Systems and method for assessing functionality of dual check valve arrangements in medical tubing sets

A dual one-way check valve arrangement (300) that may be used for assessing an operating condition of at least one of first and second check valves (304, 308) situated in series along/within a section of a patient-specific section of tubing (244). A pressure sensor (332) may be associated with at least part of the flow path between the first and second check valves (304, 308) and may be operable to provide an indication of a failed condition of at least one of the first and second check valves (304, 308). In one embodiment, the pressure sensor (332) may change from a first state to a second state upon fluid pressure within the flow path between the first and second check valves (304, 308) falling below a predetermined level. For instance, the predetermined level may be a cracking pressure of at least one of the first and second check valves (304, 308). The change in state may be visually discernible on an exterior of the pressure sensor (332).

FIELD OF THE INVENTION

The present invention generally relates to the field of medical fluid delivery systems and, more particularly, to systems and methods for monitoring an operating condition of one or more check valves of a medical fluid delivery system.

BACKGROUND

Various medical procedures require that one or more medical fluids be injected into a patient. For example, medical imaging procedures oftentimes involve the injection of contrast media into a patient, possibly along with saline and/or other fluids. Other medical procedures involve injecting one or more fluids into a patient for therapeutic purposes. Power injectors may be used for these types of applications.

A power injector generally includes what is commonly referred to as a powerhead. One or more syringes may be mounted to the powerhead in various manners (e.g., detachably; rear-loading; front-loading; side-loading). Each syringe typically includes what may be characterized as a syringe plunger, piston, or the like. Each such syringe plunger is designed to interface with (e.g., contact and/or temporarily interconnect with) an appropriate syringe plunger driver that is incorporated into the powerhead, such that operation of the syringe plunger driver axially advances the associated syringe plunger inside and relative to a barrel of the syringe. One typical syringe plunger driver is in the form of a ram that is mounted on a threaded lead or drive screw. Rotation of the drive screw in one rotational direction advances the associated ram in one axial direction, while rotation of the drive screw in the opposite rotational direction advances the associated ram in the opposite axial direction.

One way to categorize syringes used by power injectors is the manner in which they are filled or loaded with fluid. Power injector syringes may be pre-filled—syringes that are filled with fluid at one facility and then shipped to another facility (e.g., an end-use facility). Empty syringes may be shipped to the end-use facility, and may then be filled with fluid in at least two general manners. An empty syringe may be filled with fluid at one location within the end-use facility (e.g., at a filling station), and then transferred to another location within the end-use facility (e.g., an imaging suite) where the fluid-containing syringe is then installed on a power injector. Alternatively, an empty syringe may be installed on a power injector at the end-use facility (e.g., in an imaging suite) and then loaded or filled with fluid.

Individual empty syringes may be filled in accordance with the foregoing from what may be characterized as a single dose container. In this case, the syringe is used for a single injection on a single patient. Any contrast media remaining in the syringe after this single injection is thereby wasted. The entire tubing set extending from the power injector to the patient (including the various components that may be incorporated into the tubing set, such as one or more valves and a catheter) is also discarded.

SUMMARY

A first aspect of the present invention is directed to a medical fluid tubing set that includes a first section of medical fluid tubing, first and second check valves, and a pressure sensor. The first and second check valves are situated in series along/within the first section of medical fluid tubing, and the pressure sensor is associated with a space within the first section of medical fluid tubing that is located at least somewhere between the first and second check valves.

A number of feature refinements and additional features are applicable to the first aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. As such, each of the following features that will be discussed may be, but are not required to be, used with any other feature or combination of features of the first aspect. The following discussion is applicable to the first aspect, up to the start of the discussion of a second aspect of the present invention.

In an embodiment, the pressure sensor may provide the function of monitoring for a failed condition of the medical fluid tubing set. For instance, the failed condition may be when at least one of the first and second check valves is at least presumed to have failed (e.g., has allowed fluid to flow in more than one direction through the check valve; when a check valve has allowed for an undesired backflow). In an embodiment, the pressure sensor may be operable to provide an indication that at least one of the first and second check valves is at least presumed to have failed. As an example, the indication may be at least one of visual, audible, tactile, or any combination thereof. The pressure sensor may be useful in determining whether one or more portions of the medical fluid tubing set may need to be replaced before a subsequent injection procedure. In an embodiment, the first section of medical fluid tubing may be patient-specific. Moreover, the medical fluid tubing set may further include a second section of medical tubing fluidly interconnectable to the first section of medical tubing, and the second section of medical tubing may be reusable (e.g., for use with multiple patients, or a multi-patient tubing section). In this regard, the reusable portion of the medical fluid tubing set may be discarded and/or replaced if the pressure sensor determines that a failed condition has occurred or otherwise provides an indication that at least one of the first and second check valves is at least presumed to have failed.

In an embodiment, the pressure sensor may be responsive to a fluid pressure in a first region of the first section of medical fluid tubing. In one variation, this first region may be located between the first and second check valves. For instance, the pressure sensor may respond to the fluid pressure by changing from a first state to a second state upon fluid pressure within the first region falling below a predetermined level. In one arrangement, the predetermined level may be a cracking pressure (e.g., a pressure differential required to open the corresponding check valve) of at least one of the first and second check valves. In another arrangement, the predetermined level may be the cracking pressure of each of the first and second check valves.

The pressure sensor may be subject to a number of characterizations. In an embodiment, the pressure sensor may be situated on the first section of medical fluid tubing. Further, the pressure sensor may be situated in series with the first and second check valves, and/or may be situated between the first and second check valves. The pressure sensor may also be fluidly interconnectable with the first section of medical fluid tubing.

In an embodiment, the pressure sensor may include a movable element. For instance, the movable element of the pressure sensor may be operable to perform at least one of measuring fluid pressure and providing an indication related to the measured fluid pressure. In a variation, a first position of the movable element may be associated with a proper functioning of the first and second check valves and a second position of the movable element may be associated with at least a presumed failure of at least one of the first and second check valves. These two positions of the movable element may be viewable or discernable from an exterior of the pressure sensor (e.g., by providing a change in shape of the exterior of the pressure sensor).

In one arrangement, the pressure sensor may further include a biasing member (e.g., compression spring, wave spring) interconnected with the movable element, and which biases the movable element into one of its two primary positions. Multiple biasing members could be used as well. At least one biasing member may bias the movable element into either the first position (that which is associated with a presumed proper functioning of the first and second check valves) or the second position (that which is associated with at least one of the first and second check valves at least being presumed to have failed). Additionally, the pressure sensor may further include a housing constructed of any appropriate material (e.g., plastic, metal). In one setup, the movable element may include a portion that protrudes from the housing in the first position and is substantially concealed by the housing in the second position. In another setup, the movable element may include a portion that protrudes from the housing in the second position and that is substantially concealed by the housing in the first position.

The above-noted movable element may be characterized as being movable between two different positions—one being associated with the first and second check valves being presumed to be functional, and the other being associated with at least one of the first and second check valves being presumed to have failed. This change in position of the movable element may be visually perceptible on an exterior of the pressure sensor (e.g., by viewing an exterior of the pressure sensor). Movement of the movable element between two different positions may also be characterized as providing a visually perceptible change in shape of the exterior of the pressure sensor.

In another arrangement, at least a portion of the movable element may be discernable in one of the first and second positions and may not be discernable in the other of the first and second positions. For instance, a failed condition of at least one of the first and second check valves may be presumed when the portion of the movable element is not discernable and a properly functioning condition of each of the first and second check valves may be presumed when the portion of the movable element is discernable, or vice versa. In one variation, the housing may include a window (e.g., a semi-transparent or a transparent portion). In one embodiment, the portion of the movable element may be discernable through the window in one of the first and second positions and may not be discernable in the other of the first and second positions. In another embodiment, the movable element may be discernable through the window in each of the first and second positions, and a change in shape of the movable element may be discerned by a movement between the first and second positions. In yet another embodiment, at least part of the movable element may be discernable in one of the first and second positions, and the entirety of the movable element may not be discernable through the window in the other of the first and second positions.

The movable element may be in any appropriate form. For instance, in one variation, the movable element may be in the form of a substantially non-deformable piston—the piston may move other than by a deformation or change in shape between the two noted positions. In another variation, the movable element may include a diaphragm. An exterior of this diaphragm may experience a visually-discernable shape change in response to an at least presumed failed condition of at least one of the first and second check valves.

In an embodiment, the pressure sensor may include a port that is fluidly interconnectable with the first section of medical fluid tubing. The pressure sensor may also include a pressure transducer interconnected to the port. It will be appreciated that the pressure transducer may appropriately measure or monitor the fluid pressure in the first section of medical tubing and may communicate with any appropriate device (e.g., computing device, control system) to transmit fluid pressure readings thereto and/or allow control of the pressure transducer in any appropriate manner.

In an embodiment, any of the above medical fluid tubing sets may be usable as part of a medical fluid injection system. For instance, a medical fluid injection system may include an injection device, a multi-patient tubing section interconnected with the injection device, and any of the above-described medical fluid tubing sets. In this embodiment, the medical fluid tubing set includes or may be characterized as a patient-specific tubing section and is interconnected with the multi-patient tubing section such that the multi-patient tubing section is located between the injection device and the patient-specific tubing section. In one variation, a fluid source may be fluidly interconnected with the injection device. For instance, the fluid source may include a volume of any appropriate fluid (e.g., saline, contrast media) to accommodate multiple injections by the injection device.

A second aspect of the present invention is provided by a method of evaluating a medical fluid tubing set. The tubing set includes a first section of medical tubing and first and second check valves that are spaced along/within the first section of medical tubing. The method includes monitoring a fluid pressure in the first section of medical tubing between the first and second check valves, and assessing an operating condition of at least one of the first and second check valves based on the monitoring step.

A number of feature refinements and additional features are applicable to the second aspect of the present invention. These feature refinements and additional features may be used individually or in any combination. As such, each of the following features that will be discussed may be, but are not required to be, used with any other feature or combination of features of the second aspect. The following discussion is applicable to at least the second aspect.

In an embodiment, the monitoring step may be selected from the group consisting of mechanically monitoring the fluid pressure (e.g., with a movable element), electrically monitoring the fluid pressure (e.g., with a pressure transducer), or a combination thereof. In one variation, the method may further include a step of providing an indication upon the assessing step identifying at least a possible failure of at least one of the first and second check valves. For example, the indication may be selected from the group consisting of visual, audible, tactile, or any combination thereof.

The assessing step may be subject to a number of characterizations. In an embodiment, the assessing step may include comparing the fluid pressure from the monitoring step to a cracking pressure of at least one of the first and second check valves. In an embodiment, the assessing step may include associating a failed condition of at least one of the first and second check valves with the monitoring step identifying a predetermined drop in magnitude of the fluid pressure. In an embodiment, the assessing step may include associating a failed condition of at least one of the first and second check valves with the monitoring step identifying that the fluid pressure is less than a cracking pressure of at least one of or each of the first and second check valves. In one arrangement, the medical fluid tubing set may be discarded if the assessing step identifies an occurrence of the failed condition. In another arrangement, only a portion of the medical fluid tubing set may need to be discarded if the assessing step does not identify the occurrence of a failed condition.

In an embodiment, the method may include the steps of directing a flow of fluid through the medical fluid tubing set, opening each of the first and second check valves in response to the directing step, terminating the directing step, and closing the first and second check valves in response to the terminating step. Thereafter, the assessing step may include determining if at least one of the first and second check valves has opened after the closing step and prior to any further initiation of the directing step. For instance, it may be determined that at least one of the first and second check valves has opened if the fluid pressure identified in the monitoring step is less than a cracking pressure of at least one of the first and second check valves.

In an embodiment, a method of using a tubing arrangement may include executing any of the above-described evaluating methods. For instance, a method of using a tubing arrangement may include delivering a first fluid through the medical fluid tubing set, where the medical fluid tubing set further comprises a multi-patient section of medical tubing. The first section of medical tubing may be replaced after the first fluid delivering step, and a second fluid may be delivered through the medical fluid tubing set after the replacing step.

In one arrangement, the method may include replacing the multi-patient tubing section prior to the second fluid delivering step. Here, the replacing the multi-patient tubing section step may be executed in response to the assessing step identifying a presumed failed condition of at least one of the first and second check valves.

A number of feature refinements and additional features are separately applicable to each of above-noted first and second aspects of the present invention. These feature refinements and additional features may be used individually or in any combination in relation to each of the above-noted first and second aspects. Any feature of any other various aspects of the present invention that is intended to be limited to a “singular” context or the like will be clearly set forth herein by terms such as “only,” “single,” “limited to,” or the like. Merely introducing a feature in accordance with commonly accepted antecedent basis practice does not limit the corresponding feature to the singular (e.g., indicating that a power injector includes “a syringe” alone does not mean that the power injector includes only a single syringe). Moreover, any failure to use phrases such as “at least one” also does not limit the corresponding feature to the singular (e.g., indicating that a power injector includes “a syringe” alone does not mean that the power injector includes only a single syringe). Use of the phrase “at least generally” or the like in relation to a particular feature encompasses the corresponding characteristic and insubstantial variations thereof (e.g., indicating that a syringe barrel is at least generally cylindrical encompasses the syringe barrel actually being cylindrical). Finally, a reference of a feature in conjunction with the phrase “In one embodiment” does not limit the use of the feature to a single embodiment.

Any power injector that may be utilized to provide a fluid discharge may be of any appropriate size, shape, configuration, and/or type. Any such power injector may utilize one or more syringe plunger drivers of any appropriate size, shape, configuration, and/or type, where each such syringe plunger driver is capable of at least bi-directional movement (e.g., a movement in a first direction for discharging fluid; a movement in a second direction for accommodating a loading and/or drawing of fluid and/or so as to return to a position for a subsequent fluid discharge operation), and where each such syringe plunger driver may interact with its corresponding syringe plunger in any appropriate manner (e.g., by mechanical contact; by an appropriate coupling (mechanical or otherwise)) so as to be able to advance the syringe plunger in at least one direction (e.g., to discharge fluid). Each syringe plunger driver may utilize one or more drive sources of any appropriate size, shape, configuration, and/or type. Multiple drive source outputs may be combined in any appropriate manner to advance a single syringe plunger at a given time. One or more drive sources may be dedicated to a single syringe plunger driver, one or more drive sources may be associated with multiple syringe plunger drivers (e.g., incorporating a transmission of sorts to change the output from one syringe plunger to another syringe plunger), or a combination thereof. Representative drive source forms include a brushed or brushless electric motor, a hydraulic motor, a pneumatic motor, a piezoelectric motor, or a stepper motor.

Any such power injector may be used for any appropriate application where the delivery of one or more medical fluids is desired, including without limitation any appropriate medical imaging application (e.g., computed tomography or CT imaging; magnetic resonance imaging or MRI; single photon emission computed tomography or SPECT imaging; positron emission tomography or PET imaging; X-ray imaging; angiographic imaging; optical imaging; ultrasound imaging) and/or any appropriate medical diagnostic and/or therapeutic application (e.g., injection of chemotherapy, pain management, etc.). Any such 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 any such 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 utilized with any such power injector in any appropriate manner (e.g., detachably; front-loaded; rear-loaded; side-loaded), any appropriate medical fluid may be discharged from a given syringe of any such power injector (e.g., contrast media, therapeutic fluid, a radiopharmaceutical, saline, and any combination thereof), 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 (e.g., medical tubing set), where this conduit is fluidly interconnected with the syringe in any appropriate manner and directs fluid to a desired location (e.g., to a catheter that is inserted into a patient for injection). Multiple syringes may discharge into a common conduit (e.g., for provision to a single injection site), or one syringe may discharge into one conduit (e.g., for provision to one injection site), while another syringe may discharge into a different conduit (e.g., for provision to a different injection site). In one embodiment, each syringe includes a syringe barrel and a plunger that is disposed within and movable relative to the syringe barrel. This plunger may interface with the power injector's syringe plunger drive assembly such that the syringe plunger drive assembly is able to advance the plunger in at least one direction, and possibly in two different, opposite directions.

As used herein, the term “fluidly interconnected” refers to two or more components or entities being connected (directly or indirectly) in a manner such that fluid can flow (e.g., unidirectionally or bidirectionally) in a predetermined flow path therebetween at least at some point in time (e.g., after opening one or more valves). For example, “an injection device fluidly interconnected to a patient” describes a configuration where fluid can flow from the injection device through any interconnecting devices (e.g., tubing, connectors) and into the patient (e.g., into the vasculature of the patient).

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 any 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 the powerhead12and, when installed, 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 associated with the powerhead12in a manner that allows the syringe28to be disposed therein as a part of or after installing the syringe28on the powerhead12. The same pressure jacket26will typically remain associated with 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 and/or if the syringe(s)28to be utilized with the power injector10is (are) of sufficient durability to withstand high-pressure injections without the additional support provided by a pressure jacket26. 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 assembly or syringe plunger driver14that interacts (e.g., interfaces) with the syringe28(e.g., a plunger32thereof) to 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 interacting or 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 interact or interface 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.

Generally, the syringe plunger drive assembly14of the power injector10may interact with the syringe plunger32of the syringe28in any appropriate manner (e.g., by mechanical contact; by an appropriate coupling (mechanical or otherwise)) so as to be able to move or advance the syringe plunger32(relative to the syringe barrel30) in at least one direction (e.g., to discharge fluid from the corresponding syringe28). That is, although the syringe plunger drive assembly14may be capable of bi-directional motion (e.g., via operation of the same drive source16), the power injector10may be configured such that the operation of the syringe plunger drive assembly14actually only moves each syringe plunger32being used by the power injector10in only one direction. However, the syringe plunger drive assembly14may be configured to interact with each syringe plunger32being used by the power injector10so as to be able to move each such syringe plunger32in each of two different directions (e.g. in different directions along a common axial path).

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 desired. In this case, the syringe plunger drive assembly14may be retracted for purposes of executing another fluid delivery operation (e.g., after another pre-filled syringe28has been installed). Even when a ram coupler22and syringe plunger coupler34are utilized, 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 directly 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. Two 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 or 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 a 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(FIG. 2C), which are each part of a syringe plunger drive assembly or syringe plunger driver56(FIG. 2C) for 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 ram74(FIG. 2C) may 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(FIG. 2C), 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 ram74(FIG. 2C) may 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 or syringe plunger driver 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) and/or any appropriate medical diagnostic and/or therapeutic application (e.g., injection of chemotherapy, pain management, etc.). Representative medical imaging applications for the power injectors10,40include without limitation computed tomography or CT imaging, magnetic resonance imaging or MRI, single photon emission computed tomography or SPECT imaging, positron emission tomography or 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). Multiple syringes may discharge into a common conduit (e.g., for provision to a single injection site), or one syringe may discharge into one conduit (e.g., for provision to one injection site), while another syringe may discharge into a different conduit (e.g., for provision to a different injection site). Each such syringe utilized by each of the power injectors10,40may include any appropriate fluid (e.g., a medical fluid), for instance contrast media, therapeutic fluid, a radiopharmaceutical, saline, and any combination thereof. 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; side-loading configurations may be utilized).

FIG. 3presents one embodiment of an injection system220(e.g., a multi-dose injection system; a medical fluid injection system; a multi-dose medical fluid injection system) which may incorporate one or more components of the power injector40ofFIG. 2A. A first fluid source222may be fluidly interconnected with a first injection device226by first fluid source tubing224. A second fluid source228may be fluidly interconnected with a second injection device232by second fluid source tubing230. Any appropriate fluid may be utilized by each of the first fluid source222and the second fluid source228. In one embodiment, the first fluid source222utilizes contrast media, while the second fluid source228utilizes saline or any other appropriate biocompatible flushing media. Each of the first fluid source222and the second fluid source228may have a fluid volume that is sufficient for multiple injections or injection procedures (e.g., for multiple patients).

The first injection device226and the second injection device232each may be of any appropriate size, shape, configuration, and/or type (e.g., a power injector). The first fluid source tubing224and the second fluid source tubing230each may be in the form of any appropriate conduit (e.g., medical tubing). Any appropriate component or combination of components may be incorporated in either one or each of the first fluid source tubing224and the second fluid source tubing230(e.g., one or more valves of any appropriate type).

A reusable, multi-use or multi-patient section of tubing234may be fluidly interconnected with each of the injection devices226,232. There may be three different parts or sections of the multi-patient tubing section234—first injection device tubing236that extends from the first injection device226, second injection device tubing238that extends from the second injection device232, and common discharge tubing240. Fluid discharged from the first injection device226may be directed into the first injection device tubing236, and then into the common discharge tubing240. Fluid discharged from the second injection device232may be directed into the second injection device tubing238, and then into the common discharge tubing240.

The first injection device tubing236, the second injection device tubing238, and the common discharge tubing240may be integrally formed, or one or more appropriate connectors may be utilized to fluidly interconnect adjacent sections of the multi-patient tubing section234. An appropriate connector may be used to install the first injection device tubing236to the first injection device226, while an appropriate connector may be used to install the second injection device tubing238to the second injection device232. A connector242of any appropriate type may be provided at a free end of the common discharge tubing240.

A disposable, single-use, single-patient, or patient-specific tubing set or tubing section244may be fluidly interconnected with the common discharge tubing240of the multi-patient tubing section234by a connector246of any appropriate type such that the multi-patient tubing section234is located between the first and second injection devices226,232and the patient-specific tubing section244. The patient-specific tubing section244includes tubing248. An appropriate vasculature access device (e.g., a catheter)250may be appropriately interconnected with the tubing248(e.g., via an appropriate connector).

Any appropriate component or combination of components may be incorporated in either one or each of the multi-patient tubing section234and the patient-specific tubing section244(e.g., one or more valves of any appropriate type). The tubing utilized by each of the multi-patient tubing section234and the patient-specific tubing section244may be of any appropriate type (e.g., medical tubing).

FIG. 4presents another embodiment of an injection system260(e.g., a multi-dose injection system; a medical fluid injection system; a multi-dose medical fluid injection system). The injection system260may include a first fluid source262, a second fluid source266, a power injector270, a reusable or multi-patient section of tubing276, and the above-discussed patient-specific tubing section244. The first fluid source262may be fluidly interconnected with a first syringe272installed on the power injector270by first fluid source tubing278(which may be part of the multi-patient tubing section276). The second fluid source266may be fluidly interconnected with a second syringe274installed on the power injector270by second fluid source tubing280(which may be part of the multi-patient tubing section276). Any appropriate fluid may be utilized by each of the first fluid source262and the second fluid source266. In one embodiment, the first fluid source262utilizes contrast media, while the second fluid source266utilizes saline or any other appropriate biocompatible flushing media. Each of the first fluid source262and the second fluid source266may have a fluid volume that is sufficient for multiple injections or injection procedures (e.g., for multiple patients). The first fluid source tubing278and the second fluid source tubing280each may be in the form of any appropriate conduit (e.g., medical tubing). Any appropriate component or combination of components may be incorporated in either one or each of the first fluid source tubing278and the second fluid source tubing280(e.g., one or more valves of any appropriate type).

The multi-patient tubing section276may include first syringe tubing282that extends from the first syringe272on the power injector270, second syringe tubing284that extends from the second syringe274on the power injector270, and common discharge tubing286. Fluid discharged by the power injector270from the first syringe272is directed into the first syringe tubing282, and then into the common discharge tubing286. Fluid discharged by the power injector270from the second syringe274is directed into the second syringe tubing284, and then into the common discharge tubing286.

The first fluid source tubing278, the second fluid source tubing280, the first syringe tubing282, the second syringe tubing284, and the common discharge tubing286may be integrally formed, an appropriate connector may be utilized to fluidly interconnect each pair of adjacent sections of the multi-patient tubing section276, or part of the multi-patient tubing section276may be integrally formed with one or more other portions of the multi-patient tubing section276being incorporated by one or more connectors. An appropriate connector may be used to install the first syringe tubing282to the first syringe272, while an appropriate connector may be used to install the second syringe tubing284to the second syringe274. A connector290of any appropriate type may be provided at a free end of the common discharge tubing286.

Any appropriate component or combination of components may be incorporated in either one or each of the multi-patient tubing section276and the patient-specific tubing section244as previously noted (e.g., one or more valves of any appropriate type). For instance, each of the first syringe tubing282and the second syringe tubing284may include an appropriate valve288(e.g., a stopcock) to allow fluid from the fluid sources262,266to be loaded into the respective syringes272,274without being directed into the patient-specific tubing section244. The tubing utilized by the multi-patient tubing section276may be of any appropriate type (e.g., medical tubing).

FIG. 5presents a dual check valve arrangement300that may be used by the injection systems220,260ofFIGS. 3 and 4, or any other appropriate fluid delivery system. For instance, the arrangement300may be incorporated into the patient-specific tubing section244ofFIGS. 3 and 4, although it is contemplated that the arrangement300could be appropriately incorporated into any other portion of tubing (e.g., medical tubing) where it is desired to at least attempt to reduce the potential for fluid flow from one side of the arrangement300(e.g., downstream side312) to another side of the arrangement300(e.g., upstream side316). Hereafter, the check valve arrangement300may be described in relation to the injection system220ofFIG. 3and where the arrangement300is incorporated into the patient-specific tubing section244(although the discussion is of course equally applicable to the injection system260ofFIG. 4). As such: 1) the upstream side316of the arrangement300would be located between the multi-patient tubing section234and the downstream side312of the arrangement300; and 2) the downstream side312of the arrangement300would be located between the vasculature access device250and the upstream side316of the arrangement300.

The arrangement300broadly includes first and second check valves304,308, respectively (which hereafter may be simply referred to collectively as “first and second check valves304,308”), appropriately disposed along/within tubing248that includes first, second and third portions320,324,328, respectively. The first and second check valves304,308, along with the tubing248, each may be of any appropriate size, shape, configuration and/or type. The arrangement300also includes what may be characterized as a sterility detection device in the form of a pressure sensor332that will be more fully described below. It will be appreciated that the arrangement300may serve to at least attempt to reduce the potential for fluid flow from the patient-specific tubing section244upstream (e.g., in a direction “To Injection Device” as indicated inFIG. 5) into the multi-patient tubing section234(illustrated inFIG. 3; or into the multi-patient tubing section276in the injection system260ofFIG. 4) and thus at least attempt to only allow fluid flow downstream (e.g., in a direction “To Patient” as indicated inFIG. 5). In this regard, the arrangement300may at least attempt to reduce the potential for contamination of the multi-patient tubing section234with fluids from any patient. As such, the multi-patient tubing section234may be used to supply fluid to one or more patients by the arrangement300. The first and second check valves304,308may each be in the form of a one-way check valve (i.e., configured to allow flow in only a single direction, when functioning properly) and may be appropriately serially disposed along/within the tubing248(e.g., the check valves304,308are disposed in spaced relation within the flow path through the tubing248). Such an arrangement provides a level of redundancy in that if one of the one-way check valves fails, the other one-way check valve may remain functional and reduce the potential of backflow of fluids from the patient into the multi-patient tubing section234.

The pressure sensor332broadly serves to provide at least one user-perceptible indication (e.g., visual, tactile, audible, or any combination thereof) that one or both (e.g., at least one) of the first and second check valves304,308may have failed. Stated otherwise, the pressure sensor332may provide at least one signal to a user that the sterile barrier between the downstream and upstream sides312,316, respectively, of the arrangement300may be properly functioning (e.g., is in tact) and/or may have failed. The pressure sensor332functions at least in part by appropriately monitoring for a failed condition of at least one of the first and second check valves304,308(e.g., that at least one of the first and second check valves is at least presumed to have failed, and thereby including a situation where only one of the check valves304,308may have failed, or where both of the check valves304,308may have failed) by appropriately measuring, recording or otherwise monitoring (e.g., mechanically and/or electrically) a first region of fluid pressure in the second portion324of tubing248in the portion of the flow path extending between the first and second check valves304,308.

Each of the first and second check valves304,308may require a fluid pressure differential between upstream and downstream sides of each of the first and second check valves304,308(hereinafter “fluid pressure differential”) that is equal to or greater than a “cracking pressure” (i.e., the minimum amount by which the upstream pressure of a check valve must be greater than the downstream pressure of the check value before the first and second check valves304,308will open and allow fluid to flow in the downstream direction). Thereafter, when the fluid pressure differential of each of the first and second check valves304,308drops below its respective cracking pressure, each of the first and second check valves304,308should close assuming normal operation, and thus attempt to prevent fluid from flowing from its downstream side to its upstream side. At this point (assuming each of the first and second check valves304,308has the same cracking pressure), the fluid pressure within the second portion324of tubing248should always be equal to or greater than the cracking pressure of at least one of the check valves304,308.

For instance, assume each of the first and second check valves304,308has a cracking pressure of 0.5 psi, fluid is flowing through the tubing248and the first and second check valves304,308at 10 psi in the downstream direction (e.g., to a patient), and that the fluid pressure differential of each check valve304,308is greater than its cracking pressure (e.g., each of the first and second check valves304,308is open). After the fluid source is turned off or the flow is otherwise stopped, the upstream pressure of each of the first and second check valves304,308will drop such that the fluid pressure differential falls to a level approximately equal to the cracking pressure and the first and second check valves304,308should close. When both of the first and second check valves304,308close, the fluid pressure within the second portion324of the tubing248should remain constant (as no fluid should be able to pass through the properly functioning first and second check valves304,308in the upstream direction) and in this example may be approximately equal to just less than 10 psi. Nevertheless, what is important is that the fluid pressure will always be at least about equal to or above the cracking pressure of the first and second check valves304,308assuming normal functioning of the first and second check valves304,308. Thus, assuming the fluid pressure within the second portion324of tubing248is equal to or above the cracking pressure of the first and second check valves304,308, only the patient-specific tubing section244(that incorporates the arrangement300) and/or other downstream components needs to be replaced before a subsequent injection using the injection system220(e.g., in relation to a different patient).

When the fluid pressure within the second portion324of the tubing248drops below the cracking pressure of the first and second check valves304,308, however, it may be assumed that at least one of the first and second check valves304,308has allowed fluid to flow from its downstream side to its upstream side and that the sterile barrier between the downstream and upstream sides312,316, respectively, of the arrangement300may have failed. As such, it may be necessary at this point to replace all components of the injection system220that have been in contact with the fluid (e.g., both the patient-specific tubing section244and the multi-patient tubing section234(which again has incorporated the arrangement300)).

With reference now toFIGS. 5,6A, and6B, one embodiment of the pressure sensor332for monitoring for a failed condition of at least one of the first and second check valves304,308is illustrated. The pressure sensor332is operable to appropriately monitor (e.g., measure, record, observe) the fluid pressure within the second portion324of tubing248and provide a user-perceptible indication that one or more of the first and second check valves304,308may have failed. The pressure sensor332may be fluidly interconnectable with the tubing248and may be situated in series in the flow path between the first and second check valves304,308on the second portion324of tubing248. The pressure sensor332may include a housing336, a movable element340that is movable relative to the housing336, and a biasing member in the form of a spring360, each of which may be of any appropriate size, shape, configuration and/or type. Generally, the position of the movable element340relative to the housing336is at least influenced by the magnitude of the fluid pressure within the pressure sensor332, or more specifically the pressure within the second portion324of tubing248.

The second portion324of tubing248may be appropriately fluidly interconnected to the housing336, allowing fluid within the injection system200to pass into and out of a chamber344(illustrated inFIGS. 6A and 6B) within the housing336. In this regard, it may be assumed that the fluid pressure within the second portion324of tubing248is at least approximately equal to the fluid pressure within the chamber344. A portion (e.g., movable element340) of the pressure sensor332may be operable to change from a first state to a second state (e.g., from the position inFIG. 6Bto the position inFIG. 6A) upon the fluid pressure within the second portion324becoming equal to or above a predetermined fluid pressure level (e.g., the cracking pressure of the first and second check valves304,308). Furthermore, the movable element340may be operable to change from the second state back to the first state (e.g., from the position inFIG. 6Ato the position inFIG. 6B) upon the fluid pressure within the second portion324of tubing248(corresponding to the pressure within the chamber344) falling below the predetermined fluid pressure level. For instance, the movable element340may be operable to move along an axial direction348between the first and second states.

Now referring in particular toFIGS. 6A and 6B, the movable element340may include a piston352(e.g., a substantially non-deformable piston) and a piston rod356. While the piston352and piston rod356are shown as being integrally connected, it will be appreciated that the piston352and piston rod356may be appropriately bonded or otherwise connected to each other. The piston352may be operable to slide or otherwise move within the chamber344in a first direction (e.g., away from the second portion324of tubing248) in response to fluid pressure within the second portion324of tubing248and chamber344, and in a second direction (e.g., towards the second portion324of tubing248; opposite of the noted first direction) in response to a biasing force from a biasing member which may be in the form of a spring360(e.g., coil, compression) that may be appropriately interconnected (e.g., permanently, removably) to and/or interact with the movable element340and one or more portions of the housing336. Any appropriate biasing member or combination of biasing members may be utilized to bias the movable element340toward the noted second position.

The piston352of the movable element340may be designed to reduce the potential of fluid flow between a first side of the piston352(e.g., adjacent to the chamber344; the side that interfaces with the chamber344) and an opposite second side of the piston352. The piston rod356may extend from the opposite second side of the piston352and be operable to appropriately selectively slide and protrude through an opening364in the housing336in a manner as described below. What is of importance with regard to the movable element340is as follows: 1) the position of the movable element340relative to the housing336is influenced by the pressure within the chamber344, which is directly related to the pressure within the second portion324of tubing248; and 2) when there is a change in pressure within the chamber344that is indicative of a failure of one or both of the check valves304,308, the position of the movable element340relative to the housing336should change, and this change in position should be visually discernible exteriorly of the pressure sensor332(e.g., by a resulting change in shape of the pressure sensor332).

The spring360may be selected (e.g., according to spring constant, kind and grade of material, number of coils, controlling diameter) to provide a biasing force against a portion of the movable element340(e.g., piston352) that is just less than the predetermined fluid pressure level (e.g., the cracking pressure of the first and second check valves304,308). In this regard, until fluid in the patient-specific tubing section244has been pressurized to at least the cracking pressure of the first and second check valves304,308, the biasing force created by the spring360should serve to urge the movable element340in the second direction towards the second portion324of tubing248where the piston rod356may be at least substantially concealed by the housing336(more generally, a retracted position) as illustrated inFIG. 6B. Thereafter, once fluid in the patient-specific tubing section244has been pressurized to at least the cracking pressure of the first and second check valves304,308, such fluid pressure should overcome the biasing force created by the spring360and urge the movable element340in the first direction away from the second portion324of the tubing248until the piston rod356protrudes from the housing336as illustrated inFIG. 6A(more generally, a protruded position or a more protruded position than that described above). At this point and assuming normal functionality of the first and second check valves304,308, the piston rod356should remain protruded from the housing336because the fluid pressure within the second portion324of the tubing248(and hence the chamber344) should not drop below the predetermined fluid pressure level (e.g., the cracking pressure of the first and second check valves304,308) as previously described if the check valves304,308are functioning properly. In this regard, a protruded or first orientation or position of the movable element340as illustrated inFIG. 6Amay be associated with a proper functioning of the first and second check valves304,308. The piston rod356may be appropriately marked or indicated (e.g., brightly colored or patterned) to aid a user in perceiving the protruded first orientation of the piston rod356. As previously discussed, only the patient-specific tubing section244(incorporating the tubing arrangement300) may need to be replaced after an injection procedure if the movable element340has remained in the protruded first orientation or position.

In the case of fluid pressure within the second portion324of the tubing248and chamber344falling below the predetermined fluid pressure level, the spring360should overcome such fluid pressure and urge the movable element340in the second direction towards the second portion324of the tubing248. The biasing force generated by the spring360should move the piston rod356to a retracted position (e.g., into the housing336) where it may become at least substantially concealed by the housing336as illustrated inFIG. 6B. As a drop in fluid pressure within the second portion324and chamber344below the predetermined fluid pressure level may signal that at least one of the first and second check valves304,308has at least presumably failed, a substantially concealed or second orientation or position of the movable element340may be associated with a failed condition of at least one of the first and second check valves304,308and indicate that now both the patient-specific and multi-patient tubing sections244,234, respectively, should be replaced before a subsequent injection procedure.

The pressure sensor332may be characterized as changing shape or appearance to provide a visual indication of at least a potential failure of the check valve304, the check valve308, or both. The pressure sensor332is of one shape at a time when both of the check valves304,308are at least presumed to be functional (FIG. 6A, and where the piston rod356is an extended or protruded position). The pressure sensor332is of a different shape at a time when at least one of the check valves304,308may have failed (FIG. 6B, and where the piston rod356is less extended compared to theFIG. 6Aposition (generally, a retracted position), and where the piston rod356may in fact be concealed by the housing336).

While the cracking pressure of the first check valve304has been discussed as being the same as that of the second check valve308, in other embodiments the first and second check valves304,308may have different cracking pressures. In this regard, the predetermined fluid pressure level may be intentionally created to be different than the cracking pressure of the first and second check valves304,308. For instance, the first check valve304may be chosen to have a cracking pressure less than that of the second check valve308. As the second check valve308would thus require a greater pressure differential than does the first check valve304to open, it may be more sensitive to pressure fluctuations in the patient-specific tubing section244. Thus, upon a decrease in fluid pressure within the patient-specific tubing section244, the second check valve308may close before the first check valve304, and thus the fluid within the second portion324and chamber344may maintain a pressure that is less than the cracking pressure of the second check valve308even when both of the first and second check valves304,308are properly functioning. Thus, the predetermined fluid pressure level for the arrangement300in this situation may be designed to be at a pressure that is between the cracking pressure of the first and second check valves304,308. Accordingly, the spring360may be designed to provide a biasing force against the movable element340that is just less than such a predetermined fluid pressure level. Other arrangements of first and second check valves304,308having various cracking pressures accordingly creating various predetermined fluid pressure levels are also envisioned.

FIGS. 7A and 7Bpresent another embodiment of a pressure sensor that may be used in place of the pressure sensor332ofFIGS. 5,6A and6B. Corresponding components between the embodiments are identified by common reference numerals. Those corresponding components that differ in at least some respect from the embodiment ofFIGS. 5,6A and6B are identified by a “single prime” designation inFIGS. 7A and 7B. The one or more components of the pressure sensor332′ may be of any appropriate size, shape, configuration and/or type. For instance, the pressure sensor332′ may include a housing336′ having a moveable element340and a spring360′ (or any other appropriate biasing member or combination of biasing members) appropriately mounted within the housing336′ to indicate that at least one of the first and second check valves304,308is at least presumed to have failed. The primary differences between the pressure sensor332ofFIGS. 5,6A and6B and the pressure sensor332′ ofFIGS. 7A and 7Bare: the use of a wave spring as the spring360′ in place of the compression spring ofFIGS. 5 and 6(although other types of springs (e.g., compression) and/or biasing members could also be used); and a substantially concealed or first position or orientation of the movable element340as illustrated inFIG. 7Ato indicate a normal or proper function of the first and second check valves304,308and a protruded or second position or orientation as illustrated inFIG. 7Bto indicate at least a presumed failure or failed condition of at least one of the first and second check valves304,308, instead of vice versa as inFIGS. 5,6A and6B. That is and for the case of the pressure sensor332′, the movable element340is in a retracted position when the check valves304,308are at least presumed to be functional, and moves to an extended or more protruded position when at least one of the check valves304,308is at least presumed to have failed.

In the embodiment ofFIGS. 7A and 7B, the spring360′ may be appropriately selected to provide a biasing force against the movable element340(e.g., against the piston352) that urges the movable element340into the second position (such that the piston rod356protrudes from the housing336′, as shown inFIG. 7B) upon the fluid pressure within the second portion324of tubing248and the chamber344dropping below the predetermined fluid pressure level. Again, the piston rod356may be appropriately patterned or colored such that when a user observes the piston rod356, a failed condition of at least one of the first and second check valves304,308may be presumed, thereby indicating that the patient-specific and multi-patient sections244,234should both be replaced before a subsequent injection procedure (e.g., for a second patient). It should be appreciated that the piston rod356could be incorporated by the spring360′ (alleviating the need for the piston352—the spring360′ therefore being in the form of a diaphragm or the like that is exposed to the fluid in the chamber344).

FIGS. 8A and 8Bpresent another embodiment of the pressure sensor332ofFIGS. 5,6A, and6B, and corresponding components between the embodiments are identified by common reference numerals. Those corresponding components that differ in at least some respect from the embodiment ofFIGS. 5,6A, and6B are identified by a “double prime” designation inFIGS. 8A and 8B. The one or more components of the pressure sensor332″ may be of any appropriate size, shape, configuration and/or type. The primary difference between the pressure sensor332ofFIGS. 5,6A, and6B and the pressure sensor332″ ofFIGS. 8A and 8Bis the use of a flexible diaphragm368as the movable element340″ instead of the spring360, piston352and piston rod356ofFIGS. 5,6A and6B, as well as the use of a window372(e.g., transparent; semi-transparent) that allows for external viewing for some type of change in relation to the diaphragm368(e.g., a change in state of some type). One state of the diaphragm368is associated with presumed proper functioning of the check valves304,308, and the other state of the diaphragm368is associated with an at least presumed failure of either one or both of the check valves304,308. The pressure sensor332″ may be configured such that the diaphragm368is visible through the window372when the check valves304,308are presumed to be functioning properly and not visible through the window372when at least one of the check valves304,308is at least presumed to have failed, or vice versa.

In the embodiment ofFIGS. 8A and 8B, the flexible diaphragm368may be appropriately selected to provide a biasing force that urges the flexible diaphragm368into a position such that it is not discernable (e.g., visually) from an exterior of the pressure sensor332″ through the window372. Thus, when a user can visually observe or otherwise discern the existence or presence of the flexible diaphragm368through the window372(e.g., a first position or orientation, shown inFIG. 8A), the fluid pressure within the second portion324of tubing248and chamber344is presumably equal to or above the predetermined fluid pressure level, and the first and second check valves304,308are presumed to be in a normal or proper functioning condition. When the user can no longer visually observe or otherwise discern the existence of presence of the flexible diaphragm368through the window372(e.g., a second position or orientation, shown inFIG. 8B), fluid pressure within the second portion324of tubing248and the chamber344has dropped below the predetermined fluid pressure level and a failed condition of at least one of the first and second check valves304,308may be presumed.

The housing336″ may include any appropriate portion that aids in attempting to visually discern the existence or presence of the flexible diaphragm368upon the fluid pressure within the second portion324of tubing248assuming a pressure equal to or above the predetermined fluid pressure level. For instance, the housing336″ may include the noted window372(e.g., a transparent or semi-transparent portion) through which the flexible diaphragm368may be discernable in the first position and which is not discernable in the second position in one embodiment. For instance, the flexible diaphragm368may actually come into contact with the window372when the flexible diaphragm368is in its first position in the illustrated embodiment (associated with a condition where the check valves304,308are at least presumed to be functioning properly) and may not contact the window372when the flexible diaphragm368is in its second position in the illustrated embodiment (associated with a condition where at least one of the check valves304,308is presumed to have failed).

An exterior of the flexible diaphragm368could also undergo a visually-discernable shape change when transitioning between the first and second positions, where the flexible diaphragm368would be visible through the window372in each of the first and second positions. In any case, the flexible diaphragm368may be appropriately patterned or colored to aid a user in visually perceiving or otherwise discerning the flexible diaphragm368in at least its first position (again, associated with a presumed normal working condition of the first and second check valves304,308). Other portions of the housing336″ may also be at least semi-transparent to aid in visually perceiving the flexible diaphragm368. While pressure sensors including either a biasing element (e.g., spring) and movable element and/or a flexible diaphragm have been discussed, it is contemplated that any other mechanical device that responds to fluid pressure may be appropriately utilized in conjunction with or as part of the pressure sensor for measuring or otherwise monitoring the fluid pressure within the patient-specific tubing section244between the first and second check valves304,308.

FIG. 9presents another embodiment of the pressure sensor332ofFIGS. 5,6A, and6B. Corresponding components between the embodiments are identified by common reference numerals. Those corresponding components that differ in at least some respect from the embodiment ofFIGS. 5,6A and6B are identified by a “triple prime” designation inFIG. 9. The one or more components of the pressure sensor332′″ may be of any appropriate size, shape, configuration and/or type. The primary differences between the pressure sensor332ofFIGS. 5,6A, and6B and the pressure sensor332′″ ofFIG. 9are: the use of a housing336′″ that includes a fluid port376instead of the movable element340and spring360; and a reusable pressure transducer380of any appropriate type (e.g., piezoresistive, capacitive) interconnected to the fluid port376for measuring or otherwise monitoring fluid pressure within the second portion324and chamber344(not shown inFIG. 9). More generally, whereas the above-described embodiments are based upon mechanical movements that is visually discernible to provide an indication that at least one of the check valves304,308may have failed, the embodiment ofFIG. 9may be characterized as acquiring a pressure measurement and sending a resulting signal (e.g., electrical, optical) that may be used to provide an indication of at least a potential failure of one or both of the check valves304,308.

As the fluid port376provides access to the chamber344of the housing336′″, the port376may be characterized as being fluidly interconnectable with the second portion324of the tubing248. Furthermore, the fluid port376of the housing336′″ and a portion of the pressure transducer380may have corresponding mating structures (not labeled) to allow the pressure transducer380to be removably fluidly interconnected to the chamber344of the housing336′″. As an example, an inside surface of the fluid port376and a portion of the pressure transducer380could be correspondingly threaded or have any other appropriate types of mating structures. In one arrangement, the pressure transducer380may be a self-contained arrangement that is operable to provide a user-perceptible or discernable signal (e.g., visual, audible, tactile) or feedback that the fluid pressure within the chamber344and second portion324is at least one of below, equal to or above the predetermined fluid pressure level or that the multi and patient-specific tubing section234,244are undergoing an initial pressurization to purge air from the injection system220(e.g., at the beginning of an injection procedure). For instance, the pressure transducer380may include a first colored light (e.g., LED, not shown) that indicates that the multi and patient-specific tubing section234,244are undergoing an initial pressurization and have not yet reached the predetermined fluid pressure level, a different second colored light that indicates a normal working condition of the first and second check valves304,308(e.g., the fluid pressure within the chamber344is equal to or above the predetermined fluid pressure level), and a different third colored light that indicates a failed condition of at least one of the first and second check valves304,308(e.g., the fluid pressure within the chamber344is below predetermined fluid pressure level). As another example, the pressure transducer380may include one or more audible signals to indicate at least one of an initial pressurization, a normal condition and a failed condition.

In other arrangements, the pressure transducer380may be in appropriate communication (e.g., via signal line384, wirelessly) with any type of computing device or control system that would allow a user to control the pressure transducer384and/or obtain fluid pressure readings therefrom. In one arrangement, the pressure transducer384may be appropriately coupled to another component of the injection system220(e.g., console42and/or GUI52ofFIG. 2A) so that the injection system220can, inter alia, appropriately notify (e.g., audible, visual) a user of a working or failed condition of the first and second check valves304,308, display a message to change the multi-patient and/or patient-specific tubing sections234,244, and/or attempt to prevent reuse of the multi-patient and/or patient-specific tubing sections234,244. It will be appreciated that after a procedure on a first patient, the pressure transducer380may be appropriately removed or disconnected (e.g., unscrewed) from the housing336′″ and then reattached or connected to the housing3366′″ of another (e.g., a new) patient-specific tubing section244for a subsequent procedure (e.g., on another patient). To allow such reuse of the pressure transducer380, the pressure transducer380may be isolated by an appropriate diaphragm. The pressure transducer380may also be appropriately sterilized between uses.

FIG. 10is a flowchart of a method400of using and/or evaluating a tubing arrangement (e.g., medical fluid tubing set). One step404may be to appropriately fluidly interconnect or otherwise attach a new multi-use tubing section234to the first and/or second injection device226,232. Any appropriate connectors may be used to install the multi-use tubing section234to the first and/or second injection device226,232. In step408, a patient-specific tubing section244may be fluidly interconnected or otherwise attached with the multi-patient tubing section234by a connector of any appropriate type such that the multi-patient tubing section234is located between the first and second injection devices226,232and the patient-specific tubing section244. At this point, the multi-patient and patient-specific tubing sections234,244function as a first tubing arrangement or tubing set. Also as part of this step, any appropriate vasculature access device (e.g., a catheter) may be appropriately interconnected with the patient-specific tubing section244via an appropriate connector, although the vasculature access device may also be interconnected to the patient-specific tubing section244before the patient-specific tubing section244is interconnected with the multi-patient tubing section234.

The next step412may be to deliver or otherwise direct a flow of fluid through the tubing arrangement until at least each of the first and second check valves304,308opens (e.g., until the fluid pressure in the patient-specific tubing section244becomes equal to or higher than the cracking pressure of the first and second check valves304,308). This step412may serve the function of purging air from the injection system and readying the injection system for an injection sequence. At some later point in time, fluid delivery may be terminated in step416after which each of the first and second check valves304,308should eventually close assuming normal working conditions of the first and second check valves304,308. Pursuant to step420, fluid pressure in the patient-specific tubing section244between the first and second check valves304,308may be appropriately monitored. This pressure-monitoring function of step420may be executed after step412and/or after step416. It will be appreciated that the monitoring of step420may be selected from the group consisting of electrically monitoring the fluid pressure, mechanically monitoring the fluid pressure, or a combination of electrically and mechanically monitoring the fluid pressure (e.g., using any of the embodiments described herein).

One form of monitoring the fluid pressure may be measuring the fluid pressure (e.g., absolute) within the patient-specific tubing section244between the first and second check valves304,308. An operating condition of one of the first and second check valves304,308may be assessed based on the monitoring performed in step420. For instance, one manner of assessing the operating condition may be to determine whether the monitored fluid pressure is equal to or above the predetermined fluid pressure level in step424. As previously discussed, the predetermined fluid pressure level may be equal to the cracking pressure of the first and second check valves304,308or may be equal to a fluid pressure above or below the cracking pressure of at least one of the first and second check valves304,308if the first and second check valves304,308are selected to have different cracking pressures. Nevertheless, if the monitored fluid pressure is equal to or above the predetermined fluid pressure level, the patient-specific tubing section244may be discarded and replaced in step428before subsequent fluid delivery. The original multi-patient and new patient-specific tubing sections234,244now form another (e.g., second) tubing arrangement and the method may return to step412to again deliver fluid through the tubing arrangement (e.g., for another patient) until at least each of the first and second check valves304,308opens.

If the monitored fluid pressure is not equal to or above (e.g., is less than) the predetermined fluid pressure through the execution of step420, a failed condition of at least one of the first and second check valves304,308may be presumed. Stated otherwise, it may be presumed that at least one of the first and second check valves304,308has opened or otherwise not closed properly and has let fluid flow upstream towards the multi-patient tubing section234. As this scenario may have resulted in the contamination of the multi-patient tubing section234with fluid from the patient-specific tubing section244, it may be required to discard and replace both the multi-patient and patient-specific tubing sections234,244before a subsequent fluid delivery operation is initiated. Other actions may also be required (e.g., replacement of one or more syringes on the associated injection device). The new multi-patient and patient-specific tubing sections234,244now form another tubing arrangement or tubing set, and the method may return to step412to again deliver fluid through the tubing arrangement (e.g., for another patient) until at least each of the first and second check valves304,308opens. In other arrangements, a failed condition of at least one of the first and second check valves304,308may be presumed if the monitoring from step420identifies a predetermined drop in magnitude. Nonetheless, a presumed failed condition of at least one of the first and second check valves304,308may result in a user-perceptible indication being provided that is selected from the group consisting of visual, audible, tactile, or any combination of visual, audible or tactile.