RU2575309C2 - System and method for planning and monitoring of multidose radiopharmaceutical use in radiopharmaceutical injectors - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment, namely to radiopharmaceutical administration facilities. A method for planning and monitoring of the radiopharmaceutical use consists in obtaining a patient's graph for various radiopharmaceutical injection procedures, establishing thereby a configuration of a multidose container applicable for various radiopharmaceutical injection procedures, transmitting the patient's graph onto a radiopharmaceutical liquid delivery system, specifying the multidose container configuration on the radiopharmaceutical liquid delivery system, performing various radiopharmaceutical injection procedures according to the patient's graph, monitoring the multidose container configuration during various radiopharmaceutical injection procedures, determining if there is a risk that at least one of various radiopharmaceutical injection procedures cannot be terminated properly with reference to one or more patient's graph alternations, and generating an emergency signal in response to the risk determined. Implementing the method involves a machine-readable carrier comprises processor instructions. The delivery system comprises a radiopharmaceutical source, a disposable kit for injections configured so as to provide a liquid flow from the radiopharmaceutical source to the patient, a pumping mechanism in a liquid connection with the disposable kit for injections and radiopharmaceutical source, a control unit functionally connected with the pumping mechanism and configured to obtain the patient's graph, specify the multidose container configuration applicable during various radiopharmaceutical injection procedures, control the pumping mechanism for performing various radiopharmaceutical injection procedures in accordance with the patient's graph, monitoring the multidose container configuration during various radiopharmaceutical injection procedures, determine if there is a risk that at least one of various radiopharmaceutical injection procedures cannot be terminated properly with reference to one or more patient's graph alternations, and generate an emergency signal in response to the risk determined. A method for optimising a graph of various radiopharmaceutical injection procedures involves obtaining the graph of various radiopharmaceutical injection procedures to obtain the planned patient's graph, transmitting it onto a radiopharmaceutical liquid delivery system, adjusting the planned patient's graph to obtain the updated planned patient's graph, providing one or more alternations in at least one of a radioactive dose or infusion time for at least one of the next patient in the updated planned patient's graph, and generating an emergency signal.

EFFECT: using the invention enables simplifying the multidose container configuration.

15 cl, 26 dwg

Description

This application claims priority to Provisional Application US Serial No. 61/351463, filed June 4, 2010, entitled "System and Method for Planning and Monitoring the Use of a Multi-dose Radiopharmaceutical in Radiopharmaceutical Injectors", and this provisional application is incorporated herein by reference fullness.

BACKGROUND OF THE INVENTION

Field of Invention

This disclosure relates to the administration of pharmaceutical substances, typically inherently harmful or toxic pharmaceutical substances, such as radioactive pharmaceutical substances, commonly known as radiopharmaceuticals, to human and animal subjects and, more specifically, to a method and system for planning and monitoring the use of a multi-dose radiopharmaceutical on radiopharmaceutical injectors.

Description of the prior art

The administration of radioactive pharmaceutical substances or drugs, usually referred to as radiopharmaceuticals, is often used in the medical field to provide information or obtain images of the internal structures and / or functions of the body, including, but not limited to, the bone, vascular system, organs and organ systems and other fabric. Additionally, such radiopharmaceuticals can be used as therapeutic agents to kill or inhibit the growth of target cells or target tissues, such as cancer cells.

Two types of imaging procedures using radiopharmaceuticals are positron emission tomography (PET) or single photon emission computed tomography (SPECT) procedures. PET and SPECT are non-invasive, three-dimensional imaging procedures that provide information related to physiological and biochemical processes in patients. PET and SPECT images, for example, of a brain or other organ, are obtained by injecting a dose of a radiopharmaceutical to the patient and then imaging based on radiation emitted by the radiopharmaceutical. A radiopharmaceutical typically includes a radioactive substance, such as a radioisotope, that can be absorbed by certain cells in the brain or other organs that concentrate it there.

Radioisotopes, especially those with short half-lives, can be relatively safely administered to patients in the form of a labeled substrate, ligand, drug, antibody, neurotransmitter, or other compound or molecule that is normally processed or used by the body, such as glucose. The radioisotope acts as an indicator of specific physiological or biological processes. For example, fluorodeoxyglucose (FDG) is a normal glucose molecule, the main energy fuel of cells, to which a radioisotope or radioactive fluorine (i.e. ¹⁸ F) is attached. ^{An 18} F radioisotope is obtained on a cyclotron equipped with an apparatus for synthesizing an FDG molecule.

Cells (for example, in the brain) that are more active during a given period of time after injection of FDG will absorb more FDG, as they have a higher metabolism and need more energy. ^{The 18} F radioisotope in the FDG molecule undergoes radioactive decay, emitting a positron. When a positron collides with an electron, annihilation occurs, releasing an energy impulse in the form of two beams of gamma rays in opposite directions. A PET scanner detects emitted gamma rays to compose a three-dimensional image.

To provide cell uptake of the radiopharmaceutical, the patient is typically at rest for a period of time (45-90 minutes for FDG), after which the radiopharmaceutical is administered. After enough time for cell uptake to occur, the patient is typically placed on a movable bed that slides into a PET (or SPECT) or other suitable scanner. A PET scanner includes several rings of radiation detectors. Each detector emits a short-term pulse of light each time it hits with a gamma ray coming from a radioisotope in the patient's body. The light pulse is amplified using, for example, a photomultiplier, and information is sent to a computer to form images of the patient.

To minimize the dose to patients, radiopharmaceuticals containing radioisotopes such as fluorine-18, technetium-99, carbon-11, copper-64, gallium-67, iodine-123, nitrogen-13, oxygen-15, rubidium-82, thallium-201, chromium-51, iodine-131, iodine-151, iridium-192, phosphorus-32, samarium-153 and yttrium-90, having relatively short half-lives, are typically used for PET and SPECT imaging procedures and other radiotherapy . ¹⁸ F, for example, has a half-life of 109.7 minutes.

Due to its short half-life, the radioisotope radioactivity level will rapidly decline after it is produced in a cyclotron or reactor. Therefore, the elapsed time (and a corresponding decrease in the level of radioisotope radioactivity) after synthesis of the radiopharmaceutical should be included in the calculation of the volume of the radiopharmaceutical that must be injected into the patient to deliver the required dose of radiation. If the time delay after synthesis is long relative to the half-life of the radioisotope or if the calculated volume of the radiopharmaceutical to be injected into the patient is insufficient to deliver the necessary dose of radiation, then the delivered dose of radiation may be too low to provide diagnostic quality images, leading to unproductive time and effort and exposing the patient and medical staff to unnecessary exposure.

In addition, the radiopharmaceuticals used in imaging and therapeutic procedures are harmful to attendants. These products are toxic and can have physical and / or chemical effects on nursing staff, such as medical consultants, imaging technicians, nurses, and pharmacists. Excessive radiation exposure is harmful to medical personnel due to professional repeated exposure to radiopharmaceuticals. However, due to the short half-life of typical radiopharmaceuticals and the small dosages used, the risk-benefit ratio of radiation exposure for individual patients is acceptable. The constant and repeated exposure of medical personnel to radiopharmaceuticals over an extended period of time is a significant problem in the field of medical radiology.

With previous background in the art, an illustrative current practice for the creation, production, and administration of radiopharmaceuticals will now be described. Typical radiopharmaceutical treatment practices in the United States include the presence of a radiopharmaceutical that was originally produced at a location remote from the treatment site, typically a hospital, through an external medical radiology facility and then delivered to the treatment site for further preparation, such as individual dosing and administration. The treatment site, such as a hospital, orders specific radioactive substances so that they are ready at a specific time for specific patients. These substances are prepared with the help of an external medical radiology institution and with sufficient radioactivity so that they have the necessary level of radioactivity at the appointed time. For example, an external provider in medical radiology may have a device equipped with a cyclotron or a radioisotope generator in, for example, a lead-protected enclosure where a radiopharmaceutical, namely a radioactive isotope, is generated or created. Further steps in the cleaning or preparation of the dose, namely the placement of the radioisotope in the injection form, may occur at a location remote from the treatment site. Thus, an external provider can provide a radiopharmaceutical substance to a treatment site having the desired level of radioactivity at a given time. Further preparation of the “individual” dose of the radiopharmaceutical may occur at the treatment site. Alternatively, the external provider may provide a “ready-made” radiopharmaceutical that is ready for injection to a specific patient at a specific time so that the treatment site staff only needs to confirm that the exact radioactive dosage is present in the radiopharmaceutical, for example in a stand-alone radiation dosimetry device, as described previously. During the process described above, there is frequent contact in the immediate vicinity of radioactive materials from personnel and, as described previously, radio-shielding devices for handling and transportation are necessary to protect this personnel.

Transport containers are usually used to transport radiopharmaceuticals, which are individual doses prepared for individual patients, to a medical institution. At a hospital, data on each unit dose is entered into the institution’s computer either manually or by reading a barcode, floppy disk, or other similar data format that can accompany or is located on a transport or radiopharmaceutical container. When it is time to deliver a specific unit dose to a specific patient, the hospital staff must, for example, remove the syringe containing the radiopharmaceutical from the transport container and confirm that the dose in the syringe is within the range assigned to that patient. Alternatively, maintenance personnel should transfer the radiopharmaceutical to the radioprotective syringe, as stated above, and confirm the dosage. If the dose is too high, a certain amount is taken into a radioprotective waste container. If the dose is too low, then either another syringe is used, and / or an additional agent is injected into the syringe, if one is available. While it is possible for treatment site attendants to be involved in the preparation of a dosage, it is a typical United States practice to have a radiopharmaceutical delivered to a treatment site that will have the desired level of radioactivity at a given time. The manual manipulation of the radiopharmaceutical at the treatment site is limited at the treatment site due to this procedure. Nevertheless, various manual controls are necessary to confirm that the correct radiopharmaceutical dose is ready for injection to a particular patient. These human controls include visual examinations and measurements of radioactivity, as indicated above.

As an example of the foregoing, in PET imaging, an injectable radiopharmaceutical, such as, for example, FDG (fluorodeoxyglucose), is produced in a cyclotron device at an external medical radiology facility. After that, the FDG is treated so that it is in a radiopharmaceutical form and transferred to a container for an individual dose (i.e., container, vial, syringe, etc.) and the container is loaded into a transport container to prevent undesirable radiation exposure to personnel, such as a radiopharmacologist, technician, and driver responsible for creating, manipulating, and transporting the FDG from the cyclotron to the PET imaging site. Since the half-life of FDG is short, approximately 110 minutes, it is necessary to quickly transport FDG to the PET imaging site. Depending on the time transport delay and the initial level of FDG radioactivity during production, it may be necessary to re-measure the level of FDG radioactivity at the location of the PET image. As an example, if the level of radioactivity is too high, a transport radiopharmacologist or radiopharmacologist at the PET imaging site may be required to dilute FDG with a diluent such as, for example, saline, and remove part of the volume or extract liquid to reduce radioactivity before injection to the patient. During this whole process, the manipulation of FDG from creation to injection to the patient can be completely non-automated. In this process, radio-shielding products, as previously described (i.e., transport containers, syringe screens, L-blocks, etc.), are used to shield patients from FDG. While shielding can reduce the radiological effects on the radiopharmacologist, the radiopharmacologist can still be exposed to radiation from the radiopharmaceutical during manual mixing, reducing the volume and / or dilution process necessary to obtain the required dose. After the injection, and often after an additional delay, in order to allow the radiopharmaceutical to reach and be absorbed by the necessary areas of interest in the body, the patient is typically placed on a movable bed, which is remotely inserted into the circular opening of the tomograph called gantry. Around the circular hole and inside the gantry are several rings of radiation detectors. In one type of radiation detector, each detector emits a short pulse of light each time, when it encounters a gamma ray coming from a radionuclide inside the patient's body. The light pulse is amplified by a photomultiplier, turning into an electronic signal, and information is sent to a computer, which controls the device and records image data.

Clinical institutions that inject radiopharmaceuticals typically do this using single-use doses provided for each patient. Institutions order standardized doses that have been analyzed by the planned injection time for each planned patient. These doses are often ordered with a sufficient supply of activity to accommodate the breakdown of the radiopharmaceutical due to the small difference between the planned and actual injection times. Institutions typically order excess unit doses to cater for additional patients or to mitigate sudden changes in schedule within their intended patient enrollment.

However, it is becoming more common to have radiopharmaceuticals delivered in a multi-dose format to the treatment site. A multi-dose container provides all scheduled doses for a patient in one container. The dose for the patient is removed from the multi-dose container during injection. Optimally, a multi-dose container will serve all patients, including planned patients who have not received a dose at their scheduled time, and possibly unplanned patients.

When determining the configuration of a container for a patient’s schedule, medical consultants should coordinate cost minimization with the ability to handle deviations in the schedule. In this regard, the configuration of the container will typically be taken into account only for a typical change in the schedule for a given place of work of a medical consultant. There will be times when emergency schedule changes will make the ordered multi-dose container inadequate to serve the patient’s planned schedule. Consulting physicians should take remedial actions, such as ordering more doses when they have a lack of activity. Due to the long lead time for ordering doses, it is imperative that medical consultants be notified of the alleged shortage in their multi-dose container as early as possible. Accordingly, there is a need for a system and method for quickly and easily determining the configuration of a multi-dose container that meets the planned schedule of the patient with sufficient margin to allow for an allowable change in schedule while minimizing the cost of the multi-dose container.

Moreover, when determining the configuration of the container for the schedule of their patients, coordinate cost minimization with the ability to handle deviations in the schedule. In this regard, the container configuration will typically be taken into account only for a typical schedule change for a given place of work of medical consultants. There will be times when emergency schedule changes will make the ordered multi-dose container inadequate to serve the patient’s planned schedule. Consulting physicians should take remedial actions, such as ordering more doses when they are about to have a lack of activity. Due to the long lead time for ordering doses, it is imperative that medical consultants be made aware of the alleged shortage in their multi-dose container as early as possible. Accordingly, there is an additional need for a system and method for monitoring the use of a multi-dose container and anticipating a possible shortage at the earliest possible moment.

SUMMARY OF THE INVENTION

Therefore, the aim of the present disclosure is to provide a method and system that overcome some or all of the disadvantages and shortcomings that are obvious in the prior art. More specifically, the systems and methods described herein allow a clinician to quickly and easily determine a multi-dose container configuration that matches a patient’s planned schedule with sufficient margin to allow for acceptable schedule changes while minimizing the cost of a multi-dose container. In addition, the systems and methods of the present disclosure allow monitoring the use of a multi-dose container and anticipate a possible shortage at the earliest possible moment.

Accordingly, a method for planning and monitoring the use of a radiopharmaceutical is provided during a plurality of radiopharmaceutical injection procedures. The method includes the following: providing a schedule of a plurality of radiopharmaceutical injection procedures to obtain a planned patient schedule; based on the patient’s planned schedule, calculating a multi-dose container configuration for use in a plurality of radiopharmaceutical injection procedures; transfer of the planned patient schedule to the radiopharmaceutical fluid delivery system; providing a multi-dose container configuration for a radiopharmaceutical fluid delivery system; and performing a plurality of radiopharmaceutical injection procedures based on a planned patient schedule.

The schedule may include the time of the injection procedure for each patient and the activity removed from the multi-dose container of the radiopharmaceutical for each patient. The step of providing a schedule may include at least one of the following: manually entering time and activity for each patient into a computer; retrieving time and activity for each patient from a storage device connected to a computer; and retrieving time and activity for each patient from a patient device located remotely through a network. A planned patient schedule can be provided so that it is editable after it was initially provided to coordinate additional patients, cancellations, temporary modifications to patients that are already provided on the patient’s planned schedule, modifications regarding activity removed from a multi-dose radiopharmaceutical container funds to patients already provided on the patient’s planned schedule, or any combination of these.

The method may further include the steps of: monitoring a multi-dose container configuration during a plurality of radiopharmaceutical injection procedures; determining whether there is a risk that at least one of the plurality of radiopharmaceutical injection procedures may not be completed correctly; and alerting the operator if there is a risk that at least one of the plurality of injection procedures of the radiopharmaceutical may not be completed. The step of monitoring the configuration of the multi-dose container may include: determining the residual activity of the radiopharmaceutical and the configuration volume of the multi-dose container to provide an estimate of the residual activity; and adjusting the estimation of residual activity based on isotope decay. The step of determining the residual activity of the multi-dose container radiopharmaceutical configuration tool can be carried out using one of the following: an ionization chamber, a CZT crystal detector, a Geiger-Muller counter, and a scintillation counter.

The method may further include the step of displaying the planned patient schedule on the graphical user interface of the radiopharmaceutical fluid delivery system. The operator alert step may include highlighting one of a plurality of radiopharmaceutical injection procedures on a screen in a patient’s planned schedule. The method may also include the step of updating the patient’s planned schedule to agree on the maximum number of the multiple radiopharmaceutical injection procedures if there is a risk that at least one of the many radiopharmaceutical injection procedures may not be completed.

Additionally provided is a product having a computer-readable storage medium containing instructions that, when executed, allow the processor to do the following: download a schedule of many injection procedures of the radiopharmaceutical to create a planned schedule of the patient; and based on the patient’s planned schedule, calculate the configuration of the multi-dose container for use in a plurality of radiopharmaceutical injection procedures.

The product may also include instructions that, when executed, allow the processor to transfer the planned patient schedule to the radiopharmaceutical fluid delivery system. The schedule may include the time of the injection procedure for each patient and the activity removed from the multi-dose container of the radiopharmaceutical for each patient. The step of providing a schedule may include at least one of the following: manually entering time and activity for each patient into a computer, extracting time and activity for each patient from a storage device connected to the computer, and extracting time and activity for each patient from the patient’s device, remotely located through the network. The planned patient schedule can be edited after initial loading to coordinate additional patients, cancellations, temporary modifications to patients already provided on the planned patient schedule, modifications regarding activity removed from the multidose container of the radiopharmaceutical to patients already provided on the planned patient schedule, or any combination of this.

It also provides planning and monitoring software stored on a storage medium for planning and monitoring the use of the radiopharmaceutical during a plurality of injection procedures of the radiopharmaceutical. The software includes programming instructions that, when executed, allow the processor to do the following: download a schedule of multiple radiopharmaceutical injection procedures to obtain a planned patient schedule; and based on the patient’s planned schedule, calculate the configuration of the multi-dose container for use in a plurality of radiopharmaceutical injection procedures.

The planning and monitoring software may further include instructions that, when executed, allow the processor to transfer the planned patient schedule to the radiopharmaceutical fluid delivery system. The schedule may include the time of the injection procedure for each patient and the activity removed from the multi-dose container of the radiopharmaceutical for each patient. The step of providing a schedule may include at least one of the following: manually entering time and activity for each patient into a computer, extracting time and activity for each patient from a storage device connected to the computer, and extracting time and activity for each patient from the patient’s device, remotely located through the network. A planned patient schedule can be made so that it is editable after initial loading to accommodate additional patients, cancellations, temporary modifications to patients already provided on a planned patient schedule, modifications regarding activity removed from a multi-dose container of a radiopharmaceutical to patients already provided on the planned schedule of the patient, or any combination of this.

Additionally provided is a radiopharmaceutical fluid delivery device for administering a radiopharmaceutical injection procedure. A radiopharmaceutical fluid delivery device includes the following: a disposable administration kit for providing fluid flow from a radiopharmaceutical source of a radiopharmaceutical fluid delivery device to a patient; a pumping mechanism in fluid communication with a disposable administration kit and a radiopharmaceutical source for pumping fluid from a radiopharmaceutical source and through a disposable patient administration kit; a control unit operably connected to the pump mechanism and configured to: a) obtain a schedule of a plurality of radiopharmaceutical injection procedures; and b) monitor the pumping mechanism for a plurality of radiopharmaceutical injection procedures based on a schedule; and a display unit operatively connected to the control unit for displaying the graph to the operator.

The control unit may be further configured to: c) monitor the configuration of the multi-dose container during the multiple injection procedures of the radiopharmaceutical; d) determine if there is a risk that at least one of the many injection procedures of the radiopharmaceutical may not be completed correctly; and e) notify the operator if there is a risk that at least one of the many injection procedures of the radiopharmaceutical may not be completed.

A disposable administration kit may be a disposable administration kit for a plurality of patients, which includes a component of a medical fluid; component of a radiopharmaceutical; a coil component connected to the component of the medical fluid and the component of the radiopharmaceutical; and a spent component connected to the component of the medical fluid, the component of the coil and the component of the radiopharmaceutical.

Also provided is a method for optimizing the schedule of a plurality of radiopharmaceutical injection procedures. The method includes the steps of the following: providing a schedule of a plurality of radiopharmaceutical injection procedures to obtain a planned patient schedule; transfer of the planned patient schedule to the radiopharmaceutical fluid delivery system; change in the planned schedule of the patient; and suggesting changes in at least one of the radioactive dose and the infusion time for the at least one subsequent patient in the patient’s planned schedule. The method may also include the step of: determining a new, optimized patient schedule based on the proposed changes.

The schedule may include the time of the injection procedure for each patient and the activity removed from the multi-dose container of the radiopharmaceutical for each patient. The step of providing a schedule may include at least one of the following: manually entering time and activity for each patient into a computer; extracting time and activity for each patient from a storage device connected to a computer; and retrieving time and activity for each patient from a patient device located remotely through the network. A planned patient schedule can be provided so that it is editable after it was initially provided to coordinate additional patients, cancellations, temporary modifications to patients already provided on the patient’s planned schedule, modifications regarding activity removed from the multi-dose container of the radiopharmaceutical , patients already provided on the patient’s planned schedule, or any combination of this.

These and other signs and characteristics of the present disclosure, as well as the functioning methods and functions of related structural elements and the combination of parts and measures of economy during production, will become more apparent when considering the following description and the attached claims with reference to the attached graphic materials, all of which form part of this descriptions of the invention, where the same reference signs denote the corresponding parts in various figures. It should be clearly understood, however, that the graphic materials are intended solely for the purpose of illustration and description and are not intended to limit the scope of this disclosure. As used in the description of the invention and the claims, the singular form includes references to the plural forms, unless the context clearly dictates otherwise.

BRIEF DESCRIPTION OF GRAPHIC MATERIALS

FIG. 1A is a perspective view of a fluid delivery system according to an embodiment;

FIG. 1B is another perspective view of the fluid delivery system of FIG. 1A with a radioprotective coating thereon in an extended position;

FIG. 1C is a plan view of a fluid delivery system shown in FIGURES 1A and 1B with various streamline components located therein;

FIG. 1D is a cross-sectional view taken along the line 1D-1D of FIG. 1A;

FIGURE 1E is a cross-sectional view taken along line 1E-1E of FIGURE 1A;

FIG.1F is a block diagram illustrating a control system for use with the fluid delivery system of FIG.1A;

FIG. 2A is a schematic illustration of a set of streamlines for multiple patients and its components according to an embodiment;

FIG. 2B is an exploded view showing a set of flow lines for multiple patients shown in FIG. 2A connected to a fluid source and located above the fluid delivery system shown in FIGURES 1A-1E;

FIGA is a side view of a preferred embodiment of a coil assembly according to an embodiment;

FIG.3B is a view in partial section of FIG.3A;

FIG.3C is a horizontal projection (in partial section) taken along the line 3C-3C of FIG.3A;

FIG. 3D is a cross-sectional view taken along the 3D-3D line of FIG. 3A;

FIGURE 3E is a perspective view of the core element of the coil assembly shown in FIGURE 3A;

FIG. 3F is an enlarged image of FIG. 1D showing a coil assembly in an ionization chamber of a fluid delivery system;

FIG. 4A is a side view of preferred embodiments of a system supporting a screen of a container and a container access system according to an embodiment;

FIG. 4B is a perspective view showing a container screen, a system supporting a container screen, and a container access system of FIG. 4A;

FIG. 4C is a side view of a pharmaceutical container that can be used in a fluid delivery system according to an embodiment;

FIG. 5 is a simplified schematic diagram of a fluid delivery system of FIG. 1A in a first operational state according to an embodiment;

FIG.6 is a simplified schematic diagram of a fluid delivery system of FIG.1A in a second operational state according to an embodiment;

FIG. 7 is a simplified schematic diagram of a fluid delivery system of FIG. 1A in a third operating state according to an embodiment;

FIG. 8 is a simplified schematic diagram of a fluid delivery system of FIG. 1A in a fourth operating state according to an embodiment;

FIG. 9 is a simplified schematic diagram of a fluid delivery system of FIG. 1A in a fifth operational state according to an embodiment;

FIG. 10 is a sequence diagram of a method for performing an injection procedure according to an embodiment;

FIGURE 11 is a bar graph showing activity levels measured at various stages of an injection procedure according to an embodiment;

FIGURES 12-18 are various display images of a computer running multi-dose scheduling software of a radiopharmaceutical on a radiopharmaceutical injector according to an embodiment; and

FIGURES 19-26 represent various graphical user interface images for use in injection procedures according to an embodiment.

DESCRIPTION OF PREFERRED EMBODIMENTS

For the purposes of the description herein, the expressions “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal” and their derivatives will relate to the orientation of the embodiments disclosed in the figures shown. However, it should be understood that the embodiments may take alternative changes and sequences of steps, unless the contrary is clearly defined. It should also be understood that the specific devices and methods illustrated in the attached graphic materials and described in the following description of the invention are merely illustrative embodiments. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be construed as limiting.

It should be understood that the disclosed embodiments may take various alternative changes and sequences of steps, unless the contrary is clearly defined. It should also be understood that the specific devices and methods illustrated in the attached graphic materials and described in the following description of the invention are merely illustrative embodiments.

An exemplary radiopharmaceutical fluid delivery system for use with the system disclosed herein is disclosed in US Patent Application Publication No. 2008/0177126 to Tate et al., The disclosure of which is incorporated herein by reference. More specifically, FIGURES 1A-1F show an illustrative embodiment of such a radiopharmaceutical fluid delivery system 10. The fluid delivery system 10 may be configured as a trolley apparatus 9 having wheels 13 and / or rollers 12 to allow the system to be movable. One or more of the wheels 13 may be lockable to prevent the system 10 from moving if it is in the desired position. The system 10 also preferably includes one or more handles 14 to allow the operator to move or position the system 10. Alternatively, the fluid delivery system 10 may be a free-standing apparatus or a fixed-position apparatus.

The fluid delivery system 10 includes a display or graphical user interface (GUI) 15 for programming and operating the system 10. The GUI display 15 may be attached to one of the handles 14 (as shown) of the system 10. The display 15 may be a color display and include a touch screen characteristic as is known in the art for ease of use. The display 15 can be locked, but preferably pivotally connected to the fluid delivery system 10 (as shown), by means of a movable arm 11, which is pivotally connected to the connection 16. Additionally, the display 15 can be tilted or pivoted with respect to the arm 11, so that ensure optimal display layout 15 for the operator.

With specific reference to FIG. 1F, a touch screen GUI display 15 may be part of a control system 5 implemented as a computer 1000 in a computer system environment 1002 used to control the injection procedure of a fluid delivery system 10. While any suitable computer device may be used to control the fluid delivery system 10, an illustrative embodiment of one computer system and computer system environment 1002 will be discussed herein below with reference to FIG. 1F. This computer system environment 1002 may include, but is not limited to, at least one computer 1000 having certain components for the corresponding operation, code execution, and data creation and transfer. For example, computer 1000 includes a processor element 1004 (typically referred to as a central processing element or CPU) that serves to execute computer instructions received in an appropriate form and data format. Additionally, this processor element 1004 may be in the form of multiple processors that execute code sequentially, in parallel, or in any other way for the appropriate implementation of computerized instructions.

In order to facilitate appropriate data transfer and information processing between the various components of computer 1000, a system bus 1006 is used. System bus 1006 can be any of several types of bus structures, including a storage bus or memory controller, a peripheral bus, or a local bus using any of variety of bus architectures. In particular, system bus 1006 facilitates the transfer of data and information between various components (either internal or external to computer 1000) through a variety of interfaces, as discussed herein below.

Computer 1000 may include a variety of discrete components of computer-readable media. For example, this computer-readable medium may include any medium that may be accessible by computer 1000, such as volatile medium, non-volatile medium, removable medium, non-removable medium, etc. As a further example, this computer-readable medium may include computer storage medium, such as a medium, implemented by any method or technology for storing information, such as computer-readable instructions, data structures, program modules or other data, random access memory (RAM), read-only memory storage device (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory or other memory technology, CD-ROM, universal digital flat disks (DVDs), or other optical disk drive, magnetic tapes, magnetic tape, magnetic disk drive or other magnetic storage devices, or any other medium that can be used to store the necessary information and which can be accessed by computer 1000 . Further, this computer-readable medium may include a communication medium, such as computer-readable instructions, data structures, program modules, or other data in a modulated data signal, such as As a carrier wave or other transport mechanism, and includes any information delivery medium, wired medium (such as a wired network and a direct wired connection) and wireless medium (such as acoustic signals, radio frequency signals, optical signals, infrared signals, biometric signals, barcode signals etc.). Of course, combinations of any of the above should also be included in the scope of computer-readable media.

The computer 1000 further includes system memory 1008 with a computer storage medium in the form of volatile and non-volatile memory, such as ROM and RAM. A basic input / output system (BIOS) with associated computer routines helps in transferring information between components within the computer 1000 and is normally stored in ROM. The RAM portion of the system memory 1008 typically contains data and program modules that are immediately accessible to or immediately processed by the processor element 1004, such as, for example, the operating system, program application interfaces, application programs, program modules, program data, and other computer readable code, based on instructions.

The computer 1000 may also include other removable or non-removable, volatile or non-volatile computer storage media products. For example, computer 1000 may include a non-removable storage device interface 1010 that communicates with and controls a hard disk drive 1012, i.e. a non-removable, non-volatile magnetic medium, an interface of a removable, non-volatile storage device 1014 that communicates with and controls a magnetic disk drive element 1016 (which reads from and writes to a removable, non-volatile magnetic disk 1018), an optical disk drive element 1020 (which reads with and writes to a removable, non-volatile optical disk, such as a CD ROM 1022), via a Universal Serial Bus (USB) port for use in conjunction with a removable memory card 1023, etc. However, it is contemplated that other removable or non-removable, volatile or non-volatile computer storage media may be used in the illustrative computer system environment 1002, including, but not limited to, magnetic tape tapes, DVDs, digital video tapes, solid state RAM, solid state ROM, etc. .d. These various removable or non-removable, volatile or non-volatile magnetic media are coupled to the processor element 1004 and other components of the computer 1000 via a system bus 1006. The drives and associated computer storage media discussed above and illustrated in FIG. 1F provide storage for operating systems , machine-readable instructions, application programs, data structures, program modules, program data and other machine-readable code based on instructions for computers user 1000 (duplicating or not information and data in the system memory 1008).

Preferably, the operator of the fluid delivery system 10 will enter commands, information and data into the computer 1000 using the touch screen GUI display 15 via the operator input interface 1028. However, it has been contemplated that an operator can enter commands, information and data into a computer 1000 using other attachable or functional input devices, such as a keyboard 1024, a mouse 1026, etc., via an operator input interface 1028. Of course, a variety of such input devices can be used, for example, a microphone, trackball, joystick, touchpad, scanner, etc., including any layout that facilitates entering data and information into computer 1000 from an external source. As discussed, these and other input devices are often connected to the processor element 1004 via an operator input interface 1028 connected to the system bus 1006, but can be connected using another interface and bus structures such as a parallel port, a game port, or USB. Still further, data and information can be presented or provided to the operator in an understandable form or format via certain output devices, such as a GUI display 15 (to visually show this information and data in electronic form), a printer 1032 (to physically show this information and printed data), speaker 1034 (to acoustically present this information and data in sound form), etc. All of these devices are connected to a computer 1000 via an output interface 1036 connected to the system bus 1006. It is contemplated that any such peripheral output devices are used to provide operator information and data.

Computer 1000 may operate in a networked environment 1038 by using a communications device 1040 that is integrated with or remote from the computer. This communication device 1040 operates using and is in communication with other components of the computer 1000 via the communication interface 1042. Using this arrangement, the computer 1000 can connect to or otherwise establish communication with one or more remote computers, such as a remote computer 1044 of the hospital information system, which typically includes many or all of the components described above in connection with the computer 1000. Using appropriate devices 1040 communications, such as a modem, network interface or adapter, etc., the computer 1000 can function within and establish communications through a local area network (LAN) and wide area network (WAN), but can kzhe include other networks, such as virtual corporate network (VPN), office network, a corporate network, an intranet, the Internet, etc. It should be understood that the network connections shown are illustrative and other means of forming a communication channel between computers 1000, 1044 can be used.

As used herein, computer 1000 includes or can be used to execute appropriate custom-designed or general software for carrying out and implementing the processing steps of the methods and systems disclosed herein, thereby forming a specialized and specific computer system. Accordingly, the methods and systems of the present invention may include one or more computers 1000 or similar computer devices having computer-readable storage media capable of storing computer-readable program code or instructions that cause processor element 1004 to execute, configure, or otherwise implement methods, processes, and manipulations of data transformations discussed in this document. Still further, the computer 1000 may be in the form of a personal computer connected to a fluid delivery system 10, a processor integrated with the fluid delivery system 10, a computer provided remotely from the fluid delivery system 10, or any other type of computer device having the necessary processing hardware in order to appropriately process the data in order to efficiently implement the computer-implemented method and system of the present invention.

Returning to FIGURES 1A-1E, the fluid delivery system 10 may include a retractable lid or cover 20 having a main handle, including release of 1 latches (see FIGURES 1D and 1E) and a secondary handle 21. The cover 20 may cover the upper surface 103, which determines the number in-depth parts, such as wells and grooves, in which a container or container (see 902 in FIG. 4C) of a pharmaceutical or radiopharmaceutical (discussed in detail below) and various components of a set of 200 streamlines for multiple patients (herein below, the MPDS, discussed in more detail below) may be located during the injection procedure. A locking mechanism, such as a combination lock or key lock (not shown), can be used to lock the cover 20 in the closed position, for example, to prevent the use or access to the system 10 by unauthorized personnel. In another embodiment, the lock mechanism may be a lock implemented by software, such as a password protected access point, that is accessible through the display 15 and is adapted to lock the cover in the closed position and / or to prevent unauthorized personnel from accessing or operating the system 10.

The lid 20 is sliding or sliding (using, for example, the main handle and releasing the latches 1) with respect to the trolley 9 to allow insertion and removal of the container or container 902 and MPDS 200 from the fluid delivery system 10. The lid 20, top surface 103, and various other parts of the trolley 9 preferably include a suitable radioactive shield (such as lead) to minimize the potential radiation exposure of the radiopharmaceutical to the operator. In this way, the radiopharmaceutical container 902 and the MPDS 200 components may lie below the plane of the surface 103, while the surface 103 or one or more of its parts may be covered with a lid 20 during use to limit radiation exposure to the operator or other medical personnel. Additionally, instead of the sliding cover 20, the surface 103 itself can be located on a part of the fluid delivery system 10 (for example, a sectional type mechanism) that slides in relation to the rest of the fluid delivery system 10.

As further shown in FIGURES 1A, 1B, and 1D, the fluid delivery system 10 includes a pump mechanism, such as a peristaltic pump 22, a removable / removable source of medical fluid 23 (such as saline solution), an output device, such as a printer 1032 and an interrupt button 25 . The peristaltic pump 22 is shown in the closed position in FIG. 1A, but can be open (see FIGURES 1B, 1C and 2B) to obtain the length of pipe 27 (see FIGURES 1C and 2A) in a fluid connection to a source of medical fluid 23 for injecting fluid into a patient (discussed in more detail below). While a peristaltic pump 22 is currently preferred, any suitable type of pump mechanism, such as a piston-controlled syringe pump, gear pump, rotary pump or in-line pump, can be used.

Printer 1032 can be used to create injection records and / or patient imaging procedures, to be included in patient medical records, or for billing or inventory purposes. Printer 1032 may be pivotally coupled to system 10 (see FIG. 1B) to allow an operator to load paper or labels into printer 1032.

The interrupt button 25 allows the operator to quickly and easily pause or interrupt the injection procedure in the event of, for example, patient discomfort or an emergency, without having to access the GUI display 15 (which can also be used to pause or interrupt the injection procedure). The interrupt button 25 may be connected to the LED and / or circuit board to provide visual and / or audible alarms when the interrupt button 25 has been activated.

Returning to FIGURES 1C-1F, 2A and 2B, additional features and components of a fluid delivery system 10 will be discussed, including top surface 103, MPDS 200, a container access system 600, and a set of 700 flow lines for one patient (hereinafter SPDS) .

As shown in FIG. 1C, the upper surface 103 typically sets up holes and grooves or grooves in which the various components of the MPDS 200 are located. In particular, the first groove or groove 107 accommodates the first section 204 of the MPDS 200 pipe and the pipe mount 150 for holding section 204 of the pipeline and prevent it from bending or intertwining with, for example, SPDS 700. The first section 204 of the pipeline may also include a length of pipe 27, which is located within the peristaltic pump 22 and is in fluid connection to the source nickname 23 medical fluid.

The first groove 107 leads into a second recess or groove 113, which accommodates a second pump mechanism 180, such as a peristaltic pump, and a T-shaped connector 205 (including check valves 214, 215) of the MPDS 200. As shown in FIG. 1C, the second groove 113 also leads to the first well 111, which houses the container access system 600 and the vial or container for the radiopharmaceutical 902 located in the screen 554 of the container or container (discussed in more detail below) and to the second well 121, which houses the dose calibrator or ionization chamber 160 for of systems 10 fluid delivery. As shown in FIGURES 1D and 3F, the ionization chamber 160 preferably places the coil assembly 400 MPDS 200 (discussed in more detail below). Although the system is described as including an ionization chamber 160 for detecting activity of a radiopharmaceutical fluid, this should not be construed as limiting the scope of this disclosure, since any suitable activity detector may be used, such as, but not limited to, a CZT crystal detector, a Geiger-Muller counter, a scintillation counter and a parabolic detector, such as a parabolic sensor, disclosed in US Patent Application No. 12/664653, which is incorporated herein by reference.

A third recess or groove 125 extends from the second well 121 to the third well 127 and further along the surface 103 of the fluid delivery system 10. The chute 125 accommodates the T-shaped connector 222 of the MPDS 200, two shut-off valves 170, 172, an air detector 174, and a support or holder 176 for holding the MPDS 200 connecting head 228. The shut-off valves 170, 172 may be actuated and controlled by system 10 fluid delivery, but alternatively may be manually actuated. In another alternative embodiment, the shutoff valves 170, 172 and the T-shaped connector 222 of the MPDS 200 may be replaced by a manual or automated 3-way valve.

The third well 127 accommodates a waste receptacle or bag 224 for receiving medical fluid and / or pharmaceuticals that are discarded during, for example, a pumping procedure (discussed in more detail below) to prepare a system 10 for an injection procedure.

As shown in FIG. 1C, the SPDS 700 includes a pipe length (preferably coiled as shown) having a first end 702 that connects to the MPDS 200 connecting head 228, and a patient end 704 having a Luer connector that attaches to, for example, a catheter (not shown) placed in the vein structure of the patient. As discussed in more detail below, the MPDS 200 can be used for multiple patients, but the SPDS 700 is intended to be used per patient and is discarded after use by one patient to prevent, for example, cross-infection between patients.

As can be understood after referring again to FIGS. 1A-1E, the secondary handle 21 of the cover 20 overlaps the pipe mount 150 and the support 176 when the cover 20 and the handle 21 are closed to cover the MPDS 200. The secondary handle 21 can be opened by clicking (from the closed position 1A) without removing cover 20 to allow the operator to connect the SPDS 700 to the MPDS 200 (as discussed in more detail below). As best shown in FIG. 1C, the SPDS 700 can be placed under the secondary handle 21 when it is closed.

The fluid delivery system 10 further includes a system controller 5 (see FIGURES 1D and 1E) in conjunction with various components thereof, including a GUI 15, pumps 22, 180, a meter or ionization chamber 160, an interrupt button 25, an air detector 174, a printer 1032, and motors 30, 31 (see FIG. 3F) for shut-off valves 170, 172, respectively, for controlling the operation of the system 10. The system controller 5 may be implemented as a computer 1000, as discussed in more detail herein above with reference to FIG. 1F.

As can be understood, the holes and grooves formed in the upper surface 103 can be sized, configured or arranged to fit the length, design or configuration of the MPDS 200 or its other components, including the radiopharmaceutical container 902, container screen 554, container access system 600, ionization chamber 160, waste receiver 224, etc.

It should be understood that FIG. 1C is in no way intended to convey the dimensions or relative dimensions of the above-mentioned recessed portions or components of the MPDS; instead, FIG. 1C conveys the general mutual arrangements of such recessed parts with respect to each other.

It should be further understood and accepted that the recessed portions shown with respect to FIG. 1C are included throughout a suitable radioactive shield to further minimize operator exposure.

Returning now to FIGURES 2A and 2B, an embodiment of the MPDS 200 and its components will be discussed. In addition, the specific details of the coil assembly 400 used in the MPDS 200 are shown and described with respect to FIGURES 3A-3F and FIG. 1D.

For the purpose of a general overview, the MPDS 200 according to at least one embodiment ensures that the FDG (or other radiopharmaceutical) comes from the radiopharmaceutical container in bulk 902 and fits into the coil assembly 400, which allows the ionization chamber 160 to measure the amount of activity in the coil assy 400. Once the system has prepared a dose having the desired level of activity, the fluid delivery system 10 will deliver the dose of FDG to the patient (via SPDS 700).

Typically, the MPDS 200 can be considered in terms of four components: (1) a component of a medical fluid or saline; (2) an FDG or pharmaceutical component; (3) component coil assembly; and (4) a spent component. The saline component moves the saline from the filling source 23 (for example, by means of a peristaltic pump 22). This is then used to flush the MPDS 200 (i.e., remove air from it), place the FDG in the coil assembly 400 in the ionization chamber 160, and then deliver the dose to the patient.

The FDG component serves to move the FDG from the container 902 of the radiopharmaceutical in bulk (for example, by means of a peristaltic pump 180) and place it in a stream line towards the ionization chamber 160.

The coil assembly component is used to house the radiopharmaceutical to ensure that its level of radioactivity is optimally measured by the ionization chamber 160. By arranging the coil assembly 400 (as discussed in more detail below), the radiopharmaceutical can be optimally oriented and positioned within the "linear plot "ionization chamber 160 for more accurate measurement of its level of activity and preparation of the optimal dose for injection to the patient.

The spent component contains saline and / or radiopharmaceutical fluid that is discarded during the flushing and dose preparation procedures that are used to prepare the streamline and pharmaceutical dose for injection to the patient.

FIG. 2A schematically illustrates an MPDS 200 according to an embodiment. The MPDS 200 shown in FIG. 2A may be pre-connected, as shown, and may be initially stored in a sterile bag or container for use in an injector device, such as a fluid delivery system 10, if necessary. For a non-limiting and illustrative perception of the way in which the MPDS 200 can be integrated into the injector, simultaneous reference can be made to FIGURES 1A-1E and 2B (and discussed above in this document).

The main components of the MPDS 200 include, as shown: a needle 202 for connecting the MPDS 200 to a source of 23 medical fluid or saline; ventilated cannula 208 for connection to a source of FDG or other radiopharmaceutical; coil assembly 400; T-connector 205 with check valves 214, 215 for fluidly connecting a salt solution source 23, a radiopharmaceutical source, and a coil assembly 400; waste bag 224; a connecting head 228 and a T-shaped connector 222 for fluidly connecting the coil assembly 400, a waste bag 224, and a connecting head 228.

In general, the MPDS 200 and fluid delivery system 10 are configured to flush (i.e. remove air from) the MPDS 200, deliver a pharmaceutical product (e.g., FDG) to a patient, and ensure saline flow, while minimizing or eliminating exposure to administrative or operational personnel the harmful effects of a pharmaceutical and minimizing or eliminating the creation of polluting waste. Moreover, the MPDS 200 and other elements disclosed herein also facilitate the safe delivery of a pharmaceutical to multiple destinations (e.g., delivering a dose of a series of patients).

The T-shaped connector 205 and the check valves 214, 215 match the first pipe section 204, which is in fluid communication with the needle 202, and the second pipe section 210 in fluid communication with the cannula 208. The check valves 214, 215 can be integrally composed with T- shaped connector 205 can either be separate components, or they can be combined into one double check valve. Check valves 214, 215 prevent the saline solution from being pumped by the peristaltic pump 22 into the second pipe section 210 and pharmaceuticals by the peristaltic pump 180 from being pumped into the first pipe section 204.

The third section 216 of the pipeline leads to the coil assembly 400 (including the tubular coil 444), and the fourth section 220 of the pipeline leads from the coil assembly 400 to the T-shaped connector 222. As described below, the tubular coil 444 is formed from section 217 of the pipeline, which has sizes different from those of the third section 216 of the pipeline and the fourth section 220 of the pipeline.

A fifth pipe section 226 leads from a T-shaped connector 222 to a waste receptacle 224 and a sixth pipe section 230 leads from a T-shaped connector 222 to a connecting head 228. As shown in FIG. 1C, the connecting head 228 is connected to the first end 702 of the SPDS 700 for delivering a pharmaceutical to a patient.

The connection head 228 may be a Luer lock valve (Part No. 245204024 provided by Halkey-Roberts Corporation of St. Petersburg, Fla.), Which is biased to close or seal the MPDS 200 connection head 228 when the SPDS 700 is not connected to it. The sealing valve with Luer connector prevents the MPDS 200 from becoming contaminated and allows the operator to swab or clean (using, for example, a cloth moistened with alcohol) the connection head 228 before attaching the SPDS 700 to it. Alternatively, however, the connecting head 228 may be a standard Luer connector, as is known in the art.

As schematically shown in FIG. 2A, the length of the pipe 27 of the first pipe section 204 can be placed inside the pump 22 (indicated by dashed lines) for pumping saline or other medical fluid from the source 23 and a portion of the second pipe section 210 can be placed inside the pump 180 ( shown by dashed lines) for pumping the radiopharmaceutical from the source of the radiopharmaceutical.

The absolute and relative dimensions of the components shown in FIG. 2A, including piping, can be selected to better suit upcoming applications. The first pipe section 204 may be approximately 56.75 inches long, has an external diameter (OD) of approximately 0.188 inches and an internal diameter (ID) of approximately 0.062 inches, and has a hardness of 45 conventional units. The second section 210 of the pipeline can be approximately 8.75 inches in length and is formed from a small diameter pipeline having an OD of about 0.094 inches and an ID of about 0.032 inches and a hardness of 45 conventional units. The third section of the pipeline 216 may be approximately 15 inches in length, has an OD of approximately 0.163 inches and an ID of approximately 0.062 inches and a hardness of 60 conventional units. The fourth pipe section 220 may be approximately 12 inches in length, has an OD of approximately 0.163 inches and an ID of approximately 0.062 inches, and has a hardness of 60 conventional units. The fifth pipeline section 226 and the sixth pipeline section 230 may each be approximately 5 inches in length, have an OD of approximately 0.163 inches and an ID of approximately 0.062 inches, and have a hardness of 60 conventional units. The pipe in the 444 tubular coil can be approximately 41 inches in length, has an OD of about 0.218 inches, and an ID of about 0.156 inches and a hardness of 80 conventional units. All of these dimensions are provided for illustrative purposes only and should not be construed as limiting the present disclosure.

The small-diameter pipe of the second pipe section 210 may be formed, for example, of silicone, C-Flex, or silicone-like PVC material. Essentially, the use of a small diameter pipeline in the second section 210 of the pipeline improves the accuracy of the volume and thereby improves the accuracy of the measured activity (i.e., the pharmaceutical delivered to the patient) and reduces the waste of the radiopharmaceutical.

As a conduit material for other conduit sections 204, 216, 220, 226, 230 and a tubular coil 444, substantially any suitable polymeric material, including standard PVC or pump conduit, may be used.

Referring again to FIGURES 1A-2B, the placement of the MPDS 200 in the fluid delivery system 10 and the SPDS 700 connection will now be discussed. To install the system 10, for example, at the beginning of the day, the operator lifts the secondary handle 21, clamps the main handle and release 1 of the latches and pushes a cover 20 to open the top surface 103 of the system 10. If the used MPDS 200 is present in the system 10, the operator will remove and discard it.

The new MPDS 200 can be removed from its (typically sterile) packaging and placed in the system 10, as shown in FIG. 1C. This includes placing the waste receiver 224 in well 127, placing the coil assembly 400 in the ionization chamber 160, placing the second pipe section 210 in a functional connection with the pump 180, placing the pipe length 27 of the first pipe section 204 in a functional connection with the pump 22 and the pipe mount 150 placing the ventilated cannula 208 in fluidic connection to a radiopharmaceutical source or container 902 located in well 111; placing the fifth section of the pipeline 226 into a functional connection with with a flap valve 170 and placing the sixth section of the pipeline 230 in functional connection with a shut-off valve 172, an air detector 174 and a support 176. The salt solution source 23 can be hung on hook 6 (see FIGURES 1A, 1B and 2B) or otherwise mounted on system 10 liquid delivery, and the needle 202 is inserted into port 7 (see FIGURES 1A, 1B and 2B) of the source 23 for the fluid connection of the MPDS 200 to the source 23. Of course, this installation procedure does not have to be performed in the manner described above, but can be performed in any acceptable order consistent with its description or graphic materials.

After the MPDS 200 is installed and flushed (as discussed below), the first end 702 of the SPDS 700 is connected to the connecting head 228 of the MPDS 200 and the SPDS 700 is flushed to provide a fluid connection at the end 704 of the patient SPDS 700, which then connects to a catheter (not shown ) located in the patient. The SPDS 700 can be a coiled tubing formed from standard PVC, approximately 60 inches in length and having an OD of approximately 0,100 inches and an ID of approximately 0,060 inches and a hardness of 90 conventional units.

As shown in FIGURES 2A and 2B, the MPDS 200 includes a coil assembly 400. In the broadest sense, the coil assembly 400 may include a pipe section (including portions of the third and fourth pipe sections 216, 220) that is simply assembled (wound or not wound in a spiral, amorphous) and placed inside the ionization chamber 160.

As shown in FIGURES 3A-3F, however, a more desirable embodiment of the coil assembly 400 includes a (preferably thermoformable) core element or structure 446, which is preferably configured to ensure that the pipe section 217 is wound on it and becomes spiral wound tubular section shown at 444. In this regard, a spiral wound tubular section or tubular coil 444 may be formed on core element 446 to facilitate optimal placement of the tube chatogo coil 444 inside the ionization chamber 160.

To facilitate the positioning of the tubular coil 444, the core 446 may include a tubular channel 410 delimited by the protrusions 412, 414 (see FIG. 3B), which hold the tubular coil 444 between them to hold the tubular coil 444 in position and prevent the formation of kinks in the tube. Additionally, the upper surface 420 of core 446 defines an inlet or groove 422 and an outlet or groove 424 to accommodate the third pipe section 216 and the fourth pipe section 220, respectively.

The core element 446 may preferably be self-centering when it is inserted into the cup 162 of the ionization chamber 160 of the fluid delivery system 10, thereby facilitating optimal functioning (see FIG. 3F). This can be achieved either through the structural features of the coil assembly 400, the structure of the core element 446 per se, or a combination thereof when used with the glass 162 of the ionization chamber 160.

As best shown in FIG. 3E, core element 446 can be formed by folding two elements (450, 452) together with a single loop 455. Suitable locking mechanisms for securing the mold can be injection molded onto core element 446 to facilitate fixation elements 450, 452 together.

FIGURES 1C, 1D and 3F show the coil assembly 400 located concentrically in the cup 162 of the ionization chamber 160. The core element 446 and the tubular coil 444 are sized and sized so that the coil assembly 400 is optimally positioned within the “linear portion” ionization chamber 160, so that the ionization chamber 160 can accurately determine the level of activity of one or more volumes of the radiopharmaceutical that is located inside the tubular coil 444. The "linear portion" of the ionization chamber before constitutes a site in which measurements of activity levels are repeatable and predictable. For the illustrative ionization chamber (Model IK-102 Short Ionization Chamber provided by Veenstra Instruments) used in system 10, the “linear portion” is located within a window of 5 mm to 65 mm, measured from the main or lower wall 160a of the ionization chamber 160 (see FIG. .3F).

The tubular coil 444 may consist of approximately 7 revolutions (see FIGURES 3A and 3B) formed from a pipeline length of approximately 41.0 inches. As shown in FIG. 3B, the height h of the tubular coil 444 is approximately 1.53 inches and the diameter w of the tubular coil 444 is approximately 1.95 inches. Tubular coil 444 is preferably formed from a tube having an OD of 0.218 inches and an ID of 0.156 inches. Additionally, based on the length and ID of the pipeline, the tubular coil 444 preferably has a volumetric capacity of approximately 12.5 ml.

As previously discussed, the source, container or container 902 (see FIG. 4C) of the pharmaceutical or radiopharmaceutical is placed in a fluid delivery system 10 (for example, in a well 111 formed on the upper surface 103) to prepare and carry out the injection procedure. The radiopharmaceutical container or container 902 is typically placed in a conventional container screen or container 554 for transportation by personnel.

Returning now to FIGURES 4A and 4B, an illustrative embodiment of a device supporting a container screen or system 500 and a container access system 600 is shown. The container access system 600 is movably located within the well 111 of the fluid delivery system 10 and operates to hold the container screen 554 and to access the contents of the container 902 contained therein.

As best shown in FIG. 4A, the container screen 554 (containing the container of the radiopharmaceutical product 902) includes a flange 504 formed along its upper end and a removable lid 562 with a diaphragm that tightly and movably contacts the container screen 554 (for example, by threading ) to allow insertion and removal of the container 902 from it.

As shown in FIGURES 4A and 4B, the support system 500 includes a clamp member 502 that movably comes into contact with a flange 504 formed on the container screen 554. The collar 502 can be formed in two sections 506, 508 that are pivotally connected together (for example, at one end thereof) to allow the collar 502 to come into contact and out of contact with the flange 504.

The collar 502 includes two elongated grooves 510 formed on its upper surface. As best shown in FIG. 4B, each groove 510 includes a pin 512 located therein and extending between their two opposite walls 514.

The carrier system 500 further includes a handle member 520 that contacts the clamp member 502 and the diaphragm cover 562 to allow the container screen 554 (and container 902) to be carried and installed in the fluid delivery system 10. Handle member 520 includes a handle 556 that is rigidly connected to a typically U-shaped spacer 564a. The spacer 564a defines two downward levers 530 having grooves 532 formed thereon.

Each of the grooves 532 forms a thin hook at their ends and is adapted to come into contact and hold the second strut 564b, which supports the plunger 566, which is usually in the form of a truncated cone, which is joined, as a rule, with a truncated cone-shaped recess of the cover 562 with a diaphragm (see FIG. 4B).

The second spacer 564b is also typically U-shaped and defines two downward levers 534 having hooks 536 formed therein. The open ends of the hooks 536 are formed at opposite ends of the levers 534 and are adapted to receive and hold the pins 512 in the grooves 510 of the collar 502. The grooves 510 are sized to provide sufficient clearance for the levers 534 to be inserted into them (downward) and for hooks 536, to come into contact with the pins 512 (by rotating the handle 556).

The plunger 566 is connected to the second spacer 564b via a connector (such as a screw 540) and a spring 538. The plunger 566 is deflected by a spring 538 to provide a snug fit between the plunger 566 and the diaphragm cover 562.

To contact and transfer the container screen 554, the collar 502 is connected to the flange 504 of the container screen 554, as described above. The handle element 520 then moves closer to the container screen 554 (with the help of an operator who clamps the handle 556 and moves the element 520 to position) and the levers 534 are lowered into the grooves 510 of the collar 502. In fact, at the same time, the plunger 566 comes into contact with the cover 562 with a diaphragm, with a spring 538 providing a tight fit between the two elements. The operator then rotates the handle element 520 in a clockwise direction (see arrow AA in FIG. 4A) to install the pins 512 in the slots 510 into the hooks 536 of the levers 534.

The operator then lifts the combined container screen 554 and the container support system 500 (by moving the handle element 520 in the upward direction) and moves it to, for example, the liquid delivery system 10. The operator then lowers the container screen 554 into the container access system 600 located in well 111 (see FIG. 4A) and rotates the handle element 520 counterclockwise to disengage the hooks 536 from the pins 512. The operator then lifts the handle 556 to upward direction for removing levers 534 from grooves 510 and plunger 566 from diaphragm cap 562, thereby leaving a container screen 554 (with cap 562 with diaphragm and clamp 502) in a container access system 600 in well 111 (see FIG. 4B).

In an illustrative embodiment, the plunger 566 includes a radioactive shield (such as lead) to shield the operator from exposure that would otherwise seep through or radiate from the diaphragm of the diaphragm cap 562. Together with the container screen 554 and the diaphragm cover 562, the plunger 566 of the container carrier system 500 shields the operator from exposure to radiation from the radiopharmaceutical and prevents undesired radiation exposure. Additionally, by extending the handle 556 from the container screen 554, the distance between the two acts to reduce any possible radiation exposure to the operator.

As discussed above with respect to FIGURES 4A-4B, the fluid delivery system 10 includes a container access system 600 that is movably located within the well 111 of the fluid delivery system 10 and is adapted to hold the container screen 554 and to provide access to the contents of the container 902 inside the screen 554 container.

Because containers (such as container 902 described herein) typically come in various sizes, such as 10 ml, 15 ml, 20 ml, and 30 ml, a fluid delivery system 10 is provided to accommodate different container sizes . To do this, the fluid delivery system 10 may include one or more screens of containers and container access systems. Thus, depending on the size of the container used in the clinical facility or for a specific procedure, the operator of the fluid delivery system 10 can select the appropriate container screen and access system for the container and place it in the well 111 of the fluid delivery system to provide a fluid injection procedure.

Referring again to FIGURES 1C and 2A, as soon as the MPDS 200 is installed in the fluid delivery system 10, the needle 202 is placed in a fluid connection to a salt solution source 23 and the cannula 208 is inserted into a container 902 and placed in a fluid connection with a pharmaceutical agent therein, and the procedure injection can be carried out.

An exemplary injection procedure is discussed herein below with reference to FIGURES 5-11. Many changes to the injection procedure can be made within the scope of this disclosure. For example, the radiopharmaceutical container 902 may be of any suitable multi-dose container configuration. This multi-dose container configuration may include a dose of a radiopharmaceutical for a plurality of patients provided in any suitable container for storing radiopharmaceuticals. A multi-dose container configuration may include a dose of a radiopharmaceutical for a plurality of patients provided in a syringe. In addition, the configuration of a multi-dose container may be a plurality of containers suitable for storing radiopharmaceuticals, where each container stores a certain amount of the composition of the radiopharmaceutical. A microfluidic device or other radiopharmaceutical formulation technology capable of real-time generation of a certain amount of radiopharmaceutical may also be used as a multi-dose container configuration. Moreover, the configuration of a multi-dose container may be a plurality of suitable containers, each of which contains a different radiopharmaceutical liquid. The configuration of the multi-dose container may also be a pre-loaded amount of radiopharmaceutical fluid in the coil of the piping of the kit for administration. Alternatively, a single dose container may also be used. Accordingly, the injection procedure described herein below is not intended to limit this disclosure, and while container 902 is described herein below, this should not be construed as limiting since any variety of containers for a radiopharmaceutical can be used. Moreover, the following procedure describes the use of a first volume, bolus or portion 800 and a second volume, bolus or portion 802 of a radiopharmaceutical delivered to a patient. It should also not be construed as limiting the injection methods for the injection procedure disclosed herein, since any suitable number of blanks can be delivered to the patient.

An exemplary injection procedure can typically be divided into five phases. In the initial phase 910, the device is initialized with the wells installed. In calibration phase 920, steps are performed to calibrate the radioactivity in container 902. In delivery phase 930, the radiopharmaceutical is delivered to the destination. At 940, a decision is made whether another injection should be given. If so, the operation will continue again from calibration phase 920. If not, shutdown phase 950 will follow.

Before starting the operation, the operator will have to determine two quantitative quantities: the necessary Ar activity to be administered by injection to the patient; and quantified activity concentration in the container (activity per unit volume, for example, expressed in MBq / ml) Cv. This data is sent to the system controller 5. The operation then begins with an initialization period 910.

The initialization period 910 includes the following steps.

Step 911 (Initial filling of the radiopharmaceutical to mark C): In the first step, the entire pipeline is filled with saline, thereby eliminating air from the pipeline system. To do this, the T-shaped connector 205, the non-return valve 214 and the non-return valve 215 (hereinafter the valve V1) are placed in a state that connects the ports “c” and “b”, while the T-connector 222, the shut-off valve 170 and the shut-off valve 172 (hereinafter, valve V2 below) is placed in positions "d" and "e". Pump 22 is flushed with saline to mark B (see FIG. 5). Pipeline section 210 is then inserted into a container containing saline. Valve V1 is brought into a position that connects ports "a" and "b", while valve V2 is still connecting "d" and "e". The pump 180 is now flushed with brine until the pipeline is completely filled with brine from mark A (see FIG. 5) to the end point under valve V2, and thus the air is completely expelled from the system. Pipeline section 210 is then inserted into container 902 containing a radiopharmaceutical. Valve V1 is brought into a position that connects ports "a" and "b", while valve V2 connects ports "d" and "f". Pump 180 may function to pump the radiopharmaceutical into container 902 from inlet mark A and pass mark B on valve V1 to mark C in the third pipe section 216. There is no need to know exactly the volume of the radiopharmaceutical between marks B and C in the third section 216 of the pipeline; it is enough to make sure that the section of the pipeline from A to B is completely filled with a radiopharmaceutical, and that the activity in the volume between B and C is not greater than the required final activity of Ar. The situation at the end of step 911 is illustrated in FIG. 5, where the volume of the radiopharmaceutical between the marks B and C is indicated by the 800 reference number.

Step 912 (flushing the displaced volume to the dose calibrator). Valve V1 is now switched to the position in which it connects ports “c” and “b”. Pump 22 may function to pump brine from source 23 toward valve V1. The volume to be pumped is slightly larger than the volume in the third section of the pipeline 216, i.e. slightly larger than the volume between marks B and D. This volume does not need to be known exactly. Thereby, the “displaced volume” 800 is moved to the coil section 444. The situation at the end of this step is illustrated in FIG. 6.

 Step 913 (Initial Activity Determination): The activity of volume 800 in coil section 444 is measured using an ionization chamber 160 (measurement M1). This activity will be called "shifted activity" A1. System Controller 5 now calculates the missing Am activity necessary to achieve the total Ar activity, as shown in Equation 1 in this document below:

This is illustrated in FIG. 11 in the leftmost column. From it and the estimated activity concentration in the container, Cv, the estimated missing volume Va1 that still needs to be left is calculated as shown in Equation 2 in this document below:

$$Va\mathrm{one}=\frac{Am}{Cv}\text{(Equation 2)}$$

It is important to note that this calculation is still based on an estimate of the concentration of activity in the container, and the result cannot be expected with high accuracy. It is additionally important to note that in this calculation there is no need for knowledge of the displaced volume 800. In addition, the ionization chamber 160 may be any suitable activity detector. Such detectors include standard Geiger-Muller counters, scintillation counters, an ionization chamber, a cadmium zinc tellurium (CZT) crystal detector, etc., which must be calibrated to obtain a sufficiently accurate measurement of the actual activity in the section of the coil 444. It is desirable that the activity detector was an ionization chamber.

This step completes the initialization 910. In the next calibration phase 920, the following steps are performed.

Step 921 (Filling the radiopharmaceutical to mark C). Valve V1 is switched to the position in which it connects ports "a" and "b". Pump 180 may function to pump volume Vc ′ through valve V1, filling the filling section to mark C. This situation is illustrated in FIG. 7, where this volume is indicated by reference number 802. The volume Vc ′ is chosen to be approximately half the estimated missing volume Va1, as set forth in Equation 3 below in this document:

$$Vc\text{'}\text{'}\approx \frac{Va\mathrm{one}}{2}\text{(Equation 3)}$$

It is important to note that the volume Vc ′ is known exactly in system internal units. The exact nature of these units depends on the type of pump used, for example, units may be pump revolutions, pump cycles, etc. If the volumetric flowmeter is placed in one line with the pump, then the units provided with the flowmeter can be used as system internal units. Depending on the type of pump and type of pipeline, the volume resolution in this step can be very small, and even small volumes can be delivered accurately. In addition, a predictive flow rate determination system, as discussed in more detail herein below, can be used as system internal units.

Step 922 (Flushing volume Vc ′ to ionization chamber 160). Valve V1 is switched so that it connects ports "c" and "b". Pump 22 may function to pump a little more than the volume between the marks B and D of the saline solution through valve V1. Thus, the volume 802, which is equal to Vc ′, of the radiopharmaceutical is transferred to the coil section 444. The situation at the end of this step is illustrated in FIG. 8.

Step 923 (Activity Calibration). The activity in the coil section 444 is measured using an ionization chamber (measurement M2). This activity level will be called A2. It corresponds to the sum of the displaced activity A1 and the activity of the volume Vc ′, which will be called the “reference activity” Ac ′. This is illustrated in the second column of FIG. 11. Now, the concentration of activity in the container in system internal units, Cs, is calculated as set forth herein in Equation 4 below:

$$Cs=\frac{Ac\text{'}\text{'}}{Vc\text{'}\text{'}}=\frac{(A2-A\mathrm{one})}{Vc\text{'}\text{'}}\text{(Equation 4)}$$

The system is now calibrated in system internal units. After that, the volume Vc ″ is determined. The activity of Ac ″, which is still necessary to achieve the total activity of Ar, is determined as described in Equation 5:

$$Ac"=Ar-A2\text{(Equation 5)}$$

From this, the volume Vc ″ that still needs to be delivered is calculated in system internal units as set forth in Equation 6 in this document below:

$$Vc"=\frac{Ac"}{Cs}=\frac{(Ar-A2)}{Cs}=\frac{(Ar-A2)}{(A2-A\mathrm{one})Vc\text{'}\text{'}}\text{(Equation 6)}$$

This completes the calibration phase 920. In the next delivery phase 930, the following steps are carried out.

Step 931 (Filling the radiopharmaceutical to C ″). Valve V1 is switched to the position in which it connects ports "a" and "b". Pump 180 may function to pump the volume Vc ″ through valve V1, filling the third section 216 of the pipeline to mark C ″. This situation is illustrated in FIG. 9, where this volume is indicated by reference number 804.

Step 932 (Flushing volume Vc "to ionization chamber 160). Valve V1 is switched to connect ports" c "and" b ". Pump 22 may function to pump a little more than the volume between the marks B and D of the saline solution through the valve V1. Thus, the volume 804, which is equal to Vc, of the radiopharmaceutical is transferred to the coil section 444. Alternatively, the total activity in the coil section 444 is now measured (optional M3 measurement, see the right column of FIG. 11). It must exactly correspond to the total necessary Ar activity, provided that the volume of the coil section 444 is large enough to accommodate all three volumes 800, 802, and 804 inside this section. The latter condition can always be fulfilled if the volume of the coil section 444 is at least five times the volume of the third pipeline section 216. If a significant discrepancy is detected, the system is stopped.

Step 933 (Delivery to Injection Catheter). The valve V2 is switched so that it connects the ports "d" and "e". Pump 22 may function to pump at least the volume of coil section 444, plus the volume of conduit from coil section 444 to the injection catheter and the volume of the injection catheter itself, saline through valve V1. Thereby, all the liquid in the coil section 444 is supplied to the patient, and precisely the required dose of radioactivity is delivered to the patient.

This completes the delivery phase 930. If another injection of the same radiopharmaceutical (same or different patient) is necessary, then the operation is continued by repeating calibration and delivery phases 920 and 930. Otherwise, the operation is stopped using an acceptable shutdown procedure, which may include additional saline flushing cycles.

When repeating calibration phase 920, there is no need for additional initialization, as in phase 910, since the coil section 444 is already washed with saline and the radiopharmaceutical reaches exactly B. The activity is not present in the coil section 444. Therefore, in the above calculations, A1 can be set to zero in this case, and Am is set to Ar. No need for additional changes. The three-phase procedure with phases 910, 920 and 930 is now simplified to a two-phase procedure with phases 920 and 930 only.

It should be understood that various embodiments of the disclosed device and related methods of operation provide a number of inherent safety features. In particular, there is a high degree of duplication in the functioning of the device, so that even in the event of failure of one component, such as a pump or valve, it is impossible that more than the necessary dose is delivered to the patient. In particular, by design, the system will only allow the dose within the 444 coil section to be delivered to the patient. This is because during the actual delivery of the radiopharmaceutical, there is no connection between the container 902 and the liquid delivery line. The discrete nature of successive measurements of activity within the coil section 444 is another feature that enhances safety. At step 932, the activity in the coil section 444 is known in advance and the measurement M3 simply serves to confirm that the correct amount of activity is present in the coil section 444. If significant discrepancies between the expected result and the actual measurement are detected, the operation will be stopped immediately and an alarm will be given .

It will also be understood that in normal operation no amount of radiopharmaceutical will enter the waste tank 224. Thus, the generation of radioactive waste is minimized.

The disclosure now refers to specific embodiments, as illustrated in FIGURES 12-23, which can presumably be used in programming and operating a fluid delivery system, as broadly understood herein.

With reference to FIGURES 12-18, screen shots of the program used to determine the configuration of a multi-dose container that corresponds to the patient’s planned schedule with sufficient margin to allow for an allowable change in the schedule while minimizing the cost of the multi-dose container are illustrated. When starting the multi-dose container planning software on a computer, such as computer 1044, a clinician will be presented with a screen 1300, as illustrated in FIG. 12. Schedule 1302 is then provided as an input to planning a multi-dose container. This graph 1302 represents the patient load that is expected to be served by a multi-dose radiopharmaceutical container, such as container 902. Graph 1302 may include the time of the injection procedure (time entered in column 1304) for each patient, and activity (entered in column 1306 marked activity) removed from the multi-dose container 902 of the radiopharmaceutical for each patient.

Schedule 1302 can be entered using the following: manually entering time and activity for each patient into computer 1044 using an input device such as a keyboard; extracting time and activity for each patient from a storage device connected to a computer; or retrieving time and activity for each patient from a patient device located remotely through a network. While a computer can be used to enter graph 1302, this should not be construed as limiting the present disclosure, since any suitable computer device, such as, but not limited to, a mobile phone, personal digital assistant (PDA), or injector control system 5 , can be used to enter schedule 1302. In addition, while schedule 1302 was described herein above as a daily injection procedure schedule, this should not be construed as limiting the present disclosure, as any This time period can be used, such as a week, a month or a year.

Block 1308. The fill time allows the clinician to enter the time, preferably immediately after the first scheduled patient, at which the clinician will prepare the fluid delivery system 10 for use, as described herein above. By this time, a small amount of activity can be removed from container 902 to confirm the contents of container 902 or for the automatic injection system to remove air from the MPDS 200 and SPDS 700. The activity associated with this action is not provided by the clinician.

As soon as the clinician has entered the schedule 1302 and entered the fill time using the fill time block 1308, the clinician presses the update button 1310. With specific reference to FIG. 13, the update schematic button 1310 allows the computer processor 1044 to execute an algorithm to determine various operational container configurations and depicts these container configurations as blocks 1312 in diagram 1314. The x-axis of the diagram may be the volume of the container 902 and the y-axis may be the activity of the radiopharmaceutical liquid inside container 902. For example, point 1316 will represent a container having a volume of 20 ml and containing a radiopharmaceutical liquid having an activity level of 700 mCi.

The system determines the correct placement of blocks 1312 in diagram 1314 as follows. The order of the container of the radiopharmaceutical is typically determined by four parameters: (1) radiopharmaceutical / radioisotope; (2) sample time; (3) sample volume; and (4) sample activity. The radiopharmaceutical is generally established for use (e.g., FDG for PET). A sample time is the time at which a container contains a specific sample activity. Sample times are usually provided based on normal delivery schedules and can be determined by a clinician. Unknown factors to be determined are sample volume and sample activity. When the system determines these factors, all available solutions are placed on the diagram 1314 in the form of blocks 1312, as shown in FIG.13.

These values are determined by calculating all pairs of container volume and activity at a specific sample time, which may correspond to this graph, taking into account the operational limitations of the injection system to obtain blocks 1312 in diagram 1314.

The model considers the following operational limitations of the system: (1) Fill volume: the volume removed from the container to perform system installation operations, which cannot be used for dosing to the patient; (2) The minimum volume of 1316 doses: the minimum volume of radiopharmaceutical fluid in a single dose for the patient; (3) The maximum volume of 1318 doses: the maximum volume of radiopharmaceutical fluid in a single dose for the patient; (4) Unrecoverable volume 1320: the volume of the radiopharmaceutical fluid that the system cannot remove from the container; (5) Maximum activity 1322 of the container: the maximum activity of the container that can be entered into the system (individual values can be used to fill 1322a and to dose the patient 1322b); (6) The maximum concentration of 1324 containers: the maximum concentration of activity that is expected from the radiopharmaceutical fluid; (7) The maximum volume of 1326 containers: the maximum volume that can accommodate a container; and (8) Decomposition constant: the amount of radioactive decay for a radiopharmaceutical of interest. These values can be adjusted and changed by accessing the menu 1328 options from the vertical menu 1330 tools, as shown in FIG.

In order to make the calculations reliable, the clinician can provide the system with the volume provided in Step 1332 (for example, 0.5 ml) and Activity 1334 (for example, 10 mCi), which provide acceptable accuracy with respect to the entire solution space. These values can also be adjusted and changed by accessing the menu 1328 options from the vertical menu 1330 tools, as shown in FIG.19.

Based on the operational limitations listed above, it should be clear that only container volumes in the range from Unrecoverable Volume 1320 to Maximum Container Volume 1326 with a step of Volume Step 1332 should be considered, and container activity in the range from zero to Maximum Container Activity during Filling 1322a, referring to a given sample time, with the step of Step 1334 of the activity should be reviewed by the system.

Accepting this limitation of the operating range, the rules for determining container activity / container volume pairs, which are represented by blocks 1312 in FIG. 13, which correspond to the schedule, are as follows.

The first, initial concentration should be defined as Container Activity divided by Container Volume, referring to the container sample time. After that, the activity of the first patient is determined as follows: calculating the activity remaining after pouring by lowering the Initial concentration to the Planned injection time, and calculating the activity in accordance with the following expression: (concentration * (Container volume - Fill volume)). Then this activity decreases to the planned time of injection of the first patient. Next, the volume required for each dose of the patient is determined by lowering the Initial concentration to the Planned injection time, then the dose volume is calculated as the Planned dose / concentration.

A pair of container volume / container activity is considered an acceptable solution if all of the following is supported: 1) The initial concentration is greater than the maximum concentration of the container; 2) The minimum dose volume is less than or equal to all dose volumes that are less than or equal to the maximum dose volume; 3) the difference between the Container Volume and the sum of the Pour Volume and the Volumes of all doses is greater than the Unrecoverable Volume; and 4) the activity of the first patient is greater than the maximum activity of the container in the injection to the first patient.

The shaded area provided by block 1312 in FIG. 13 shows a typical solution space from the previous algorithm for a given graph of patient 1302 and sample container time. With reference to FIG. 14, this decision space is limited as follows:

B1) this boundary represents the highest attainable concentration in the system. The slope of this line is the lesser of the following: a) Maximum container concentration and b) Planned dose / Minimum dose volume of the first patient;

B2) this boundary represents the outgoing exactly Unrecoverable Volume remaining in container 902 with the last patient (the dose size of the last patient is limited by the residual recoverable volume in the system instead of the absolute size of the Maximum dose);

B3) this boundary represents the minimum activity necessary to comply with all the scheduled patients and fill without any other operational limitations of the system coming into force (for container configurations along this boundary, the dose volume of the last patient will be between the Minimum dose volume and the Maximum dose volume and will be a small amount of recoverable activity remaining in the container);

B4) this boundary represents the minimum concentration limit. The slope of this line represents the Planned Dose / Maximum Dose Volume of the last patient. For container configurations along this boundary, the dose volume of the last patient will be the Maximum dose volume and there may be a relatively large volume of radiopharmaceutical remaining in the container;

B5) this boundary represents the maximum volume of the vial; and

B6) this boundary represents the absolute limits of the maximum activity of the vial. A slope at this boundary appears if there is a higher Maximum activity of the vial when filling than when dosing, and the Planned injection time of the first patient is very close to the Planned injection time of the fill. Consulting physicians can choose any solution within the space provided by blocks 1312 to fit their schedule.

With reference to FIG. 15, schedule 1302 is editable after it is initially provided to accommodate additional patients, cancellations, temporary modifications to patients already provided on the patient’s planned schedule, modifications regarding activity removed from the multi-dose container of the radiopharmaceutical to patients, already provided on the patient’s planned schedule, or any combination of this. For example, a clinician may click on one of the activity values in graph 1302 using a mouse or any other suitable input device. Menu 1336 then appears, allowing the user to change the amount of activity for the patient. As soon as the clinician completes updating of any values in the schedule 1302 to obtain a new schedule 1302 ', the update schematic button 1310 is pressed and the algorithm discussed in this document is executed on the new schedule 1302' to obtain all pairs of container volume and container activity at a specific time samples that can fit the new schedule 1302 ', taking into account the operational limitations of the injection system, as represented by blocks 1312' in the diagram 1314 in FIG.16.

With reference to FIG. 17, activity units can be changed from mCi to MBq, using menu 1338 to obtain a new graph 1302 ", where activity is measured in MBq. In addition, after activity units have been changed to MBq, the clinician clicks on a schematic update button 1310 so that the algorithm discussed in this document is executed on a new schedule 1302 "to receive all pairs of container volume and container activity at a specific sample time, which may correspond to the new schedule 1302", taking into account the operating tional limit injection system, as represented by blocks 1312 "in the diagram 1314 in Figure 17. Computer 1044 can be connected to a printer so that a printed copy (printout) of both graphics 1302,1302 'or 1302 "and a diagram of a workable configuration of container 1314 can be created.

With reference to FIG. 18, a graph 1302, 1302 'or 1302 "may be transferred to the fluid delivery system of the radiopharmaceutical 10 by selecting the Export button 1340 from the pop-up file menu. This forces the computer 1044 to either save the graph to a removable storage device such as a flash drive -memory, or send a schedule to the fluid delivery system via the network 10. The clinician then orders the correct configuration of the multi-dose container and provides the configuration of the multi-dose container on the radiophase fluid delivery system devel- means 10 as described herein above.

With reference to FIGURES 20-26, a multi-dose container configuration monitoring system is described that provides for multi-dose use of a radiopharmaceutical according to the schedule of waiting patients and notifies medical consultants when there is a risk of inability to administer doses on a full schedule. FIGURES 20-26 schematically illustrate various embodiments of the layout of a touch screen 1100 displayed on a graphical user interface, such as GUI 15, that can be used with a fluid delivery system 10. By way of non-limiting example, such a touch screen arrangement can be used in conjunction with a system controller 5 of any of a variety of fluid delivery systems, as provided broadly herein.

In order to clearly and unambiguously inform the operator of the current status of the liquid delivery system 10, the GUI 15 with legible characters and icons, including extremely operator-friendly data entry mechanisms, are provided in a broad sense. The operator will thus be able to intuitively understand and perform various tasks for operating the fluid delivery system 10.

While the layout of the touch screen is provided in conjunction with FIGURES 20-26, it should be understood that other types of layouts for data input are possible that will achieve an equivalent purpose. For example, input using the on-screen or hardware key can be used, as well as layouts with the trackball, layouts with the mouse or the touchpad of cursor control (remote from the screen).

With continued reference to FIG. 20, the main operator interface provided on the touch screen is illustrated before the injection procedure has been started and before the schedule has been transferred to it. After that, the operator prepares the system 10 for the fluid delivery procedure, the system 10 creates a display 1100, shown in FIG. 20, which shows on its upper left side that the “System is ready”. The touch screen includes a saline field 1102 and a pharmaceutical or FDG field 1104 providing an indicator of the amount of saline in source 23 and FDG in container 902, respectively. For example, a saline solution field 1102 indicates that 664 ml of saline solution is available and an FDG1104 field indicates that 372 mCi FDG are available, as shown. 1106 shows a sensory field showing the desired activity (currently displayed as 15.0 mCi) for the injection procedure to be performed. When system 10 is activated, the desired activity field 1106 can display a default activity value that can be pre-programmed in system 10 or preset by the operator. Alternatively, the desired activity field 1106 may be set by default with respect to the last activity level that has been programmed in system 10.

1112, 1114, 1116 and 1118, respectively, in FIG. 20, cyclic status icons are indicated that provide a quick and easy reference to various aspects of the system status and, in fact, will be displayed when the system status aspect is “on” or “active” , or provide status information to the system 10. Thus, the left-to-right icons 1112-1118 respectively transmit information on the following aspects of the system: present activity 1112, fluid movement / injection status 1114, air check / fill status 1116 and s ATUS 1118 system battery.

A system battery (not shown) provides power to the system controller 5 and the ionization chamber 160 (to maintain the ionization chamber in its normal functional state) when the system 10 is disconnected from the AC source. The system battery charges while system 10 is connected to an AC source.

20 also shows four additional sensor fields 1120-1123 along its lower part. A reload button 1120 is activated to reload or clear information, such as case identification information, desired activity level, etc., from the treatment screens. The configuration button 1121 is activated to access the configuration screens for system 10. The schedule button 1122 is activated to access the scheduling interface to allow the operator to schedule a plurality of injection procedures into the system 10. The treatment button 1123 is activated to access the injection control screen shown in FIG. 19. In addition, the operator can enter case information, including patient identification and injection site information, into system 10. When the operator activates the edit button 1208 in the case ID field 1206, a Case Information pop-up display is provided to enter a patient identification number or other the identification number and injection site at which the radiopharmaceutical will be injected or injected.

If the operator wants to schedule a schedule for one or more injection procedures, he activates the schedule button 1122, thereby creating a pop-up window 1126, shown in FIG.21. At this point, the operator can enter the schedule 1302, 1302 'or 1302 "created as described herein above by pressing the schedule button 1128. The operator can modify this schedule 1302, 1302' or 1302" or create a new schedule by pressing on the button 1130 add destination. The operator can also clear any schedule that is already in the system 10 by pressing the clear schedule button 1132. As soon as the schedule is entered, it appears in the window 1134 schedule. The operator can view the schedule and make any appropriate changes using the button 1130 to add an appointment. Once the operator is satisfied with the schedule, he presses the treatment button 1123 and returns to the main operation screen 1101 with the chart subwindow 1136 filled in with the entered schedule, as shown in FIG. 22. If for some purpose during the operation the system determines that the current configuration of the multi-dose container will not be able to provide the scheduled activity to the scheduled time at the scheduled time, the system will provide an alert to the operator in the information window 1142 and highlight the scheduled 1144 injection procedure in window 1134 graphics as shown in FIG. 23. System controller 5 may offer permissions so that the schedule is able to suitably infuse the patient, which may include adjusting the time of the injection procedure or adjusting the activity of the dose schedule, for example, by presenting to the operator the range of activity levels 1146 that are available to the patient. For example, the operator attempted to schedule an injection procedure at 16:00, which required a radiopharmaceutical with an activity level of 925 MBq. If the current configuration of the multi-dose container is not able to accommodate such an injection procedure, then the injection procedure 1144 provided for in the schedule is displayed and the range of activity levels 1146, such as 18-430 MBq, is presented to the operator, which will enable the operator to schedule the patient at 16:00. This range represents the minimum dose activity and maximum dose activity achievable for this patient. If this level of activity is available to the operator, then the operator can adjust the injection procedure at 16:00 in order to have an activity level of 18-430 MBq everywhere. If this level is not available, then the operator must cancel the procedure or adjust the time of infusion.

The system may also be able to recommend and propose changes in the radioactive dose and / or time of infusion for the following patients in the schedule together to maximize the ability of the system and the operator to infuse all patients in the schedule. The proposed changes may be for each subsequent patient or for the whole schedule. Any proposed changes to the schedule must be approved by the operator.

With reference to FIG. 24, the operator, after filling in the system, as discussed hereinabove, then activates the infusion button (not shown) to start the injection procedures provided in the subwindow 1136 of the graph.

System 10 further includes a multi-dose container configuration monitoring system, which involves multi-dose use of a radiopharmaceutical according to the schedule of pending patients and notifies consultants when there is an inability to administer doses on a full schedule. The correct functioning of the monitoring algorithm requires compliance with certain preconditions. If any of these prerequisites is not met, instead of predicting the use of the container on the chart, the monitor should indicate to the user that it is not possible to provide a forecast for the use of the radiopharmaceutical until the precondition is satisfied.

Preconditions are as follows. First, monitoring requires that, as an input, a patient schedule is entered, as discussed above in this document. The schedule is editable after the initial input to accommodate additional patients, cancellation and modification of the time / dose of the prescribed schedule to patients. In order for the monitor to work correctly, the operator must have a scheduled fill input and the times / doses provided for the schedule for all patients.

The following precondition is that the monitor requires an assessment of the residual recoverable activity and volume of the radiopharmaceutical at a given time. This is typically based on baseline information about a multi-dose container sample than on liquid removed from a multi-dose container, and is adjusted for unrecoverable volume and isotopic decay. An activity monitoring device, such as an ionization chamber, a CZT crystal detector, a Geiger-Muller counter, or a scintillation counter, can be used to determine this information.

The third prerequisite is based on the fact that a monitor algorithm is provided to predict dosing for the following patients. It is possible that one patient missed a turn, in this case, the monitor can realistically compare the patient with the current time. However, a reliable prognosis is not possible if more than one patient misses a turn. Accordingly, a monitor requires that no more than one patient awaiting a dose be scheduled in the past.

If all preconditions are met, the monitor uses the following algorithm to determine if a given patient schedule can be followed. The monitor uses the same system operational limitations discussed in this document above, as well as: 1) Recoverable volume: the volume remaining in the multi-dose container available for dispensing (this is the total volume remaining in the multi-dose container is less than the non-recoverable volume); and 2) Recoverable activity: activity remaining in a multi-dose container, available for dosing. Accepting these parameters, the monitor will determine the prospects of observing this schedule with a multi-dose container according to the following algorithm: 1) set the initial values of the parameters, such as Initial concentration and Initial time; and 2) for each item in the schedule that has not yet been completed (for example, filling, patients who have not received a dose), take the following action in order according to the schedule for the injection time: 2.1) set the Delta time to a large difference between the schedule for the injection time and start time or zero; 2.2) establish the Current concentration by reducing the Initial concentration by Delta time; 2.3) for patient points, set Dose Activity to the Planned Dose and for fill points, set Dose Activity to the Fill Volume multiplied by the Current Concentration; 2.4) for patient points, calculate the Dose Volume as the Dose Activity divided by the Current concentration and for the fill points, set the Dose Volume to the Fill Volume; 2.5) calculate the Maximum dose activity as the Current Concentration multiplied by the smallest of the Maximum dose volume or Recoverable volume; 2.6) calculate the Minimum dose activity as the Minimum dose volume multiplied by the Current concentration; and 2.7) if any of the following is true, then mark the current and subsequent items in the schedule as having the risk of dosing with the current multi-dose container 902:

a. Dose activity is less than the minimum dose activity; and

b. Dose activity is greater than the maximum dose activity.

If step 2.7 determines that the scheduled item has this risk, processing should be stopped and the operator should be warned. Otherwise, the parameters for processing the next item in the graph are updated by updating the Recoverable Volume by subtracting the Dose Volume from it.

Items in the graph can be marked by highlighting on the screen the items in the subwindow 1136 of the graph, as shown in FIG. 25 with the position number 38, to notify the operator that it is likely that an action is necessary in their part. Moreover, the first item with risk in the graph should represent the Minimum dose activity and Maximum dose activity achievable for this patient, thereby providing the operator with sufficient information to determine the best course of action for this item. For example, a clinician may decide to administer a dose to a patient using the current container 902, even if the patient is at risk if the shortage is still within an acceptable dosage range.

In addition, as soon as the points are completed, the schedule is updated using actual indicators of injection time and doses. This provides the clinician with a history of injections using the current container. In addition, an icon, such as a green mark 1140 for the completed injection procedure and a yellow P 1138 for the partial injection procedure, can be placed after each item in the graph in the graph subwindow 1136, as shown in FIG. 26.

The main goal of planning and monitoring multi-dose pharmaceutical procedures is to optimize the schedule of injection procedures to minimize the amount of radiopharmaceutical that is emitted and to maximize the number of injection procedures that are performed using this radiopharmaceutical configuration. Accordingly, the system uses a two-step procedure to achieve this goal. Firstly, the operator uploads a schedule of injection procedures to the system, which includes the time and the required level of activity for each of the procedures and provides the user with many configurations of a multidose container of a radiopharmaceutical that can be used to meet these needs, as discussed in this document above with reference FIGURES 12-19. Along with the time and the necessary level of activity for each injection procedure, the system can also consider at least one of the following factors in determining the many configurations of a multidose container of a radiopharmaceutical that are presented to the user: 1) delivery logistics; 2) the distance from the institution receiving the radiopharmaceutical; 3) container size; 4) the flexibility of using a radiopharmaceutical; 5) the schedule for receipt at the institution receiving the radiopharmaceutical; 6) loss of the injection system (for example, waste, pouring, etc.); and 7) the half-life of the radiopharmaceutical. However, these factors should not be construed as limiting the present disclosure, as the system may also consider a variety of other factors that may need to be considered in this definition. After that, the operator selects the appropriate configuration of the multi-dose container of the radiopharmaceutical and starts the scheduled injection procedures.

The second stage of the procedure takes place, if the schedule changes during the injection procedures, the system then recommends a new schedule that optimizes the number of scans and / or injections that can be performed by suggesting changes in the radioactive dose and / or time of infusion for each next patient or for the whole schedule. This maximizes the ability of the systems to infusion to all patients on schedule and minimize the waste of the radiopharmaceutical.

Although various embodiments have been described in detail for the purpose of illustration, it should be understood that such a part serves solely this purpose and that the disclosure is not limited to the disclosed embodiments, but, on the contrary, is intended to encompass modifications and equivalent arrangements. For example, it should be understood that this disclosure implies that, as far as possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims (15)

1. A method for planning and monitoring the use of a radiopharmaceutical, wherein the method includes the following:
obtaining a patient schedule for a plurality of radiopharmaceutical injection procedures;
based on the patient's schedule, determining the configuration of a multi-dose container for use in a plurality of radiopharmaceutical injection procedures;
transferring a patient's schedule to a radiopharmaceutical fluid delivery system;
providing a multi-dose container configuration on a radiopharmaceutical fluid delivery system;
conducting multiple injection procedures of the radiopharmaceutical based on the patient's schedule;
monitoring the configuration of a multi-dose container during a plurality of radiopharmaceutical injection procedures;
determining if there is a risk that at least one of the many radiopharmaceutical injection procedures cannot be completed properly due to one or more changes in the patient's schedule; and
providing an alarm in response to risk in determining it. 2. The method of claim 1, wherein the patient schedule includes, for each of the plurality of patients, the time of the injection procedure of the radiopharmaceutical for the patient and activity removed from the multi-dose container of the radiopharmaceutical for the patient. 3. The method according to claim 1, further comprising the following:
editing the patient schedule after configuring the multi-dose container to accommodate one or more of the following: additional patient, canceled patient, temporary modification for the patient on the patient schedule, and modification with respect to activity removed from the multi-dose container configuration for the patient on the patient schedule. 4. The method according to p. 1, where monitoring the configuration of a multi-dose container includes the following:
determination of the residual activity and the configuration volume of the multi-dose container to provide an estimate of the residual activity; and
regulation of the assessment of residual activity based on isotopic decay. 5. The method according to claim 1, further comprising the following:
updating the patient's schedule so that it accommodates the maximum number of many procedures for injecting a radiopharmaceutical in response to risk in determining it. 6. The method according to p. 1, further comprising the following:
displaying a patient graph on a graphical user interface of a radiopharmaceutical fluid delivery system. 7. A computer-readable storage medium for planning and monitoring the use of a radiopharmaceutical, containing instructions that, when executed, allow the processor to do the following:
Obtain a patient schedule for multiple radiopharmaceutical injection procedures
on the basis of the patient’s schedule, determine the configuration of the multi-dose container for use in a plurality of radiopharmaceutical injection procedures;
monitor the configuration of a multi-dose container during a variety of radiopharmaceutical injection procedures;
determine if there is a risk that at least one of the many radiopharmaceutical injection procedures cannot be completed properly due to one or more changes in the patient's schedule; and
provide an alarm in response to risk when determining it. 8. The computer-readable storage medium according to claim 7, containing additional instructions that, when executed, allow the processor to transfer the patient's schedule to the radiopharmaceutical fluid delivery system. 9. The computer-readable storage medium of claim 7, wherein the schedule includes, for each of a plurality of patients:
injection procedure time for the patient; and
activity removed from the configuration of a multi-dose container for a patient. 10. The computer-readable storage medium according to claim 9, where the instructions, which, when executed, allow the processor to obtain a schedule, allow the processor to carry out at least one of the following:
receive time and activity for the patient from the user through the computer;
get time and activity for a patient from a storage device connected to a computer; and
get time and activity for a patient from a patient device located remotely through a network. 11. The computer-readable storage medium according to claim 7, containing additional instructions that, when executed, allow the processor to edit the patient’s schedule after the multi-dose container is configured to accommodate one or more of the following: additional patient, canceled patient, temporary modification for the patient to patient schedule; and modification with respect to activity removed from the configuration of the multi-dose container for the patient in the patient schedule. 12. A fluid delivery system for a radiopharmaceutical, comprising:
source of radiopharmaceutical;
a disposable administration kit configured to provide fluid flow from a radiopharmaceutical source to a patient;
a fluid communication mechanism with a disposable administration kit and a source of a radiopharmaceutical, and configured to pump fluid from a radiopharmaceutical source through a disposable administration kit to a patient;
a control unit operably connected to the pump mechanism and configured to obtain a patient schedule, determine the configuration of a multi-dose container for use in a plurality of radiopharmaceutical injection procedures, control the pump mechanism for a plurality of radiopharmaceutical injection procedures based on a patient schedule, monitor the multi-dose configuration container during many radiopharmaceutical injection procedures, determine if tvuet there is a risk that at least one of the plurality of radiopharmaceutical injection procedures can not be completed properly in connection with one or more changes in the patient's chart, and to provide an alarm signal in response to the risk in its definition; and
a display unit operably connected to a control unit for displaying a graph. 13. The radiopharmaceutical fluid delivery system of claim 12, wherein the disposable administration kit includes the following:
component of the medical fluid;
component of a radiopharmaceutical;
a coil component connected to the component of the medical fluid and the component of the radiopharmaceutical; and
a waste container connected to a medical fluid component, a coil component, and a radiopharmaceutical component. 14. A method for optimizing a schedule of a plurality of radiopharmaceutical injection procedures, wherein the method includes the following:
obtaining a schedule of multiple radiopharmaceutical injection procedures to obtain a planned patient schedule;
transferring the patient’s planned schedule to the radiopharmaceutical fluid delivery system;
changing the planned patient schedule to obtain an updated planned patient schedule;
suggesting one or more changes in at least one of the radioactive dose and infusion time for at least one next patient in the updated planned schedule of the patient; and
providing an alarm in response to the risk that at least one of the plurality of radiopharmaceutical injection procedures cannot be completed properly due to one or more of the alleged changes. 15. The method according to p. 14, further comprising:
Definition of a new, optimized patient schedule based on one or more proposed changes.

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