Patent Application
20050277833
The present invention relates generally to handling, mixing, and/or dispensing systems and methods. More particularly the present invention relates to a system, method, and/or computer program product for the handling, mixing, dispensing, and/or injection of a mixture containing, for example, radiopharmaceutical agents, for use in various types of diagnostic imaging and/or therapeutic procedures.
Emissions from radioactive sources are often used in the medical field to provide imagery of internal body structures including, but not limited to, bone, vascular, organ systems, and other tissue. In addition, such emissions may also be used as therapeutic agents to inhibit the growth of targeted cells or tissue, such as, for instance, cancer cells. In addition, some pharmaceutical agents and/or radiopharmaceutical agents having hazardous physical and/or chemical effects when exposed to individuals (including, but not limited to, clinicians, imaging technicians, and pharmacists) are also often used in the medical field in therapeutic, diagnostic, and/or other medical procedures.
According to conventional radiographic diagnostic imaging techniques, such as X-ray procedures, X-rays pass through a target object and expose an underlying photographic film. The developed film then provides an image of the radiodensity pattern of the object. Less radiodense areas produce a greater blackening of the film; more radiodense, bony tissues produce a lighter image. Effective contrast agents for X-ray may be either less radiodense than body tissues or more radiodense. The less radiodense agents include, for example, air and other gases; an example of a more radiodense contrast material is a barium sulfate suspension.
Computed tomography (CT) is superior to conventional radiography in its ability to image, with extremely high resolution, a succession of thin sections of an object at specific points, lines or planes along the X, Y, or Z axis of the target object. However, because this procedure is also based on the detection of differences in radiodensity, requirements for contrast agents in CT are essentially identical with those for conventional radiography.
Magnetic resonance imaging (MR) systems for body imaging operate on a different physical principle. Generally, MR relies on the atomic properties (nuclear resonance) of protons in tissues when they are scanned with radio frequency radiation. The protons in the tissue, which resonate at slightly different frequencies, produce a signal that a computer uses to tell one tissue from another. MR can provide detailed three-dimensional soft tissue images.
Other imaging methods, however, that are used to obtain information about function-related tissues, may use radiopharmaceutical agents and/or other pharmaceutical agents as tracers to interact with the targeted tissues. These methods include, but are not limited to, procedures such as single photon emission computerized tomography (SPECT) and positron emission tomography (PET). SPECT uses a molecule normally found in the body in which one of the atoms of the molecule is replaced by a radioactive atom contained within a radiopharmaceutical agent that is injected into the individual. The radiopharmaceutical agent, which is chosen for its ability to interact with specific tissues, is sometimes called a tracer. The tracer emits photons that can be detected as the tissue is scanned at various angles or as the photons pass through a detector array. In certain embodiments, a computer reconstructs a 3-dimensional color tracer image. PET uses radiopharmaceutical agents as tracers to produce 3-D color images with a greater sensitivity than with SPECT. PET can be used in combination with CT to create a complimentary imaging effect in an imaging technique called CT-PET.
The radioactivity levels of the radiopharmaceutical agents used as tracers in, for instance, SPECT and PET procedures, are measured by medical personnel such as radio-pharmacists, to determine the radiation dose that the individual will receive during the course of a diagnostic procedure. The radiation dose received depends on a number of factors, including the half-life of the radiopharmaceutical agent (which, in turn, determines the total time the individual is exposed to radiation from the radiopharmaceutical agent), and the initial radioactivity level of the radiopharmaceutical agent at the time it is injected into the individual.
In PET imaging, an injectable radiopharmaceutical agent such as, for instance, FDG (fluorodeoxyglucose), is fabricated in a cyclotron device. Thereafter, the FDG may be transferred in a container device that may further comprise, for instance, an inner container device and a shielding, to prevent unnecessary radiation exposure to personnel, such as the radio-pharmacist, responsible for transporting/handling 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 the FDG to the PET imaging site. Depending upon the elapsed transport time and the initial radioactivity level of the FDG at the time of fabrication, it is often required that the radioactivity level needs to be re-measured at the PET imaging site. Should a specific initial FDG radioactivity level, typically expressed milliCuries/milliliter be required at the time of patient injection, a radio-pharmacist at the PET imaging site may dilute the raw FDG with a diluent such as, for instance, IV saline solution, prior to loading the injection device with a specified volume. During this process, the handling of the FDG from container device to injection device for patient injection may be entirely manual. Within this process, several products are currently marketed to aid in shielding individuals from FDG during handling and dose calibration (measuring radiation). Although shielding may reduce the radiation exposure of the radio-pharmacist in handling the shielded vial, the radio-pharmacist may still be exposed to emissions from the radiopharmaceutical agent during the manual mixing and/or dilution process required to obtain the required dose. In addition, in some medical procedures, pharmaceutical agents or other materials emanating toxic and/or otherwise harmful emissions may be suitable for dispensing into an individual for diagnostic, therapeutic, and/or other medical procedures. It may be preferable, however, to shield individuals administering such procedures (including, but not limited to clinicians, pharmacists, and technicians), from the harmful emanations of such agents and/or materials.
Thus, there exists a need for a system, method, and/or computer program product for handling, mixing, dispensing, and injecting a mixture containing a first material, such as, for instance, a radiopharmaceutical agent and a second material, such as, for instance, an intravenous saline solution, such that an operator of such a system (e.g., a radio-pharmacist, clinician, or other individual) is subjected to reduced exposure to and/or reduced handling of the first material or mixtures formed that may contain the first material. In addition, there exists a need for a system and method for automatically mixing, diluting, and/or dispensing into an injection device such that the mixture containing, for instance, a radiopharmaceutical agent, provides a selected radiation dose amount when injected into an individual.
In at least one alternative embodiment, the present invention provides a system comprising one or more container devices for holding a first set of one or more materials and one or more dispensing devices for holding a mixture of at least a portion of the first material and a set of one or more second materials, and other substances as well. The system of the present invention may also comprise one or more mixing devices or automated injector devices for receiving the containers so as to reduce the handling of the first material contained in the containers, for example. The mixing device may be further capable of mixing at least a portion of the first material with at least a portion of the second material according to a predetermined ratio to form a mixture. The mixing device may also direct the mixture to the dispensing device for dispensing one or more mixtures into an individual. In some embodiments of the present invention, the mixing device may be integrated with an automated injector device such that the power injection device may receive the one or more container devices to mix at least a portion of the first material with at least a portion of the second material according to a predetermined ratio to form the one or more mixtures that may then be automatically injected into an individual.
According to other aspects of the present invention, the present invention may further comprise one or more second containers for holding the second material, and a computer device operably engaged with the mixing device and configured to cooperate with the mixing device to produce the mixture according to the predetermined ratio. In other embodiments, the one or more container devices and the one or more dispensing devices may each further comprise one or more shieldings for shielding operators from radiation or other caustic or hazardous emissions that may emanate from the first or second materials and the resulting mixtures, respectively.
Another embodiment of the present invention comprises a method and/or computer program product for forming a mixture. Such a method may comprise steps for receiving at least a first container suitable for holding a first set of one or more materials at at least one mixing device, wherein the mixing device is capable of receiving the first container so as to reduce the manual handling of the first material that may be contained therein. At least a portion of the first material is mixed with at least a portion of a second material according to a predetermined ratio to form the mixture using the mixing device, the mixing device being further suitable for receiving one or more dispensing devices suitable for holding the mixture. The mixture formed by the mixing device is then directed to the one or more dispensing devices, wherein the one or more dispensing devices are suitable for dispensing the mixture so as to reduce the handling of the mixture contained within the dispensing device.
In other embodiments, the method of the present invention may further comprise the steps of dispensing the mixture to an individual using the dispensing device, inputting a predetermined radiation dose amount into a computer device operably engaged with the mixing device, converting the radiation dose amount into the predetermined ratio of first material to second material in the mixture, and injecting the mixture into an individual. The present invention may comprise mixing multiple materials in various combinations.
Embodiments of the present invention may also include a system and method whereby a mixture comprising at least a portion of a first and a second material is formed and transferred to a dispensing device wherein an operator using the system is minimally exposed to the first material and/or mixture formed by the mixing device of the system. Some embodiments of the present invention also provide a system wherein a computer device, in communication with a mixing device, may form a mixture by mixing a first material comprising, for instance, a radiopharmaceutical agent, and a second material, serving as a diluent, wherein the mixture is automatically formed having a predetermined radiation dose amount that is based on a predetermined ratio of the first material to the second material in the mixture.
The present invention also includes a mixture formed by the method embodiments described above including the steps of: operably engaging one or more containers, each one or more container holding one or more materials, with a mixing device, so as to supply the one or more materials to the mixing device and reduce handling of the one or more materials contained in the one or more containers; mixing, with the mixing device, one or more materials according to a predetermined ratio to form the mixture; and directing and/or situating the mixture relative to a dispensing device. Furthermore, according to other embodiments of the present inventions a method for preparing a radiopharmaceutical agent for injection into an individual is provided, which first comprises engaging one or more containers suitable for holding one or more materials, the one or more materials comprising one or more radiopharmaceutical agents, with a mixing device, so as to supply the materials to the mixing device and reduce handling of the materials contained in the one or more containers. The embodiment for preparing a radiopharmaceutical agent for injection further comprises the steps of: mixing, with the mixing device, the one or more materials according to a predetermined ratio to form the mixture; and directing the mixture to a dispensing device, the dispensing device being adapted for dispensing the mixture into an individual.
Such embodiments provide significant advantages as described and otherwise discussed herein.
Reference will now be made to the accompanying drawings, which are not necessarily drawn to scale. The drawings are for illustrative purposes only, and are not intended to limit the scope of the present invention.
The present invention will be described with reference to the accompanying drawings, where applicable. It is understood that the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided for illustrative purposes only. Like numbers refer to like elements throughout.
While the embodiments of the system and method for handling, mixing, dispensing and/or injecting mixtures including, for instance, radiopharmaceutical agents, are described below in the context of PET imaging techniques utilizing FDG as the first material, it should be understood that the embodiments of the present invention may also be utilized to handle, mix, dispense, and/or inject a variety of substances such that the substances are diluted, mixed, and/or manipulated such that the first and second materials are mixed according to a predetermined ratio to produce a mixture characterized by, for instance, a selected radiation dose amount. Further, the mixtures formed by the various embodiments of the present invention may be utilized in a variety of different imaging and/or therapeutic procedures requiring a mixture comprising a, pharmaceutical agent, for example.
As used herein, the term “material” may include, but it not limited to, one or more components which may include, but are not limited to, pharmaceutical agents, radiopharmaceutical agents, therapeutic agents, diagnostic agents, chemical compounds, diluents, flushing media, contrast media, or other materials that may be suitable and/or necessary for use in therapeutic, diagnostic, and/or medical procedures.
As used herein, the term “mixture” includes, but is not limited to, a combination, fusion, and/or blend of one or more of the materials or components described herein. According to some embodiments of the present invention, the mixture may be formed by physically and/or chemically mixing one or more of the materials or components described herein. Thus, “mixtures” of the present invention may include, but are not limited to, physical or chemical combinations of materials or components.
According to some embodiments, “radiopharmaceutical agents” may comprise radioactive materials capable of emitting radiation that may be harmful to individuals administering such material if the material is not shielded to reduce the amount of emitted radiation. Further, in some embodiments, pharmaceutical agents may also comprise toxic, caustic, and/or otherwise hazardous compounds such that the handling of such pharmaceutical agents by individuals should be reduced whenever possible.
The term “radiopharmaceutical agent” also includes, but is not limited to, a material, mixture, and/or pharmaceutical agent emitting radiation therefrom and/or providing a quantifiable radiation dose to an individual exposed thereto. Radiopharmaceutical agents may be capable of emitting radiation for treating a medical condition (for example, such as a cancerous tumor), diagnosing a medical condition (for example, by providing a radioactive marker that is detectable by an imaging or other diagnostic device), or providing images of a patient as part of a medical imaging procedure (for example, by acting as a radioactive marker or contrast media). The radiopharmaceutical agents of the present invention may be administered to an individual via injection, ingestion, or other suitable means. The term “radiation dose” includes, but is not limited to, an amount of radiation absorbed by an individual during a therapeutic, diagnostic, and/or medical procedure, wherein the radiation does may be measured using units of measure that may include, but are not limited to rem, Roentgen, curies, and/or other suitable units of measure for radiation dosage. According to embodiments of the present invention, a predetermined radiation dose may be calculated by a computer device with input from an individual in order to prepare a radiopharmaceutical agent capable of providing the predetermined radiation dose.
As used herein, the term “diluent” includes, but is not limited to, a material that may comprise liquid, solid, or gaseous materials suitable for dilution of one or more pharmaceutical agents, mixtures, or materials. Diluents may comprise various materials including, but not limited to, water, saline solutions, flushing media, intravenous solutions, or other materials suitable for diluting, flushing, or diminishing the effects of a pharmaceutical agent. In some embodiments, the diluent may be physically and/or chemically mixed with a radiopharmaceutical agent to prepare a mixture capable of providing a predetermined radiation dose when administered to an individual.
The container device 110 may also comprise shielding 113 including, but not limited to, a lead, tungsten, polycarbonate layer, or any other layer having a thickness suitable for reducing a radiation dose received by an individual operating the present invention, wherein the radiation dose may be produced by the first material 115. One skilled in the art will appreciate that the shielding 113 may be accomplished in various manners and the shielding 113 may be altered in material, thickness, number of shielding components, and other parameters in order to provide an individual with appropriate protection from a variety of radiation types, including, but not limited to, x-rays, beta radiation, gamma radiation, and other forms of radiation, depending on the characteristics of the first material 115 contained within the container device 110. One skilled in the art will appreciate that the shielding 113 may, in some cases, be incapable of completely eliminating the absorption of radiation by an individual, however, according to the various embodiments of the present invention, the shielding 113 is suitable for reducing, and in some cases minimizing and/or eliminating the radiation dose received by an individual from a material placed within the container device 110. The shielding 113 may also be suitable for protecting an individual from other toxic and/or hazardous effects of the materials, in addition to radiation. For example, the shielding 113 may provide means for reducing an individual's exposure to toxic and/or hazardous effects that may include, but are not limited to, toxic fumes, caustic materials, and/or otherwise harmful emissions that may emanate from materials contained within the container device 110.
According to one embodiment, the container 110 may further comprise an inner container 111 for holding the first material 115. In this embodiment, the inner container 111 may be placed within the shielding 113 of the container 110 so as to provide shielding from radiation emissions that may be produced by the first material 115 which may further comprise one or more radiopharmaceutical agents or other pharmaceutical agents. The inner container 111 may further comprise a material, including but not limited to, for example, a vial composed of polymer, glass, metal, or other material suitable for containing the first material 115. Furthermore, the inner container 111 may be, in some embodiments, reusable for multiple mixing iterations in the present invention. According to other embodiments, the inner container 111 may be discarded and replaced after the first material 115 is removed from the container device 110 as described below. Furthermore, according to some embodiments, the container device 110 may be provided without an inner container 111, such that the first material 115 is held directly within the container 110. Further, in alternative embodiments, the container 110 may be provided with multiple inner containers 111 that may comprise additional material layers suitable for shielding an individual from the first material 115 or emissions emanating therefrom. According to embodiments of the present invention, the container device 110 (and inner container 111, where applicable) may be suitable for minimizing handling of the first material 115 by a clinician or other operator of the present invention. Such embodiments may be especially suitable for minimizing individuals' handling of toxic, caustic, and/or otherwise harmful materials that may be components of the first material 115.
As shown in
The container 110 and/or mixing device 130, according to other embodiments of the present invention, may be operably engaged with a measuring device 117 (such as, for example, a first radiation measurement device, or dosimetry device 117) suitable for determining a radiation dose emitted by the first material 115. In such embodiments, the measuring device 117 may be located on or integrated into the container 110 such that as the container device is received by the mixing device 130 of the system, the measuring device may be in communication with a measuring port disposed on an exterior surface of the mixing device 130. In other embodiments of the present invention, the container 110 may alternatively comprise a measuring port such that as the container device is received by the mixing device 130 of the system, the measuring port may be in communication with a measuring device 134 disposed on an exterior surface of the mixing device 130. The measuring device 117,134 utilized in the various embodiments of the present invention may comprise various types of radiation detection sensors, including, but not limited to, a dosimeter, Geiger counter, and/or other radiation detection means. One skilled in the art will appreciate that the measuring device 117, 134 may comprise different types of radiation detection sensors suitable for measuring the radiation dose produced by various types of, for instance, radiopharmaceutical agents, that may be utilized in the embodiments of the present invention. In addition, according to some other embodiments of the present invention, the measuring device 117, 134 may comprise a radiation detection sensor operably engaged with a digital circuit so as to provide digital information to the computer device 135 corresponding to the radioactivity level of the first material such that the predetermined ratio may be selected to produce a mixture having a predetermined radioactivity level. As described below, the computer device 135 may be operably engaged with and in communication with the dispensing device 120, according to some embodiments of the present invention.
The container 110 may also further comprise a first memory device 118 operably engaged therewith. The first memory device 118 may be configured to receive a data set related to the first material, wherein the data within the data set related to the first material may include, but is not limited to: radiation dose of the first material at its time of fabrication, method of fabrication (such as cyclotron or irradiating device), time of fabrication, type of substance (such as, for example, FDG), and other data related to the first material. In one alternative embodiment, the data set related to the first material may be transferred to the first memory device 118 by a wire-based electronic connection such as USB port, or other physical wire connection. In other embodiments, the data set related to the first material may be transferred to the first memory device 118 by wireless methods including, but not limited to, radio frequency (RF), infra-red (IR), bluetooth or other wireless methods. The data set related to the first material stored in the first memory device 118 may be useful, for instance, in aiding the operator of the system in identifying the first material and the characteristics thereof, by, for instance, interrogating the first memory device 118, using for instance RFID technology, wire-based electronic connection, or other suitable connection to an electronic device adapted to display the data set related to the first material upon electronically interrogating the first memory device 118. In one alternative embodiment of the present invention, the computer device 135 may be in communication with the mixing device 130 of the present invention and may be configured to be capable of interrogating the first memory device 118 to access the data set related to the first material contained within the container device 110 so as to be capable of cross-checking, for example, the expected radiation dose of the first material (which may be calculated by the computer device 135, for example, based on the known half-life of the first material and the radioactivity level of the first material at the time it was placed in the container device 110). Thus, the computer device 135 may be adapted for comparing the calculated expected radiation dose of the first material with the detected radiation level of the first material that may be transmitted by the measuring device 117, 134 that may be operably engaged with the container device 110 in order to determine the substantially real-time radiation level of the first material.
According to some embodiments of the present invention, a plurality of container devices 110 may be used to contain a corresponding plurality of first materials which may comprise a variety of different materials, components, mixtures, or other compounds suitable for administering to an individual as part of a diagnostic, therapeutic, and/or medical procedure. In addition, the mixing device 130 described herein may be capable of operably engaging the plurality of container devices so as to be capable of mixing a plurality of first materials to generate a mixture containing, for example, one to ten (or more) first materials to form a mixture as described herein.
The mixing device 130 may be configured to mix at least a portion of the first material 115 with at least a portion of the second material 145. The first material may comprise, for instance, a radiopharmaceutical agent that is fabricated in a cyclotron or irradiating device and received from the container device 110 previously described. The second material 145 may comprise a diluent, such as, for instance, intravenous saline solution that may be suitable for diluting the first material. The second material 145 may be provided by the mixing device 130 via a second container 140 configured to hold the second material and in some embodiments, operably engaged with the mixing device. In other embodiments, the second material 145 may be provided by the mixing device 130 via a separate reservoir or other fluid system in fluid communication with the mixing device 130. The mixing device 130 may further comprise an internal tubing set 133 configured to mix at least a portion of the first material 115 with at least a portion of the second material 145 according to a predetermined ratio, to form a mixture 125. In one embodiment, the internal tubing set 133 may further comprise disposable polymer tubing to be replaced between each mixing cycle or at selected intervals such that, in some embodiments, a newly provided disposable sterile internal tubing set 133 may be operably engaged with the mixing device 130 prior to each subsequent mixing operation. The internal tubing set 133 may further be in communication with the fluid port 132, container device 110, second container device 140 and via a plurality of valve mechanisms actuated via electromechanical devices that may be controlled by the computer device 135 described generally below.
The mixing device 130, according to some embodiments of the present invention, may further comprise a computer device 135 that may be operably engaged with the mixing device 130 and capable of cooperating with the mixing device 130 and/or measuring device 117,134 to form a mixture 125. The mixture 125 may be formed by mixing at least a portion of the first material 115 with at least a portion of a second material 145 that may be provided by the mixing device 130, according to a predetermined ratio to form the mixture 125. According to some embodiments of the present invention, the computer device 135, in cooperation with the measuring device 117, 134 may determine the radiation dose emitted by, for instance, a radiopharmaceutical agent or other component of the first material 115, and in response, adjust the predetermined ratio to provide a mixture having a selected radiation dose amount. In other embodiments, the computer device 135 may be further capable of receiving an input from an operator, wherein the input may comprise, for instance, the selected radiation dose amount. The computer device may further be capable of receiving an input comprising, for instance, an individual data set that is related to an individual to whom the mixture 125 (such as, for instance, a diluted radiopharmaceutical agent) is to be dispensed during a medical procedure such as, for example, a PET imaging procedure and/or other imaging modalities. The individual data set may comprise, for instance, weight of the individual, height of the individual, time and date of the procedure, patient identification number, and other information that may be used to calculate, for instance, an appropriate radiation dose amount. One skilled in the art will appreciate that the selected radiation dose amount of the mixture 125 may be attained by mixing a first material 115 comprising for instance, a radiopharmaceutical agent characterized by a radiation dose, with a second material, comprising for instance, an intravenous saline solution, such that the first and second materials are mixed according to a predetermined ratio. One skilled in the art will also appreciate that the selected radiation dose amount of the mixture 125 may vary depending on various factors related to the type of imaging, diagnostic, and/or therapeutic procedure being performed, the size of the individual to which the mixture 125 is being dispensed, and other factors, including, but not limited to, the radiation dose of the first material 115 prior to forming the mixture 125.
The computer device 135 may be further adapted to communicate with a data port 136 that may be disposed, for instance, on an outer surface of the mixing device 130 so as to communicate with a second memory device 127 that may be operably engaged with a dispensing device 120. The dispensing device 120 may hold the mixture 125 formed by the mixing device 130 of the present invention as described more specifically below. The data port 136 may further comprise, for instance, a physical electronic connection between the mixing device 130 and the second memory device 127. According to other embodiments, the data port 136 may comprise a transceiver for sending data to the second memory device 127 via wireless methods such, as for instance, radio frequency (RF) techniques, infra-red (IR) connections, bluetooth and/or other suitable wireless methods.
As described above, the dispensing device 120 may further comprise a second memory device 127 configured to receive a data set related to the mixture 125, wherein the data within the data set related to the mixture may include: selected radiation dose amount of the mixture at its time of formation in the mixing device 130, classification of first material 115 used to form the mixture 125 (such as, for example, FDG), and other data related to the mixture 125. The data set related to the mixture may be transferred to the second memory device 127 from the data port 136 by a wire-based electronic connection such as USB port, or other physical wire connection. In some embodiments, the data set related to the mixture may be transferred to the second memory device 127 from the data port 136 by wireless methods including, but not limited to, radio frequency (RF), infra-red (IR), bluetooth or other suitable wireless methods. The data set related to the mixture 125 stored in the second memory device 127 operably engaged with the dispensing device 120 may be useful, for example, in aiding the operator of the system in identifying the mixture and the characteristics thereof, by, for example, interrogating the second memory device 127, using technologies including, but not limited to, RFID technology, wire-based electronic connection, or any other suitable connection to an electronic device adapted to display the data set related to the mixture upon electronically interrogating the second memory device 127.
The dispensing device 120, as shown in
According to another embodiment, the dispensing device 120 may further comprise a cartridge device 121 for holding the mixture 125. In this embodiment, the cartridge device 121 may be placed within the shielding 123 of the dispensing device 120 so as to provide shielding from radiation emissions that may be produced by the mixture 125 which may further comprise diluted pharmaceutical and/or radiopharmaceutical agents of various types. The cartridge device 121 may further comprise, for example, a vial or syringe composed of polymer, glass, metal, or any other material suitable for containing the mixture 125. Furthermore, the cartridge device 121 may be, in some embodiments, reusable for multiple injection iterations in the system of the present invention. According to other embodiments, the cartridge device 121 may be disposable, and thus discarded and replaced after the mixture 125 is dispensed from the dispensing device 120 as described herein.
The dispensing device 120 may, in some embodiments, be an injection device adapted to inject at least a portion of the mixture 125 into an individual, such as, for example, an individual undergoing a PET imaging procedure. The dispensing device 120 further comprising the shielding 123 operably engaged therewith may be used, for example, with a hand-operated injection unit, adapted to inject at least a portion of the mixture 125 into an individual. The shielding 123 may protect, for example, an operator of the system, from a radiation dose emitted from the mixture 125 as at least a portion of the mixture is hand-injected into the individual. In embodiments of the present invention wherein the dispensing device 120 can also function as an injection device, one skilled in the art will appreciate that the dispensing device may further comprise, for instance, a syringe mechanism, compatible with a hand-injector, and/or power injector device 210 as described herein. In other embodiments, the dispensing device may further be suitable for dispensing the mixture to an individual for oral ingestion.
As shown in
Furthermore, the power injector device 210 may interrogate and/or receive a data set related to the mixture 125 from, for example, the second memory device 127 that may be operably engaged with the dispensing device 120, as described herein. In such embodiments, the power injector device 210 may identify the mixture 125 held by the dispensing device 120 so as to ensure that the selected radiation dose amount is provided to the individual, in light of the procedure type and the data related to the mixture 125.
For embodiments of the present invention where the dispensing device 120 is compatible with, for instance, a power injector 210, the dispensing device, may further comprise a measuring port 128, compatible, for instance, with a measuring device 215 that may be operably engaged with the power injector device 210 as shown in
According to other embodiments of the present system, a power injector device 210 may be operably engaged with the dispensing device 120 (such as a syringe functionally encapsulated as part of the dispensing device 120). Furthermore, the power injector device may include its own radiation measuring device 215 that may measure the radiation dose of a mixture 125 comprising, for instance, one or more pharmaceutical agents and/or radiopharmaceutical agents. The pharmaceutical agents within the mixture 125 may be held within the dispensing device 120 such that the power injector device 210 can inject at least a portion of the mixture 125 into an individual in the form of, for instance, a predetermined radiation dose amount. One skilled in the art will appreciate that the power injector device 210 may further comprise, for example, a computer device, display, control systems, and other components necessary to automatically purge a connection with the individual prior to injecting the mixture 125, and automatically inject the mixture 125 according to a pre-defined flow rate and volume such that at least a portion of the mixture 125 is automatically injected into the individual.
According to some embodiments of the present invention, a plurality of dispensing devices 120 may be operably engaged with the mixing device 130 so as to be capable of receiving a corresponding plurality of mixtures that may be formed by the present invention. Thus, the mixing device 130 described herein may be capable of operably engaging the plurality of dispensing devices so as to be capable of dispensing the corresponding plurality of mixtures to one or more individuals (such a single mixing device may be capable of centrally administering mixtures to a plurality of different individuals). In other embodiments, the plurality of dispensing devices may be utilized to dispense the corresponding plurality of mixtures to a single individual as part of a therapeutic, diagnostic, and/or medical procedure requiring the dispensation of a plurality of mixtures containing, for example, one or more first materials. For example, the mixing device 130 may be operably engaged with one to ten (or more) dispensing devices 120 so as to be further capable of providing a corresponding plurality of mixtures to one or more individuals in a diagnostic, therapeutic, and/or medical procedure.
In other embodiments of the invention, such as those shown generally in
As described herein, the system of the present invention may comprise a first container device 110 for holding a first material 115. The container device 110 may thus be operably engaged with the integrated power injector device 210 and mixing device 130, described in detail above, so as to reduce manual handling of the first material 115 and to mix at least a portion of the first material 115 with at least a portion of a second material 145 according to a predetermined ratio to form the mixture 125. Furthermore, because the mixing device 130 and power injector device 210 are integrated in such embodiments, handling of the mixture 125 may also be reduced prior to injection of the mixture 125 into an individual. According to some embodiments of the present invention, the automated injector device 210 (and the integrated mixing device 130 included therein) may further comprise a disposable sterile tubing set 133 (or other internal tubing set 133) for mixing at least a portion of the first material 115 (such as a radiopharmaceutical agent or other pharmaceutical agent) with at least a portion of the second material 145 (such as an intravenous saline solution) to form a mixture 125 having a predetermined ratio of first material to second material. The system of these embodiments may further comprise multiple container devices 110/140 configured to hold various types of first materials 115 and second materials 145. The container devices 110, 140 may be engageable with the automated injector device for providing the various materials thereto with minimal handling. Furthermore, the power injector device 210 may be capable of injecting the mixture 125 into an individual via a dispensing device 120 selectively operably engaged with the power injector device 210.
In addition, the dispensing device 120 (including, but not limited to a syringe) may be operably engaged with the power injector device 210 in a substantially fluid-tight manner so as to reduce manual handling of the mixture contained within the dispensing device 120. For example, the dispensing device 120 may be fitted with a fluid-tight threaded connection or luer fitting for connecting (via a fluid-tight seal) to the dispensing device 210. Furthermore, the dispensing device 120, as described herein with respect to other system embodiments of the present invention, may also comprise a second shielding device 123 operably engaged therewith for shielding a user from emissions originating from the mixture 125 contained within the dispensing device 120. According to some embodiments, the dispensing device 120 may be capable of operably engaging (via a luer lock or other fluid-tight connection known to those skilled in the art) an intravenous line 310 capable of carrying the mixture 125 from the dispensing device 120 to an individual (such as a human patient awaiting an imaging procedure that is dependent upon the injection of the mixture 125 in order to produce a medical image of the individual).
Furthermore, as shown in
According to some embodiments of the present invention, the dispensing device 120 comprises a second radiation measurement device (integrated with, for example, the measurement port 128) operably engaged therewith for determining a radioactivity level of the mixture 125 and for transferring the determined radioactivity level of the mixture to the computer device 135 such that the power injector device 210 may be capable of dispensing a dose of the mixture 125 to the individual corresponding to a predetermined radiation dose. In one alternative embodiment, the computer device 135 may, in response to the determined radioactivity level of the mixture 125, direct the automated injector device 210 to adjust the overall amount of the mixture 125 that is administered to the individual via the dispensing device 120. Furthermore, the computer device 135 may also direct the automated injector device 210 to adjust the predetermined ratio of the mixture 125 by increasing the amount of first material 115 and/or second material 145 that is present in the resultant mixture 125 until a selected radiation dose is achieved and confirmed by the second radiation measurement device 128.
Additionally, such a power injector device 210 may further comprise, for instance, multiple dispensing cartridges or syringes containing, mixtures, flushing agents (including, but not limited to, intravenous saline solution, water, or other suitable diluents), first materials 115 and/or second materials 145. The outlet of each cartridge may be in fluid communication to the line 310 delivering the pharmaceutical agent, radiopharmaceutical agent, or other mixture 125 to the patient for diagnostic, therapeutic, imaging, dilution, and/or flushing purposes. Such a line would assure that any volume of material in the tube going to the patient is effectively utilized.
In step 420, the mixing device 130 mixes at least a portion of the first material 115 with at least a portion of the second material 145 according to a predetermined ratio to form the mixture 125. The mixing step 420 may further comprise, for instance, the steps of receiving the dispensing device 120 configured to hold the mixture 125; determining the predetermined ratio using a selected radiation dose amount input by an operator of the system; and determining the radiation dose of the first material 115 measured by, for instance, the measuring device 117, 134 in step 410. The mixing step 420 includes, for instance, mixing at least a portion of the first material 115 with at least a portion of the second material 145 according to a predetermined ratio in the internal tubing set 133 of the mixing device 130.
Step 430 comprises transferring the mixture 125 to the dispensing device 120. Step 430 may occur automatically as the mixing device 130 forms the mixture 125 and transfers the mixture to the dispensing device 120 received in the mixing device 130 as shown in
As shown in
Referring to
Thus, as shown in
In addition to providing systems and methods, the present invention also provides computer program products for performing the operations described above. The computer program products have a computer readable storage medium having computer readable program code means embodied in the medium. With reference to
Accordingly, blocks or steps of the block diagrams, flowcharts or control flow illustrations support, among other things, combinations of means for performing the specified functions, combinations of steps for performing the specified functions and program instruction means for performing the specified functions. It will also be understood that each block or step of the block diagrams, flowcharts or control flow illustrations, and combinations thereof, can be implemented by special purpose hardware-based computer systems which perform the specified functions or steps, or combinations of special purpose hardware and computer instructions.
Other modifications and other embodiments of the invention set forth herein will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings presented in the foregoing descriptions and on the associated drawings. Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.
Further, throughout the description, where compositions are described as having, including, or comprising specific components, or where processes systems or methods are described as having, including, or comprising specific steps, it is contemplated that compositions or the present invention may also consist essentially or, or consist of the recited components, and that the processes or methods of the present invention also consist essentially or consist of the recited steps. Further, it should be understood that the order of steps or order of performing certain actions are immaterial so long as the invention remains operable. Moreover, two or more steps or actions may be conducted simultaneously with respect to the invention disclosed herein.
This application claims the benefit of U.S. Provisional Application No. 60/574,875, filed May 27, 2004, which is incorporated herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 60574875 | May 2004 | US |
