one or more display output units, and the one or more display output units are communicably coupled to one or more of the dosimeter, the linear encoder, the optical sensor, the linear displacement sensor, the flow sensor, the ultrasonic sensor, the magnetic encoder, the laser distance sensor, the inductance sensor, the radial encoder, the volume measurement sensor, and the mechanical transducer.

50. The handheld delivery device according to claim 48, wherein the handheld delivery device further comprises a remote display, and the remote display is communicably coupled to one or more of the dosimeter, the linear encoder, the optical sensor, the linear displacement sensor, the flow sensor, the ultrasonic sensor, the magnetic encoder, the laser distance sensor, the inductance sensor a, the radial encoder, the volume measurement sensor, and the mechanical transducer.

51. The handheld delivery device according to claim 50, wherein the remote display comprises a smart device, a tablet, or a computer.

52. A handheld delivery device, wherein the handheld delivery device comprises a housing including a manifold disposed therein, a first device disposed within the housing for storing a first fluid medium, the first device being in fluid communication with the manifold, a second device disposed within the housing for storing a second fluid medium, the second device being in fluid communication with the manifold, a syringe at least partially disposed within the housing, the syringe an external chamber, An internal chamber disposed within the external chamber for storing therapeutic particles, and A syringe including a needle disposed within the external chamber, the needle being in fluid communication with the manifold and the external chamber being fluidly coupled to the manifold via the needle. The internal chamber is configured to translate within the external chamber and engage the needle such that the internal chamber fluidly couples to the manifold when engaged with the needle. A handheld delivery device in which the therapeutic particles, the first fluid medium, and the second fluid medium are received in the manifold, thereby forming a mixture therein.

53. The handheld delivery device according to claim 52, wherein the handheld delivery device Further comprises one or more of a dosimeter, a linear encoder, an optical sensor, a linear displacement sensor, a flow sensor, an ultrasonic sensor, a magnetic encoder, a laser distance sensor, an inductance sensor, a radial encoder, a volume measurement sensor, and a mechanical transducer.

54. The handheld delivery device according to claim 53, wherein the handheld delivery device Further comprises one or more display output units, the one or more display output units being communicably coupled to one or more of the dosimeter, the linear encoder, the optical sensor, the linear displacement sensor, the flow sensor, the ultrasonic sensor, the magnetic encoder, the laser distance sensor, the inductance sensor, the radial encoder, the volume measurement sensor, and the mechanical transducer.

55. The handheld delivery device according to claim 53, wherein the handheld delivery device Further comprises a remote display, the remote display being communicably coupled to one or more of the dosimeter, the linear encoder, the optical sensor, the linear displacement sensor, the flow sensor, the ultrasonic sensor, the magnetic encoder, the laser distance sensor, the inductance sensor, the radial encoder, the volume measurement sensor, and the mechanical transducer.

56. The handheld delivery device according to claim 55, wherein the remote display comprises a smart device, a tablet, or a computer, the handheld delivery device. **Claim 57** The handheld delivery device according to any one of claims 52 to 56, wherein the syringe includes a handle extending outwardly from the housing, such that the handle is accessible from outside the housing, the handheld delivery device. **Claim 58** The handheld delivery device according to any one of claims 52 to 57, wherein the inner chamber translates within the outer chamber in response to actuation of the handle outside the housing and is configured to engage the needle, the handheld delivery device. **Claim 59** The handheld delivery device according to any one of claims 52 to 58, wherein the housing includes a first switch, the first switch is communicatively coupled to the first device, and actuation of the first switch automatically delivers the first fluid medium to the manifold, the handheld delivery device. **Claim 60** The handheld delivery device according to claim 59, wherein the housing includes a second switch, the second switch is communicatively coupled to the second device, and actuation of the second switch automatically delivers the second fluid medium to the manifold, the handheld delivery device. **Claim 61** The handheld delivery device according to claim 60, wherein the housing includes a third switch, the third switch is communicatively coupled to the syringe, and actuation of the third switch causes the inner chamber to translate within the outer chamber, the handheld delivery device. **Claim 62** A sterile container assembly, the sterile container assembly comprising an upper housing including a closed end and an open end, the closed end of the upper housing including a material configured to form a liquid seal therein, the open end of the upper housing including an upper joining system, the upper housing and A lower housing including a closed end and an open end, wherein the closed end of the lower housing includes a material configured to form a liquid seal therein, and the open end of the lower housing includes a lower joining system, and the lower housing is provided with, The upper housing and the lower housing are sized and shaped to receive a device therein when the open end of the upper housing is coupled to the open end of the lower housing via the upper joining system that engages the lower joining system. A sterile container assembly in which a gasket seal is formed between the open end of the upper housing and the open end of the lower housing in response to the upper joining system engaging the lower joining system.

63. The sterile container assembly according to claim 62, The upper housing and the lower housing are configured to suppress leakage of therapeutic particles out of the sterile container assembly when the gasket seal is formed between the open end of the upper housing and the open end of the lower housing.

64. The sterile container assembly according to claim 62, The closed end of the upper housing and the closed end of the lower housing are configured to promote water vapor permeation through the liquid seal formed at the closed end of the upper housing and the closed end of the lower housing when the open end of the upper housing is coupled to the open end of the lower housing.

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