Patent ID: 12201802

DETAILED DESCRIPTION

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 system100(hereinafter “fluid injector system100”) having a MUDS130(shown inFIG.1B) configured for delivering fluid to a patient using a SUDS190(shown inFIG.8A). The fluid injector system100includes multiple components as individually described herein. Generally, the fluid injector system100has 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 system100and the fluid delivery set associated therewith are likewise described in detail herein.

With reference toFIG.1A, the fluid injector system100includes an injector housing102having opposed lateral sides104, a distal or upper end106, and a proximal or lower end108. In some aspects, the housing102may be supported on a base110having one or more wheels112for rotatable and movable support of the housing102on a floor surface. The one or more wheels112may be lockable to prevent the housing102from inadvertently moving once positioned at a desired location. At least one handle114may be provided to facilitate moving and positioning the fluid injector system100. In other aspects, the housing102may be removably or non-removably secured to a fixed surface, such as a floor, ceiling, wall, or other structure. The housing102encloses 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 elements103(shown inFIG.2) associated with the fluid injector system100described herein. Such piston elements103may 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 base110.

With reference toFIG.1B, and with continued reference toFIG.1A, the fluid injector system100has at least one door116that encloses at least some of the mechanical drive components, electrical and power components, and control components. The door116is desirably movable between an open position (shown inFIG.1B) and a closed position (shown inFIG.1A). In some aspects, the door116may be lockable.

The fluid injector system100further includes at least one bulk fluid connector118for connection with at least one bulk fluid source120. In some aspects, a plurality of bulk fluid connectors118may be provided. For example, as shown inFIGS.1A and1B, three bulk fluid connectors118may be provided in a side-by-side or other arrangement. In some aspects, the at least one bulk fluid connector118may be a spike configured for removably connecting to the at least one bulk fluid source120, such as a vial, a bottle, or a bag. The at least one bulk fluid connector118may have a reusable or non-reusable interface with each new bulk fluid source120. The at least one bulk fluid connector118may be formed on the multi-patient disposable set, as described herein. The at least one bulk fluid source120may be configured for receiving a medical fluid, such as saline, contrast solution, or other medical fluid, for delivery to the fluid injector system100. The housing102may have at least one support member122for supporting the at least one bulk fluid source120once it is connected to the fluid injector system100.

With reference toFIG.1A, the fluid injector system100includes one or more user interfaces124, such as a graphical user interface (GUI) display window. The user interface124may display information pertinent to a fluid injection procedure involving fluid injector system100, such as current flow rate, fluid pressure, and volume remaining in the at least one bulk fluid source120connected to the fluid injector system100and may be a touch screen GUI that allows an operator to input commands and/or data for operation of fluid injector system100. While the user interface124is shown on the injector housing102, such user interface124may also be in the form of a remote display that is wired or wirelessly linked to the housing102and control and mechanical elements of fluid injector system100. In some aspects, the user interface124may be a tablet computer that is detachably connected to the housing102and is in wired or wirelessly linked communication with the housing102. Additionally, the fluid injector system100and/or user interface124may include at least one control button126for tactile operation by an attendant operator of the fluid injector system100. 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 button126may be hard-wired or wirelessly connected to the electronic control device(s) associated with the fluid injector system100to provide direct input to the electronic control device(s). The at least one control button126may also be graphically part of the user interface124, such as a touch screen. In either arrangement, the at least one control button126desirably provides certain individual control features to the attendant operator of the fluid injector system100, such as but not limited to: (1) acknowledging that a multi-patient disposable set has been loaded or unloaded; (2) locking/unlocking of the multi-patient disposable set; (3) filling/purging of the fluid injector system100; (4) inputting information and/or data related to the patient and/or injection procedure, and (5) initiating/stopping an injection procedure. The user interface124and/or any electronic processing units associated with the fluid injector system100may be wired or wirelessly connected to an operation and/or data storage system such as a hospital network system.

With reference toFIG.1B, the fluid injector system includes a MUDS130that is removably connected to the fluid injector system100for delivering one or more fluids from the one or more bulk fluid sources120to the patient. The fluid injector system100includes at least one slot or access port128for releasably connecting a SUDS to the MUDS130, as described herein. The MUDS130may include one or more syringes or pumps132. In some aspects, the number of syringes132may correspond to the number of bulk fluid sources120. For example, with reference toFIG.1B, the MUDS130has three syringes132in a side-by-side arrangement such that each syringe132is fluidly connectable to one of the bulk fluid sources120. Each syringe132may be fluidly connectable to one of the bulk fluid sources120by a corresponding bulk fluid connector118and an associated MUDS fluid path134. The MUDS fluid path134may be formed as a flexible tube with a spike element at its terminal end that connects to the bulk fluid connector118. In some aspects, the bulk fluid connector118may be provided directly on the MUDS130.

With reference toFIGS.2-3A, the MUDS130is removably connectable to the housing102of the fluid injector system100. The MUDS130may include a frame154for supporting the one or more syringes132. The syringes132may be removably or non-removably connected to the frame154. In certain aspects, the at least one syringe132may be co-molded with the frame154or alternatively, adhered or welded to frame154. With reference toFIG.3B, each syringe132has an elongated, substantially cylindrical syringe body138having a front or distal end140and a rear or proximal end142. A syringe plunger144is disposed within the syringe body138and is reciprocally movable within the syringe body138due to movement of a piston element associated with the fluid injector system100. The distal end140of the syringe body138is generally conical-shaped and tapers to an apex or cone point145which is adapted to interface with a corresponding apex curve formed in the recess defined in the fluid injector system100, as described herein. The syringe apex or cone point145is located along a central longitudinal axis L of the syringe body138.

With continued reference toFIG.3B, each syringe132may have a filling port147in fluid communication with the MUDS fluid path134for filling a syringe interior139with fluid from a bulk fluid source120(shown inFIG.2). Each syringe132may further have discharge outlet or conduit146at the terminal end of the apex or cone point145. The discharge outlet146of each syringe132is in fluid communication with a manifold148. In some aspects, the manifold148may fluidly connect a plurality of syringes132. In certain aspects, the manifold148may also provide support for the syringes132such that the syringes132can be handled as a single, unitary structure. In some aspects, the manifold148supports the distal end140of each syringe132while the frame154supports the proximal end142of each syringe132. In some aspects, the at least a portion of the manifold148may be monolithically formed with at least one syringe132. In other aspects, the manifold148may be formed separately from the plurality of syringes132and include a plurality of conduits148acorresponding to each of the plurality of syringes132, wherein the individual conduits148amay be attached or adhered to the individual outlet ports146of each of the plurality of syringes132, for example by an appropriate adhesive or welding. The syringes132may be arranged in a side-by-side orientation, or any other orientation that retains the relative positioning of the syringes132.

With reference toFIGS.10A-10C, the MUDS130is illustrated in accordance with another aspect. The MUDS130may include a plurality of syringes132in a side-by-side, or other arrangement, with each syringe132being fluidly connectable to one of the bulk fluid sources120(shown inFIG.2). Each syringe132may be in fluid communication with the manifold148. The manifold148may include a plate-like structure that extends between the discharge outlets146of the syringes132such that the manifold148monolithically connects the syringes132. The manifold148may have a fluid pathway149that is in fluid communication with each syringe132. The fluid pathway149may be in fluid communication with one or more fluid outlet lines152(shown inFIG.2). A first portion148aof the manifold148may be monolithically formed with each syringe132, such as by molding, adhesive means, or welding, while a second portion148b(shown inFIG.11) may be permanently or non-permanently connected to the first portion148a. In some aspects, the first portion148aof the manifold148may be connected to the second portion148bby welding, adhesive, one or more fasteners, or any other connection means. The combination of the first portion148aand the second portion148bmay create a fluid path within the manifold that fluidly connects the discharge ports146of each of the plurality of syringes132and the one or more fluid outlet lines152. At least one of the first portion148aand the second portion148bmay have a channel151extending around a circumference of the manifold148surrounding the discharge outlets146. The channel151may be configured for receiving a gasket153(shown inFIG.11) for sealing the interface between the first portion148aand the second portion148b. With reference toFIGS.10B-10C, a valve receiving cavity155may be provided at the terminal end of the apex or cone point145of each syringe132. The valve receiving cavity155may extend into the syringe interior139in a direction aligned with a longitudinal axis L of each syringe132(shown inFIG.10C). In some aspects, the valve receiving cavity155is in fluid communication with the syringe interior139, the filling port147and the discharge outlet146. The valve receiving cavity155is configured for receiving a valve136(shown inFIG.11). As described herein, at least a portion of the valve136may be rotatable about the longitudinal axis L and within the valve receiving cavity155. The valve136may be operable between a filling position for filling the syringe interior139with fluid and a delivery position for delivering the fluid from the syringe interior139. In some aspects, the valve136may be rotatable between a first position, where the filling port147is in fluid communication with the syringe interior139while the discharge outlet146is in fluid isolation from the syringe interior139, and a second position, where the discharge outlet146is in fluid communication with the syringe interior139while the filling port147is in fluid isolation from the syringe interior139. The valve136may have a third position where the interior of the syringe139is isolated from both the filling port147and the discharge outlet146. In the first position, the valve136may be configured for filling the syringe interior139with fluid from a bulk fluid source120through the MUDS fluid path134while preventing fluid from being delivered to the manifold148. In the second position, the valve136may be configured for delivering fluid from the syringe interior139to the manifold148through the discharge outlet146while preventing fluid from being delivered through the filling port147. The valve136may also be configured for preventing fluid flow through the filling port147and the discharge outlet146such that fluid cannot be delivered into or from the syringe interior139. In some aspects, the valve136may be rotatable to partially open or partially closed the discharge outlet146and/or the filling port147. In various aspects, the valves136on each syringe132may be controlled independently of each other, for example, such that various medical fluids can be delivered into one or more syringes132and/or, simultaneously or sequentially, be delivered out of one or more other syringes132. The valves136of the plurality of syringes132may be controlled, for example, through the electronic control device(s) associated with the fluid injector system100

With reference toFIG.10D, the MUDS130is illustrated in accordance with another aspect. The MUDS130may include a plurality of syringes132in a side-by-side, or other arrangement, with each syringe132being fluidly connectable to one of the bulk fluid sources120(shown inFIG.2). The MUDS130may include a frame154for supporting the one or more syringes132. The syringes132may be removably or non-removably connected to the frame154. In some aspects, each syringe may be fluidly connectable to one of the bulk fluid sources120by way of the bulk fluid connector118and the MUDS fluid path134. The apex or cone point145of each syringe132may have a discharge outlet146, a filling port147, and a valve receiving cavity155. The valve receiving cavity155may extend into the syringe interior in a direction substantially parallel with a longitudinal axis L of each syringe132(see e.g.,FIG.11). The discharge outlet146and the filling port147may extend toward the syringe interior in a direction substantially perpendicular to the longitudinal axis L of each syringe132. The discharge outlet146and the filling port147may be arranged opposite to one another around an outer circumference of the apex or cone point145. In some aspects, the valve receiving cavity155is in fluid communication with the syringe interior, the filling port147and the discharge outlet146.

With continued reference toFIG.10D, the discharge outlet146of each syringe132may be connected to a manifold148. Each syringe132may be formed separately and be independently connectable to the manifold148. The manifold148may be a tubular structure having a one or more conduits148afor connecting to the discharge outlets146of the syringes132. In some aspects, the conduits148amay be removably or non-removably connected to the discharge outlets146. For example, each conduit148amay be adhesively connected, laser or ultrasonic vibration welded, or permanently and non-removably fastened by one or more mechanical fasteners to the respective discharge outlet146. Alternatively, each conduit148amay be removably connected to the respective discharge outlet146, such as, for example, an interference fit, one or more clips, or other mechanical connection means. The manifold148may have a main fluid channel148bthat is in fluid communication with each syringe132through the respective conduit148a. In some aspects, the one or more conduits148aare monolithically formed with the main fluid channel148b. One end of the main fluid channel148bmay be in fluid communication with one or more fluid outlet lines152to deliver fluid from the syringes132to the patient, as described herein.

The valve receiving cavity155is configured for receiving the valve136. As described herein, at least a portion of the valve136may be rotatable about the longitudinal axis L and within the valve receiving cavity155. The valve136may 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 valve136may be rotatable between a first position, where the filling port147is in fluid communication with the syringe interior while the discharge outlet146is in fluid isolation from the syringe interior, and a second position, where the discharge outlet146is in fluid communication with the syringe interior while the filling port147is in fluid isolation from the syringe interior. In the first position, the valve136may be configured for filling the syringe interior with fluid from a bulk fluid source120through the MUDS fluid path134while preventing fluid from being delivered to the manifold148. In the second position, the valve136may be configured for delivering fluid from the syringe interior to the manifold148through the discharge outlet146while preventing fluid from being delivered through the filling port147. The valve136may also be configured for preventing fluid flow through the filling port147and the discharge outlet146such that fluid cannot be delivered into or from the syringe interior. In some aspects, the valve136may be rotatable to partially open or partially close the discharge outlet146and/or the filling port147. In various aspects, the valves136on each syringe132may be controlled independently of each other such that fluid can be delivered into one or more syringes132while, simultaneously or sequentially, being delivered out of one or more other syringes132.

With further reference toFIG.2, the MUDS130is removably connectable to the housing102of the fluid injector system100. As will be appreciated by one having ordinary skill in the art, it may be desirable to construct at least a portion of the MUDS130from a clear medical grade plastic in order to facilitate visual verification that a fluid connection has been established with the fluid injector system100. Visual verification is also desirable for confirming that no air bubbles are present within various fluid connections. Alternatively, at least a portion of the MUDS130and/or door116may 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 toFIG.2, a schematic view of various fluid paths of the fluid injector system100is provided. The MUDS130may include one or more valves136, such as stopcock valves, for controlling which medical fluid or combinations of medical fluids are withdrawn from the multi-dose bulk fluid source120and/or are delivered to a patient through each syringe132. In some aspects, the one or more valves136may be provided on the distal end140of the plurality of syringes132or on the manifold148. The manifold148may be in fluid communication via valves136and/or syringes132with a first end of the MUDS fluid path134that connects each syringe132to the corresponding bulk fluid source120. The opposing second end of the MUDS fluid path134may be connected to the respective bulk fluid connector118that is configured for fluidly connecting with the bulk fluid source120. Depending on the position of the one or more valves136, fluid may be drawn into the one or more syringes132, or it may be delivered from the one or more syringes132. In a first position, such as during the filling of the syringes132, the one or more valves136are oriented such that fluid flows from the bulk fluid source120into the desired syringe132through the MUDS fluid path134. During the filling procedure, the one or more valves136are positioned such that fluid flow through one or more fluid outlet lines152or manifold148is blocked. In a second position, such as during a fluid delivery procedure, fluid from one or more syringes132is delivered to the manifold148through the one or more fluid outlet lines152or syringe valve outlet ports. During the delivery procedure, the one or more valves136are positioned such that fluid flow through the MUDS fluid path134is blocked. The one or more valves136, the MUDS fluid path134, and/or fluid outlet lines152may be integrated into the manifold148. The one or more valves136may be selectively positioned to the first or second position by manual or automatic handling. For example, the operator may position the one or more valves136into the desired position for filling or fluid delivery. In other aspects, at least a portion of the fluid injector system100is operable for automatically positioning the one or more valves136into 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. PCT/US2012/056355 and U.S. Application Publication No. 2014/0228762, each filed Sep. 20, 2012, the disclosures of which are incorporated by this reference.

With specific reference toFIG.3B, the MUDS130further includes a frame154receiving at least a portion of the proximal end142of the at least one syringe132. In some aspects, the frame154may be shaped to receive at least a portion of the proximal end142of each syringe132. In some aspects, the fluid outlet line152may be connected to the frame154. The frame154, in some aspects, defines at least a portion of a connection port192for connecting a SUDS to the MUDS130. The frame154may have a handle for grasping the MUDS130during insertion into and removal from the fluid injector system100. In certain aspects, the connection port192, may be formed as part of or adhered/welded to the frame154to form a single MUDS unit.

With reference toFIG.2, in some aspects, the fluid outlet line152may also be connected to a waste reservoir156on the fluid injector system100. The waste reservoir156is desirably separate from the syringes132to prevent contamination. In some aspects, the waste reservoir156is configured to receive waste fluid expelled from the syringes132during, for example, a priming operation. The waste reservoir156may be removable from the housing102in order to dispose of the contents of the waste reservoir156. In other aspects, the waste reservoir156may have a draining port (not shown) for emptying the contents of the waste reservoir156without removing the waste reservoir156from the housing102. In some aspects, the waste reservoir156is provided as a separate component from the MUDS130.

With the foregoing description of the fluid injector system100and the MUDS130in mind, exemplary loading and unloading of MUDS130into a receiving space158(shown inFIG.3A) on the housing102will now be described with reference toFIGS.3A-5B. In the following discussion, it is assumed that the MUDS130may be connected to and removed from connection with the fluid injector system100for use with a single or multiple patients. Referring initially toFIG.3A, the receiving space158has a bottom plate160separated from a top plate162by a rear sidewall164. The bottom plate160has a plurality of openings166through which the piston elements103of the fluid injector system100extend to engage the respective plungers144of the MUDS130. At least one bottom guide168is formed on the bottom plate160for guiding the frame154of the MUDS130as the MUDS130is loaded into the fluid injector system100. In some aspects, the bottom guide168may be configured as a pair of walls raised relative to the bottom plate160and narrowing in an insertion direction toward the rear sidewall164. During insertion, the bottom guide168defines a guiding surface that locates the frame154of the MUDS130and guides the frame154toward the rear sidewall164of the receiving space158. In this manner, the MUDS130can be aligned into the receiving space158even when MUDS130is initially misaligned with the receiving space158.

With reference toFIG.3B, and with continued reference toFIG.3A, the top plate162is configured to receive the distal end140of the at least one syringe132. The top plate162has one or more syringe slots170(shown inFIG.3A) that are shaped to receive at least a portion of the distal end140of the syringes132. In some aspects, when the MUDS130is inserted into the receiving space158, the syringe slots170of the top plate162may be disposed between the distal end140of the at least one syringe132and the manifold148. The top plate162may be rotatable about a pivot point P1, shown inFIG.3B, or it may be movable in a vertical direction relative to the MUDS130. In a first position, such as during loading of the MUDS130into the receiving space158, the top plate162may be raised such that the apex or cone point145of the at least one syringe132clears a lower surface of the top plate162. In some aspects, the top plate162can default to the first position each time the MUDS130is removed from the receiving space158, such as by a biasing mechanism. In other aspects, the top plate162can be urged to the first position as the apex or cone point145of the at least one syringe132engages the at least one syringe slot170.

As the MUDS130engages the rear sidewall164, such as shown inFIG.4A, the MUDS130can be locked in the receiving space158by moving the top plate162to a second position. In the second position, the top plate162is lowered such that the apex or cone point145of the at least one syringe132engages the lower surface of the top plate162. In some aspects, the top plate162can be urged to the second position by a biasing mechanism (not shown). In other aspects, the top plate162can be manually moved to the second position by pivoting the top plate162in a direction of arrow A shown inFIGS.4A-4B. The top plate162can be locked relative to the MUDS130to prevent removal of the MUDS130from the receiving space158by a latch172. The latch172may be operable to prevent the top plate162from rotating about the pivot point P1. The latch172may be an over-center, spring-loaded latch that is pivotable about a pivot point P2in a direction of arrow B shown inFIG.4B. With reference toFIG.4C, when the MUDS130is locked within the receiving space158, the lower surface of the top plate162engages the apex or cone point145of the at least one syringe132. In the locked position, the longitudinal axis L of each syringe132is aligned with a center of each syringe slot170. Removal of the MUDS130from the receiving space158when the top plate162is in the locked position is prevented by the engagement of the lower surface of the top plate162with the apex or cone point145of the at least one syringe132. Once locked, the top plate162retains the syringes132from moving axially during an injection procedure.

With reference toFIGS.5A-5B, the MUDS130is removed from the receiving space158by unlocking the top plate162from the apex or cone point or conical portion145of the at least one syringe132. In the following discussion, it is assumed that the MUDS130may be removed from connection with the fluid injector system100and discarded as medical waste. In some aspects, the top plate162is unlocked by unlatching the latch172through a pivoting movement of the latch172about the pivot point P2in a direction of arrow C shown inFIG.5A. As the latch172is unlatched, the top plate162is pivoted upwards relative to the MUDS130in a direction of arrow D shown inFIG.5B. By unlocking the top plate162, the top plate162can be moved (i.e., pivoted or raised) relative to the MUDS130to allow the apex or cone point or conical portion145of the at least one syringe132to clear the syringe slot170(shown inFIG.3A) of the top plate162. The MUDS130can then be extracted in a direction opposite the insertion direction by moving the MUDS130away from the rear sidewall164(shown inFIG.3A).

With reference toFIG.6, in some aspects, the MUDS130may have one or more rotatable valves136that control fluid flow through the manifold148. The one or more valves136may be rotatable between various positions to effect fluid filling or delivery. In some aspects, a coupling mechanism174may be provided to rotate the one or more valves136and thereby control the arrangement of the MUDS130for fluid filling or delivery. The coupling mechanism174may be in the form of a rotatable coupling176that engages the at least one rotatable valve136. In some aspects, the rotatable coupling176has a blade178that is configured to engage with a slot180on the at least one rotatable valve136. The rotatable coupling176may be rotatable using a drive mechanism (not shown) provided on the fluid injector system100to rotate coupling176by up to 360 degrees until the blade178engages slot180. The coupling mechanism174may include a sensor (not shown) that senses when blade178engages slot180and instructs the coupling mechanism174to stop rotating coupling176. According to various aspects, the coupling mechanism174is capable of engaging and coupling to the valve136regardless of the initial orientation of the slot180. Thus, any rotational movement of valve136, for example during manufacture, shipping, or insertion of MUDS130, may be compensated for. Once the blade178of the rotatable coupling176engages the slot180on the at least one rotatable valve136, rotation of the rotatable coupling176causes a corresponding rotation of the rotatable valve136. In this manner, the arrangement of the one or more valves136can be switched between a position for filling the one or more syringes132(shown inFIG.3A) and a position for delivering fluid from the one or more syringes132.

With reference toFIGS.12A-12C, the valve136has a valve body250configured for being rotatably received within at least a portion of the valve receiving cavity155(shown inFIG.11). In some aspects, the valve136is configured to be received within the valve receiving cavity155in a substantially vertical orientation such that the valve136can interface with the coupling mechanism174on the injector. The valve body250has a valve stem252connected to a valve head254. The valve stem252may be shaped to be received within at least a portion of the valve receiving cavity155. The valve head254may be monolithically formed with the valve stem252, such as by molding. In some aspects, the valve head254is formed separately from the valve stem252and is removably or non-removably connected to the valve stem252. The valve stem252and the valve head254may be formed from same or different materials. In some aspects, the valve stem252is formed as a substantially cylindrical member with the valve head254monolithically formed with the valve stem252such that the valve head254extends radially outward relative to the valve stem252. In various aspects, the valve head254may be circular, square, rectangular, or shaped to have any regular or irregular geometric shape having one or more linear or curvilinear edges. The valve stem252and the valve head254may be aligned or offset relative to a longitudinal axis256of the valve136.

At least a portion of the valve136may be made from an elastomeric material to provide sealing against the sidewall of the valve receiving cavity155. In some aspects, at least a portion of the valve136may be made from biocompatible, non-pyrogenic, latex free, and/or DEHP free materials. In other aspects, the valve136may 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 valve136may be configured for various sterilization techniques, including, without limitation, electron beam sterilization, gamma sterilization, and/or ethylene oxide sterilization. In other aspects, the valve136may be configured for use over a predetermined period, such as a period of 24 hours, before the syringe132, along with the valve136must be disposed. In some aspects, the valve136may be rated for a maximum operating pressure greater than 350 psi. In other aspects, actuation torque needed to rotate the valve136may be less than 3 N-m, with a failure torque greater than 2.5 times the actuation torque. In other aspects, the valve136may be configured for rotation at 60 rpm or more. In other aspects, an internal fluid loss of the valve136may be less than 0.5% of the total requested volume. In other aspects, the valve136may have allowable leakage of less than 0.1 ml for a 200 ml syringe132.

With reference toFIG.12A, the valve head254has the slot180formed as a recess that extends into the valve head254. In some aspects, the valve head254may have a plurality of slots. The slot180may extend across at least a portion of an upper surface of the valve head254. In some aspects, the slot180may be aligned with the longitudinal axis256of the valve136such that the slot180extends in a radial direction relative to the longitudinal axis256. In other aspects, the slot180may be offset relative to the longitudinal axis256of the valve136. The slot180may have a uniform or non-uniform width along its length. The slot180may be surrounded by one or more recesses258having one or more ribs260extending between the slot180and an outer circumference262of the valve head254. The slot180may extend at a uniform or non-uniform depth into the valve head254along the length of the slot180. The slot180may have a flat bottom, or it may be angled to form a v-shape into the valve head254.

With reference toFIGS.12C, the valve stem252is desirably hollow with a sidewall264defining an outer shape of the valve stem252. The hollow valve stem252has an interior268with an open bottom end266. The valve stem252has a first side opening270extending through the sidewall264at a location offset from the bottom end266. The first side opening270is in fluid communication with the interior268of the valve stem252. The first side opening270may extend through the sidewall264in a direction that is perpendicular or oblique relative to the longitudinal axis256of the valve136. In some aspects, a plurality of first side openings270may be provided. In such aspects, the plurality of first side openings270may extend circumferentially around an outer circumference of the valve stem252and/or axially along the longitudinal axis256of the valve136.

With reference toFIG.12C, an insert272may be received within the interior268of the valve stem252. In some aspects, the insert272may be monolithically formed with the valve136, such as by co-molding the insert272with the valve136. At least a portion of the insert272may extend into the recess258formed on the valve head254to prevent rotation of the insert272relative to the valve stem252. The insert272has a hollow body with a circumferential sidewall274surrounding an interior275having an open bottom end276. At least one second side opening278extends through the sidewall274of the hollow body of the insert272. The second side opening278is aligned with the first side opening270of the valve stem252such that the first side opening270and the second side opening278are in fluid communication with each other. In this manner, the first side opening270is in fluid communication with the interior275of the insert272by way of an L-shaped fluid path.

Prior to connection with the fluid injector system100, the one or more valves136may be misaligned relative to the coupling mechanism174on the fluid injector system100. In order to align the one or more valves136for rotation with the coupling mechanism174, the rotatable coupling176is rotatable into self-alignment with the at least one valve136. As the MUDS130(shown inFIG.3A) is loaded into the receiving space158of the fluid injector system100, at least a portion of the valve136, such as a portion of its outer sidewall182(shown inFIG.7A), engages at least a portion of the rotatable coupling176. Referring toFIG.7A, the blade178of the rotatable coupling176may have an inclined surface184that is angled relative to the outer sidewall182of the valve136. Upon contact with the inclined surface184, the outer sidewall182of the valve136slides along the inclined surface184as the MUDS130is moved into the receiving space158. Valve sidewall182may include a beveled, chamfered, or rounded edge183on the distal perimeter of the valve side wall182which may facilitate engagement between the inclined surface184and the valve136. Such sliding movement causes the rotatable coupling176to move vertically in a direction of arrow E inFIG.7A. In some aspects, the rotatable coupling176may be spring-loaded, such that, when the blade178is moved in the direction of arrow E, for example when the blade178is not correctly aligned with slot180, a restoring force is stored in an elastically-resilient member188. As shown inFIG.7C, slot180may have a lip181on one end which limits the orientation of the blade178to a single orientation for insertion into slot180, for example when inclined surface184of blade178is adjacent to the lip181. When the MUDS130is fully inserted into the receiving space, the blade178of the rotatable coupling176is positioned on an upper surface186of the valve136. To align the valve136with the rotatable coupling176, the rotatable coupling176is rotated relative to the valve136until the blade178is aligned with the slot180. Once aligned, the blade178is lowered into the slot180. The rotatable coupling176may then be urged into the slot180under the restoring action of the elastically-resilient member188. The slot180may have sidewalls that narrow starting from the upper surface186to facilitate the insertion of the blade178into the slot180. Once the blade178is inserted into the slot180, the rotatable coupling176can adjust the orientation of the valve136for fluid filling or delivery, as described herein. As there is only one correct orientation between each valve136and each rotatable coupling176, an operating system of the injector can determine the orientation of each valve136and determine the correct rotation of each rotatable coupling176necessary for filling or delivering fluid from each of the plurality of syringes132of the MUDS130.

Having generally described the components of the fluid injector system100and the MUDS130, the structure and method of use of a SUDS190and its interaction with MUDS130will now be described.

With reference toFIGS.8A and8B, the fluid injector system100has a connection port192that is configured to form a releasable fluid connection with at least a portion of the SUDS190. In some aspects, the connection port192may be formed on the MUDS130. The connection port192may be shielded by at least a portion of the housing102of the fluid injector system100. For example, recessing the connection port192within the interior of the housing102may preserve the sterility of the connection port192by preventing or limiting a user or patient from touching and contaminating the portions of the connection port192that contact the fluid to be injected to the patient. In some aspects, the connection port192is recessed within an opening194formed on the housing102of the fluid injector system100, or the connection port192may have a shielding structure (not shown) that surrounds at least a portion of the connection port192. In other aspects, the connection port192may be formed directly on the housing102and connected to the MUDS130by a fluid path (not shown). As described herein, the SUDS190may be connected to the connection port192, formed on at least a portion of the MUDS130and/or the housing102. Desirably, the connection between the SUDS190and the connection port192is a releasable connection to allow the SUDS190to be selectively disconnected from the connection port192(FIG.8A) and connected to the connection port192(FIG.8B). In some aspects, the SUDS190may be disconnected from the connection port192and disposed after each fluid delivery procedure and a new SUDS190may be connected to the connection port192for a subsequent fluid delivery procedure.

With continued reference toFIGS.8A and8B, a waste inlet port196may be provided separately from the connection port192. The waste inlet port196is in fluid communication with the waste reservoir156. In some aspects, the waste reservoir156is provided separately from the SUDS190such that the fluid from the waste inlet port196can be delivered to the waste reservoir156. At least a portion of the SUDS190may be releasably connected to or associated with the waste inlet port196for introducing waste fluid into the waste reservoir156during, for example, a priming operation that expels air from the SUDS190. The waste reservoir156may have a viewing window198with indicia200, such as graduated markings, that indicate the fill level of the waste reservoir156.

With reference toFIG.9A, the SUDS190has a fluid inlet port202that is configured for releasable connection with the connection port192(shown inFIG.8A). The fluid inlet port202receives fluid delivered from the fluid injector system100. The fluid inlet port202is desirably a hollow, tubular structure, as shown inFIG.9B. The SUDS190further has a waste outlet port204that is configured for releasable connection or association with the waste inlet port196(shown inFIG.8A). The waste outlet port204receives waste fluid and delivers such waste fluid to the waste reservoir156during, for example, a priming operation of the SUDS190. The waste outlet port204is desirably a hollow, tubular structure, as shown inFIG.9B. The waste outlet port204may be connected to, inserted into, or located in the waste inlet port202so that the waste fluid may flow through the waste inlet port202and continue into waste reservoir156. The fluid inlet port202and the waste outlet port204may be spaced apart from each other by a spacer206. In some aspects, the spacer206is dimensioned to position the fluid inlet port202and the waste outlet port204for alignment with the connection port192and the waste inlet port196, respectively. It is noted that the SUDS190is shown inFIG.9Ain a state after removal from packaging (not shown). Prior to use, the SUDS190is desirably packaged in a pre-sterilized, sealed package that protects the SUDS190from contamination with air or surface-borne contaminants. Alternatively, the sealed package and SUDS190may be sterilized after packaging.

The SUDS190desirably has an asymmetrical structure, so that the user can only attach the SUDS190to the MUDS130in one orientation. In this manner, the user is prevented from attaching the fluid inlet port202to the waste inlet port196. In some aspects, a fin207may be provided on at least a portion of the SUDS190to prevent erroneous insertion of the SUDS190in the connection port192. In certain aspects, the fin207may be formed on the spacer206proximate to the waste outlet port204. In this manner, the fin207may interfere with the incorrect insertion of the SUDS190into the connection port192. Structures and shapes other than a fin207may be used to prevent erroneous insertion of the SUDS190into connection port192,

In some aspects, tubing208may be connected at its proximal end210to the fluid inlet port202. The tubing208is configured to deliver fluid received from the fluid inlet port202. The distal end212of the tubing208may have a connector214that is configured for connection with the waste outlet port204or a fluid path connected to the patient (not shown). The tubing208may be made from a flexible material, such as a medical grade plastic material, that allows the tubing208to be coiled. The connector214may 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 connector214may have a one-way valve to prevent backflow of fluid. Alternatively, a one-way valve may be located elsewhere in the SUDS190between fluid inlet port202and connector214.

With continued reference toFIG.9A, the SUDS190may have a locking tab216that is configured for selectively locking the SUDS190with the fluid injector system100depending on the engagement of the locking tab216with at least a portion of the fluid injector system100. In some aspects, the locking tab216may be a flexible tab that is deflectable between an engaged position and a disengaged position by deflecting at least a portion of the locking tab216. The locking tab216may have a pressing surface218that, when pressed, causes the locking tab216to be deflected from the engaged position to the disengaged position for insertion and removal of the SUDS190from the fluid injector system100. In some aspects, the locking tab216may be configured for releasable locking engagement with a receiving slot217on the MUDS130(shown inFIG.9C).

With reference toFIG.9B, the SUDS190may have a first annular skirt224extending circumferentially around a proximal end226of the fluid inlet port202and a second annular skirt220extending circumferentially around a distal end222of the fluid inlet port202. The first and second annular skirts224,220surround the fluid inlet port202to prevent inadvertent contact and contamination. The first annular skirt224may have one or more recesses228(shown inFIG.9A) extending through a sidewall thereof. The one or more recesses228may provide a locking interface with a corresponding locking element (not shown) on the fluid injector system100. The second annular skirt220may have at least one indentation230(shown inFIG.9A) to facilitate grasping and handling of the SUDS190. In some aspects, the second annular skirt220may have a textured surface having one or more ribs232(shown inFIG.9A) to facilitate gripping and handling of the SUDS190.

With continued reference toFIG.9B, at least one annular seal234may be provided around the proximal end226of the fluid inlet port202. The at least one annular seal234may seal the fluid inlet port202to prevent fluid from leaking through the SUDS190. The at least one annular seal234may provide a fluid seal between the SUDS190and the MUDS130when they are fluidly connected with one another to allow fluid to flow from the MUDS130to the SUDS190without leaking. A one-way valve236may be provided within a lumen of the fluid inlet port202to prevent fluid from flowing in a reverse direction from the SUDS190into the MUDS130.

With reference toFIG.9C, the SUDS190shown inFIG.9Ais shown connected to the fluid injector system100. WhileFIG.9Cillustrates the connection port192formed on the MUDS130, in other aspects, the connection port192may be formed on a portion of the housing102(shown inFIG.1). The fluid inlet port202of the SUDS190is connected to the connection port192to establish a fluid path in a direction of arrow F shown inFIG.9C. Fluid passing through the fluid inlet port202flows through the one-way valve236and into tubing208. Any fluid that may drip from the interface between the fluid inlet port202and the connection port192is collected in the waste reservoir156. The waste reservoir156may be shaped to collect any fluid that may drip from the SUDS190when it is removed from the MUDS130. Additionally, when the SUDS190is connected to the connection port192, the outlet of the waste outlet port204is positioned within the waste inlet port196such that waste fluid from the tubing208may be discharged into the waste reservoir156. The spacer206may define an insertion stop surface to define the depth of insertion of the SUDS190into the connection port192.

FIGS.13-24illustrate various connection configurations between the terminal end of the apex or cone point or distal conical end145of the one or more syringes132and the manifold148including at least one manifold conduit, wherein the manifold conduit148ais in fluid connection with a main fluid channel148band 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 syringe132. According to these aspects, the at least one manifold conduit148acomprises a filling port147configured for fluid communication with a MUDS fluid line134, a discharge outlet146in fluid communication with the main fluid channel148b, and a valve receiving cavity155, wherein the discharge outlet146and the filling port147are in fluid communication with an interior139of the at least one syringe132through a valve assembly272in a valve receiving cavity155.

With reference toFIGS.13A-C, one aspect of a syringe/manifold connection configuration including a swivel nut connection is shown. The distal conical end1346of the at least one syringe132includes a male luer tip and a circumferential groove1390. Circumferential groove1390is configured to receive an inward radial flange1385of threaded swivel nut1380including internal threads1382. Conduit syringe attachment end1372of manifold conduit1370includes a female luer tip configured for fluid tight connection with male luer tip of distal conical end1346. Internal threads1382threadably interact with complementary threads1375on the conduit syringe attachment end1372of manifold conduit1370to connect the manifold conduit1370with distal conical end1346.

With reference toFIGS.14A-B, one aspect of a syringe/manifold connection configuration including an overmolded manifold connection with solvent bond is shown. The conduit syringe attachment end1472of the at least one manifold conduit1470comprises an overmolded polymer sheath1476that forms a fluid tight connection by a solvent bond between an outer surface of the conduit syringe attachment end1472and an inner surface of the syringe fluid port1446. In certain aspects the at least one syringe and/or manifold conduit1470may be made of a first polymeric material, such as, for example polycarbonate, and the overmolded polymer sheath1476may be made of a second polymeric material, such as polyurethane, that may be overmolded on the conduit syringe attachment end1472during manufacture. The polymeric sheath1476may 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 inFIGS.15A and15B, the syringe fluid port1546may comprise the overmolded polymer sheath1576that has been overmolded on an outer surface of the syringe fluid port1546, which then forms a fluid tight connection and seal with the inner surface of the conduit syringe attachment end1572of the at least one manifold conduit1570.

With reference toFIGS.16A-C, one aspect of a syringe/manifold connection configuration including a stem lock configuration using the stem of the valve assembly136to connect the syringe and manifold is shown. According to this aspect, an inner surface1649of the syringe fluid port1646comprises a locking flange1685extending radially inward and the inner surface of the conduit syringe attachment end1672comprises a locking flange1673extending radially inward. Valve assembly136comprises a syringe locking groove1695and a manifold locking groove1690configured to form locking engagements with the locking flanges1685,1673of the syringe fluid port1646and conduit syringe attachment end1672. Certain aspects may further include one or more o-rings between the valve assembly and one or both of the syringe fluid port1646and conduit syringe attachment end1672.

With reference toFIGS.17A-C, 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 end1772is bonded to an inner circumferential surface of the syringe fluid port1746by a UV activated adhesive. To accommodate for potential swelling of the UV activated adhesive during cure, the syringe fill port1746may comprise a plurality of lateral slots1790to allow for expansion of the UV activated adhesive during the curing process, where excess adhesive may expand through the lateral slots1790. In another aspect (not shown), the conduit syringe attachment end1772may 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 toFIGS.18A-C, one aspect of a syringe/manifold connection configuration including a plurality of flexible clip elements is shown. According to one aspect the conical distal end145may comprise a plurality of distally facing flexible clips1890configured to engage a radial flange1875on an outer circumference of the conduit syringe attachment end1872of the manifold conduit1870. The syringe fluid port1846may include a male luer tip that sealably engages a female luer tip on the conduit syringe attachment end1872. In other aspect (not shown), the flexible clips may be located on the conduit syringe attachment end1872and project proximally to engage a corresponding flange on the syringe fluid port1846.

With reference toFIGS.19A-D, one aspect of a syringe/manifold connection configuration including a C-clip locking feature is shown. According to this aspect, syringe fluid port1946includes a longitudinal slot1995and the conduit syringe attachment end1972comprises a radial flange1975. The conduit syringe attachment end1972is inserted into the syringe fluid port1946to a point where the radial flange1975is immediately proximal to the longitudinal slot1995. Connection between the conduit syringe attachment end1972and the syringe fluid port1746is maintained by a C-clip1990inserted into longitudinal slot1995immediately distal to the radial flange. The conduit syringe attachment end1972may further comprise one or more O-rings1999configured to form a fluid tight seal between the conduit syringe attachment end1972and the syringe fluid port1946.

With reference toFIGS.20A-B, one aspect of a syringe/manifold connection configuration including a laser weld feature is shown. According to this aspect, one of the syringe fluid port2046and the conduit syringe attachment end2072comprises a radial flange2085with a surface configured for laser welding and the other of the syringe fluid port2046and the conduit syringe attachment end2072comprises a complementary radial receiving flange2073that receives the radial flange2085and has a complementary surface configured for laser welding. The radial flange2085and the complimentary radial receiving flange2073are connected by a laser weld2086therebetween.

With reference toFIGS.21A-B, one aspect of a syringe/manifold connection configuration including an ultrasonic weld feature is shown. According to this aspect, one of the syringe fluid port2146and the conduit syringe attachment end2172comprises a circumferential receiving slot2185including an energy director2186and the other of the syringe fluid port2146and the conduit syringe attachment end2172comprises a terminal portion2175that engages and is received in the circumferential receiving slot2185. The terminal portion2175and the circumferential receiving slog2185are connected by an ultrasonic weld therebetween by exposure to ultrasonic vibrations, which may be directed by energy director2186.

With reference toFIGS.22A-B, one aspect of a syringe/manifold connection configuration including luer seal with UV adhesive bond is shown. According to this aspect, the syringe fluid port2246may comprise a female luer connector which forms a liquid tight connection with a male luer connector on the conduit syringe attachment end2272. When assembling the luer connection, a distal circumferential slot2080is formed between the syringe fluid port2246and the conduit syringe attachment end2272. The distal circumferential slot2080is configured for receiving a UV activated adhesive which forms an adhesive connection between the syringe fluid port2246and the conduit syringe attachment end2272upon irradiation with UV radiation. Reversal of the luer connections between the syringe fluid port2246and the conduit syringe attachment end2272is also contemplated.

With reference toFIGS.23A-B, one aspect of a syringe/manifold connection configuration including a UV adhesive bond between the syringe fluid port2346and the manifold conduit2370is shown. According to this aspect, engagement between the syringe fluid port2346and the conduit syringe attachment end2372defines a tubular space2380between an inner surface of the syringe fluid port2346and an outer surface of the conduit syringe attachment end2372. When assembling the connection, a UV activated adhesive is received within the tubular space2380which forms an adhesive connection between the syringe fluid port2346and the conduit syringe attachment end2372upon irradiation with UV radiation. Reversal of the connections between the syringe fluid port2346and the conduit syringe attachment end2372is also contemplated.

With reference toFIGS.24A-B, 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 port2446may comprise a female luer connector which forms a liquid tight connection with a male luer connector on the conduit syringe attachment end2472. Upon assembling the luer connection, a laser tack weld2480is formed at the interface between the syringe fluid port2446and the conduit syringe attachment end2472. Reversal of the luer connections between the syringe fluid port2246and the conduit syringe attachment end2272is also contemplated.

With reference toFIGS.25Aand B, the fluid injector system100may have a sensor system238adapted to identify when the SUDS190is in fluid communication with the MUDS130. The sensor system238may include at least one sensing element, such as sensor fin240on the SUDS190and a corresponding sensor242on the fluid injector system100or MUDS130. The sensor242may be configured to detect the presence and absence of the at least one sensor fin240, or other sensing element. In some aspects, the sensing element, such as the at least one sensor fin240is formed on the locking tab216of the SUDS190, such as shown inFIG.9A. In other aspects, the sensing element, such as the at least one sensor fin240may be formed on any portion of the SUDS190. The sensor242may be an optical sensor that is seated and secured within a respective mount formed on the housing102of the fluid injector system100. As will be appreciated by those versed in the field of powered medical fluid injectors, the sensor242may 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 sensor242. The sensing element, such as the sensor fin240may have one or more reflective surfaces that reflect visible or infrared light to be detected by the sensor242. In other aspects, mechanical interaction between the sensing element and the sensor242may be used.

In some aspects, the SUDS190may further include reuse prevention features (not shown). For example, the SUDS190may include one or more breakable, sensor elements, tabs or structures that fold or break when the SUDS190is removed from the MUDS130. Absence of these features may prevent reinsertion and reuse of the SUDS190after removal. In this manner, it can be assured that the SUDS190is only used for one fluid delivery procedure.

Having generally described the components of the fluid injector system100, the MUDS130, and the SUDS190, a method of operation of using the SUDS190will now be described in detail. In use, a medical technician or user removes the disposable SUDS190from its packaging (not shown) and inserts the fluid inlet port202into the connection port192on the MUDS130. As described above, the SUDS190must be inserted in the correct orientation, such that the fluid inlet port202is aligned for connection with the connection port192, and the waste outlet port204is aligned for connection with the waste inlet port196. The SUDS190may be secured to the MUDS130by inserting the locking tab216into the receiving slot217on the MUDS130. Once the SUDS190is securely connected to the MUDS130, for example as sensed by the sensor242, the fluid injector system100(shown inFIGS.1A and1B) draws fluid into one or more of the plurality of syringes132of the MUDS130and performs an automatic priming operation for removing air from the MUDS130and the SUDS190. During such priming operation, fluid from the MUDS130is injected through the connection port192and into the tubing208of the SUDS190. The fluid flows through the tubing208and through the waste outlet port204and into the waste reservoir156. Once the automatic priming operation is completed, the medical technician disconnects the connector214from the waste outlet port204. The connector214may 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 SUDS190is disconnected from the patient and the MUDS130by disengaging the locking tab216of the SUDS190from the receiving slot217on the MUDS130. The medical technician may then dispose of the SUDS190. In certain aspects, removing the SUDS190from the MUDS130causes reuse prevention features (not shown) to activate, thereby preventing reinsertion and reuse of the SUDS190.

With reference toFIG.26, a connection interface between the SUDS190and the MUDS130is shown in accordance with another aspect. The MUDS130has a connection port192that may be configured as a hollow, tubular structure having a luer lock connector24(either a male luer lock connector or a female luer lock connector depending on the desired application), extending from a distal end of the port192into an interior of the port192. Accordingly, the proximal opening of the luer lock connector24is recessed within the interior of the port192. The luer lock connector24may include screw threads30(shown inFIG.27B) for securing the MUDS130to the SUDS190. For example, the screw threads30may be positioned on an outer shroud32surrounding the luer lock connector24, as shown inFIGS.27A and27B. Screw threads30may also be positioned on the luer lock connector24itself. The luer lock connector24defines a fluid passageway34(shown inFIG.27B) extending therethrough, from the proximal end of the connection port192to the distal opening thereof. While the connection port192is depicted as including a luer lock connector24, 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 connector24for the connection port192is 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 MUDS130has a waste inlet port196(shown inFIG.26) that may also be configured as a hollow, tubular structure. The waste inlet port196includes a tapered distal nozzle36attached to a fluid conduit, such as flexible tubing that connects the waste inlet port196to the waste reservoir156(shown inFIG.2).

With reference again toFIG.26, as described in detail herein, the MUDS130is adapted for connecting to the SUDS190, which is disposed of after a single use. It is noted that the SUDS190is shown inFIG.26in a state after removal from packaging (not shown). Prior to use, the SUDS190is desirably packaged in a pre-sterilized, sealed package that protects the SUDS190from contamination with air or surface-borne contaminants.

The SUDS190may have two or more ports, corresponding to the connection port192and waste inlet port196of the MUDS130. For convenience, the ports of the SUDS190are equivalent to the fluid inlet port202and the waste outlet port204of the SUDS190described with reference toFIGS.9A-9B. The ports202,204may be provided in an enclosure42suitable for receipt within the housing20of the MUDS130, as shown inFIG.27B. The enclosure42desirably has an asymmetrical structure, so that the user can only attach the SUDS190to the MUDS130in one orientation only. Thus, for example, the user is prevented from attaching the connection port192of the MUDS130to the SUDS190waste outlet port204. The ports202,204and enclosure42of the SUDS190may be made from a material suitable for medical applications, such as medical grade plastic. The tubing208of the SUDS190is connected between the proximal end of the fluid inlet port202and the end of the waste outlet port204through check valves. The tubing208may be provided in a wound or coiled configuration for easy packaging and maneuverability.

With reference toFIGS.27A and27B, the SUDS190fluid inlet port202is a hollow, tubular structure configured for insertion in the connection port192of the MUDS130. The SUDS190fluid inlet port202includes a tubular conduit, such as a luer lock connector44, defining a fluid passageway46extending from a proximal end of the port202, located adjacent to the MUDS130, and the distal end of the port204, connected to the tubing208. The luer lock connector44is adapted to connect to the luer lock connector24of the MUDS130. When securely connected, the connection port192of the MUDS130is in fluid communication with the fluid inlet port202of the SUDS190. The luer lock connector44may include a thumbwheel52for securing the connection port192of the MUDS130to the SUDS190fluid inlet port202. The thumbwheel52may be integrally formed with the luer lock connector44or may be a separate structure fixedly connected to the luer lock connector44by conventional means. The thumbwheel52rotates the luer lock connector44causing tabs54, extending therefrom, to engage the corresponding screw threads30in the connection port192. The tubing208is connected to the fluid inlet port202through an opening56on the thumbwheel52, such that a continuous fluid connection is established from the MUDS130to the tubing208.

With continued reference toFIGS.27A and27B, the SUDS190also includes the SUDS190waste outlet port204. The SUDS waste outlet port204has a fluid passageway58, defined by a tubular conduit60, extending between the waste inlet port196of the MUDS130, and the tubing208. The tubing208may not be directly connected to the waste inlet port196of the MUDS130. Instead, the tubular conduit60of the SUDS190may separate the tubing208from the MUDS130, thereby ensuring that the tubing208and the connector214are isolated from the waste inlet port196of the MUDS130. The tubular conduit60may be recessed from the waste inlet port196of the MUDS130by a portion of the single-use connector enclosure42, to reduce the likelihood of contamination. The tubular conduit60may also be angled, relative to the horizontal, to facilitate fluid flow through the SUDS190waste outlet port204and into the waste inlet port196of the MUDS130. In some aspects, the SUDS190may further include reuse prevention features (not shown). For example, the SUDS190may include breakable tabs or structures that fold or break when the SUDS190is removed from the MUDS130. In this manner, it can be assured that the SUDS190is only used for one fluid delivery procedure.

With reference toFIGS.28A-28F, a method of operation of the aspect of the connection assembly between the SUDS190and MUDS130depicted inFIGS.26-27Bwill now be described in detail. In use, a medical technician or user removes the disposable SUDS190from its packaging and inserts the SUDS190into the corresponding MUDS130. As described above, the SUDS190must be inserted in the correct orientation, such that the connection port192of the MUDS130engages the SUDS190fluid inlet port202, and the waste inlet port196of the MUDS130engages the SUDS190waste outlet port204. As shown inFIG.28B, the medical technician then rotates the thumbwheel52to secure the SUDS190to the MUDS130. Once the SUDS190is securely connected to the MUDS130, the fluid injector system100(shown inFIGS.1A and1B) draws fluid into one or more of the plurality of syringes132of the MUDS130and performs an automatic priming operation (FIG.28C) for removing air from the MUDS130and the SUDS190. During such priming operation, fluid from the MUDS130is injected through the connection port192and into the tubing208of the SUDS190. The fluid flows through the tubing208and through the waste outlet port204and into the waste reservoir156. Once the automatic priming operation is completed, the medical technician disconnects the connector214from the waste outlet port204(FIG.28D). The connector214may 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.28E). Once the fluid delivery is completed, the user the connector214from the patient and rotates the thumbwheel52to remove the SUDS190from the MUDS130(FIG.28F). The medical technician may then dispose of the SUDS190. In certain aspects, removing the SUDS190from the MUDS130causes reuse prevention features (not shown), such as tabs extending from a portion of the SUDS190, to fold or break, preventing reinsertion of the SUDS190.

With reference toFIG.29, a further aspect of a connector assembly having a SUDS190and a MUDS130is illustrated. In this aspect of the assembly, the SUDS190includes a cannula port62for receiving a needle cannula129connected to a connector214. The cannula129, used for fluid delivery to a patient, can be inserted into the cannula port62after being removed from the patient. The cannula port62may cover a contaminated end of the cannula129during disposal of the cannula129. In this aspect, the single-use enclosure42is desirably long enough so that the entire length of the needle cannula129may be inserted in the enclosure42for a safe disposal.

With reference toFIGS.30A and30B, a further aspect of a connector assembly having a SUDS190and a MUDS130is illustrated. The connector assembly is provided in a vertical orientation with the connection port192of the MUDS130positioned above the waste inlet port196. The MUDS130includes a drip channel64extending between the connection port192and waste inlet port196. Any fluid leaking from the connection port192is directed downward through the drip channel64by gravity. The drip channel64exits into the waste inlet port196. Accordingly, any fluid expelled from the drip channel64is directed through the waste inlet port196and is collected in the waste reservoir156. Alternatively, the MUDS130may be provided with an absorbent material, such as an absorbent pad66shown inFIG.30C, surrounding a portion of the connection port192and the waste inlet port196. The absorbent material is provided to absorb any fluid drips during removal of the SUDS190for improved drip management.

With reference toFIGS.31A-31C, a further aspect of the connector assembly having a SUDS190and a MUDS130having a plurality of press-fit connectors is illustrated. As shown inFIG.31A, the SUDS190includes a fluid inlet port202and waste outlet port204. The SUDS190includes disconnection tabs68, rather than a thumbwheel. The SUDS190also includes an alignment structure70extending from the enclosure42of the SUDS190and is configured for insertion in a corresponding slot72of the MUDS130(shown inFIG.31B).

As shown in the cross-sectional view depicted inFIG.31C, the SUDS190is inserted into and aligned with the MUDS130by alignment channels71. The disconnection tabs68are integrally formed with a tubular shroud74having an inwardly extending flange76at one end thereof. The shroud74surrounds a tubular conduit80on the SUDS190. When the SUDS190is inserted into the MUDS130, the flange76forms an interference engagement with a corresponding ridge78extending from a portion of the connection port192of the MUDS130. The interference engagement creates a substantially fluid-tight connection between the MUDS130and the SUDS190. Pressing the disconnection tabs68of the SUDS190disengages the flange76from the ridge78to allow a user to remove the SUDS190from the MUDS130. With reference toFIG.32, the connection assembly, having a MUDS130and SUDS190with disconnection tabs68described above, may also be provided in a vertical configuration.

With reference toFIGS.33A and33B, a further aspect of the connector assembly having a SUDS190and a MUDS130is illustrated. The MUDS130includes the connection port192and waste inlet port196, as described in previous aspects. The connection port192includes a co-molded sealing surface82for enhancing the connection between the SUDS190and the MUDS130. The SUDS190includes external alignment surfaces84, integrally formed with the enclosure42, for correctly aligning the SUDS190and the MUDS130. The alignment surfaces84also recess the fluid inlet port202and the waste outlet port204of the SUDS190to reduce the possibility of contamination prior to use.

With reference toFIGS.34A-36B, various aspects of the tubing208are illustrated. For example, the tubing208may be wound about a holding structure133, such as a spool or frame member, for ensuring that the tubing208does not unwind while being removed from its packaging or when the SUDS190is being connected to the MUDS130. With reference toFIG.36A, the tubing208may further include a removable external clip135. The clip135connects about the wound tubing208to prevent the tubing208from unwinding during removal from packaging or auto-priming. With reference toFIG.36B, in a further aspect, the tubing208is provided with uncoiled portions137to keep the tubing208away from the SUDS190. A coiled portion139of the tubing208hangs below the un-coiled portions137, when the SUDS190is connected to the MUDS130.

With reference toFIG.37, an electronic control device900may be associated with fluid injector system100to control the filling and delivery operations. In some aspects, the electronic control device900may control the operation of various valves, piston members, and other elements to effect a desired filling or delivery procedure. For example, the electronic control device900may 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 device900, 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 device900. 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 device900further includes a system memory908with 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 device900and is normally stored in ROM. The RAM portion of the system memory908typically contains data and program modules that are immediately accessible to or presently being operated on by the processing unit904, e.g., an operating system, application programming interfaces, application programs, program modules, program data, and other instruction-based computer-readable codes.

With continued reference toFIG.37, the electronic control device900may also include other removable or non-removable, volatile or non-volatile, transitory or non-transitory computer storage media products. For example, the electronic control device900may include a non-removable memory interface910that communicates with and controls a hard disk drive912, e.g., a non-removable, non-volatile magnetic medium; and a removable, non-volatile memory interface914that communicates with and controls a magnetic disk drive unit916(which reads from and writes to a removable, non-volatile magnetic disk918), an optical disk drive unit920(which reads from and writes to a removable, non-volatile optical disk922, such as a CD ROM), a Universal Serial Bus (USB) port921for 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 environment902, 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 unit904and other components of the electronic control device900via the system bus906. The drives and their associated computer storage media, discussed above and illustrated inFIG.37, 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 device900(whether duplicative or not of this information and data in the system memory908).

A user may enter commands, information, and data into the electronic control device900through certain attachable or operable input devices, such as the user interface124shown inFIG.1A, via a user input interface928. 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 device900from an outside source. As discussed, these and other input devices are often connected to the processing unit904through the user input interface928coupled to the system bus906, 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 monitor930(to visually display this information and data in electronic form), a printer932(to physically display this information and data in print form), a speaker934(to audibly present this information and data in audible form), etc. All of these devices are in communication with the electronic control device900through an output interface936coupled to the system bus906. It is envisioned that any such peripheral output devices be used to provide information and data to the user.

The electronic control device900may operate in a network environment938through the use of a communications device940, which is integral to the electronic control device900or remote therefrom. This communications device940is operable by and in communication with the other components of the electronic control device900through a communications interface942. Using such an arrangement, the electronic control device900may connect with or otherwise communicate with one or more remote computers, such as a remote computer944, 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 device900. Using appropriate communication devices940, e.g., a modem, a network interface or adapter, etc., the computer944may 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 device900includes, 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 devices900or similar computing devices having a computer-readable storage medium capable of storing computer-readable program code or instructions that cause the processing unit904to 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 device900may 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 device900can control a database physically stored on a separate processor of the network or otherwise.

In some aspects, the electronic control device900may be programmed so that automatic refill occurs based upon a preprogrammed trigger minimum volume in the respective syringes132. For example, when the volume of fluid remaining in at least one of the syringes132is less than a programmed volume, a syringe refill procedure is automatically initiated by the electronic control device900. The electronic control device900associated with the fluid injector system100may determine that the preprogrammed trigger minimum volume has been reached by tracking the fluid volume dispensed from the respective syringes132during operation of the fluid injector system100. Alternatively, fluid level sensors may be incorporated into the fluid injector system100and inputs from these fluid level sensors may be provided to the electronic control device900so that the electronic control device900may determine when the preprogrammed trigger minimum volume has been reached in at least one of the syringes132. The fill volume and rate of refill can be preprogrammed in the electronic control device900. The automatic refill procedure can be stopped either automatically by the electronic control device900or 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 syringes132to perform the next programmed fluid injection procedure.

During a refill procedure it is possible that one or more of the bulk fluid sources120associated with the respective syringes132may become empty, (e.g., initially lack sufficient fluid to complete a full refill of the one or more syringes132). A replacement bulk fluid source120is, therefore, necessary and replacement of such bulk fluid source120is desirably made quickly. The fluid injector system100may have an indicator, such as an audible and/or visual indicator, to indicate to the operator that a change of the bulk fluid source120is necessary before the fluid injector system100may be used.

While several aspects of multi-fluid delivery systems and multi- and SUDS connectors therefor are shown in the accompanying figures and described hereinabove in detail, other aspects will be apparent to, and readily made by, those skilled in the art without departing from the scope and spirit of the disclosure. For example, it is to be understood that this disclosure contemplates that, to the extent possible, one or more features of any aspect can be combined with one or more features of any other aspect. Accordingly, the foregoing description is intended to be illustrative rather than restrictive.