Fluid delivery system with multi-dose fluid source

A fluid delivery system (400A) is generally directed to allowing fluid sources or other fluid delivery components to be reused with multiple fluid targets (318), and includes at least one fluid source (314) fluidly interconnectable with at least one sterilization zone (316) and at least one fluid target (318). This sterilization zone (316) could include one or more sterilization systems that attempt to neutralize contaminants entering the fluid delivery system (400A) by a backflow from the fluid target (318). One such sterilization system (500A-D) includes a container (502a-d) and a flush system (520) for sterilizing the container (502a-d) between uses. Another sterilization system (600) includes a flowpath (604) exposed to an output of an energy source (602) capable of destroying contaminants. Yet another sterilization system could include a sterilizing substance (710) that engages and moves along an interior surface (705) of a housing (704) to treat contamination thereon.

FIELD OF THE INVENTION

The present invention generally relates to the field of fluid delivery systems and, more particularly, to incorporating one or more sterilization zones in a fluid delivery system that accommodates using a multi-dose fluid source.

BACKGROUND

Medical contrast media is a relatively expensive product. Factory pre-filled syringes or vials may be used to transport individual contrast media doses to the point of use. In this case, it is common for a certain amount of contrast media to be left after an injection procedure (e.g., based upon differences between patients, differences between imaging requirements, or both). Any remaining contrast media is typically disposed of as waste. It has at least been suggested to utilize a bulk storage container of contrast media that may be used to supply contrast media for multiple injection procedures. Since contrast media tends to be a parenteral drug, and since contamination may be introduced into the fluid delivery system when fluidly connected with a patient, sterilization may be a concern when using a multi-dose contrast media source for multiple patients.

SUMMARY

The present invention is generally directed to providing a sterilization function in relation to the delivery of a fluid. First and second aspects of the present invention are generally directed to providing a sterilization function utilizing an energy source output. Third and fourth aspects of the present invention are generally directed to providing a sterilization function utilizing an intermediate chamber or container somewhere between a fluid source and a fluid target. Fifth and sixth aspects of the present invention are generally directed to providing a sterilization function utilizing a “wiping action” or the like of a surface that is exposed to fluid, where the surface that is exposed to fluid that may be delivered to a patient, and where the wiping action is provided by a sterilizing element or medium. Each of these various aspects will now be addressed in more detail.

A first aspect of the present invention is embodied by a fluid delivery system having a fluid reservoir, an injector, and an energy source. A first flowpath extends from the fluid source to a fluid target. The injector is at least fluidly interconnectable with the first flowpath. At least part of the first flowpath is exposed to an output from the energy source. This exposure may be utilized to at least reduce the contamination level of fluid passing through the first flowpath (e.g., to reduce the potential for contaminants migrating from the fluid target back to the fluid reservoir and/or the injector).

Various refinements exist of the features noted in relation to the first aspect of the present invention. Further features may also be incorporated in the first aspect of the present invention as well. These refinements and additional features may exist individually or in any combination. The following discussion, up to the introduction of a second aspect of the present invention, pertains to this first aspect.

The first flowpath may be defined in any appropriate manner, for instance in the form of or otherwise defined by at least one conduit. Each conduit may be of any appropriate size, shape, configuration, and/or type (e.g., medical tubing). In one embodiment, the first flowpath includes first and second conduit sections that are detachably interconnected in any appropriate manner, with the first conduit section extending from the second conduit section to the fluid target, with the first conduit section being in the form of a disposable, and with the second conduit section being reusable for multiple fluid delivery procedures (e.g., for use with a number of fluid targets). At least part of the first conduit section may be exposed to the output of the energy source.

The energy source may be of any appropriate size, shape, configuration, and/or type. One embodiment has the energy source being in the form of a heater. Another embodiment has the energy source being in the form of a radiation source that emits radiation at one or more wavelengths. Having at least about 5 inches or 13 centimeters of the first conduit section exposed to the output from the energy source may further reduce the potential of contaminants from the fluid target being able to migrate back through the fluid delivery system to the fluid reservoir and/or the injector.

A second aspect of the present invention is embodied by a method for delivering fluid. A flowpath extends from a fluid reservoir to a first fluid target. Fluid is stored in a fluid reservoir, and at least some of this fluid is discharged or released from the fluid reservoir. A first dose of fluid from that which has been discharged from the fluid reservoir is delivered to the first fluid target via the noted flowpath. At least part of the flowpath is exposed to an energy source output (e.g., to reduce the potential for contaminants migrating from the first fluid target back to the fluid reservoir).

Various refinements exist of the features noted in relation to the second aspect of the present invention. Further features may also be incorporated in the second aspect of the present invention as well. These refinements and additional features may exist individually or in any combination. The following discussion, up to the introduction of a third aspect of the present invention, pertains to this second aspect. The output from the energy source may be of any appropriate type or combination of types. The energy source output to which at least part of the flowpath is exposed may be in the form of radiation (e.g., gamma radiation). Radiation of any appropriate wavelength or combination of wavelengths may be utilized (e.g., ultraviolet light, infrared light). Heat may also be utilized as the energy source output, and this heat may be generated in any appropriate manner. One embodiment entails heating fluid within the exposed portion of the flowpath to a temperature of at least about 104° F. or 40° C.

The length of the flowpath that is exposed to an energy source output may be selected to further reduce the potential of contaminants being able to proceed through the exposure zone to reach the fluid reservoir. In one embodiment, one or more aspects of the energy source output (e.g., the dose or dose rate), along with the length of the flowpath to be exposed to the energy source output, may be selected so as to significantly reduce the potential of a contaminant being able to proceed entirely through this exposed portion of the flowpath. In one embodiment, the length of the flowpath that is exposed to the energy source output is at least about 5 inches or 13 centimeters.

One of the benefits associating with exposing at least part of the flowpath to an energy source output is that the fluid reservoir may contain a sufficient quantity of fluid so as to be usable for multiple fluid targets and/or multiple fluid delivery procedures. In one embodiment, the first fluid target is disconnected from the fluid reservoir (e.g., physically and/or fluidly). At least some of the fluid within the fluid reservoir is discharged or released from the fluid reservoir. A second fluid target is connected to the fluid reservoir. A second dose of fluid from that which has been discharged from the fluid reservoir is delivered to the second fluid target. Any appropriate sequence may be utilized in relation to this delivery of a second dose of fluid to the second fluid target. For instance, fluid for the second dose may be discharged or released from the fluid reservoir after the first fluid target has been disconnected (e.g., physically and/or fluidly) from the fluid reservoir. The second fluid target may be connected to the fluid reservoir after the first fluid target has been disconnected from the fluid reservoir.

A third aspect of the present invention is embodied by a fluid delivery system having a fluid reservoir, a first container, an injector, and a flush system, where the injector is not part of the flush system. The first container may be fluidly interconnected with the fluid reservoir, the injector may be fluidly interconnected with at least one of the fluid reservoir and the first container, and the flush system may be fluidly interconnected with the first container. The injector may be operated to direct a flow through a conduit to a fluid target.

Various refinements exist of the features noted in relation to the third aspect of the present invention. Further features may also be incorporated in the third aspect of the present invention as well. These refinements and additional features may exist individually or in any combination. The following discussion, up to the introduction of a fourth aspect of the present invention, pertains to this third aspect. The flush system may be in the form of a flush source and a flush receptacle, each of which may be of any appropriate size, shape, configuration, and/or type. For instance, the flush source may utilize a single flushing medium or a combination of two or more flushing mediums of any appropriate form, where each flushing medium may provide any appropriate function or combination of functions (e.g., sterilization). Representative flushing mediums include without limitation alcohol, steam, ETO (ethylene oxide), a sterilizing fluid, water, air, an inert gas or combination of inert gases, bleach, hydrogen peroxide, oxygen, and any combination thereof. The flush receptacle may be in the form of any appropriate container, storage vessel, or the like, or may simply be in the form of a drain or the like.

The fluid reservoir may be selectively fluidly interconnected with and fluidly isolated from the first container in any appropriate manner. The first container may be selectively fluidly interconnected with and fluidly isolated from the flush source in any appropriate manner. The fluid target may be selectively fluidly interconnected with and fluidly isolated from the first container in any appropriate manner. The flush receptacle may be selectively fluidly interconnected with and fluidly isolated from the first container in any appropriate manner. For instance, one or more valves (e.g., check valves, throttle valves, gate valves, solenoid valves), flow control devices, or the like may be utilized in relation to providing the desired “state” of fluid communication between the above-noted pairs of structures.

A number of configurations exist for directing a flushing medium both into and out of the first container (e.g., to provide a sterilizing function). Stated another way, the flush system may be integrated with the fluid delivery system in various manners. Representative integrations of a flush system will now be addressed.

In a first embodiment, the first container includes a first inlet port and a first outlet port, where the fluid reservoir and the flush source each may be fluidly interconnected with the first inlet port, and where the fluid target and flush receptacle each may be fluidly interconnected with the first outlet port. Both the fluid reservoir and flush source could remain physically interconnected with the first container through the first inlet port, and yet could be either fluidly isolated from or fluidly connected to the first container (e.g., via one or more valves, flow control devices, or the like). The first inlet port could also be physically disconnected from the fluid reservoir and physically connected to the flush source, to fluidly isolate and fluidly interconnect, respectively, these structures, and vice versa. Similarly, both the fluid target and flush receptacle could remain physically interconnected with the first container through the first outlet port, and yet could be either fluidly isolated from or fluidly connected to the first container (e.g., via one or more valves, flow control devices, or the like). The first outlet port could also be physically disconnected from the fluid target and physically connected to the flush receptacle, to fluidly isolate and fluidly interconnect, respectively, these structures, and vice versa. Each of the fluid reservoir, the fluid target, the flush source, and the flush receptacle may be fluidly interconnected with and fluidly isolated from the first container in any appropriate manner. In any case, at least one flushing medium may be directed into the first container from the flush source through the first inlet port, while the fluid reservoir and fluid target are each fluidly isolated from the first container. Flushing medium may be directed out of the first container and into the flush receptacle through the first outlet port, while the fluid reservoir and fluid target are each fluidly isolated from the first container.

In a second embodiment, the first container includes first and second inlet ports, along with a first outlet port. The first inlet port is fluidly interconnectable with the fluid reservoir, while the second inlet port is fluidly interconnectable with the flush source. Both the fluid target and the flush receptacle may be fluidly interconnected with the first outlet port. The fluid target and flush receptacle could remain physically interconnected with the first container through the first outlet port, and yet could be either fluidly isolated from or fluidly connected to the first container (e.g., via one or more valves, flow control devices, or the like). The first outlet port could also be physically disconnected from the fluid target and physically connected to the flush receptacle, to fluidly isolate and fluidly interconnect, respectively, these structures, and vice versa. Each of the fluid reservoir, the fluid target, the flush source, and the flush receptacle may be fluidly interconnected with and fluidly isolated from the first container in any appropriate manner. In any case, at least one flushing medium may be directed into the first container from the flush source through the second inlet port, while the fluid reservoir and fluid target are each fluidly isolated from the first container. Flushing medium may be directed out of the first container and into the flush receptacle through the first outlet port, while the fluid reservoir and fluid target are each fluidly isolated from the first container.

In a third embodiment, the first container includes first and second inlet ports, as well as first and second outlet ports. The first inlet port may be fluidly interconnected with the fluid reservoir, while the second inlet port may be fluidly interconnected with the flush source. The first outlet port may be fluidly interconnected with the fluid target, while the second outlet port may be fluidly interconnected with the flush receptacle. The second inlet port and second outlet port may be characterized as flushing ports. Each of the fluid reservoir, the fluid target, the flush source, and the flush receptacle may be fluidly interconnected with and fluidly isolated from the first container in any appropriate manner. In any case, at least one flushing medium may be directed into the first container from the flush source through the second inlet port, while the fluid reservoir and fluid target are each fluidly isolated from the first container. Flushing medium may be directed out of the first container and into the flush receptacle through the second outlet port, while the fluid reservoir and fluid target are each fluidly isolated from the first container.

In a fourth embodiment, the first container includes a first inlet port, a first outlet port, and a flushing port, where the fluid reservoir may be fluidly interconnected with the first inlet port, where the fluid target may be fluidly interconnected with the first outlet port, and where each of the flush source and flush receptacle may be fluidly interconnected with the flushing port. Each of the fluid reservoir, the fluid target, the flush source, and the flush receptacle may be fluidly interconnected with and fluidly isolated from the first container in any appropriate manner. In any case, at least one flushing medium may be directed into the first container from the flush source through the flushing port, while the fluid reservoir and fluid target are each fluidly isolated from the first container. Flushing medium may be directed out of the first container through the first flushing port and into the flush receptacle, while the fluid reservoir and fluid target are each fluidly isolated from the first container.

Any appropriate function or combination of functions may be provided by a flushing of the first container. Any appropriate number of flushes of the first container may be undertaken. In one embodiment and after the first container has been sterilized, clean water and/or air/inert gas may be used to flush the first container. The first container may be sterilized in any appropriate manner, such as by flushing the first container with an appropriate sterilizing medium, by exposing the first container to an output of an energy source (e.g., heat, gamma radiation, ultraviolet light, infrared light, and any combination thereof), or both. In the second instance, the first container may be sterilized without its interior surfaces being physically contacted.

A fourth aspect of the present invention is embodied by a method for delivering fluid. A first fluid quantity is directed from a fluid reservoir into a first container. A first dose is delivered to a first fluid target, where the first dose is at least part of the first fluid quantity. After the first dose has been retrieved or discharged from the first container, at least some of any of the original first fluid quantity that remains in the first container may be removed from the first container (e.g., an attempt may be made to “drain” the first container). A second fluid quantity is directed from the fluid reservoir into the first container. A second dose is delivered to a second fluid target, where the second dose is at least part of the second fluid quantity. Therefore, the fourth aspect encompasses the successive delivery of fluid to multiple fluid targets.

Various refinements exist of the features noted in relation to the fourth aspect of the present invention. Further features may also be incorporated in the fourth aspect of the present invention as well. These refinements and additional features may exist individually or in any combination. The following discussion, up to the introduction of a fifth aspect of the present invention, pertains to this fourth aspect. The first fluid quantity in the second fluid quantity may be of the same or different amounts. The first dose and the second dose may be of the same or different amounts. The first dose may be any portion of the first fluid quantity, including being the entirety of the first fluid quantity. The second dose may be any portion of the second fluid quantity, including being the entirety of the second fluid quantity.

Any remainder of the first fluid quantity within the first container, where the remainder is that which may remain within the first container after the first dose has been removed from the first container, may be removed from the first container in any appropriate manner. At least some of this remainder may be withdrawn from the first container and directed back into the fluid reservoir. The first container may include an outlet port that is fluidly interconnectable with the first fluid target, and the first fluid target may be disconnected from or at least fluidly isolated from this outlet port such that at least some of the remainder may be discharged from the first container through this outlet port without proceeding to the first fluid target. The first container may include an outlet port that is fluidly interconnectable with the first fluid target, along with a separate bleed port (e.g., a second outlet port) that may be utilized to at least partially drain the first container. An appropriate fluid may be directed through the first container to remove any remainder of the first fluid quantity. Any appropriate combination of the foregoing may be utilized to attempt to “drain” the first container.

The first container may be flushed in any appropriate manner after at least some of any remainder of the first fluid quantity has been removed or drained from the first container (e.g., in accordance with the third aspect). Any flushing of the first container may provide any appropriate function or combination of functions in the manner discussed above in relation to the third aspect. The first container may also be sterilized in the manner discussed above in relation to the third aspect (e.g., flushing and/or exposing the first container to an energy source output).

A flushing medium may be directed through the first container, where the first container remains physically interconnected with each of the fluid reservoir in the first fluid target, and without having any of this flushing medium proceed to either the fluid reservoir or the first fluid target. The fluid reservoir and the first fluid target each may be fluidly isolated from the first container, and thereafter a flushing medium may be introduced into and discharged from the first container. In a first embodiment, the fluid reservoir is fluidly isolated from an inlet port of the first container and the first fluid target is fluidly isolated from an outlet port of the first container, and thereafter a flushing medium is introduced into and discharged from the first container through the inlet and outlet ports, respectively. In a second embodiment, the fluid reservoir is fluidly isolated from a first inlet port of the first container and the first fluid target is fluidly isolated from an outlet port of the first container, and thereafter a flushing medium is introduced into and discharged from the first container through a second inlet port and the outlet port, respectively. In a third embodiment, the fluid reservoir is fluidly isolated from an inlet port of the first container and the first fluid target is fluidly isolated from an outlet port of the first container, and thereafter a flushing medium is introduced into and discharged from the first container through first and second flushing ports, respectively. In a fourth embodiment, the fluid reservoir is fluidly isolated from an inlet port of the first container and the first fluid target is fluidly isolated from an outlet port of the first container, and thereafter a flushing medium is introduced into and discharged from the first container through a common flushing port.

A fifth aspect of the present invention is embodied by what may be characterized as a flow control device. This flow control device includes a housing and a plunger. At least part of the plunger is movably disposed within the housing. First and second seals are mounted on and spaced along the plunger, and furthermore engage an interior surface of the housing. A first sterilizing substance is contained between the first and second seals.

Various refinements exist of the features noted in relation to the fifth aspect of the present invention. Further features may also be incorporated in the fifth aspect of the present invention as well. These refinements and additional features may exist individually or in any combination. The following discussion, up to the introduction of a sixth aspect of the present invention, pertains to this fifth aspect. The flow control device may be incorporated by a fluid delivery system that includes a fluid reservoir. Fluid from this fluid reservoir may be directed to the flow control device. A discharge or output from the flow control device may be directed to a fluid target. In one embodiment, the flow control device is of the “pass through” type in relation to a fluid flow from a fluid reservoir.

The first and second seals may be many appropriate size, shape, configuration, and/or type. In one embodiment, the first and second seals are in the form of O-rings. Any appropriate spacing between the first and second seals may be utilized. The first and second seals may move along with the plunger relative to the housing. As such, the first sterilizing substance that is retained between the first and second seals may move along with the plunger relative to the housing as well. Moving the first sterilizing substance along the interior surface of the housing may “wipe” an engaged portion of the interior surface to address contamination.

The first sterilizing substance may engage the interior surface of the housing. The phrase “engaging the interior surface of the housing” or the like encompasses engaging any portion of the interior surface, and including engaging the entirety of the interior surface. The first sterilizing substance may be of any appropriate type and/or form. The first sterilizing substance may be in the form of a sterilizing liquid, a solid or other carrier that is impregnated with or that contains a sterilizing liquid. A sterilizing substance may be incorporated by or integrated with a sponge, cloth, a porous material, a hydrophilic material, and any combination thereof.

The flow control device may be in the form of a syringe. In this case, the housing may be in the form of a syringe barrel and at least part of the plunger may be disposed within the syringe barrel. The plunger may extend beyond an end of the syringe barrel and may be hand-activated. Another option is for the syringe to be adapted for use with a power injector, where a drive of the power injector may be interconnected with the plunger in any appropriate manner to move the plunger relative to the syringe barrel (e.g., to provide a fluid discharge from the syringe barrel).

The flow control device may include at least one biasing member that is engaged with the plunger. Any such biasing member may be of any appropriate size, shape, configuration, and/or type. Any appropriate number of biasing members may be utilized. In one embodiment, the plunger is biased away from an open position for the flow control device (e.g., an “open” position being one that allow flow through the flow control device), and toward a closed position for the flow control device (e.g., a “closed” position being one that does not allow flow through the flow control device). For instance, the plunger may be biased to a position that does not accommodate a flow out of the flow control device.

Third and fourth seals may be mounted on and spaced along the plunger. The third and fourth seals may engage an interior surface of the housing, and a second sterilizing substance may be contained between the third and fourth seals. The features discussed above in relation to the first sterilizing substance are equally applicable to the second sterilizing substance. Although the first and second sterilizing substances may be the same, such need not be the case. The third and fourth seals may move along with the plunger relative to the housing. As such, the second sterilizing substance that is retained between the third and fourth seals may move along with the plunger relative to the housing as well. Moving the second sterilizing substance along the interior surface of the housing may “wipe” an engaged portion of the interior surface to address contamination.

The first and second seals may define a first seal pair, while the above-noted third and fourth seals may define a second seal pair. The first and second seal pairs may be spaced any appropriate distance along the plunger. In one embodiment and with the plunger being in position where there is no flow out of the flow control device, the first seal pair may be at least generally disposed toward or at an inlet to the flow control device and the second seal pair may be disposed at least generally toward or at an outlet of the flow control device.

The housing may include first and second flow passages that may be in selective fluid communication. In one embodiment, the first and second flow passages may be fluidly isolated from each other when the plunger is in a first position (e.g., a closed position for the flow control device, where there is no flow out of the flow control device). In one embodiment, the first and second passages may be in fluid communication when the plunger is in a second position (e.g., an open position for the flow control device, where there is a flow out of the flow control device).

A fifth seal may be mounted on the plunger at a location that is between the above-noted first and second seal pairs, and where this fifth seal is engageable with the interior surface of the housing. Any appropriate spacing between the fifth seal and each of the first and second seal pairs may be utilized. This fifth seal may block fluid communication between the above-noted first and second flow passages when the plunger is in a first position (e.g., a closed position for the flow control device, where there is no flow out of the flow control device). Moving the plunger to a second position may establish fluid communication between the first and second flow passages (e.g., an open position for the flow control device, where there is a flow out of the flow control device). That is, moving the plunger to the second position may move the fifth seal so that it no longer is disposed between the first and second flow passages to establish a fluid communication therebetween.

The flow control device may include a cap that is detachably or removably engaged with the housing. This cap may be removed to allow the flow control device to be fluidly interconnected with another structure, such as a connector that is fluidly interconnectable with a fluid target. This connector may be part of a tubing set or the like that extends from the flow control device to a fluid target (e.g., a patient).

The above-noted connector may be detachably or removably interconnected with the housing in any appropriate manner, such as by a threaded engagement. The connector may include a third flow passage. Interconnecting the connector with the flow control device may fluidly interconnect the above-noted first and second flow passages of the flow control device with the third flow passage of the connector. In one embodiment, the connector includes a first member of any appropriate configuration (e.g., a second, stationary plunger of sorts). The third flow passage may extend from a sidewall to an interior portion of the first member. Sixth and seventh seals may be mounted on and spaced along the first member at a location such that third flow passage intersects with the sidewall of the first member at a location between these sixth and seventh seals.

The above-noted connector may utilize any appropriate cover or cap (e.g., a peel-off strip or the like). This cover or cap may be removed when the connector is being interconnected with the flow control device. The first member of the connector may be directed into the interior of the flow control device, such that the above-noted sixth and seventh seals engage the interior surface of the housing. Advancing the connector relative to the housing may bring the first member of the connector into engagement with the plunger such that the plunger is moved from a “closed position” to an “open position” where flow proceeds through the flow control device, into the connector, and then to a fluid target (e.g., via tubing on which the connector is mounted). For instance, installing the connector to the flow control device may establish fluid communication between the above-noted first and second flow passages of the flow control device, and may also establish fluid communication between the third flow passage of the connector and the first and second flow passages of the flow control device.

A sixth aspect of the present invention is embodied by a method for delivering fluid. Fluid may be provided to a flow control device, where this flow control device includes a housing having an interior surface that defines at least part of a conduit. A sterilizing element may be moved along at least part of the interior surface. Fluid may be discharged from the flow control device. At least some fluid that is discharged from the flow control device will flow through a portion of the conduit that was contacted by the sterilizing element.

Various refinements exist of the features noted in relation to the sixth aspect of the present invention. Further features may also be incorporated in the sixth aspect of the present invention as well. These refinements and additional features may exist individually or in any combination. The following discussion pertains to this sixth aspect unless otherwise noted. Fluid may be provided to the flow control device in any appropriate manner. In one embodiment, the flow control device is in the form of a syringe, and fluid may be loaded into this syringe in any appropriate manner. In one embodiment, fluid is provided to the flow control device by fluidly interconnecting the flow control device with a fluid reservoir. This fluid reservoir may contain multiple fluid doses, for instance for multiple fluid targets. A first fluid dose may be retrieved from the fluid reservoir, loaded into and/or passed through the flow control device, and discharged from the flow control device (e.g., to a first fluid target). A second fluid dose may be retrieved from the fluid reservoir after the first fluid dose has been discharged from the flow control device, loaded into and/or passed through the flow control device, and discharged from the flow control device (e.g., to a second fluid target). It should be appreciated that the entire first and second fluid dose need not be contained within the flow control device at any one time.

The sterilizing element may be mounted on a plunger that is disposed within the conduit. The plunger may be moved within the conduit in any appropriate manner, which in turn may move the sterilizing element along the interior surface of the conduit. The sterilizing element may be characterized as being movable at least generally between first and second positions, and where the flow control device may be characterized as having a flowpath that extends through the flow control device and that includes at least the above-noted conduit. At least part of the flowpath through the flow control device may be blocked with the sterilizing element being in its first position, whereas the flowpath through the flow control device may be open with the sterilizing element being in its second position. In one embodiment, at least part of the flow control device is biased to a position where at least part of the flowpath is blocked.

A first fluid target may be fluidly interconnected with the flow control device. A movement of the first sterilizing element may be responsive to or caused by the establishment of a fluid interconnection between the first fluid target and the flow control device. After fluid has been provided to the first fluid target through the flow control device, the first fluid target may be disconnected from the flow control device. This disconnection may cause the sterilizing element to move relative to the conduit. The sterilizing element may move to a position that is associated with terminating a fluid output from the flow control device. In any case and subsequent to the disconnection of the first fluid target from the flow control device, a second fluid target may be fluidly interconnected with the flow control device. The fluidly interconnecting the second fluid target with the flow control device may again move the sterilizing element relative to the conduit. Once a sufficient interconnection exists between the second fluid target and the flow control device, fluid may exit the flow control device and be directed toward the second fluid target. In one embodiment, fluid provided from the flow control device to each of the first and second fluid targets is received from a common fluid reservoir.

A target side connector may be coupled with the flow control device, and the target side connector may be fluidly interconnectable with a fluid target. An open end of the target side connector may be sealed prior to being engaged with the flow control device. An open end of the flow control device may be sealed prior to being engaged with the target side connector. Each of these seals may be removed such that the target side connector and flow control device may be coupled. Coupling the target side connector and the flow control device may cause the sterilizing element to move relative to the conduit associated with the flow control device.

Various refinements exist of the features noted in relation to each of the above-noted first through the sixth aspects of the present invention. Further features may also be incorporated in each of the above-noted first through the sixth aspects of the present invention as well. These refinements and additional features may exist individually or in any desired combination in relation to each of the first through the sixth aspects. That is, each of the following features that will be discussed is not required to be used with any other feature or combination of features unless otherwise specified.

Any fluid reservoir that is utilized may be of any size, shape, configuration, and/or type. Multiple fluid reservoirs may be utilized as well. Any appropriate fluid may be stored within any fluid reservoir that is being utilized, including without limitation contrast media, a radiopharmaceutical, saline, and any combination thereof. In one embodiment, multiple fluid doses are stored in the fluid reservoir. A “dose” may be in the form of a predetermined fluid quantity that is intended to be delivered to each of multiple fluid targets. Each dose may or may not be of the same fluid quantity.

Any fluid target may be of any appropriate size, shape, configuration, and/or type. One embodiment has the fluid target being in the form of a patient. Another embodiment has the fluid target being in the form of an animal. In any case, fluid may be delivered in any appropriate manner to a fluid target. For instance, fluid may be injected into a particular fluid target. Fluid may also be topically delivered to a particular fluid target.

An injector may be used to create a fluid flow to a fluid target, and this injector may be of any appropriate size, shape, configuration, and/or type. One embodiment has the injector being in the form of a hand-operated unit (e.g., a manually operable syringe). Another embodiment has the injector being in the form of a power injector (e.g., a syringe that is interconnectable with and driven by operation of a powerhead). Multiple injectors could also be utilized and disposed in any appropriate arrangement.

Any power injector 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 return to a position for a subsequent fluid discharge operation). The power injector may be used for any appropriate application where the delivery of one or more fluids is desired and in any appropriate manner (e.g., via injection into a fluid target such as a patient), including without limitation any appropriate medical application (e.g., computed tomography or CT imaging; magnetic resonance imaging or MRI; SPECT imaging; PET imaging; X-ray imaging; angiographic imaging; optical imaging; ultrasound imaging). The power injector may be used in conjunction with any component or combination of components, such as an appropriate imaging system (e.g., a CT scanner). For instance, information could be conveyed between the power injector and one or more other components (e.g., scan delay information, injection start signal, injection rate). Any appropriate number of syringes may be integrated with the power injector in any appropriate manner (e.g., detachably; front-loaded; rear-loaded; side-loaded), any appropriate fluid may be discharged from a given syringe of the power injector, and any appropriate fluid may be discharged from a multiple syringe power injector configuration in any appropriate manner (e.g., sequentially, simultaneously), or any combination thereof. In one embodiment, fluid discharged from a syringe by operation of the power injector is directed into a conduit, where this conduit is fluidly interconnected with the syringe in any appropriate manner and directs fluid to a desired location (e.g., to a patient, for instance for injection).

DETAILED DESCRIPTION

FIG. 1presents a schematic of one embodiment of a power injector10having a powerhead12. One or more graphical user interfaces or GUIs11may be associated with the powerhead12. Each GUI11: 1) may be of any appropriate size, shape, configuration, and/or type; 2) may be operatively interconnected with the powerhead12in any appropriate manner; 3) may be disposed at any appropriate location; 4) may be configured to provide one or any combination of the following functions: controlling one or more aspects of the operation of the power injector10; inputting/editing one or more parameters associated with the operation of the power injector10; and displaying appropriate information (e.g., associated with the operation of the power injector10); or 5) any combination of the foregoing. Any appropriate number of GUIs11may be utilized. In one embodiment, the power injector10includes a GUI11that is incorporated by a console that is separate from but which communicates with the powerhead12. In another embodiment, the power injector10includes a GUI11that is part of the powerhead12. In yet another embodiment, the power injector10utilizes one GUI11on a separate console that communicates with the powerhead12, and also utilizes another GUI11that is on the powerhead12. Each GUI11could provide the same functionality or set of functionalities, or the GUIs11may differ in at least some respect in relation to their respective functionalities.

A syringe28may be installed on this powerhead12and may be considered to be part of the power injector10. Some injection procedures may result in a relatively high pressure being generated within the syringe28. In this regard, it may be desirable to dispose the syringe28within a pressure jacket26. The pressure jacket26is typically installed on the powerhead12, followed by disposing the syringe28within the pressure jacket26. The same pressure jacket26will typically remain installed on the powerhead12, as various syringes28are positioned within and removed from the pressure jacket26for multiple injection procedures. The power injector10may eliminate the pressure jacket26if the power injector10is configured/utilized for low-pressure injections. In any case, fluid discharged from the syringe28may be directed into a conduit38of any appropriate size, shape, configuration, and/or type, which may be fluidly interconnected with the syringe28in any appropriate manner, and which may direct fluid to any appropriate location (e.g., to a patient).

The powerhead12includes a syringe plunger drive assembly14that interfaces with the syringe28to discharge fluid from the syringe28. This syringe plunger drive assembly14includes a drive source16(e.g., a motor of any appropriate size, shape, configuration, and/or type, optional gearing, and the like) that powers a drive output18(e.g., a rotatable drive screw). A ram20may be advanced along an appropriate path (e.g., axial) by the drive output18. The ram20may include a coupler22for interfacing with a corresponding portion of the syringe28in a manner that will be discussed below.

The syringe28includes a plunger or piston32that is movably disposed within a syringe barrel30(e.g., for axial reciprocation along an axis coinciding with the double-headed arrow B). The plunger32may include a coupler34. This syringe plunger coupler34may interconnect with the ram coupler22to allow the syringe plunger drive assembly14to retract the syringe plunger32within the syringe barrel30. The syringe plunger coupler34may be in the form of a shaft36athat extends from a body of the syringe plunger32, together with a head or button36b. However, the syringe plunger coupler34may be of any appropriate size, shape, configuration, and/or type.

Retraction of the syringe plunger32may be utilized to accommodate a loading of fluid into the syringe barrel30for a subsequent injection or discharge, may be utilized to actually draw fluid into the syringe barrel30for a subsequent injection or discharge, or for any other appropriate purpose. Certain configurations may not require that the syringe plunger drive assembly14be able to retract the syringe plunger32, in which case the ram coupler22and syringe plunger coupler34may not be required. Even when a ram coupler22and syringe plunger coupler34are utilized, it may such that these components may or may not be coupled when the ram20advances the syringe plunger32to discharge fluid from the syringe28(e.g., the ram20may simply push on the syringe plunger coupler34or on a proximal end of the syringe plunger32). Any single motion or combination of motions in any appropriate dimension or combination of dimensions may be utilized to dispose the ram coupler22and syringe plunger coupler34in a coupled state or condition, to dispose the ram coupler22and syringe plunger coupler34in an un-coupled state or condition, or both.

The syringe28may be installed on the powerhead12in any appropriate manner. For instance, the syringe28could be configured to be installed directly on the powerhead12. In the illustrated embodiment, a housing24is appropriately mounted on the powerhead12to provide an interface between the syringe28and the powerhead12. This housing24may be in the form of an adapter to which one or more configurations of syringes28may be installed, and where at least one configuration for a syringe28could be installed directly on the powerhead12without using any such adapter. The housing24may also be in the form of a faceplate to which one or more configurations of syringes28may be installed. In this case, it may be such that a faceplate is required to install a syringe28on the powerhead12—the syringe28could not be installed on the powerhead12without the faceplate. When a pressure jacket26is being used, it may be installed on the powerhead12in the various manners discussed herein in relation to the syringe28, and the syringe28will then thereafter be installed in the pressure jacket26.

The housing24may be mounted on and remain in a fixed position relative to the powerhead12when installing a syringe28. Another option is to movably interconnect the housing24and the powerhead12to accommodate installing a syringe28. For instance, the housing24may move within a plane that contains the double-headed arrow A to provide one or more of coupled state or condition and an un-coupled state or condition between the ram coupler22and the syringe plunger coupler34.

One particular power injector configuration is illustrated inFIG. 2A, is identified by a reference numeral40, and is at least generally in accordance with the power injector10ofFIG. 1. The power injector40includes a powerhead50that is mounted on a portable stand48. A pair of syringes86a,86bfor the power injector40are mounted on the powerhead50. Fluid may be discharged from the syringes86a,86bduring operation of the power injector40.

The portable stand48may be of any appropriate size, shape, configuration, and/or type. Wheels, rollers, casters, or the like may be utilized to make the stand48portable. The powerhead50could be maintained in a fixed position relative to the portable stand48. However, it may be desirable to allow the position of the powerhead50to be adjustable relative to the portable stand48in at least some manner. For instance, it may be desirable to have the powerhead50in one position relative to the portable stand48when loading fluid into one or more of the syringes86a,86b, and to have the powerhead50in a different position relative to the portable stand48for performance of an injection procedure. In this regard, the powerhead50may be movably interconnected with the portable stand48in any appropriate manner (e.g., such that the powerhead50may be pivoted through at least a certain range of motion, and thereafter maintained in the desired position).

It should be appreciated that the powerhead50could be supported in any appropriate manner for providing fluid. For instance, instead of being mounted on a portable structure, the powerhead50could be interconnected with a support assembly, that in turn is mounted to an appropriate structure (e.g., ceiling, wall, floor). Any support assembly for the powerhead50may be positionally adjustable in at least some respect (e.g., by having one or more support sections that may be repositioned relative to one more other support sections), or may be maintained in a fixed position. Moreover, the powerhead50may be integrated with any such support assembly so as to either be maintained in a fixed position or so as to be adjustable relative the support assembly.

The powerhead50includes a graphical user interface or GUI52. This GUI52may be configured to provide one or any combination of the following functions: controlling one or more aspects of the operation of the power injector40; inputting/editing one or more parameters associated with the operation of the power injector40; and displaying appropriate information (e.g., associated with the operation of the power injector40). The power injector40may also include a console42and powerpack46that each may be in communication with the powerhead50in any appropriate manner (e.g., via one or more cables), that may be placed on a table or mounted on an electronics rack in an examination room or at any other appropriate location, or both. The powerpack46may include one or more of the following and in any appropriate combination: a power supply for the injector40; interface circuitry for providing communication between the console42and powerhead50; circuitry for permitting connection of the power injector40to remote units such as remote consoles, remote hand or foot control switches, or other original equipment manufacturer (OEM) remote control connections (e.g., to allow for the operation of power injector40to be synchronized with the x-ray exposure of an imaging system); and any other appropriate componentry. The console42may include a touch screen display44, which in turn may provide one or more of the following functions and in any appropriate combination: allowing an operator to remotely control one or more aspects of the operation of the power injector40; allowing an operator to enter/edit one or more parameters associated with the operation of the power injector40; allowing an operator to specify and store programs for automated operation of the power injector40(which can later be automatically executed by the power injector40upon initiation by the operator); and displaying any appropriate information relation to the power injector40and including any aspect of its operation.

Various details regarding the integration of the syringes86a,86bwith the powerhead50are presented inFIG. 2B. Each of the syringes86a,86bincludes the same general components. The syringe86aincludes plunger or piston90athat is movably disposed within a syringe barrel88a. Movement of the plunger90aalong an axis100a(FIG. 2A) via operation of the powerhead50will discharge fluid from within the syringe barrel88athrough a nozzle89aof the syringe86a. An appropriate conduit (not shown) will typically be fluidly interconnected with the nozzle89ain any appropriate manner to direct fluid to a desired location (e.g., a patient). Similarly, the syringe86bincludes plunger or piston90bthat is movably disposed within a syringe barrel88b. Movement of the plunger90balong an axis100b(FIG. 2A) via operation of the powerhead50will discharge fluid from within the syringe barrel88bthrough a nozzle89bof the syringe86b. An appropriate conduit (not shown) will typically be fluidly interconnected with the nozzle89bin any appropriate manner to direct fluid to a desired location (e.g., a patient).

The syringe86ais interconnected with the powerhead50via an intermediate faceplate102a. This faceplate102aincludes a cradle104that supports at least part of the syringe barrel88a, and which may provide/accommodate any additional functionality or combination of functionalities. A mounting82ais disposed on and is fixed relative to the powerhead50for interfacing with the faceplate102a. A ram coupler76of a ram74, which are each part of a syringe plunger drive assembly56for the syringe86a, is positioned in proximity to the faceplate102awhen mounted on the powerhead50. Details regarding the syringe plunger drive assembly56will be discussed in more detail below in relation toFIG. 2C. Generally, the ram coupler76may be coupled with the syringe plunger90aof the syringe86a, and the ram coupler76and ram74may then be moved relative to the powerhead50to move the syringe plunger90aalong the axis100a(FIG. 2A). It may be such that the ram coupler76is engaged with, but not actually coupled to, the syringe plunger90awhen moving the syringe plunger90ato discharge fluid through the nozzle89aof the syringe86a.

The faceplate102amay be moved at least generally within a plane that is orthogonal to the axes100a,100b(associated with movement of the syringe plungers90a,90b, respectively, and illustrated inFIG. 2A), both to mount the faceplate102aon and remove the faceplate102afrom its mounting82aon the powerhead50. The faceplate102amay be used to couple the syringe plunger90awith its corresponding ram coupler76on the powerhead50. In this regard, the faceplate102aincludes a pair of handles106a. Generally and with the syringe86abeing initially positioned within the faceplate102a, the handles106amay be moved to in turn move/translate the syringe86aat least generally within a plane that is orthogonal to the axes100a,100b(associated with movement of the syringe plungers90a,90b, respectively, and illustrated inFIG. 2A). Moving the handles106ato one position moves/translates the syringe86a(relative to the faceplate102a) in an at least generally downward direction to couple its syringe plunger90awith its corresponding ram coupler76. Moving the handles106ato another position moves/translates the syringe86a(relative to the faceplate102a) in an at least generally upward direction to uncouple its syringe plunger90afrom its corresponding ram coupler76.

The syringe86bis interconnected with the powerhead50via an intermediate faceplate102b. A mounting82bis disposed on and is fixed relative to the powerhead50for interfacing with the faceplate102b. A ram coupler76of a ram74, which are each part of a syringe plunger drive assembly56for the syringe86b, is positioned in proximity to the faceplate102bwhen mounted to the powerhead50. Details regarding the syringe plunger drive assembly56again will be discussed in more detail below in relation toFIG. 2C. Generally, the ram coupler76may be coupled with the syringe plunger90bof the syringe86b, and the ram coupler76and ram74may be moved relative to the powerhead50to move the syringe plunger90balong the axis100b(FIG. 2A). It may be such that the ram coupler76is engaged with, but not actually coupled to, the syringe plunger90bwhen moving the syringe plunger90bto discharge fluid through the nozzle89bof the syringe86b.

The faceplate102bmay be moved at least generally within a plane that is orthogonal to the axes100a,100b(associated with movement of the syringe plungers90a,90b, respectively, and illustrated inFIG. 2A), both to mount the faceplate102bon and remove the faceplate102bfrom its mounting82bon the powerhead50. The faceplate102balso may be used to couple the syringe plunger90bwith its corresponding ram coupler76on the powerhead50. In this regard, the faceplate102bmay include a handle106b. Generally and with the syringe86bbeing initially positioned within the faceplate102b, the syringe86bmay be rotated along its long axis100b(FIG. 2A) and relative to the faceplate102b. This rotation may be realized by moving the handle106b, by grasping and turning the syringe86b, or both. In any case, this rotation moves/translates both the syringe86band the faceplate102bat least generally within a plane that is orthogonal to the axes100a,100b(associated with movement of the syringe plungers90a,90b, respectively, and illustrated inFIG. 2A). Rotating the syringe86bin one direction moves/translates the syringe86band faceplate102bin an at least generally downward direction to couple the syringe plunger90bwith its corresponding ram coupler76. Rotating the syringe86bin the opposite direction moves/translates the syringe86band faceplate102bin an at least generally upward direction to uncouple its syringe plunger90bfrom its corresponding ram coupler76.

As illustrated inFIG. 2B, the syringe plunger90bincludes a plunger body92and a syringe plunger coupler94. This syringe plunger coupler94includes a shaft98that extends from the plunger body92, along with a head96that is spaced from the plunger body92. Each of the ram couplers76includes a larger slot that is positioned behind a smaller slot on the face of the ram coupler76. The head96of the syringe plunger coupler94may be positioned within the larger slot of the ram coupler76, and the shaft98of the syringe plunger coupler94may extend through the smaller slot on the face of the ram coupler76when the syringe plunger90band its corresponding ram coupler76are in a coupled state or condition. The syringe plunger90amay include a similar syringe plunger coupler94for interfacing with its corresponding ram coupler76.

The powerhead50is utilized to discharge fluid from the syringes86a,86bin the case of the power injector40. That is, the powerhead50provides the motive force to discharge fluid from each of the syringes86a,86b. One embodiment of what may be characterized as a syringe plunger drive assembly is illustrated inFIG. 2C, is identified by reference numeral56, and may be utilized by the powerhead50to discharge fluid from each of the syringes86a,86b. A separate syringe plunger drive assembly56may be incorporated into the powerhead50for each of the syringes86a,86b. In this regard and referring back toFIGS. 2A-B, the powerhead50may include hand-operated knobs80aand80bfor use in separately controlling each of the syringe plunger drive assemblies56.

Initially and in relation to the syringe plunger drive assembly56ofFIG. 2C, each of its individual components may be of any appropriate size, shape, configuration and/or type. The syringe plunger drive assembly56includes a motor58, which has an output shaft60. A drive gear62is mounted on and rotates with the output shaft60of the motor58. The drive gear62is engaged or is at least engageable with a driven gear64. This driven gear64is mounted on and rotates with a drive screw or shaft66. The axis about which the drive screw66rotates is identified by reference numeral68. One or more bearings72appropriately support the drive screw66.

A carriage or ram74is movably mounted on the drive screw66. Generally, rotation of the drive screw66in one direction axially advances the ram74along the drive screw66(and thereby along axis68) in the direction of the corresponding syringe86a/b, while rotation of the drive screw66in the opposite direction axially advances the ram74along the drive screw66(and thereby along axis68) away from the corresponding syringe86a/b. In this regard, the perimeter of at least part of the drive screw66includes helical threads70that interface with at least part of the ram74. The ram74is also movably mounted within an appropriate bushing78that does not allow the ram74to rotate during a rotation of the drive screw66. Therefore, the rotation of the drive screw66provides for an axial movement of the ram74in a direction determined by the rotational direction of the drive screw66.

The ram74includes a coupler76that that may be detachably coupled with a syringe plunger coupler94of the syringe plunger90a/bof the corresponding syringe86a/b. When the ram coupler76and syringe plunger coupler94are appropriately coupled, the syringe plunger90a/bmoves along with ram74.FIG. 2Cillustrates a configuration where the syringe86a/bmay be moved along its corresponding axis100a/bwithout being coupled to the ram74. When the syringe86a/bis moved along its corresponding axis100a/bsuch that the head96of its syringe plunger90a/bis aligned with the ram coupler76, but with the axes68still in the offset configuration ofFIG. 2C, the syringe86a/bmay be translated within a plane that is orthogonal to the axis68along which the ram74moves. This establishes a coupled engagement between the ram coupler76and the syringe plunger coupler96in the above-noted manner.

The power injectors10,40of FIGS.1and2A-C each may be used for any appropriate application, including without limitation for medical imaging applications where fluid is injected into a subject (e.g., a patient). Representative medical imaging applications for the power injectors10,40include without limitation computed tomography or CT imaging, magnetic resonance imaging or MRI, SPECT imaging, PET imaging, X-ray imaging, angiographic imaging, optical imaging, and ultrasound imaging. The power injectors10,40each could be used alone or in combination with one or more other components. The power injectors10,40each may be operatively interconnected with one or more components, for instance so that information may be conveyed between the power injector10,40and one or more other components (e.g., scan delay information, injection start signal, injection rate).

Any number of syringes may be utilized by each of the power injectors10,40, including without limitation single-head configurations (for a single syringe) and dual-head configurations (for two syringes). In the case of a multiple syringe configuration, each power injector10,40may discharge fluid from the various syringes in any appropriate manner and according to any timing sequence (e.g., sequential discharges from two or more syringes, simultaneous discharges from two or more syringes, or any combination thereof). Each such syringe utilized by each of the power injectors10,40may include any appropriate fluid, for instance contrast media, a radiopharmaceutical, or saline. Each such syringe utilized by each of the power injectors10,40may be installed in any appropriate manner (e.g., rear-loading configurations may be utilized; front-loading configurations may be utilized).

Many applications, including without limitation various medical and veterinary procedures, require that one or more doses of a fluid be delivered to a subject or patient, or more generally a fluid target.FIG. 3Apresents a perspective view of one embodiment of a fluid delivery system300A that may be employed in such applications, or any other appropriate application. A fluid reservoir302is fluidly interconnectable with both a fluid target318and an injector306a, where the injector306ais in the form of a power injector. The fluid reservoir302may contain any appropriate fluid, including a single fluid or a combination of different fluids (e.g., contrast media, a radiopharmaceutical, saline, and any combination thereof). The fluid target318may be of any appropriate type (e.g., a patient, an animal). The fluid target318may receive fluid from the fluid reservoir302in any appropriate manner, including without limitation by injection in any appropriate manner. The power injector306amay be of any appropriate size, shape, configuration, and/or type (e.g., at least generally in accordance with the discussion presented above regarding the power injector10ofFIG. 1and the power injector40ofFIG. 2A), and includes a powerhead310. Therefore, although the powerhead310is depicted with a single syringe312, the injector306amay be of a dual-head configuration (e.g., in accordance with the power injector40ofFIG. 2A).

The fluid delivery system300A includes what is commonly referred to as a “tubing set” or the like, which is identified by reference numeral307. The tubing set307fluidly interconnects the fluid reservoir302, the power injector306a, and the fluid target318. The tubing set307includes what may be characterized as a reusable section309, as well as what may be characterized as a disposable section308. The tubing set307may be of any appropriate size, shape, configuration, and/or type, may utilize any appropriate conduit or combination of conduits disposed in any appropriate arrangement, may incorporate one or more components in any appropriate manner and which provide any appropriate function or combination of functions, or any combination thereof.

One or more directional flow control devices304may be incorporated at any appropriate location throughout the tubing set307. For instance, one or more directional flow control devices304may be employed to control fluid flow during loading of the syringe312, during subsequent injection of the fluid into the fluid target318, or both. Each of the directional flow control devices304utilized by the fluid delivery system300A may be of any appropriate size, shape, configuration, and/or type. In one embodiment, the directional flow control devices304may be in the form of check valves oriented to reduce the potential for a backflow of fluid into the fluid reservoir302during injection or from the fluid target318during loading of the syringe312.

FIG. 3Bis a perspective view of another embodiment of a fluid delivery system300B having many of the same components just described, but having an injector306bthat is in the form of a hand-activated syringe. In these and other embodiments, fluid is retrieved from the fluid reservoir302and then provided to a fluid target318via the tubing set307. Although the fluid reservoir302is depicted inFIGS. 3A-Bas a discrete component, in other embodiments it may be in the form of a prefilled syringe or may otherwise be integrated with an injector of any appropriate type (e.g., injector306a; syringe306b). The fluid reservoir302may contain a standardized quantity of fluid, which may be more than the total amount required by a given fluid target318.

The tubing set307used by each of the fluid delivery systems300A and300B ofFIGS. 3A and 3B, respectively, again includes a disposable section308and a reusable section309. Generally, one or more sterilization zones may be distributed throughout the tubing set307such that the reusable section309of the tubing set307, as well as all upstream components of the respective fluid delivery system300A,300B, may be used to provide fluid to multiple fluid targets318(e.g., on a successive basis). This then allows the fluid reservoir302to contain multiple fluid doses. Various fluid delivery systems that incorporate at least one such sterilization zone will be addressed below in relation toFIGS. 4A-C. Various embodiments of sterilization systems that may be used in these sterilization zones will be addressed below in relation to FIGS.5AD and6-8. Without incorporating one or more sterilization zones in the fluid delivery systems300A,300B ofFIGS. 3A-B, many fluid delivery system components would typically be changed and discarded on a per-fluid target318basis. This may include, for example, the entire tubing set307, the fluid reservoir302, the syringe312ofFIG. 3A, and the injector/syringe306bofFIG. 3B, along with other fluid path components that may be exposed to contaminants emanating from the fluid target318. When the fluid reservoir302is discarded and replaced for successive fluid targets318, any fluid remaining therein is typically wasted. In at least certain instances, the discarded fluid may be an expensive product (e.g., contrast media).

FIG. 4Apresents a schematic of one embodiment of a fluid delivery system400A having a fluid source314fluidly interconnected by a tubing set307with at least one sterilization zone316and a fluid target318. The fluid source314may be of any appropriate size, shape, configuration, and/or type. In various embodiments, the fluid source314may include a fluid reservoir, alone or in combination with a delivery device, where the delivery device includes an injector or other mechanism that may direct fluid through at least one sterilization zone316before reaching the fluid target318. The fluid reservoir and delivery device may be discrete components, such as the fluid reservoir302and the injectors306a,306bofFIGS. 3A-B, or may be integrated into a single unit. Any separate fluid reservoir and delivery device may be disposed in any appropriate arrangement relative to a sterilization zone316and/or the fluid target318. In various embodiments, the fluid delivery system400A may include a plurality of fluid sources314, sterilization zones316, and/or fluid targets318.

Any appropriate number of sterilization zones316may be utilized. In any case, the tubing set307has a disposable section308generally disposed between the fluid target318and at least one sterilization zone316(e.g., an adjacent-most sterilization zone316), and a reusable section309generally disposed between the fluid source314and at least one sterilization zone316(e.g., an adjacent-most sterilization zone316). Each sterilization zone316includes at least one sterilization system to reduce the potential for contaminants from the fluid target318flowing back through the tubing set307and reaching the fluid source314, thus reducing waste by enabling the fluid source314to be reused for multiple fluid targets318.

FIG. 4Billustrates another embodiment of a fluid delivery system400B having two fluid sources314fluidly interconnected with one or more sterilization zones316and a fluid target318by a tubing set307. The tubing set307includes a disposable section308extending at least from the fluid target318to at least one sterilization zone316(e.g., an adjacent-most sterilization zone316), as well as a reusable section309extending at least from one of the fluid sources314to at least one sterilization zone316(e.g., an adjacent-most sterilization zone316). In one embodiment, the two fluid sources314include, respectively, a fluid reservoir302and an injector306, where the injector306may be in the form of a power injector, a hand-activated syringe, or any other appropriate delivery device as described above. Fluid passes from the fluid reservoir302through at least one sterilization zone316(a single sterilization zone316in the illustrated embodiment) to reach the injector306. The injector306then directs the fluid through at least one sterilization zone316(a single sterilization zone316and illustrated embodiment) to reach the fluid target318. The fluid delivery system400B may utilize any appropriate number of sterilization zones316, including using only one of the sterilization zones316. In any case, each sterilization zone316includes at least one sterilization system to reduce the potential for contaminants from the fluid target318flowing back through the tubing set307and reaching the fluid source314that includes the fluid reservoir302, thus reducing waste by enabling the fluid reservoir302to be reused for multiple fluid targets. In embodiments utilizing a sterilization zone316between the injector306and the fluid target318, components of the injector306may also be protected from contamination emanating from the fluid target318.

FIG. 4Cshows another embodiment of a fluid delivery system400C having a fluid target318fluidly interconnected by a tubing set307to a plurality of fluid sources314and one or more sterilization zones316, where each sterilization zone316includes at least one sterilization system as described above. The tubing set307again includes a disposable section308that extends at least from the fluid target318to at least one sterilization zone316. The tubing set307also has one or more reusable sections309, where each reusable section309extends from one of the fluid sources314at least as far as a sterilization zone316disposed between that fluid source314and the fluid target318, if any. As in the fluid delivery system400B ofFIG. 4B, the fluid sources314may include, respectively, a fluid reservoir302and an injector306. In a first stage, fluid may flow from the fluid reservoir302to the injector306, optionally passing through one or more sterilization zones316. In a next stage, fluid may flow from the injector306to the fluid target318, optionally passing through one or more sterilization zones316. Although the illustrated embodiment uses three sterilization zones316, the fluid delivery system400C may be adapted to include any appropriate number of sterilization zones (e.g., using only one or two of the sterilization zones316). Depending on which of the sterilization zones316are included in the fluid delivery system400C, one or both of the fluid sources314may be protected from contamination emanating from the fluid target318.

FIGS. 5A-Dillustrate various embodiments of a sterilization system that may be used by the fluid delivery systems300A-B and400A-C ofFIGS. 3A-Band4A-C described above, or any other appropriate fluid delivery system. Referring first toFIG. 5A, an intermediate chamber sterilization system500A includes a flush system520and a container502a. The flush system520includes both a flush source508and a flush receptacle510that are each fluidly interconnectable with the container502avia a first inlet port504and a first outlet port506, respectively. The flush source508may contain any appropriate flushing medium, including without limitation alcohol, steam, ETO, sterilizing fluid, water, air, an inert gas, a combination of inert gases, bleach, hydrogen peroxide, oxygen, any appropriate drying agent, and any combination thereof. The flush source508may utilize a single flushing medium or a combination of two or more different flushing mediums, which may be delivered by the flush source508in any appropriate manner and in any appropriate sequence. Each flushing medium may provide any appropriate function or combination of functions. Multiple flushing mediums may be directed through the container502aon any appropriate basis.

The flush source508may be of any appropriate configuration to provide the functionality noted herein. The flush receptacle510also may be of any appropriate configuration, for instance in the form of a storage vessel or in the form of a waste drain or the like. The first inlet port504and/or the first outlet port506of the container502a, as well as any additional ports, may be arranged to work passively, for example using a check valve system. Alternatively, they may utilize manually operated components such as push or twist ports, or employ solenoid valve actuation or some other automatic system. The ports504,506of the container502a, as well as any other container ports, need not incorporate any flow control functionality. Instead, flow control functionality may be provided by valving or the like incorporated into any conduit. The intermediate chamber sterilization system500A may also use one or more flow regulators to facilitate fluidly interconnecting and disconnecting/isolating the container502awith the flush source508, the flush receptacle510, a fluid source314, and/or a fluid target318. Each such flow regulator may be of any appropriate size, shape, configuration, and/or type, and may be designed to work passively, automatically, manually, based upon one or more signals, or using any combination of these methods.

During a fluid delivery stage in the case of the sterilization system500A, the first inlet port504is fluidly interconnected with a fluid source314via a fluid source flow regulator512a, and the first outlet port506is fluidly interconnected with a fluid target318via a fluid target flow regulator512b. A flush source flow regulator512cand a flush receptacle flow regulator512dremain in a closed position such that the container502ais fluidly disconnected or isolated from the flush source508and the flush receptacle510. A first fluid quantity thereby may be directed from the fluid source314into the container502a, after which at least part of the first fluid quantity may be directed from the container502ato the fluid target318.

After a desired amount of fluid has been delivered to the fluid target318, the fluid flow to the fluid target318may be terminated in any appropriate manner (e.g., by the fluid target flow regulator512b). Moreover, the fluid volume in the container502amay be reduced, or the container502amay be emptied of any remaining fluid, by reversing the direction of flow so as to return at least some of the remaining fluid to the fluid source314. In embodiments employing this technique, it may be necessary to prevent backflow of fluid from the fluid target318, which may be accomplished, for example, by closing the first outlet port506and/or the fluid target flow regulator512bto fluidly disconnect or isolate the container502afrom the fluid target318. Additionally or alternatively, the container502amay be emptied by closing the fluid target flow regulator512bor otherwise fluidly disconnecting or isolating the container502afrom the fluid target318, opening the flush receptacle flow regulator512d, and then bleeding off any remaining fluid through the first output port506into the flush receptacle510. In another aspect, one or more flow regulators may be configured to fluidly disconnect or isolate the container502afrom the fluid source314and the fluid target318and to fluidly connect the container502ato the flush source508and the flush receptacle510. The container502amay then be flushed by directing a flushing medium from the flush source508into the container502athrough the first inlet port504, out of the container502athrough the first outlet port506, and into the flush receptacle510.

Another embodiment of an intermediate chamber sterilization system500B is depicted inFIG. 5Band includes a container502bhaving all the features of the container502aofFIG. 5A, plus a second inlet port514. A flush system520ithat includes a flush source508and flush receptacle510is fluidly connectable with the container502b, although in a different arrangement from that presented inFIG. 5A(and thereby a superscripted “i” is utilized to identify the flush system520i). The flush source508is fluidly interconnected with the second inlet port514, which may eliminate the need to use one or more flow regulators to selectively interconnect the first inlet port504with one of the fluid source314and the flush source508. While fluid is being delivered to the fluid target318, the first inlet and outlet ports504,506and the fluid target flow regulator512bare open, while the second inlet port514and the flush receptacle flow regulator512dremain closed. The container502bmay then be fluidly disconnected or isolated from the fluid target318by closing the first outlet port506and/or the fluid target flow regulator512b, after which at least some of the remaining fluid in the container502bmay be emptied back into the fluid source314as described above. Additionally or alternatively, the container502bmay be emptied into the flush receptacle510after opening the first outlet port506and the flush receptacle flow regulator512dand after closing the fluid target flow regulator512b. Once flow leaving the container502bvia the first outlet port506is redirected from the fluid target318to the flush receptacle510, and regardless of whether or by what method at least some of remaining fluid in container502bis removed, the first inlet port504may be closed and the second inlet port514may be opened. The container502bmay then be sterilized by directing at least one flushing medium from the flush source508into the container502bthrough the second inlet port514, out of the container502bthrough the first outlet port506, and into the flush receptacle510, at least generally in the manner discussed above regarding theFIG. 5Aembodiment.

In another embodiment, an intermediate chamber sterilization system500C includes a container502chaving all the features of the container502bofFIG. 5B, plus a second outlet port516as shown inFIG. 5C. A flush system520iithat includes a flush source508and flush receptacle510is fluidly connectable with the container502c, although in a different arrangement from that presented inFIGS. 5A-B(and thereby a superscripted “ii” is utilized to identify the flush system520ii). This configuration allows the container502cto be in selective fluid communication either with the fluid source314and the fluid target318, or with the flush source508and the flush receptacle510, without the need for external flow regulators. After fluid has been delivered to the fluid target318, the container502cmay be fluidly disconnected or isolated from the fluid target318in any appropriate manner. At least some of the remaining fluid in the container502cmay be removed and directed into the fluid source314as described above by first closing the second inlet port514(e.g., a flushing port) and the first and second outlet ports506,516(e.g., the second outlet port516may be referred to as a flushing port) and opening the first inlet port504. Additionally or alternatively, at least some of the remaining fluid in the container502cmay be directed into the flush receptacle after first closing the first inlet and outlet ports504,506and opening the second outlet port516. The container502cmay be flushed by further opening the second inlet port514and then directing at least one flushing medium from the flush source508into the container502cthrough the second inlet port514, out of the container502cthrough the second outlet port516, and into the flush receptacle510at least generally in the manner discussed above regarding theFIG. 5Aembodiment.

FIG. 5Dillustrates another embodiment of an intermediate chamber sterilization system500D that includes a container502dhaving a first inlet port504, a first outlet port506, and a flush port518, where the flush port518is in selective fluid communication with a flush source508and a flush receptacle510. A flush system520iiithat includes a flush source508and flush receptacle510is fluidly connectable with the container502d, although in a different arrangement from that presented inFIGS. 5A-C(and thereby a superscripted “iii” is utilized to identify the flush system5209. After fluid has been delivered to the fluid target318, the container502dmay be fluidly disconnected or isolated from the fluid target318. At least some of the remaining fluid in the container502dmay then be removed by closing the flushing port518and the first outlet port506and then directing at least some of the remaining fluid back to the fluid source314through the first inlet port504. Alternatively or additionally, at least some of the remaining fluid in the container502dmay be directed into the flush receptacle510through the flush port518after closing the first inlet and outlet ports504,506, closing the flush source flow regulator512c, and opening the flush receptacle flow regulator512d. Flushing the container502dmay involve directing at least one flushing medium from the flush source508into the container502dthrough the flush port518, and then removing this flushing medium from of the container502dout through the same flush port518and directing the same to the flush receptacle510. During this process, the flow regulators512c,512dmay be alternately opened and closed to establish fluid communication between the flushing port518and the flush source508or the flush receptacle510as appropriate. Alternatively, the flow regulators512c,512dmay be unidirectional in nature, such that each flow regulator512c,512dallows fluid to flow in only one direction as shown by the arrows inFIG. 5D.

Each of the ports for the containers502a-dofFIGS. 5A-Dmay or may not incorporate flow control functionality (e.g., valving). Fluid disconnection or isolation of the various components noted in relation to the embodiments ofFIGS. 5A-Dmay be realized in any appropriate manner, as may establishing a fluid communication between noted components. The flushing of each of the containers502a-dmay be repeated one or more times using a common or a combination of two or more flushing mediums. At least one flushing operation may provide a sterilization function for the relevant container502a-d. For example, sterilizing the container502a-dmay include, without limitation, first flushing the container502a-dwith alcohol, next flushing the container502a-dwith water, and finally flushing the container502a-dwith an inert gas or other drying agent.

One or more intermediate chamber sterilization systems500A-D may be located in any one or more of the sterilization zones316of the fluid delivery systems400A-C described above. Thus, although the preceding discussion refers to fluidly interconnecting and fluidly disconnecting or isolating the container502a-dto and from the fluid source314and the fluid target318, it is understood that those connections may be indirect. For example, when an intermediate chamber sterilization system500A-D is used in a sterilization zone316located between the two fluid sources314of the fluid delivery system400B ofFIG. 4B, it may be directly connected to the injector306and only indirectly connected to the fluid target318.

FIG. 6illustrates another embodiment of a sterilization system600that may be used by the fluid delivery systems300A-B and400A-C ofFIGS. 3A-Band4A-C described above, or any other appropriate fluid delivery system. The sterilization system600includes an energy source602and a flowpath604, where at least part of the flowpath604having a length L may be exposed to an output of the energy source602. The energy source602may include, without limitation, a source of heat, radiation, or other radiative energy capable of reducing a contamination level of a fluid in the flowpath604given a certain level of exposure, for instance by neutralizing and/or eliminating bacteria or other contamination present in a fluid passing through the flowpath604(e.g., heat, gamma radiation, ultraviolet radiation, infrared light, and any combination thereof). Reducing a contamination level may encompass exposing the fluid to a certain temperature or radiation dose for a specified exposure time, where the specified exposure time is at least long enough to ensure reduction of the contamination to a permissible level with an acceptable degree of certainty. The contamination may further have a maximum propagation speed at which it can diffuse through the fluid or otherwise spread to neighboring elements of substance. A minimum value for the length L can then be calculated by multiplying the maximum propagation speed of the contamination by the specified exposure time. Contamination entering the exposed portion of the flowpath604from the direction of the fluid target318should be prevented from propagating beyond the exposed portion in the direction of the fluid source314. The sterilization system600may be utilized in one or more sterilization zones316, such that fluid flowing between a fluid source314and a fluid target318passes through the flowpath604and is thereby exposed to the output of the energy source602. In this way, contaminants entering the fluid delivery system400A-C from the fluid target318should be prevented from infiltrating the fluid source314.

FIGS. 7A-Cpresent schematics (e.g., cutaway views) of another embodiment of a sterilization system that may be used by the fluid delivery systems300A-B and400A-C ofFIGS. 3A-Band4A-C described above, or any other appropriate fluid delivery system. A self-sterilizing flow control device700includes a plunger702movably disposed within a housing704having an interior surface705. This interior surface705may define a conduit or flowpath for fluid flow, may interface with fluid within the flow control device700, or both. First and second seals706,708are mounted on and spaced along the plunger702, and engage the interior surface705of the housing704. A first sterilizing substance710is contained between the first and second seals706,708, such that any contaminants attempting to pass by the first and second seals706,708encounter the first sterilizing substance710. Additionally, third and fourth seals712,714are mounted and spaced along the plunger702at some distance from the first and second seals706,708. A second sterilizing substance716may be disposed between the third and fourth seals712,714. The first and second sterilizing substances710,716also engage the interior surface705of the housing704, such that moving the plunger702within the housing704wipes the sterilizing substances710,716along at least part of the interior surface705to treat contamination thereon. Each of the sterilizing substances710,716may include, without limitation, a sterilizing liquid, a sterilizing gel, a sterilizing gas, and any combination thereof, or a sponge, cloth, a porous material, a hydrophilic material, and any combination thereof impregnated with any appropriate agent having suitable sterilizing properties.

The self-sterilizing flow control device700also has first and second flow passages718,720, where the first flow passage718may be fluidly interconnected with a fluid source314. A fifth seal728, mounted on the plunger702between a seal pair defined by the first and second seals706,708and a seal pair defined by the third and fourth seals712,714, is situated so as to block fluid communication between the first and second flow passages718,720when the plunger702is in a closed position, as illustrated inFIG. 7A. Thus, a fluid722entering the first flow passage718flows only as far as the fifth seal728with the self-sterilizing flow control device700being in its closed position. The self-sterilizing flow control device700also includes a biasing member726engaged between the plunger702and an end wall724of the housing704, where the biasing member726biases the plunger702toward the closed position ofFIG. 7A. Although the biasing member726is represented inFIG. 7Aas a spring, it should be understood that any appropriate way of biasing the plunger702to the closed position ofFIG. 7may be utilized by the self-sterilizing flow control device700(e.g., using one or more biasing elements of any appropriate size, shape, configuration, and/or type).

The self-sterilizing flow control device700ofFIG. 7Aalso includes a cap730. The cap730is removably attached to an end of the housing704. In one embodiment, the cap730screws onto helical threads732situated on the end of the housing704. However, it should be understood that the cap730may removably interface with the housing704in any appropriate manner.

FIG. 7Bis a schematic (e.g., a cutaway view) of a fluid target side connector740for use in conjunction with the self-sterilizing flow control device700ofFIG. 7A. A connector housing742contains a first member746on which are mounted sixth and seventh seals748,750. A third flow passage752intersects a sidewall747of the first member746between the sixth and seventh seals748,750and extends through the first member746, such that the third flow passage752may be fluidly interconnected with a fluid target318. A protective cover744is removably attached to an end of the connector housing742, where the protective cover744may be implemented as a peel-off cover or any other suitable covering. Any way of removably attaching the protective cover744to the connector housing742may be utilized. The target side connector740may also have helical threads754situated on an interior wall756of the connector housing742to threadably engage with the helical threads732on the end of the housing704. However, any appropriate way of coupling the fluid target side connector740to the self-sterilizing flow control device700may be utilized.

After the protective cover744has been removed from the connector housing742(FIG. 7B), and after the cap730has been removed from the housing704of the self-sterilizing flow control device700(FIG. 7A), the fluid target side connector740may be interconnected with the self-sterilizing flow control device700as shown inFIG. 7C. Coupling the fluid target side connector740with the self-sterilizing flow control device700causes the first member746of the fluid target side connector740to engage the plunger702of the self-sterilizing flow control device700and push it away from the closed position ofFIG. 7A, thereby wiping the sterilizing substances710,716along portions of the interior surface705to treat any contamination thereon before fluid is delivered to the fluid target318. Once the fluid target side connector740is fully engaged with the self-sterilizing flow control device700, the plunger702is disposed in its open position ofFIG. 7C, such that the fifth seal728no longer blocks fluid communication between the first and second flow passages718,720of the self-sterilizing flow control device700. Additionally, the third flow passage752of the fluid target side connector740is now aligned with the second flow passage720of the self-sterilizing flow control device700, such that the first, second, and third flow passages718,720,752form a continuous flowpath758. The sixth and seventh seals748,750of the fluid target side connector740engage the interior surface705of the housing704of the self-sterilizing flow control device700to guide fluid into the third flow passage752of the fluid target side connector740. In this way, a fluid722entering the self-sterilizing flow control device700from the fluid source314may flow through the continuous flowpath758toward the fluid target318.

Once or after a desired amount of fluid has been delivered to the fluid target318, the fluid target side connector740may be disconnected from the self-sterilizing flow control device700. Removing the target side connector740allows the biasing member726to move the plunger702back to the closed position illustrated inFIG. 7A. This motion of the plunger702in turn causes the sterilizing substances710,716to again be wiped along portions of the interior surface705of the housing704, thereby treating any contamination left on the interior surface705after delivering fluid to the fluid target318.

FIG. 8is a schematic (e.g., cutaway view) of another embodiment of a self-sterilizing flow control device800that at least generally utilizes at least part of the sterilizing principles of the self-sterilizing flow control device700ofFIGS. 7A-C. Corresponding components between the embodiments ofFIGS. 7A-CandFIG. 8are identified by the same reference numeral. Those corresponding components that differ in at least some respect are further identified by a “single prime” designation. The self-sterilizing flow control device800includes a plunger702′ movably disposed within a housing704′ having an interior surface705′. First and second seals706,708are mounted on and spaced along the plunger702′ and engage the interior surface705′ of the housing704′. A sterilizing substance710is contained between the first and second seals706,708, such that any contaminants attempting to pass by the first and second seals706,708encounter the sterilizing substance710. The sterilizing substance710also engages the interior surface705′ of the housing704′, such that moving the plunger702′ within the housing704′ wipes the sterilizing substance710along at least part of the interior surface705′ to treat contamination thereon.

In the illustrated embodiment, the self-sterilizing flow control device800is generally configured as a syringe, where the housing704′ forms the barrel of the syringe and further includes a nozzle760. The plunger702′ may extend beyond an end of the housing704′ and may include without limitation a handle762for manually advancing the plunger702′. Alternatively, the plunger702′ may include any means of coupling the plunger702′ to a power injector, such as by including the syringe plunger coupler94ofFIGS. 2B-C. Loading the self-sterilizing flow control device800may involve retracting the plunger702to draw or otherwise allow fluid to flow into the housing704′ through the nozzle760, while discharging the self-sterilizing flow control device800includes advancing the plunger702to expel fluid through the nozzle760. Thus, at least a portion of the interior surface705′ of the housing704′ undergoes a sterilizing treatment before and/or after every injection through advancement of the plunger702′.

Each of the sterilization systems500A-D,600,700, and800ofFIGS. 5A-8, or any combination thereof, may be incorporated into the fluid delivery systems300A-B and400A-C ofFIGS. 3A-Band4A-C, respectively, or any other fluid delivery system as appropriate to reduce potential back-contamination from a fluid target318to one or more fluid sources314. Furthermore, elements of the sterilization systems described above may be combined to create other embodiments; for example, the energy source602ofFIG. 6may be configured to interface with any of the containers502a-dof the intermediate chamber sterilization systems500A-D ofFIGS. 5A-Das an additional or alternative method of reducing contamination inside the container502a-d. In any case, fluid is provided to the fluid target318with less risk of contaminants infiltrating a fluid source314, such that the fluid source314may be reused for subsequent fluid targets318. Other fluid delivery components located opposite a sterilization zone316from the fluid target318, such as a reusable section309of a tubing set307, may also be sufficiently protected from contamination to be reused for successive fluid targets318. Some of the many resulting advantages may include reduced packaging costs, quicker procedure times when fewer parts are replaced between successive fluid targets318, reduced fluid waste, and safer delivery of high-value or high-purity substances.