BACKGROUND

[0001 ] Typically, bulk supplies of a contrast solution and/or a saline flush solution used in radiological procedures are provided to an injector from a fluid bag, a bottle or some other type of container that is hung from a pole near the injector. The fluid in the container is accessed through a spike connected to a fluid line that supplies the injector.

[0002] Conventional spikes and tubing tend to be narrow because they can alternatively be used to supply fluids for intravenous drips for patients, which typically require a low fluid flow rate. In some cases, however, high fluid flow rates are required for injectors. For example, radiological procedures may require injectors that have high capacity or high fluid injection rates. As such, standard spike and tubing sets are often too narrow to provide sufficient fluid flow for these procedures.

SUMMARY

[0003] The invention described in this document is not limited to the particular systems, methodologies or protocols described, as these may vary. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present disclosure.

[0004] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural reference unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. As used herein, the term

"comprising" means "including, but not limited to." |0005| In an embodiment, a system for enabling high fluid rate injection may include a hollow dip tube, an introducer having a hollow sleeve, and a sharp tip-end located at a distal end of the introducer. The hollow sleeve comprises an opening at a proximal end. The introducer is configured to receive the hollow dip tube through the opening. The sharp tip-end is configured to pierce a septum of a container.

[0006] In an embodiment, a method of enabling high fluid rate injection may include inserting at least a portion of an introducer into a septum of a container containing a fluid. The introducer comprises a hollow sleeve. A sharp tip-end is located at a distal end of the introducer. The hollow sleeve has an opening at a proximal end. The method further includes inserting a hollow dip tube into the opening of the hollow sleeve and withdrawing at least a portion of the fluid in the container through the hollow dip tube.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIGS. 1A-C depict an illustrative introducer and dip tube according to an embodiment. The sequence of illustrations in FIGS. 1 A-C also discloses an illustrative operation of inserting the introducer into a container and the dip tube into the introducer according to an embodiment.

[0008[ FIGS. 2A-C depict illustrative introducers having differing sharp tip-ends according to embodiments.

[0009] FIGS. 3A-C depict illustrative dip tubes according to embodiments.

[0010] FIG. 4 depicts an illustrative system for using a combined dip tube and introducer according to an embodiment. [00111 FIG. 5 depicts a flow diagram of an illustrative method of enabling high fluid rate injection according to an embodiment.

DETAILED DESCRIPTION

[0012] This disclosure discloses a spike and tubing set designed to handle large flow and/or high capacity injection procedures. In particular, this disclosure discloses embodiments directed to high capacity spike and tubing sets for use with bottled contrast solutions and/or saline solutions, a system incorporating the spike and tubing set, and methods for their use.

[0013] FIGS. 1A-C depict an illustrative introducer and dip tube according to an embodiment. The sequence of illustrations in FIGS. 1A-C also discloses an illustrative operation of inserting the introducer into a container and the dip tube into the introducer according to an embodiment. As shown in FIG. 1A, a dip tube 100 and an introducer 110 may be used to withdraw a fluid 130 from a container 120. The container 120 may include a septum (not shown) forming a sterile seal for the fluid 130 within. The introducer 110 may have a sharp tip- end 140 located at a distal end.

[0014] As shown in FIG. I B, the sharp tip-end 140 is configured to pierce the septum so that the tip-end extends through the septum and into the interior space of the container 120. The introducer 110 and/or the tip-end 140 may be formed so that the interior of the container 120 remain sterile after the tip-end pierces the septum. For example, the introducer 110 may seal the location at which the septum is pierced to maintain sterility.

[0015] As shown in FIG. 1 C, at the time of fluid delivery, the dip tube 100 may be fed through the introducer 110 to allow the dip tube to enter the container 120 and contact the fluid 130. In an embodiment, the tip-end 140 of the introducer 110 may detach from the sleeve of the introducer when the dip tube 100 is fed through the introducer. In one embodiment, the tip-end 140 may be made of a material that will sink to the bottom of the fluid 130 upon detachment from the introducer 110. In an alternate embodiment, the tip-end 140 may be made of a buoyant material that can float on the surface of the fluid 130. In such an embodiment, a detector system may determine the amount of fluid 130 in the container 120 by monitoring the vertical displacement of the tip-end 140 on the meniscus of the fluid. In an embodiment, a buoyant tip-end 140 may be configured to be easily detectable within the container 120 in order to assist in determining a level of the fluid 130 within the container. For example, the buoyant tip-end 140 may be fluorescent.

[0016] In an embodiment, the tip-end 140 may be a separate detachable piece that is inserted into the distal end of the introducer 110 prior to use. The tip-end 140 may be seated, for example, by an interference fit within the introducer 110. Other methods of fitting a separate tip- end 140 within the introducer 110 may be performed within the scope of this disclosure.

[0017] In an alternate embodiment, the tip-end 140 may be formed as part of the introducer 110. In such an embodiment, the tip-end 140 may be configured to be separable from the remainder of the introducer 110. For example, the introducer 110 may be scored when manufactured to identify a location at which the tip-end 140 is to separate from the remainder of the introducer upon the application of a force through the introducer towards the tip-end.

[0018] In an embodiment, the tip-end 140 may be substantially or completely solid to prevent fluid from passing therethrough. In such an embodiment, the tip-end 140 may prevent fluid from being withdrawn from a container 120 until the tip-end is separated from the introducer 110. [0019] In an embodiment, the tip-end 140 may be configured to separate from the introducer 1 10. but remain lodged in the en d of the dip tube 100. In such an embodiment, the tip-end 140 may be hollow and allow fluid to pass through to the dip tube 100. In such an embodiment, the tip-end 140 may operate as a filter for the fluid entering the dip tube 100 to prevent impurities or other materials from passing through.

[0020] FIGS. 2A-C depict illustrative introducers having differing sharp tip-ends according to embodiments. FIG. 2 A depicts various projections of a first embodiment of an introducer 210 and sharp tip-end 250a. The introducer 210 may include an opening 21 1 through which a dip tube may be placed. The introducer 210 may also include a sleeve 216 to help guide the dip tube through the introducer. The sleeve 216 may be fabricated so as to form an air-tight seal against the dip tube.

[0021 ] The introducer 210 may have a top surface (not labeled) and a bottom surface 214. The bottom surface 214 may be configured so that it forms, for example, an air-tight seal against a lip of a container.

[0022] As a fluid is withdrawn from a container, replacement air must be supplied to equalize the pressure within the container. To maintain fluid sterility, an air filter 212 may also be incorporated into the introducer 210 thereby permitting sterile filtered air to enter the container and equalize pressure during fluid withdrawal.

[0023] Several embodiments are possible for the tip-end 250a-c. As shown in FIG. 2A, a first embodiment for the tip-end 250a may be hollow and may have a number of fins capable of piercing the bottle septum. Tip end 250a may be useful in an embodiment in which the tip-end is retained on the end of the dip tube, the fluid being drawn through the hollow tip-end and through the dip tube. As shown in FIG. 2B, a second embodiment for the tip-end 250b may be sealed and separable from the introducer 210. The tip-end 250b may be seated within the introducer via an interference fit with the sleeve 216. The tip-end 250b may be buoyant and float on the fluid in the container after it is separated from the introducer 210. As shown in FIG. 2C. a third embodiment for the tip-end 250c may be sealed and separable from the introducer 210. The tip-end 250c may be seated within the introducer via an interference fit with the sleeve 216. The tip-end 250c may be configured to sink to the bottom of a container upon separation from the introducer 210.

[0024] In an embodiment, the tip-ends 250b,c may be substantially or completely solid to prevent fluid from passing therethrough. In such an embodiment, the tip-ends 250b,c may prevent fluid from being withdrawn from a container until the tip-end is separated from the introducer 210.

[0025] FIGS. 3A-C depict illustrative dip tubes according to embodiments. As shown in FIG. 3A, the dip tube 300 may incorporate one or more sensor components and/or one or more detector components. For example, the dip tube 300 may incorporate one or more temperature sensors, such as 302, along its length. Such temperature sensors 302 may provide information to an operator regarding the temperature of a fluid in a container in which the dip tube is present. This may be especially useful for a container that is undergoing a heating process because it may permit an operator to assess temperature gradients within the fluid in the container. In an embodiment, the one or more temperature sensors 302 may include an electronic device. In an embodiment, the one or more temperature sensors 302 may include a strip of thermochromic material covering at least a portion of the length of the dip tube 300. The thermochromic material may change color based on the temperature of the fluid located in close proximity to the material. Additional and/or alternative temperature sensors may be used within the scope of this disclosure.

[0026] In an embodiment, one or more sensors may be used to determine the amount or level of fluid in the container. In an embodiment, a resistive level detector 304 may cover at least a portion of the length of the dip tube 300. The resistive level detector 304 may have a current source located towards one end (for example, a distal end) of the dip tube 300 and a current detector located towards an opposing end (for example, a proximal end) of the dip tube. The current through the resistive element 304 may be measured, for example, as the fluid within the container is withdrawn. If the fluid is ionic and capable of carrying charge, a charge through the fluid may migrate in parallel with the charge through the resistive clement 304. As such, the measured current may be greater when the fluid level covers more of the resistive element 304. As fluid is withdrawn from the container, the fluid level drops, and the fluid-based charge path parallel to the resistive element 304 decreases. This results in a decrease in measured current flow because the current path is primarily through the resistive element 304 alone.

[0027] In an embodiment, one or more fluid level detection sensors 306a, b may be capacitive. For example, the dip tube 300 may include a pair of parallel capacitor elements 306a,b. The fluid between the capacitor elements 306a,b may act as a dielectric component. As a result, as the fluid level falls, the capacitance between the capacitor elements 306a, b may change, and the change in capacitance may be measured by any conventional detection method. Capacitor elements, such as 306a,b, may be particularly useful for solutions having non- conductive fluids.

[0028] In an embodiment, the one or more sensors may be connected to one or more fluid monitoring device to determine how much fluid is available in a container. The fluid monitoring device may indicate whether the container has sufficient fluid volume for an injection procedure, whether the container has a low volume, whether a user should change the container to a new container or the like. In an embodiment, the one or more sensors may be coupled irelessly or via a wired connection to a hospital monitoring system. In an embodiment, the one or more sensors may identify one or more of a temperature of the fluid, a weight of the fluid, a level of the fluid, or a bar code associated with the fluid.

[0029] FIG. 4 depicts an illustrative system for using a combined dip tube and introducer according to an embodiment. As shown in FIG. 4, a dip tube 400, an introducer 410, and a fluid container 420 are shown in an exploded configuration. The components are illustrated in relation to a stand 460. The stand 460 may include an upright portion 470 and a base 480. As shown in FIG. 4, the container 420 is positioned such that its bottom situated against the base 480. It may be appreciated that the base 480 may be used for container 420 support. In an embodiment, the base 480 may include a heating element to maintain the container 420 at a constant temperature. In an embodiment, the base 480 may include a temperature sensor to detect the temperature of the container 420 and its contents. In an embodiment, the base 480 may include a scale capable of weighing the container 420. The weight of the container may be monitored during fluid withdrawal to detect the amount of fluid remaining in the container 420.

|0030] In an embodiment, a user may manually force the tip-end of the introducer 410 through the septum of the container 420, and manually force the dip tube 400 through the sleeve of the introducer. In an alternate embodiment, an automated system may include a stabilizing mechanism (such as a clamp, not shown) that stabilizes the container 420 against the upright portion 470. The tip-end of the introducer 410 may be forced through the septum by an automated presser (not shown) that moves along the upright portion 470. Similarly, the dip tube 400 may be mounted on an insertion device (not shown) that similarly moves along the upright portion 470 and forces the dip tube through the introducer 410. The upright portion 470 may also include one or more electronic devices that mate with one or more temperature sensors, such as 302, one or more resistive elements, such as 304, and/or one or more capacitive elements, such as 306a,b, for fluid detection within the container 420.

|0031] FIG. 5 depicts a flow diagram of an illustrative method of enabling high fluid rate injection according to an embodiment. As shown in FIG. 5, at least a portion of an introducer may be inserted 505 into a septum of a container containing a fluid. The introducer may include a hollow sleeve and a sharp tip-end at a distal end of the hollow sleeve. The hollow sleeve has an opening at a proximal end. In an embodiment, the introducer may further include an air filter surrounding the opening of the hollow sleeve to allow for sterile filtered air to enter the container and equalize pressure during fluid draw.

[0032] A hollow dip tube may be inserted 510 into the opening of the hollow sleeve. In an embodiment, the sharp tip-end is separable from the introducer and is buoyant. In such an embodiment, the operation of inserting 510 the hollow dip tube into the hollow sleeve of the introducer may cause the sharp tip-end to separate from the introducer. In such an embodiment, a fluid level in the container may be determined 525 by identifying the location of the separated sharp tip-end in the container.

[0033] At least a portion of the fluid in the container may be withdrawn 515 through the hollow dip tube. In an embodiment, the fluid may comprise a contrast solution, a saline flush solution or the like. In an embodiment, the fluid may be useful for completing a medical imaging procedure. |0034| In an embodiment, the fluid may be withdrawn 515 from the container by siphoning the fluid from the container. In an embodiment, the fluid may be withdrawn 515 from the container by suctioning the fluid from the container. In an embodiment, the fluid may be stored at pressure within the container and withdrawn 515 from the container based on the pressure differential. In an embodiment, the fluid may be withdrawn 515 from the container using gravity. The container may be pierced on an upper side or a lower side of the container. The selection of the type of method by which the fluid is withdrawn 515 may be dependent upon the position of the septum when it is pierced. Alternate methods of withdrawing 515 the fluid may be performed within the scope of this disclosure. In addition, one or more devices, if any, used to withdraw 515 the fluid will be known to those of ordinary skill in the art based on the teachings herein.

[0035] In an embodiment, one or more properties of the fluid may be sensed 520 using one or more sensors located at least in part on an outer surface of the hollow dip tube. In an embodiment, the one or more sensors may include a temperature sensor. In such an

embodiment, sensing 520 the one or more properties may comprise sensing a temperature of the fluid using the temperature sensor.

[0036] In an alternate embodiment, the one or more sensors may include a resistance detector. The resistance detector may include a resistive element, a current source and a current detector. The resistive element may be located on the outer surface of the hollow dip tube. The current source may be electrically connected to a first end of the resistive element. In an embodiment, the current source may be located on the outer surface of the hollow dip tube. In an alternate embodiment, the current source may be remote from the hollow dip tube. The current detector may be electrically connected to a second end of the resistive element. In an embodiment, the current detector may be located on the outer surface of the hollow dip tube. In an alternate embodiment, the current detector may be remote from the hollow dip tube. In such embodiments, sensing 520 the one or more properties may comprise sensing a resistance as the fluid is withdrawn from the container. The resistance level may be used to determine 525 a fluid level in the container, such as in the manner described above in reference to FIG. 3B.

|0037] In yet another embodiment, the one or more sensors may include a first capacitor element on a first side of the outer surface and a second capacitor element on a second side of the outer surface. In an embodiment, the first side and the second side may be opposing sides of the outer surface. In such embodiments, sensing 520 the one or more properties may comprise sensing a capacitance using the first and second capacitor elements. The capacitance may be used to determine 525 a fluid level in the container, such as in the manner described above in reference to FIG. 3C.

EXAMPLES

Example 1 : Siphon-Based Injection with Buoyant Tip-End

[0038) Λ bottle or other container having a septum and containing a fluid will be placed with the septum facing in an upward direction. The septum will be pierced by an introducer having a sharp tip-end configured to be buoyant with respect to the fluid in the container. A dip tube will be inserted through the tip-end, whereby the tip-end will be separated from the introducer. The tip-end, once separated from the introducer, will float to the top of the fluid in the container. The fluid will be siphoned or suctioned out of the container to provide the fluid to a fluid administration location, such as a point of injection into a patient, via the dip tube. The fluid level remaining in the container at any given time will be observable based on the position of the separated tip-end within the container.

Example 2: Siphon-Based Injection with Filtering Tip-End

[0039] A bottle or other container having a septum and containing a fluid will be placed with the septum facing in an upward direction. The septum will be pierced by an introducer having a sharp tip-end. A dip tube will be inserted through the tip-end. whereby the tip-end will be separated from the introducer and lodged within the dip tube. The fluid will be siphoned or suctioned out of the container through the tip-end and the dip tube to provide the fluid to a fluid administration location, such as a point of injection into a patient, via the dip tube. The tip-end will be used to filter the fluid and/or to sense one or more characteristics of the f luid.

Example 3: Gravity-Based Injection

[0040] A fluid bag or other container having a septum and containing a fluid will be placed with the septum facing in a upward direction. The septum will be pierced by an introducer having a sharp tip-end. A dip tube will be inserted through the tip-end, whereby the tip-end will be separated from the introducer. The bag will then be inverted to cause the septum to face in a downward direction. The tip-end, once separated from the introducer, will float to the top of the fluid in the container. The fluid will be withdrawn from the container via a gravity-based feed to provide the fluid to a fluid administration location, such as a point of injection into a patient, via the dip tube. A hook will be used to hold the bag in a suspended position. The hook will be part of a weighing mechanism used to determine an amount of fluid remaining in the bag by determining the weight of the bag and a density of the fluid. The density of the fluid in the bag will be determined by scanning a drug code from the bag which indicates the type of fluid in the bag. A database will then be accessed to identify the density of the particular fluid.

(0041 ] It will be appreciated that various of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. It will also be appreciated that various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art which alternatives, variations and improvements are also intended to be encompassed by the following claims.