Patent Description:
In many medical diagnostic and therapeutic procedures, a medical practitioner, such as a physician, injects a patient with one or more medical fluids. In recent years, a number of medical fluid delivery systems for pressurized injection of fluids, such as a contrast solution (often referred to simply as "contrast"), a flushing agent, such as saline, and other medical fluids, have been developed for use in procedures such as angiography, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and other imaging procedures. In general, these medical fluid delivery systems are designed to deliver a preset amount of fluid at a preset flow rate.

In some injection procedures, a medical practitioner places a catheter or needle into a vein or artery of the patient. The catheter or needle is connected to either a manual or an automatic fluid injector system by way of tubing and a connector that interfaces with the fluid injector system. Automatic fluid injector systems typically include at least one syringe connected to at least one fluid injector having, for example, a powered linear piston. The at least one syringe includes, for example, a source of contrast and/or a source of flushing fluid. The medical practitioner enters settings into an electronic control system of the fluid injector for a fixed volume of contrast and/or saline and a fixed rate of injection for each. A single-use disposable set (SUDS) connector and associated tubing is connected to the fluid injector system for delivering one or more fluids to the patient.

While various manual and automatic fluid delivery systems are known in the medical field, improved multi-fluid delivery systems adapted for use in medical diagnostic and therapeutic procedures where one or more fluids are supplied to a patient during such procedures continue to be in demand.

From <CIT> a medical connector for providing a sterile connection between a multi-use portion and a single-use portion of a fluid delivery system is known. The medical connector includes a fluid inlet port configured for removable engagement with a connection port of a multi-use disposable set (MUDS) to establish a fluid connection therewith and a waste outlet port configured for removable engagement with a waste inlet port of the MUDS to establish a fluid connection therewith. A patient fluid line is connected, at a first end, to the fluid inlet port and connected, at a second end, to the waste outlet port. Fluid flow through the patient fluid line is unidirectional from the first end to the second end. The patient fluid line is configured for being disconnected from the waste outlet port for delivering fluid to a patient. A multi-fluid delivery system having the medical connector and MUDS is also disclosed. The medical field continues to demand improved medical devices and systems used to supply fluids to patients during various medical procedures.

In view of the foregoing, a need exists for an improved medical connector assembly for connecting a single-use portion of a medical assembly to a multi-use portion of the assembly. The assembly should be configured to retain sterility of the fluid path through the single-use and multi-use portions of the assembly and, particularly, should maintain sterility of portions of the assembly which are reusable. Furthermore, the system should be arranged to permit automatic priming, defined as removing air from the fluid line, for easier fluid injections.

Therefore, a multi-use disposable set (MUDS) configured to address some or all of these needs is provided herein as claimed in claim <NUM> and the claims dependent thereon.

The features and characteristics of the multi-use disposable set (MUDS) , as well as the methods of operation and functions of the related elements of structures and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only, and are not intended as a definition of the limits of the disclosure. As used in the specification and the claims, the singular form of "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

For purposes of the description hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the disclosure as it is oriented in the drawing figures. When used in relation to a syringe of a MUDS, the term "proximal" refers to a portion of a syringe nearest a piston element for delivering fluid from a syringe. When used in relation to a SUDS connector, the term "proximal" refers to a portion of a SUDS connector nearest to a multi-fluid injector system when a SUDS connector is oriented for connecting with a multi-fluid injector system. When used in relation to a syringe of a MUDS, the term "distal" refers to a portion of a syringe nearest to a delivery nozzle. When used in relation to a SUDS connector, the term "distal" refers to a portion of a SUDS connector nearest to a user when a SUDS connector is oriented for connecting with a multi-fluid injector system. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the disclosure. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.

Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, the present disclosure is generally directed to a multi-fluid medical injector/injection system <NUM> (hereinafter "fluid injector system <NUM>") having a MUDS <NUM> (shown in <FIG>) configured for delivering fluid to a patient using a SUDS <NUM> (shown in <FIG>). The fluid injection system <NUM> and the SUDS <NUM> described herein are not subject-matter of the present invention. Subject-matter of the present invention is a MUDS as defined by the appended claims. Any features defined by the independent claims are required to form an embodiment of the invention, even if referred to in the following description as optional. The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the disclosure.

The fluid injector system <NUM> includes multiple components as individually described herein. Generally, the fluid injector system <NUM> has a powered injector administrator or device and a fluid delivery set intended to be associated with the injector to deliver one or more fluids from one or more multi-dose containers under pressure into a patient, as described herein. The various devices, components, and features of the fluid injector system <NUM> and the fluid delivery set associated therewith are likewise described in detail herein.

With reference to <FIG>, the fluid injector system <NUM> includes an injector housing <NUM> having opposed lateral sides <NUM>, a distal or upper end <NUM>, and a proximal or lower end <NUM>. In some aspects, the housing <NUM> may be supported on a base <NUM> having one or more wheels <NUM> for rotatable and movable support of the housing <NUM> on a floor surface. The one or more wheels <NUM> may be lockable to prevent the housing <NUM> from inadvertently moving once positioned at a desired location. At least one handle <NUM> may be provided to facilitate moving and positioning the fluid injector system <NUM>. In other aspects, the housing <NUM> may be removably or non-removably secured to a fixed surface, such as a floor, ceiling, wall, or other structure. The housing <NUM> encloses the various mechanical drive components, electrical and power components necessary to drive the mechanical drive components, and control components, such as electronic memory and electronic control devices (hereinafter electronic control device(s)), used to control operation of reciprocally movable piston elements <NUM> (shown in <FIG>) associated with the fluid injector system <NUM> described herein. Such piston elements <NUM> may be reciprocally operable via electro-mechanical drive components such as a ball screw shaft driven by a motor, a voice coil actuator, a rack-and-pinion gear drive, a linear motor, and the like. In some aspects, at least some of the mechanical drive components, electrical and power components, and control components may be provided on the base <NUM>.

With reference to <FIG>, and with continued reference to <FIG>, the fluid injector system <NUM> has at least one door <NUM> that encloses at least some of the mechanical drive components, electrical and power components, and control components. The door <NUM> is desirably movable between an open position (shown in <FIG>) and a closed position (shown in <FIG>). In some aspects, the door <NUM> may be lockable.

The fluid injector system <NUM> further includes at least one bulk fluid connector <NUM> for connection with at least one bulk fluid source <NUM>. In some aspects, a plurality of bulk fluid connectors <NUM> may be provided. For example, as shown in <FIG> and <FIG>, three bulk fluid connectors <NUM> may be provided in a side-by-side or other arrangement. In some aspects, the at least one bulk fluid connector <NUM> may be a spike configured for removably connecting to the at least one bulk fluid source <NUM>, such as a vial, a bottle, or a bag. The at least one bulk fluid connector <NUM> may have a reusable or non-reusable interface with each new bulk fluid source <NUM>. The at least one bulk fluid connector <NUM> may be formed on the multi-patient disposable set, as described herein. The at least one bulk fluid source <NUM> may be configured for receiving a medical fluid, such as saline, contrast solution, or other medical fluid, for delivery to the fluid injector system <NUM>. The housing <NUM> may have at least one support member <NUM> for supporting the at least one bulk fluid source <NUM> once it is connected to the fluid injector system <NUM>.

With reference to <FIG>, the fluid injector system <NUM> includes one or more user interfaces <NUM>, such as a graphical user interface (GUI) display window. The user interface <NUM> may display information pertinent to a fluid injection procedure involving fluid injector system <NUM>, such as current flow rate, fluid pressure, and volume remaining in the at least one bulk fluid source <NUM> connected to the fluid injector system <NUM> and may be a touch screen GUI that allows an operator to input commands and/or data for operation of fluid injector system <NUM>. While the user interface <NUM> is shown on the injector housing <NUM>, such user interface <NUM> may also be in the form of a remote display that is wired or wirelessly linked to the housing <NUM> and control and mechanical elements of fluid injector system <NUM>. In some aspects, the user interface <NUM> may be a tablet computer that is detachably connected to the housing <NUM> and is in wired or wirelessly linked communication with the housing <NUM>. Additionally, the fluid injector system <NUM> and/or user interface <NUM> may include at least one control button <NUM> for tactile operation by an attendant operator of the fluid injector system <NUM>. In certain aspects, the at least one control button may be part of a keyboard for inputting commands and/or data by the operator. The at least one control button <NUM> may be hardwired or wirelessly connected to the electronic control device(s) associated with the fluid injector system <NUM> to provide direct input to the electronic control device(s). The at least one control button <NUM> may also be graphically part of the user interface <NUM>, such as a touch screen. In either arrangement, the at least one control button <NUM> desirably provides certain individual control features to the attendant operator of the fluid injector system <NUM>, such as but not limited to: (<NUM>) acknowledging that a multi-patient disposable set has been loaded or unloaded; (<NUM>) locking/unlocking of the multi-patient disposable set; (<NUM>) filling/purging of the fluid injector system <NUM>; (<NUM>) inputting information and/or data related to the patient and/or injection procedure, and (<NUM>) initiating/stopping an injection procedure. The user interface <NUM> and/or any electronic processing units associated with the fluid injector system <NUM> may be wired or wirelessly connected to an operation and/or data storage system such as a hospital network system.

With reference to <FIG>, the fluid injector system includes a MUDS <NUM> that is removably connected to the fluid injector system <NUM> for delivering one or more fluids from the one or more bulk fluid sources <NUM> to the patient. The fluid injector system <NUM> includes at least one slot or access port <NUM> for releasably connecting a SUDS to the MUDS <NUM>, as described herein. The MUDS <NUM> may include one or more syringes or pumps <NUM>. In some aspects, the number of syringes <NUM> may correspond to the number of bulk fluid sources <NUM>. For example, with reference to <FIG>, the MUDS <NUM> has three syringes <NUM> in a side-by-side arrangement such that each syringe <NUM> is fluidly connectable to one of the bulk fluid sources <NUM>. Each syringe <NUM> may be fluidly connectable to one of the bulk fluid sources <NUM> by a corresponding bulk fluid connector <NUM> and an associated MUDS fluid path <NUM>. The MUDS fluid path <NUM> may be formed as a flexible tube with a spike element at its terminal end that connects to the bulk fluid connector <NUM>. In some aspects, the bulk fluid connector <NUM> may be provided directly on the MUDS <NUM>.

With reference to <FIG>, the MUDS <NUM> is removably connectable to the housing <NUM> of the fluid injector system <NUM>. The MUDS <NUM> may include a frame <NUM> for supporting the one or more syringes <NUM>. The syringes <NUM> may be removably or non-removably connected to the frame <NUM>. In certain aspects, the at least one syringe <NUM> may be co-molded with the frame <NUM> or alternatively, adhered or welded to frame <NUM>. With reference to <FIG>, each syringe <NUM> has an elongated, substantially cylindrical syringe body <NUM> having a front or distal end <NUM> and a rear or proximal end <NUM>. A syringe plunger <NUM> is disposed within the syringe body <NUM> and is reciprocally movable within the syringe body <NUM> due to movement of a piston element associated with the fluid injector system <NUM>. The distal end <NUM> of the syringe body <NUM> is generally conical-shaped and tapers to an apex or cone point <NUM> which is adapted to interface with a corresponding apex curve formed in the recess defined in the fluid injector system <NUM>, as described herein. The syringe apex or cone point <NUM> is located along a central longitudinal axis L of the syringe body <NUM>.

With continued reference to <FIG>, each syringe <NUM> may have a filling port <NUM> in fluid communication with the MUDS fluid path <NUM> for filling a syringe interior <NUM> with fluid from a bulk fluid source <NUM> (shown in <FIG>). Each syringe <NUM> may further have discharge outlet or conduit <NUM> at the terminal end of the apex or cone point <NUM>. The discharge outlet <NUM> of each syringe <NUM> is in fluid communication with a manifold <NUM>. In some aspects, the manifold <NUM> may fluidly connect a plurality of syringes <NUM>. In certain aspects, the manifold <NUM> may also provide support for the syringes <NUM> such that the syringes <NUM> can be handled as a single, unitary structure. In some aspects, the manifold <NUM> supports the distal end <NUM> of each syringe <NUM> while the frame <NUM> supports the proximal end <NUM> of each syringe <NUM>. In some aspects, the at least a portion of the manifold <NUM> may be monolithically formed with at least one syringe <NUM>. In other aspects, the manifold <NUM> may be formed separately from the plurality of syringes <NUM> and include a plurality of conduits 148a corresponding to each of the plurality of syringes <NUM>, wherein the individual conduits 148a may be attached or adhered to the individual outlet ports <NUM> of each of the plurality of syringes <NUM>, for example by an appropriate adhesive or welding. The syringes <NUM> may be arranged in a side-by-side orientation, or any other orientation that retains the relative positioning of the syringes <NUM>.

With reference to <FIG>, the MUDS <NUM> is illustrated in accordance with another aspect. The MUDS <NUM> may include a plurality of syringes <NUM> in a side-by-side, or other arrangement, with each syringe <NUM> being fluidly connectable to one of the bulk fluid sources <NUM> (shown in <FIG>). Each syringe <NUM> may be in fluid communication with the manifold <NUM>. The manifold <NUM> may include a plate-like structure that extends between the discharge outlets <NUM> of the syringes <NUM> such that the manifold <NUM> monolithically connects the syringes <NUM>. The manifold <NUM> may have a fluid pathway <NUM> that is in fluid communication with each syringe <NUM>. The fluid pathway <NUM> may be in fluid communication with one or more fluid outlet lines <NUM> (shown in <FIG>). A first portion 148a of the manifold <NUM> may be monolithically formed with each syringe <NUM>, such as by molding, adhesive means, or welding, while a second portion 148b (shown in <FIG>) may be permanently or non-permanently connected to the first portion 148a. In some aspects, the first portion 148a of the manifold <NUM> may be connected to the second portion 148b by welding, adhesive, one or more fasteners, or any other connection means. The combination of the first portion 148a and the second portion 148b may create a fluid path within the manifold that fluidly connects the discharge ports <NUM> of each of the plurality of syringes <NUM> and the one or more fluid outlet lines <NUM>. At least one of the first portion 148a and the second portion 148b may have a channel <NUM> extending around a circumference of the manifold <NUM> surrounding the discharge outlets <NUM>. The channel <NUM> may be configured for receiving a gasket <NUM> (shown in <FIG>) for sealing the interface between the first portion 148a and the second portion 148b. With reference to <FIG>, a valve receiving cavity <NUM> may be provided at the terminal end of the apex or cone point <NUM> of each syringe <NUM>. The valve receiving cavity <NUM> may extend into the syringe interior <NUM> in a direction aligned with a longitudinal axis L of each syringe <NUM> (shown in <FIG>). In some aspects, the valve receiving cavity <NUM> is in fluid communication with the syringe interior <NUM>, the filling port <NUM> and the discharge outlet <NUM>. The valve receiving cavity <NUM> is configured for receiving a valve <NUM> (shown in <FIG>). As described herein, at least a portion of the valve <NUM> may be rotatable about the longitudinal axis L and within the valve receiving cavity <NUM>. The valve <NUM> may be operable between a filling position for filling the syringe interior <NUM> with fluid and a delivery position for delivering the fluid from the syringe interior <NUM>. In some aspects, the valve <NUM> may be rotatable between a first position, where the filling port <NUM> is in fluid communication with the syringe interior <NUM> while the discharge outlet <NUM> is in fluid isolation from the syringe interior <NUM>, and a second position, where the discharge outlet <NUM> is in fluid communication with the syringe interior <NUM> while the filling port <NUM> is in fluid isolation from the syringe interior <NUM>. The valve <NUM> may have a third position where the interior of the syringe <NUM> is isolated from both the filling port <NUM> and the discharge outlet <NUM>. In the first position, the valve <NUM> may be configured for filling the syringe interior <NUM> with fluid from a bulk fluid source <NUM> through the MUDS fluid path <NUM> while preventing fluid from being delivered to the manifold <NUM>. In the second position, the valve <NUM> may be configured for delivering fluid from the syringe interior <NUM> to the manifold <NUM> through the discharge outlet <NUM> while preventing fluid from being delivered through the filling port <NUM>. The valve <NUM> may also be configured for preventing fluid flow through the filling port <NUM> and the discharge outlet <NUM> such that fluid cannot be delivered into or from the syringe interior <NUM>. In some aspects, the valve <NUM> may be rotatable to partially open or partially closed the discharge outlet <NUM> and/or the filling port <NUM>. In various aspects, the valves <NUM> on each syringe <NUM> may be controlled independently of each other, for example, such that various medical fluids can be delivered into one or more syringes <NUM> and/or, simultaneously or sequentially, be delivered out of one or more other syringes <NUM>. The valves <NUM> of the plurality of syringes <NUM> may be controlled, for example, through the electronic control device(s) associated with the fluid injector system <NUM>.

With reference to <FIG>, the MUDS <NUM> is illustrated in accordance with another aspect. The MUDS <NUM> may include a plurality of syringes <NUM> in a side-by-side, or other arrangement, with each syringe <NUM> being fluidly connectable to one of the bulk fluid sources <NUM> (shown in <FIG>). The MUDS <NUM> may include a frame <NUM> for supporting the one or more syringes <NUM>. The syringes <NUM> may be removably or non-removably connected to the frame <NUM>. In some aspects, each syringe may be fluidly connectable to one of the bulk fluid sources <NUM> by way of the bulk fluid connector <NUM> and the MUDS fluid path <NUM>. The apex or cone point <NUM> of each syringe <NUM> may have a discharge outlet <NUM>, a filling port <NUM>, and a valve receiving cavity <NUM>. The valve receiving cavity <NUM> may extend into the syringe interior in a direction substantially parallel with a longitudinal axis L of each syringe <NUM> (see e.g., <FIG>). The discharge outlet <NUM> and the filling port <NUM> may extend toward the syringe interior in a direction substantially perpendicular to the longitudinal axis L of each syringe <NUM>. The discharge outlet <NUM> and the filling port <NUM> may be arranged opposite to one another around an outer circumference of the apex or cone point <NUM>. In some aspects, the valve receiving cavity <NUM> is in fluid communication with the syringe interior, the filling port <NUM> and the discharge outlet <NUM>.

With continued reference to <FIG>, the discharge outlet <NUM> of each syringe <NUM> may be connected to a manifold <NUM>. Each syringe <NUM> may be formed separately and be independently connectable to the manifold <NUM>. The manifold <NUM> may be a tubular structure having a one or more conduits 148a for connecting to the discharge outlets <NUM> of the syringes <NUM>. In some aspects, the conduits 148a may be removably or non-removably connected to the discharge outlets <NUM>. For example, each conduit 148a may be adhesively connected, laser or ultrasonic vibration welded, or permanently and non-removably fastened by one or more mechanical fasteners to the respective discharge outlet <NUM>. Alternatively, each conduit 148a may be removably connected to the respective discharge outlet <NUM>, such as, for example, an interference fit, one or more clips, or other mechanical connection means. The manifold <NUM> may have a main fluid channel 148b that is in fluid communication with each syringe <NUM> through the respective conduit 148a. In some aspects, the one or more conduits 148a are monolithically formed with the main fluid channel 148b. One end of the main fluid channel 148b may be in fluid communication with one or more fluid outlet lines <NUM> to deliver fluid from the syringes <NUM> to the patient, as described herein.

The valve receiving cavity <NUM> is configured for receiving the valve <NUM>. As described herein, at least a portion of the valve <NUM> may be rotatable about the longitudinal axis L and within the valve receiving cavity <NUM>. The valve <NUM> may be operable between a filling position for filling the syringe interior with fluid and a delivery position for delivering the fluid from the syringe interior. In some aspects, the valve <NUM> may be rotatable between a first position, where the filling port <NUM> is in fluid communication with the syringe interior while the discharge outlet <NUM> is in fluid isolation from the syringe interior, and a second position, where the discharge outlet <NUM> is in fluid communication with the syringe interior while the filling port <NUM> is in fluid isolation from the syringe interior. In the first position, the valve <NUM> may be configured for filling the syringe interior with fluid from a bulk fluid source <NUM> through the MUDS fluid path <NUM> while preventing fluid from being delivered to the manifold <NUM>. In the second position, the valve <NUM> may be configured for delivering fluid from the syringe interior to the manifold <NUM> through the discharge outlet <NUM> while preventing fluid from being delivered through the filling port <NUM>. The valve <NUM> may also be configured for preventing fluid flow through the filling port <NUM> and the discharge outlet <NUM> such that fluid cannot be delivered into or from the syringe interior. In some aspects, the valve <NUM> may be rotatable to partially open or partially close the discharge outlet <NUM> and/or the filling port <NUM>. In various aspects, the valves <NUM> on each syringe <NUM> may be controlled independently of each other such that fluid can be delivered into one or more syringes <NUM> while, simultaneously or sequentially, being delivered out of one or more other syringes <NUM>.

With further reference to <FIG>, the MUDS <NUM> is removably connectable to the housing <NUM> of the fluid injector system <NUM>. As will be appreciated by one having ordinary skill in the art, it may be desirable to construct at least a portion of the MUDS <NUM> from a clear medical grade plastic in order to facilitate visual verification that a fluid connection has been established with the fluid injector system <NUM>. Visual verification is also desirable for confirming that no air bubbles are present within various fluid connections. Alternatively, at least a portion of the MUDS <NUM> and/or door <NUM> may include windows (not shown) for visualization of the connection between various components. Various optical sensors (not shown) may also be provided to detect and verify the connections. Additionally, various lighting elements (not shown), such as light emitting diodes (LEDs), may be provided to actuate one or more optical sensors and indicate that a suitable connection has been established between the various components.

With continued reference to <FIG>, a schematic view of various fluid paths of the fluid injector system <NUM> is provided. The MUDS <NUM> may include one or more valves <NUM>, such as stopcock valves, for controlling which medical fluid or combinations of medical fluids are withdrawn from the multi-dose bulk fluid source <NUM> and/or are delivered to a patient through each syringe <NUM>. In some aspects, the one or more valves <NUM> may be provided on the distal end <NUM> of the plurality of syringes <NUM> or on the manifold <NUM>. The manifold <NUM> may be in fluid communication via valves <NUM> and/or syringes <NUM> with a first end of the MUDS fluid path <NUM> that connects each syringe <NUM> to the corresponding bulk fluid source <NUM>. The opposing second end of the MUDS fluid path <NUM> may be connected to the respective bulk fluid connector <NUM> that is configured for fluidly connecting with the bulk fluid source <NUM>. Depending on the position of the one or more valves <NUM>, fluid may be drawn into the one or more syringes <NUM>, or it may be delivered from the one or more syringes <NUM>. In a first position, such as during the filling of the syringes <NUM>, the one or more valves <NUM> are oriented such that fluid flows from the bulk fluid source <NUM> into the desired syringe <NUM> through the MUDS fluid path <NUM>. During the filling procedure, the one or more valves <NUM> are positioned such that fluid flow through one or more fluid outlet lines <NUM> or manifold <NUM> is blocked. In a second position, such as during a fluid delivery procedure, fluid from one or more syringes <NUM> is delivered to the manifold <NUM> through the one or more fluid outlet lines <NUM> or syringe valve outlet ports. During the delivery procedure, the one or more valves <NUM> are positioned such that fluid flow through the MUDS fluid path <NUM> is blocked. The one or more valves <NUM>, the MUDS fluid path <NUM>, and/or fluid outlet lines <NUM> may be integrated into the manifold <NUM>. The one or more valves <NUM> may be selectively positioned to the first or second position by manual or automatic handling. For example, the operator may position the one or more valves <NUM> into the desired position for filling or fluid delivery. In other aspects, at least a portion of the fluid injector system <NUM> is operable for automatically positioning the one or more valves <NUM> into a desired position for filling or fluid delivery based on input by the operator, as described herein. Suitable examples of valve body structures are shown in International Application No. <CIT> and <CIT>.

With specific reference to <FIG>, the MUDS <NUM> further includes a frame <NUM> receiving at least a portion of the proximal end <NUM> of the at least one syringe <NUM>. In some aspects, the frame <NUM> may be shaped to receive at least a portion of the proximal end <NUM> of each syringe <NUM>. In some aspects, the fluid outlet line <NUM> may be connected to the frame <NUM>. The frame <NUM>, in some aspects, defines at least a portion of a connection port <NUM> for connecting a SUDS to the MUDS <NUM>. The frame <NUM> may have a handle for grasping the MUDS <NUM> during insertion into and removal from the fluid injector system <NUM>. In certain aspects, the connection port <NUM>, may be formed as part of or adhered/welded to the frame <NUM> to form a single MUDS unit.

With reference to <FIG>, in some aspects, the fluid outlet line <NUM> may also be connected to a waste reservoir <NUM> on the fluid injector system <NUM>. The waste reservoir <NUM> is desirably separate from the syringes <NUM> to prevent contamination. In some aspects, the waste reservoir <NUM> is configured to receive waste fluid expelled from the syringes <NUM> during, for example, a priming operation. The waste reservoir <NUM> may be removable from the housing <NUM> in order to dispose of the contents of the waste reservoir <NUM>. In other aspects, the waste reservoir <NUM> may have a draining port (not shown) for emptying the contents of the waste reservoir <NUM> without removing the waste reservoir <NUM> from the housing <NUM>. In some aspects, the waste reservoir <NUM> is provided as a separate component from the MUDS <NUM>.

With the foregoing description of the fluid injector system <NUM> and the MUDS <NUM> in mind, exemplary loading and unloading of MUDS <NUM> into a receiving space <NUM> (shown in <FIG>) on the housing <NUM> will now be described with reference to <FIG>. In the following discussion, it is assumed that the MUDS <NUM> may be connected to and removed from connection with the fluid injector system <NUM> for use with a single or multiple patients. Referring initially to <FIG>, the receiving space <NUM> has a bottom plate <NUM> separated from a top plate <NUM> by a rear sidewall <NUM>. The bottom plate <NUM> has a plurality of openings <NUM> through which the piston elements <NUM> of the fluid injector system <NUM> extend to engage the respective plungers <NUM> of the MUDS <NUM>. At least one bottom guide <NUM> is formed on the bottom plate <NUM> for guiding the frame <NUM> of the MUDS <NUM> as the MUDS <NUM> is loaded into the fluid injector system <NUM>. In some aspects, the bottom guide <NUM> may be configured as a pair of walls raised relative to the bottom plate <NUM> and narrowing in an insertion direction toward the rear sidewall <NUM>. During insertion, the bottom guide <NUM> defines a guiding surface that locates the frame <NUM> of the MUDS <NUM> and guides the frame <NUM> toward the rear sidewall <NUM> of the receiving space <NUM>. In this manner, the MUDS <NUM> can be aligned into the receiving space <NUM> even when MUDS <NUM> is initially misaligned with the receiving space <NUM>.

With reference to <FIG>, and with continued reference to <FIG>, the top plate <NUM> is configured to receive the distal end <NUM> of the at least one syringe <NUM>. The top plate <NUM> has one or more syringe slots <NUM> (shown in <FIG>) that are shaped to receive at least a portion of the distal end <NUM> of the syringes <NUM>. In some aspects, when the MUDS <NUM> is inserted into the receiving space <NUM>, the syringe slots <NUM> of the top plate <NUM> may be disposed between the distal end <NUM> of the at least one syringe <NUM> and the manifold <NUM>. The top plate <NUM> may be rotatable about a pivot point P1, shown in <FIG>, or it may be movable in a vertical direction relative to the MUDS <NUM>. In a first position, such as during loading of the MUDS <NUM> into the receiving space <NUM>, the top plate <NUM> may be raised such that the apex or cone point <NUM> of the at least one syringe <NUM> clears a lower surface of the top plate <NUM>. In some aspects, the top plate <NUM> can default to the first position each time the MUDS <NUM> is removed from the receiving space <NUM>, such as by a biasing mechanism. In other aspects, the top plate <NUM> can be urged to the first position as the apex or cone point <NUM> of the at least one syringe <NUM> engages the at least one syringe slot <NUM>.

As the MUDS <NUM> engages the rear sidewall <NUM>, such as shown in <FIG>, the MUDS <NUM> can be locked in the receiving space <NUM> by moving the top plate <NUM> to a second position. In the second position, the top plate <NUM> is lowered such that the apex or cone point <NUM> of the at least one syringe <NUM> engages the lower surface of the top plate <NUM>. In some aspects, the top plate <NUM> can be urged to the second position by a biasing mechanism (not shown). In other aspects, the top plate <NUM> can be manually moved to the second position by pivoting the top plate <NUM> in a direction of arrow A shown in <FIG>. The top plate <NUM> can be locked relative to the MUDS <NUM> to prevent removal of the MUDS <NUM> from the receiving space <NUM> by a latch <NUM>. The latch <NUM> may be operable to prevent the top plate <NUM> from rotating about the pivot point P1. The latch <NUM> may be an over-center, springloaded latch that is pivotable about a pivot point P2 in a direction of arrow B shown in <FIG>. With reference to <FIG>, when the MUDS <NUM> is locked within the receiving space <NUM>, the lower surface of the top plate <NUM> engages the apex or cone point <NUM> of the at least one syringe <NUM>. In the locked position, the longitudinal axis L of each syringe <NUM> is aligned with a center of each syringe slot <NUM>. Removal of the MUDS <NUM> from the receiving space <NUM> when the top plate <NUM> is in the locked position is prevented by the engagement of the lower surface of the top plate <NUM> with the apex or cone point <NUM> of the at least one syringe <NUM>. Once locked, the top plate <NUM> retains the syringes <NUM> from moving axially during an injection procedure.

With reference to <FIG>, the MUDS <NUM> is removed from the receiving space <NUM> by unlocking the top plate <NUM> from the apex or cone point or conical portion <NUM> of the at least one syringe <NUM>. In the following discussion, it is assumed that the MUDS <NUM> may be removed from connection with the fluid injector system <NUM> and discarded as medical waste. In some aspects, the top plate <NUM> is unlocked by unlatching the latch <NUM> through a pivoting movement of the latch <NUM> about the pivot point P2 in a direction of arrow C shown in <FIG>. As the latch <NUM> is unlatched, the top plate <NUM> is pivoted upwards relative to the MUDS <NUM> in a direction of arrow D shown in <FIG>. By unlocking the top plate <NUM>, the top plate <NUM> can be moved (i.e., pivoted or raised) relative to the MUDS <NUM> to allow the apex or cone point or conical portion <NUM> of the at least one syringe <NUM> to clear the syringe slot <NUM> (shown in <FIG>) of the top plate <NUM>. The MUDS <NUM> can then be extracted in a direction opposite the insertion direction by moving the MUDS <NUM> away from the rear sidewall <NUM> (shown in <FIG>).

With reference to <FIG>, according to the invention the MUDS <NUM> has one or more rotatable valves <NUM> that control fluid flow through the manifold <NUM>. The one or more valves <NUM> are rotatable between various positions to effect fluid filling or delivery. A coupling mechanism <NUM> is provided to rotate the one or more valves <NUM> and thereby control the arrangement of the MUDS <NUM> for fluid filling or delivery. The coupling mechanism <NUM> is in the form of a rotatable coupling <NUM> that engages the at least one rotatable valve <NUM>. The rotatable coupling <NUM> has a blade <NUM> that is configured to engage with a slot <NUM> on the at least one rotatable valve <NUM>. The rotatable coupling <NUM> may be rotatable using a drive mechanism (not shown) provided on the fluid injector system <NUM> to rotate coupling <NUM> by up to <NUM> degrees until the blade <NUM> engages slot <NUM>. The coupling mechanism <NUM> may include a sensor (not shown) that senses when blade <NUM> engages slot <NUM> and instructs the coupling mechanism <NUM> to stop rotating coupling <NUM>. The coupling mechanism <NUM> is capable of engaging and coupling to the valve <NUM> regardless of the initial orientation of the slot <NUM>. Thus, any rotational movement of valve <NUM>, for example during manufacture, shipping, or insertion of MUDS <NUM>, may be compensated for. Once the blade <NUM> of the rotatable coupling <NUM> engages the slot <NUM> on the at least one rotatable valve <NUM>, rotation of the rotatable coupling <NUM> causes a corresponding rotation of the rotatable valve <NUM>. In this manner, the arrangement of the one or more valves <NUM> can be switched between a position for filling the one or more syringes <NUM> (shown in <FIG>) and a position for delivering fluid from the one or more syringes <NUM>.

With reference to <FIG>, the valve <NUM> has a valve body <NUM> configured for being rotatably received within at least a portion of the valve receiving cavity <NUM> (shown in <FIG>). In some aspects, the valve <NUM> is configured to be received within the valve receiving cavity <NUM> in a substantially vertical orientation such that the valve <NUM> can interface with the coupling mechanism <NUM> on the injector. The valve body <NUM> has a valve stem <NUM> connected to a valve head <NUM>. The valve stem <NUM> may be shaped to be received within at least a portion of the valve receiving cavity <NUM>. The valve head <NUM> may be monolithically formed with the valve stem <NUM>, such as by molding. In some aspects, the valve head <NUM> is formed separately from the valve stem <NUM> and is removably or non-removably connected to the valve stem <NUM>. The valve stem <NUM> and the valve head <NUM> may be formed from same or different materials. In some aspects, the valve stem <NUM> is formed as a substantially cylindrical member with the valve head <NUM> monolithically formed with the valve stem <NUM> such that the valve head <NUM> extends radially outward relative to the valve stem <NUM>. In various aspects, the valve head <NUM> may be circular, square, rectangular, or shaped to have any regular or irregular geometric shape having one or more linear or curvilinear edges. The valve stem <NUM> and the valve head <NUM> may be aligned or offset relative to a longitudinal axis <NUM> of the valve <NUM>.

At least a portion of the valve <NUM> may be made from an elastomeric material to provide sealing against the sidewall of the valve receiving cavity <NUM>. In some aspects, at least a portion of the valve <NUM> may be made from biocompatible, non-pyrogenic, latex free, and/or DEHP free materials. In other aspects, the valve <NUM> may be made from a material that is compatible with various medical fluids including, without limitation, various contrast solutions and saline solutions. In other aspects, the valve <NUM> may be configured for various sterilization techniques, including, without limitation, electron beam sterilization, gamma sterilization, and/or ethylene oxide sterilization. In other aspects, the valve <NUM> may be configured for use over a predetermined period, such as a period of <NUM> hours, before the syringe <NUM>, along with the valve <NUM> must be disposed. In some aspects, the valve <NUM> may be rated for a maximum operating pressure greater than <NUM> atm (<NUM> psi). In other aspects, actuation torque needed to rotate the valve <NUM> may be less than <NUM> N-m, with a failure torque greater than <NUM> times the actuation torque. In other aspects, the valve <NUM> may be configured for rotation at <NUM> rpm or more. In other aspects, an internal fluid loss of the valve <NUM> may be less than <NUM>% of the total requested volume. In other aspects, the valve <NUM> may have allowable leakage of less than <NUM> for a <NUM> syringe <NUM>.

With reference to <FIG>, the valve head <NUM> has the slot <NUM> formed as a recess that extends into the valve head <NUM>. In some aspects, the valve head <NUM> may have a plurality of slots. The slot <NUM> may extend across at least a portion of an upper surface of the valve head <NUM>. In some aspects, the slot <NUM> may be aligned with the longitudinal axis <NUM> of the valve <NUM> such that the slot <NUM> extends in a radial direction relative to the longitudinal axis <NUM>. In other aspects, the slot <NUM> may be offset relative to the longitudinal axis <NUM> of the valve <NUM>. The slot <NUM> may have a uniform or non-uniform width along its length. The slot <NUM> may be surrounded by one or more recesses <NUM> having one or more ribs <NUM> extending between the slot <NUM> and an outer circumference <NUM> of the valve head <NUM>. The slot <NUM> may extend at a uniform or non-uniform depth into the valve head <NUM> along the length of the slot <NUM>. The slot <NUM> may have a flat bottom, or it may be angled to form a v-shape into the valve head <NUM>.

With reference to <FIG>, the valve stem <NUM> is desirably hollow with a sidewall <NUM> defining an outer shape of the valve stem <NUM>. The hollow valve stem <NUM> has an interior <NUM> with an open bottom end <NUM>. The valve stem <NUM> has a first side opening <NUM> extending through the sidewall <NUM> at a location offset from the bottom end <NUM>. The first side opening <NUM> is in fluid communication with the interior <NUM> of the valve stem <NUM>. The first side opening <NUM> may extend through the sidewall <NUM> in a direction that is perpendicular or oblique relative to the longitudinal axis <NUM> of the valve <NUM>. In some aspects, a plurality of first side openings <NUM> may be provided. In such aspects, the plurality of first side openings <NUM> may extend circumferentially around an outer circumference of the valve stem <NUM> and/or axially along the longitudinal axis <NUM> of the valve <NUM>.

With reference to <FIG>, an insert <NUM> may be received within the interior <NUM> of the valve stem <NUM>. In some aspects, the insert <NUM> may be monolithically formed with the valve <NUM>, such as by co-molding the insert <NUM> with the valve <NUM>. At least a portion of the insert <NUM> may extend into the recess <NUM> formed on the valve head <NUM> to prevent rotation of the insert <NUM> relative to the valve stem <NUM>. The insert <NUM> has a hollow body with a circumferential sidewall <NUM> surrounding an interior <NUM> having an open bottom end <NUM>. At least one second side opening <NUM> extends through the sidewall <NUM> of the hollow body of the insert <NUM>. The second side opening <NUM> is aligned with the first side opening <NUM> of the valve stem <NUM> such that the first side opening <NUM> and the second side opening <NUM> are in fluid communication with each other. In this manner, the first side opening <NUM> is in fluid communication with the interior <NUM> of the insert <NUM> by way of an L-shaped fluid path.

Prior to connection with the fluid injector system <NUM>, the one or more valves <NUM> may be misaligned relative to the coupling mechanism <NUM> on the fluid injector system <NUM>. In order to align the one or more valves <NUM> for rotation with the coupling mechanism <NUM>, the rotatable coupling <NUM> is rotatable into self-alignment with the at least one valve <NUM>. As the MUDS <NUM> (shown in <FIG>) is loaded into the receiving space <NUM> of the fluid injector system <NUM>, at least a portion of the valve <NUM>, such as a portion of its outer sidewall <NUM> (shown in <FIG>), engages at least a portion of the rotatable coupling <NUM>. Referring to <FIG>, the blade <NUM> of the rotatable coupling <NUM> may have an inclined surface <NUM> that is angled relative to the outer sidewall <NUM> of the valve <NUM>. Upon contact with the inclined surface <NUM>, the outer sidewall <NUM> of the valve <NUM> slides along the inclined surface <NUM> as the MUDS <NUM> is moved into the receiving space <NUM>. Valve sidewall <NUM> may include a beveled, chamfered, or rounded edge <NUM> on the distal perimeter of the valve side wall <NUM> which may facilitate engagement between the inclined surface <NUM> and the valve <NUM>. Such sliding movement causes the rotatable coupling <NUM> to move vertically in a direction of arrow E in <FIG>. In some aspects, the rotatable coupling <NUM> may be springloaded, such that, when the blade <NUM> is moved in the direction of arrow E, for example when the blade <NUM> is not correctly aligned with slot <NUM>, a restoring force is stored in an elastically-resilient member <NUM>. As shown in <FIG>, slot <NUM> has a lip <NUM> on one end which limits the orientation of the blade <NUM> to a single orientation for insertion into slot <NUM>, for example when inclined surface <NUM> of blade <NUM> is adjacent to the lip <NUM>. When the MUDS <NUM> is fully inserted into the receiving space, the blade <NUM> of the rotatable coupling <NUM> is positioned on an upper surface <NUM> of the valve <NUM>. To align the valve <NUM> with the rotatable coupling <NUM>, the rotatable coupling <NUM> is rotated relative to the valve <NUM> until the blade <NUM> is aligned with the slot <NUM>. Once aligned, the blade <NUM> is lowered into the slot <NUM>. The rotatable coupling <NUM> may then be urged into the slot <NUM> under the restoring action of the elastically-resilient member <NUM>. The slot <NUM> may have sidewalls that narrow starting from the upper surface <NUM> to facilitate the insertion of the blade <NUM> into the slot <NUM>. Once the blade <NUM> is inserted into the slot <NUM>, the rotatable coupling <NUM> can adjust the orientation of the valve <NUM> for fluid filling or delivery, as described herein. As there is only one correct orientation between each valve <NUM> and each rotatable coupling <NUM>, an operating system of the injector can determine the orientation of each valve <NUM> and determine the correct rotation of each rotatable coupling <NUM> necessary for filling or delivering fluid from each of the plurality of syringes <NUM> of the MUDS <NUM>.

Having generally described the components of the fluid injector system <NUM> and the MUDS <NUM>, the structure and method of use of a SUDS <NUM> and its interaction with MUDS <NUM> will now be described.

With reference to <FIG> and <FIG>, the fluid injector system <NUM> has a connection port <NUM> that is configured to form a releasable fluid connection with at least a portion of the SUDS <NUM>. In some aspects, the connection port <NUM> may be formed on the MUDS <NUM>. The connection port <NUM> may be shielded by at least a portion of the housing <NUM> of the fluid injector system <NUM>. For example, recessing the connection port <NUM> within the interior of the housing <NUM> may preserve the sterility of the connection port <NUM> by preventing or limiting a user or patient from touching and contaminating the portions of the connection port <NUM> that contact the fluid to be injected to the patient. In some aspects, the connection port <NUM> is recessed within an opening <NUM> formed on the housing <NUM> of the fluid injector system <NUM>, or the connection port <NUM> may have a shielding structure (not shown) that surrounds at least a portion of the connection port <NUM>. In other aspects, the connection port <NUM> may be formed directly on the housing <NUM> and connected to the MUDS <NUM> by a fluid path (not shown). As described herein, the SUDS <NUM> may be connected to the connection port <NUM>, formed on at least a portion of the MUDS <NUM> and/or the housing <NUM>. Desirably, the connection between the SUDS <NUM> and the connection port <NUM> is a releasable connection to allow the SUDS <NUM> to be selectively disconnected from the connection port <NUM> (<FIG>) and connected to the connection port <NUM> (<FIG>). In some aspects, the SUDS <NUM> may be disconnected from the connection port <NUM> and disposed after each fluid delivery procedure and a new SUDS <NUM> may be connected to the connection port <NUM> for a subsequent fluid delivery procedure.

With continued reference to <FIG> and <FIG>, a waste inlet port <NUM> may be provided separately from the connection port <NUM>. The waste inlet port <NUM> is in fluid communication with the waste reservoir <NUM>. In some aspects, the waste reservoir <NUM> is provided separately from the SUDS <NUM> such that the fluid from the waste inlet port <NUM> can be delivered to the waste reservoir <NUM>. At least a portion of the SUDS <NUM> may be releasably connected to or associated with the waste inlet port <NUM> for introducing waste fluid into the waste reservoir <NUM> during, for example, a priming operation that expels air from the SUDS <NUM>. The waste reservoir <NUM> may have a viewing window <NUM> with indicia <NUM>, such as graduated markings, that indicate the fill level of the waste reservoir <NUM>.

With reference to <FIG>, the SUDS <NUM> has a fluid inlet port <NUM> that is configured for releasable connection with the connection port <NUM> (shown in <FIG>). The fluid inlet port <NUM> receives fluid delivered from the fluid injector system <NUM>. The fluid inlet port <NUM> is desirably a hollow, tubular structure, as shown in <FIG>. The SUDS <NUM> further has a waste outlet port <NUM> that is configured for releasable connection or association with the waste inlet port <NUM> (shown in <FIG>). The waste outlet port <NUM> receives waste fluid and delivers such waste fluid to the waste reservoir <NUM> during, for example, a priming operation of the SUDS <NUM>. The waste outlet port <NUM> is desirably a hollow, tubular structure, as shown in <FIG>. The waste outlet port <NUM> may be connected to, inserted into, or located in the waste inlet port <NUM> so that the waste fluid may flow through the waste inlet port <NUM> and continue into waste reservoir <NUM>. The fluid inlet port <NUM> and the waste outlet port <NUM> may be spaced apart from each other by a spacer <NUM>. In some aspects, the spacer <NUM> is dimensioned to position the fluid inlet port <NUM> and the waste outlet port <NUM> for alignment with the connection port <NUM> and the waste inlet port <NUM>, respectively. It is noted that the SUDS <NUM> is shown in <FIG> in a state after removal from packaging (not shown). Prior to use, the SUDS <NUM> is desirably packaged in a pre-sterilized, sealed package that protects the SUDS <NUM> from contamination with air or surface-borne contaminants. Alternatively, the sealed package and SUDS <NUM> may be sterilized after packaging.

The SUDS <NUM> desirably has an asymmetrical structure, so that the user can only attach the SUDS <NUM> to the MUDS <NUM> in one orientation. In this manner, the user is prevented from attaching the fluid inlet port <NUM> to the waste inlet port <NUM>. In some aspects, a fin <NUM> may be provided on at least a portion of the SUDS <NUM> to prevent erroneous insertion of the SUDS <NUM> in the connection port <NUM>. In certain aspects, the fin <NUM> may be formed on the spacer <NUM> proximate to the waste outlet port <NUM>. In this manner, the fin <NUM> may interfere with the incorrect insertion of the SUDS <NUM> into the connection port <NUM>. Structures and shapes other than a fin <NUM> may be used to prevent erroneous insertion of the SUDS <NUM> into connection port <NUM>,.

In some aspects, tubing <NUM> may be connected at its proximal end <NUM> to the fluid inlet port <NUM>. The tubing <NUM> is configured to deliver fluid received from the fluid inlet port <NUM>. The distal end <NUM> of the tubing <NUM> may have a connector <NUM> that is configured for connection with the waste outlet port <NUM> or a fluid path connected to the patient (not shown). The tubing <NUM> may be made from a flexible material, such as a medical grade plastic material, that allows the tubing <NUM> to be coiled. The connector <NUM> may be a luer-lock connector (either a male luer-lock connector or a female luer-lock connector depending on the desired application) or other medical connector configuration. In some aspects, the connector <NUM> may have a one-way valve to prevent backflow of fluid. Alternatively, a one-way valve may be located elsewhere in the SUDS <NUM> between fluid inlet port <NUM> and connector <NUM>.

With continued reference to <FIG>, the SUDS <NUM> may have a locking tab <NUM> that is configured for selectively locking the SUDS <NUM> with the fluid injector system <NUM> depending on the engagement of the locking tab <NUM> with at least a portion of the fluid injector system <NUM>. In some aspects, the locking tab <NUM> may be a flexible tab that is deflectable between an engaged position and a disengaged position by deflecting at least a portion of the locking tab <NUM>. The locking tab <NUM> may have a pressing surface <NUM> that, when pressed, causes the locking tab <NUM> to be deflected from the engaged position to the disengaged position for insertion and removal of the SUDS <NUM> from the fluid injector system <NUM>. In some aspects, the locking tab <NUM> may be configured for releasable locking engagement with a receiving slot <NUM> on the MUDS <NUM> (shown in <FIG>).

With reference to <FIG>, the SUDS <NUM> may have a first annular skirt <NUM> extending circumferentially around a proximal end <NUM> of the fluid inlet port <NUM> and a second annular skirt <NUM> extending circumferentially around a distal end <NUM> of the fluid inlet port <NUM>. The first and second annular skirts <NUM>, <NUM> surround the fluid inlet port <NUM> to prevent inadvertent contact and contamination. The first annular skirt <NUM> may have one or more recesses <NUM> (shown in <FIG>) extending through a sidewall thereof. The one or more recesses <NUM> may provide a locking interface with a corresponding locking element (not shown) on the fluid injector system <NUM>. The second annular skirt <NUM> may have at least one indentation <NUM> (shown in <FIG>) to facilitate grasping and handling of the SUDS <NUM>. In some aspects, the second annular skirt <NUM> may have a textured surface having one or more ribs <NUM> (shown in <FIG>) to facilitate gripping and handling of the SUDS <NUM>.

With continued reference to <FIG>, at least one annular seal <NUM> may be provided around the proximal end <NUM> of the fluid inlet port <NUM>. The at least one annular seal <NUM> may seal the fluid inlet port <NUM> to prevent fluid from leaking through the SUDS <NUM>. The at least one annular seal <NUM> may provide a fluid seal between the SUDS <NUM> and the MUDS <NUM> when they are fluidly connected with one another to allow fluid to flow from the MUDS <NUM> to the SUDS <NUM> without leaking. A one-way valve <NUM> may be provided within a lumen of the fluid inlet port <NUM> to prevent fluid from flowing in a reverse direction from the SUDS <NUM> into the MUDS <NUM>.

With reference to <FIG>, the SUDS <NUM> shown in <FIG> is shown connected to the fluid injector system <NUM>. While <FIG> illustrates the connection port <NUM> formed on the MUDS <NUM>, in other aspects, the connection port <NUM> may be formed on a portion of the housing <NUM> (shown in <FIG>). The fluid inlet port <NUM> of the SUDS <NUM> is connected to the connection port <NUM> to establish a fluid path in a direction of arrow F shown in <FIG>. Fluid passing through the fluid inlet port <NUM> flows through the one-way valve <NUM> and into tubing <NUM>. Any fluid that may drip from the interface between the fluid inlet port <NUM> and the connection port <NUM> is collected in the waste reservoir <NUM>. The waste reservoir <NUM> may be shaped to collect any fluid that may drip from the SUDS <NUM> when it is removed from the MUDS <NUM>. Additionally, when the SUDS <NUM> is connected to the connection port <NUM>, the outlet of the waste outlet port <NUM> is positioned within the waste inlet port <NUM> such that waste fluid from the tubing <NUM> may be discharged into the waste reservoir <NUM>. The spacer <NUM> may define an insertion stop surface to define the depth of insertion of the SUDS <NUM> into the connection port <NUM>.

<FIG> illustrate various connection configurations between the terminal end of the apex or cone point or distal conical end <NUM> of the one or more syringes <NUM> and the manifold <NUM> including at least one manifold conduit, wherein the manifold conduit 148a is in fluid connection with a main fluid channel 148b and a conduit syringe attachment end, wherein the conduit syringe attachment end is in fluid communication with the syringe fluid port of the at least one syringe <NUM>. According to these aspects, the at least one manifold conduit 148a comprises a filling port <NUM> configured for fluid communication with a MUDS fluid line <NUM>, a discharge outlet <NUM> in fluid communication with the main fluid channel 148b, and a valve receiving cavity <NUM>, wherein the discharge outlet <NUM> and the filling port <NUM> are in fluid communication with an interior <NUM> of the at least one syringe <NUM> through a valve assembly <NUM> in a valve receiving cavity <NUM>.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including a swivel nut connection is shown. The distal conical end <NUM> of the at least one syringe <NUM> includes a male luer tip and a circumferential groove <NUM>. Circumferential groove <NUM> is configured to receive an inward radial flange <NUM> of threaded swivel nut <NUM> including internal threads <NUM>. Conduit syringe attachment end <NUM> of manifold conduit <NUM> includes a female luer tip configured for fluid tight connection with male luer tip of distal conical end <NUM>. Internal threads <NUM> threadibly interact with complementary threads <NUM> on the conduit syringe attachment end <NUM> of manifold conduit <NUM> to connect the manifold conduit <NUM> with distal conical end <NUM>.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including an overmolded manifold connection with solvent bond is shown. The conduit syringe attachment end <NUM> of the at least one manifold conduit <NUM> comprises an overmolded polymer sheath <NUM> that forms a fluid tight connection by a solvent bond between an outer surface of the conduit syringe attachment end <NUM> and an inner surface of the syringe fluid port <NUM>. In certain aspects the at least one syringe and/or manifold conduit <NUM> may be made of a first polymeric material, such as, for example polycarbonate, and the overmolded polymer sheath <NUM> may be made of a second polymeric material, such as polyurethane, that may be overmolded on the conduit syringe attachment end <NUM> during manufacture. The polymeric sheath <NUM> may then be treated with a solvent, such as but not limited to cyclohexanone, methyl ethyl ketone or other suitable solvent, that at least partially dissolves the second polymeric material, forming a solvent bond with between the two surfaces upon setting. According to another aspect illustrated in <FIG>, the syringe fluid port <NUM> may comprise the overmolded polymer sheath <NUM> that has been overmolded on an outer surface of the syringe fluid port <NUM>, which then forms a fluid tight connection and seal with the inner surface of the conduit syringe attachment end <NUM> of the at least one manifold conduit <NUM>.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including a stem lock configuration using the stem of the valve assembly <NUM> to connect the syringe and manifold is shown. According to this aspect, an inner surface <NUM> of the syringe fluid port <NUM> comprises a locking flange <NUM> extending radially inward and the inner surface of the conduit syringe attachment end <NUM> comprises a locking flange <NUM> extending radially inward. Valve assembly <NUM> comprises a syringe locking groove <NUM> and a manifold locking groove <NUM> configured to form locking engagements with the locking flanges <NUM>, <NUM> of the syringe fluid port <NUM> and conduit syringe attachment end <NUM>. Certain aspects may further include one or more o-rings between the valve assembly and one or both of the syringe fluid port <NUM> and conduit syringe attachment end <NUM>.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including a UV activated adhesive. According to this aspect, the outer circumferential surface of the conduit syringe attachment end <NUM> is bonded to an inner circumferential surface of the syringe fluid port <NUM> by a UV activated adhesive. To accommodate for potential swelling of the UV activated adhesive during cure, the syringe fill port <NUM> may comprise a plurality of lateral slots <NUM> to allow for expansion of the UV activated adhesive during the curing process, where excess adhesive may expand through the lateral slots <NUM>. In another aspect (not shown), the conduit syringe attachment end <NUM> may comprise a plurality of lateral slots to allow for expansion of the UV activated adhesive during the curing process, where excess adhesive may expand through the lateral slots.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including a plurality of flexible clip elements is shown. According to one aspect the conical distal end <NUM> may comprise a plurality of distally facing flexible clips <NUM> configured to engage a radial flange <NUM> on an outer circumference of the conduit syringe attachment end <NUM> of the manifold conduit <NUM>. The syringe fluid port <NUM> may include a male luer tip that sealably engages a female luer tip on the conduit syringe attachment end <NUM>. In other aspect (not shown), the flexible clips may be located on the conduit syringe attachment end <NUM> and project proximally to engage a corresponding flange on the syringe fluid port <NUM>.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including a C-clip locking feature is shown. According to this aspect, syringe fluid port <NUM> includes a longitudinal slot <NUM> and the conduit syringe attachment end <NUM> comprises a radial flange <NUM>. The conduit syringe attachment end <NUM> is inserted into the syringe fluid port <NUM> to a point where the radial flange <NUM> is immediately proximal to the longitudinal slot <NUM>. Connection between the conduit syringe attachment end <NUM> and the syringe fluid port <NUM> is maintained by a C-clip <NUM> inserted into longitudinal slot <NUM> immediately distal to the radial flange. The conduit syringe attachment end <NUM> may further comprise one or more O-rings <NUM> configured to form a fluid tight seal between the conduit syringe attachment end <NUM> and the syringe fluid port <NUM>.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including a laser weld feature is shown. According to this aspect, one of the syringe fluid port <NUM> and the conduit syringe attachment end <NUM> comprises a radial flange <NUM> with a surface configured for laser welding and the other of the syringe fluid port <NUM> and the conduit syringe attachment end <NUM> comprises a complementary radial receiving flange <NUM> that receives the radial flange <NUM> and has a complementary surface configured for laser welding. The radial flange <NUM> and the complimentary radial receiving flange <NUM> are connected by a laser weld <NUM> therebetween.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including an ultrasonic weld feature is shown. According to this aspect, one of the syringe fluid port <NUM> and the conduit syringe attachment end <NUM> comprises a circumferential receiving slot <NUM> including an energy director <NUM> and the other of the syringe fluid port <NUM> and the conduit syringe attachment end <NUM> comprises a terminal portion <NUM> that engages and is received in the circumferential receiving slot <NUM>. The terminal portion <NUM> and the circumferential receiving slog <NUM> are connected by an ultrasonic weld therebetween by exposure to ultrasonic vibrations, which may be directed by energy director <NUM>.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including luer seal with UV adhesive bond is shown. According to this aspect, the syringe fluid port <NUM> may comprise a female luer connector which forms a liquid tight connection with a male luer connector on the conduit syringe attachment end <NUM>. When assembling the luer connection, a distal circumferential slot <NUM> is formed between the syringe fluid port <NUM> and the conduit syringe attachment end <NUM>. The distal circumferential slot <NUM> is configured for receiving a UV activated adhesive which forms an adhesive connection between the syringe fluid port <NUM> and the conduit syringe attachment end <NUM> upon irradiation with UV radiation. Reversal of the luer connections between the syringe fluid port <NUM> and the conduit syringe attachment end <NUM> is also contemplated.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including a UV adhesive bond between the syringe fluid port <NUM> and the manifold conduit <NUM> is shown. According to this aspect, engagement between the syringe fluid port <NUM> and the conduit syringe attachment end <NUM> defines a tubular space <NUM> between an inner surface of the syringe fluid port <NUM> and an outer surface of the conduit syringe attachment end <NUM>. When assembling the connection, a UV activated adhesive is received within the tubular space <NUM> which forms an adhesive connection between the syringe fluid port <NUM> and the conduit syringe attachment end <NUM> upon irradiation with UV radiation. Reversal of the connections between the syringe fluid port <NUM> and the conduit syringe attachment end <NUM> is also contemplated.

With reference to <FIG>, one aspect of a syringe/manifold connection configuration including luer seal with a laser tack weld is shown. According to this aspect, the syringe fluid port <NUM> may comprise a female luer connector which forms a liquid tight connection with a male luer connector on the conduit syringe attachment end <NUM>. Upon assembling the luer connection, a laser tack weld <NUM> is formed at the interface between the syringe fluid port <NUM> and the conduit syringe attachment end <NUM>. Reversal of the luer connections between the syringe fluid port <NUM> and the conduit syringe attachment end <NUM> is also contemplated.

With reference to <FIG>, the fluid injector system <NUM> may have a sensor system <NUM> adapted to identify when the SUDS <NUM> is in fluid communication with the MUDS <NUM>. The sensor system <NUM> may include at least one sensing element, such as sensor fin <NUM> on the SUDS <NUM> and a corresponding sensor <NUM> on the fluid injector system <NUM> or MUDS <NUM>. The sensor <NUM> may be configured to detect the presence and absence of the at least one sensor fin <NUM>, or other sensing element. In some aspects, the sensing element, such as the at least one sensor fin <NUM> is formed on the locking tab <NUM> of the SUDS <NUM>, such as shown in <FIG>. In other aspects, the sensing element, such as the at least one sensor fin <NUM> may be formed on any portion of the SUDS <NUM>. The sensor <NUM> may be an optical sensor that is seated and secured within a respective mount formed on the housing <NUM> of the fluid injector system <NUM>. As will be appreciated by those versed in the field of powered medical fluid injectors, the sensor <NUM> may be electronically coupled to an electronic control device used to discretely control operation of the fluid injector system, such as the operation of the one or more piston elements, based, at least in part, on input from the sensor <NUM>. The sensing element, such as the sensor fin <NUM> may have one or more reflective surfaces that reflect visible or infrared light to be detected by the sensor <NUM>. In other aspects, mechanical interaction between the sensing element and the sensor <NUM> may be used.

In some aspects, the SUDS <NUM> may further include reuse prevention features (not shown). For example, the SUDS <NUM> may include one or more breakable, sensor elements, tabs or structures that fold or break when the SUDS <NUM> is removed from the MUDS <NUM>. Absence of these features may prevent reinsertion and reuse of the SUDS <NUM> after removal. In this manner, it can be assured that the SUDS <NUM> is only used for one fluid delivery procedure.

Having generally described the components of the fluid injector system <NUM>, the MUDS <NUM>, and the SUDS <NUM>, a method of operation of using the SUDS <NUM> will now be described in detail. In use, a medical technician or user removes the disposable SUDS <NUM> from its packaging (not shown) and inserts the fluid inlet port <NUM> into the connection port <NUM> on the MUDS <NUM>. As described above, the SUDS <NUM> must be inserted in the correct orientation, such that the fluid inlet port <NUM> is aligned for connection with the connection port <NUM>, and the waste outlet port <NUM> is aligned for connection with the waste inlet port <NUM>. The SUDS <NUM> may be secured to the MUDS <NUM> by inserting the locking tab <NUM> into the receiving slot <NUM> on the MUDS <NUM>. Once the SUDS <NUM> is securely connected to the MUDS <NUM>, for example as sensed by the sensor <NUM>, the fluid injector system <NUM> (shown in <FIG> and <FIG>) draws fluid into one or more of the plurality of syringes <NUM> of the MUDS <NUM> and performs an automatic priming operation for removing air from the MUDS <NUM> and the SUDS <NUM>. During such priming operation, fluid from the MUDS <NUM> is injected through the connection port <NUM> and into the tubing <NUM> of the SUDS <NUM>. The fluid flows through the tubing <NUM> and through the waste outlet port <NUM> and into the waste reservoir <NUM>. Once the automatic priming operation is completed, the medical technician disconnects the connector <NUM> from the waste outlet port <NUM>. The connector <NUM> may then be connected to the patient through a catheter, vascular access device, needle, or additional fluid path set to facilitate fluid delivery to the patient. Once the fluid delivery is completed, the SUDS <NUM> is disconnected from the patient and the MUDS <NUM> by disengaging the locking tab <NUM> of the SUDS <NUM> from the receiving slot <NUM> on the MUDS <NUM>. The medical technician may then dispose of the SUDS <NUM>. In certain aspects, removing the SUDS <NUM> from the MUDS <NUM> causes reuse prevention features (not shown) to activate, thereby preventing reinsertion and reuse of the SUDS <NUM>.

With reference to <FIG>, a connection interface between the SUDS <NUM> and the MUDS <NUM> is shown in accordance with another aspect. The MUDS <NUM> has a connection port <NUM> that may be configured as a hollow, tubular structure having a luer lock connector <NUM> (either a male luer lock connector or a female luer lock connector depending on the desired application), extending from a distal end of the port <NUM> into an interior of the port <NUM>. Accordingly, the proximal opening of the luer lock connector <NUM> is recessed within the interior of the port <NUM>. The luer lock connector <NUM> may include screw threads <NUM> (shown in <FIG>) for securing the MUDS <NUM> to the SUDS <NUM>. For example, the screw threads <NUM> may be positioned on an outer shroud <NUM> surrounding the luer lock connector <NUM>, as shown in <FIG>. Screw threads <NUM> may also be positioned on the luer lock connector <NUM> itself. The luer lock connector <NUM> defines a fluid passageway <NUM> (shown in <FIG>) extending therethrough, from the proximal end of the connection port <NUM> to the distal opening thereof. While the connection port <NUM> is depicted as including a luer lock connector <NUM>, other styles of connectors, including, but not limited to, clip-in connectors, bayonet connectors, press fit connectors, and the like, may be used within the scope of the present disclosure. Additionally, in certain aspects, the connector <NUM> for the connection port <NUM> is desirably a non-standard connector (e.g. a connector with an unusual size or shape) so that connectors produced by third parties cannot be attached.

The MUDS <NUM> has a waste inlet port <NUM> (shown in <FIG>) that may also be configured as a hollow, tubular structure. The waste inlet port <NUM> includes a tapered distal nozzle <NUM> attached to a fluid conduit, such as flexible tubing that connects the waste inlet port <NUM> to the waste reservoir <NUM> (shown in <FIG>).

With reference again to <FIG>, as described in detail herein, the MUDS <NUM> is adapted for connecting to the SUDS <NUM>, which is disposed of after a single use. It is noted that the SUDS <NUM> is shown in <FIG> in a state after removal from packaging (not shown). Prior to use, the SUDS <NUM> is desirably packaged in a pre-sterilized, sealed package that protects the SUDS <NUM> from contamination with air or surface-borne contaminants.

The SUDS <NUM> may have two or more ports, corresponding to the connection port <NUM> and waste inlet port <NUM> of the MUDS <NUM>. For convenience, the ports of the SUDS <NUM> are equivalent to the fluid inlet port <NUM> and the waste outlet port <NUM> of the SUDS <NUM> described with reference to <FIG>. The ports <NUM>, <NUM> may be provided in an enclosure <NUM> suitable for receipt within the housing <NUM> of the MUDS <NUM>, as shown in <FIG>. The enclosure <NUM> desirably has an asymmetrical structure, so that the user can only attach the SUDS <NUM> to the MUDS <NUM> in one orientation only. Thus, for example, the user is prevented from attaching the connection port <NUM> of the MUDS <NUM> to the SUDS <NUM> waste outlet port <NUM>. The ports <NUM>, <NUM> and enclosure <NUM> of the SUDS <NUM> may be made from a material suitable for medical applications, such as medical grade plastic. The tubing <NUM> of the SUDS <NUM> is connected between the proximal end of the fluid inlet port <NUM> and the end of the waste outlet port <NUM> through check valves. The tubing <NUM> may be provided in a wound or coiled configuration for easy packaging and maneuverability.

With reference to <FIG>, the SUDS <NUM> fluid inlet port <NUM> is a hollow, tubular structure configured for insertion in the connection port <NUM> of the MUDS <NUM>. The SUDS <NUM> fluid inlet port <NUM> includes a tubular conduit, such as a luer lock connector <NUM>, defining a fluid passageway <NUM> extending from a proximal end of the port <NUM>, located adjacent to the MUDS <NUM>, and the distal end of the port <NUM>, connected to the tubing <NUM>. The luer lock connector <NUM> is adapted to connect to the luer lock connector <NUM> of the MUDS <NUM>. When securely connected, the connection port <NUM> of the MUDS <NUM> is in fluid communication with the fluid inlet port <NUM> of the SUDS <NUM>. The luer lock connector <NUM> may include a thumbwheel <NUM> for securing the connection port <NUM> of the MUDS <NUM> to the SUDS <NUM> fluid inlet port <NUM>. The thumbwheel <NUM> may be integrally formed with the luer lock connector <NUM> or may be a separate structure fixedly connected to the luer lock connector <NUM> by conventional means. The thumbwheel <NUM> rotates the luer lock connector <NUM> causing tabs <NUM>, extending therefrom, to engage the corresponding screw threads <NUM> in the connection port <NUM>. The tubing <NUM> is connected to the fluid inlet port <NUM> through an opening <NUM> on the thumbwheel <NUM>, such that a continuous fluid connection is established from the MUDS <NUM> to the tubing <NUM>.

With continued reference to <FIG>, the SUDS <NUM> also includes the SUDS <NUM> waste outlet port <NUM>. The SUDS waste outlet port <NUM> has a fluid passageway <NUM>, defined by a tubular conduit <NUM>, extending between the waste inlet port <NUM> of the MUDS <NUM>, and the tubing <NUM>. The tubing <NUM> may not be directly connected to the waste inlet port <NUM> of the MUDS <NUM>. Instead, the tubular conduit <NUM> of the SUDS <NUM> may separate the tubing <NUM> from the MUDS <NUM>, thereby ensuring that the tubing <NUM> and the connector <NUM> are isolated from the waste inlet port <NUM> of the MUDS <NUM>. The tubular conduit <NUM> may be recessed from the waste inlet port <NUM> of the MUDS <NUM> by a portion of the single-use connector enclosure <NUM>, to reduce the likelihood of contamination. The tubular conduit <NUM> may also be angled, relative to the horizontal, to facilitate fluid flow through the SUDS <NUM> waste outlet port <NUM> and into the waste inlet port <NUM> of the MUDS <NUM>. In some aspects, the SUDS <NUM> may further include reuse prevention features (not shown). For example, the SUDS <NUM> may include breakable tabs or structures that fold or break when the SUDS <NUM> is removed from the MUDS <NUM>. In this manner, it can be assured that the SUDS <NUM> is only used for one fluid delivery procedure.

With reference to <FIG>, a method of operation of the aspect of the connection assembly between the SUDS <NUM> and MUDS <NUM> depicted in <FIG> will now be described in detail. In use, a medical technician or user removes the disposable SUDS <NUM> from its packaging and inserts the SUDS <NUM> into the corresponding MUDS <NUM>. As described above, the SUDS <NUM> must be inserted in the correct orientation, such that the connection port <NUM> of the MUDS <NUM> engages the SUDS <NUM> fluid inlet port <NUM>, and the waste inlet port <NUM> of the MUDS <NUM> engages the SUDS <NUM> waste outlet port <NUM>. As shown in <FIG>, the medical technician then rotates the thumbwheel <NUM> to secure the SUDS <NUM> to the MUDS <NUM>. Once the SUDS <NUM> is securely connected to the MUDS <NUM>, the fluid injector system <NUM> (shown in <FIG> and <FIG>) draws fluid into one or more of the plurality of syringes <NUM> of the MUDS <NUM> and performs an automatic priming operation (<FIG>) for removing air from the MUDS <NUM> and the SUDS <NUM>. During such priming operation, fluid from the MUDS <NUM> is injected through the connection port <NUM> and into the tubing <NUM> of the SUDS <NUM>. The fluid flows through the tubing <NUM> and through the waste outlet port <NUM> and into the waste reservoir <NUM>. Once the automatic priming operation is completed, the medical technician disconnects the connector <NUM> from the waste outlet port <NUM> (<FIG>). The connector <NUM> may then be connected to the patient through a catheter, vascular access device, or additional fluid path set to facilitate fluid delivery to the patient (<FIG>). Once the fluid delivery is completed, the user the connector <NUM> from the patient and rotates the thumbwheel <NUM> to remove the SUDS <NUM> from the MUDS <NUM> (<FIG>). The medical technician may then dispose of the SUDS <NUM>. In certain aspects, removing the SUDS <NUM> from the MUDS <NUM> causes reuse prevention features (not shown), such as tabs extending from a portion of the SUDS <NUM>, to fold or break, preventing reinsertion of the SUDS <NUM>.

With reference to <FIG>, a further aspect of a connector assembly having a SUDS <NUM> and a MUDS <NUM> is illustrated. In this aspect of the assembly, the SUDS <NUM> includes a cannula port <NUM> for receiving a needle cannula <NUM> connected to a connector <NUM>. The cannula <NUM>, used for fluid delivery to a patient, can be inserted into the cannula port <NUM> after being removed from the patient. The cannula port <NUM> may cover a contaminated end of the cannula <NUM> during disposal of the cannula <NUM>. In this aspect, the single-use enclosure <NUM> is desirably long enough so that the entire length of the needle cannula <NUM> may be inserted in the enclosure <NUM> for a safe disposal.

With reference to <FIG> and <FIG>, a further aspect of a connector assembly having a SUDS <NUM> and a MUDS <NUM> is illustrated. The connector assembly is provided in a vertical orientation with the connection port <NUM> of the MUDS <NUM> positioned above the waste inlet port <NUM>. The MUDS <NUM> includes a drip channel <NUM> extending between the connection port <NUM> and waste inlet port <NUM>. Any fluid leaking from the connection port <NUM> is directed downward through the drip channel <NUM> by gravity. The drip channel <NUM> exits into the waste inlet port <NUM>. Accordingly, any fluid expelled from the drip channel <NUM> is directed through the waste inlet port <NUM> and is collected in the waste reservoir <NUM>. Alternatively, the MUDS <NUM> may be provided with an absorbent material, such as an absorbent pad <NUM> shown in <FIG>, surrounding a portion of the connection port <NUM> and the waste inlet port <NUM>. The absorbent material is provided to absorb any fluid drips during removal of the SUDS <NUM> for improved drip management.

With reference to <FIG>, a further aspect of the connector assembly having a SUDS <NUM> and a MUDS <NUM> having a plurality of press-fit connectors is illustrated. As shown in <FIG>, the SUDS <NUM> includes a fluid inlet port <NUM> and waste outlet port <NUM>. The SUDS <NUM> includes disconnection tabs <NUM>, rather than a thumbwheel. The SUDS <NUM> also includes an alignment structure <NUM> extending from the enclosure <NUM> of the SUDS <NUM> and is configured for insertion in a corresponding slot <NUM> of the MUDS <NUM> (shown in <FIG>).

As shown in the cross-sectional view depicted in <FIG>, the SUDS <NUM> is inserted into and aligned with the MUDS <NUM> by alignment channels <NUM>. The disconnection tabs <NUM> are integrally formed with a tubular shroud <NUM> having an inwardly extending flange <NUM> at one end thereof. The shroud <NUM> surrounds a tubular conduit <NUM> on the SUDS <NUM>. When the SUDS <NUM> is inserted into the MUDS <NUM>, the flange <NUM> forms an interference engagement with a corresponding ridge <NUM> extending from a portion of the connection port <NUM> of the MUDS <NUM>. The interference engagement creates a substantially fluid-tight connection between the MUDS <NUM> and the SUDS <NUM>. Pressing the disconnection tabs <NUM> of the SUDS <NUM> disengages the flange <NUM> from the ridge <NUM> to allow a user to remove the SUDS <NUM> from the MUDS <NUM>. With reference to <FIG>, the connection assembly, having a MUDS <NUM> and SUDS <NUM> with disconnection tabs <NUM> described above, may also be provided in a vertical configuration.

With reference to <FIG>, a further aspect of the connector assembly having a SUDS <NUM> and a MUDS <NUM> is illustrated. The MUDS <NUM> includes the connection port <NUM> and waste inlet port <NUM>, as described in previous aspects. The connection port <NUM> includes a co-molded sealing surface <NUM> for enhancing the connection between the SUDS <NUM> and the MUDS <NUM>. The SUDS <NUM> includes external alignment surfaces <NUM>, integrally formed with the enclosure <NUM>, for correctly aligning the SUDS <NUM> and the MUDS <NUM>. The alignment surfaces <NUM> also recess the fluid inlet port <NUM> and the waste outlet port <NUM> of the SUDS <NUM> to reduce the possibility of contamination prior to use.

With reference to <FIG>, various aspects of the tubing <NUM> are illustrated. For example, the tubing <NUM> may be wound about a holding structure <NUM>, such as a spool or frame member, for ensuring that the tubing <NUM> does not unwind while being removed from its packaging or when the SUDS <NUM> is being connected to the MUDS <NUM>. With reference to <FIG>, the tubing <NUM> may further include a removable external clip <NUM>. The clip <NUM> connects about the wound tubing <NUM> to prevent the tubing <NUM> from unwinding during removal from packaging or auto-priming. With reference to <FIG>, in a further aspect, the tubing <NUM> is provided with uncoiled portions <NUM> to keep the tubing <NUM> away from the SUDS <NUM>. A coiled portion <NUM> of the tubing <NUM> hangs below the un-coiled portions <NUM>, when the SUDS <NUM> is connected to the MUDS <NUM>.

With reference to <FIG>, an electronic control device <NUM> may be associated with fluid injector system <NUM> to control the filling and delivery operations. In some aspects, the electronic control device <NUM> may control the operation of various valves, piston members, and other elements to effect a desired filling or delivery procedure. For example, the electronic control device <NUM> may include a variety of discrete computer-readable media components. For example, this computer-readable media may include any media that can be accessed by the electronic control device <NUM>, such as volatile media, non-volatile media, removable media, non-removable media, transitory media, non-transitory media, etc. As a further example, this computer-readable media may include computer storage media, such as media implemented in any method or technology for storage of information, such as computer-readable instructions, data structures, program modules, or other data; random access memory (RAM), read only memory (ROM), electrically erasable programmable read only memory (EEPROM), flash memory, or other memory technology; CD-ROM, digital versatile disks (DVDs), or other optical disk storage; magnetic cassettes, magnetic tape, magnetic disk storage, or other magnetic storage devices; or any other medium which can be used to store the desired information and which can be accessed by the electronic control device <NUM>. Further, this computer-readable media may include communications media, such as computer-readable instructions, data structures, program modules, or other data in a modulated data signal, such as a carrier wave or other transport mechanism and include any information delivery media, wired media (such as a wired network and a direct-wired connection), and wireless media (such as acoustic signals, radio frequency signals, optical signals, infrared signals, biometric signals, bar code signals, etc.). Of course, combinations of any of the above should also be included within the scope of computer-readable media.

The electronic control device <NUM> further includes a system memory <NUM> with computer storage media in the form of volatile and non-volatile memory, such as ROM and RAM. A basic input/output system (BIOS) with appropriate computer-based routines assists in transferring information between components within the electronic control device <NUM> and is normally stored in ROM. The RAM portion of the system memory <NUM> typically contains data and program modules that are immediately accessible to or presently being operated on by the processing unit <NUM>, e.g., an operating system, application programming interfaces, application programs, program modules, program data, and other instruction-based computer-readable codes.

With continued reference to <FIG>, the electronic control device <NUM> may also include other removable or non-removable, volatile or non-volatile, transitory or non-transitory computer storage media products. For example, the electronic control device <NUM> may include a non-removable memory interface <NUM> that communicates with and controls a hard disk drive <NUM>, e.g., a non-removable, non-volatile magnetic medium; and a removable, non-volatile memory interface <NUM> that communicates with and controls a magnetic disk drive unit <NUM> (which reads from and writes to a removable, non-volatile magnetic disk <NUM>), an optical disk drive unit <NUM> (which reads from and writes to a removable, non-volatile optical disk <NUM>, such as a CD ROM), a Universal Serial Bus (USB) port <NUM> for use in connection with a removable memory card, etc. However, it is envisioned that other removable or non-removable, volatile or non-volatile computer storage media can be used in the exemplary computing system environment <NUM>, including, but not limited to, magnetic tape cassettes, DVDs, digital video tape, solid state RAM, solid state ROM, etc. These various removable or non-removable, volatile or non-volatile magnetic media are in communication with the processing unit <NUM> and other components of the electronic control device <NUM> via the system bus <NUM>. The drives and their associated computer storage media, discussed above and illustrated in <FIG>, provide storage of operating systems, computer-readable instructions, application programs, data structures, program modules, program data, and other instruction-based, computer-readable code for the electronic control device <NUM> (whether duplicative or not of this information and data in the system memory <NUM>).

A user may enter commands, information, and data into the electronic control device <NUM> through certain attachable or operable input devices, such as the user interface <NUM> shown in <FIG>, via a user input interface <NUM>. Of course, a variety of such input devices may be utilized, e.g., a microphone, a trackball, a joystick, a touchpad, a touch-screen, a scanner, etc., including any arrangement that facilitates the input of data, and information to the electronic control device <NUM> from an outside source. As discussed, these and other input devices are often connected to the processing unit <NUM> through the user input interface <NUM> coupled to the system bus <NUM>, but may be connected by other interface and bus structures, such as a parallel port, game port, or a USB. Still further, data and information can be presented or provided to a user in an intelligible form or format through certain output devices, such as a monitor <NUM> (to visually display this information and data in electronic form), a printer <NUM> (to physically display this information and data in print form), a speaker <NUM> (to audibly present this information and data in audible form), etc. All of these devices are in communication with the electronic control device <NUM> through an output interface <NUM> coupled to the system bus <NUM>. It is envisioned that any such peripheral output devices be used to provide information and data to the user.

The electronic control device <NUM> may operate in a network environment <NUM> through the use of a communications device <NUM>, which is integral to the electronic control device <NUM> or remote therefrom. This communications device <NUM> is operable by and in communication with the other components of the electronic control device <NUM> through a communications interface <NUM>. Using such an arrangement, the electronic control device <NUM> may connect with or otherwise communicate with one or more remote computers, such as a remote computer <NUM>, which may be a personal computer, a server, a router, a network personal computer, a peer device, or other common network nodes, and typically includes many or all of the components described above in connection with the electronic control device <NUM>. Using appropriate communication devices <NUM>, e.g., a modem, a network interface or adapter, etc., the computer <NUM> may operate within and communicate through a local area network (LAN) and a wide area network (WAN), but may also include other networks such as a virtual private network (VPN), an office network, an enterprise network, an intranet, the Internet, etc..

As used herein, the electronic control device <NUM> includes, or is operable to execute appropriate custom-designed or conventional software to perform and implement the processing steps of the method and system of the present disclosure, thereby forming a specialized and particular computing system. Accordingly, the presently-disclosed method and system may include one or more electronic control devices <NUM> or similar computing devices having a computer-readable storage medium capable of storing computer-readable program code or instructions that cause the processing unit <NUM> to execute, configure, or otherwise implement the methods, processes, and transformational data manipulations discussed hereinafter in connection with the present disclosure. Still further, the electronic control device <NUM> may be in the form of a personal computer, a personal digital assistant, a portable computer, a laptop, a palmtop, a mobile device, a mobile telephone, a server, or any other type of computing device having the necessary processing hardware to appropriately process data to effectively implement the presently-disclosed computer-implemented method and system.

It will be apparent to one skilled in the relevant arts that the system may utilize databases physically located on one or more computers which may or may not be the same as their respective servers. For example, programming software on electronic control device <NUM> can control a database physically stored on a separate processor of the network or otherwise.

In some aspects, the electronic control device <NUM> may be programmed so that automatic refill occurs based upon a preprogrammed trigger minimum volume in the respective syringes <NUM>. For example, when the volume of fluid remaining in at least one of the syringes <NUM> is less than a programmed volume, a syringe refill procedure is automatically initiated by the electronic control device <NUM>. The electronic control device <NUM> associated with the fluid injector system <NUM> may determine that the preprogrammed trigger minimum volume has been reached by tracking the fluid volume dispensed from the respective syringes <NUM> during operation of the fluid injector system <NUM>. Alternatively, fluid level sensors may be incorporated into the fluid injector system <NUM> and inputs from these fluid level sensors may be provided to the electronic control device <NUM> so that the electronic control device <NUM> may determine when the preprogrammed trigger minimum volume has been reached in at least one of the syringes <NUM>. The fill volume and rate of refill can be preprogrammed in the electronic control device <NUM>. The automatic refill procedure can be stopped either automatically by the electronic control device <NUM> or may be manually interrupted. In addition, an automatic refill procedure may be initiated when, at the completion of a fluid injection procedure, there is not enough fluid in at least one of the syringes <NUM> to perform the next programmed fluid injection procedure.

Claim 1:
A multi-use disposable set (MUDS) (<NUM>) comprising:
at least one syringe (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>) spaced apart from the proximal end (<NUM>) along a longitudinal axis, and a plunger (<NUM>) reciprocally movable within a syringe interior (<NUM>) between the proximal end (<NUM>) and the distal end (<NUM>);
a manifold (<NUM>) in fluid communication with the distal end (<NUM>) of the at least one syringe (<NUM>);
at least one valve (<NUM>) at a distal end of the at least one syringe (<NUM>) and in fluid communication with the syringe interior (<NUM>), wherein the at least one valve is operable between a filling position for filling the syringe interior (<NUM>) with fluid and a delivery position for delivering the fluid from the syringe interior (<NUM>);
at least one connection port (<NUM>) in fluid communication with the manifold (<NUM>) and the syringe interior (<NUM>) when the at least one valve (<NUM>) is in the delivery position,
characterized in that said at least one valve (<NUM>) is adapted for connection to a coupling mechanism (<NUM>) of a fluid injector (<NUM>), said coupling mechanism (<NUM>) having a rotatable coupling (<NUM>) having a blade (<NUM>) for coupling between the coupling mechanism (<NUM>) and said at least one valve (<NUM>), wherein the at least one valve (<NUM>) comprises a valve head (<NUM>) with a slot (<NUM>) recessed into the valve head (<NUM>), wherein the slot (<NUM>) has a lip (<NUM>) on one end of the slot (<NUM>) which limits an orientation of the blade (<NUM>) of the coupling mechanism (<NUM>) of the fluid injector system (<NUM>) to a single self-aligned orientation.