Radiopharmaceutical delivery system for patient infusion

Abstract

The present invention relates to a therapeutic diagnostic delivery system or radiopharmaceutical delivery system (100) with a movable ergonomic workstation (3) having on the side (s) a handle to move a cart. The radiopharmaceutical delivery system (100) includes a simple design and a plurality of enhanced safety features for a user. The delivery system (100) comprises a jettable secondary containment system (2) that protects the core workstation from contamination, a configurable dose conveyor (6) that allows safe delivery of strong radiation doses between a strong radiation laboratory to an infusion site, and a jettable sealed fluid cartridge (7) to draw customized volumes from vials or syringes. The delivery system (100) includes a therapeutic diagnostic information management system having a computer screen (19) as a graphical user interface (GUI), the computer screen having a retractable rotating arm (20), in order to receive various patient infusion parameters and effectively manage delivery of a desired dose to a patient.

Description

Technical Field

[0001] This invention relates to radiopharmaceutical infusion systems. More specifically, this invention relates to therapeutic, diagnostic, or radiopharmaceutical delivery systems that, by combining and pairing novel syringe shielding devices with patient infusion pump devices, enable patient infusion of radiopharmaceutical components within outpatient care clinics and / or hospitals. Background Technology

[0002] Radiopharmaceuticals are important for the treatment and diagnosis of a wide range of diseases. The safe and efficient use of these important and potentially hazardous radioisotopes, with their short or long half-lives, is crucial during the intended use by patients and / or healthcare providers. These radioisotopes play key roles in the diagnosis and treatment of a variety of diseases. Most widely available radiopharmaceuticals are produced using a variety of known techniques. For example, Co-60 is used in the treatment of cancer, I-131 in the treatment of hyperthyroidism, C-14 in respiratory testing, Tc-99m and Rb-82 as tracers in myocardial perfusion imaging, Ga-68 for imaging solid tumors, and Ac-225, Lu-177, and At-211 for therapeutic purposes. Due to the short half-lives of some radiopharmaceuticals, the entire imaging and administration protocol needs to be completed in a very short time. Some radiopharmaceuticals are typically prepared at field facilities at an appropriate driving distance from the patient to prevent undue attenuation before use. Furthermore, these radioactive isotopes pose unwanted radiation hazards to users, healthcare providers, and patients. Therefore, safe operating techniques, including the use of shielding systems, are crucial to avoiding various unwanted health hazards.

[0003] Currently, nuclear medicine technicians configure non-radioactive chemotherapy / IV infusion peristaltic pumps for administering therapeutic and diagnostic radiopharmaceuticals to patients within hospitals. Beyond providing safe / shielded delivery systems and minimizing undesirable health hazards from radiation exposure to patients, users / healthcare providers, and the environment, the need for next-generation infusion system technologies for therapeutic and diagnostic radiopharmaceuticals requiring slow infusion (i.e., 1 ml / min) and for diagnostic infusions that fall under the "push" type remains unmet.

[0004] Currently available infusion systems and methods have several drawbacks, such as the lack of radiation shielding and the inability to flush or clean the drug syringe with saline to ensure adequate dosage to the patient. Furthermore, current methods do not combine syringes; instead, they rely on an extended spinal needle piercing the rubber diaphragm of a glass vial to draw the drug, which can introduce air into the patient's IV line, leading to incomplete or inaccurate dosing and the risk of air embolism. Additionally, not all infusion pumps can accommodate the 60cc syringe volume required for the infusion of some therapeutic radiopharmaceuticals. The need for an infusion system solution that delivers all necessary specialty radiopharmaceutical protocol supplies (such as ionization chambers, Geiger-Mueller counters, IV tubing, and radioactive waste) to the patient remains unmet. Moreover, in the USP General Chapter… <825> The guidelines for the preparation, synthesis, dispensing, and repackaging of radiopharmaceuticals have been published. Based on the outline of the published drug information and standards, customers are prohibited from handling highly active drugs without a cleanroom, and hospitals and pharmacies should follow these guidelines. This invention will promote hospital and pharmacy compliance and safety by delivering quality-controlled drugs in shielded syringes for dose-directed infusion to patients. More specifically, the need for advanced and efficient therapeutic and diagnostic delivery systems combined with radiation-shielded syringe infusion pumps that can provide greater radiation safety for patients and users / healthcare providers remains unmet. Summary of the Invention

[0005] This invention relates to a therapeutic diagnostic delivery system or radiopharmaceutical delivery system that enables patient infusion of radiotherapy drugs in a hospital setting by combining a novel syringe shielding device with a patient infusion pump device.

[0006] One aspect of the present invention is to provide an ergonomic therapeutic diagnostic delivery system with a movable trolley for delivering therapeutic radiopharmaceutical doses to patient infusion rooms in hospitals or clinics.

[0007] One aspect of the invention is the use of an automated infusion system to deliver patient-specific therapeutic diagnostic doses of various radiopharmaceutical therapeutic diagnostic drugs. However, it should be understood that the dosing and administration of radiopharmaceuticals can be fully automated, semi-automated, or manual.

[0008] One aspect of the present invention is to automate the infusion of radiopharmaceuticals for therapeutic purposes.

[0009] One aspect of the invention is to enhance the ability of healthcare providers to monitor and protect the health of patients from radiation hazards while treating them.

[0010] One aspect of the present invention is to provide localized radiation shielding to a syringe containing a radiopharmaceutical.

[0011] One aspect of the present invention is to provide an infusion system capable of delivering radiopharmaceutical components through the use of manual, automated, semi-automated, computer-controlled, or any combination thereof processing.

[0012] One aspect of the invention is to allow the syringe to be “flushed” with saline solution automatically, semi-automatically, manually, and / or in a combination thereof after infusion to ensure that all the drug has been injected.

[0013] One aspect of the invention is to provide a "trolley" with an accessory management system to allow healthcare providers to keep all necessary supplies readily available.

[0014] One aspect of the invention is to provide a contamination management system including a removal tray to direct any fluid leaks to a collection pad or waste bin, the removal tray having an integrated channel system.

[0015] Another aspect of the present invention is to provide a treatment diagnostic information management system for controlling patient infusion parameters.

[0016] Another aspect of the invention is a display that shows different colors to indicate various operating states of the device during use.

[0017] One aspect of the present invention is to provide a therapeutic diagnostic delivery system (100), comprising:

[0018] i) An ergonomic, portable cart with an integrated handle;

[0019] ii) A treatment diagnostic information system having a computer screen (19) as a graphical user interface (GUI);

[0020] iii) Shielded infusion pumps; and

[0021] iv) Configurable dose delivery device (6);

[0022] The configurable dose delivery device (6) includes:

[0023] a) Separable radioactive dose delivery and containment module (13);

[0024] b) Shielding optimized for different doses of activity (18);

[0025] c) The radioactive dose in the standard syringe (8);

[0026] d) A single-handed grip (12) that allows the radiation dose to be delivered from the dose delivery device to an external dose calibrator;

[0027] e) An adapter (9) that converts the Luer lock injector type to a push-in connector; and

[0028] f) A sterile cap (11) that has the characteristics of being an integral part of workflow management.

[0029] One aspect of the present invention is to provide a therapeutic diagnostic delivery system (100), comprising:

[0030] i) An ergonomic, portable cart with an integrated handle;

[0031] ii) Shielding optimized for different doses of activity (18);

[0032] iii) A treatment diagnostic information system having a computer screen (19) as a graphical user interface (GUI);

[0033] iv) Shielded infusion pumps; and

[0034] v) Disposable sealed fluid box (7);

[0035] The disposable sealed fluid box (7) includes:

[0036] a) One or more optional integrated flow channels (17);

[0037] b) One or more sealed leak-free / drip-free connections (10); and

[0038] c) One or more guiding features and mechanical interlocks used for workflow management (16).

[0039] One aspect of the present invention is to provide a therapeutic diagnostic delivery system (100), comprising:

[0040] i) An ergonomic, portable cart with an integrated handle;

[0041] ii) Shielding optimized for different doses of activity (18);

[0042] iii) A treatment diagnostic information system having a computer screen (19) as a graphical user interface (GUI);

[0043] iv) Shielded infusion pumps; and

[0044] v) Workstation (3);

[0045] The workstation (3) includes:

[0046] a) Status lighting system for illuminating the work area to enable long-distance monitoring (1);

[0047] b) A disposable secondary containment system to protect the core workstation from contamination (e.g., radioactive isotopes, radiation) (2).

[0048] c) Airborne shielded handling system (4); and

[0049] d) A foot-operated actuation system (5) that enables locking and unlocking modes during device movement, for example, for locking and unlocking wheels on a movable trolley. Attached Figure Description

[0050] Figure 1A and Figure 1B A schematic diagram illustrating a therapeutic diagnostic delivery system or a radiopharmaceutical delivery system. Figure 1C and Figure 1D These represent the rear and front views of a therapeutic diagnostic delivery system or a radiopharmaceutical delivery system, respectively.

[0051] Figure 2 A schematic diagram illustrating a shielded syringe system.

[0052] Figure 3 A schematic diagram illustrating a configurable dose delivery device is shown.

[0053] Figure 4 The illustration shows a disposable sealed fluid cartridge comprising, for example, an integrated flow channel for connecting a radioisotope dose source and a saline source to an infusion pump, and a channel for connecting to a patient line for infusing the desired radioisotope dose to the patient. The flow channel allows bidirectional flow of fluid for both drug delivery to the patient and backwashing with saline to “flush” out any residual radiopharmaceutical cavities.

[0054] Figure 5 The diagram illustrates the shielding optimized for different doses of activity.

[0055] Figure 6 A diagram is shown of a disposable, sealed fluid cartridge (7) that allows a healthcare provider to draw a custom volume of fluid from a vial or syringe.

[0056] Figure 7 A diagram showing a disposable sealed fluid cartridge (7) connected to a medicine bottle (26) via a compression fitting.

[0057] Figure 8 A diagram is shown of a disposable, sealed fluid cartridge (7) with a dose adapter (9) connected to a vial (26) via a compression fitting, the compression fitting having coded ports to eliminate errors in the patient / saline line.

[0058] Figure 9A diagram showing a disposable sealed fluid cartridge (7) connected to the syringe via a compression fitting to reduce leakage.

[0059] Figure 10 A diagram is shown of a disposable sealed fluid cartridge (7) with an adapter (9) that connects to a syringe (8) via a compression fitting, the compression fitting having coded ports to eliminate errors in the patient / saline line.

[0060] Figure 11 A diagram shows a configurable dosing delivery device (6) that is directly connected to a custom-designed, disposable, sealed fluid cartridge (7) shielded by a lead glass viewing window (29).

[0061] Figure 12 This is a flowchart illustrating the preparation and administration of radioisotope doses to patients using the system in a hospital or outpatient clinic. Detailed Implementation

[0062] The invention can be more readily understood by reading the following detailed description of the invention and its included embodiments.

[0063] The term "approximately" as used in this invention refers to measurable values ​​such as parameters, quantities, durations, etc., and is intended to cover variations in specified values, particularly ±10% or less, preferably ±5% or less, such variations are suitable for implementation in the disclosed invention. It should be understood that the values ​​referred to by the modifier "approximately" are themselves preferably specifically disclosed.

[0064] Unless the context clearly specifies otherwise, the singular form used in this specification also includes the plural. Thus, for example, when referring to "a system" or "an apparatus" or "a process" or "a component," it also includes one or more systems, one or more apparatuses, one or more processes, or one or more components, as well as one or more steps, elements, or units of the type described herein and / or that a person skilled in the art would recognize upon reading this disclosure and related documents.

[0065] As used in this article, the term "imaging" refers to the techniques and processes used to create images of various parts of the human body for diagnostic and therapeutic purposes within digital health. Examples of imaging include X-ray radiography, fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT), medical ultrasound examinations or endoscopic ultrasound elastography, tactile imaging, thermal imaging, and nuclear medicine functional imaging techniques such as positron emission tomography (PET), dynamic positron emission tomography, and single-photon emission computed tomography (SPECT). Imaging is used to reveal the internal structures of the body and can be used to diagnose and treat diseases.

[0066] As used in this article, the term "SPECT" refers to Single Photon Emission Computed Tomography, a nuclear medicine computed tomography imaging technique that uses gamma rays and provides true 3D information. This information is typically presented as cross-sectional slices of the patient but can be freely reformatted or manipulated as needed. The technique requires the delivery of a gamma-emitting radioisotope (radionucleoside) into the patient's body, usually by injection into the bloodstream. The labeled radioisotope is typically attached to a specific ligand to produce a radioligand and / or radiopharmaceutical whose properties bind it to a specific type of tissue. This allows the radiopharmaceutical to be delivered and bound to a region of interest within the body, where the SPECT camera assesses the ligand concentration. The radioactive isotopes commonly 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 (Ga-67).

[0067] As used in this article, “positron emission tomography (PET)” refers to a functional imaging technique that uses radiopharmaceuticals, known as radiotracers or radiopharmaceuticals, to visualize and measure changes in metabolic processes and other physiological activities, including blood flow, regional chemical composition, and uptake. Different radiotracers can be used for various imaging purposes, depending on the target process within the body. Commonly used radioisotopes in PET imaging are carbon-11 (C-11), 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).

[0068] As used herein, the terms “treatment” and “use of treatment” refer to the attempt to cure, improve, alleviate, treat, and / or prevent diseases and / or other ailments in the human body. The term “treatment” also refers to drug therapy or pharmacological therapy, which means treating a disease by applying a drug (medicine). This term can be used to indicate the treatment or prevention of the development of a disease, as well as the relief of pain and symptoms of a specific condition. Nuclear medicine treatment can be given with the aid of radioactive isotopes, such as alpha emitters like actinium-225 (Ac-225) and astatine-211 (At-211), and beta emitters such as lutetium-177 (Lu-177) and lead-212 (Pb-212).

[0069] As used in this article, the term "computed tomography (CT)" refers to computed tomography imaging, in which a beam of X-rays, directed at the patient and rotating around the body, generates signals that are processed by the machine's computer to produce cross-sectional images of the body. These slices are tomographic images and contain more detailed information than conventional X-rays. Once the machine's computer has collected several consecutive slices, they can be digitally "stacked" together to form a three-dimensional image of the patient, allowing for easier identification and localization of basic structures and possible tumors or abnormalities.

[0070] The term "magnetic resonance imaging (MRI)" as used in this article refers to a non-invasive imaging technique that produces detailed 3D anatomical images used for disease detection, diagnosis, and treatment monitoring. MRI is based on the technique of exciting and detecting changes in the rotational axis direction of protons found in the water that constitutes living tissue.

[0071] As used in this article, the term "hybrid molecular imaging" refers to the fusion of two or more imaging techniques into a single, novel imaging modality. This imaging modality is synergistic and more powerful than the sum of its parts. Hybrid imaging represents image acquisition on a system that physically combines complementary imaging modalities to improve diagnostic accuracy and confidence, as well as patient comfort. Hybrid imaging combines the strengths of two imaging modalities in a single imaging session, thereby more accurately diagnosing and locating cancer while improving patient comfort. These are generated by overlaying two images at two different spatial scales: a low spatial scale obtained by filtering one image with a low-pass filter; and a high spatial scale obtained by filtering the second image with a high-pass filter. Examples of hybrid imaging modalities include PET-CT, SPECT-CT, and PET-MRI.

[0072] As used herein, the terms "automated infusion system" or "semi-automated infusion system" refer to systems for the generation and / or infusion and administration of radionuclides or radiotracers into a subject. Automated and semi-automated infusion systems include, but are not limited to, dosimeters, computers, controllers, display devices, activity detectors, storage cabinets, trolleys, waste management systems, sensors, optical display systems, shielding kits, alarm or alert mechanisms, tubing, source vials, diluents or eluents, pumps, and valves and / or combinations thereof. Automated and semi-automated infusion systems may be communicatively or electronically coupled to an imaging system.

[0073] As used in this article, the term "diagnosis" refers to the management of identifying a disease, condition, or injury from its signs or symptoms. A health history, physical examination, and tests such as blood tests, imaging, scans, and biopsies can be used to aid in making a diagnosis. As used in this article, the term "assessment" refers to the qualitative and / or quantitative evaluation of blood perfusion, solid tumors, or any other disease or abnormality in a body part or region of interest (ROI).

[0074] As used herein, the term "ergonomic portable trolley" refers to a wheeled trolley that is ergonomically designed and easily moved or transported. The portable trolley has a foot-operated locking and unlocking mechanism for the wheels.

[0075] As used herein, the term "infusion pump" refers to an infusion pump that can be shielded with radiation-protective shielding materials such as lead, tungsten, or other radiation-protective materials. The pump is a single-drive pump system that is electronically controlled to draw transition volumes from various types of supply containers (physiological saline, strong radioactivity (e.g., radioisotope doses)) to the required volume, and uses the same system to infuse the patient with the required flow rate and accuracy control.

[0076] As used herein, the term "standard syringe" refers to a syringe with a standard volume. The syringe used herein is the Jubilant shielded syringe, a patented and proprietary product of U.S. Patent No. 11,179,518 B2.

[0077] As used herein, the term "detachable radioactive dose delivery and containment module" refers to a detachable module in which a syringe containing a radioactive dose is assembled, the module comprising: (a) a single-handed grip enabling the dose to be delivered from a dose delivery device to an external dose calibrator; (b) an adapter converting a Luer lock syringe into a push-in connector; and (c) a sterile cap having features as part of workflow management. The sterile cap is used to protect the syringe from leakage and also from radiation emitted from the radiopharmaceutical contained within the syringe.

[0078] The term “dose calibrator” as used in this article refers to a device used in nuclear medicine to determine the exact activity of a radiation dose to be administered to a patient.

[0079] The term “Luer lock syringe” as used in this article refers to a syringe in which the needle can be twisted to the tip and locked in place, providing a secure connection and preventing accidental dislodgement of the needle and accidental injection of the contents.

[0080] The term "medical fluid" as used in this article refers to radiopharmaceuticals administered to patients.

[0081] The term “infusion parameters” as used in this article refers to one or more of the following: infusion rate, infusion mode, desired dose, desired activity, and / or any patient infusion-related data.

[0082] The term “pollution management system” as used in this article refers to a removable tray with an integrated channel system to direct any fluid leaks to a collection pad or waste bin.

[0083] As used herein, the term "radioactive dose" refers to the dose of a radiopharmaceutical component required to perform imaging within a subject, wherein the radiopharmaceutical component includes an active radioisotope used for imaging and treatment. The dose range of the radionuclide to be administered to the subject is from 0.27 μCi to 1000 mCi.

[0084] The term “attachment management system” as used in this article refers to a storage cabinet or box used for storage purposes.

[0085] The term "graphical user interface (GUI)" as used in this article refers to the interface through which a user interacts with a device such as a computer. Here, the computer screen acts as the GUI.

[0086] As used herein, the term "shield" refers to shielding against different dose activities. Here, different dose activities refer to different syringe volumes containing strong radioactive doses (i.e., radiopharmaceuticals). Syringe volumes can be 10cc, 20cc, 30cc, 60cc syringes, and vials can have volumes up to 30cc. The dose shield is used to shield syringes of different sizes and diameters, wherein the shielding (18) system is adapted to various sizes of syringes inserted or connected. The shield can be selected from a variety of suitable materials, including lead and tungsten. In one configuration, the shield is secured to 0.25-inch thick tungsten that will be sufficient to shield any volume or type of therapeutic radiation. The shield is defined to be suitable for receiving and retaining the internal cavity of a syringe or vial with a fluid cartridge. While a single shield can be used for all applications, shields of different sizes are also included within the scope of this invention if desired.

[0087] As used herein, the term "configurable dose delivery device" refers to a "caddy" that allows for the safe delivery of high doses of radiation between a high-radiation laboratory and an infusion site. The configurable dose delivery device includes: a separable dose delivery and containment module (13); a shield optimized for different dose activities (18); a dose of radiation in a standard syringe (8); and a single-handed grip (12) that allows the dose of radiation to be delivered from the dose delivery device to an external dose calibrator.

[0088] The term “shielded disposal system” as used in this article refers to a shielded waste management system with pedal-operated waste bins to avoid manually opening the bin lids, the space for the disposal bins, and / or the waste bins themselves.

[0089] The term “treatment diagnostic information system” as used in this article refers to programmable software used to control the operation of the delivery system.

[0090] The term "push-in connector" as used in this article refers to a type of easily removable compression fitting or quick-connect fitting that allows attachment of equipment without the nominal use of tools.

[0091] As used in this article, the term "PET" refers to positron emission tomography (PET), a type of diagnostic imaging. PET utilizes a dose of radiopharmaceutical generated, for example, in a radioisotope generator by elution and then injected or infused into the patient. The dose of the infused radiopharmaceutical is absorbed by the cells of the patient's target organ and emits radiation detected by a PET scanner to generate an image of the organ.

[0092] As used herein, the term "therapeutic diagnostic delivery system" refers to a mobile trolley for radiopharmaceutical delivery equipped with a shielded syringe and infusion pump. The terms "therapeutic diagnostic delivery system" and "radiopharmaceutical delivery system" refer to the same drug infusion system with the same functionality.

[0093] The term “system error” as used in this article refers to errors in the infusion system, such as incorrect eluent, incorrect infusion rate, incorrect infusion mode, undesirable dose, and undesirable activity.

[0094] As used herein, the term "controller" or "control system" refers to a computer or part thereof that is programmed to perform specific calculations, execute instructions, and control various activities of the infusion system based on user input or automatically.

[0095] The term "coded port" as used in this document refers to the two ports on the fluid cartridge: the patient port and the saline / cold port, one for saline inlet and one for medication outlet. These ports are configured differently to prevent user confusion and patient errors.

[0096] As used herein, the term "adapter" refers to a connector used to attach a syringe or vial to a disposable sealing case via a compression fitting. The adapter can be tagged, meaning it can be labeled using RFID, barcodes, QR codes, and other such tags.

[0097] In an embodiment of the present invention, the therapeutic diagnostic delivery system (100) includes:

[0098] i) An ergonomic, portable cart with an integrated handle;

[0099] ii) A treatment diagnostic information system having a computer screen (19) as a graphical user interface (GUI);

[0100] iii) Shielded infusion pumps; and

[0101] iv) Configurable dose delivery device (6);

[0102] The configurable dose delivery device (6) includes:

[0103] a) Separable radioactive dose delivery and containment module (13);

[0104] b) Shielding optimized for different doses of activity (18);

[0105] c) The radioactive dose in the standard syringe (8);

[0106] d) A single-handed grip (12) that allows the radiation dose to be delivered from the dose delivery device to an external dose calibrator;

[0107] e) An adapter (9) that converts the Luer lock injector type to a push-in connector; and

[0108] f) A sterile cap (11) that has the characteristics of being an integral part of workflow management.

[0109] In an embodiment of the present invention, the therapeutic diagnostic delivery system (100) includes:

[0110] i) An ergonomic, portable cart with an integrated handle;

[0111] ii) Shielding optimized for different doses of activity (18);

[0112] iii) A treatment diagnostic information system having a computer screen (19) as a graphical user interface;

[0113] iv) Shielded infusion pumps; and

[0114] v) Disposable sealed fluid box (7);

[0115] The disposable sealed fluid box (7) includes:

[0116] a) One or more optional integrated flow channels (17);

[0117] b) One or more sealed leak-free / drip-free connections (10); and

[0118] c) One or more guiding features and mechanical interlocks used for workflow management (16).

[0119] In an embodiment of the present invention, the therapeutic diagnostic delivery system (100) includes:

[0120] i) An ergonomic, portable cart with an integrated handle;

[0121] ii) Shielding optimized for different doses of activity (18);

[0122] iii) A treatment diagnostic information system having a computer screen (19) as a graphical user interface;

[0123] iv) Shielded infusion pumps; and

[0124] v) Workstation (3);

[0125] The workstation (3) includes:

[0126] a) Status lighting system for illuminating the work area to enable distance or long-distance monitoring (1);

[0127] b) Disposable secondary containment system to protect the core workstation from contamination (2);

[0128] c) Airborne shielded handling system (4); and

[0129] d) A foot-operated actuation system that enables locking and unlocking modes during device movement (5).

[0130] Embodiments of the present invention include the delivery system wherein the computer screen (19) is foldable and has a retractable rotating arm (20).

[0131] Embodiments of the present invention include the delivery system, wherein the syringe (8) may have different sizes and / or volumes. Furthermore, the delivery system also supports manufacturer-supplied vials. In one implementation, the delivery system has the capability to infuse 10cc, 20cc, 30cc, and 60cc syringes and vials with a maximum volume of 30cc.

[0132] Embodiments of the present invention include the delivery system and also include a control system for controlling the infusion of medical fluids.

[0133] Embodiments of the present invention include the delivery system, wherein the status light system (1) is controlled by the control system.

[0134] Embodiments of the present invention include the delivery system, and further include a treatment diagnostic information management system for controlling infusion parameters for patients.

[0135] Embodiments of the present invention include the delivery system and also include a contamination management system. The contamination management system includes a removal tray having an integrated channel system to direct any fluid leaks to a collection pad or waste bin.

[0136] Embodiments of the present invention include the delivery system, wherein the delivery system further includes attachment management.

[0137] Embodiments of the present invention include the delivery system with accessory management, wherein the accessory management includes storage for infusion supplies such as chux pads, gloves and other required items.

[0138] Embodiments of the present invention include the delivery system described above, which uses an automated infusion system to provide patient-specific therapeutic diagnostic doses of various radiopharmaceutical therapeutic diagnostic drugs.

[0139] Embodiments of the present invention include the delivery system wherein the graphical user interface (GUI) is used to receive infusion parameters such as infusion rate, infusion mode, desired dose, desired activity, and / or any patient infusion-related data. The patient-specific dose is based on patient profile data, which includes patient weight, gender, age, or patient physical or health history data.

[0140] In one embodiment, the invention includes a delivery system (100) that supports drug-specific infusion parameters, meaning that the infusion parameters can be different for different radiopharmaceuticals. This feature is supported by using custom software with drug-specific infusion parameters.

[0141] In an embodiment of the present invention, the radiopharmaceutical delivery system (100) includes:

[0142] (i) An ergonomically designed mobile cart with an integrated handle;

[0143] (ii) An information system having a computer screen (19) as a graphical user interface (GUI);

[0144] (iii) A shielded injection pump; and

[0145] (iv) Configurable dose delivery device (6);

[0146] The configurable dose delivery device (6) includes:

[0147] a) Separable radioactive dose delivery and containment module (13);

[0148] b) Shielding optimized for different types, quantities and volumes of radionuclides (18);

[0149] c) The radioactive dose in the syringe (8) or vial (26); and

[0150] d) A disposable, sealed fluid cartridge (7) that is connected to a syringe (8) or vial (26) via a compression fitting.

[0151] In an embodiment of the present invention, the radiopharmaceutical delivery system (100) includes:

[0152] (i) An ergonomically designed mobile cart with an integrated handle;

[0153] (ii) An information system having a computer screen (19) as a graphical user interface (GUI);

[0154] (iii) Shielded infusion pump;

[0155] (iv) A status light system for illuminating the work area to enable distance or long-distance monitoring (1); and

[0156] (iv) Configurable dose delivery device (6);

[0157] The configurable dose delivery device (6) includes:

[0158] a) Separable radioactive dose delivery and containment module (13);

[0159] b) Shielding optimized for different types, quantities and amounts of radionuclides (18);

[0160] c) The radioactive dose in the syringe (8) or vial (26); and

[0161] d) A disposable, sealed fluid cartridge (7) that is connected to a syringe (8) or vial (26) via a compression fitting.

[0162] The disposable, sealable fluid cartridge allows healthcare professionals to draw a customized volume from the vial or syringe.

[0163] Embodiments of the present invention include the delivery system with a syringe, wherein the syringe (8) may be one of a plurality of different standard specifications.

[0164] Embodiments of the present invention include the delivery system, wherein the shielding (18) system is configured to be used appropriately with a wide range of syringes (8) that are inserted or connected.

[0165] Embodiments of the present invention include the delivery system wherein the computer screen (19), which serves as a graphical user interface (GUI), is mounted on a retractable rotating arm.

[0166] Embodiments of the present invention include the delivery system wherein the fluid cartridge allows for the extraction of a customized volume based on the patient’s weight, sex, age, other physical parameters, or health history data.

[0167] Embodiments of the present invention include the delivery system, wherein the delivery system supports drug-specific infusion parameters.

[0168] Embodiments of the present invention include the delivery system wherein the separable radioactive dose delivery and containment module (13) is shielded by a lead glass viewing window (29).

[0169] Embodiments of the present invention include the delivery system, wherein the fluid cartridge includes coded ports to eliminate errors in patient tubing or saline tubing.

[0170] Embodiments of the present invention include the delivery system, wherein the system monitors and tracks one or more of the following: the total volume in the syringe, the total volume of real-time drug delivery, the total volume from the IV bag, and the total volume infused into the patient.

[0171] Embodiments of the present invention include the delivery system and also include a control system for controlling the infusion of medical fluids.

[0172] Embodiments of the present invention include the delivery system, wherein the controller is configured to abort infusion processing when a system error is detected.

[0173] Embodiments of the present invention include the delivery system, wherein the status light system (1) indicates different states of the device (e.g., administration, administration completed) using various colors.

[0174] Embodiments of the present invention include the delivery system, wherein the status light system (1) is controlled by the control system.

[0175] Embodiments of the present invention include the delivery system, wherein the system has audible alarm features to alert the user in real time to one or more of the following: fluid blockage, pump failure, or any deviation from the programmed volume and / or expected sequence of events.

[0176] Embodiments of the present invention include the delivery system, wherein the pump protects the patient from air infusion that could cause air embolism, and includes an alarm signal for real-time air detection.

[0177] In embodiments of the present invention, the radiopharmaceutical delivery system includes:

[0178] Configurable dose delivery device (6); separable radioactive dose delivery and containment module (13); shield (18); disposable sealed fluid cartridge (7); and syringe (8) or vial (26); wherein the disposable sealed fluid cartridge (7) comprises:

[0179] (i) One or more selectable integrated flow channels (17);

[0180] (ii) An adapter (9) for assembling a syringe (8) or a medicine bottle;

[0181] (iii) Encoded patient port and saline port; and

[0182] (iv) One or more pressure sensors (27, 28);

[0183] The disposable sealed fluid cartridge is allowed to draw a customized volume from the vial (26) or syringe (8).

[0184] Embodiments of the present invention include the delivery system (100) wherein an adapter (9) of a disposable sealed fluid cartridge (7) is connected to a syringe (8) or vial (26) via a compression fitting to reduce leakage connections.

[0185] Embodiments of the present invention include the delivery system (100), wherein the customized volume drawn by the fluid cartridge is based on one or more of the patient’s weight, sex, age, health history data and / or other physical parameters.

[0186] Embodiments of the present invention include the delivery system, wherein the controller is configured to abort infusion processing due to a system error.

[0187] Embodiments of the present invention include the delivery system programmed with software that can be remotely updated to add new features and drug compatibility. The software also has safety features to ensure the correct patient and / or correct dosage.

[0188] Embodiments of the present invention include the delivery system, which includes software security programmed to prevent unauthorized access and may have software firewall capabilities to prevent hacking and unauthorized remote access to patient data.

[0189] Embodiments of the present invention include the delivery system having an infusion pump, wherein the infusion pump is used to deliver therapeutic and diagnostic radiopharmaceutical preparations intravenously and intraarterially at a controlled infusion rate or as a bolus injection in combination with a supply of commercially available 0.9% saline. The infusion pump will be compatible only with various single-dose or multi-dose syringes or vials.

[0190] Embodiments of the present invention include the delivery system, wherein the system has audible alarm features to alert the user in real time to fluid blockage, pump failure, or any deviation from the programmed volume and / or expected sequence of events.

[0191] Embodiments of the invention include the delivery system wherein the pump protects the patient from air infusion that could cause air embolism and includes an alarm signal for real-time activation of air detection. The pump should be designed to prevent the delivery of liquid medication by a single action following air detection accompanied by the alarm signal. This advantageously prevents the operator from easily disregarding safety warnings and potentially endangering the patient.

[0192] Embodiments of the present invention include the delivery system, which includes a pressure sensor to monitor fluid blockage in real time.

[0193] Figure 1A , Figure 1B , Figure 1C and Figure 1D The construction of a therapeutic diagnostic delivery system or radiopharmaceutical delivery system (100) is shown. The system (100) includes a mobile or portable ergonomic workstation (3) with handles on the sides or back for moving a trolley via wheels (21). The workstation (3) of the therapeutic diagnostic delivery system (100) also includes an airborne shielded disposal system (4) for waste collection (see [reference needed]). Figure 1B The shielded treatment system (4) is operated by a foot-operated actuation system (5) that enables locking and unlocking of the wheels during transport of the device (100). The therapeutic diagnostic delivery system or radiopharmaceutical delivery system (100) also includes a foldable computer screen (19) mounted to a retractable rotating arm (20) and a status light system (1) illuminating the work area, allowing the operator to monitor the status of the system from a distance within the work area. The primary purpose of distance monitoring is to ensure that the provider maintains a distance from the radiation patient to ensure low exposure. For example, if a healthcare provider is using the delivery system (100) to administer a dose of radiopharmaceutical to a patient and the provider needs to leave the room and walk through a corridor, the provider will be able to easily observe the delivery system and see the status light system (1) as green or blue, indicating that the operation is being performed correctly. Conversely, if the provider sees the status light system (1) change from green to orange or red, the provider will know that they should quickly return to investigate the change in status. Figure 1B The treatment diagnostic delivery system (100) also includes a disposable secondary containment system (2) to protect the core workstation from contamination. Figure 1CThe therapeutic diagnostic system (100) includes a configurable dose delivery device (6) with a disposable, sealed fluid cartridge (7). The therapeutic diagnostic delivery system or radiopharmaceutical delivery system (100) also includes a storage tray (22) and storage space (23) for storing medical equipment and other necessary items for radiopharmaceutical administration.

[0194] Figure 2 A schematic cross-sectional view of a shielded syringe system (101) is shown. A radioactive dosing standard syringe (8) is shielded by a shielding material (i.e., lead, steel, tungsten, or a combination of shielding materials). The shielding material is configured in the shape of a cylinder (14) arranged around the syringe (8). The therapeutic diagnostic delivery system (100) also includes an adapter (9) to convert a Luer-type syringe into a push-in connector with a sterile cap (11) having a leak-free / drip-free connection (10).

[0195] Figure 3 A configurable dose delivery device (6) is shown (e.g.) Figure 1A The schematic diagram (102) shown in the figure illustrates that the configurable dose delivery device (6) has an integrated handle (15) to facilitate the transfer from the shipping bag to the point where it is ready to be installed in the workstation (3) for infusion (as shown in the figure). Figure 1A and 1B The configurable dose delivery device (6) is used for two-handed delivery of the radioactive dose (as shown in the diagram), and has a single-handed grip (12) to allow the dose to be delivered from the dose delivery device (6) (as shown in the diagram). Figure 1A and 1B (As shown) is transported to an external dose calibrator for measuring the activity of the radiopharmaceutical prior to infusion. The dose delivery device (6) (as shown) Figure 1A and 1B (as shown) includes an onboard shield (14) that provides protection throughout the entire workflow of shipping, preparation, and delivery. The configurable dosing delivery unit (6) (as shown) includes an onboard shield (14) that provides protection throughout the entire process of shipment, preparation, and delivery. Figure 1A and 1B The diagram also includes guidance features and mechanical interlocks (16) for workflow management, as well as a separable radioactive dose module (13). The separable radioactive dose module consists of a syringe with a strong radioactive dose to be infused into the patient.

[0196] Figure 4 A disposable, sealed fluid cartridge (7) is shown for a therapeutic diagnostic delivery system or radiopharmaceutical delivery system (100) comprising one or more selectable integrated flow channels (17). Figure 1A The diagram (103) shown in the figure illustrates this. The flow channel refers to the channel used to connect the high-radiation dose source, the saline source to the infusion pump, and then back to the patient line to deliver the accurate dose to the patient.

[0197] Figure 5 A diagram (104) illustrates a shield (18) for a therapeutic diagnostic delivery system or radiopharmaceutical delivery system (100) optimized for different dose activities. Here, different dose activities refer to different volumes of syringes consisting of strong radioactive doses (i.e., radiopharmaceutical doses). The syringe volume can be 10cc, 20cc, 30cc, or 60cc syringes, and the vial volume can be up to 30cc. The dose shield is used to shield syringes of different sizes and diameters, wherein the shield (18) system can be used with syringes of different sizes that are inserted or connected.

[0198] Figure 6 A diagram is shown of a disposable, sealed fluid cartridge (7) having a patient port (24) and a saline / cold port (25), the disposable, sealed fluid cartridge (7) having a cavity that allows a customized volume to be drawn from a vial or syringe. The fluid cartridge includes a pump system to draw the required volume from various supply container types (saline, high-dose radioactive materials) to a transitional volume (i.e., “delivery”), and uses the same system to infuse radiopharmaceuticals to the patient with the required flow rate, accuracy, etc.

[0199] Figure 7 A disposable, sealed fluid cartridge (7) is shown connected to a vial (26) via a compression fitting using an adapter (9) that can be optionally labeled. Figure 8 The connection between the disposable sealed fluid cartridge (7) and the adapter (9) is shown. The adapter (9) is connected to the vial (26) via a compression fitting having a port for eliminating erroneous codes in the patient / saline line. The disposable sealed fluid cartridge (7) consists of one or more automated on / off check valves connected to a high-radioactive dose source channel and a saline source channel to draw medication and saline from the source container. Furthermore, the high-radioactive dose channel and the saline channel are connected to an infusion pump to infuse the required dose from the patient line to the patient.

[0200] Figure 9 A disposable sealed fluid cartridge (7) is shown connected to the syringe (8) via an adapter (9) to reduce leakage. Figure 10 The connection between a disposable sealed fluid cartridge (7) and an adapter (9) is shown. The adapter (9) is connected to a syringe (8) via a compression fitting with coded ports to eliminate errors in the patient / saline tubing.

[0201] Furthermore, the disposable sealed fluid cartridge (7) consists of two pressure sensors: a patient line pressure sensor (27) for measuring pressure in the patient line and a pressure sensor (26) for detecting pressure from a syringe (8) or vial (26). Figure 8 and 10 The strong radioactive dose pressure sensor (28) shows the dose pressure of the radiation.

[0202] Figure 11 A configurable dosing delivery device (6) is shown, which is directly connected to a small box that serves as a shielded observation window (29) made of lead glass.

[0203] Figure 12 This is a flowchart illustrating the operation of the delivery system 100. In a first step 110, a dose of radioactive isotope is prepared and placed in a container suitable for the radioactive isotope. The container may be a syringe (8) or vial (26) as described above. The syringe or vial is then placed in the dose delivery unit (6) by holding the upper handle (12) and pulling out the receiving module (13) from the dose delivery unit. The syringe or vial is inserted into the opening in the receiving module, and then the receiving module is returned to the dose delivery unit. The healthcare provider is protected from radiation by the shielding (14) assembly of the delivery unit. The dose is typically prepared elsewhere and delivered to the radiopharmacy or hospital in a transport package such as a bag, box, or other container. While the radioactive isotope is being delivered to the radiopharmacy or hospital, the shielding assembly (14) protects the person in contact with the dose delivery unit from radiation exposure.

[0204] In the second step 120, a radioisotope dose is received in a delivery package at a radiopharmacy or hospital laboratory and prepared for injection into a patient. When the delivery package is received at the radiopharmacy or hospital, the radioisotope dose is contained within the dose delivery device (6). The healthcare provider removes the dose delivery device from the delivery package, places it on a surface such as a counter in a laboratory, and removes the containment module (13) from the dose delivery device. Since this may expose the healthcare provider to radiation, the provider places the containment module (13) into a shielded container such as a shielded conduit for temporary storage during fluid cartridge preparation. The shielded conduit may be circular, square, or any convenient construction suitable for holding and containing the module (13). With the containment module removed from the delivery device (6), the provider then removes the sterile cap located on the underside of the dose delivery device.

[0205] As the sterile cap is removed from the dosing delivery device, the volume of the delivery device is exposed. The lower surface of this volume is defined by a first plate and the upper surface by a second plate. One or both of the first and second plates may include guides or grooves for receiving a fluid cartridge (7). The guides or grooves are configured to mate with the bottom, top, and / or side surfaces of the fluid cartridge, thereby allowing the fluid cartridge to be received only in a single direction within the container. This safety feature prevents incorrect insertion of the fluid cartridge. In one implementation, the plate has guides and / or grooves and interlocks. The interlocks can be used to hold the fluid cartridge in place when it is positioned on the guides or grooves. The interlocks can be configured to have a first portion on the guides, grooves, or plate and a second portion on the fluid cartridge. In this way, a popping noise and / or tactile sensation that the provider can notice can be experienced when the fluid cartridge is correctly aligned and positioned.

[0206] The provider inserts the fluid cartridge into the volume and pushes it in until proper placement is achieved, for example by experiencing a popping sound and / or tactile sensation. The provider then grasps the upper handle (12) on the receiving module (13), removes the module from the shielded container, and inserts the opposite or lower end of the module into an opening on the top surface of the uppermost plate of the dose delivery device. Typically, this uppermost plate is different from the upper plate that defines the volume for receiving the fluid cartridge. The opposite or lower end of the module is pushed through the opening in the upper plate until the lower end contacts the adapter (9) within one side of the fluid cartridge. The module is then pushed further in until a fluid-tight connection is achieved between the vial or syringe within the receiving module and the adapter in the fluid cartridge. The provider then mounts the receiving module (13) onto the cart.

[0207] According to step 130, the provider moves the cart from the laboratory where the fluid cartridge is prepared to the ward or other suitable location where the radioisotope dose is intended to be administered. The location will, of course, depend on the purpose of the radioisotope administration. For treatment purposes, the patient may be in a ward. For diagnostic procedures such as PET scans, the patient may be in a suite equipped with a PET scanner and associated equipment. In either case, the provider moves the cart to the patient and connects a disposable fluid line from the patient port on the fluid cartridge to the IV line inside the patient's body. The provider then operates the keyboard or on-screen prompts to administer the desired volume of radioisotope at the desired flow rate.

[0208] At this stage of the treatment, the pump assembly in the fluid cartridge is prepared with saline and a radioisotope (step 140). To prepare the pump assembly, the provider first connects a disposable fluid line between the saline syringe mounted on the cart and the saline port of the fluid cartridge. The provider then uses keyboard or on-screen controls to operate the software to prepare the pump. This operation is typically automated and depends at least on the dose to be received by the patient. Additionally, in step 150, when the fluid cartridge is filled with radioisotope, the pump draws fluid from the saline syringe and the radioisotope vial (or syringe) into the delivery chamber of the fluid cartridge. At this stage of the treatment, the pump is prepared, filled, and the dose to be administered to the patient is ready.

[0209] According to step 160, during administration of a radioactive isotope, the area around the trolley is illuminated with a set color indicating the action being taken. For example, the illumination may be red during administration of the radioactive isotope, switch to yellow when administration is nearly complete, for example, 95% complete, and switch to green or blue when administration is complete. The color is chosen to indicate to the viewer the potential danger from the radioactive isotope. Using color in this way allows the provider operating the PET scanner to view the status of the system from a distance, such as the PET scanner's control booth. If the patient is in a ward, the provider will be alerted to the danger of radiation while the dose is being administered and will know they are outside the room.

[0210] According to step 170, after the dose is infused, some radioisotope dose may remain in the high-dose container. To utilize this residual dose, the provider initiates a backflushing operation. For this step, the pump draws saline from the saline container into the delivery chamber of the fluid cartridge and then pushes that saline into the radioisotope dose container. The pump then again loads the radioisotope dose from the radioisotope dose container into the delivery chamber to administer the residual dose to the patient. This process is repeated until the entire dose in the radioisotope dose container has been used. The main advantage of this step is that waste of the radioisotope dose is minimized by using the backflushing step.

[0211] According to step 180, when the radioisotope dose is completed, the provider removes the fluid tubing extending from the patient's IV line to the patient port of the fluid cartridge. The provider may then discard the tubing in a removable container in the cart. Similarly, the provider may disconnect the fluid tubing from the saline syringe and place it in a removable container. Similarly, the fluid cartridge may be pulled from the dose delivery device and placed in a removable container. The provider may then return the cart to the laboratory for storage and cleaning.

[0212] In embodiments of the invention, the therapeutic diagnostic delivery system or radiopharmaceutical delivery system includes a therapeutic diagnostic information management system comprising a computer screen having a graphical user interface (GUI) for receiving various patient infusion parameters, including one or more of infusion rate, infusion mode, desired dose, desired activity, and / or any patient infusion-related data. The therapeutic diagnostic information system may also include a control system for controlling the infusion process, wherein the status of lights is used to indicate different states of the device, with different colors representing the device status.

[0213] In an embodiment of the invention, the therapeutic diagnostic delivery system or radiopharmaceutical delivery system (100) includes a contamination management system comprising a tray with an integrated channel system to direct any fluid leaks to a collection pad or waste bin. The therapeutic diagnostic delivery system also includes accessory management for storing all infusion supplies, including chux liners, gloves, and other equipment.

[0214] Figure 6 Another embodiment of the present invention discloses a front view of a therapeutic diagnostic delivery system or radiopharmaceutical delivery system (100) having a configurable dose delivery device (6) directly connected to a custom-designed, disposable, sealed fluid cartridge (7) shielded by a lead-glass viewing window (29). The “cartridge” allows for the safe delivery of high-intensity radioactive doses between high-intensity radiation laboratories and infusion sites.

[0215] The therapeutic diagnostic delivery system or radiopharmaceutical delivery system (100) includes a dose-configurable delivery unit that serves as a "box" for delivering a strong radioactive dose from a separable radioactive dose delivery and containment module (13) in syringes of different sizes from the pharmacy to the infusion site. The strong radioactive dose in the syringe is shielded in a configurable dose shield to protect against radiation emitted from the radiopharmaceutical in the syringe. Furthermore, the configurable dose delivery unit (6) is attached to a disposable, sealed fluid cartridge to initiate drug infusion to the patient.

[0216] Radiopharmaceutical infusion for patients involves four main modes: preparation, filling, infusion, and backflushing. Preparation mode essentially involves checking all infusion lines connected to the pump, dosing vessel, and saline vessel for air bubbles or any blockages. In filling mode, a disposable fluid cartridge draws the required volume from various supply vessel types (saline, high-dose) to a transition volume (i.e., "delivery"), and in infusion mode, the same system is used to infuse the patient with the required flow rate, accuracy, and other controls. In backflushing mode, the system is backflushed with a specific amount of saline through the infusion lines to the patient to push any residual dose to the patient.

[0217] By ensuring cybersecurity compliance before dispensing radiopharmaceuticals to patients, embodiments of the present invention provide enhanced security for radiopharmaceutical delivery. Prior to radiopharmaceutical infusion, this process ensures cybersecurity in the radiopharmaceutical delivery system by configuring the controller to scan the system, network, or connected devices to detect any unauthorized connections and / or malware. This configuration and process protect the system from unauthorized connections and / or malware and alert operators to any actual or potential unauthorized connections and / or malware.

[0218] In an embodiment of the invention, the controller is configured to force the system into a safe mode upon detecting an unauthorized connection or malware. In such a case, the controller is configured to suspend system operation upon detecting any threat from an unauthorized connection or malware, and to remain inactive until the malware is destroyed.

[0219] Each embodiment disclosed herein is contemplated to be applicable to every other embodiment disclosed. Therefore, all combinations of the various elements described herein fall within the scope of this invention.

Claims

1. A radiopharmaceutical delivery system (100), comprising: (i) A mobile cart with an integrated handle; (ii) An information system having a computer screen (19) configured as a graphical user interface (GUI); (iii) Infusion pump; as well as (iv) A configurable dose delivery device (6), wherein the configurable dose delivery device (6) comprises: a) Separable radioactive dose delivery and containment module (13); b) Shielding for one or more of different types, quantities and volumes of radionuclides (18); c) The radioactive dose in the syringe (8) or vial (26); and d) A disposable, sealed fluid cartridge (7) that is connected to a syringe (8) or vial (26) via a compression fitting.

2. The delivery system according to claim 1, wherein, The syringe (8) can be selected from different standard sizes.

3. The delivery system according to claim 1, wherein, The shielding (18) system is configured for use with syringes of various sizes that are inserted into or connected to.

4. The delivery system according to claim 1, wherein, The computer screen (19) serves as a graphical user interface (GUI) with a retractable rotating arm (20).

5. The delivery system according to claim 1, wherein, The disposable sealed fluid cartridge (7) is configured to allow a customized volume to be drawn from a vial or syringe based on one or more of the patient’s weight, sex, age, other physical parameters or health history data.

6. The delivery system according to claim 1, wherein, The drug delivery system (100) is configured to support drug-specific infusion parameters.

7. The delivery system according to claim 1, wherein, The separable radioactive dose delivery and containment module (13) is shielded and includes a lead glass viewing window (29).

8. The delivery system according to claim 1, wherein, The disposable sealed fluid cartridge (7) includes an coded port for eliminating errors when connecting patient tubing or saline tubing to the fluid cartridge.

9. The delivery system according to claim 1, wherein, The system is configured to monitor and track one or more of the following: the total volume in the syringe, the total volume of real-time drug delivery, the total volume from the IV bag, and the total volume infused into the patient.

10. The delivery system according to claim 1, wherein, The system also includes a control system for controlling the infusion of medical fluids into the patient's body.

11. The delivery system according to claim 10, wherein, The control system is configured to abort infusion processing in case of system error.

12. The delivery system according to claim 1, wherein, The system features audible alarms to alert the user in real time to one or more of the following: fluid blockage, pump failure, deviation from programmed volume, and expected sequence of events.

13. The delivery system according to claim 1, wherein, The shielded infusion pump is configured to protect the patient from air infusion and includes an alarm signal for real-time air detection.

14. A radiopharmaceutical delivery system (100), comprising: (i) A movable cart having at least one handle; (ii) An information system having a computer screen (19) as a graphical user interface (GUI); (iii) Infusion pump; (iv) A status light system (1) for illuminating the work area to monitor the status of the infusion; as well as (iv) Configurable dose delivery device (6); The configurable dose delivery device (6) includes: a) Separable radioactive dose delivery and containment module (13); b) A shield configured for use with one or more of different types, quantities and values ​​of radionuclides (18); c) The radioactive dose contained in the syringe (8) or vial (26); and d) A disposable, sealed fluid cartridge (7) that is connected to a syringe (8) or vial (26) via a compression fitting. The disposable sealable fluid cartridge is configured to draw a customizable volume from a syringe or vial.

15. The delivery system according to claim 14, wherein, The status light system (1) uses various colors to indicate different states of the device.

16. The delivery system according to claim 14, wherein, The status light system (1) is controlled by the control system.

17. A radiopharmaceutical delivery system (100), comprising: Configurable dose delivery device (6); Separable radioactive dose delivery and containment module (13); shield (18); disposable sealed fluid cartridge (7); and syringe (8) or vial (26). The disposable sealed fluid box (7) includes: (i) One or more selectable integrated flow channels (17); (ii) An adapter (9) for assembling a syringe (8) or a vial (26); (iii) Encoded patient port (24) and saline port (25); and (iv) One or more pressure sensors (27, 28); The disposable sealable fluid cartridge is configured to draw a customizable volume from a syringe or vial.

18. The delivery system according to claim 17, wherein, The adapter (9) is tagged using one or more of RFID, barcode or QR code.

19. The delivery system according to claim 17, wherein, The disposable sealed fluid cartridge (7) is configured to draw a customizable volume based on one or more of the patient’s weight, sex, age, health history data and / or other physical parameters.

20. The delivery system according to claim 17, wherein, The disposable sealed fluid cartridge (7) includes a port for eliminating incorrect coding in the selection of patient and saline lines.

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