Methods and systems for administration of liquid content

Abstract

A system and method may include a delivery system including a reservoir in fluid communication with a conduit; a junction positioned downstream of the conduit, and having a first pathway terminating in a container accommodating a solution having content to be delivered to a site of interest, and a second pathway; and a pressure source designed to direct fluid from the reservoir along the conduit, while applying pressure to the container so that the solution along with the content within the container can be directed to the site of interest via the second pathway.

Description

Attorney Docket No. 215532-010501 / PCTElectronically Filed: November 3, 2025METHODS AND SYSTEMS FOR ADMINISTRATION OF LIQUID CONTENTCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 63 / 715,067, filed November 01, 2024, and hereby incorporated by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure is directed to methods and systems for delivery of fluids, solutions, medications, particulates, and other substances.BACKGROUND

[0003] Malignant tumors of the liver include primary tumors like hepatocellular carcinoma(HCC) and intrahepatic cholangiocarcinoma, with HCC being the most common primary liver tumor. Additionally, metastatic tumors from sites such as the bowel, breast, lung, and esophagus can involve the liver. For some patients, curative treatment can be offered through surgical resection of a liver tumor. However, many patients with primary or metastatic liver cancers will have underlying medical comorbidities or impaired liver function that preclude radical liver surgery. Additionally, the anatomic location or extent of a liver tumor may render it technically unresectable.

[0004] Alternative treatment modalities for inoperable patients with liver tumors includes selective intraarterial embolization of the tumor with microsphere particles. Liver tumors possess an alternate blood supply from the normal liver parenchyma. Most primary and metastatic liver tumors will receive the majority of their blood supply from the systemic arterial circulation through branches of the celiac axis. However, the normal hepatocytes receive their blood supply through the portal venous circulation. By taking advantage of this difference in blood supply, intraarterial embolization selectively targets the tumor vasculature while preserving the majority of the blood supply for normal hepatocytes. Further, similar to the liver, the lungs are supplied with blood from two distinct supplies from the pulmonary artery and the bronchial artery. Most lung tumors derive their blood supply from the bronchial artery while the majority of the lung parenchyma derives its1ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 blood supply from the pulmonary artery. Therefore, much the same as the liver, branches of the bronchial artery can be embolized with a low risk of damage to the surrounding normal lung parenchyma. Further still, the instant disclosure includes applicability in treatment of gliomas in the brain or spinal cord and tumors of the prostate, among others.

[0005] Microspheres used for embolization of liver tumors can include drug eluting materials that are used to deliver chemotherapeutic agents. Alternatively, microspheres may contain radioactivity for a procedure commonly known as radioembolization. The most commonly used radioisotope is yttrium-90 (Y-90), which is a pure beta emitting isotope. Y-90 has a half-life of 64.1 hours and the beta particle emitted has an energy of 2.28 MeV. Y-90 is produced through the decay of strontium-90, a fission product of uranium in nuclear reactors, and it decays to zirconium-90. There are currently only two available Y-90 microspheres. Currently available glass spheres are microspheres composed of glass measuring 20 - 30 microns. Currently available resin spheres vary in size and measure between 20 - 60 microns.

[0006] Low linear energy transfer forms of radiation, including the 2.28 MeV beta particles produced through the decay of Y-90, kill cancer cells through what is known as the indirect effect. The indirect effect causes strand breaks in the phospho-ribose backbone of DNA in chromosomes. Single strand breaks are easily repaired, but double strand DNA breaks will often lead to cell death at the time of mitosis. The indirect effect is mediated by the formation of hydroxyl and peroxide free radicals that are created when ionizing radiation passes through the body. The formation of these free radicals requires the presence of oxygen, and therefore the indirect effect is enhanced in well oxygenated tissues. This can be mathematically represented as the oxygen enhancement ratio (OER) and tissues with a robust vascular supply of well oxygenated blood have a higher OER. Through embolization of the small arteries feeding a tumor, the cancer cells are in a more hypoxic environment leading to a lower OER and thus a lower level of tumor cell kill.

[0007] Radiosensitizers are chemicals that enhance radiation related cell kill. Hypoxic cell radiosensitizers selectively enhance the killing of hypoxic cells, while having little effect on cells with normal oxygenation. Nitroimidazoles are a class of antibiotic medications (metronidazole being the most widely used as an antimicrobial) that also provide hypoxic cell radiosensitization. Misonidazole is a second generation 2-nitroimidazole that was shown to improve outcomes when2ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 used in conjunction with radiotherapy to treat head and neck cancer patients in a Dutch randomized study (DAHANCA 2). More recently, DAHANCA 5-85 showed an improvement in both local control and overall survival with the addition of nimorazole to radiotherapy for treatment of head and neck cancer. Unfortunately, the systemic use of medications like misonidazole and nimorazole is limited by their side effects including central nervous system toxicity, and the logistics of accurately timing the medication dose with radiotherapy.

[0008] Local delivery of a hypoxic cell radiosensitizer could increase the therapeutic ratio of radioembolization by enhancing tumor cell kill while also mitigating the systemic side effects of the radiosensitizing drug. In 1992, Wang, et al, published the results of an animal study that involved intrahepatic arterial infusion of misonidazole in rabbits with VX2 liver cancer cells. The hepatic artery infusion of misonidazole was then followed by 15 Gray external beam radiation therapy. When compared to rabbits who did not receive misonidazole, those who underwent hepatic arterial infusion demonstrated the greatest tumor response showing extensive fibrosis and necrosis.

[0009] In addition to hypoxic cell radiosensitization, many other chemicals and pharmaceuticals have been shown to have radiosensitizing properties. Chemotherapy medications are often delivered concurrently with external beam radiation therapy, taking advantage of synergistic cell killing effects due to radiosensitization. Alkylating agents and antimetabolite chemotherapy drugs inhibit DNA repair pathways that cells utilize to repair sublethal damage from ionizing radiation. The accumulation of sublethal damage that is not properly repaired leads to enhanced cell death. Taxane chemotherapy agents and other microtubule inhibitors arrest the cell cycle in the G2 - M phase interface, where cells are most sensitive to radiotherapy. Additionally, through radiation induced upregulation of antigen presenting cells (dendritic cells, etc.) and other proinflammatory effects, there is a well-documented synergy between ionizing radiation and immunotherapies used to upregulate immune targeting of cancer cells. These medications include anti-CTLA4 drugs, anti PD-1 and PDL-1 drugs / checkpoint inhibitors, chimeric antigen receptor T-cell (CAR-T) therapy, and other immunomodulating medications.

[0010] Currently, primary liver cancers account for one of the leading causes of cancer related deaths with the most common being hepatocellular carcinoma (HCC). One current3ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 treatment is trans-arterial embolization (TARE) and TARE is a proven treatment of hyper vascular liver tumors like HCC which bear an otherwise poor prognosis. TARE is typically performed by injecting radiation emitting microspheres through a microcatheter that is placed in arteries which feed the tumor. Currently, the radioactive microspheres are transferred from a reactor to the hospital for treatment of the patient. The spheres are then transferred from the V-vial either directly into the delivery device and into the patient, or via an intermediate loading step in the nuclear medicine department. For safety, the V-vial is maintained within multiple enclosures to prevent the healthcare team from being unnecessarily exposed to the radiation. However, traditional TARE delivery relies on separate inflow and outflow needles being inserted into the enclosures and then into the V-vial. The need for two needles to be inserted through the multiple enclosures and into the same rubber seal, or septum, at the top of the V-vial can be a complicated process which can potentially expose the medical practitioners to radiation.

[0011] While there have been minor advancements in TARE delivery, there are certain principles in the context of radiation handling which remain a consistent goal of for the interventional radiologist, the patient, and the rest of the care team. For example, simple, efficient, and safe set-up of the delivery system. The device can, if possible, rely on standard, or custom made, V-vials to interface with hospital equipment, have as few components as possible to reduce the footprint in the interventional suite, and it should be easy to prime to reduce set-up time and complications.

[0012] Here a novel system, device, and method of delivering an embolic bead, or other content, is disclosed that can combine delivery of a radiation emitting embolic bead having a drug eluting capability and radiation, via e.g., a radiosensitizer. The present invention also provides a system, device, and method for delivering, for example, a radiopharmaceutical, bland embolic, or chemotherapeutic agent, among others, and can be used to deliver any solution, particulate, or fluid from a container to a patient.SUMMARY

[0013] The present disclosure is directed to methods of making and using particles for use in treatment of tumor cells, and other conditions.4ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025

[0014] A delivery system is disclosed herein. The delivery system includes a source of fluid in fluid communication with a fluid conduit; a junction having in fluid communication with the fluid conduit, and having a first path in fluid communication with a substantially rigid container accommodating a content to be delivered to a site of interest, and a second path in fluid communication with a delivery conduit; and a pressure source designed to direct fluid from the source along the conduit, while applying pressure to the substantially rigid container so that the content and fluid within the container along with fluid can subsequently be directed to the site of interest.

[0015] In some embodiments, the pressure source can be one of a syringe or a saline bag. The fluid can be one of saline, contrast solution, or a mixture thereof. The first path can be disposed in the substantially rigid container. The pressure source can be configured to deliver a flow of the fluid in a first direction into the substantially rigid container and can be configured to allow a mixture of the fluid and content to exit the substantially rigid container through the junction in a second direction towards the delivery conduit. The flow of fluid into the substantially rigid container can agitate the content to create a suspension of the content in the fluid. The pressure source can be configured to deliver the fluid through the fluid conduit in a first direction to compress air within the substantially rigid container. The compressed air can be configured to apply pressure to a solution of the fluid and content within the substantially rigid container to push the solution through the second path in a second direction towards the second path.

[0016] In some embodiments, the substantially rigid container can be a vial containing radioactivated beads. The vial can be disposed within radioactive shielding. The delivery system can additionally include a solution of the content and the fluid disposed within the substantially rigid container; the pressure source can be configured to apply a vacuum pressure to the solution to expand a fixed mass of air contained within the substantially rigid container to draw the solution out of the substantially rigid container; and a fluid delivery source can be configured to deliver fluid through the system to flush the solution into the site of interest. In some embodiments, the content can be at least one of embolic beads, radioactive beads, radiopharmaceutical, chemotherapy agents, drug, or a combination thereof.5ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025

[0017] A method of delivering a solution is disclosed herein. The method includes coupling a fluid conduit to a fluid in in fluid communication with a junction, the junction having a first path being in fluid communication with the fluid conduit, a second path being in fluid communication with a substantially rigid container of a content to be delivered to a site of interest, and a third path in fluid communication with a delivery conduit; inserting a portion of the second path into the substantially rigid container; and applying pressure with a pressure source to the substantially rigid container to deliver a solution of the content and the fluid to the site of interest.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1A illustrates a prior art TARE delivery device;

[0019] FIG. IB illustrates a prior art TARE delivery device;

[0020] FIG. 2A illustrates a multilayered radiation container according to an embodiment;

[0021] FIG. 2B illustrates a multilayered radiation container according to an embodiment;

[0022] FIG. 3A illustrates a delivery device according to an embodiment;

[0023] FIG. 3B illustrates an air spring according to an embodiment;

[0024] FIG. 4 illustrates a delivery device according to an embodiment;

[0025] FIGS. 5-8 illustrate various charts and tables of data related to the delivery device of FIG. 3 A; and

[0026] FIG. 9 illustrates a delivery device according to an embodiment.DETAILED DESCRIPTION

[0027] The present disclosure aims to deliver fluid using innovative and novel techniques to both mix a fluid and deliver that fluid using a pressure source. In one embodiment, the present disclosure aims to treat tumors using delivery of liquid content to a site of interest. In an embodiment, the present disclosure provides a system to deliver radioembolization embolic beads to treat tumors using, in one embodiment, radioembolization embolic beads which can carry and6ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 deliver a drug payload to a site of interest. In an embodiment, such treatments can be referred to as trans-arterial embolization (TARE). Current TARE methods suffer from complex devices and methods of use which require highly skilled, and trained, interventional radiologists to maintain proper safety protocols. Some current TARE delivery methods require specialized staff from a nuclear medicine department to perform an intermediate loading step which requires aspiration / injection of the beads into a syringe to form a colloid of beads within a solution, e.g., saline. This operation carries a risk of inherent complexity because the radioactive beads must first be removed from the V-vial and then settled carefully into a column, as shown in FIG. 1 A.

[0028] Other TARE devices and methods rely upon separate needles to handle the inflow of a fluid into a V-vial and outflow of a solution of the fluid and beads to the patient, as shown in FIG. IB. The dual needle configuration presents unique challenges when considering how a V- vial containing radioactive beads must be handled. As shown in FIG. 2 A, a V-vial can be contained within a multi-layered receptacle. In an embodiment, the receptacle 130 can be a multilayered box configured to shield those outside from radiation in the beads. For example, the receptacle 130 can include an acrylic shield surrounding a lead sized to contain the container 113. The acrylic shield can be surrounded by another thicker acrylic shield. The V-vial itself includes a septum through which the two needles must be inserted. However, it can be difficult to navigate two needles into the standard sized septum when the V-vial is obscured by the container and the proximity to radiation emitting materials.

[0029] Thus, the instant disclosure provides methods and systems for delivering liquid content to a site of interest. For example, such systems can be used for delivery of a fluid and or a mixture of radiation emitting beads to a site of interest, e.g., a patient, in a safe, effective, and controllable manner. In an embodiment, the systems disclosed herein can include a single pathway leading to and from a container, thereby minimizing the complexity, and danger, of inserting multiple fluid pathways into a container. In an embodiment, the systems disclosed herein can include a single needle, catheter, conduit, or other such pathway, that is inserted within a container, e.g., a V-vial, thereby minimizing the complexity, and danger, of inserting multiple needles into a V-vial.7ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025

[0030] Although delivery of radiation emitting beads to a patient is disclosed, it should be understood that the present invention can include delivery of any content from a container, as described herein. The delivery of content residing in a substantially rigid container using the disclosed delivery devices, through the methods in the disclosure described herein, is a novel concept. While reference is made in this disclosure to beads, it should be understood that any substance, or content, can be contained within the container within the scope of this disclosure. For example, the container can contain embolic beads. In an embodiment, the embolic beads can be radioactive beads. In another embodiment, the embolic beads can be bland beads. In some embodiments, the content can be a radiopharmaceutical. In some embodiments, the content can be a chemotherapy agent. In an embodiment, the content can be a solution of a liquid and a particulate (e.g., beads of any type). In some embodiments, the content can be a mixture of drugs, with or without particulates, within the vial. Moreover, it is contemplated that the instant disclosure can be used to deliver any combination of the content discussed herein.

[0031] Moreover, while the present disclosure discusses delivery of a solution from a substantially rigid container with a single in / out fluid conduit to a site of interest, e.g., a patient, it should be understood that the present disclosure can be used to deliver a solution, or suspension, in other applications, e.g., in large scale manufacturing, microfluidics, consumer products (e.g., printers) or other such applications. For example, the instant delivery device can be used for drug delivery, in a laboratory fluid delivery, in veterinary medicine, etc. In an embodiment, in place of extension lines, any fluid conduit can be used. In an embodiment, in place of a cannula, any tubing can be used. In some embodiments, in place of splitters, any junction can be used. In an embodiment, in place of a V-vial, any substantially rigid container can be used. In some embodiments, in place of a catheter, any flexible or non-flexible tubing can be used. In some embodiments, any of the medical field specific structure can be replaced with industry agnostic fluid components having substantially the same functionality to direct or restrict fluid flow.

[0032] In an embodiment, the instant system can rely on a substantially rigid container arriving at a desired location. For example, the substantially rigid container can be a V-vial as shipped from the reactor, or manufacturer, to reduce radiation handling by the medical staff, e.g., the nuclear medicine department of a hospital. In an embodiment, the instant system and methods can provide a way to simplify the interaction with the radiation containing container by using a8ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 single fluid pathway within the container. The single fluid pathway extending into the substantially rigid container concept can rely on the container accommodating a fixed mass of air, above a fluid. As is understood, because air is a compressible fluid, the fixed mass of air will be compressible. In an embodiment, the air volume within the container can be used as an air spring which can enable the use of a single fluid pathway for delivery of the content within the container to a site of interest, e.g., within a patient. The system can provide a series of valves, e.g., check valves, and fluid flow controllers, e.g., stopcocks, ball valves, solenoid valves, etc., to allow for a volume of fluid to be delivered from a fluid source into the container via the single fluid pathway. As fluid enters the container, the air above the fluid can compress thereby creating an air spring which can exert a downward force onto the fluid which can act to force fluid back up through the single fluid pathway and towards a junction which can lead to a fluid delivery pathway to a site of interest.

[0033] As shown in FIG. 3 A, a liquid content delivery system, or delivery system, 100 can be provided with a fluid source, or reservoir, 101 from which fluid can be introduced into the system by, for example a delivery mechanism. In some embodiments, the fluid source 101 and the delivery mechanism can be one component, such a syringe that can hold the fluid. Fluid introduced from the source 101 into the system 100, in an embodiment, can be used to actuate priming of the system 100 and delivering the liquid content, e.g., beads, embolic beads, radioactive beads, radiopharmaceutical, chemotherapy agents, or some combination thereof, from the container 113 to a site of interest through a delivery pathway 115. In some embodiments, the container 113 can include any particulate or fluid content to be delivered, or administered, to the patient, including, but not limited to: beads, bland beads, embolic beads, radioactive beads, radiopharmaceutical, chemotherapy agents, or some combination thereof.

[0034] In an embodiment, for example, in the case that the container 113 contains a radioactive substance, it may be necessary to further minimize exposure of nearby individuals to the radiation. As shown in FIG. 2B, the receptacle 130, in an embodiment, can be a box formed from radiation blocking materials, e.g., acrylic. In some embodiments, the receptacle 130 can be formed from a clear material to allow a user to visualize the interior of the receptacle 130. While the receptacle 130 is shown in the form of a cuboid, e.g., a cube, any geometric shape can be used. The receptacle 130, in an embodiment, can include a cover 132, formed of a similar material to9ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 further contain the radiation within the container 113 to prevent, or minimize, any radiation from escaping the receptacle 130. In some embodiments, receptacle 130 can include slots 134a, 134b to allow for conduits to access the container 113 within the receptacle 130. While two slots 134a, 134b are shown, any number of slots can be included. In an embodiment where radioactive substances are disposed within the container 113, an inner receptacle 137 can be included to surround the container 113. In some embodiments, the inner receptacle 137 can be formed from acrylic or other radiation blocking material. The inner receptacle 137, in an embodiment, can include a through hole at the top to allow a fluid pathway to extend through the inner receptacle 137 and into the container 113. In some embodiments the container 113 can further have an intermediary receptacle 135 arranged outside of the inner receptacle 137. The intermediary receptacle 135 can be a two part construction, having a base to hold the container 113 and a cover to surround the container 113. In an embodiment, the intermediary receptacle 135 can be formed from lead to contain additional types of radiation not blocked by, for example, acrylic. In some embodiments, the receptacle 130 can include a mechanism, such as a rotatable handle, 136 to engage with valves disposed within the receptacle 130. The rotatable handle 136 can be axially movable to engage the valve and rotatable to actuate the valve. In some embodiments, the receptacle 130 can additionally include a component, such as a rig 138, to hold and constrain certain portions of a fluid delivery system 100, for example, to maintain the relative location of the delivery system 100 within the receptacle 130. As will be appreciated, the receptacle 130 and the associated features may not be needed in use with the delivery system 100, depending on what substances are being delivered from the container 113.

[0035] The fluid source 101 can be a syringe, as known in the art. In some embodiments, the fluid source 101 can be a saline bag, a raised saline bag (i.e., fluid therein can act through gravity by being vertically above the system), a syringe pump, or a pressurized saline bag which can be triggered on and off. In an embodiment, the fluid source 101 can have a volume from approximately 1 mL to approximately 20 mL, or more. In an embodiment, the delivery system 100 can include a valve 102 downstream of the fluid source 101. The valve 102 can be, for example, a check valve, a dual check valve, or a T or Y luer connector with two one-way check valves, or with a single check valve. The valve 102 can enable re-filling of the fluid source 101 without removal of the fluid source from the delivery system 100. For example, in some cases it10ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 may be necessary to refill the fluid source 101 to deliver the necessary volume of fluid to the site of interest, e.g., into the patient for therapeutic efficacy. In an embodiment, a refill mechanism 103, e.g., a syringe or saline bag, can be connected to the valve 102 to allow for the refill saline to be directed into the fluid source 101. In some embodiments, the fluid source 101 can be removed from the system for refilling with additional fluid, then reconnected to the delivery system 100.

[0036] In some embodiments, for example in medical applications, the delivery device can include a junction 104, e.g., a Y-connector, downstream of the valve 102 which can be fluidly connected to a fluid source 105 which can contain for example contrast to allow fluid to be delivered through the delivery system 100. In some embodiments, a valve 106 can be located between the fluid source 105 and the junction 104 to prevent backflow of the saline into the contrast source. In an example, contrast flushing can be used to confirm placement of the fluid delivery pathway 115 without removing the fluid source 101 from the system, thereby adding to the functionality of the device. For example, in some embodiments, after insertion of the fluid delivery pathway 115 into the patient, even minimal movements of the system 100 can affect the desired delivery location of the fluid. Thus, it may be necessary to provide contrast to re-position the fluid delivery pathway 115 before delivering the fluid to a site of interest, e.g., the patient, by injecting contrast. The contrast can be used to visualize and to determine proper placement of the distal end of the delivery catheter. In some embodiments, the contrast can be visualized on an external monitor via fluoroscopy. In some embodiments, in lieu of the junction 104 and separate fluid source 105, a contrast filled syringe could be swapped in the place of the fluid source 101, for this process.

[0037] In some embodiments, for example as shown in FIG. 3 A, a fluid conduit 107 can extend downstream, or distally, from junction 104 to deliver the saline, or in certain examples, the contrast, towards a junction 108, connector, or splitter. In an embodiment, the junction 108 can be a second Y-connector. In some embodiments, e.g., in a medical setting, the fluid conduit 107 can have a length sufficient to provide a safe distance between the medical practitioner and the radiation emitting beads, as well as additional flexibility to the interventional radiologist when administering the treatment. In some embodiments, an overpressure valve can be used at any point before the junction 108 as a potential safety measure to prevent the delivery device from becoming over pressurized due to a user error or a defect in the system. The junction 108 can be described 11ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 as a connector having at least three branches, with one branch fluidly connected to the fluid conduit 107, one branch in fluid connection with a fluid pathway 110, and a branch in fluid connection with the fluid delivery pathway 115. Of course, a splitter with more than three branches can be employed depending on the application.

[0038] In an embodiment, the fluid conduit 107 can extend downstream, or distally, towards the junction 108. The junction 108 can facilitate a junction between the inlet flow from the fluid source 101 and the container 113 containing the beads to the fluid delivery pathway 115. A Y-connector can be used to minimize microsphere, or bead, settling due to gravity. In some embodiments, a T-connector or other junction can be used. However, any 3-way connector, including a 2-way stop-cock can be used within the system to direct the flow of saline, contrast, or beads to the patient.

[0039] As discussed above, the junction 108 can fluidly connect the fluid conduit 107 to the container 113. In some embodiments, the fluid conduit 107 can provide saline or another delivery fluid. A first branch of the junction can provide a fluid- tight connection to the fluid conduit 107, a second branch can provide a fluid-tight connection to fluid pathway 110 leading to the container 113, and the third branch can provide a fluid- tight connection to a fluid conduit 114 and the fluid delivery pathway 115. Between the junction 108 and the container 113 a valve 109, e.g. a stopcock, can be installed to selectively restrict fluid from entering the container. For example, the valve 109 can be used to turn off access to the container 113 when priming the system or delivering contrast to confirm the fluid delivery pathway’s 115 position relative to the site of interest. In an embodiment, the valve can be a 2- way stopcock is used as an alternative to a 3 -way junction, or Y-connector.

[0040] In an embodiment, the delivery system 100 can include only a fluid pathway 110 that fluidly connects the junction 108 to the container 113. In an embodiment, the fluid pathway 110 can be a canula, in the case of medical use. This fluid pathway 110 can fluidly communicate with the container 113. For example, an injection of fluid from the fluid conduit 107 can drive fluid, e.g., saline, through the junction 108, directly the site of interest and, additionally, into the container 113, thereby compressing the air. The compressed air can apply a pressure on the solution in the container 113 to deliver a solution to the site of interest. For example, in cases12ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 where the site of interest is a patient, the use of the instant system 100 can enable efficient, cyclic delivery via small pulsatile injections using only a single canula, as shown schematically in FIG. 3B. In an embodiment the container 113 can generally include a cap 112, e.g., an aluminum cap crimped to seal the container 113. The cap can include a cover 111 which can be penetrated with the fluid pathway 110. In an embodiment, the cover 111 can be rubber to seal the container 113 while permitting the fluid pathway 110 to puncture, or otherwise be advanced, therethrough. The container 113 can, in an embodiment, be a vial that contains radioactive beads (or microspheres), water (or saline), and air. The size of the container can be varied to accommodate more, or less, fluid and air. For example, the diameter or height of the container can be varied to adjust the total volume that can accommodate the fluid and air. The air can be compressed and pressurized, thereby acting as an air spring to prime microspheres after every pulsatile injection of saline to enable delivery with only a fluid pathway 110. For example, as fluid is delivered into the container from the fluid source 101 through the fluid pathway 110, the air in the container 113 can compress to store energy and exert a pressure onto the surface of the solution of water and beads. When the delivery of saline from the fluid source 101 is stopped, the pressure from the compressed air can force the solution back through the fluid pathway 110 towards the junction 108. As there can be incompressible fluid already in the fluid conduit 107 and the first branch of the junction 108, the solution in the container 113, including any particulates stored therein, can flow through the third branch of the junction 108 and towards the site of interest. In some embodiments, the third branch of the junction 108 can be in fluid-tight communication with a fluid conduit 114. In an embodiment, for example in a medical application for delivery of radioactive content, the fluid conduit 114 can provide an interventional radiologist with additional length of catheter to the patient. In an embodiment, a fluid delivery pathway 115 can be selectively placed at a site of interest. For example, the fluid delivery pathway 115 can be a microcatheter which can be selectively placed into an artery of a patient to supply the beads to the tumor. The fluid delivery pathway 115 can have a distal size of approximately 2.0 Fr to approximately 2.4 Fr and an inner diameter of approximately 0.66 to approximately 0.80 mm. Smaller fluid delivery pathways 115 in this range can be used for desired applications, e.g., super selective embolization, where very precise navigation into small or distal locations, e.g., branches of the hepatic artery may be required. In some embodiments, the fluid delivery pathway 115 can have a distal size of approximately 2.5 Fr to approximately 2.8 Fr and approximately 0.83 to approximately 0.93 mm13ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 inner diameter, for example where less selective procedures where access to larger vessels is sufficient.

[0041] In some embodiments, the delivery system 100 can include a radiation detector (not shown) in-line with the fluid flow. For example, a radiation detector can be disposed in-line with the fluid flow, or about the various fluid lines, downstream of a radiation source, e.g., the container 113. The radiation detector can be a known radiation detector in the art. In some embodiments, the radiation detector can measure the amount of radiation being delivered to the patient through the fluid delivery pathway 115, to ensure that the patient does not receive an amount of radiation over the medically acceptable amounts. Additionally, or alternatively, the radiation detector can ensure that a full dose of beads has been extracted from the container 113 and delivered to the patient. Alternatively, or additionally, the delivery system 100 can include a particle, or bead, counter (not shown) downstream of the container 113 and in-line with the fluid flow to determine the total delivered dose or particle delivered. Such a counter can be any appropriate and / or commercially available particle counter.

[0042] In some embodiments, as shown in FIG. 4, the delivery system 100 can be substantially the same as the delivery device of FIG. 3 A. Like structures are numbered the same and a detailed description is omitted for the sake of brevity, however, the description provided with respect to FIG. 3 A can provide the necessary explanation. The delivery device of FIG. 4 can be a further simplified version of the delivery system 100 of FIG. 3 A that omits a refill mechanism 103 and a fluid source 105. As there is a single fluid source 101, saline bag, or other fluid vessel, a valve 102 can be disposed between the fluid source 101 and the fluid conduit 107. In some embodiments, the valve 102 can prevent back-flow of fluid into the fluid source 101 and allow the fluid source 101 to be replaced, if additional fluid is required. In some embodiments, a syringe containing contrast can be installed onto the valve 102 a determine and confirm the position of the fluid delivery pathway 115 before the delivery of fluid to the site of interest.

[0043] In a method of use, the delivery device can be provided to deliver beads, or microspheres, to a patient using positive pressure within the container 113 such that only a single fluid pathway 110, or needle, can be inserted into the container, thereby simplifying set up by an interventional radiologist and providing a reliable flow of beads to treat the tumor. While reference14ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 is made to a specific medical procedure with respect to the following method of use, one of ordinary skill in the art would understand that the instant delivery system 100 can be used in any number of other applications, where the components would be sized accordingly for the intended use, as disclosed herein.

[0044] In an embodiment, the method can include a priming step, for example the delivery device can be primed with fluid prior to use. In some embodiments the fluid can be saline, water, other inert fluids, a medication, or other fluids as needed. The user can inject a small amount of fluid via the fluid source 105 to prime the contrast junction of the junction 104. The priming step can be completed before the delivery system 100 is connected to the container 113. Using the fluid source 101, the user can inject saline through the delivery system 100 until no visible air, or mostly no visible air, remains within the delivery system 100. The fluid source 101 can be refilled in preparation for use.

[0045] Once the delivery system 100 has been primed, the user, e.g., an interventional radiologist, can connect the tubing set to an acrylic housing to position the fluid pathway 110, e.g., a needle or cannula, into the shielded container 113. For example, the user can expose the cover 111 and insert the fluid pathway 110 through the cover 111 of the container 113 until the fluid pathway 110 reaches the predetermined stopper position such that a portion of the fluid pathway 110 rests j ust above the base of the container 113.

[0046] Once the system has been properly set up, the user may need to confirm that the fluid delivery pathway 115 is properly positioned at the desired delivery location. For example, in an embodiment, after inserting the fluid delivery pathway 115 within the patient, e.g., the desired arterial position, the user can connect the microcatheter to the fluid conduit 114. During the connection step, it is anticipated that the distal end of fluid delivery pathway 115 may shift from the desired position, e.g., the arterial position within the patient. Therefore, additional positioning of the fluid delivery pathway 115 may be required. In that situation, the user can inject additional contrast via the fluid source 105 to position the fluid delivery pathway 115. For example, the valve 109 can be shifted to the closed position and the user can inject contrast through the contrast port, in some embodiments check valve 106, to confirm the fluid delivery pathway 115 has not moved. With the valve 109 closed, the contrast can flow from the fluid source 105 through the fluid conduit15ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 107 to the fluid delivery pathway 115 for positioning, without concern that the contrast will enter the container 113.

[0047] Once the user is satisfied that the fluid delivery pathway 115 has been properly positioned, with or without the additional positioning steps, the user can confirm that the valve 109 has been opened through the shielding using an external articulating knob, if applicable. With the valve 109 open, fluid from the fluid source 101 can flow into, and out of, the container 113 to deliver the beads to the patient. With the fluid delivery pathway 115 position confirmed, the user can inject one or a plurality of pulses of fluid into the delivery system 100 with the fluid source 101. In an example, the fluid source 101 can be used to deliver pulses of approximately 2 mL over a rate of approximately 1 mL - approximately 2 mL / s through a first path of the junction 108. Delivery pulses in this range can result in a functional delivery rate of approximately 0.5 mL / s - approximately 5 mL / s, with approximately 1 to approximately 5 second pauses between pulses. The delivery pulses can be delivered through the junction 108 towards the container 113 through a second path of the junction 108. The delivery pulses of fluid from the delivery syringe can increase the volume of fluid in the container 113 to compress the air contained therein, as shown in FIG. 3B. In an embodiment, during the delivery pulses, the fluid from the fluid source 101 can “stir,” agitate, or mix, particulates, e.g., the beads, into a suspension to allow the resulting solution to flow easier and to dilute the delivered dosing of the solution. For example, by mixing the beads into a suspension and diluting the density of beads in the fluid the potential for the fluid conduit 114 and the fluid delivery pathway 115 can have a lower chance of being clogged. In addition, or alternatively, by diluting the delivered suspension, the delivery system 100 can prevent delivering all, or a large concentration, of the beads to one area at once, which can be problematic in certain situations.

[0048] As illustrated in at least FIG. 3B, during the pauses between the pulses, the compressed air is allowed to re-expand, akin to a piston, thereby pushing the bead suspension up and out through the single fluid pathway 110 inserted into the container through the second path of the junction 108. In some embodiments, during the pauses the bead suspension can flow toward and into a third path of the junction 108 towards the fluid delivery pathway 115 in a laminar flow, or non- laminar flow. In an embodiment, the second path of the junction 108 can be arranged to be substantially perpendicular to the floor and the third path can be at an acute angle relative to the 16ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 second path, such that the flow of the bead suspension up through the second branch then back down the third path, without entering the first path towards the fluid source 101. In an embodiment, the flow of the solution can be laminar to maintain the dilution of the beads in the fluid as the solution enters the third path.

[0049] In some embodiments, the junction 108 can be clear to allow for visualization of the flow of the bead suspension towards the fluid delivery pathway 115. In some embodiments, the junction 108 can include a lens that can magnify the flow therethrough to allow for ease of viewing. In some embodiments, it may be desired to inject a minimum total of 20 mL of the bead and fluid solution into the patient. For example, approximately 2 mL pulses of fluid can be delivered in about 20 total increments until a minimum of approximately 40 mL or approximately 60 mL has been delivered from the fluid source 101.

[0050] Advantageously, as the air within the container 113 can only be compressed to a predefined upper limit, any additional flow of fluid from the fluid source 101 will not “over compress” the air and that fluid can “over flow” into the fluid conduit 114 and into the patient. Said another way, because the air within the container 113 may only be compressed to a pre- established limit as a function of the initial volume of air, the instant arrangement can effectively function as a built in pressure relief valve ensuring that the contents of the container 113 are not over pressurized. In an embodiment, at the end of each cycle of delivery pulse and pause, the volume of air and liquid can return to an equilibrium state. Meaning, the air can return to the prepressurized volume and the liquid can similarly return to the pre-pressurization volume. In some embodiments, the container 113 can arrive at the procedure with only particles, beads, or other solids. The user can then pre-fill the container 113 with a liquid to a predetermined volume to “set” the desired initial volume of air for the system before beginning the delivery process. Alternatively, the container 113 can be varied in size to adjust the performance of the delivery system 100 by increasing or decreasing the total volume - thereby increasing or decreasing the volume of space available for air.

[0051] In some embodiments, the equilibrium state of the air volume can be varied to effect the performance of the delivery system 100. In some embodiments, the distance, or height, between the container 113 and the junction 108 can additionally be varied to change the needed17ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 pressure in the air spring to deliver the suspension up to the junction 108 and ultimately through to the fluid delivery pathway 115 into the patient. For example, the distance, or height, between the container 113 and the junction 108 can be a fixed value or can be adjustable, e.g. with a telescoping or sliding mechanism. In some embodiments, the diameter of the fluid pathway 110 can additionally, or alternatively, be varied to effect the amount of the pressure of the suspension exiting the container 113. For example, the smaller the diameter of the fluid pathway 110, the higher the delivery pressure can be from the container 113. Similarly, the diameter of any of the connections, e.g., the junction 108, can be varied such that a smaller diameter can result in a higher delivered pressure.

[0052] In an embodiment, varying the delivery pulse length and other variables can result in a more constant delivery concentration, as is illustrated in FIGS. 5-8. As the container 113 contents become diluted, the max concentration results with the start of administration. Advantageously, the instant delivery system 100 can enable enhanced versatility in delivery concentration. For example, when using approximately 2 mL pulses from the fluid source 101, the first pulse can deliver normal saline into the patient, and during the pause, beads can be primed into the fluid conduit 114, awaiting delivery. Upon the next pulse of fluid from the fluid source 101, the primed beads from the initial pulse can be delivered to the patient, and during the pause the next grouping of beads in the line can be primed. In an embodiment, the user can visualize delivery of the solution (e.g., the mixture of saline and beads) to the desired delivery location, in vivo. For example, the user can visualize, with known medical imaging technology, the desired delivery location of the solution, for example radio-opaque beads, to an organ to ensure that the solution is sufficiently encircling, encapsuling, or embedded within, the intended location.

[0053] In an alternative method, a constant, or controlled, concentration pulses can be delivered with the delivery system 100. For example, the user can deliver a first approximately 2 mL pulse to deliver normal saline into the patient, and during the pause, beads can be primed into the fluid conduit 114, awaiting delivery. In some embodiments, the next delivery pulse can then be a higher saline volume, e.g., approximately 10 mL, which can result in dilution of the delivered microspheres, or beads, waiting in the fluid conduit 114. During the pause, microspheres, or beads, can once again be primed into the fluid conduit 114, awaiting delivery. The following, third pulse18ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 can then be a smaller volume, e.g., approximately 5 mL, to account for dilution within the vial, enabling concentration tuning as desired.

[0054] In an alternative embodiment, as illustrated in FIG. 9, a negative pressure delivery device can be shown. The principle, as with the delivery device of FIGS. 3 A or 3B, is to rely on the container 213, as shipped, to reduce handling and simplify the delivery process. In an embodiment, the delivery system 200 reduces interaction with the radiation containing container, for example, container 213. Alternative to the embodiments of FIGS. 3A and 3B, the delivery system 200 of FIG. 9 can rely on the container 213, which can contain a consistent air volume, by design, that can be expanded to facilitate controlled aspiration. This air volume can be used as an air spring and can enable the use of a single fluid pathway 210 disposed in the container 213, to transport the fluid or particulates from the base of the container 213 into the fluid delivery pathway 210 by way of vacuum pressure. Those like elements which are discussed with respect to FIG. 3 A will not be described here for the sake of brevity and the discussion will begin downstream of the fluid conduit 207.

[0055] In an embodiment, the delivery system 200 can include a valve 208, e.g., a two- way stopcock, in fluid-tight connection with the distal end of the fluid conduit 207. This valve 208 can control fluid flow at the junction between the inlet flow from the fluid conduit 207, the bead containing container 213, and the fluid delivery pathway 219. In some embodiments, the connection to the bead containing container 213 can be shut off during delivery while, during priming, the connection to the fluid source 201 can be shut off.

[0056] In some embodiments, a connector 209 can be used to enable connection from the valve 208 to the fluid pathway 210 leading to the container 213. In some embodiments, other connections are contemplated to be within the scope of this disclosure, including but not limited to an integral design, female-to-male adaptors, or a female-to-female adaptor. The fluid pathway 210 can include a needle at its distal end which can be inserted through the cover 211 into the container 213 to provide a single pathway for fluid to enter and exit the container 213.

[0057] In some embodiments, the valve 208 can include a third branch that can lead to the fluid delivery pathway 219 to allow the beads to be delivered to the patient. In some embodiments, the third branch can connect to an adaptor, e.g., a female-to-female adaptor, to connect to a valve 19ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025215, e.g., a two-way stopcock. The valve 215 can provide for at least two configurations. For example, the valve 215 can enable direct connection between the container 213 and a vacuum source 216 to enable distal bead priming without drawing a vacuum on the fluid delivery pathway 219. In this first configuration, the valve 215 can shut-off fluid communication to the fluid delivery pathway 219 to prevent drawing fluid from the site of interest. Additionally, the valve 215 can be in a second configuration where to shut-off of the vacuum source 216 once the beads are primed within the container 213 to enable the fluid source 201 to deliver beads into the catheter and not the vacuum source 216.

[0058] The vacuum source 216 can, in the first position, apply a vacuum to the fluid within the container 213 to expand the stored air within the container 213. When the vacuum from the vacuum source 216 is applied, the air can expand and the colloid bead mixture can be cleared into the distal priming line. For example, the vacuum source 216 can be one of a vacuum-lock syringe, a vacuum tube or an alternate vacuum source connects to the valve 215 to enable bead priming. This vacuum source 216 can also be positioned proximal to the container 213.

[0059] In some embodiments, the vacuum source 216, which is in fluid communication with the container 213 via the valve 215, can be in fluid communication with a fluid conduit 217 via an adaptor 218. In an embodiment, the adaptor 218 can be a male-to-male adaptor to provide connection from fluid conduit 217 to the fluid delivery pathway 219. As with the other embodiments, the fluid delivery pathway 219 can be selectively placed at a site of interest, e.g., into an artery supplying the tumor after which it is connected to the fluid conduit 217. The fluid delivery pathway 219 can have a distal size of approximately 2.0 Fr to approximately 2.4 Fr and an inner diameter of approximately 0.66 to approximately 0.80 mm. Smaller fluid delivery pathways 219 within this range can be used for super selective embolization, where very precise navigation into small or distal branches of the hepatic artery may be required. In some embodiments, the fluid delivery pathway 219 can have a distal size of approximately 2.5 Fr to approximately 2.8 Fr and approximately 0.83 to approximately 0.93 mm inner diameter, where less selective procedures, where access to larger vessels is sufficient.

[0060] In a method of use, the delivery system 200 can be primed before use. For example, before the fluid pathway 210 is inserted into the container 213, the valve 208 can be adjusted to an20ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 open position to inject a small amount of fluid from the fluid source 201 through the fluid source 205 to prime the junction 204, thereby removing air from the lines of the delivery system 200. In an embodiment, a valve 206 can be arranged downstream of the fluid source 205 to prevent backflow into the fluid source 205. Using the fluid source 201, the user can inject saline through the tubing set until the remainder contains no visible air. The user can confirm that the vacuum source 216 contains some fluid to enable a wet- wet connection, approximately 5 mL. In some embodiments, the fluid source 201 may need to be refilled at this point to ensure sufficient volume of fluid to deliver the whole dose of the beads.

[0061] The user can then connect the tubing set to the acrylic housing and position the shielded container 213 within the acrylic housing. For example, the user can expose the cover 211 and insert the fluid pathway 210 until a proximal end reaches a predetermined stopper position such that the tip of the fluid pathway 210 rests just above the base of the container 213. The user can, after connecting the fluid pathway 210 to the container 213, select a desired site of interest to deliver fluid. For example, the user can select a desired arterial position, within a patient, with the fluid delivery pathway 219, to deliver the beads to the selected site. For example, the valve 215 can be actuated to turn off the connection to the vacuum source 216 to draw and hold a vacuum of air expansion in a visibly airless syringe (approximately 0.05 PSI to approximately 0.1 PSI). For example, the vacuum source can create a vacuum equivalent of approximately 1 mL - approximately 2 mL. The user can select a tubing configuration such that the suction volume does not exceed the volume of fluid within the container 213. In an embodiment, the user can then actuate the valve 215 within the shielding with an articulating knob, open the valve 208 such that the container 213 communicates with the fluid delivery pathway 219.

[0062] When the user is ready to prime the delivery system 200, for example with spheres or beads, the user can open the valve 215 such that the fluid source 201 can communicate with the container 213 to release the stored vacuum, and can allow the beads to be suctioned into the fluid conduit 217 due to the vacuum. This vacuum can be released in one step, or incrementally to control the dose of fluid delivered in smaller aliquots as desired. The valves 208, 215 can once be turned off connections to the container 213 and vacuum source 216. In an embodiment, the user can then use the fluid source 201 to inject fluid into the patient with the desired volume, for example approximately 5 mL - approximately 20 mL.21ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025

[0063] The priming and delivery steps can be repeated as many times as necessary to deliver the desired dose of beads. In some embodiments, it may be desirable to restore equilibrium within the container 213 by briefly adjusting the valve 215 such that the fluid source 201 can refill the fluid volume removed. This can allow, on subsequent uses of the vacuum, the container 213 will not run out of fluid.

[0064] As utilized herein, the terms “comprises” and “comprising” are intended to be construed as being inclusive, not exclusive. As utilized herein, the terms “exemplary”, “example”, and “illustrative”, are intended to mean “serving as an example, instance, or illustration” and should not be construed as indicating, or not indicating, a preferred or advantageous configuration relative to other configurations. As utilized herein, the terms “about”, “generally”, and “approximately” are intended to cover variations that may existing in the upper and lower limits of the ranges of subjective or objective values, such as variations in properties, parameters, sizes, and dimensions. In one non-limiting example, the terms “about”, “generally”, and “approximately” mean at, or plus 10 percent or less, or minus 10 percent or less. In one nonlimiting example, the terms “about”, “generally”, and “approximately” mean sufficiently close to be deemed by one of skill in the art in the relevant field to be included. As utilized herein, the term “substantially” refers to the complete or nearly complete extend or degree of an action, characteristic, property, state, structure, item, or result, as would be appreciated by one of skill in the art. For example, an object that is “substantially” circular would mean that the object is either completely a circle to mathematically determinable limits, or nearly a circle as would be recognized or understood by one of skill in the art. The exact allowable degree of deviation from absolute completeness may in some instances depend on the specific context. However, in general, the nearness of completion will be so as to have the same overall result as if absolute and total completion were achieved or obtained. The use of “substantially” is equally applicable when utilized in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result, as would be appreciated by one of skill in the art.

[0065] Numerous modifications and alternative embodiments of the present disclosure will be apparent to those skilled in the art in view of the foregoing description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in 22ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 2025 the art the best mode for carrying out the present disclosure. Details of the structure may vary substantially without departing from the spirit of the present disclosure, and exclusive use of all modifications that come within the scope of the appended claims is reserved. Within this specification embodiments have been described in a way which enables a clear and concise specification to be written, but it is intended and will be appreciated that embodiments may be variously combined or separated without parting from the invention. It is intended that the present disclosure be limited only to the extent required by the appended claims and the applicable rules of law.23ACTIVE 715906990v1

Claims

Attorney Docket No. 215532-010501 / PCTElectronically Filed: November 3, 2025CLAIMSWhat is claimed is:

1. A delivery system, comprising, a reservoir in fluid communication with a conduit; a junction positioned downstream of the conduit, and having a first pathway terminating in a container accommodating a solution having content to be delivered to a site of interest, and a second pathway; and a pressure source designed to direct fluid from the reservoir along the conduit, while applying pressure to the container so that the solution along with the content within the container can be directed to the site of interest via the second pathway.

2. The delivery system of claim 1, wherein the container is a substantially rigid container.

3. The delivery system of claim 1, wherein the pressure source is one of a syringe or a saline bag.

4. The delivery system of claim 1, wherein the fluid is one of a gas or a liquid.

5. The delivery system of claim 1, wherein the fluid is one of saline, contrast solution, or a mixture thereof.

6. The delivery system of claim 1, wherein the first pathway is disposed in the container.

7. The delivery system of claim 6, wherein the pressure source is configured to deliver a flow of the fluid in a first direction into the container and configured to allow the solution of the fluid and content to exit the container through the junction in a second direction towards a delivery conduit.

8. The delivery system of claim 7, wherein the flow of fluid into the container agitates the content to create a suspension of the content in the fluid to form the solution.

9. The delivery system of claim 1, wherein the pressure source is configured to deliver the fluid through the conduit in a first direction to compress air within the container.

10. The delivery system of claim 9, wherein the compressed air is configured to apply pressure to the solution of the fluid and content within the container to push the solution through the second pathway in a second direction towards the site of interest.24ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCT Electronically Filed: November 3, 202511. The delivery system of claim 1, wherein the container is a vial containing radioactivated beads.

12. The delivery system of claim 11, wherein the vial is disposed within radioactive shielding.

13. The delivery system of claim 1, further comprising, the solution of the content and the fluid disposed within the container; the pressure source is configured to apply a vacuum pressure to the solution to expand a fixed mass of air contained within the container to draw the solution out of the container; and a fluid delivery source configured to deliver fluid through the system to flush the solution into the site of interest.

14. The delivery system of claim 1, wherein the content is at least one of: embolic beads, radioactive beads, radiopharmaceutical, chemotherapy agents, drug, or a combination thereof.

15. A method of delivering a solution, the method comprising, coupling a conduit to a reservoir in communication with a junction, the reservoir accommodating a fluid, the junction being disposed downstream of the conduit and having a first pathway terminating in a container accommodating content to be delivered to a site of interest, and a second pathway; inserting a portion of the first pathway into the container; and applying pressure with a pressure source to the container to deliver a solution along with the content and the fluid to the site of interest.

16. The method of claim 15, further comprising, priming at least the first pathway with the fluid prior to the applying step.

17. The method of claim 15, further comprising, delivering, with the pressure source, a contrast fluid to the site of interest.

18. The method of claim 17, further comprising, connecting a delivery conduit to the second pathway; and determining a location of a distal end of the delivery conduit based on a visualization of the contrast fluid.25ACTIVE 715906990v1Attorney Docket No. 215532-010501 / PCTElectronically Filed: November 3, 202519. The method of claim 15, wherein the applying step further includes mixing the content and the fluid in the container.

20. The method of claim 15, wherein the applying step includes delivering the solution in a laminar flow to the site of interest.

21. The method of claim 15, wherein the content of the container is radio-opaque, and wherein the content of the container is configured to be visualized to confirm delivery to the site of interest.

22. The method of claim 21 , further comprising, adjusting a location of a delivery conduit to the site of interest based on the visualized radio-opaque content.

23. The method of claim 15, wherein the fluid is one of a liquid or a gas.

24. The method of claim 15, wherein the container is a substantially rigid container.26ACTIVE 715906990v1

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