The invention relates generally to handling radioactive substances and, more particularly, to transporting radioactive substances and/or injecting radioactive substances into a patient.
The transportation and administration of radioactive substances (e.g., radiopharmaceuticals) may often present issues regarding shielding clinicians and surrounding environments from radiation. Accordingly, radiopharmaceuticals and other radioactive substances are typically transported and stored in containers that prevent or reduce the likelihood of a significant amount of radiation reaching the surrounding environment. For example, radiopharmaceuticals may be transported in a radiation-shielded containment, colloquially referred to as a “pig.”
In accordance with typical shielding concerns, the life cycle of radiopharmaceuticals generally includes draw-up of the radiopharmaceutical or other radioactive fluid into a syringe, calibration, and placement of the syringe into a radiation-shielded containment (e.g., a pig) at a supplier facility, transporting the syringe in the radiation-shielded containment to a treatment facility, removal of the syringe from the radiation-shielded containment, injection of the radiopharmaceutical into a subject, returning the syringe to the radiation-shielded containment, and return of the radiation-shielded containment and syringe to the supplier facility. Typically, the radiation-shielded containment includes radiation shielding that completely surrounds the radiopharmaceutical to prevent or reduce the likelihood of radiation escaping into the surrounding environment. However, a potential of exposing a clinician and/or the surrounding environment to radiation may still exist. For example, the radiation-shielded containment may be opened to access the syringe, to identify the syringe, or to inspect the condition of the syringe. Accordingly, the surrounding environment may be exposed to radiation when the radiation-shielded containment is opened. Further, such a shielded containment may create additional steps in administering the radiopharmaceutical. For example, during administration of the radiopharmaceutical, the clinician may remove the syringe from the radiation-shielded containment, inject a patient, and return the syringe to the containment. Accordingly, the use of a shielded containment may add to the complexity of administering a radiopharmaceutical (e.g., removing and returning the syringe).
A first aspect of the present invention is embodied by a fluid delivery system that utilizes a containment, a first syringe, and a first conduit. The containment includes a body. First and second chambers are associated with the body (e.g., disposed therein), a passage extends between these first and second chambers, and the first syringe is disposed within the first chamber. The first conduit includes first and second conduit sections. The first conduit section is interconnected with the first syringe, which again is disposed within the first chamber of the containment. The second conduit section is disposed within the second chamber of the containment and is fluidly interconnected with the first conduit section. The first conduit extends through the passage between the first and second chambers.
A number of feature refinements and additional features are separately applicable to the first aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. The following discussion is applicable to the first aspect, up to the start of the discussion of a second aspect of the present invention. The first syringe may be loaded with an appropriate fluid and the first conduit may be fluidly connected to the first syringe (e.g., the first conduit may be mounted to a discharge nozzle of the first syringe). With the first syringe and the fluidly connected first conduit being positioned within an opened containment, the containment may be closed and/or sealed for transport to an appropriate end-use location. As will be discussed in more detail below, the first conduit (e.g., part of the second conduit section) may be withdrawn out of the containment at an end-use location for a fluid delivery operation (e.g., for injection into a patient).
The first conduit may be of any appropriate size, shape, configuration, and/or type, for instance in the form of medical tubing. The first conduit may contain a first fluid, and the first syringe may contain a second fluid. This configuration may exist when the containment is in a closed or sealed configuration, for instance where both the first syringe and first conduit are housed within or enclosed by the containment (e.g., during storage and/or transportation of the fluid delivery system to an end-use location). Each of the first and second fluids may be of any appropriate type. In one embodiment, the first fluid within the first conduit is saline, and the second fluid within the first syringe is a radioactive fluid (e.g., a radiopharmaceutical). A valve may be disposed within the first conduit and/or in a discharge nozzle of the first syringe to maintain a separated state between the first and second fluids until operation of the first syringe is initiated for a fluid discharge operation (e.g., until a syringe plunger is sufficiently advanced). This valve may be of any appropriate size, shape, configuration, and/or type (e.g., a check valve). Multiple valves may be utilized as well and disposed in any appropriate arrangement.
The containment may be in the form of a radiological containment, where a radioactive material of any appropriate type (e.g., a radiopharmaceutical) is contained in a least one of the first syringe and the first conduit. First shielding may be provided for or associated with the first chamber. This first shielding may be used by the second, third, and fourth aspects as well. In any case, the first shielding may be of any appropriate size, shape, configuration, and/or type, for instance in the form of radiological shielding. By way of example, the first shielding may include lead, tungsten, tungsten-impregnated plastic, depleted uranium, and/or any other suitable radiation shielding material. The first shielding may be incorporated by the containment in any appropriate manner (e.g., by being formed into the body of the containment; by being separately installed on the body of the containment in any appropriate manner, including by being in the form of one or more removable inserts). One or more shielding layers may be utilized for the first shielding. Multiple shielding layers may be disposed in any appropriate arrangement.
The first shielding may be characterized as extending a full 360° about the first chamber (e.g., surrounding the first chamber in at least one dimension: being of an annular configuration). For instance, the first shielding may extend completely about a longitudinal axis of the containment, which may define a length dimension for the containment. The length dimension of the first chamber may extend along this longitudinal axis as well (e.g., the first shielding may extend about the entirety of a circumference of the first chamber).
The containment may include a cap, which may also be used by each of the second, third, and fourth aspects as well. This cap may be mounted to the body of the containment in any appropriate manner. In one embodiment, the cap is detachably interconnected with the containment body, such that the cap may be installed on and removed from the containment body (e.g., via a threaded interconnection; using a snap-lock interconnection) repeatedly. In one embodiment, the containment body includes a necked end portion at an end of the second chamber that is disposed within the body of the containment. The cap may be characterized as closing or sealing an interior of the body of the containment (e.g., the second chamber).
The first conduit may be mounted or attached to (e.g., coupled with) the cap. In one embodiment, an end of the second conduit section is detachably engaged or removably coupled with the cap. Removing the cap from the body of the containment may be used to withdraw at least part of the first conduit from the interior of the containment, for instance for an injection (the first conduit remaining fluidly interconnected with the first syringe during this withdrawal). The first conduit may interact with the cap in any appropriate manner in one embodiment, the cap includes a protrusion, and an open end of the first conduit (e.g., the second conduit section, and including where an end of the second conduit section includes a fitting or connector of any appropriate type) is disposed over this protrusion to detachably couple the first conduit and the cap. After the cap has been removed from the containment body, the first conduit may be disengaged from the cap, for instance, for an injection (e.g., such that the first conduit may be coupled with a tubing set or the like).
A second aspect of the present invention is embodied by a fluid delivery system that utilizes a containment. The containment includes a body having first and second ends that are spaced along a longitudinal axis. First and second chambers are disposed within the body, and are spaced along this longitudinal axis. First shielding is provided for this first chamber. A passage is disposed within the body and extends between the first and second chambers. At least part of the passage proceeds other than collinear with the longitudinal axis and also other than parallel with the longitudinal axis.
A number of feature refinements and additional features are separately applicable to the second aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. The following discussion is applicable to the second aspect, up to the start of the discussion of a third aspect of the present invention. Initially, the passage may be shielded (e.g., second shielding). The various features discussed above with regard to the first shielding for the first chamber are each applicable to shielding for the passage as well. Although the shielding for the first chamber and the shielding for the passage could be integrated or part of a common structure, separate shielding for the first chamber and the passage could be utilized as well.
Part of the passage may extend or proceed away from the longitudinal axis of the containment. This configuration for the passage may reduce the potential for radiation escaping from the first chamber through the passage (e.g., to reduce the potential of radiation passing from the first chamber, into the second chamber, and then out of the body of the containment). In one embodiment, the passage includes a first passage section that extends from the first chamber along the longitudinal axis of the containment, as well as a second passage section that extends from the first passage section in a direction that is at least generally away from the longitudinal axis (e.g., the second passage section diverges from the longitudinal axis when progressing in a direction that is away from the first chamber). The first conduit section could be eliminated, such that the noted second conduit section directly interfaces with a discharge nozzle of the first syringe. In any case, the passage may include a third passage section that extends from the second passage section, such that the second passage section is disposed or located between the first and third passage sections. In one embodiment the first and third passage sections are parallel with and offset from each other.
A third aspect of the present invention is embodied by a fluid delivery system that utilizes a containment. The containment includes a body having an access aperture. A shutter is movable relative to the body between first and second shutter positions, where the shutter blocks the access aperture in the first shutter position, and where the shutter exposes the access aperture in the second shutter position (e.g., exposes the access aperture to an interior of the containment). A first chamber is disposed within the body, and is aligned with the access aperture. First shielding is provided for the first chamber. This first shielding may include lead, tungsten, tungsten-impregnated plastic, depleted uranium, and/or any other suitable radiation shielding material.
A number of feature refinements and additional features are separately applicable to the third aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. The following discussion is applicable to the third aspect, up to the start of the discussion of a fourth aspect of the present invention.
A first syringe may be disposed within the first chamber, and may include a plunger. The access aperture defined in the body of the containment may be adapted to allow a ram of an injection device (e.g., a power injector) to extend through the access aperture to interact with (e.g., interface with and/or mechanically engage) the syringe plunger to move the same in at least one direction (e.g., axially) and/or any appropriate purpose (e.g., to discharge fluid from the first syringe).
Any appropriate motion or combination of motions for the shutter may be utilized as the shutter moves between its first shutter position (where it blocks the access aperture) and its second shutter position (where the access aperture is exposed), including an axial or sliding motion (e.g., a movement within a single plane), a pivotal motion (e.g., a movement at least generally about an axis), or the like. The shutter may be biased to its first shutter position in any appropriate manner, for instancing using one or more biasing members of any appropriate size, shape, configuration, and/or type. Multiple biasing members may be disposed in any appropriate arrangement. The shutter may be characterized as being misaligned with the access aperture when in its second shutter position.
A label may at least initially block the access aperture of the containment, and may be of any appropriate size, shape, configuration, and/or type. The access-aperture label may be mounted to an exterior of the containment in any appropriate manner (e.g., adhesively) so as to extend over the access aperture, the shutter may be disposed within an interior of the containment, or both. The access aperture label may include radiological shielding of any appropriate type (e.g., lead, tungsten, tungsten-impregnated plastic, depleted uranium, and/or any other suitable radiation shielding material). Radiological shielding may be incorporated in any appropriate manner in relation to the access aperture label. Some embodiments may not have an access aperture label that includes radiological shielding.
Another function that may be provided by the access aperture label is as a use indicator. A first syringe may be disposed within the first chamber and may include a movable plunger to discharge contents from the first syringe. The access aperture label may be ruptured or punctured by a ram of an injection device (e.g., a power injector) that may interact with the plunger of the first syringe to advance the same (e.g., for a fluid discharge operation). This will provide a visual indication that a ram (or other object) has penetrated the label in an attempt to gain access to an interior of the containment.
Another function that may be provided by the access aperture label is storing information. Any appropriate information may be stored on the access aperture label. Examples of information that may be stored on the access aperture label include without limitation information regarding the contents of the containment (e.g., a radiopharmaceutical), patient identification information, radiopharmaceutical calibration information, warnings, instructions for use, a serial number, identification number, or any combination thereof. Information may be stored in any appropriate manner on the access aperture label (e.g., the access aperture label being in the form of a bar code, an RFID tag, or human readable label). In one embodiment, the access aperture label is machine-readable such that an appropriate device (e.g., bar code scanner, an RFID reader or reader antenna) may be used to retrieve information stored on the access aperture label.
A fourth aspect of the present invention is embodied by a fluid delivery system that utilizes a containment. The containment includes a body, a first chamber disposed within the body, first shielding for the first chamber, and a first storage compartment disposed within the body and isolated from the first chamber.
A number of feature refinements and additional features are separately applicable to the fourth aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. The following discussion is applicable to the fourth aspect, up to the start of the discussion of a fifth aspect of the present invention.
Access to the first storage compartment may be made available through a movable door. This access door may be disposed at any appropriate location on an exterior of the containment. In one embodiment, this access door is disposed on and/or defines part of a sidewall for the containment. Any way of movably integrating this access door with the containment may be utilized (e.g., the access door may remain interconnected with the containment body when opened: the access door could totally separate from the containment body when opened).
Any appropriate component or combination of components may be housed within the first storage compartment. In one embodiment, at least one fluid delivery component is stored in the first storage compartment. For instance, a patient tubing set (e.g., a disposable) may be contained within the first storage compartment, where this patient tubing set may include medical tubing, a connector on one end of the tubing (e.g., for interconnection with the first conduit after being withdrawn from the containment), a connector on the other end of the tubing set or possibly a catheter or other vascular access device, one or more valves, and the like. Exemplary fluid delivery components include without limitation a tubing set, connectors, vascular access devices, tubing, one or more valves, and the like.
A number of feature refinements and additional features are separately applicable to each of above-noted first, second, third, and fourth aspects of the present invention. These feature refinements and additional features may be used individually or in any combination relation to each of the above-noted first, second, third, and fourth aspects. Initially, each of the first, second, third, and fourth aspects may be used in combination with any one or more of the other of the first, second, third, and fourth aspects.
The containment may be of any appropriate size, shape, configuration, and/or type. For example, the first chamber defined within the body of the containment may be sized and shaped to accommodate a syringe having a radiopharmaceutical disposed therein. Any appropriate material or combination of materials may be used to define the containment. The containment may be in the form of a radiological pig. The containment may be used to transport one or more radiological materials of any appropriate type, may be used in the discharge of one or more radiological materials of any appropriate type, or both. In one embodiment, contents may be discharged from the containment without first removing a syringe therefrom. For instance, the containment may be installed on an appropriate injection device (e.g., a power injector), which may be operated to discharge contents from the containment (e.g., from a syringe disposed within the containment). One or more positional registration or indexing features of any appropriate size, shape, configuration, and/or type may be incorporated by the containment for purposes of installing the containment on such an injection device (e.g., to ensure a proper position of the containment relative to such an injection device).
The body of the containment may include first and second body sections that are movably interconnected. The first and second body sections may be movable relative to each other between open and closed positions. In one relative position, the first and second body sections may define a closed position or configuration for the containment. In another relative position, the first and second body sections may define an open position or configuration for the containment.
The first and second body sections of the containment body may be movably interconnected in any appropriate manner. For instance, one or more hinges of any appropriate size, shape, configuration, and/or type may allow the first body section to move relative to the second body section. In one embodiment, the first and second body sections are movable relative to one another about an axis that is parallel with a longitudinal or long axis of the containment. Other orientations for such an axis may be utilized.
A label may be mounted to the containment body such that it is disposed over a junction between the first and second body sections when the containment is in a closed configuration (e.g., a “body label”). This body label may be ruptured when attempting to open the containment. This will provide a visual indication that there has at least been an attempt to gain access to an interior of the containment.
Another function that may be provided by the body label is storing information. Any appropriate information may be stored on the body label. Examples of information that may be stored on the body label include without limitation information regarding the contents of the containment (e.g., a radiopharmaceutical), patient identification information, radiopharmaceutical calibration information, warnings, instructions for use, a serial number, identification number, or any combination thereof. Information may be stored in any appropriate manner on the body label (e.g., the body label being in the form of a bar code, RFID tag, or human readable label). In one embodiment, the body label is machine-readable such that an appropriate device (e.g., bar code scanner, RFID reader or reader antenna) may be used to retrieve information stored on the body label.
The containment may include a third chamber that is disposed within the containment body. The first and third chambers each may accommodate a syringe. Any appropriate number of chambers could be utilized by the containment for housing syringes. Multiple syringes may discharge into a common conduit. One or more syringes within the containment may discharge into a common conduit, one or more syringes within the containment may discharge into their own individual conduit, or any combination thereof.
A fifth aspect of the present invention is embodied by a method for delivering (e.g., injecting) a fluid. A shielded containment is transported in a closed or sealed configuration, where a syringe is disposed within this containment. This syringe contains a radiological fluid and a syringe plunger. The shielded containment is installed on a power injector. A syringe plunger driver (e.g., a ram) of the power injector interacts with the syringe plunger to move the same and discharge radiological fluid from the syringe while the syringe is located within the shielded containment.
A number of feature refinements and additional features are separately applicable to the fifth aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. The following discussion is applicable to the fifth aspect, up to the start of the discussion of a sixth aspect of the present invention.
The syringe is positioned within the shielded containment before the shielded containment is installed on the power injector. For instance, the syringe may be loaded with a radiological fluid and positioned within the shielded containment at one facility, and may then be shipped or transported to another location, for instance an end-use facility (e.g., for an injection). The syringe could be loaded with radiological fluid prior to being positioned within the shielded containment. Alternatively, an empty syringe could be positioned within the shielded containment (e.g., and thereafter disposing the first and second body sections in a closed position), and then loaded through tubing that was previously fluidly interconnected with the syringe (e.g., the above-discussed first conduit). In this second instance, the tubing could be directed into the shielded containment after being used for a fluid-loading operation (e.g., into the above-noted second chamber), and the shielded containment could then be sealed (e.g., the above-noted cap could be installed on the containment body).
Injection peripherals or a patient tubing set may be removed from a compartment of the shielded containment in preparation for a fluid delivery operation, tubing may be extracted from the shielded containment (e.g., by removing a cap from a body of the containment) in preparation for a fluid delivery operation and where this tubing is interconnected with the syringe prior to the containment being installed on the power injector, or both. This extracted tubing may be fluidly interconnected with the patient tubing set, the patient tubing set may be fluidly interconnected with a patient, and the fluid discharge operation may be in the form of an injection. This injection may be for any appropriate purpose, such as acquiring a medical image. Any appropriate fluid may be injected, including a diagnostic radiopharmaceutical, a therapeutic radiopharmaceutical, saline, and/or other appropriate flushing media, well as any combination thereof.
The shielded containment may remain in a closed position or configuration during and at least initially after the installation of the shielded containment on the power injector. Advancement of the syringe plunger driver may be used to open an access to the shielded containment, for instance by engaging and displacing/moving a shutter that blocks an access aperture to an interior of the containment. Prior to interacting with the syringe plunger, the syringe plunger driver may rupture a label that is disposed over such an access, and which may provide a visual indication that an attempt has at least been made to access the interior of the shielded containment.
A sixth aspect of the present invention is embodied by a power injector having a syringe plunger driver, a first data input device, and power injector control logic. The power injector control logic is operatively interconnected with both the first data input device and the syringe plunger driver, and includes an injection volume determination protocol and an injection protocol. The injection volume determination protocol includes a prescribed radioactive dose variable, where a value for this radioactive dose variable may be entered through the first data input device. The injection volume determination protocol is operatively interconnected with the injection protocol (e.g., such that the injection protocol may utilize an output of the injection volume determination protocol).
A number of feature refinements and additional features are separately applicable to the sixth aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. The following discussion is applicable to the sixth aspect, up to the start of the discussion of a seventh aspect of the present invention.
The first data input device may be of any appropriate type (e.g., a keyboard, a mouse, a touch pad, a track ball, a touch screen display, a soft key display, an RFID reader, a bar code scanner). The injection volume determination protocol may be in the form of a programmed sequence. The value that is intended to be input for the prescribed radioactive dose variable may be a desired radioactive dose that is to be injected into a patient. The value for the prescribed radioactive dose variable may be retrieved in any appropriate manner (e.g., machine readable; visually by a user and then manually entered).
The containment addressed above in relation to the first, second, third, and fourth aspects may be installed on the power injector for purposes of this sixth aspect. A first syringe may be disposed within a first chamber of this containment, and may include a unit dose of a radioactive fluid. The containment and/or the first syringe may be encoded with radioactivity information on this unit dose (e.g., an original radioactivity level, the time associated with such an original radioactivity level). In this regard, the injection volume determination protocol may also include an original radioactivity level variable for this unit dose. The injection volume determination protocol may calculate a current radioactivity level for this unit dose using a value that is input for the original radioactivity level variable. The injection volume determination protocol may also calculate a volume of the unit dose that should be injected into the patient, for instance using values that are input for both the original radioactivity level variable and the prescribed radioactive dose variable.
A seventh aspect of the present invention is embodied by a power injector having a syringe plunger driver, a first data input device, and power injector control logic. The power injector control logic is operatively interconnected with both the first data input device and the syringe plunger driver, and includes an injection volume determination protocol and an injection protocol. The injection volume determination protocol includes an original radioactivity level variable, where a value for this original radioactivity level variable may be entered through the first data input device. The injection volume determination protocol is operatively interconnected with the injection protocol (e.g., such that the injection protocol may utilize an output of the injection volume determination protocol).
A number of feature refinements and additional features are separately applicable to the seventh aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. The following discussion is applicable to the seventh aspect, up to the start of the discussion of a eighth aspect of the present invention.
The first data input device may be of any appropriate type (e.g., a keyboard, a mouse, a touch pad, a track ball, a touch screen display, a soft key display, an RFID reader, a bar code scanner). The injection volume determination protocol may be in the form of a programmed sequence.
The containment addressed above in relation to the first, second, third, and fourth aspects may be installed on the power injector for this seventh aspect. A first syringe may be disposed within a first chamber of this containment, and may include a unit dose of a radioactive fluid. The containment and/or the first syringe may be encoded with radioactivity information on this unit dose (e.g., an original radioactivity level, the time associated with such an original radioactivity level). This information may be retrieved in any appropriate manner (e.g., machine readable; by a user). In any case, the injection volume determination protocol may calculate a current radioactivity level for the unit dose using a value that is input for the original radioactivity level variable (and possibly also using a time associated with this original radioactivity level).
An eighth aspect of the present invention is embodiment by a method for providing an injection. A magnitude of a dose of a radioactive fluid to be injected into a patient is input to a fluid delivery system. A volume of the radioactive fluid that will provide this dose is then calculated by the fluid delivery system. The calculated volume is then injected into the patient by the fluid delivery system.
A number of feature refinements and additional features are separately applicable to the eighth aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. The following discussion is applicable to the eighth aspect, up to the start of the discussion of a ninth aspect of the present invention. Initially, the features discussed above in relation to the sixth and seventh aspects of the present invention may be used by this eight aspect.
The magnitude of the radioactive dose that is intended for injection into the patient may be a dose that has been previously prescribed by medical personnel. This magnitude may be input to the fluid delivery system in any appropriate manner, such as manually by a user (e.g., via a graphical user interface) or by a device that reads stored/encoded information (e.g., automatically by the fluid delivery system; by a user manipulating an appropriate reader).
Further information may be acquired to calculate the portion of the unit dose that should be injected into the patient so as to provide a certain radioactive dose. The original radioactivity level of the unit dose may be acquired in any appropriate manner and input to the fluid delivery system in any appropriate manner, and a current radioactivity level of the unit dose may then be calculated by the fluid delivery system. Other information may be used in this calculation, for instance a time associated with the original radioactivity level. In one embodiment, the unit dose is created at one location, and is then shipped/transported to another location. The injection is executed when the unit dose is received.
A ninth aspect of the present invention is embodiment by a method for providing an injection. A current radioactivity level of a radioactive fluid in the form of a unit dose is determined by a fluid delivery system. A patient is then injected with a volume of the radioactive fluid from the unit dose based at least in part on this determination of the current radioactivity level.
A number of feature refinements and additional features are separately applicable to the ninth aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. The following discussion is applicable to the ninth aspect. Initially, the features discussed above in relation to the sixth and seventh aspects of the present invention may be used by this ninth aspect. In one embodiment, the unit dose is created at one location, and is then shipped/transported to another location. The injection may then be executed when the unit dose is received.
Information relating to the original radioactivity level of the unit dose may be encoded or stored in any appropriate manner (e.g., on a radiological containment, on a syringe disposed within a radiological containment). This information may be retrieved/acquired in any appropriate manner (e.g., visually by a user; read via a machine). The current radioactivity level of the unit dose may be calculated by the fluid delivery system based at least in part of this original radioactivity level.
A number of feature refinements and additional features are separately applicable to each of above-noted first, second, third, fourth, fifth, sixth, seventh, eighth, and ninth aspects of the present invention. These feature refinements and additional features may be used individually or in any combination in relation to each of the above-noted first, second, third, fourth, fifth, sixth, seventh, eighth, and ninth aspects. Any feature of any other various aspects of the present invention that is intended to be limited to a “singular” context or the like will be clearly set forth herein by terms such as “only,” “single,” “limited to,” or the like. Merely introducing a feature in accordance with commonly accepted antecedent basis practice does not limit the corresponding feature to the singular (e.g., indicating that a power injector includes “a syringe” alone does not mean that the power injector includes only a single syringe). Moreover, any failure to use phrases such as “at least one” also does not limit the corresponding feature to the singular (e.g., indicating that a power injector includes “a syringe” alone does not mean that the power injector includes only a single syringe). Finally, use of the phrase “at least generally” or the like in relation to a particular feature encompasses the corresponding characteristic and insubstantial variations thereof (e.g., indicating that a syringe barrel is at least generally cylindrical encompasses the syringe barrel being cylindrical).
Any “logic” that may be utilized by any of the various aspects of the present invention may be implemented in any appropriate manner, including without limitation in any appropriate software, firmware, or hardware, using one or more platforms, using one or more processors, using memory of any appropriate type, using any single computer of any appropriate type or a multiple computers of any appropriate type and interconnected in any appropriate manner, or any combination thereof. This logic may be implemented at any single location or at multiple locations that are interconnected in any appropriate manner (e.g., via any type of network).
Any power injector that may be utilized to provide a fluid discharge may be of any appropriate size, shape, configuration, and/or type. Any such power injector may utilize one or more syringe plunger drivers of any appropriate size, shape, configuration, and/or type, where each such syringe plunger driver is capable of at least bi-directional movement (e.g., a movement in a first direction for discharging fluid; a movement in a second direction for accommodating a loading of fluid or so as to return to a position for a subsequent fluid discharge operation), and where each such syringe plunger driver may interact with its corresponding syringe plunger in any appropriate manner (e.g., by mechanical contact; by an appropriate coupling (mechanical or otherwise)) so as to be able to advance the syringe plunger in at least one direction (e.g., to discharge fluid). Each syringe plunger driver may utilize one or more drive sources of any appropriate size, shape, configuration, and/or type. Multiple drive source outputs may be combined in any appropriate manner to advance a single syringe plunger at a given time. One or more drive sources may be dedicated to a single syringe plunger driver, one or more drive sources may be associated with multiple syringe plunger drivers (e.g., incorporating a transmission of sorts to change the output from one syringe plunger to another syringe plunger), or a combination thereof. Representative drive source forms include a brushed or brushless electric motor, a hydraulic motor, a pneumatic motor, a piezoelectric motor, or a stepper motor.
Various radiological containments (e.g., pigs) are addressed below, along with one or more implementations of such radiological containments. Generally, a “radiological containment” is a structure in which one or more containers (e.g., syringes or vials) may be disposed, where at least one of these containers includes a radioactive material (e.g., a radiopharmaceutical). These radiological containments are oftentimes referred to as “pigs,” In certain embodiments addressed herein, a pig includes two body portions or sections that are split along the length of the pig. Specifically, this particular pig may be characterized as utilizing a clamshell configuration that enables a syringe or other medical containers/devices to be stored in one or more internal cavities of the pig, and accessed via separating the body sections. For example, embodiments include a pivot mechanism (e.g., a hinge) that may run the length of the pig, such that the pig may be folded open along its length. As such, first and second body sections of this pig may be characterized as being pivotally coupled to one another. Certain embodiments addressed herein include multiple chambers internal to the pig that enable tubing and/or other devices to be stored in the pig, along with a syringe or other medical container. For example, embodiments may include a first cavity or chamber that houses a syringe (e.g., loaded with a radiopharmaceutical or other radioactive fluid) and a second cavity or chamber that houses tubing that is coupled to the syringe and that may be retracted out of the pig for use in an injection. Certain embodiments enable injecting a subject (e.g., a patient) via the tubing without opening the pig to remove the syringe therefrom. Some embodiments include an aperture that enables access into an internal volume of the pig, and a shutter that prevents or reduces the likelihood of radiation escaping via this aperture. For example and in certain embodiments, the aperture enables a ram (e.g., a ram of a power injector or other injection device) to displace the shutter and to extend into the pig to engage or otherwise interact with the syringe (e.g., a plunger thereof) to discharge fluid therefrom (e.g., by advancing its plunger). Some embodiments include an aperture-sealing label that is disposed over the aperture. For example, the aperture-sealing label may be disposed over the aperture such that puncturing the label provides a visual indication that a power injector ram or the like has at least attempted to interact with the syringe. In some embodiments, the aperture-sealing label includes information encoded on or into the label (e.g., in the form of a radio frequency identification (RFID) tag and/or a bar code label). In some embodiments, the aperture-sealing label incorporates radiation shielding to prevent or reduce the likelihood of radiation escaping the pig via the aperture. Further, certain embodiments addressed herein include a compartment integral to the pig and which may be isolated from interior sections of the pig that house a syringe, tubing, or the like. In some embodiments, the compartment is capable of storing medical devices and equipment. For example, some embodiments may include a compartment integral with the body of the pig that is capable of storing a disposable patient connection set (e.g., IV set). The following includes a discussion of these and other embodiments.
One embodiment of a life cycle of a radiopharmaceutical container and associated pig is shown in
During the process described above, the radiopharmaceutical is generally enclosed in the pig 30 to prevent or reduce the likelihood of radiation escaping into the surrounding environment. In addition, the pig 30 may also provide a convenient storage/transporting container that reduces the likelihood of damage to the containers 20 (e.g., bottles or syringes). Unfortunately, during the injection process, clinicians may be required to open the pig 30 and subject themselves to radiation from the radiopharmaceutical. For example, the clinician may open the pig 30 to inspect the radiopharmaceutical container 20 or to remove the radiopharmaceutical container 20 from the pig 30 for the injection process. Disclosed below is a radiological containment or pig that may enable transportation and administration of a radiopharmaceutical without the clinician having to open the pig to remove the radioactive material therefrom.
It should be noted that although the following discussion focuses on application including radiopharmaceuticals, similar embodiments may include other applications including the transportation, storage, and administration of other radioactive substances or fluids. For example, embodiments may include a containment that is used to transport and store nuclear medicines used in the treatment of animals (e.g., livestock). In other words, the embodiments discussed below may be used in any number of nuclear medicine or similar applications that entail the handling and discharge of a radioactive material of any type and in any form.
In the illustrated embodiment, the pig 30i includes a body 90 having a first end 106 and a second end 108 that are spaced along a longitudinal axis 114. This body 90 includes a first body section 100 and a second body section 102 that are movably interconnected by a pivot mechanism 112 or the like. The pivot mechanism 112 is parallel with the longitudinal axis 114 in the illustrated embodiment. That is, the first body section 100 is movable relative to the second body section 102 at least generally about an axis that is parallel with the longitudinal axis 114 of the pig 30i. This relative movement provides both open (
The pig 30i further includes a cap 104 that may be detachably interconnected with the body 90 at its first end 106. A shutter 110 of the pig 30i is movably interconnected with the body 90 at its second end 108. The interior of the body 90 may be accessed to at least a certain degree by removing the cap 104 and by moving the shutter 110 relative to the body 90, for instance in preparation of and for providing an injection.
The first body section 100 includes a first body portion 120, a first indexing rib 122, a first neck portion 124, a first cavity portion 126, a second cavity portion 128, a first shielding layer 130, a first cavity separation portion 132, a first internal aperture portion 134, and a first external aperture portion 138. The second body section 102 includes a second body portion 140, a second indexing rib 142, a second neck portion 144, a first cavity portion 146, a second cavity portion 148, a second shielding layer 150, a second cavity separation portion 152, a second internal aperture portion 154, and a second external aperture portion 156. Generally, the first cavity portion 126 of the first body section 100 and the first body portion 146 of the second body section 102 collectively define a first chamber 162 within the pig 30 (e.g., internally disposed and for receiving the syringe 116). Similarly, the second cavity portion 128 of the first body section 100 and the second cavity portion 148 of the second body section 102 collectively define a second chamber 164 within the pig 30 (e.g., internally disposed for receiving part of the tube 118 (e.g.,
In other embodiments, the first body section 100 and the second body section 102 may include alternate geometries. For example, the separation between the first and second body sections 100 and 102 may include a horizontal plane that is parallel to but offset from the longitudinal axis 114 (e.g., above the longitudinal axis 114). Accordingly, the first and second body sections 100 and 102 may not be generally symmetrical; instead, one of these body sections may be larger than the other. Further, embodiments may include separations between the first and second body sections 100 and 102 that include multiple planes running parallel, transverse, or at other angles to the longitudinal axis 114 of the pig 30i. Moreover, the first and second body sections 100 and 102 may have indentations, extensions, or other features that are mated to one another. For example, the first body section 100 may include a lip that mates with a complementary feature of the second body section 102 to aid in sealing the pig 30 when it is closed. In any case, what is desirable is for the body 90 of the pig 30i to be of a configuration such that the body 90 may be moved in at least some respect between open and closed positions to provide open and closed configurations for the pig 30i. Any appropriate way for selectively maintaining the body 90 in its closed position may be utilized (e.g., cap 104 discussed below; one or more latches; a snap-lock relationship between the first and second body sections 100, 102 when in the closed position).
As further illustrated in the embodiment of
Embodiments may include information stored on the above-rioted sealing label 158. For example, the sealing label 158 may include patient identification information, radiopharmaceutical calibration information, warnings, instructions for use, a serial number, an identification number, or the like. In this regard, the sealing label 158 may be in the form of a bar code label, an RFID tag, or the like. Information of any type may be stored on the label 158 and in any appropriate manner. Accordingly, a clinician or one or more devices (e.g., RFID reader) may be used to read the information provided by the label 158. Embodiments may also include one or more of the sealing labels 158. For instance, several labels 158 may be placed at appropriate locations on the pig 30i to provide additional security, to provide additional/redundant information storage, or the like.
The illustrated embodiment includes a cap 104 disposed on the first and second neck portions 124 and 144 of the pig 30i when in its closed configuration. The first and second neck portions 124, 144 collectively define a necked end portion 92 for the body 90 when in its closed position, and the cap 104 may be mounted on the necked end portion 92 in any appropriate manner. For instance, the cap 104 may be detachably interconnected with the necked end portion 92 of the body 90 (e.g., via a threaded interconnection, via a snap-lock type interconnection). In any case, the cap 104 closes the first end 106 of the pig 3a, and may prevent or reduce the likelihood of the first body section 100 and the second body section 102 separating from one another (e.g., opening). Accordingly, the cap 104 may be removed prior to opening the pig 30i.
The cap 104 may also include features that enable coupling of the tube 118 to the cap 104. Coupling the tube 118 to the cap 104 may enable simplified access to the tube 118. In one embodiment, the interior surface of the cap 104 includes projection 212 over which an open end of the second tube section 118b may be disposed (e.g.,
The indexing ribs 122 and 142 may provide a reference point when locating (e.g., loading or installing) the pig 30i relative to one or more other devices. For example and in the illustrated embodiment, the indexing ribs 122 and 142 collectively define a ring-like rib 94 extending about the entire circumference of the body 90 of the pig 30i. The indexing rib 94 may provide a positional registration function (e.g., to register the position of the pig 30i relative to another device). Thus, when installing the pig 30i on an injection device (e.g., a power injector), the indexing rib 94 may be disposed in or engaged with a complementary feature (e.g., annular recess) of the injection device to provide proper alignment of the pig 30i. In other embodiments, a plurality of the indexing ribs 122 and 142 may be utilized by the pig 30i. For example, a second set of indexing ribs 122 and 142 may be located on the pig 30i. Further, the shape and location of the individual ribs 122 and 142 may be varied to accommodate specific applications. Generally, the pig 30i may include one or more features of any appropriate size, shape, configuration, and/or type to facilitate the use of the pig 30i with any appropriate device or combination of devices (e.g., to at least reduce the potential of the pig 30i being incorrectly installed on another device).
The design of the pivot mechanism 112 may be varied to accommodate specific applications. For example and in the illustrated embodiment, the pivot mechanism 112 includes an integral portion of material that extends between the first body section 100 and the second body section 102. Such a pivot mechanism 112 may be referred to as a “living hinge.” In other words, the pivot mechanism 112 includes material (e.g., plastic) that couples the first body section 100 and the second body section 102. In such an embodiment, the first body section 100 and the second body section 102 may be molded simultaneously and include a contiguous member (e.g., the pivot mechanism 112) that is formed between the first body section 100 and the second body section 102. In another embodiment, the pivot mechanism 112 may include a separate component that is affixed to the body sections 100 and 102 via adhesive or other fasteners (e.g., a separate hinge or hinges). For instance, the pig 30i may include one or more pivot mechanisms 112 that are screwed into, glued, or plastic-welded to the first body section 100 and the second body section 102. Notwithstanding the foregoing, any appropriate way of movably interconnecting the first body section 100 and the second body section 102 may be utilized, where the first body section 100 and second body section 102 are movable relative to each other but remain interconnected in at least some respect at all times.
Although the pivot mechanism 112 may provide for movable coupling of the first and second body sections 100 and 102, another embodiment may not include any pivot mechanism 112 at all. For example, an embodiment may include the first body section 100 and the second body section 102 that are completely separated in an opened position and coupled to one another in a closed position. In other words, the first body section 100 and second body section 102 may be completely disassembled from one another when opened (e.g., separately movable relative to each other) and fastened or secured to one another in any appropriate manner (e.g., with a bolt, a ring about the outer surface, or other fastening mechanism(s)) when closed.
In one embodiment, the first cavity or chamber 162 may be used to house a medical device, such as the syringe 116. For example and as shown in
Embodiments of the first cavity portions 126 and 146 may include other features conducive to housing and/or operating the syringe 116. For example and in one embodiment, the first cavity portions 126 and 146 include indentations 178 and 180, respectively, that receive or accept a lip or flange 182 of the syringe 116. In the illustrated embodiment, the indentations 178 and 180 include recessed grooves about the diameter of the semicircular sections 170 and 172, respectively. Accordingly, inserting the flange 182 of the syringe 116 relative to the pig 30 into the indentations 178 and 180 on the first and second body sections 100, 102 may ensure proper alignment of the syringe 116 and reduce movement of the syringe 116 relative to the pig 30 when in its closed configuration.
As previously discussed, the pig 30i may provide shielding of the environment from radiopharmaceuticals or other radioactive substances contained within the pig 30i. Accordingly and in certain embodiments, the first cavity portions 126 and 146 may include radiation or radiological shielding to prevent or reduce the likelihood of radiation (e.g., radiation generated by a radiopharmaceutical housed in the syringe 116) passing through the pig 30i. For example and in the illustrated embodiment, the first cavity portions 126 and 146 are lined with or otherwise incorporate a first radiation shielding layer 130 and a second radiation shielding layer 150, respectively. The radiation shielding layers 130 and 150 may include various materials that prevent or reduce the potential of radiation passing through a wall of the pig 30i. For example and in one embodiment, the radiation shielding layers 130 and 150 may include lead, tungsten, impregnated plastic, or any other suitable shielding material that may enable the pig 30i to shield the surrounding environment from radiation. In the illustrated embodiment, the shielding layers 130 and 150 collectively shield at least the first chamber 162 of the pig 30i.
As will be appreciated, the thickness and number of shielding layers 130 and 150 may be varied to enable the pig 30i to provide appropriate shielding in certain applications. For example and in radiopharmaceutical applications having low levels of radiation, the shielding layers 130 and 150 may include a single layer of material (e.g., lead) disposed proximate to the medical container (e.g., syringe 116) and having an overall thickness of about one-eighth of an inch to about one-half of an inch. However, in other applications where the pig 30i may be used to transport radiopharmaceuticals or radioactive substances that have an increased level of radiation, the shielding layers 130 and 150 may be increased in thickness and/or increased in number to provide an appropriate amount of shielding. For example, in nuclear medicine applications that include doses of radioactive substances for animals (e.g., livestock), the pig 30i may include the shielding layers 130 and 150 having a thickness of one-half of an inch or more, or including multiple layers of shielding material/substances.
The arrangement and location of the shielding layers 130 and 150 may be varied to accommodate specific applications. For example and in one embodiment, the shielding layers 130 and 150 may be integral with the first body portion 120 and the second body portion 140. In other words, the shielding layers 130 and 150 may be formed as an innermost layer or region of the cavity portions 126 and 146. For example, the interior may be formed of plastic (e.g., a plastic coating, lining, or insert) over the shielding material. However, in some embodiments, the shielding layers 130 and 150 may be provided as components that are separate from the first body portion 120 and the second body portion 140. In other words, the shielding layers 130 and 150 may include a rigid or semi-rigid inserts that may be appropriately coupled to the first body portion 120 and the second body portion 140. Providing the shielding layers 130 and 150 as inserts may enable the exchange of shielding materials without the need to dispose or exchange the remainder of the pig 30i (e.g., body portions 120 and 140). Generally, appropriate radiological shielding may be utilized in relation to the first chamber 162 of the pig 30i and this shielding may be incorporated/implemented in any appropriate manner.
In the illustrated embodiment, the second cavity 164 of the pig 30i may be configured so as to not utilize any radiation shielding material/substance. However, the entirety or a portion of the second cavity 164 may incorporate a radiation-shielding material. For example, the second cavity portions 128 and/or 148 may be lined with an appropriate radiological shielding material (e.g., lead). Any appropriate radiological shielding may be utilized in relation to the second chamber 164 of the pig 30i as desired/required, and this radiological shielding may be incorporated/implemented in any appropriate manner.
As previously discussed, embodiments of the pig 30i may include the second chamber 164. For example, in the illustrated embodiment and when the pig 30i is dosed, the second cavity portion 128 of the first body portion 120 and the second cavity portion 148 of the second body portion 140 may be aligned to collectively define the second chamber 164. In one embodiment, the second cavity portions 128 and 148 may include a semicircular cutout region of the first body portion 120 and the second body portion 140, respectively at the first end 106 of the pig 30i. Accordingly, the second chamber 164 may be in the form of a hollow chamber (e.g., cylindrical) that is internally disposed and that extends to the first end 106 of the pig 30i.
In certain embodiments, the second chamber 164 may enable housing and storing medical devices internal to the pig 30i. For example and in the illustrated embodiment, the second tube section 118b of the tube 118 may be coiled into the second chamber 164 for storage, and extracted subsequently from the second chamber 164 for a fluid delivery operation (e.g., an injection). When extracted, the tube 118 may be coupled to other medical devices (e.g., a patient line connection set) as will be discussed in more detail below with regard to
In certain embodiments, the first chamber 162 and the second chamber 164 of the pig 30i may be in communication via an aperture or passage that extends through a portion of the first and second bodies 120 and 140. For example and in the illustrated embodiment, the first cavity separation portion 132 includes a first internal aperture portion 134, and the second cavity separation portion 152 includes a second internal aperture portion 154. Accordingly, when the pig 30i is closed, the aperture portions 134 and 154 collectively define an aperture or passage 190 that extends between the first chamber 162 and the second chamber 164. In the illustrated embodiment, the passage 190 provides a passage for the tube 118 to extend from the outlet 176 of the syringe 116 to the second chanter 164. The passage 190 may include features that are conducive to blocking radiation that is emitted from a medical device (e.g., syringe 116) and/or radiopharmaceuticals disposed in the first chamber 162. For example and in the illustrated embodiment, the passage 190 incorporates an orientation that may prevent or reduce the amount of radiation that passes between the first chamber 162 and the second chamber 164. Specifically, the passage 190 includes multiple bends so as to not provide a straight-line path for radiation to pass between the first chamber 162 and the second chamber 164. In the illustrated embodiment, the passage 190 includes a first passage portion 192 having a first passage axis 194, a second passage portion 196 having a second passage axis 198, and a third passage portion 200 having a third passage axis 202. The arrangement of the axes 194, 198, and 202 are angled different relative to one another at their respective intersections such that there is not a straight-line path between the first and second chambers 162, 164. For example, the first passage axis 194 and the third passage axis 202 may be substantially parallel but offset from each other, and the second passage axis 198 is disposed at an angle to each of the first and third passage axes 194 and 202 (e.g., an included angle of 45 degrees). Further and in the illustrated embodiment, the first passage axis 194 is coincident with the longitudinal axis 114, and the third passage axis 202 is offset from but parallel to the longitudinal axis 114. As such, the second passage axis 198 may be characterized as diverging away from the longitudinal axis 114 progressing from the first passage portion 192 to the third passage portion 200. Accordingly, the passage 190 may be characterized as being of an at least generally Z-shaped configuration that enables the outlet 176 of the syringe 116 to be disposed in or proximate to the first passage portion 192, and that enables the tube 118 to extend from the outlet 176 to the second chamber 164 other than in a straight line. Generally, the passage 190 may be of any appropriate configuration that does not provide a straight-line path from the first chamber 162 to the second chamber 164.
The passage 190 may be lined with radiation shielding to prevent or reduce the potential of the radiation traveling in a straight-line path between the first and second chambers 162 and 164. For example and in the illustrated embodiment, the first shielding layer 130 may extend around the first internal aperture portion 134, and the second shielding layer 160 may extend around the second internal aperture portion 154. Similar to the discussion above regarding the configuration of the shielding layer about the first chamber 162, the shielding layers about the passage 190 may be varied in shape, thickness, composition, and the like to provide an appropriate radiation shield between the first and second chambers 162 and 164. Any appropriate radiological shielding may be utilized in relation to the passage 190, and this shielding may be incorporated/implemented in any appropriate manner.
Turning now to
As further illustrated in
The pig 30i may include other features that are conducive to the delivery of the radiopharmaceutical or other substances without removing the syringe 116 from the pig 3G and as addressed above. For example and as illustrated in
Passing the ram 222 of the injection device though the external aperture 220 of the pig 30i and interacting with (e.g., engaging) the plunger 174 of the syringe 116 may force the radiopharmaceutical, or other substances, from the syringe 116 (via the outlet 176) and into/through the tube 118. For example and as illustrated in
The pig 30i may include a mechanism to minimize the amount of radiation passing out of the first chamber 162 via the aperture 220. For instance and as discussed above, an embodiment of the pig 30i may include a shutter 110 that is at least partially disposed over the aperture 220 and that is movable relative to the body 90 of the pig 30i. Generally, the shutter 110 may be movable between a first shutter position where it blocks the aperture 220, and a second shutter position where the shutter 110 no longer blocks the aperture 220 (e.g., when the ram 222 is extending through the aperture 220). In the second shutter position for the shutter, the aperture 220 may be characterized as being exposed to the interior of the pig 30i. As illustrated in
Turning to
It should be noted that the shutter body 230 may be formed from or may otherwise incorporate a radiation-shielding material, such as lead or the like. For example, the body 230 may include shielding material throughout, or may include one or more layers of shielding material. In addition, the body 90 of the pig 30i and the shutter 110 may include features to prevent or reduce the likelihood of radiation passing out of the body 90 via the aperture 220. For example, the aperture 220 may include recesses 244 that accept the shutter body 230, and prevent or reduce the likelihood of radiation having a straight-line path via the aperture 220. In other words, the shutter body 230 may rest in the recesses 244 to overlap the edges of the first and second bodies 120 and 140 proximate to the aperture 220.
Similar to the discussion regarding
It will also be appreciated that the shutters 110, 110′ as discussed in reference to
Embodiments of the pig 30i may also include an aperture-sealing label 252 that may provide inform n, as well as a visual indication that a ram 222 of an injection device has passed through the aperture 220. For example and as illustrated in
Other embodiments of the aperture-sealing label 252 may provide features beneficial to the design and operation of the pig 30i. For example and in one embodiment, the aperture-sealing label 252 may include or incorporate a radiation shielding material. In such an embodiment, the radiation shielding may prevent or reduce the likelihood of radiation escaping the body 90 via the aperture 220. Other embodiments may store information on the aperture-sealing label 252. For example, the sealing label 252 may include patient identification information, radiopharmaceutical calibration information, warnings, instructions for use, a serial number, an identification number, or the like. The sealing label 252 may be in the form of a bar code, an REID tag, or the like. Accordingly and in one embodiment a complementary REID device may be positioned proximate to the aperture-sealing label 252 to read the REID intonation prior to injection of the radiopharmaceutical. For example, the ram 222 may include an REID sensing device that reads the REID information stared on the label 252 as the ram 222 is passed into the aperture 220. This may be beneficial to provide verification that the radiopharmaceutical is the correct type and dosage for injection into the respective subject. It should also be noted that similar embodiments may include placing a label with RFID information internal to the pig 30i (e.g., in the first chamber 162) such that the ram 222 may read the RFID information after the ram 222 has been inserted into the pig 30i (via the aperture 220).
It should be appreciated that in the above-described embodiments, the pig 30 includes a single syringe 116 that may be used to transport a single substance or a plurality of substances. In an embodiment with a syringe 116 that includes a radiopharmaceutical, it may be desirable that the entire amount of the radiopharmaceutical be flushed through the tube 118 and into the subject. For instance, the high cast of radiopharmaceuticals may make it desirable that all of the usable radiopharmaceutical be delivered into the subject, as opposed to having radiopharmaceutical being left in the tube 118 after each injection. Accordingly, embodiments of the syringe 116 may include a sequential syringe that is capable of housing and injecting two or more separate medical fluids. For example, the syringe 116 may include a pre-filled syringe having a first volume of fluid and a second volume of fluid that may be injected sequentially. Thus, certain embodiments may include advancing the plunger 174 to expel the first volume through the outlet 176 and continuing to advance the plunger 174 to eject the second volume via the outlet 176. For example, in the case of a radiopharmaceutical injection, the first volume may include a radiopharmaceutical and the second volume may include an inert solution (e.g., saline). Accordingly, continuing to advance the plunger 174 may flush the saline solution through the tubing 118 to ensure substantially all of the radiopharmaceutical is forced through the tube 118 and into the subject.
As previously discussed, the pig 30i may be employed in a variety of nuclear medicine applications, including the administration of a radiopharmaceutical. For example, the pig 30i discussed above may be employed to inject a patient with a radiopharmaceutical that may enable an imaging system to acquire data related to the injection and process the data to diagnose a patient's condition. However, the pig 30i may contain any appropriate radioactive fluid and which may provide any appropriate function or combination of functions when injected into a patient.
Turning now to
Generally, the pig 30ii from
As will be appreciated, embodiments of the fluid delivery system 80ii including dual syringes may include features similar to those described above with regard to the embodiment of
Referring now to the block diagram of
The system control 316 may include a wide range of circuits, such as imaging (e.g., radiation) source control circuits, timing circuits, circuits for coordinating data acquisition in conjunction with patient or table movements, circuits for controlling the position of imaging (e.g., radiation) detectors, and so forth. The imaging device 314, following acquisition of the image data or signals, may process the signals, such as for conversion to digital values, and forward the image data to data acquisition circuitry 318. In the case of analog media, such as photographic film, the data acquisition system 318 may generally include supports for the film, as well as equipment for developing the film and producing hard copies that may be subsequently digitized. For digital systems, the data acquisition circuitry 318 may perform a wide range of initial processing functions, such as adjustment of digital dynamic ranges, smoothing or sharpening of data, as well as compiling of data streams and files, where desired. The data is then transferred to the processor 320 where additional processing and analysis may be performed. For conventional media such as photographic film, the processor 320 may apply textual information to films, as well as attach certain notes or patient-identifying information. In a digital imaging system, the data processing circuitry of the processor 320 may perform substantial analyses of data, ordering of data, sharpening, smoothing, feature recognition, and so forth.
Ultimately, the image data may be forwarded to an operator/user interface 322 for viewing and analysis. While operations may be performed on the image data prior to viewing, the operator interface 322 is at some point useful for viewing reconstructed images based upon the image data collected. In the case of photographic film, images may be posted on light boxes or similar displays to permit radiologists and attending physicians to more easily read and annotate image sequences. The image data can also be transferred to remote locations, such as via the network 324. In addition, the operator interlace 322 may enable control of the imaging system 310 (e.g., by interfacing with the system control 316). Furthermore, the imaging system 310 may include a printer 326 to output a hard copy of images 328.
The power injector 312 in
The illustrated stand assembly 354 includes a set of four wheels 366, a chassis 368, vertical supports 370, a handle 372, and a display 374. The vertical supports 370 may adjustably elevate handle 372, display 374, and support arm 356 above chassis 368, and, in certain embodiments, it may have a recessed portion through which power cable 376 is routed. Display 374 may include a liquid crystal display, a cathode ray tube display, an organic light emitting diode display, a surface emission display, or other appropriate display. Support arm 356 of injector 312 shown in
Powerhead 352 of
In accordance with a variety of embodiments disclosed above, the injection process may include procedures that reduce the potential exposure of a clinician to radiation. For example and as illustrated in
The fluid delivery system control logic 702 of the fluid delivery system 700 may be of any appropriate form and/or configuration, may be implemented or integrated in any appropriate manner, or both (e.g., for instance in the power injector software; implemented by software, hardware, firmware, and any combination thereof). The functionality of the control logic 702 may be provided by one or more processors of any appropriate size, shape, configuration, and/or type. The functionality of the control logic 702 may be provided by one or more computers of any appropriate size, shape, configuration, and/or type. At least one graphical user interface (e.g., display 358 in
The fluid delivery system control logic 702 may be configured to include at least one fluid delivery or injection protocol 800 (e.g., for a medical application, and which may be referred to as a medical fluid delivery procedure or operation) and a delivery or injection volume determination protocol 900, and each of which may be in the form of a programmed sequence. Each injection protocol 800 may be configured to control the manner in which one or more fluids are being delivered to a fluid target, such as by being injected into a patient. A particular fluid delivery protocol 800 may be configured to deliver a programmed volume of a first fluid at a programmed flow rate, as well as a programmed volume of a second fluid at a programmed flow rate. Each delivery of each of the first and second fluids may be characterized as a phase. In one embodiment, the first fluid is contrast media and the second fluid is saline. Generally, the injection protocol 800 may be configured to include one or more phases for at least one fluid. The injection volume determination protocol 900 will be discussed in more detail below, but generally is configured to determine the volume of a unit dose necessary to provide a prescribed dose of a radiopharmaceutical, based on the real-time radioactivity level of the unit dose.
With reference to
Referring to
Step 904 of the injection volume determination protocol 900 entails acquiring the original radioactivity level of a unit dose (e.g., 25 mCi), and which may be used for an original radioactively level variable used by the protocol 900. The unit dose may be characterized as the quantity of radioactive fluid that is originally loaded into a syringe (e.g., syringe 116), and which may be housed in a radiological containment (e.g., pig 30). That is, the unit dose may be viewed as the “bulk” source to be used for an injection. In any case, other information regarding the unit dose may be acquired through execution of step 904, for instance the chemical make-up of the unit dose, the time and date that the original radioactivity level was acquired, the location where the unit dose was created, the volume of the unit dose, the approximate number of atoms of the unit dose, the half-life of the unit dose, the decay constant for the unit dose, and the like. The original radioactivity level and other information associated with the unit dose may be referred to as “unit dose information”
In one embodiment, the unit dose referenced in relation to step 904 of the injection volume determination protocol 900 is created or filled at a first location (e.g., laboratory) and then transported to a second location (e.g., hospital) where the injection protocol 800 and the injection volume determination protocol 900 are to be executed. However, the protocol 900 contemplates that the unit dose could be created at the same location that the protocols 800 and 900 are to be executed. Regardless, there will very likely be some length of time between the time the unit dose is created and the time the protocols 800 and 900 are to be executed. This length of time may be utilized by step 906 of the injection volume determination protocol 900 (described infra) to calculate the current radioactivity level of the unit dose.
Step 904 may acquire the unit dose information in any appropriate manner. In one embodiment, a containment housing the unit dose (e.g., pig 30i) is encoded or provided with the unit dose information, preferably at the time the unit dose is created or filled. For instance, the sealing label 252 of the pig 30i could be encoded or provided with the unit dose information to be read prior to injection of the radiopharmaceutical, and utilized by the protocols 800 and 900 to inject or administer an appropriate dose to a patient. In one variation, the sealing label 252 of the pig 30i may include the unit dose information on an RFD tag or the like, and this information could be read by an RFID sensing device on the ram of the syringe plunger driver (e.g., ram 222) prior to injection of the radiopharmaceutical. Any appropriate reader could be utilized. Also, a sealing label 158 on a pig 30i could be encoded or provided with the unit dose information to be read by the user, any appropriate sensing/reading device, or the like. Instead of RFID tags and a reader antenna, other information storing and sensing devices and means could be utilized such as bar codes, serial number, identification numbers, and the like. Further, alternative to sealing labels for providing the user or healthcare practitioner with the unit dose information, the protocol 900 envisages other means such as a verified certificate or other documentation accompanying the unit dose to be read by the user or a sensing device, information provided on a syringe, or the like. Generally, the unit dose information may be acquired in any appropriate manner for purposes of step 904 of the protocol 900.
The current radioactivity level of the unit dose is acquired in step 906 of the injection volume determination protocol 900. For instance, the protocol 900 may determine the quantity of time elapsed since the original radioactivity level of the unit dose was acquired, such as for example, by reading or sensing the unit dose information on the sealing label or other documentation as previously described. Thereafter, the protocol 900 may provide for the execution of a number of calculations. For instance, the protocol 900 may obtain a first calculation in the form of taking the base log to the negative power of the decay constant of the unit dose, multiplied by the time elapsed since the original radioactivity level of the unit dose was acquired. Next, the protocol 900 may provide for the execution of a second calculation in the form of multiplying the original radioactivity level by the first calculation. Finally, the protocol 900 may obtain a real-time determination of the radioactivity of the unit dose by dividing the second calculation by the volume of the radioactive fluid in the unit dose. While one method has been described to acquire the current radioactivity level of the unit dose, it should be appreciated that various other methods and devices can be utilized without departing from the spirit and scope of the protocol 900. In one embodiment, the current radioactivity level of the unit dose is acquired through execution of step 906 without removing a syringe (e.g., syringe 116) from a radiological containment (e.g., pig 30i), where the syringe contains a radiopharmaceutical or other radioactive fluid/material.
Once the unit dose current radioactivity level is acquired pursuant to step 906 of the injection volume determination protocol 900 the protocol 900 calculates the injection volume of the unit dose that should provide the prescribed dose, all through execution of step 908. For instance, the prescribed dose (step 902) may be divided by the real-time unit dose radioactivity level (step 906) in order to obtain the required injection volume. Once step 908 calculates the injection volume of the unit dose that should provide the prescribed dose, the injection volume determination protocol 900 returns to the injection protocol 800 via execution of step 910. However, the protocol 900 also contemplates that the injection volume determination protocol 900 could be utilized by a healthcare practitioner apart from the injection protocol 800. For instance, the practitioner may desire to know a real-time determination of a unit dose volume to produce some “prescribed” dose radioactivity level for running experiments or other studies, calibrating the control system or power injector, or the like.
While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the following appended claims.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US09/58210 | 9/24/2009 | WO | 00 | 3/14/2011 |
Number | Date | Country | |
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61194749 | Sep 2008 | US |