Radiopharmaceutical distribution system for patient infusion.

Description

1 / 37 Radiopharmaceutical distribution system for patient infusion. TECHNICAL FIELD OF THE INVENTION

[001] The present invention relates to a radiopharmaceutical infusion system. More particularly, the present invention relates to a theranostic or radiopharmaceutical drug delivery system that can perform the infusion of radiopharmaceutical compositions into patients in an outpatient care clinic and / or hospital, by fitting and pairing a new syringe shielding device, in combination with a patient infusion pump device. BACKGROUND OF THE INVENTION

[002] Radiopharmaceutical drugs are important for therapeutic and diagnostic use in various diseases. The safe and efficient use of these important and potentially dangerous radioisotopes, having short or long half-lives, is essential during their intended use by patients and / or healthcare professionals. These radioisotopes play a vital role in the diagnosis and therapy of various diseases. Most widely available radiopharmaceuticals are generated by several known techniques. For example, Co-60 is used in cancer treatment, I-131 is used in the treatment of hyperthyroidism, C-14 is used in breath tests, Tc-99m and Rb-82 are used as tracers in myocardial perfusion imaging, Ga-68 is used for solid tumor imaging, and Ac-225, Lu-177, and At-211 are used for therapeutic purposes. Due to the short half-lives of some radiopharmaceuticals, the entire imaging and administration procedure needs to be completed within a short period of time.Some radiopharmaceuticals are usually prepared in on-site facilities, maintaining an adequate distance from the patient site to avoid undue deterioration. Petition 870250103981, dated 11 / 13 / 2025, page 10 / 60 2 / 37 radiopharmaceutical before use. Additionally, these radioisotopes have undesirable radiation hazards for users or healthcare professionals, as well as for patients. Therefore, safe handling techniques, including the use of shielded systems, are essential to prevent various undesirable health risks.

[003] Currently, Nuclear Medicine Technologists configure a non-radioactive intravenous / chemotherapeutic infusion peristaltic pump for the infusion of theranostic radiopharmaceuticals into patients in hospitals. There is an unmet need in infusion system technology for next-generation theranostic / therapeutic radiopharmaceuticals that require slow infusion (i.e., 1 mL / minute), while diagnostic infusions are of the “bolus” type, in addition to providing a safe / shielded delivery system and minimizing undesirable health risks to patients, users / healthcare professionals, and the environment from radiation exposure.

[004] Currently, available infusion systems and methods have several disadvantages, such as the absence of radiation shielding and the lack of ability to rinse or wash the drug syringe with saline solution to ensure an adequate dose for the patient. Furthermore, current methods do not incorporate a syringe; instead, they rely on extended spinal needles to pierce the rubber septum of a glass tube to withdraw the drug, which can lead to the introduction of air into the patient's intravenous line, resulting in incomplete or inaccurate drug administration and a risk of gas embolism for the patient. Additionally, not all infusion pumps can accommodate a 60 cc syringe volume, which is the size required for the infusion of some radiopharmaceuticals for therapy. There is an unmet need for an infusion system solution to carry all the supplies required for radiopharmaceutical procedures. Petition 870250103981, dated 11 / 13 / 2025, p. 11 / 60 3 / 37 specialized patient equipment, such as ion chambers, Geiger-Mueller counters, intravenous tubing, and radioactive waste disposal. In addition, there is a guideline published in the USP General Chapter. <825> Regarding the preparation, composition, dispensing, and repackaging of radiopharmaceuticals. According to the published compendium of drug information and standards, customers are prohibited from handling highly active drugs without a cleanroom, and hospitals and pharmacies must comply with the guidelines. The present invention will facilitate compliance and safety for hospitals and pharmacies by providing quality-controlled drugs in a shielded syringe for infusion to patients based on dose.More specifically, there is an unmet need to develop an advanced and efficient theranostic delivery system in combination with a shielded syringe infusion pump, which can provide greater safety against increased radiation for the patient, as well as for healthcare users / professionals. SUMMARY OF THE INVENTION

[005] The present invention relates to a theranostic delivery system or radiopharmaceutical drug delivery system that can perform the infusion of radioactive therapeutic drugs into patients in a hospital setting by pairing a novel syringe shielding device in combination with a patient infusion pump device.

[006] One aspect of the present invention is to provide an ergonomic theranostic delivery system with a mobile cart for transporting the therapeutic radiopharmaceutical dose to the patient's infusion room in the hospital or clinic.

[007] One aspect of the present invention is to provide patient-specific theranostic dosing of different radiopharmaceutical theranostic drugs using an automated infusion system. However, Petition 870250103981, dated 11 / 13 / 2025, page 12 / 60 4 / 37 It should be understood that the dose and administration of the radiopharmaceutical can be fully automated, semi-automated, or manual.

[008] One aspect of the present invention is to automate the infusion of radiopharmaceuticals for therapeutic purposes.

[009] One aspect of the present invention is to facilitate the ability of healthcare professionals to monitor and protect their health from radiation risks when treating patients.

[010] One aspect of the present invention is to provide shielding against localized radiation to the syringe containing the radioactive drug.

[011] One aspect of the present invention is to provide an infusion system that can deliver the radiopharmaceutical composition using a process that is manual, automated, semi-automated, computer-controlled, or any combination thereof.

[012] One aspect of the present invention is that it allows the syringe to be “rinsed with saline solution after infusion, either automatically, semi-automatically, manually and / or in combinations thereof, to ensure that all the drug is injected.

[013] One aspect of the present invention is to provide a “cart with an accessory management system to enable the health professional to keep all necessary supplies in ready-to-use condition.

[014] One aspect of the present invention is to provide a contamination management system comprising a removal tray with an integral channel system to direct any fluid leakage towards a collection platform or waste bin.

[015] Yet another aspect of the present invention is to provide a theranostics informatics management system that controls the infusion parameter. Petition 870250103981, dated 11 / 13 / 2025, page 13 / 60 5 / 37 of the patient.

[016] Another aspect of the present invention is a display for showing different colors to indicate various operating states of the device during use.

[017] One aspect of the present invention is to provide a theranostic delivery system (100) comprising: i) an ergonomic mobile cart with an integrated handle; ii) a theranostic informatics system with a computer screen (19) as a graphical user interface (GUI); iii) a shielded infusion pump; and iv) a configurable dose conveyor (6); wherein the configurable dose carrier (6) comprises: a) a separable radioactive dose transport and containment module (13); b) an optimized shielding (18) for different dose activities; c) a radioactive dose in a standard syringe (8); d) a hand grip (12) to enable the transfer of the radioactive dose from the dose carrier to an external dose calibrator; (e) an adapter (9) for converting a luer lock syringe type into a pushfit connector; and f) a sterile lid (11) with attributes that are an integral part of workflow management.

[018] One aspect of the present invention is to provide a theranostic delivery system (100) comprising: i) an ergonomic mobile cart with an integrated handle; ii) a shield (18) that is optimized for different activities of Petition 870250103981, dated 11 / 13 / 2025, page 14 / 60 6 / 37 dose; iii) a theranostic informatics system with a computer screen (19) as a graphical user interface (GUI); iv) a shielded infusion pump; and v) a disposable sealed fluid cartridge (7); wherein the disposable sealed fluid cartridge (7) comprises: a) one or more selectable integrated flow channels (17); b) one or more leak-proof / drip-free sealed connections (10); and c) one or more guide attributes and mechanical interlocks (16) for workflow management.

[019] One aspect of the present invention is to provide a theranostic delivery system (100) comprising: i) an ergonomic mobile cart with an integrated handle; ii) a shielding (18) optimized for different dose activities; iii) a theranostic informatics system with a computer screen (19) as a graphical user interface (GUI); iv) a shielded infusion pump; and v) a workstation (3); where the workstation (3) comprises: a) a status light system (1) that illuminates the work area to enable long-distance monitoring; b) a disposable secondary containment system (2) that protects the core workstation from contamination (e.g., radioisotope, radiation); c) an onboard armored disposal system (4); and d) a foot-operated system (5) to enable locked modes and Petition 870250103981, dated 11 / 13 / 2025, page 15 / 60 7 / 37 unlocked during the device's journey, for example, to lock and unlock wheels on a mobile cart. BRIEF DESCRIPTION OF THE DRAWINGS

[020] Fig. 1A and Fig. 1B show diagrams of a schematic representation of a theranostic delivery system or radiopharmaceutical drug delivery system. Fig. 1C and Fig. 1D represent the front and rear views, respectively, of the theranostic delivery system or radiopharmaceutical drug delivery system.

[021] Fig. 2 shows a diagram of a schematic representation of a shielded syringe system.

[022] Fig. 3 shows a diagram of a schematic representation of a configurable dose carrier.

[023] Fig. 4 shows a diagram of a disposable sealed fluid cartridge containing selectable integrated flow channels, for example, to connect the radioisotope dose source and the saline solution source to the infusion pump and the channel that is connected to a patient line for infusion of the desired radioisotope dose to a patient. The flow channels allow bidirectional fluid flow for drug delivery to the patient and backflushing with saline solution to “rinse the cavity of any remaining radiopharmaceutical drug.

[024] Fig. 5 shows a diagram of a shield that is optimized for different dose activities.

[025] Fig. 6 shows a diagram of a disposable sealed fluid cartridge (7), which allows the healthcare professional to withdraw a customized volume from a tube or syringe.

[026] Fig. 7 shows a diagram of a disposable sealed fluid cartridge (7) in a connection with a tube (26) via a fitting of Petition 870250103981, dated 11 / 13 / 2025, page 16 / 60 8 / 37 compression.

[027] Fig. 8 shows a diagram of a disposable sealed fluid cartridge (7) with a dose adapter (9) in a connection to the tubing (26) via a compression fitting with a coded port to eliminate errors in the patient / saline lines.

[028] Fig. 9 shows a diagram of a disposable sealed fluid cartridge (7) connected to a syringe via a compression fitting to reduce leaking connections.

[029] Fig. 10 shows a diagram of a disposable sealed fluid cartridge (7) with an adapter (9) in a connection to the syringe (8) via a compression fitting with a coded port to eliminate errors in the patient / saline lines.

[030] Fig. 11 shows a diagram of a configurable dose carrier (6) that is connected by caddy in line with a custom shielded disposable sealed fluid cartridge (7) with a lead glass viewing window (29).

[031] Fig. 12 is a flowchart showing the use of the system to prepare and administer a dose of radioisotope to a patient in a hospital or outpatient clinic. DETAILED DESCRIPTION OF THE INVENTION

[032] The present invention can be more easily understood by reading the following detailed description of the invention and the embodiments included.

[033] The term “about”, as used in the present invention, refers to a measurable value, such as a parameter, an amount, a time duration and the like, and is intended to encompass variations of and in relation to the specified value, in particular variations of ±10% or less, preferably ±5% or less of the specified value, such variations are appropriate to be Petition 870250103981, dated 11 / 13 / 2025, p. 17 / 60 9 / 37 realized in the disclosed invention. It should be understood that the value to which the modifier “about” refers is also specifically, and preferably, disclosed.

[034] As used in the descriptive report of the present invention, the singular forms “a”, “an” and “the” include plural references, unless the context clearly indicates otherwise. Thus, for example, a reference to “a system” or “a device” or “a process” or “a composition” includes one or more systems, one or more devices, one or more processes or compositions, with one or more steps or ingredients or elements of the type described in this invention and / or which will become apparent to those skilled in the art upon reading this disclosure and so forth.

[035] As used in the present invention, the term “imaging” refers to techniques and processes used to create images of various parts of the human body for diagnostic and treatment purposes in digital health. For example, imaging includes X-ray radiography, Fluoroscopy, Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Medical Ultrasound or Endoscopic Ultrasound Elastography, Tactile Imaging, Thermography, Medical Photography, and functional imaging techniques in nuclear medicine, for example Positron Emission Tomography (PET), Dynamic Positron Emission Tomography, and Single Photon Emission Computed Tomography (SPECT). Imaging is used to reveal internal body structures and can be used to diagnose and treat diseases.

[036] As used in the present invention, the term “SPECT” refers to Single Photon Emission Computed Tomography, a nuclear medicine tomographic imaging technique that uses gamma rays and provides true 3D information. This information is typically presented as Petition 870250103981, dated 11 / 13 / 2025, page 18 / 60 10 / 37 cross-sectional slices of the patient, but can be freely reformatted or manipulated as required. The technique requires the delivery of a gamma-ray emitting radioisotope (a radionuclide) into the patient, typically through injection into the bloodstream. A tracer radioisotope is usually attached to a specific ligand to create a radioligand and / or radiopharmaceutical, whose properties bind it to certain types of tissues. This allows the radiopharmaceutical to be carried and bound to a region of interest in the body, where a SPECT camera assesses the ligand concentration. The radioisotopes typically used in SPECT imaging are iodine-123 (I-123), indium-111 (In-111), technetium-99m (Tc-99m), xenon-133 (Xe-133), thallium-201 (Tl-201), krypton-87m (Kr-81m), and gallium-67 (Ga67).

[037] As used in the present invention, the term “Positron Emission Tomography (PET)” refers to a functional imaging technique that uses radioactive substances known as radiotracers or radiopharmaceuticals to visualize and measure changes in metabolic processes and other physiological activities, including blood flow, regional chemical composition, and absorption. Different radiotracers can be used for various imaging purposes, depending on the target process within the body. Radioisotopes typically used in PET imaging are carbon-11 (C11), nitrogen-13 (N-13), oxygen-15 (O-15), fluorine-18 (F-18), rubidium-82 (Rb-82), copper-64 (Cu-64), zirconium-89 (Zr-89), and gallium-68 (Ga-68).

[038] As used in the present invention, the terms “therapy” and “therapeutic use” refer to the attempt to cure, improve, mitigate, treat and / or prevent diseases and / or other conditions in humans. The term “therapy” also refers to pharmacotherapy or pharmacological therapy, which refers to the treatment of diseases through the application of medications (drugs). The Petition 870250103981, dated 11 / 13 / 2025, p. 19 / 60 The term 11 / 37 can be used to indicate the treatment or prevention of the development of a disease, as well as to alleviate pain and symptoms of a specific condition. Nuclear medicine therapy can be given with the help of radioisotopes such as alpha emitters, actinium-225 (Ac-225), astatine-211 (At-211), etc., and beta emitters, such as lutetium-177 (Lu-177), lead-212 (Pb-212), etc.

[039] As used in the present invention, the term “Computed Tomography (CT)” refers to computerized X-ray imaging in which an X-ray beam directed at a patient and rotated around the body produces signals that are processed by the machine's computer to generate cross-sectional images of the body. These slices are tomographic images and contain more detailed information than conventional X-rays. After the machine's computer collects a number of successive slices, they can be digitally “stacked” to form a three-dimensional image of the patient, which allows for easier identification and location of basic structures, as well as possible tumors or abnormalities.

[040] As used in the present invention, the term “Magnetic Resonance Imaging (MRI)” is a non-invasive imaging technology that produces detailed 3D anatomical images, which are used for disease detection, diagnosis and treatment monitoring. MRI is based on a technology that excites and detects the change in the direction of the axis of rotation of protons found in the water that makes up living tissues.

[041] As used in the present invention, the term “Hybrid Molecular Imaging” refers to the fusion of two or more imaging technologies into a single, novel form of imaging. This form of imaging is synergistic, meaning it is more powerful than the sum of its parts. Hybrid imaging Petition 870250103981, dated 11 / 13 / 2025, page 20 / 60 12 / 37 denotes image acquisition in systems that physically combine complementary imaging modalities for improved diagnostic accuracy and confidence, as well as increased patient comfort. Hybrid imaging combines the strengths of two imaging modalities in one imaging session to diagnose and locate cancers more accurately, increasing patient comfort. This is achieved by overlaying two images at two different spatial scales: the low spatial scale is obtained by filtering one image with a low-pass filter; the high spatial scale is obtained by filtering a second image with a high-pass filter. Examples of hybrid imaging modalities include PET-CT, SPECT-CT, and PET-MRI.

[042] As used in the present invention, the term “automated infusion system” or “semi-automated infusion system” refers to a system for generating and / or infusing a radionuclide or radiotracer and administering it to an individual. The automated infusion system and the semi-automated infusion system include, but are not limited to, a dose calibrator, computer, controller, display device, activity detector, cabinet, cart, waste management system, sensors, light display system, shielding assembly, alarm or alert mechanism, tubing, source tube, diluent or eluent, pump and valves and / or combinations thereof. The automated infusion system and the semi-automated infusion system may be coupled communicatively or electronically to the imaging system.

[043] As used in the present invention, the term “diagnosis” refers to the process of identifying a disease, condition, or injury from its signs and symptoms. A health history, physical examination, and tests such as blood tests, imaging, scanning, and biopsies may be used. Petition 870250103981, dated 11 / 13 / 2025, page 21 / 60 13 / 37 to help make a diagnosis.

[044] As used in the present invention, the term “evaluation” refers to a qualitative and / or quantitative assessment of blood perfusion, solid tumors, or any other diseases or abnormalities in a part of the body or region of interest (ROI).

[045] As used in the present invention, the term “ergonomic mobile cart” refers to a wheeled cart that is ergonomic in design and easily mobile or transportable. The mobile cart having a foot-operated locking mechanism and a wheel release mechanism.

[046] As used in the present invention, the term “infusion pump” refers to an infusion pump that can be shielded, a radiation shield made of radiation shielding material, such as lead, tungsten or other radiation shielding materials. The pump is a single-drive, electronically controlled pump system for drawing interim volumes from various types of supply containers (saline solution, hot (e.g., radioisotope dose)) to the required volume and using the same system to infuse the patient with the required control of flow rates and accuracy.

[047] As used in the present invention, the term “standard syringe” refers to a syringe with standard volume. The syringes used in the present invention were a patented and proprietary Jubilant shielded syringe, pursuant to U.S. Patent No. 11,179,518 B2.

[048] As used in the present invention, the term “separable radioactive dose transport and containment module” refers to a separable module in which the syringe containing a radioactive dose is fitted and the module consists of (a) a hand grip to enable dose transfer from the dose carrier to an external dose calibrator. Petition 870250103981, dated 11 / 13 / 2025, page 22 / 60 14 / 37 (b) an adapter to convert a luer-type syringe to a pushfit connector (c) a sterile cap with attributes that are an integral part of workflow management. The sterile cap is used to protect the syringe against leaks and also to protect against radiation emitted by the radiopharmaceutical drugs contained in the syringe.

[049] As used in the present invention, the term “dose calibrator” refers to a device that is used in nuclear medicine to determine the exact activity of a radioactive dose to be administered to the patient.

[050] As used in the present invention, the term “luer lock syringe” refers to a syringe that enables a needle to be rotated at the tip and locked in place, providing a secure connection and preventing accidental removal of the needle, as well as accidental injection of contents.

[051] As used in the present invention, the term “medical fluid” refers to a radiopharmaceutical drug for infusion into patients.

[052] As used in the present invention, the term “infusion parameter” refers to one or more of the following: infusion rate, infusion mode, desired dose, desired activity, and / or any data related to patient infusion.

[053] As used in the present invention, the term “contamination management system” refers to a removable tray with an integral channel system to direct any fluid leaks to a collection platform or waste bin.

[054] As used in the present invention, the term “radioactive dose” refers to the dose of a radiopharmaceutical composition required to perform imaging on an individual, wherein the radiopharmaceutical composition comprises an active radioisotope used for imaging and therapy. The dose of Petition 870250103981, dated 11 / 13 / 2025, page 23 / 60 15 / 37 The dosage of a radionuclide to be administered to an individual varies from 0.27 uCi to 1000 mCi.

[055] As used in the present invention, the term “accessory management system” refers to a cabinet or box for storage purposes.

[056] As used in the present invention, the term “graphical user interface (GUI)” refers to an interface through which a user interacts with devices such as computers. Here, a computer screen is functioning as a GUI.

[057] As used in the present invention, the term “shielding” refers to shielding for dose activities of different sizes. Here, different dose activities refer to different syringe volumes, which consist of the hot dose (i.e., radiopharmaceutical drug). The syringe volume can be 10 cc, 20 cc, 30 cc, 60 cc and the tube volume is up to 30 cc. Dose shielding is used to shield syringes of different sizes and diameters, wherein the shielding system (18) is suitable for a variety of syringe sizes being inserted or connected. The shielding can be selected from a variety of suitable materials, including lead and tungsten. In one configuration, the shielding is fixed in 0.25 inch thick tungsten, which will be sufficient to shield any volume or type of therapeutic radiation. The shielding defines an internal cavity that is suitable for receiving and holding a syringe or tube with the fluid cartridge.Although a single shield can be used for all applications, if desired, shields of different sizes are included within the scope of the invention.

[058] As used in the present invention, the term “configurable dose transporter” refers to a “Caddy” that allows the safe transport of the warm dose between the warm laboratory and the infusion site. The transporter of Petition 870250103981, dated 11 / 13 / 2025, p. 24 / 60 16 / 37 configurable dose comprises; a separable radioactive dose transport and containment module (13); a shield (18) optimized for different dose activities; a radioactive dose in a standard syringe (8); a hand grip (12) to enable radioactive dose transfer from the dose carrier to an external dose calibrator.

[059] As used in the present invention, the term “shielded disposal system” refers to a shielded waste management system with a pedal-operated waste bin to avoid the use of hands to open a waste bin lid, a space for the disposal bin and / or a waste bin.

[060] As used in the present invention, the term “Theranostic informatics system” refers to programmable software for controlling the operation of the distribution system.

[061] As used in the present invention, the term “pushfit connector” refers to a type of compression fitting or quick-connect fitting that is easily removable and allows equipment to be attached, nominally without the use of tools.

[062] As used in the present invention, the term “PET” stands for Positron Emission Tomography (PET), which is a type of diagnostic imaging. PET uses doses of a radiopharmaceutical, for example, generated by elution within a radioisotope generator, which are injected or infused into a patient. The infused dose of the radiopharmaceutical is absorbed by the cells of a target organ in the patient and emits radiation, which is detected by a PET scanner in order to generate an image of the organ.

[063] As used in the present invention, the term “Theranostic distribution system” refers to the mobile radiopharmaceutical drug distribution cart with shielded syringe and pump device. Petition 870250103981, dated 11 / 13 / 2025, page 25 / 60 17 / 37 infusion. The terms “theranostic delivery system” and “radiopharmaceutical drug delivery system” refer to the same drug infusion system with the same functionality.

[064] As used in the present invention, the term “system error” refers to an error in the infusion system such as wrong eluent, undesirable profile such as wrong infusion rate, wrong infusion mode, undesired dose and undesired activity.

[065] As used in the present invention, the term “controller” or “control system” refers to a computer or part thereof programmed to perform certain calculations, execute instructions, and control various activities of an infusion system based on user input or automatically.

[066] As used in the present invention, the term “coded port” refers to two ports on the fluid cartridge, namely, patient port and saline / cold solution port, one for saline solution input and the other for drug output. They are of different configuration types so that the user does not confuse the two and create a patient error.

[067] As used in the present invention, the term “adapter” refers to a connector that is used to connect the syringe or tube to the sealed disposable cartridge via a compression fitting. The adapter can be labeled, meaning that the adapter is labeled with RFID, barcode, QR code and other such labels.

[068] In one embodiment of the present invention, a theranostic distribution system (100) comprises: i) an ergonomic mobile cart with an integrated handle; ii) a theranostic informatics system with a computer screen (19) as a graphical user interface (GUI); Petition 870250103981, dated 11 / 13 / 2025, page 26 / 60 18 / 37 iii) a shielded infusion pump; and iv) a configurable dose conveyor (6); wherein the configurable dose carrier (6) comprises: a) a separable radioactive dose transport and containment module (13); b) a shield (18) that is optimized for different dose activities; c) a radioactive dose in a standard syringe (8); d) a hand grip (12) to enable the transfer of the radioactive dose from the dose carrier to an external dose calibrator; (e) an adapter (9) for converting a luer lock syringe type into a pushfit connector; and f) a sterile lid (11) with attributes that are an integral part of workflow management.

[069] In one embodiment of the present invention, a theranostic distribution system (100) comprises: i) an ergonomic mobile cart with an integrated handle; ii) a shield (18) that is optimized for different dose activities; iii) a theranostic informatics system with a computer screen (19) as a graphical user interface; iv) a shielded infusion pump; and v) a disposable sealed fluid cartridge (7); wherein the disposable sealed fluid cartridge (7) comprises: a) one or more selectable integrated flow channels (17); b) one or more leak-proof sealed connections Petition 870250103981, dated 11 / 13 / 2025, page 27 / 60 19 / 37 drip (10); and c) one or more guide attributes and mechanical interlocks (16) for workflow management.

[070] In one embodiment of the present invention, a theranostic distribution system (100) comprises: i) an ergonomic mobile cart with an integrated handle; ii) a shield (18) that is optimized for different dose activities; iii) a theranostic informatics system with a computer screen (19) as a graphical user interface; iv) a shielded infusion pump; and v) a workstation (3); where the workstation (3) comprises: a) a status light system (1) that illuminates the work area to enable remote or long-distance monitoring; b) a disposable secondary containment system (2) that protects the core workstation from contamination; c) an onboard armored disposal system (4); and d) a foot-operated system (5) to enable locked and unlocked modes during device travel.

[071] One embodiment of the present invention includes the distribution system, in which the computer screen (19) is foldable and has a retractable rotating arm (20).

[072] One embodiment of the present invention includes the dispensing system, in which the syringe (8) can be of different sizes and / or volumes. Additionally, the dispensing system also supports the manufacturer's tubing. In one implementation, the dispensing system has the ability to infuse Petition 870250103981, dated 11 / 13 / 2025, page 28 / 60 20 / 37 includes a 10 cc, 20 cc, 30 cc, and 60 cc syringe, and a tube with a volume of up to 30 cc.

[073] One embodiment of the present invention includes the distribution system and further comprises a control system for controlling the medical fluid infusion process.

[074] One embodiment of the present invention includes the distribution system, in which the status light system (1) is controlled by the control system.

[075] One embodiment of the present invention includes the delivery system and further comprises a theranostic informatics management system that controls the infusion parameters for the patient.

[076] One embodiment of the present invention includes the distribution system and further comprises a contamination management system. The contamination management system comprises a removal tray with an integral channel system to direct any fluid leakage towards a collection platform or waste bin.

[077] One embodiment of the present invention includes the distribution system, wherein the distribution system further comprises an accessory management system.

[078] One embodiment of the present invention includes the dispensing system with accessory management and the accessory management comprises storage for infusion supplies such as pacifiers, gloves and other items as needed.

[079] One embodiment of the present invention includes the delivery system for delivering patient-specific theranostic dosing of different radiopharmaceutical theranostic drugs using the automated infusion system. Petition 870250103981, dated 11 / 13 / 2025, page 29 / 60 21 / 37

[080] One embodiment of the present invention includes the delivery system, in which the graphical user interface (GUI) is used to receive infusion parameters such as infusion rate, infusion mode, desired dose, desired activity and / or any data related to patient infusion. The patient-specific dosage is based on patient profile data, which include weight, sex, age or physical data and patient health history.

[081] In one embodiment, the present invention includes the delivery system (100), wherein the delivery system supports drug-specific infusion parameters, meaning that for different radiopharmaceutical drugs the infusion parameter may be different. This attribute is supported by the use of customized software with drug-specific infusion parameters.

[082] In one embodiment of the present invention, a radiopharmaceutical drug delivery system (100) comprises: (i) an ergonomic mobile cart with an integrated handle; (ii) a computer system with a computer screen (19) as a graphical user interface (GUI); (iii) a shielded infusion pump; and (iv) a configurable dose conveyor (6); wherein the configurable dose carrier (6) comprises: a) a separable radioactive dose transport and containment module (13); b) a shield (18) that is optimized for different types, quantities and volumes of radionuclides; c) a radioactive dose in a syringe (8) or tube (26); and d) a disposable sealed fluid cartridge (7) connected to a Petition 870250103981, dated 11 / 13 / 2025, page 30 / 60 22 / 37 syringe (8) or tube (26) via a compression fitting.

[083] In one embodiment of the present invention, a radiopharmaceutical drug delivery system (100) comprises: (i) an ergonomic mobile cart with an integrated handle; (ii) a computer system with a computer screen (19) as a graphical user interface (GUI); (iii) a shielded infusion pump; (iv) a status light system (1) that illuminates the work area to enable remote or long-range monitoring; and (v) a configurable dose carrier (6); where the configurable dose carrier (6) comprises: a) a separable radioactive dose transport and containment module (13); b) a shield (18) that is optimized for different types, quantities and amounts of radionuclides; c) a radioactive dose in a syringe (8) or tube (26); and d) a disposable sealed fluid cartridge (7) connected to a syringe (8) or tube (26) via a compression fitting; in which the disposable sealed fluid cartridge allows a healthcare professional to withdraw a customized volume from the tube or syringe.

[084] One embodiment of the present invention includes the syringe dispensing system, wherein the syringe (8) may be of multiple different standard sizes.

[085] One embodiment of the present invention includes the dispensing system, in which the shielding system (18) is configured to be used appropriately with a wide range of syringe sizes (8) being inserted or connected. Petition 870250103981, dated 11 / 13 / 2025, page 31 / 60 23 / 37

[086] One embodiment of the present invention includes the distribution system, in which the computer screen (19) as a graphical user interface (GUI) is mounted on a retractable rotating arm.

[087] One embodiment of the present invention includes the dispensing system, in which the fluid cartridge allows the dispensing of a customized volume based on the patient’s weight, sex, age, other physical parameters or health history data.

[088] One embodiment of the present invention includes the delivery system, wherein the delivery system supports the specific drug infusion parameter.

[089] One embodiment of the present invention includes the distribution system, in which the separable radioactive dose transport and containment module (13) is shielded with a lead glass viewing area (29).

[090] One embodiment of the present invention includes the dispensing system, in which the fluid cartridge includes a coded port to eliminate errors in the patient line or saline line.

[091] One embodiment of the present invention includes the delivery system, in which the system monitors and tracks one or more of the following: total volume in syringes, total volume administered in real time, total volume of an intravenous bag, total volume infused into the patient.

[092] One embodiment of the present invention includes the distribution system and further comprises a control system for controlling the infusion process of a medical fluid.

[093] One embodiment of the present invention includes the distribution system, in which the controller is configured to interrupt the infusion process upon detecting a system error.

[094] One embodiment of the present invention includes the system of Petition 870250103981, dated 11 / 13 / 2025, page 32 / 60 24 / 37 distribution, in which the status light system (1) indicates the different states of the device (e.g., administration, administration completed) with various colors.

[095] One embodiment of the present invention includes the distribution system, in which the status light system (1) is controlled by the control system.

[096] One embodiment of the present invention includes the distribution system, wherein the system has an audible alarm attribute to alert the user about one or more fluid occlusions, pump failure or any deviation from the programmed volume and / or expected sequence of events in real time.

[097] One embodiment of the present invention includes the delivery system, in which the pump protects the patient from an air infusion that causes a gas embolism and includes an alarm signal for real-time air detection.

[098] In one embodiment of the present invention, a radiopharmaceutical drug delivery system comprises; a configurable dose carrier (6); a separable radioactive dose transport and containment module (13); a shield (18); a disposable sealed fluid cartridge (7); and a syringe (8) or tube (26); wherein the disposable sealed fluid cartridge (7) comprises: (i) one or more selectable integrated flow channels (17); (ii) an adapter (9) to fit onto the syringe (8) or tube; (iii) a coded patient port and a saline port; and (iv) one or more pressure sensors (27, 28); where the disposable sealed fluid cartridge allows you to withdraw a customized volume from the tube (26) or syringe (8). Petition 870250103981, dated 11 / 13 / 2025, page 33 / 60 25 / 37

[099] One embodiment of the present invention includes the dispensing system (100), in which the adapter (9) of a disposable sealed fluid cartridge (7) is connected to a syringe (8) or tube (26) via a compression fitting to reduce leaking connections.

[100] One embodiment of the present invention includes the dispensing system (100), wherein the customized volume dispensed from the fluid cartridge is based on one or more of the patient’s weight, sex, age, health history and / or other physical parameters.

[101] One embodiment of the present invention includes the distribution system, in which the controller is configured to interrupt the infusion process due to a system error.

[102] One embodiment of the present invention includes the delivery system, which is programmed with software that is capable of being updated remotely to add new functionalities and drug compatibility. The software also has safety attributes to ensure the correct patient and / or the correct dose.

[103] One embodiment of the present invention includes the distribution system, which includes software security programmed to prevent unauthorized access and may have software firewall capability to prevent hackers and unauthorized remote access to patient data.

[104] One embodiment of the present invention includes the delivery system with an infusion pump wherein the infusion pump is indicated for intravenous and intra-arterial delivery of theranostic radiopharmaceutical agents at controlled infusion rates or as a bolus injection combined with a supply of commercially available normal 0.9% saline solution. The infusion pump will only be compatible with single-dose or multi-dose syringes or tubing. Petition 870250103981, dated 11 / 13 / 2025, page 34 / 60 26 / 37

[105] One embodiment of the present invention includes the distribution system, wherein the system has an audible alarm attribute to alert the user about fluid occlusions, pump failure or any deviation from programmed volume and / or expected sequence of events in real time.

[106] One embodiment of the present invention includes the delivery system, in which the pump protects the patient from an air infusion that causes gas embolism and includes an air detection alarm signal that is activated in real time. The pump must have protection such that, after air detection with the accompanying alarm signal, it is not possible to continue the delivery of liquid drug with a single action. This advantageously prevents the operator from easily ignoring a safety warning and potentially endangering a patient.

[107] One embodiment of the present invention includes the distribution system, which includes a pressure sensor to monitor fluid occlusion in real time.

[108] Figs. 1A, 1B, 1C and 1D illustrate the configuration of a theranostic delivery system or radiopharmaceutical drug delivery system (100). The system (100) includes a mobile or mobile ergonomic workstation (3) having side or rear handles for moving the cart via wheels (21). The workstation (3) of the theranostic delivery system (100) also includes an embedded shielded disposal system (4) (see Fig. 1B) for waste collection. The shielded disposal system (4) is operated by a foot-operated system (5) that enables locked and unlocked wheel modes during transport of the device (100). The theranostic delivery system or radiopharmaceutical drug delivery system (100) also includes a foldable computer screen (19) mounted on a retractable rotating arm (20) and a light system. Petition 870250103981, dated 11 / 13 / 2025, page 35 / 60 27 / 37 status (1) which illuminates the work area, enabling the operator to monitor the system status remotely within the work area. The main objective of remote monitoring is to keep the professional at a safe distance from the radioactive patient to ensure low exposure. For example, if a healthcare professional is using the delivery system (100) to deliver a radiopharmaceutical dose to a patient, and the professional needs to leave the room and cross the corridor, the professional will be able to easily glance at the delivery system and see that the status light system (1) is, for example, green or blue, indicating that the operation is proceeding properly. On the other hand, if the professional sees the status light system (1) change from green to orange or red, the professional will know that they should quickly return to investigate the status change. The theranostic delivery system (100) in Fig.1B also includes a disposable secondary containment system (2) that protects the core workstation from contamination. The theranostic system (100) in Fig. 1C includes a configurable dose carrier (6) with a disposable sealed fluid cartridge (7). The theranostic delivery system or radiopharmaceutical drug delivery system (100) also includes a storage tray (22) and storage space (23) for storing medical equipment and other items needed for radiopharmaceutical administration.

[109] Fig. 2 shows a cross-sectional view of a schematic representation of a shielded syringe system (101). The standard radioactive dose syringe (8) is shielded by shielding materials, namely lead, steel, tungsten or combinations of shielding materials. The shielding materials are configured in the form of a cylinder (14) which is positioned around the syringe (8). The theranostic delivery system (100) also includes an adapter (9) to convert a luer-type syringe into a connector. Petition 870250103981, dated 11 / 13 / 2025, page 36 / 60 28 / 37 pushfit with sterile cap (11) having a leak-free / drip-free connection (10).

[110] Fig. 3 shows a diagram (102) of a schematic representation of a configurable dose carrier (6) (as shown in Fig. 1A) having integrated handles (15) to enable two-handed transfer from a delivery bag to the prepared radioactive dose to be installed in the workstation (3) for infusion (as shown in Figs. 1A and 1B) and having a one-handed grip (12) to enable dose transfer from the dose carrier (6) (as shown in Figs. 1A and 1B) to an external dose calibrator for measuring the activity of the radiopharmaceutical drugs before infusion. The dose carrier (6) (as shown in Figs. 1A and 1B) includes embedded shielding (14) with protection during all delivery, preparation and transport workflows.The configurable dose carrier (6) (as shown in Figures 1A and 1B) additionally includes guide features and mechanical interlocks (16) for workflow management and a separable radioactive dose module (13). The separable radioactive dose module consists of a syringe with the hot dose to be infused into a patient.

[111] Fig. 4 shows a diagram (103) of a disposable sealed fluid cartridge (7) (as shown in Fig. 1A) of a theranostic delivery system or radiopharmaceutical drug delivery system (100) containing one or more selectable integrated flow channels (17). The flow channel refers to the channel that is used to connect the hot dose source, the saline solution source to the infusion pump, and then this channel is connected back to the patient line for infusion of the precise dose to the patient.

[112] Fig. 5 shows a diagram (104) of the shielding (18) of the theranostic delivery system or drug delivery system. Petition 870250103981, dated 11 / 13 / 2025, pp. 37 / 60 29 / 37 radiopharmaceuticals (100) which is optimized for different dose activities. Here, different dose activities refer to different syringe volumes, which consist of the hot dose (i.e., radiopharmaceutical drugs). The syringe volume can be 10 cc, 20 cc, 30 cc, 60 cc and a tube volume can be up to 30 cc. Dose shielding is used to shield syringes of different sizes and diameters, where the shielding system (18) can be used with different syringe sizes being inserted or connected.

[113] Fig. 6 shows a diagram of a disposable sealed fluid cartridge (7) with patient port (24) and saline / cold solution port (25) having a cavity that will allow customized volumes to be withdrawn from a tube or syringe. The cartridge includes a pump system to draw the required volumes from various types of supply containers (saline solution, hot dose) to an interim volume (i.e., “Transfer”) and use the same system to infuse the patient with the radiopharmaceutical with the required control of flow rates, accuracy, etc.

[114] Fig. 7 illustrates a disposable sealed fluid cartridge (7) in a connection with the tubing (26) via a compression fitting with the aid of an adapter (9), which may optionally be labeled. Fig. 8 illustrates the connection of the disposable sealed fluid cartridge (7) with the adapter (9) in connection with the tubing (26) via a compression fitting with a coded port to eliminate errors in patient / saline lines. The disposable fluid cartridge (7) consists of one or more automated ON / OFF check valves that are connected to the hot dose source channel and the saline source channel to withdraw the drug and saline from the source container. Additionally, the hot dose channel and the saline channel are connected to the infusion pump to infuse the required dose to the patient from the patient line. Petition 870250103981, dated 11 / 13 / 2025, pp. 38 / 60 30 / 37

[115] Fig. 9 illustrates a disposable sealed fluid cartridge (7) connected to the syringe (8) via a compression fitting with the aid of an adapter (9) to reduce leaking connections. Fig. 10 illustrates the connection of the disposable sealed fluid cartridge (7) with the adapter (9) in a connection with the syringe (8) via a compression fitting with a coded port to eliminate errors in patient / saline lines.

[116] Additionally, the disposable sealed fluid cartridge (7) consists of two pressure sensors which are the patient line pressure sensor (27) to measure the pressure in the patient line and the hot dose pressure sensor (28) to detect the dose pressure of the syringe (8) or the tube (26) (as shown in Figures 8 and 10).

[117] Fig. 11 illustrates a configurable dose carrier (6) that is connected by caddy in line with a custom shielded disposable sealed fluid cartridge (7) with a lead glass viewing window (29).

[118] Figure 12 is a flowchart showing the operation of the distribution system 100. In a first step 110, a dose of radioisotope is prepared and placed in a suitable container for the radioisotope. The container may be the syringe (8) or the tube (26) described above. The syringe or tube is then placed in the dose carrier (6) by holding the upper grip (12) and pulling the containment module (13) of the dose carrier. The syringe or tube is inserted into an opening in the containment module, which is then placed back into the dose carrier. Due to the shielding component (14) of the carrier, the healthcare professional is protected from the radioactivity of the radioisotope inside the syringe or tube. Typically, this dose is prepared elsewhere and transported to a radiopharmacy or hospital in a cargo container, such as a bag, box or other container. The component of Petition 870250103981, dated 11 / 13 / 2025, pp. 39 / 60 31 / 37 shielding (14) protects those who come into contact with the dose carrier from exposure to radioactivity while the radioisotope is being transported to the radiopharmacy or hospital.

[119] In a second step 120, the radioisotope dose is received in the loading container at a radiopharmacy or hospital laboratory and prepared for injection into a patient. The radioisotope dose is inside the dose carrier (6) when the loading container is received at the radiopharmacy or hospital. The healthcare professional removes the dose carrier from the loading container, places it on a surface, such as a counter in a laboratory, and removes the containment module (13) from the dose carrier. As this may expose the healthcare professional to radiation, the professional places the containment module (13) in a shielded container, such as a shielded tube, for temporary storage during cartridge preparation. The shielded tube may be round, square, or any convenient configuration suitable for holding and containing the module (13).With the containment module removed from the conveyor (6), the professional then removes the sterile cap located at the bottom of the dose conveyor.

[120] With the sterile cap removed from the dose carrier, a volume containing the carrier is exposed. The volume is defined on a lower surface by a first plate and on an upper surface by a second plate. One or both of the first and second plates may include guides or grooves to receive the fluid cartridge (7). The guide or grooves are configured to engage with the bottom, top, and / or side surfaces of the fluid cartridge, so that the cartridge can only be received within the volume in a single orientation. This safety feature prevents incorrect insertion of the fluid cartridge. In one implementation, the plates have guides Petition 870250103981, dated 11 / 13 / 2025, pages 40 / 60 32 / 37 and / or grooves and interlocks. When the fluid cartridge is positioned against the guides or grooves, interlocks can be used to retain the cartridge in place. The interlocks can be configured to have a first part in the guide, groove or plate and a second part in the fluid cartridge. In this way, a clicking noise and / or a tactile sensation perceptible to the professional can be experienced when the cartridge is properly oriented and positioned.

[121] The practitioner inserts the cartridge into the volume and advances it until proper positioning is achieved, for example, by feeling a click and / or tactile sensation. The practitioner then holds the upper grip (12) on the containment module (13), removes the module from the shielded container and inserts the opposite or lower end of the module into the opening on the top surface of the uppermost plate of the dose carrier. Generally, this upper plate is different from the uppermost plate defining the volume to receive the fluid cartridge. The opposite or lower end of the module is advanced through an opening in the upper plate until the lower end contacts the adapter (9) inside a side of the fluid cartridge. The module is then advanced further until a fluid-tight connection between the tubing or syringe inside the containment module and the adapter on the fluid cartridge is achieved.The professional then assembles the restraint module (13) on the cart.

[122] According to step 130, the professional takes the laboratory cart where the cartridge was prepared to the patient's room or other suitable location to administer the radioisotope dosage. The location, of course, will depend on the purpose of the radioisotope administration. To treat a condition, the patient may be in a patient room. For a diagnostic procedure, such as a PET scan, the patient Petition 870250103981, dated 11 / 13 / 2025, page 41 / 60 33 / 37 may be in a suite with a PET scanner and associated equipment. In either situation, the practitioner advances the cart to the patient and connects a disposable fluid line from the patient port on the fluid cartridge to an intravenous line in the patient. The practitioner then operates the keypad or on-screen instructions to administer the desired volume of radioisotope at the desired fluid rate.

[123] At this stage of the process, the pump component in the fluid cartridge is ready to be primed with saline solution and the radioisotope (step 140). To prime the pump component, the practitioner first connects a disposable fluid line between a saline syringe mounted on the cart and the saline port of the fluid cartridge. The practitioner then uses a keypad or on-screen controls to operate the software and prime the pump. This operation is usually automated and depends at least on the dose to be received by the patient. Additionally, in step 150 of loading the fluid cartridge with radioisotope, the pump draws fluid from the saline syringe and the radioisotope tube (or syringe) into a transfer chamber of the cartridge. At this stage of the process, the pump is primed, loaded, and the dose is ready to be administered to the patient.

[124] According to step 160, when the radioisotope is being administered, the area of ​​the cart around the screen will be illuminated in an adjusted color indicative of the action being taken. For example, during the administration of the radioisotope, the illumination may be red; when the administration is almost complete, for example, 95% complete, the illumination may transition to yellow, and when the administration is complete, the illumination may transition to green or blue. The colors are selected to indicate to an observer the potential danger of the radioactive isotope. The use of colors in this way allows a professional operating Petition 870250103981, dated 11 / 13 / 2025, pp. 42 / 60 34 / 37 A PET scanner allows you to view the system status from a distance, for example, from the PET scanner control booth. If the patient is in a patient room, the healthcare professional will be alerted to the radiation hazard while the dose is being administered and will know to stay out of the room.

[125] According to step 170, after the dose infusion, some of the radioisotope dose likely remains in the hot dose container. To use this residual radioisotope dose, the practitioner initiates a backwash operation to utilize the residual dose. In this step, the pump removes saline solution from the saline solution container to the cartridge transfer chamber and then pushes the saline solution into the radioisotope dose container. Then, once again, the pump carries the radioisotope dose from the radioisotope dose container to the transfer chamber to administer the residual dose to the patient. This process is repeated until all the dose in the radioisotope dose container is used. The main advantage of this step is that, by using a backwash step, the waste of radioisotope dose will be minimized.

[126] According to step 180, when the radioisotope dose is complete, the practitioner removes the fluid tubing that runs from the patient's intravenous line to the patient port of the fluid cartridge. The practitioner can then discard the tubing into the removable container on the cart. The practitioner can also disconnect and place the fluid tubing from the saline syringe into the removable container. The fluid cartridge can also be pulled from the dose carrier and placed in the removable container. The practitioner can then return the cart to the laboratory for storage and cleaning.

[127] In one embodiment according to the present invention, the system Petition 870250103981, dated 11 / 13 / 2025, pp. 43 / 60 35 / 37 of theranostic distribution or radiopharmaceutical drug delivery system is comprised of a theranostic informatics management system, which consists of a computer screen with a graphical user interface (GUI) to receive various patient infusion parameters, including one or more of the infusion rate, infusion mode, desired dose, desired activity and / or any data related to the patient infusion. This theranostic informatics system may also include a control system to control the infusion process with status lights used to show the different device states with different colors representing the device state.

[128] In one embodiment according to the present invention, the theranostic delivery system or radiopharmaceutical drug delivery system (100) comprises a contamination management system, which includes a tray with an integral channel system to direct any fluid leaks to a collection platform or waste bin. The theranostic delivery system also includes an accessory management system for storing all infusion supplies, including chux, gloves and other equipment.

[129] Another embodiment of the invention in Fig. 6 discloses the front view of the theranostic delivery system or radiopharmaceutical drug delivery system (100) with a configurable dose carrier (6) that is connected by caddy in line with the custom shielded disposable sealed fluid cartridge (7) with lead glass viewing window (29). The “Caddy” allows the safe transport of the warm dose between the hot laboratory and the infusion site.

[130] The theranostic delivery system or radiopharmaceutical drug delivery system (100) comprises a configurable conveyor Petition 870250103981, dated 11 / 13 / 2025, pp. 44 / 60 36 / 37 dose which is a “caddy” that is used to transport the hot dose in a separable radioactive dose transport and containment module (13) in a syringe of different sizes from pharmaceuticals to the infusion site. The hot dose in a syringe is shielded by a configurable dose shield to protect from radiation emitted by the radiopharmaceutical drug in the syringe. Additionally, the configurable dose carrier (6) is attached to a disposable sealed fluid cartridge to initiate drug infusion into the patient.

[131] The infusion of radiopharmaceuticals into the patient comprises four main modes: preparation, prime, infusion, and backflushing. The prime mode is basically a process of checking for air bubbles or any occlusion in all infusion lines that are connected to the pump, the dose container, and the saline solution container. In the loading mode, the disposable fluid cartridge draws the required volumes from the various types of supply containers (saline solution, hot dose) to an interim volume (i.e., “Transfer”) and uses the same system in the infusion mode to infuse the patient with the required control of flow rates, accuracy, etc. In the backflushing mode, the system is backflushed through the infusion line with specific amounts of saline solution to push the residual dose into the patient.

[132] One embodiment of the present invention provides the patient with increased safety from a radiopharmaceutical drug delivery by ensuring compliance with cybersecurity before dispensing a radiopharmaceutical drug to the patient. The present process ensures cybersecurity in the radiopharmaceutical drug delivery system based on the controller being configured to scan the system, network, or connected devices to detect any unauthorized connection. Petition 870250103981, dated 11 / 13 / 2025, pp. 45 / 60 37 / 37 authorized and / or malware, prior to infusion of the radiopharmaceutical drug. This configuration and procedure ensure that the system is free of unauthorized connections and / or malware and alert the operator to any actual or potential unauthorized connections and / or malware.

[133] In one embodiment of the present invention, the controller is configured to force the system to enter safe mode if an unauthorized connection or malware is detected. In this case, the controller is configured to interrupt system operation in case of any threat of an unauthorized connection or malware detected and keep all system operations stopped until the malware is neutralized.

[134] Each embodiment disclosed in the present invention is contemplated as being applicable to each of the other embodiments disclosed. Thus, all combinations of the various elements described in the present invention are within the scope of the invention. Petition 870250103981, dated 11 / 13 / 2025, pp. 46 / 60

Claims

1 / 5 CLAIMS 1. Radiopharmaceutical drug delivery system (100), characterized in that it comprises: (i) a mobile cart with an integrated handle; (ii) a computer system with a computer screen (19) configured as a graphical user interface (GUI); (iii) an infusion pump; and (iv) a configurable dose carrier (6), wherein the configurable dose carrier (6) comprises: a) a separable radioactive dose transport and containment module (13); b) a shield (18) for use with one or more of different types, quantities and volumes of radionuclides; c) a radioactive dose in a syringe (8) or tube (26); d) a disposable sealed fluid cartridge (7) connected to the syringe (8) or tube (26) via a compression fitting.

2. Dispensing system according to claim 1, characterized in that the syringe (8) can be selected from different standard sizes.

3. Delivery system according to claim 1, characterized in that the shielding system (18) is configured to be used with a variety of syringe sizes being inserted or connected.

4. Distribution system according to claim 1, characterized in that the computer screen (19) as a graphical user interface (GUI) having a retractable rotating arm (20).

5. Dispensing system according to claim 1, Petition 870250087660, dated 09 / 26 / 2025, pp. 101 / 106 2 / 5 characterized in that the disposable sealed fluid cartridge (7) is configured to allow the withdrawal of customized volumes from the tube or syringe based on one or more of the patient's weight, sex, age, other physical parameters or health history data.

6. Distribution system, according to claim 1, characterized in that the drug distribution system (100) is configured to support a specific drug infusion parameter.

7. Distribution system, according to claim 1, characterized in that the separable radioactive dose transport and containment module (13) is shielded and includes a lead glass viewing area (29).

8. Distribution system according to claim 1, characterized in that the disposable sealed fluid cartridge (7) comprises a coded port to eliminate errors in connecting a patient line or a saline solution line to the cartridge.

9. A distribution system, according to claim 1, characterized in that it is configured to monitor and track one or more of the following: total volumes in syringes, total volume administered in real time, total volume of an intravenous bag, and total volume infused into the patient.

10. A distribution system according to claim 1, characterized in that it further comprises a control system for controlling the infusion process of a medical fluid into a patient.

11. Distribution system according to claim 10, characterized in that the control system is configured to interrupt the infusion process due to a system error. Petition 870250087660, dated 09 / 26 / 2025, pp. 102 / 106 3 / 5 12. Distribution system, according to claim 1, characterized in that it has an audible alarm attribute to alert the user to the occurrence of one or more of a fluid occlusion, a pump failure, a deviation from a programmed volume, and an expected sequence of events in real time.

13. Distribution system, according to claim 1, characterized in that the shielded infusion pump is configured to protect the patient from air infusion and comprises an alarm signal for real-time air detection.

14. Radiopharmaceutical drug delivery system (100), characterized in that it comprises: (i) a mobile cart with at least one handle; (ii) a computer system with a computer screen (19) as a graphical user interface (GUI); (iii) an infusion pump; (iv) a status light system (1) that illuminates the work area to monitor the status of an infusion; and (v) a configurable dose carrier (6); wherein the configurable dose carrier (6) comprises: a) a separable radioactive dose transport and containment module (13); b) a shield (18) configured to be used with one or more of different types, quantities and amounts of radionuclides; c) a radioactive dose within a syringe (8) or a tube (26); d) a disposable sealed fluid cartridge (7) connected to the syringe (8) or tube (26) via a compression fitting; Petition 870250087660, dated 09 / 26 / 2025, page.103 / 106 4 / 5 where the disposable sealed fluid cartridge is configured to withdraw customizable volumes from the syringe or tube.

15. Distribution system according to claim 14, characterized in that the status light system (1) indicates the different states of the device with various colors.

16. Distribution system according to claim 14, characterized in that the status light system (1) is controlled by a control system.

17. Radiopharmaceutical drug delivery system (100), characterized in that it comprises: a configurable dose carrier (6); a separable radioactive dose transport and containment module (13); a shield (18); a disposable sealed fluid cartridge (7); and a syringe (8) or a tube (26); wherein the disposable sealed fluid cartridge (7) comprises: (i) one or more selectable integrated flow channels (17); (ii) an adapter (9) for fitting onto the syringe (8) or tube (26); (iii) a coded patient port (24) and a saline solution port (25); and (iv) one or more pressure sensors (27, 28); wherein the disposable sealed fluid cartridge is configured to withdraw a customizable volume from the syringe or tube.

18. Distribution system according to claim 17, characterized in that the adapter (9) is labeled with one or more of RFID, barcode or QR code.

19. Delivery system according to claim 17, characterized in that the disposable sealed fluid cartridge (7) is configured to withdraw a customizable volume based on one or more of the patient's weight, sex, age, health history data and / or other physical parameters.

20. Distribution system according to claim 17, characterized in that the disposable sealed fluid cartridge (7) comprises coded ports to eliminate errors in patient selection and saline solution lines. Petition 870250087660, dated 09 / 26 / 2025, pp. 105 / 106

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