Radiopharmaceutical delivery system for patient infusion

Abstract

The present invention relates to a theranostics delivery system or radiopharmaceutical delivery system (100) comprising a movable ergonomic workstation (3) having a handle on the side for moving a cart. The radiopharmaceutical delivery system (100) includes a simple design and several enhanced safety features for the user. The delivery system (100) includes a disposable secondary containment system (2) to protect the core workstation from contamination, a configurable dose transporter (6) to enable the safe transport of hot doses between the hot lab and the injection site, and a disposable sealed fluid cartridge (7) for drawing custom volumes from vials or syringes. The delivery system (100) includes a theranostics information science management system comprising a computer screen (19) as a graphical user interface (GUI) with a retractable rotating arm (20) to receive various patient injection parameters and to effectively manage the delivery of desired doses to patients.

Description

Technical Field

[0001] The present invention relates to a radiopharmaceutical injection system. More particularly, the present invention relates to a Ceranosistics or radiopharmaceutical delivery system capable of performing patient injection of a radiopharmaceutical composition in an outpatient clinic and / or hospital by setting and pairing a novel syringe shield device in combination with a patient injection pump device.

Background Art

[0002] Radiopharmaceuticals are important for the therapy and diagnostic use of various diseases. The safe and efficient use of these important and potentially dangerous radioisotopes, which have either a short or long half-life, is essential during their intended use by patients and / or healthcare providers. These radioisotopes play a decisive role in the diagnosis and therapy of various diseases. Most of the widely available radiopharmaceuticals are produced by various known techniques. For example, Co-60 is used for cancer treatment, I-131 is used for the treatment of hyperthyroidism, C-14 is used for breath tests, Tc-99m, Rb-82 are used as tracers in myocardial blood flow imaging, Ga-68 is used for imaging solid tumors, and Ac-225, Lu-177, and At-211 are used for therapeutic purposes. Due to the short half-life of some radiopharmaceuticals, the overall imaging and administration procedures essentially need to be completed within a short time period. Some radiopharmaceuticals are usually prepared at an on-site facility having a suitable distance accessible by car from the patient's location to prevent excessive decay of the radiopharmaceutical before use. Additionally, these radioisotopes have undesirable radiation hazard side effects on users or healthcare providers as well as patients. Therefore, safety handling techniques, including using a shielded system, are essential to avoid various undesirable health hazards.

[0003] Currently, nuclear medicine technologists configure non-radioactive chemotherapeutic / IV infusion peristaltic pumps for the infusion of theranostic radiopharmaceuticals into patients within hospitals. While diagnostic infusions are of the "bolus" type, in the technology of infusion systems for new generation theranostic / therapeutic radiopharmaceuticals requiring slow infusion (i.e., 1 ml / min), there is an unmet need to provide a safe / shielded delivery system, in addition to minimizing undesirable health damage to patients, users / healthcare providers, and the environment from radiation exposure.

[0004] Currently available infusion systems and methods have several drawbacks, including the lack of radiation shielding and the inability to flush or wash drug syringes with saline to ensure the correct dose to the patient. Furthermore, current methods do not incorporate syringes; instead, they rely on extended spinal needles to puncture the rubber septum of glass vials to extract the drug, which can lead to the introduction of air into the patient's IV line, resulting in incomplete or inaccurate drug administration and a risk of air embolism in the patient. In addition, not all infusion pumps can accommodate the 60cc syringe volume required for the infusion of some radiopharmaceuticals for therapy. There is an unmet need for infusion system solutions to supply patients with all the necessary specialized radiopharmaceutical procedural supplies, such as ion chambers, Geiger-Müller counters, IV tubes, and radioactive waste. Also, regarding the preparation, compounding, dispensing, and repackaging of radiopharmaceuticals, the USP General Chapter <825> Guidelines have been published in [location]. According to the published summary of drug information and standards, customers are prohibited from handling highly radioactive drugs without a cleanroom, and hospitals and pharmacies must comply with these guidelines. This invention facilitates compliance and safety in hospitals and pharmacies by providing quality-controlled drugs in shielded syringes for dose-based patient infusion. More specifically, there is an unmet need to develop an advanced and efficient theranostics delivery system combined with a radiation-shielded syringe infusion pump that can provide increased radiation safety for patients and users / healthcare providers. [Overview of the project] [Problems that the invention aims to solve]

[0005] The present invention relates to a theranostics delivery system or radiopharmaceutical delivery system that enables patient infusion of radiopharmaceuticals in a hospital environment by pairing a novel syringe shield device with a patient infusion pump device. [Means for solving the problem]

[0006] One aspect of the present invention is to provide an ergonomic theranostics delivery system with a mobile cart for transporting therapeutic radiopharmaceutical doses to a patient infusion room in a hospital or clinic.

[0007] One aspect of the present invention is to provide patient-specific theranostic drug administration of different radiopharmaceutical theranostic drugs using an automated injection system. However, it should be understood that the administration and administration of radiopharmaceuticals may 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 present invention is to facilitate the ability of healthcare providers to monitor their own health and protect themselves from radiation damage while treating patients.

[0010] One aspect of the present invention is to provide a localized radiation shield for a syringe containing a radioactive drug.

[0011] One aspect of the present invention is to provide an injection system capable of delivering a radiopharmaceutical composition by using a process that is manual, automatic, semi-automatic, computer-controlled, or any combination thereof.

[0012] One aspect of the present invention is to enable the syringe to be "rinsed" with saline solution automatically, semi-automatically, manually, and / or any combination thereof after injection, in order to ensure that the entire drug is injected.

[0013] One aspect of the present invention is to provide a “cart” with an accessory management system to enable healthcare providers to keep all essential supplies readily available.

[0014] One aspect of the present invention provides a contamination control system including a removable tray with an integrated channel system for directing any fluid spills toward a collection pad or waste container.

[0015] Yet another aspect of the present invention is to provide a theranostics information science management system for controlling patient infusion parameters.

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

[0017] One aspect of the present invention provides a theranostics delivery system (100), the theranostics delivery system (100) is i) Ergonomically designed mobile cart with integrated handle, ii) A theranostics information science system with a computer screen (19) as a graphical user interface (GUI), iii) Shielded injection pump, and iv) Equipped with a configurable dose transporter (6), The configurable dose transporter (6) is: a) Separable radioactive dose transport and containment module (13), b) Shields optimized for different doses of radioactivity (18) c) Radioactive dose in a standard syringe (8), d) A one-handed grip (12) to enable the transfer of radioactive dose from the dose transporter to an external dose calibrator. e) Adapter (9) for converting a Luer lock syringe type to a push-in connector, and f) It is equipped with a sterile cap (11) that has a function that is an integral part of the workflow management.

[0018] One aspect of the present invention provides a theranostics delivery system (100), the theranostics delivery system (100) is i) An ergonomic mobile cart with an integrated handle, ii) A shield (18) optimized for different dosages of radioactivity, iii) A Celanostics information science system with a computer screen (19) as a graphical user interface (GUI), iv) A shielding injection pump, and v) A disposable sealed fluid cartridge (7), The disposable sealed fluid cartridge (7) a) One or more selectable integrated flow paths (17), b) One or more sealed leak - free / drip - free connections (10), and c) One or more guiding functions and mechanical interlocks (16) for workflow management.

[0019] One aspect of the present invention is to provide a Celanostics delivery system (100), the Celanostics delivery system (100) i) An ergonomic mobile cart with an integrated handle, ii) A shield (18) optimized for different dosages of radioactivity, iii) A Celanostics information science system with a computer screen (19) as a graphical user interface (GUI), iv) A shielding injection pump, and v) A workstation (3), The workstation (3) 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 central workstation from contamination (e.g., radioisotopes, radiation), c) A mounted shielding waste system (4), and d) A foot - actuated system (5) for enabling lock and unlock modes during device movement, for example, to lock and unlock the wheels on the mobile cart. [Brief explanation of the drawing]

[0020] [Figure 1A] This is a schematic diagram of a theranostics delivery system or radiopharmaceutical delivery system. [Figure 1B] This is a schematic diagram of a theranostics delivery system or radiopharmaceutical delivery system. [Figure 1C] This is a rear view of a theranostics delivery system or a radiopharmaceutical delivery system. [Figure 1D] This is a front view of a theranostics delivery system or radiopharmaceutical delivery system. [Figure 2] This is a schematic diagram of a shielded syringe system. [Figure 3] This is a schematic diagram of a configurable dose transporter. [Figure 4] The figure shows a disposable sealed fluid cartridge including a selectable integrated channel for connecting, for example, a radioisotope dose source and a saline source to an infusion pump and a channel connected to a patient line, for the injection of a desired dose of radioisotope to a patient, wherein the channel allows for bidirectional flow of the fluid for drug delivery to the patient and for backflushing with saline to "rinse" any remaining radiopharmaceutical cavity. [Figure 5] This figure shows shields optimized for different doses of radiation. [Figure 6] This figure shows a disposable sealed fluid cartridge (7) that allows healthcare providers to draw custom volumes from vials or syringes. [Figure 7] This figure shows a disposable sealed fluid cartridge (7) connected to a vial (26) by a compression fitting. [Figure 8] This figure shows a disposable sealed fluid cartridge (7) with a dose adapter (9) connected to a vial (26) by a compression fitting, which has a corded port to eliminate errors in the patient / saline line. [Figure 9]This figure shows a disposable sealed fluid cartridge (7) connected to a syringe by a compression fitting to reduce leakage connections. [Figure 10] This figure shows a disposable sealed fluid cartridge (7) with an adapter (9) connected to a syringe (8) by a compression fitting, which has a corded port to eliminate errors in the patient / saline line. [Figure 11] This figure shows a configurable dose transporter (6), which is a caddy, connected in a straight line to a custom disposable sealed fluid cartridge (7) shielded by a lead glass observation window (29). [Figure 12] This flowchart shows the use of a system for preparing and administering radioisotope doses to patients in a hospital or outpatient clinic. [Modes for carrying out the invention]

[0021] The present invention can be more readily understood by reading the following detailed description of the invention and the embodiments included.

[0022] When used herein, the term “about” refers to a measurable value such as a parameter, quantity, time period, and the like, and is intended to include variations in and from a specified value, in particular variations of ±10%, preferably ±5%, from a specified value, such variations being appropriate for implementation in the disclosed invention. It should be understood that the values ​​referred to by the modifying phrase “about” are also disclosed, specifically and preferably, in themselves.

[0023] When used in the specification of the present invention, the singular forms "a," "an," and "the" include plural references unless the context otherwise clearly indicates otherwise. Thus, for example, references to "(a) system," "(a) apparatus," "(a) process," or "(a) composition" include one or more systems, one or more apparatus, one or more processes, or compositions, each involving one or more steps, materials, or elements of the type described herein and / or that become apparent to those skilled in the art by reading this disclosure.

[0024] As used herein, 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. For example, imaging includes radiography, fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT), medical ultrasound or endoscopic ultrasound elastography, tactile imaging, thermographic 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 structure of the body and may also be used to diagnose and treat diseases.

[0025] As used herein, the term “SPECT” refers to single-photon emission computed tomography, a gamma-ray-based nuclear medicine tomography imaging technique that provides true 3D information. This information is typically represented as cross-sectional slices of a patient, but can be freely reformatted or manipulated as needed. The technique requires the delivery of gamma-emitting radioisotopes (radionuclides) into the patient, usually by injection into the bloodstream. Marker radioisotopes are typically attached to specific ligands to create radioactive ligands and / or radiopharmaceuticals, whose properties cause them to bind to specific types of tissue. This allows the radiopharmaceutical to be delivered to and bound in the desired area within the body, where a SPECT camera assesses the ligand concentration. The radioactive isotopes 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 (Ga-67).

[0026] As used herein, the term “positron emission tomography (PET)” refers to a functional imaging technique that uses radioactive materials known as radiotracers or radiopharmaceuticals to visualize and measure changes in metabolic processes, as well as changes in other physiological activities, including blood flow, local chemical composition, and absorption. Different radiotracers may be used for various imaging purposes depending on the target process in the body. Radioisotopes typically used 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).

[0027] As used herein, the terms “therapy” and “therapeutic use” refer to attempts to cure, improve, alleviate, treat, and / or prevent diseases and / or other disorders in humans. The term “therapy” also refers to pharmacotherapy or pharmacological therapy, which refers to the treatment of a disease by the application of drugs. This term may be used to indicate treating or preventing the progression of a disease, as well as alleviating pain and symptoms of a particular disease. Nuclear medicine therapy may be performed with the help of radioactive isotopes such as alpha emitters actinium-225 (Ac-225) and astatine-211 (At-211), and beta emitters such as lutetium-177 (Lu-177) and lead-212 (Pb-212).

[0028] As used herein, the term “computed tomography (CT)” refers to computerized X-ray imaging in which a beam of X-rays directed at a patient and rotated around the body produces signals that are processed by a 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. As the machine’s computer collects a number of consecutive slices, they are digitally “stacked” together to form a three-dimensional image of the patient, enabling easier identification and localization of basic structures as well as potential tumors or abnormalities.

[0029] As used herein, the term “magnetic resonance imaging (MRI)” is a non-invasive imaging technique that produces three-dimensional detailed anatomical images used for disease detection, diagnosis, and treatment monitoring. MRI is a technique that excites and detects changes in the direction of the axis of rotation of protons found in the water that makes up living tissue.

[0030] As used herein, the term “hybrid molecular imaging” refers to the fusion of two or more imaging techniques into a single, novel form of imaging. This form of imaging is synergistic, and it is more powerful than the sum of its parts. Hybrid imaging refers to image acquisition on a system that physically combines complementary imaging modalities for improved diagnostic accuracy and certainty, as well as increased patient comfort. Hybrid imaging combines the intensities of two imaging modalities into a single imaging session to more accurately diagnose and localize cancer while increasing patient comfort. These are generated by superimposing two images at different spatial scales. The low spatial scale is obtained by filtering one image with a low-pass filter, and the high spatial scale is obtained by filtering the second image with a wide-pass filter. Examples of hybrid imaging modalities include PET-CT, SPECT-CT, and PET-MRI.

[0031] As used herein, the terms “automated injection system” or “semi-automated injection system” refer to a system for the generation and / or injection of radionuclides or radiotraceers, and for their administration to a subject. Automatic and semi-automated injection systems include, but are not limited to, dose calibrators, computers, controllers, display devices, radioactivity detectors, cabinets, carts, waste management systems, sensors, optical display systems, shielding assemblies, alarm or warning mechanisms, tubing, source vials, diluents or eluents, pumps, and valves, and / or combinations thereof. Automatic and semi-automated injection systems may be communicatively or electrically coupled to an imaging system.

[0032] As used herein, the term “diagnosis” refers to the process of identifying a disease, illness, or injury based on its signs and symptoms. Medical history, physical examination, and tests such as blood tests, imaging, scanning, and biopsies may be used to aid in the diagnosis.

[0033] As used herein, the term “assessment” refers to a qualitative and / or quantitative assessment of blood perfusion, solid tumors, or any other disease or abnormality in a body part or region of interest (ROI).

[0034] As used herein, the term “ergonomically designed mobile cart” refers to a wheeled cart whose design is ergonomic and which is easily movable or transportable. The mobile cart has a foot-operated locking and unlocking mechanism for the wheels.

[0035] As used herein, the term “infusion pump” refers to an infusion pump that can be shielded with a radiation shielding shield made of radiation shielding material such as lead, tungsten, or other radiation-protective material. A pump is a single driven pump system that is electrically controlled to draw a provisional volume (e.g., saline solution, hot (e.g., radioisotope dose)) from various supply container types to a desired volume and infuse it into the patient with the required control and precision of flow rate using that same system.

[0036] As used herein, the term “standard syringe” refers to a syringe having a standard volume. The syringe used herein was the patented and proprietary Jubilant shielded syringe, as defined by U.S. Patent No. 11,179,518B2.

[0037] As used herein, the term “separable radioactive dose transport and containment module” refers to a separable module into which a syringe containing a radioactive dose is fitted, the module comprising (a) a one-handed grip for enabling the transfer of the dose from a dose transporter to an external dose calibrator, (b) an adapter for converting a syringe lure type to a push-in connector, and (c) a sterile cap with a function that is an integral part of workflow control. The sterile cap is used to protect the syringe from leakage and also from radiation emitted from the radiopharmaceutical contained within the syringe.

[0038] As used herein, the term “dose calibrator” refers to a device used in nuclear medicine to determine the precise radioactivity of a radioactive dose to be administered to a patient.

[0039] As used herein, the term “Luer lock syringe” refers to a syringe that provides a secure connection by allowing the needle to be twisted upwards at the tip and locked in place, thereby preventing accidental removal of the needle and accidental injection of its contents.

[0040] As used herein, the term “medical fluid” refers to a radiopharmaceutical intended for patient infusion.

[0041] As used herein, the term “infusion parameter” refers to one or more of the following: infusion rate, infusion mode, desired dose, desired radioactivity, and / or any patient infusion-related data.

[0042] As used herein, the term “contamination control system” refers to a removable tray with an integrated channel system for directing any fluid spills toward a collection pad or waste container.

[0043] As used herein, the term “radioactive dose” refers to the dose of a radiopharmaceutical composition required to perform imaging in a subject, and the radiopharmaceutical composition contains active radioisotopes used for imaging and therapy. The dose of radionuclide to be administered to the subject ranges from 0.27 uCi to 1000 mCi.

[0044] As used herein, the term “accessory management system” refers to a cabinet or box intended for storage.

[0045] As used herein, the term "graphical user interface (GUI)" refers to the interface through which a user interacts with a device such as a computer. In this context, the computer screen functions as a GUI.

[0046] As used herein, the term “shield” refers to a shield for doses of different sizes of radioactivity. Here, different doses of radioactivity refer to different volumes of syringes containing hot doses (i.e., radiopharmaceuticals). Syringe volumes can be 10cc, 20cc, 30cc, and 60cc syringes, and vial volumes can be up to 30cc. Dose shields are used to shield syringes of different sizes and diameters, and the shield(18) system is suitable for the insertion or connection of syringes of various sizes. Shields can be selected from a variety of suitable materials, including lead and tungsten. In one configuration, the shield is fixed to 0.25-inch thick tungsten, which is sufficient for shielding any volume or type of therapeutic radiation. The shield defines a lumen suitable for receiving and holding either a syringe or a vial together with a fluid cartridge. A single shield may be used for all applications, but shields of different sizes are included within the scope of the invention, where desired.

[0047] As used herein, the term “configurable dose transporter” refers to a “caddy” that enables the secure transport of hot doses between a hot lab and an injection site. The configurable dose transporter comprises a separable radioactive dose transport and containment module (13), a shield (18) optimized for different doses of radioactivity, a radioactive dose in a standard syringe (8), and a one-handed grip (12) for enabling the transfer of radioactive doses from the dose transporter to an external dose calibrator.

[0048] As used herein, the term “shielded waste system” refers to a shielded waste management system that includes a lid for the waste bin, a space for the waste bin, and / or a pedal-operated waste bin to avoid the use of hands to open the waste bin.

[0049] As used herein, the term “Theranostics Information Science System” refers to programmable software for controlling the operation of a delivery system.

[0050] As used herein, the term “push-in connector” refers to a type of compression fitting or quick-connect fitting that is easily detachable, nominally enabling the installation of equipment without the use of tools.

[0051] As used herein, the term “PET” refers to positron emission tomography (PET), a type of diagnostic imaging. PET utilizes a dose of a radiopharmaceutical, which is injected or infused into a patient, for example, by elution in a radioisotope generator. The injected dose of radiopharmaceutical is absorbed by cells in the patient’s target organ, emitting radiation that is detected by a PET scanner to produce an image of the organ.

[0052] As used herein, the term “Theranostic delivery system” refers to a mobile cart for radiopharmaceutical delivery with a shielded syringe and infusion pump device. The terms “Theranostic delivery system” and “Radiopharmaceutical delivery system” refer to the same drug infusion system having the same function.

[0053] As used herein, the term “system error” refers to errors in an injection system, such as the wrong eluent, the wrong injection rate, the wrong injection mode, the wrong dose, and the undesirable profile, such as the undesirable radioactivity.

[0054] As used herein, the terms “controller” or “control system” refer to a computer or part thereof that is programmed to perform specific calculations, execute instructions, and control various activities of an injection system, either based on user input or automatically.

[0055] As used herein, the term “coded port” refers to the two ports on a fluid cartridge: the patient port and the saline / cold port, one for saline fluid to enter and the other for drug dispensing. Because they are of different configuration types, users will not confuse the two, thus preventing patient errors.

[0056] As used herein, the term “adapter” refers to a connector used to connect a syringe or vial to a disposable sealed cartridge by compression fitting. Adapters may be tagged, meaning that the adapter is tagged with RFID, barcode, QR code, and other such tags.

[0057] In one embodiment of the present invention, the theranostics delivery system (100) is i) Ergonomically designed mobile cart with integrated handle, ii) A theranostics information science system with a computer screen (19) as a graphical user interface (GUI), iii) Shielded injection pump, and iv) Equipped with a configurable dose transporter (6), The configurable dose transporter (6) is: a) Separable radioactive dose transport and containment module (13), b) Shields optimized for different doses of radioactivity (18) c) Radioactive dose in a standard syringe (8), d) A one-handed grip (12) to enable the transfer of radioactive dose from the dose transporter to an external dose calibrator. e) Adapter (9) for converting a Luer lock syringe type to a push-in connector, and f) It is equipped with a sterile cap (11) that has a function that is an integral part of the workflow management.

[0058] In one embodiment of the present invention, the theranostics delivery system (100) is i) Ergonomically designed mobile cart with integrated handle, ii) Shields optimized for different doses of radioactivity (18), iii) A theranostics information science system with a computer screen (19) as a graphical user interface, iv) Shielded injection pump, and v) Equipped with a disposable sealed fluid cartridge (7), The disposable sealed fluid cartridge (7) is a) One or more selectable integrated channel (17), b) One or more sealed leak-free / drop-free connections (10), and c) It includes one or more guide functions and mechanical interlocks (16) for workflow management.

[0059] In one embodiment of the present invention, the theranostics delivery system (100) is i) Ergonomically designed mobile cart with integrated handle, ii) Shields optimized for different doses of radioactivity (18), iii) A theranostics information science system with a computer screen (19) as a graphical user interface, iv) Shielded injection pump, and v) Equipped with workstations (3), Workstation (3) is a) A state lighting system (1) that illuminates the work area to enable distance or long-range monitoring. b) A disposable secondary containment system to protect core workstations from contamination (2) c) Mounted shielding waste system (4), and d) A foot-operated system (5) for enabling lock and unlock modes while the device is being moved.

[0060] One embodiment of the present invention includes a delivery system in which a computer screen (19) is foldable and has a retractable rotating arm (20).

[0061] One embodiment of the present invention includes a delivery system, wherein the syringe (8) may be of different sizes and / or volumes. Furthermore, the delivery system also supports manufacturer vials. In one implementation, the delivery system has the ability to inject into 10cc, 20cc, 30cc, and 60cc syringes, and into vials up to 30cc in volume.

[0062] One embodiment of the present invention includes a delivery system and further comprises a control system for controlling the process of injecting a medical fluid.

[0063] One embodiment of the present invention includes a delivery system, the state light system (1) being controlled by a control system.

[0064] One embodiment of the present invention includes a delivery system and further comprises a theranostics information science management system for controlling infusion parameters for a patient.

[0065] One embodiment of the present invention includes a delivery system and further comprises a contamination control system. The contamination control system includes a removable tray with an integrated channel system for directing any fluid spills toward a collection pad or waste container.

[0066] One embodiment of the present invention includes a delivery system, the delivery system further comprising accessory management.

[0067] One embodiment of the present invention includes a delivery system with accessory management, which, if necessary, includes storage for infusion supplies such as chux, gloves, and other articles.

[0068] One embodiment of the present invention includes a delivery system to provide patient-specific theranostic dosing of different radiopharmaceutical theranostic drugs using an automated injection system.

[0069] One embodiment of the present invention includes a delivery system in which a graphical user interface (GUI) is used to receive infusion parameters such as infusion rate, infusion mode, desired dose, desired radioactivity, and / or any patient infusion-related data. Patient-specific medication is based on patient profile data, including the patient's weight, sex, age, or the patient's physical and medical history data.

[0070] In one embodiment, the present invention includes a delivery system (100) that supports drug-specific infusion parameters, meaning that the infusion parameters may differ for different radiopharmaceuticals. This functionality is supported by using custom software along with the drug-specific infusion parameters.

[0071] In one embodiment of the present invention, the radiopharmaceutical delivery system (100) is (i) Ergonomically designed mobile cart with integrated handle, (ii) Information science systems with a computer screen (19) as a graphical user interface (GUI), (iii) Shielded injection pump, and (iv) comprising a configurable dose transporter (6), The configurable dose transporter (6) is: a) Separable radioactive dose transport and containment module (13), b) Shields optimized for different radionuclide types, quantities, and volumes (18) c) the radioactive dose in the syringe (8) or vial (26), and d) A disposable sealed fluid cartridge (7) is connected to a syringe (8) or vial (26) by a compression fitting.

[0072] In one embodiment of the present invention, the radiopharmaceutical delivery system (100) is (i) Ergonomically designed mobile cart with integrated handle, (ii) Information science systems with a computer screen (19) as a graphical user interface (GUI), (iii) Shielded injection pump, (iv) A state lighting system (1) for illuminating the work area to enable distance or long-range monitoring, and (v) comprising a configurable dose transporter (6), The configurable dose transporter (6) is: a) Separable radioactive dose transport and containment module (13), b) Shields optimized for different radionuclide types, quantities, and amounts (18) c) the radioactive dose in the syringe (8) or vial (26), and d) comprising a disposable sealed fluid cartridge (7) connected to a syringe (8) or vial (26) by a compression fitting, Disposable sealed fluid cartridges allow healthcare professionals to draw custom volumes from vials or syringes.

[0073] One embodiment of the present invention includes a delivery system with a syringe, the syringe (8) may be one of several different standard sizes.

[0074] One embodiment of the present invention includes a delivery system, the shield (18) system being configured to be suitably used with a wide range of syringes (8) of various sizes inserted or connected.

[0075] One embodiment of the present invention includes a delivery system in which a computer screen (19) as a graphical user interface (GUI) is mounted on a retractable rotating arm.

[0076] One embodiment of the present invention includes a delivery system in which a fluid cartridge allows for the extraction of a custom volume based on the patient's weight, sex, age, other physical parameters, or medical history data.

[0077] One embodiment of the present invention includes a delivery system that supports drug-specific injection parameters.

[0078] One embodiment of the present invention includes a delivery system in which a separable radioactive dose delivery and containment module (13) is shielded by a lead glass observation area (29).

[0079] One embodiment of the present invention includes a delivery system in which a fluid cartridge includes a coded port to eliminate errors in a patient line or saline line.

[0080] One embodiment of the present invention includes a delivery system that monitors and tracks one or more of the following: the total volume in the syringe, the total volume administered in real time, the total volume from the IV bag, and the total volume injected into the patient.

[0081] One embodiment of the present invention includes a delivery system and further comprises a control system for controlling the process of injecting a medical fluid.

[0082] One embodiment of the present invention includes a delivery system, the controller of which is configured to stop the injection process when it detects a system error.

[0083] One embodiment of the present invention includes a delivery system in which a state light system (1) indicates different states of the device (e.g., administration, administration complete) in various colors.

[0084] One embodiment of the present invention includes a delivery system, the state light system (1) being controlled by a control system.

[0085] One embodiment of the present invention includes a delivery system having an audible alarm function to warn the user of one or more of the following: fluid blockage, pump failure, or any deviation from a programmed volume, and / or a predictive sequence of events in real time.

[0086] One embodiment of the present invention includes a delivery system in which a pump protects the patient from air infusion that could cause air embolism and includes a warning signal for real-time air detection.

[0087] In one embodiment of the present invention, the radiopharmaceutical delivery system is The system comprises a configurable dose transporter (6), a separable radioactive dose transport and containment module (13), a shield (18), a disposable sealed fluid cartridge (7), and a syringe (8) or vial (26), wherein the disposable sealed fluid cartridge (7) is (i) One or more selectable integrated channels (17), (ii) an adapter (9) for fitting a syringe (8) or vial, (iii) Coded patient port and saline port, and (iv) comprising one or more pressure sensors (27, 28), Disposable sealed fluid cartridges allow for the extraction of custom volumes from vials (26) or syringes (8).

[0088] One embodiment of the present invention includes a delivery system (100) in which an adapter (9) of a disposable sealed fluid cartridge (7) is connected to a syringe (8) or vial (26) by a compression fitting to reduce leakage connections.

[0089] One embodiment of the present invention includes a delivery system (100) in which the fluid cartridge drawout custom volume is based on one or more of the patient's weight, sex, age, medical history data, and / or other physical parameters.

[0090] One embodiment of the present invention includes a delivery system, the controller being configured to stop the injection process due to a system error.

[0091] One embodiment of the present invention includes a delivery system programmed with software that can be remotely updated to add new functions and drug compatibility. The software also has security features to ensure the correct patient and / or correct dosage.

[0092] One embodiment of the present invention includes a delivery system that includes software security programmed to prevent unauthorized access and may also have software firewall capabilities to prevent hackers and unauthorized remote access to patient data.

[0093] One embodiment of the present invention includes a delivery system with an infusion pump, which is shown here for intravenous and intra-arterial delivery of theranostic radiopharmaceuticals at a controlled infusion rate or as a bolus infusion combined with a commercially available conventional 0.9% saline supply. The infusion pump is compatible only with various single-dose or multi-dose syringes or vials.

[0094] One embodiment of the present invention includes a delivery system having an audible alarm function to warn the user of fluid blockage, pump failure, or any deviation from a programmed volume, and / or a predictive sequence of events in real time.

[0095] One embodiment of the present invention includes a delivery system in which a pump protects the patient from air infusion causing air embolism and includes a warning signal for air detection that is activated in real time. The pump shall have protection so as not to allow liquid drug delivery to continue by a single action after air detection by the accompanying warning signal. This is advantageous as it prevents the operator from easily disregarding safety warnings and potentially endangering the patient.

[0096] One embodiment of the present invention includes a delivery system that includes a pressure sensor for monitoring fluid blockage in real time.

[0097] Figures 1A, 1B, 1C, and 1D illustrate the configuration of a theranostics delivery system or radiopharmaceutical delivery system (100). The system (100) includes a mobile or movable ergonomic workstation (3) having handles on the side or rear for moving a cart by wheels (21). The workstation (3) of the theranostics delivery system (100) also includes an on-board shielded waste system (4) for waste collection (see Figure 1B). The shielded waste system (4) is operated by a foot-operated system (5) that allows the wheels to be locked and unlocked during transport of the device (100). The theranostics delivery system or radiopharmaceutical delivery system (100) also includes a foldable computer screen (19) mounted on a retractable rotating arm (20), and a status light system (1) for illuminating the work area, thereby allowing an operator to monitor the status of the system from a distance within the work area. The primary purpose of remote monitoring is to keep providers away from radioactive patients to ensure low exposure. For example, if a healthcare provider is using a delivery system (100) to deliver a radiopharmaceutical dose to a patient, and the provider needs to walk out of the room and down a corridor, the provider can 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. Conversely, if the provider sees the status light system (1) changing from green to orange or red, the provider knows that they should quickly return to investigate the change in status. The theranostics delivery system (100) in Figure 1B also includes a disposable secondary containment system (2) to protect the core workstation from contamination. The theranostics system (100) in Figure 1C includes a configurable dose transporter (6) with a disposable sealed fluid cartridge (7). The theranostics delivery system or radiopharmaceutical delivery system (100) also includes storage trays (22) and storage spaces (23) for storing medical devices and other necessary items for radiopharmaceutical management.

[0098] Figure 2 shows a schematic cross-sectional view of the shielding syringe system (101). The radioactive dose standard syringe (8) is shielded by a shielding material, i.e., lead, steel, tungsten, or a combination of shielding materials. The shielding material consists of a cylinder (14) positioned around the syringe (8). The theranostics delivery system (100) also includes an adapter (9) to convert the syringe lure type to a push-in connector with a sterile cap (11) having a leak-free / droplet-free connection (10).

[0099] Figure 3 shows a schematic diagram (102) of a configurable dose transporter (6) (as shown in Figure 1A) having a single handle (15) to allow two-handed movement from a delivery bag to a ready radioactive dose to be placed on an injection workstation (3) (as shown in Figures 1A and 1B), and a single-handed grip (12) to allow transfer of the dose from a dose transporter (6) (as shown in Figures 1A and 1B) to an external dose calibrator for measuring the radioactivity of the radiopharmaceutical before injection. The dose transporter (6) (as shown in Figures 1A and 1B) includes an onboard shield (14) with protection throughout the entire workflow in delivery, preparation, and transport. The configurable dose transporter (6) (as shown in Figures 1A and 1B) further includes guide functions and mechanical interlocks (16) for workflow management, as well as a detachable radioactive dose module (13). The detachable radioactive dose module consists of a syringe with a hot dose to be injected into the patient.

[0100] Figure 4 shows a diagram (103) of a disposable sealed fluid cartridge (7) (as shown in Figure 1A) of a theranostics delivery system or radiopharmaceutical delivery system (100) including one or more selectable integrated flow channels (17). The flow channels refer to a flow channel used to connect a hot dose source, a saline source to an infusion pump, and a flow channel that is then connected back to the patient line for the infusion of a precise dose to the patient.

[0101] Figure 5 shows a diagram (104) of a shield (18) for a theranostics delivery system or radiopharmaceutical delivery system (100) optimized for different dose radioactivity. Here, different dose radioactivity refers to different volumes of syringes consisting of hot doses (i.e., radiopharmaceuticals). Syringe volumes can be 10cc, 20cc, 30cc, and 60cc syringes, and vial volumes are up to 30cc. The dose shield is used to shield syringes of different sizes and diameters, and the shield (18) system can be used with syringes of different sizes inserted or connected.

[0102] Figure 6 shows a diagram of a disposable sealed fluid cartridge (7) with a patient port (24) and a saline / cold port (25) having a cavity that allows a custom volume to be drawn from a vial or syringe. The cartridge includes a pump system that draws (i.e., "transfers") the required volume from various supply container types (saline, hot dose) to a provisional volume and uses that same system to inject the radiopharmaceutical into the patient with the necessary controls such as flow rate and precision.

[0103] Figure 7 illustrates a disposable sealed fluid cartridge (7) connected to a vial (26) by a compression fitting with the help of an adapter (9) which can be optionally tagged. Figure 8 illustrates the connection of a disposable sealed fluid cartridge (7) with an adapter (9) connected to a vial (26) by a compression fitting, with a corded port to eliminate errors in the patient / saline line. The disposable fluid cartridge (7) consists of one or more auto-ON / OFF check valves connected to a hot dose source channel and a saline source channel to draw drug and saline from source containers. Furthermore, the hot dose channel and saline channel are connected to an infusion pump to infuse the required dose into the patient from the patient line.

[0104] Figure 9 illustrates a disposable sealed fluid cartridge (7) connected to a syringe (8) by a compression fitting with the help of an adapter (9) to reduce leak connections. Figure 10 illustrates the connection of a disposable sealed fluid cartridge (7) with an adapter (9) connected to a syringe (8) by a compression fitting, with a corded port to eliminate errors in the patient / saline line.

[0105] Additionally, the disposable sealed fluid cartridge (7) comprises two pressure sensors: a patient line pressure sensor (27) for measuring pressure within the patient line, and a hot dose pressure sensor (28) for detecting the pressure of a dose from a syringe (8) or vial (26) (as shown in Figures 8 and 10).

[0106] Figure 11 illustrates a configurable dose transporter (6), which is a caddy connected in line with a custom disposable sealed fluid cartridge (7) shielded by a lead glass observation window (29).

[0107] Figure 12 is a flowchart illustrating the operation of the delivery system 100. In the first step 110, the radioactive isotope dose 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 into the dose transporter (6) by grasping the upper grip (12) and withdrawing the containment module (13) from the dose transporter. The syringe or vial is inserted into the opening in the containment module, and the containment module is then returned into the dose transporter. Due to the shield (14) components of the transporter, healthcare providers are protected from the radioactivity of the radioactive isotope in the syringe or vial. Typically, this dose is prepared elsewhere and transported to a radiopharmaceutical or hospital in a transport enclosure such as a bag, box, or other container. The shielding component (14) protects from exposure to radioactivity any objects that will come into contact with the dose transporter while the radioactive isotopes are being transported to a radioactive pharmacy or hospital.

[0108] In the second step 120, the radioisotope dose is received in a transport container at a radiopharmaceutical or hospital laboratory and prepared for injection into the patient. The radioisotope dose is in the dose transporter (6) when the transport container is received at the radiopharmaceutical or hospital. The healthcare provider removes the dose transporter from the transport container and places it on a surface such as a counter in the laboratory, and removes the containment module (13) from the dose transporter. Since this may expose the healthcare provider to radiation, the provider places the containment module (13) in a shielding container such as a shielding tube for temporary storage while the cartridge is being prepared. The shielding tube may be round, square, or any simple configuration suitable for holding and containing the module (13). With the containment module removed from the transporter (6), the provider then removes the sterile cap located on the underside of the dose transporter.

[0109] With the sterile cap removed from the dose transporter, the volumetric section with the transporter is exposed. This volumetric section is defined on its bottom by a first plate and on its top 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 engage with the bottom, top, and / or sides of the fluid cartridge so that the cartridge can only be received into the volumetric section in a single orientation. This safety feature prevents incorrect insertion of the fluid cartridge. In one implementation configuration, the plates have guides and / or grooves as well as an interlock. When the fluid cartridge is positioned relative to the guides or grooves, the interlock may be used to hold the cartridge in place. The interlock may be configured to have a first portion on the guide, groove, or plate and a second portion on the fluid cartridge. In this configuration, a popping sound and / or tactile sensation may be felt by the provider when the cartridge is properly oriented and in place.

[0110] The provider inserts the cartridge into the volumetric section and advances it until proper placement is achieved, for example, by feeling a popping sound and / or tactile sensation. The provider then grasps the upper grip (12) on the containment module (13), removes the module from the shielding container, and inserts the opposite or lower end of the module into the opening on the upper surface of the top plate of the dose transporter. Generally, this top plate is different from the upper plate that defines the volumetric section for receiving the fluid cartridge. The opposite or lower end of the module is advanced through the opening in the upper plate until the lower end contacts the adapter (9) in one side of the fluid cartridge. The module is then advanced further until a fluid-sealed connection is achieved between the vial or syringe in the containment module and the adapter in the fluid cartridge. The provider then attaches the containment module (13) to the cart.

[0111] According to step 130, the provider moves the cart from the laboratory where the cartridge was primed to the patient's room or other suitable location where the radioisotope dose is intended to be administered. The location, of course, depends on the purpose of the radioisotope administration. For the treatment of a disease, the patient may be in a patient's room. For diagnostic procedures such as a PET scan, the patient may be in a room with a PET scanner and associated equipment. In either situation, the provider moves the cart forward to the patient and connects the disposable fluid line from the patient port on the fluid cartridge to the IV line in the patient. The provider then operates the keyboard or on-screen prompts to administer the desired volume of radioisotope at the desired flow rate.

[0112] At this stage of the process, the pump components in the fluid cartridge are ready to be primed with saline and radioisotopes (step 140). To prime the pump components, the provider first connects a disposable fluid line between a saline syringe mounted on a cart and the saline port of the fluid cartridge. The provider then uses keyboard or on-screen controls to operate the software to prime the pump. This operation is generally automated and depends at least on the dose that will be received by the patient. Furthermore, in step 150, which involves filling the fluid cartridge with radioisotopes, the pump draws fluid from the saline syringe and radioisotope vial (or syringe) into the cartridge's transfer chamber. At this stage of the process, the pump is primed, filled, and ready for the dose to be administered to the patient.

[0113] According to step 160, when a radioactive isotope is being administered, the area of ​​the cart surrounding the screen is illuminated in a set color to indicate that action is taking place. For example, during the administration of the radioactive isotope, the illumination may be red; when the administration is nearing completion, e.g., 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 the observer the potential hazard from the radioactive isotope. The use of color in this manner allows the provider operating the PET scanner to view the system status from a distance, for example, from the PET scanner's control booth. If the patient is in a hospital room, the provider is warned of the radiation hazard while the dose is being administered and knows that they should not be in the room.

[0114] According to Step 170, after dose injection, a portion of the radioisotope dose is likely to remain in the hot dose container. To use this residual radioisotope dose, the provider initiates a backflush operation to utilize the residual dose. For this step, the pump draws saline from the saline container into the cartridge's transfer chamber and pushes that saline into the radioisotope dose container. Then, once again, the pump loads the radioisotope dose from the radioisotope dose container into the transfer chamber to administer the residual dose to the patient. This process is repeated until the entire dose in the radioisotope dose container is used. The main advantage of this step is that by using the backflush step, the waste of radioisotope dose is minimized.

[0115] According to step 180, when the radioisotope dose is complete, the provider removes the fluid tube extending from the patient's IV line to the patient port of the fluid cartridge. The provider may then discard the tube in the removable container in the cart. The provider may similarly detach the fluid tube from the saline syringe in the removable container and set it aside. The fluid cartridge may similarly be pulled away from the dose transporter and placed in the removable container. The provider may then return the cart to the laboratory for storage and cleaning.

[0116] In one embodiment of the present invention, a theranostics delivery system or radiopharmaceutical delivery system comprises a theranostics information science management system consisting of a computer screen with a graphical user interface (GUI) for receiving various patient infusion parameters, including one or more of the following: infusion rate, infusion mode, desired dose, desired radioactivity, and / or any patient infusion-related data. The theranostics information science system may also include a control system for controlling the infusion process by lighting conditions used to indicate different states of the device using different colors representing the state of the device.

[0117] In one embodiment of the present invention, the theranostics delivery system or radiopharmaceutical delivery system (100) includes a contamination control system including a tray with an integrated channel system to direct any fluid leaks toward a collection pad or waste container. The theranostics delivery system also includes an accessory control system for storing all infusion supplies, including chucks, gloves, and other equipment.

[0118] Another embodiment of the present invention shown in Figure 6 discloses a front view of a theranostics delivery system or radiopharmaceutical delivery system (100) with a configurable dose transporter (6), which is a caddy, connected in line with a custom disposable sealed fluid cartridge (7) shielded by a lead glass observation window (29). The "caddy" enables the secure transport of hot doses between the hot lab and the injection site.

[0119] The theranostics delivery system or radiopharmaceutical delivery system (100) comprises a dose-configurable transporter, which is a “caddy” used to transport hot doses in separable radiopharmaceutical transport and containment modules (13) of different sizes from a pharmacy to an infusion site. The hot doses in the syringes are shielded within a configurable dose shield to protect them from radiation emitted from the radiopharmaceutical in the syringes. Furthermore, the configurable dose transporter (6) is fitted with a disposable sealed fluid cartridge to initiate drug infusion to the patient.

[0120] The infusion of radiopharmaceuticals into patients involves four main modes: priming, filling, infusion, and backflushing. The priming mode is essentially the process of checking for air bubbles or any blockages in all infusion lines connected to the pump, dose container, and saline container. In the filling mode, a disposable fluid cartridge draws (i.e., "transfers") the required volume from various supply container types (saline, hot dose) to a provisional volume, and in the infusion mode, the same system is used to infuse the patient with the necessary controls such as flow rate and precision. In the backflushing mode, the system is backflushed to the patient through the infusion lines with a specific amount of saline to push out any residual dose.

[0121] One embodiment of the present invention provides patients with enhanced safety in radiopharmaceutical delivery by ensuring cybersecurity compliance before dispensing radiopharmaceuticals to patients. The process ensures cybersecurity within the radiopharmaceutical delivery system based on a controller configured to scan the system, network, or connected devices to detect any unauthorized connections and / or malware before the injection of the radiopharmaceutical. This configuration and procedure ensure that the system is protected from unauthorized connections and / or malware and alerts the operator in the event of any actual or potential unauthorized connections and / or malware.

[0122] In one embodiment of the present invention, the controller is configured to force the system into safe mode if an unauthorized connection or malware is detected. In such a situation, the controller is configured to stop the system operation in the event of any threat, such as the detection of an unauthorized connection or malware, and to maintain that any system operation is suspended until the malware is disabled.

[0123] Each embodiment disclosed herein is intended to be applicable to each of the other disclosed embodiments. Therefore, all combinations of the various elements described herein fall within the scope of the present invention.

Claims

1. A radiopharmaceutical delivery system (100), (i) A movable cart with an integrated handle, (ii) Information science system with a computer screen (19) configured as a graphical user interface (GUI), (iii) injection pump, and (iv) comprising a configurable dose transporter (6), the configurable dose transporter (6) a) Separable radioactive dose transport and containment module (13), b) Shielding for use with one or more different radionuclide types, quantities, and volumes (18) c) the radioactive dose in the syringe (8) or vial (26), and d) A delivery system comprising a disposable sealed fluid cartridge (7) connected to the syringe (8) or vial (26) by 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 shield (18) system is configured to be used with syringes of various sizes inserted or connected.

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

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

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

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

8. The delivery system according to claim 1, wherein the disposable sealed fluid cartridge (7) is provided with a corded port for eliminating errors in connecting a patient line or saline line to the cartridge.

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

10. The delivery system according to claim 1, further comprising a control system for controlling the process of injecting medical fluids into a patient.

11. The delivery system according to claim 10, wherein the control system is configured to stop the injection process due to a system error.

12. The delivery system according to claim 1, wherein the system has an audible alarm function to warn the user of the occurrence of one or more of the following: fluid blockage, pump failure, deviation from a programmed volume, and a real-time predictive sequence of events.

13. The delivery system according to claim 1, wherein the shielding 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), (i) A movable cart with at least one handle, (ii) Information science systems with a computer screen (19) as a graphical user interface (GUI), (iii) Injection pump, (iv) A status light system (1) for illuminating the work area to monitor the injection status, and (v) comprising a configurable dose transporter (6), The configurable dose transporter (6) is a) Separable radioactive dose transport and containment module (13), b) A shield (18) configured to be used with one or more different radionuclide types, quantities, and amounts. c) the radioactive dose in the syringe (8) or vial (26), and d) A disposable sealed fluid cartridge (7) is connected to the syringe (8) or vial (26) by a compression fitting, The disposable sealed fluid cartridge is configured to draw a customizable volume from the syringe or vial as part of a delivery system.

15. The delivery system according to claim 14, wherein the state light system (1) indicates different states of the system with various colors.

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

17. A radiopharmaceutical delivery system (100), The system comprises a configurable dose transporter (6), a separable radioactive dose transport and containment module (13), a shield (18), a disposable sealed fluid cartridge (7), and a syringe (8) or vial (26), The disposable sealed fluid cartridge (7) is (i) One or more selectable integrated channels (17), (ii) an adapter (9) for fitting the syringe (8) or the vial (26), (iii) Coded patient port (24) and saline port (25), and (iv) comprising one or more pressure sensors (27, 28), The disposable sealed fluid cartridge is configured to draw a customizable volume from the syringe or vial as part of a delivery system.

18. The delivery system according to claim 17, wherein the adapter (9) is tagged with one or more of RFID, barcodes, or QR codes.

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, medical history data, and / or other physical parameters.

20. The delivery system according to claim 17, wherein the disposable sealed fluid cartridge (7) is equipped with a corded port to eliminate errors in selecting the patient port and the saline port.

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