Prime tube configuration for syringes

Abstract

We offer Prime Tube. [Solution] The prime tube includes a side wall defining an internal chamber having an expandable volume, a connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of a fluid reservoir containing medical fluid, and a closure associated with the distal end of the side wall, which is permeable to air and substantially impermeable to medical fluid. The expandable volume of the internal chamber is configured to increase as medical fluid enters the internal chamber.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 065,095, filed Aug. 13, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure generally relates to prime tubes for syringes and / or pumps, such as syringes used in fluid injector systems for injecting contrast media for contrast - enhanced imaging procedures. Specifically, the present disclosure relates to prime tubes used for priming and / or purging air from a reservoir after filling the reservoir and prior to executing an injection protocol, and the prime tube assists in determining when air is purged from the reservoir.

Background Art

[0003] Powered fluid injector systems are widely used in medical imaging procedures such as angiography, computed tomography (CT), and nuclear magnetic resonance (NMR) / magnetic resonance imaging (MRI). Such injector systems provide fluid delivery accuracy and precision beyond what can be achieved with a manual syringe and can provide numerous safety features to prevent injury to the patient during the injection procedure.

[0004] During some injection procedures, it is essential that no air is injected into the patient. Air can be present in the syringe or reservoir of a fluid injector system as packaged by the manufacturer. In addition, air can accumulate in the syringe or reservoir during automatic or manual filling of the syringe from one or more bulk fluid sources. Any air present in the volume must be purged prior to the injection procedure to avoid causing an air embolism.

[0005] For example, after the syringe is filled with fluid, the tubing set may be connected to the syringe's outlet, and the system may be operated to prime the system by expelling air through the tubing until the syringe and tubing are filled with air only. While this technique is effective for purging air from the tubing connected to the syringe, dispensing fluid from the end of the tubing may cause contamination or fouling of system components, which can lead to leaks into the injection chamber that need to be cleaned, posing a safety issue. Furthermore, in some cases, it may not be clear to the technician when the syringe is fully primed, for example, in low light or at a distance where it may be difficult to visualize the air inside the syringe, which may lead to the assumption that the syringe is primed.

[0006] Therefore, a new priming tube configuration is needed that is easily visible to retain the priming fluid and ensure priming before injection. [Overview of the project] [Means for solving the problem]

[0007] In consideration of the foregoing, there is a need for devices, systems, and methods for improved priming of syringe and fluid injector systems. Embodiments of this disclosure relate to a priming tube for use with a fluid injector. The priming tube includes a side wall defining an internal chamber having an expandable volume, a connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of a fluid reservoir containing a medical fluid, and a closure associated with the distal end of the side wall, which is permeable to air and substantially impermeable to the medical fluid. The expandable volume of the internal chamber is configured to increase as the medical fluid enters the internal chamber.

[0008] In some embodiments, the side wall includes at least one bellows. Each of the at least one bellows is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber. The volume defined by the internal chamber is greater when at least one of the at least one bellows is in the expanded state than when it is in the contracted state. In some embodiments, at least one bellows is stable in both the contracted and expanded states. The axial length of the side wall may be greater when at least one bellows is in the expanded state than when it is in the contracted state.

[0009] In some embodiments, the side walls include an elastomer material to expand the volume, which is expandable in response to an increase in fluid pressure within the internal chamber.

[0010] In some embodiments, the sidewall may be configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber. In the contracted state, the distal portion of the sidewall is rolled over the proximal portion of the sidewall. In the expanded state, the distal portion of the sidewall is at least partially unfolded from the proximal portion of the sidewall. The volume defined by the internal chamber is greater when the sidewall is expanded than when it is contracted. In some embodiments, in the contracted state, the inner surface of the distal portion of the sidewall faces the inner surface of the proximal portion of the sidewall. In some embodiments, at least a portion of the sidewall is configured to invert in response to an increase in fluid pressure within the internal chamber in order to increase the volume of the internal chamber.

[0011] In some embodiments, the side walls may be in a relaxed or bent configuration when there is no fluid flow through the internal chamber, and in a rigid, extended configuration when fluid flows into the internal chamber.

[0012] In some embodiments, the side walls may be in a coiled configuration when there is no fluid flow through the internal chamber, or in an extended configuration when fluid flows into the internal chamber.

[0013] In some embodiments, the prime tube may further include a check valve associated with the proximal end of the side wall and configured to prevent fluid leakage from the proximal end. In some embodiments, the closure may include a high-crack pressure valve.

[0014] In some embodiments, the closure may include a porous material. For example, the closure may define at least one opening having a cross-sectional area of ​​a size that allows air to pass through but substantially prevents the passage of medical fluid through at least one opening.

[0015] In some embodiments, at least one opening may be configured to produce an audible sound when air flows through the at least one opening.

[0016] Another embodiment of the present disclosure relates to a prime tube for use with a fluid injector. The prime tube includes a side wall defining an internal chamber, a connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of a fluid reservoir containing medical fluid, and a shuttle member configured to slide within the internal chamber in response to the flow of medical fluid into the internal chamber. The side wall may be rigid so as not to deform in response to fluid pressure below a predetermined threshold. In some embodiments, the shuttle member and at least one of the side wall define an air passage configured to allow air to flow distally beyond the shuttle member without sliding the shuttle member within the internal chamber. In some embodiments, the shuttle member may include a plug configured to form an interlocking fit with the outlet of the fluid reservoir so that the plug disengages from the outlet of the fluid reservoir at a predetermined fluid pressure. The plug may have an outer diameter large enough to prevent a patient administration line from being attached to the outlet of the fluid reservoir while the plug remains inside the outlet.

[0017] In some embodiments, the priming tube may include a cap having a proximal end configured to engage with the outlet of a fluid reservoir and a distal end configured to engage with a shuttle member. The shuttle member may be configured to be at least partially recessed within the outlet of the fluid reservoir before the priming operation.

[0018] In some embodiments, the prime tube further includes at least one engaging portion on the prime tube configured to hold a side wall at the outlet of the fluid reservoir. The shuttle member can engage at least one engaging portion at the outlet of the fluid reservoir to prevent the prime tube from being removed from the fluid reservoir when the shuttle member is in the initial position prior to the priming operation. During distal movement of the shuttle member within the internal chamber to a second prime position, at least one engaging portion can be released from the outlet of the fluid reservoir to allow the prime tube to be removed. In some embodiments, the shuttle member may include a tip configured to extend distally from the distal end of the prime tube when the shuttle member is moved to the second prime position.

[0019] In some embodiments, the shuttle member comprises a porous material that is permeable to air and substantially impermeable to medical fluids. For example, the shuttle member may define at least one opening having a cross-sectional area of ​​a size that allows the passage of air and substantially prohibits the passage of medical fluids.

[0020] In some embodiments, the sidewall includes at least one indicator for showing the distance the shuttle member has traveled, corresponding to the fluid filling level of the internal chamber of the prime tube. In some embodiments, the sidewall is at least partially translucent or transparent so that the shuttle member is visible through the sidewall.

[0021] Another embodiment of the present disclosure relates to a prime tube for use with a fluid injector system. The prime tube includes a side wall defining an internal chamber having an expandable volume, and a connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of a fluid reservoir containing a medical fluid. The side wall is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber. In the contracted state, the distal portion of the side wall is rolled over the proximal portion of the side wall. In the expanded state, the distal portion of the side wall is at least partially unfolded from the proximal portion of the side wall. The volume defined by the internal chamber is greater when the side wall is expanded than when it is contracted. In the contracted state, the inner surface of the distal portion of the side wall may face the inner surface of the proximal portion of the side wall.

[0022] Another embodiment of the present disclosure relates to a fluid injector system comprising at least one fluid reservoir and a primed tube configured to inject a medical fluid. The primed tube includes a side wall defining an internal chamber having an expandable volume and a connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of the fluid reservoir. The system further comprises at least one processor programmed or configured to determine the priming state of the primed tube.

[0023] In some embodiments, at least one processor is programmed or configured to determine the priming state of the prime tube based on the measured fluid pressure of at least one of the prime tube and the fluid reservoir. For example, in some embodiments, the fluid injector system may further include an actuator for injecting medical fluid from at least one reservoir, and at least one processor may be programmed or configured to determine the priming state of the prime tube based on the measured current flow of the actuator. At least one processor may be programmed or configured to determine the priming state of the prime tube based on readings of the force of a fluid injector motor associated with delivering fluid from the fluid reservoir.

[0024] In certain embodiments, at least one processor may be programmed or configured to determine the priming state of the prime tube based on at least one of the expansion of the prime tube and a change in the shape of the prime tube. In certain embodiments, at least one processor may be programmed or configured to determine the priming state of the prime tube based on the sound emitted from the prime tube. In some embodiments, the sidewalls include an elastomer material that expands to an expandable volume in response to an increase in fluid pressure within the internal chamber.

[0025] In some embodiments, the side wall may include at least one bellows. Each of the at least one bellows is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber. The expandable volume defined by the internal chamber is greater when at least one of the at least one bellows is in the expanded state than when it is in the contracted state.

[0026] In some embodiments, the sidewall is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber. In the contracted state, the distal portion of the sidewall is wound over the proximal portion of the sidewall. In the expanded state, the distal portion of the sidewall is at least partially deployed from the proximal portion of the sidewall. The expandable volume defined by the internal chamber is greater when the sidewall is in the expanded state than when it is in the contracted state.

[0027] In some embodiments, the sidewall is in a coiled configuration that is wound when there is no fluid flow through the internal chamber and in an extended configuration that is deployed when fluid flows through the internal chamber.

[0028] Another embodiment of the present disclosure is directed to a fluid injector system that includes at least one fluid reservoir configured to inject a medical fluid and a prime tube. The prime tube includes a sidewall that defines an internal chamber, a shuttle member that is slidable within the internal chamber, and a connector associated with the proximal end of the sidewall and configured to reversibly engage an outlet of the fluid reservoir. The fluid injector system further includes at least one processor that is programmed or configured to determine a priming state of the prime tube. The at least one processor may be programmed or configured to determine the priming state based on the position of the shuttle member within the internal chamber.

[0029] In some embodiments, the sidewall of the prime tube includes at least one indicator corresponding to the fluid fill level of the internal chamber, and the at least one processor may be programmed or configured to determine the priming state based on the position of the shuttle member relative to the at least one indicator.

[0030] In some embodiments, the prime tube further includes a cap having a proximal end configured to engage with the outlet of a fluid reservoir and a distal end configured to engage with a shuttle member. The shuttle member may be configured to be at least partially recessed within the outlet of the fluid reservoir before the priming operation. In some embodiments, the prime tube further includes at least one engaging feature on the prime tube configured to hold its sidewall at the outlet of the fluid reservoir. In the initial position before the priming operation, the shuttle member engages at least one engaging feature with the outlet of the fluid reservoir to prevent the prime tube from being removed from the fluid reservoir while the shuttle member is in the initial position. During distal movement of the shuttle member within the internal chamber to a second prime position, the at least one engaging feature is released from the outlet of the fluid reservoir to allow the prime tube to be removed.

[0031] Further aspects or examples of this disclosure are described in the following numbered clauses.

[0032] Clause 1. A prime tube for use with a fluid injector, the prime tube comprising: a side wall defining an internal chamber having an expandable volume; a connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of a fluid reservoir containing medical fluid; and a closure associated with the distal end of the side wall, which is permeable to air and substantially impermeable to medical fluid, wherein the expandable volume of the internal chamber is configured to increase as medical fluid enters the internal chamber.

[0033] Clause 2. The prime tube according to Clause 1, wherein the side wall comprises at least one bellows, each of which is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure in the internal chamber, and the volume defined by the internal chamber is greater when at least one of the at least one bellows is in the expanded state than when it is in the contracted state.

[0034] Clause 3. At least one bellows is stable in both the contracted and expanded states of the prime tube as described in Clause 1 or 2.

[0035] Clause 4. The axial length of the side wall is greater when at least one bellows is in an expanded state than when it is in a contracted state, according to any one of Clauses 1 to 3.

[0036] Clause 5. A prime tube according to any one of Clauses 1 to 4, wherein the side walls are made of an elastomer material configured to expand to an expandable volume in response to an increase in fluid pressure within the internal chamber.

[0037] Clause 6. A prime tube according to any one of Clauses 1 to 5, wherein the sidewall is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber, in the contracted state the distal portion of the sidewall is rolled over the proximal portion of the sidewall, and in the expanded state the distal portion of the sidewall is at least partially unfolded from the proximal portion of the sidewall, and the volume defined by the internal chamber is greater when the sidewall is expanded than when it is contracted.

[0038] Item 7. A prime tube as described in any one of items 1 to 6, wherein, in the contracted state, the inner surface of the distal portion of the side wall faces the inner surface of the proximal portion of the side wall.

[0039] Clause 8. A prime tube according to any one of Clauses 1 to 7, wherein at least a portion of the side wall is configured to invert in response to an increase in fluid pressure within the internal chamber in order to increase the volume of the internal chamber.

[0040] Clause 9. A prime tube according to any one of Clauses 1 to 8, wherein the sidewalls may be in a relaxed or bent configuration when there is no fluid flow through the internal chamber, and in a rigid, extended configuration when fluid flows through the internal chamber.

[0041] Clause 10. A prime tube according to any one of Clauses 1 to 9, wherein the sidewall is in a coiled configuration when there is no fluid flow through the internal chamber, and in an unfolded configuration when fluid flows through the internal chamber.

[0042] Clause 11. A prime tube according to any one of Clauses 1 to 10, further comprising a check valve associated with the proximal end of a side wall and configured to prevent fluid from flowing out from the proximal end.

[0043] Clause 12. The closure comprises a porous material, as described in any one of Clauses 1 to 11.

[0044] Clause 13. A prime tube according to any one of Clauses 1 to 12, wherein the closure defines at least one opening, the at least one opening having a cross-sectional area of ​​a size that allows the passage of air and substantially prohibits the passage of medical fluid through the at least one opening.

[0045] Clause 14. A prime tube according to any one of Clauses 1 to 13, wherein at least one opening is configured to produce an audible sound when air flows through at least one opening.

[0046] Clause 15. The closure is equipped with a high crack pressure valve, and is a prime tube as described in any one of Clauses 1 to 14.

[0047] Clause 16. A prime tube for use with a fluid injector, the prime tube comprising: a side wall defining an internal chamber; a connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of a fluid reservoir containing medical fluid; and a shuttle member configured to slide within the internal chamber in response to the flow of medical fluid into the internal chamber.

[0048] Clause 17. The sidewalls of the prime tube as described in Clause 16 are rigid so as not to deform in response to a fluid pressure below a predetermined threshold.

[0049] Clause 18. A prime tube according to Clause 16 or 17, wherein at least one of the shuttle member and the side wall defines an air passage configured to allow air to flow distally beyond the shuttle member without causing the shuttle member to slide within the internal chamber.

[0050] Clause 19. The prime tube according to any one of Clauses 16 to 18, wherein the shuttle member comprises a plug, the plug configured to form an interlocking fit with the outlet of the fluid reservoir such that the plug disengages from the outlet of the fluid reservoir at a predetermined fluid pressure.

[0051] Clause 20. A prime tube as described in any one of Clauses 16 to 19, having an outer diameter large enough to prevent a patient administration line from being attached to the outlet of a fluid reservoir while the plug remains inside the outlet.

[0052] Clause 21. A prime tube according to any one of Clauses 16 to 20, further comprising a cap having a proximal end configured to engage with the outlet of a fluid reservoir and a distal end configured to engage with a shuttle member, wherein the shuttle member is configured to be at least partially recessed in the outlet of the fluid reservoir before a priming operation.

[0053] Clause 22. A prime tube according to any one of Clauses 16 to 21, further comprising at least one engaging function on the prime tube configured to hold a side wall at the outlet of a fluid reservoir, wherein the shuttle member, in an initial position prior to the priming operation, locks at least one engaging function at the outlet of the fluid reservoir to prevent the prime tube from being removed from the fluid reservoir when the shuttle member is in the initial position, and when the shuttle member distally moves within the internal chamber to a second prime position, the at least one engaging function is released from the outlet of the fluid reservoir to allow the prime tube to be removed.

[0054] Clause 23. The prime tube according to any one of Clauses 16 to 22, wherein the shuttle member comprises a tip configured to extend distally from the distal end of the prime tube when the shuttle member is moved to a second prime position.

[0055] Clause 24. The prime tube according to any one of Clauses 16 to 23, wherein the shuttle component comprises a porous material that is permeable to air and substantially impermeable to medical fluids.

[0056] Clause 25. A prime tube according to any one of Clauses 16 to 24, wherein the shuttle member defines at least one opening having a cross-sectional area of ​​a size that allows the passage of air and substantially prohibits the passage of medical fluid.

[0057] Clause 26. A prime tube according to any one of Clauses 16 to 25, wherein the side wall comprises at least one indicator for indicating the distance traveled by a shuttle member corresponding to the fluid filling level of the internal chamber of the prime tube.

[0058] Clause 27. The sidewall of the prime tube as described in any one of Clauses 16 to 26 is at least partially translucent or transparent so that the shuttle member is visible through the sidewall.

[0059] Clause 28. A prime tube for use with a fluid injector system, the prime tube comprising a side wall defining an internal chamber having an expandable volume, and a connector associated with the proximal end of the side wall and configured to reversibly engage with an outlet of a fluid reservoir containing a medical fluid, wherein the side wall is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber, wherein in the contracted state the distal portion of the side wall is coiled over the proximal portion of the side wall, and in the expanded state the distal portion of the side wall is at least partially unfolded from the proximal portion of the side wall, and the volume defined by the internal chamber is greater when the side wall is expanded than when it is contracted.

[0060] Clause 29. In the contracted state, the inner surface of the distal portion of the side wall faces the inner surface of the proximal portion of the side wall, as described in Clause 28.

[0061] Clause 30. A fluid injector system comprising: at least one fluid reservoir configured for injecting a medical fluid; a prime tube having a side wall defining an internal chamber having an expandable volume, and a connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of the fluid reservoir; and at least one processor programmed or configured to determine the priming state of the prime tube.

[0062] Clause 31. The fluid injector system according to Clause 30, wherein at least one processor is programmed or configured to determine the priming state of the prime tube based on the measured fluid pressure of at least one of the prime tube and the fluid reservoir.

[0063] Clause 32. A fluid injector system according to Clause 30 or 31, further comprising an actuator for injecting a medical fluid from at least one reservoir, wherein at least one processor is programmed or configured to determine the priming state of a primed tube based on the measured current flow of the actuator.

[0064] Clause 33. A fluid injector system according to any one of Clauses 30 to 32, wherein at least one processor is programmed or configured to determine the priming state of a prime tube based on at least one of expansion and shape change of the prime tube.

[0065] Clause 34. A fluid injector system according to any one of Clauses 30 to 33, wherein at least one processor is programmed or configured to determine the priming state of a prime tube based on sounds emitted from the prime tube.

[0066] Clause 35. A fluid injector system according to any one of Clauses 30 to 34, wherein at least one processor is programmed or configured to determine the priming state of a primed tube based on readings of the force of a motor of a fluid injector associated with delivering fluid from a fluid reservoir.

[0067] Clause 36. A fluid injector system according to any one of Clauses 30 to 35, wherein the side wall comprises at least one bellows, each of which is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure in the internal chamber, and the expandable volume defined by the internal chamber is greater when at least one of the at least one bellows is in the expanded state than when it is in the contracted state.

[0068] Clause 37. A fluid injector system according to any one of Clauses 30 to 36, wherein the side walls are made of an elastomer material configured to expand to an expandable volume in response to an increase in fluid pressure within the internal chamber.

[0069] Clause 38. A fluid injector system according to any one of Clauses 30 to 37, wherein the sidewall is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber, wherein in the contracted state, the distal portion of the sidewall is rolled over the proximal portion of the sidewall, and in the expanded state, the distal portion of the sidewall is at least partially unfolded from the proximal portion of the sidewall, and the expandable volume defined by the internal chamber is greater when the sidewall is in the expanded state than when it is in the contracted state.

[0070] Clause 39. A fluid injector system according to any one of Clauses 30 to 38, wherein the sidewall is in a coiled configuration when there is no fluid flow through the internal chamber, and in an unfolded configuration when fluid flows through the internal chamber.

[0071] Clause 40. A fluid injector system comprising: at least one fluid reservoir configured for injecting a medical fluid; a primed tube having a side wall defining an internal chamber, a shuttle member slidable within the internal chamber, and a connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of the fluid reservoir; and at least one processor programmed or configured to determine the priming state of the primed tube.

[0072] Clause 41. The fluid injector system according to Clause 40, wherein at least one processor is programmed or configured to determine the priming state of the prime tube based on the position of the shuttle member in the internal chamber.

[0073] Clause 42. The fluid injector system according to Clause 40 or 41, wherein the side wall of the prime tube is provided with at least one indicator corresponding to the fluid filling level of the internal chamber, and at least one processor is programmed or configured to determine the priming state of the prime tube based on the position of the shuttle member relative to at least one indicator.

[0074] Clause 43. A fluid injector system according to any one of Clauses 40 to 42, wherein the priming tube further comprises a cap having a proximal end configured to engage with the outlet of a fluid reservoir and a distal end configured to engage with a shuttle member, the shuttle member being configured to be at least partially recessed in the outlet of the fluid reservoir before the priming operation.

[0075] Clause 44. A fluid injector system according to any one of Clauses 40 to 43, wherein the prime tube further comprises at least one engaging function on the prime tube configured to hold a side wall at the outlet of a fluid reservoir, the shuttle member, in an initial position prior to the priming operation, engages at least one engaging function at the outlet of the fluid reservoir to prevent the removal of the prime tube from the fluid reservoir when the shuttle member is in the initial position, and when the shuttle member distally moves within the internal chamber to a second prime position, the at least one engaging function is released from the outlet of the fluid reservoir to allow the removal of the prime tube.

[0076] Further details and advantages of the various examples described herein will become apparent when you consider the following detailed descriptions of the various examples in conjunction with the accompanying drawings. [Brief explanation of the drawing]

[0077] [Figure 1] This is a perspective view of a fluid injector system according to one embodiment of the present disclosure. [Figure 2A] This is a schematic diagram of a fluid injector system according to one embodiment of the present disclosure. [Figure 2B] Figure 2A is a schematic diagram of the fluid injector system, showing the prime tubes attached to each syringe (for clarity, the various components in Figure 2A are not shown in Figure 2B). [Figure 3] This is a schematic diagram of the prime tube shown in Figure 2B according to one embodiment of the present disclosure. [Figure 4A] This is a perspective view of a prime tube according to one embodiment of the present disclosure. [Figure 4B] Figure 4A is an exploded view of the prime tube. [Figure 4C] This is a side cross-sectional view of the prime tube in its contracted state, as shown in Figure 4A. [Figure 4D] This is a side cross-sectional view of the prime tube in its expanded state, as shown in Figure 4A. [Figure 4E]Figure 4A shows a graph of the pressure in the prime tube over time. [Figure 5A] This is a perspective view of a prime tube according to one embodiment of the present disclosure. [Figure 5B] Figure 5A is an exploded view of the prime tube. [Figure 5C] This is a side cross-sectional view of the prime tube in its contracted state, as shown in Figure 5A. [Figure 5D] This is a side cross-sectional view of the prime tube in its expanded state, as shown in Figure 5A. [Figure 5E] Figure 5A shows a graph of the pressure in the prime tube over time. [Figure 6A] This is a perspective view of a prime tube according to one embodiment of the present disclosure. [Figure 6B] Figure 6A is an exploded view of the prime tube. [Figure 6C] This is a side cross-sectional view of the prime tube in its contracted state, as shown in Figure 6A. [Figure 6D] This is a side cross-sectional view of the prime tube in its expanded state, as shown in Figure 6A. [Figure 6E] Figure 6A shows a graph of the pressure in the prime tube over time. [Figure 7A] This is a perspective view of a prime tube according to one embodiment of the present disclosure. [Figure 7B] Figure 7A is an exploded view of the prime tube. [Figure 7C] This is a side cross-sectional view of the prime tube in its contracted state, as shown in Figure 7A. [Figure 7D] This is a side cross-sectional view of the prime tube in its expanded state, as shown in Figure 7A. [Figure 7E] Figures 7A to 7D show graphs of the pressure of the prime tube over time. [Figure 8A] This is a perspective view of a prime tube according to one embodiment of the present disclosure. [Figure 8B] Figure 8A is an exploded view of the prime tube. [Figure 8C] This is a side cross-sectional view of the prime tube in its initial state, as shown in Figure 8A. [Figure 8D]This is a side cross-sectional view of the primed tube in Figure 8A, which is in a primed state. [Figure 8E] Figure 8A shows a graph of the pressure in the prime tube over time. [Figure 9A] This is a perspective view of a prime tube according to one embodiment of the present disclosure. [Figure 9B] Figure 9A is an exploded view of the prime tube. [Figure 9C] This is a side cross-sectional view of the prime tube in its initial state, as shown in Figure 9A. [Figure 10A] This is a perspective view of a prime tube according to one embodiment of the present disclosure. [Figure 10B] Figure 10A is an exploded view of the prime tube. [Figure 10C] Figure 10A is a side cross-sectional view of the prime tube. [Figure 11A] This is a perspective view of a prime tube according to one embodiment of the present disclosure. [Figure 11B] Figure 11A is an exploded view of the prime tube. [Figure 11C] This is a side cross-sectional view of the prime tube in its initial state, as shown in Figure 11A. [Figure 11D] This is a side cross-sectional view of the primed tube in Figure 11A, which is in a primed state. [Figure 12A] This is a perspective view of a prime tube according to one embodiment of the present disclosure. [Figure 12B] Figure 12A is an exploded view of the prime tube. [Figure 12C] This is a side cross-sectional view of the prime tube in its initial state, as shown in Figure 12A. [Figure 12D] This is a side cross-sectional view of the primed tube in Figure 12A, which is in a primed state. [Figure 13] This is a side cross-sectional view of a prime tube according to one embodiment of the present disclosure. [Figure 14A] This is a side view of a prime tube according to one embodiment of the present disclosure. [Figure 14B] This is a side view of the prime tube in its contracted state (Figure 14A). [Figure 14C]This is a side cross-sectional view of the primed tube in the expanded primed state shown in Figure 14A. [Figure 15A] This is a side view of a prime tube in its initial state according to one embodiment of the present disclosure. [Figure 15B] This is a side view of the prime tube in Figure 15A, which is part of the prime configuration. [Modes for carrying out the invention]

[0078] Referring to drawings where similar reference numerals across several figures point to similar parts, this disclosure generally covers prime tubing for use with syringes in fluid injector systems.

[0079] For the purposes of the following description, the terms “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “side,” “vertical,” and their derivatives are as relevant to this disclosure as shown in the drawings. Spatial or directional terms such as “left,” “right,” “inside,” “outside,” “up,” and “down” should not be considered limiting, as the invention may envision various alternative directions. Where used herein, the singular “a,” “an,” and “the” refer to multiple objects unless otherwise explicitly indicated by the context. All numbers used in the specification and claims should be understood in all cases to be modified by the term “about.” The terms “approximately,” “about,” and “substantially” mean a range of plus or minus 10 percent of the stated value.

[0080] As used herein, the term "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" means any one of A, B, and C, or any combination of two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more A's, one or more B's, one or more C's, one or more A's and one or more B's, one or more A's and one or more C's, one or more B's and one or more C's, or one or more of all A, B, and C. Similarly, as used herein, the term "at least two" is synonymous with "two or more." For example, the phrase "at least two of D, E, and F" means any combination of two or more of D, E, and F. For example, “at least two of D, E, and F” includes one or more Ds and one or more Es, one or more Ds and one or more Fs, one or more Es and one or more Fs, or one or more of all of D, E, and F.

[0081] It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely illustrative examples of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the examples disclosed herein should not be considered limiting.

[0082] When used in relation to components of a fluid delivery system, such as a fluid reservoir, syringe, air suspension device, or fluid line, the term “distal” refers to the part of the component closest to the patient. When used in relation to components of an injector system, such as a fluid reservoir, syringe, air suspension device, or fluid line, the term “proximal” refers to the part of the component closest to the injector of the injector system (i.e., the part of the component furthest from the patient). When used in relation to components of a fluid delivery system, such as a fluid reservoir, syringe, air suspension device, or fluid line, the term “upstream” refers to the direction away from the patient toward the injector of the injector system. For example, if a first component is referred to as “upstream” of a second component, the first component is located closer to the injector than the second component. When used in relation to components of a fluid delivery system, such as a fluid reservoir, syringe, air suspension device, or fluid line, the term “downstream” refers to the direction away from the injector of the fluid delivery system toward the patient. For example, when it is mentioned that the first component is "downstream" of the second component, the first component is located closer to the patient than the second component. Terms such as "first," "second," etc., are not intended to refer to a specific order or time series, but rather to different conditions, characteristics, or elements. The term "at least" is synonymous with "greater than or equal to." The term "not more than" is synonymous with "less than or equal to."

[0083] It should be understood that this disclosure may envision alternative variations and step sequences unless expressly otherwise specified. It should also be understood that certain devices and processes shown in the accompanying drawings and described in the following specification are merely illustrative embodiments of this disclosure. Accordingly, certain dimensions and other physical characteristics relating to the examples disclosed herein should not be considered limiting.

[0084] While the devices, systems, and methods described herein are generally described in the context of angiography (CV) infusion systems, other pressurized infusion protocols such as computed tomography (CT), ultrasound, positron emission tomography (PET), and magnetic resonance imaging (MRI) can also incorporate various embodiments of the priming tubes described herein. Furthermore, while many of the embodiments or priming tubes described herein are detailed with reference to syringes or syringe-based fluid injectors, it should be understood that various embodiments of the priming tubes described herein can be used to prime other powered infusion systems, such as those including pumps, including peristaltic pumps, that require priming of reservoirs and / or fluid tubing sets.

[0085] Referring to drawings where similar reference numerals across several figures point to similar parts, this disclosure generally covers prime tubing for syringes in fluid injector systems. Referring first to Figure 1, one embodiment of a dual syringe angiography injector system 2000 is shown. The angiography injector system 2000 is configured to inject two medical fluids through a first fluid path 210A for a medical fluid, such as an imaging contrast medium for angiography injection procedures, and a second fluid path 210B for a flushing fluid, such as saline or Ringer's lactate solution. The fluid paths 210A, 210B may be connected to outlets 16A, 16B, e.g., nozzles, of syringes 10A, 10B, respectively. The dual syringe angiography injector system 2000 may include an injector housing 12 having two syringe ports 15 configured to engage with syringes 10A, 10B. In some embodiments, syringes 10A and 10B may be held within corresponding pressure jackets 17A and 17B to prevent, for example, pressure-induced expansion and potential rupture of syringes 10A and 10B.

[0086] The fluid injector system 2000 may further include at least one graphical user interface (GUI) 11 through which an operator can visually monitor and control the status of the injection process. The GUI 11 can send and receive commands between the GUI 11 and the fluid injector system 2000 and can operately communicate with a controller 900 (see Figures 2A to 3) that receives input from the GUI 11 and the fluid injector system 2000.

[0087] Continuing to refer to Figure 1, the dual syringe angiography injector system 2000 may further include bulk fluid containers 19A and 19B for filling and refilling the respective syringes 10A and 10B with imaging contrast medium and flushing fluid, respectively. The bulk fluid containers 19A and 19B can be selectively fluid-communicated with syringes 10A and 10B via their respective bulk fluid pathways 216A and 216B and bulk fluid valves 215A and 215B.

[0088] Further details and examples of suitable non-limiting power injector systems including syringes, pressure jackets and pressure jacket retaining mechanisms, tubing, shut-off valves, controllers, and air detectors can be found in U.S. Patent Nos. 5,383,858, 7,553,294, 7,666,169, 8,945,051, 10,022,493, and 10,507,319, as well as International Application No. PCT / US2013 / 061275, International Application No. PCT / U These disclosures are described in International Application No. S2018 / 034613, International Application No. PCT / US2020 / 049885, International Application No. PCT / US2021 / 035273, International Application No. PCT / US2021 / 029963, International Application No. PCT / US2021 / 018523, International Application No. PCT / US2021 / 037623, International Application No. PCT / US2021 / 037574, and International Application No. PCT / US2021 / 045298, the entirety of which is incorporated herein by reference.

[0089] Referring here to Figure 2A, a schematic diagram of the fluid injector system 2000 shown in Figure 1 is shown. The injector system 2000 includes pistons 13A, 13B, each associated with syringes 10A, 10B and their corresponding pressure jackets 17A, 17B (see Figure 1). Each of the pistons 13A, 13B is configured to drive the respective plungers 14A, 14B in the barrels of the respective syringes 10A, 10B. The controller 900 is operablely associated with the injector system 2000 to, for example, actuate the pistons 13A, 13B to reciprocate the plungers 14A, 14B within the syringes 10A, 10B, thereby performing and stopping the injection procedure. In the corresponding peristaltic pump system, the controller 900 would be configured to actuate the rotor of the corresponding peristaltic pump. Specifically, the controller 900 may include at least one processor programmed or configured to act on various other components of the injector system 2000, such as pistons 13A, 13B and one or more valves 215A, 215B, to take in and deliver medical fluid according to programmed protocols for infusion procedures. The controller 900 may also include a computer-readable medium, such as memory, on which one or more infusion protocols can be stored for execution by at least one processor.

[0090] The controller 900 may be programmed or configured to perform a filling operation in which pistons 13A, 13B associated with each syringe 10A, 10B are drawn toward the proximal end of the syringes 10A, 10B to draw in injection fluid F (e.g., imaging contrast medium and flushing fluid) from the bulk fluid containers 19A, 19B into the syringes 10A, 10B. During such a filling operation, the controller 900 may be programmed or configured to selectively actuate bulk fluid valves 215A, 215B to establish fluid communication between each syringe 10A, 10B and the bulk fluid containers 19A, 19B via bulk fluid paths 216A, 216B in order to control the filling of the syringes 10A, 10B with the appropriate injection fluid F.

[0091] The controller 900 may be programmed or configured to perform a priming / purging operation to remove all air from syringes 10A and 10B upon completion of the filling operation. Specific details of the priming / purging operation are described herein in relation to various embodiments of the priming tube 300 shown in Figures 3 to 15B.

[0092] Following the filling and priming operations, the controller 900 may be programmed or configured to perform a delivery operation in which pistons 13A, 13B associated with one or both of the syringes 10A, 10B are moved toward the distal end of the syringes, respectively, to inject the injectable fluid F into the first fluid pathway 210A and the second fluid pathway 210B. The controller 900 may be programmed or configured to selectively actuate bulk fluid valves 215A and 215B to establish fluid communication between the syringes 10A, 10B and the patient via the fluid pathways 210A and 210B. The first fluid pathway 210A and the second fluid pathway 210B eventually merge into a patient fluid line 210C that fluidizes into communication with the patient's vascular system.

[0093] Referring here to Figure 2B, the fluid injector system 2000 is shown with the priming tube 300 attached to each of the syringes 10A and 10B. The priming tube 300 may be attached to the syringes 10A and 10B after they have been filled from bulk fluid containers 19A and 19B and before the infusion procedure. Another embodiment may focus on priming at least a portion of the tubing in preparation for a fluid infusion procedure. For example, in one embodiment, the priming tube configuration described herein may be attached to the distal end of a tubing set (as shown in Figure 2A), such as the multi-purpose portion of the tubing set, and used to ensure priming of air from the syringe and the multi-purpose portion of the tubing set. In another embodiment, the priming tube may be attached to the distal end of a newly installed single-patient tubing set (attached to a multi-purpose tubing set) to ensure priming of the single-patient tubing set before attachment to a patient catheter. Fluid paths 210A and 210B may be disconnected from syringes 10A and 10B to allow connection of the prime tube 300. With the prime tube 300 connected to syringes 10A and 10B, the fluid injector system 2000 may be operated to prime / purge syringes 10A and 10B by extending pistons 13A and 13B distally to discharge air from syringes 10A and 10B into the associated prime tube 300. In some embodiments, the controller 900 may be programmed or configured to extend each of the pistons 13A and 13B by a predetermined distance corresponding to a predetermined amount of air / fluid to discharge a predetermined amount of air / fluid from each syringe 10A and 10B into the associated prime tube 300. The predetermined amount of air / fluid can be selected to ensure that all (or substantially all) of the air in syringes 10A and 10B is discharged into the prime tube 300. For example, a predetermined air / fluid volume can be selected based on empirical data on the maximum amount of air in the syringe after the filling operation.The predetermined air / fluid volume may include a safety factor to ensure that even an unusually large amount of air is completely discharged from the syringe during the priming / purging operation. Since the predetermined air / fluid volume is typically greater than the actual amount of air present in syringes 10A and 10B, some amount of medical fluid F is discharged into the priming tube 300 along with the amount of air. Once the priming operation is complete, the priming tube 300 may be disconnected from syringes 10A and 10B, and the fluid paths 210A and 210B may be reconnected in the configuration shown in Figure 2A in preparation for the injection procedure. The priming tube 300 may be configured to retain the medical fluid F after it has been disconnected from syringes 10A and 10B to prevent leakage and spillage. In some embodiments, the priming tube 300 may be discarded after it has been disconnected from syringes 10A and 10B.

[0094] In some embodiments, the fluid injector system 2000 may include one or more priming state sensors 910 associated with the prime tube 300 and / or syringes 10A, 10B. The priming state sensors 910 may be able to communicate with the controller 900 and may be configured to detect the priming state, for example, whether the syringes 10A, 10B have been primed to remove all air from them, based on observation and / or measurement of air and fluid in the prime tube 300. In various embodiments, the priming state sensors 910 may include optical sensors (e.g., cameras), strain gauges, microphones, ammeters, limit switches, pressure transducers, or any other various sensors capable of detecting characteristics of the system 2000 that can be used to determine the priming state. Further details of the priming state sensors 910 are provided in the context of specific embodiments of the prime tube 300, as described herein with reference to Figures 4 to 15B.

[0095] Referring here to Figure 3, in some embodiments, the prime tube 300 may include a side wall 310 having a proximal end 312 and a distal end 314 that defines an internal chamber 350. The proximal end 312 of the side wall 310 may include a connector 320 configured to reversibly engage with the outlets 16A, 16B of associated fluid reservoirs such as syringes 10A, 10B. In some embodiments, the connector 320 may include one or more engaging lugs 322 having a profile that complements the side threads of the outlets 16A, 16B of syringes 10A, 10B. In some embodiments, one or more engaging lugs 322 may be configured to release from the outlets 16A, 16B of syringes 10A, 10B at a predetermined fluid pressure within the prime tube 300. In some embodiments, the connector 320 may be a female Luer connector. In another embodiment, the connector may be the male or female portion of a connector and may be configured to interface / connect with a corresponding complementary female or male connector, as described in International Application No. PCT / US2021 / 018523.

[0096] In some embodiments, the priming tube 300 may include a closure 330 associated with the distal end 314 of the side wall 310. The closure 330 may be permeable to air and substantially impermeable to liquids containing the medical fluid F. For example, according to various embodiments, the closure 330 may be a porous material, such as a material having at least one opening, having a cross-sectional area of ​​a size that allows the passage of air and substantially prohibits the passage of the medical fluid through at least one opening. Thus, during the priming operation of syringes 10A and 10B, the air discharged from syringes 10A and 10B by the pressurization of the syringe contents can flow out of the priming tube 300 through the closure 330, while all the medical fluid F discharged from syringes 10A and 10B is retained in the internal chamber 350. Due to the difference in compressibility between a gas such as air and a liquid such as a medical fluid F (e.g., contrast agent or saline solution), the pressure rises within the prime tube 300 after the air has been expelled from the syringe and the liquid has been expelled into the prime tube 300. According to various embodiments, the pressure difference between the air and the liquid medical fluid can be used to determine the priming state of the syringe. In some embodiments, the closure 330 may be made of hydrophobic medical-grade plastics, such as those commercially available under trade names Gore-tex® and Porex®, which generally allow the passage of gases but not liquids. In some embodiments, the closure 330 may be made of a solid material that defines one or more openings having a cross-sectional area sufficient to allow the passage of air from the prime tube 300 but insufficient to allow the passage of the medical fluid F. In some embodiments, the closure 330 may include an absorbent material, such as cotton or other fibrous material, to absorb the medical fluid F while allowing air to pass through the prime tube 300. In some embodiments, the closure 330 may be a solid material that is permeable to all fluids, such as air and medical fluids, so that all fluids injected from syringes 10A and 10B into the prime tube 300 are retained within the internal chamber 350.

[0097] In some embodiments, the closure 330 may include a crack pressure valve, such as a high crack pressure valve, configured to open in response to a predetermined fluid pressure. Thus, the closure 330 can remain closed as the pressure rises within the prime tube 300, or it can open at a predetermined fluid pressure to allow air and / or fluid to exit the prime tube 300.

[0098] In some embodiments, the internal chamber 350 can define an expandable volume. That is, the volume of the internal chamber 350 may increase as the side walls 310 stretch, unfold, open, or otherwise change shape. In such embodiments, the side walls 310 may be made of an expandable, foldable, and / or elastic material. In some embodiments, the expandable volume of the internal chamber 350 increases as fluid enters the internal chamber 350 so that the internal chamber 350 can receive the volume of fluid discharged from syringes 10A, 10B. In some embodiments, the internal chamber 350 may be configured to expand or become rigid in response to the increase in fluid pressure as the fluid is discharged into the internal chamber 350.

[0099] In some embodiments, the side wall 310 may be biased toward a contracted state, for example, when the prime tube 300 is supplied and initially connected to syringes 10A, 10B, and the internal chamber 350 has a minimum volume. According to certain configurations, when the internal chamber 350 expands due to an increase in fluid pressure, such fluid pressure must be maintained, or the internal chamber 350 will tend to return to a contracted state, at least partially, and discharge the fluid back through the connector 320. According to these configurations, a one-way valve 340, such as a check valve, may be provided adjacent to or integrally with the connector 320 of the prime tube 300 to prevent fluid leakage from the prime tube 300 when the body pressure is released, for example when the prime tube 300 is disconnected from syringes 10A, 10B. In this way, unintended leakage or spillage of medical fluid when the prime tube 300 is removed from the syringe is avoided.

[0100] In some embodiments, the side wall 310 can be stable in both the contracted and expanded states, such that the internal chamber 350 is not biased toward either the contracted or expanded state. In such embodiments, the release of fluid pressure from the internal chamber 350, such as when the prime tube 300 is disconnected from the syringes 10A, 10B, does not result in the internal chamber 350 returning to the contracted state. Therefore, the one-way valve 340 may not need to prevent the outflow of fluid returning from the prime tube 300. However, the one-way valve 340 may still be provided to prevent unintended fluid discharge, such as when a technician compresses the side wall 310 while removing the prime tube 300 from the syringes 10A, 10B, or when the prime tube 300 is accidentally tilted so that gravity causes the fluid within it to flow into the connector 320.

[0101] The change in shape of the side wall 310 due to the expansion of the internal chamber 350 can be used as an indicator that the priming / purging operation of syringes 10A and 10B is complete. The change in shape of the side wall 310 can be detected by a priming state sensor 910, which can transmit an output signal indicating the priming status of syringes 10A and 10B to a controller 900. In another embodiment, a technician can determine visually or audibly that the priming operation is complete.

[0102] In some embodiments, the sidewall 310 may be substantially rigid, meaning that the sidewall does not substantially deform under the pressure associated with the injection treatment, for example, 1200 psi in a CV treatment.

[0103] In some embodiments, the internal chamber 350 may have a volume sufficient to hold a predetermined amount of fluid discharged from the associated syringes 10A and 10B during the syringe priming / purging operation. In some embodiments, the volume defined by the internal chamber 350 may range from 5 mL to 30 mL, and in other embodiments from 5 mL to 10 mL. In certain embodiments, the volume should be sufficient to account for cases where two or more priming sequences are required, for example, when bubbles are still observed in the system. In certain embodiments, the priming operation may include two injection sequences: a first forced flow rate with a small discharge to remove most of the air from the system, and a second slower flow rate with a larger flow rate, optionally accompanied by tapping or vibration, to remove smaller bubbles.

[0104] To perform a priming / purging operation to expel air from syringes 10A and 10B, syringes 10A and 10B may be held in a substantially upright vertical position with outlets 16A and 16B at their highest point, and syringes 10A and 10B may be primed to purge all air from inside them, for example, by moving pistons 13A and 13B distally to expel some of the contents of the syringes (i.e., air and medical fluid F). In the vertical position, most of the air inside syringes 10A and 10B rises to the distal end of the syringe adjacent to outlets 16A and 16B due to the buoyancy of the air in the medical fluid F. When syringes 10A and 10B are primed, the air at the distal end of syringes 10A and 10B is expelled through outlets 16A and 16B and enters the internal chamber 350 of the priming tube 300. During the priming operation, to ensure that all air is primed, air can be removed from various internal surfaces of the syringe and the plunger surface. Examples of such methods for removing air bubbles (including microbubbles) from internal or plunger surfaces are described in International Publication No. 2019 / 204617, which is incorporated herein by reference, for example, by placing the syringe contents under at least partial vacuum to combine small bubbles into larger ones, or by separately shocking the syringe or piston / plunger assembly to remove air bubbles.

[0105] Referring here to Figures 4A to 15B, various embodiments of the prime tube 300 are shown. Components of the embodiments shown in Figures 4A to 15B, which have the same reference numerals as the embodiments in Figure 3, represent similar and / or functionally equivalent components. Referring first to Figures 4A to 4D, one embodiment of the prime tube 300 includes an expanding sidewall 310 having at least one bellows 316. At least one bellows 316 is configured to expand and contract in order to longitudinally increase the volume of an internal chamber that extends longitudinally between the proximal end 312 and the distal end 314 of the sidewall 310. At least one bellows 316 includes alternating wide-diameter sections 317 and narrow-diameter sections 318 (see Figure 4D). First, at least one bellows 316 is provided in a contracted state (see Figure 4C) in which the distance between the nearest wide-diameter section 317 and the farthest wide-diameter section 317 is minimized. In the contracted state shown in Figure 4C, the length of the side wall 310 and the internal volume of the internal chamber 350 are minimized compared to the expanded state shown in Figure 4D. As a result, the volume defined by the internal chamber 350 is larger in the expanded state.

[0106] Continuing to refer to Figures 4A to 4D, in some embodiments, a closure 330, in the form of a porous plug formed from a porous hydrophobic polymer or another material as described herein, substantially permeable to air and impermeable to liquid, is inserted into or otherwise connected to the distal end 314 of the prime tube 300. The closure 330 may be configured to allow air or other gases to pass through the pores of the material while preventing the medical fluid F from escaping from the internal chamber 350. It should be noted that the position of the porous plug may be located elsewhere on the prime tube 300, while still allowing air to escape from the prime tube 300 and retaining liquid within the prime tube 300.

[0107] During the priming / purging operation of syringes 10A and 10B, the air expelled from syringes 10A and 10B passes through the internal chamber 350 and exits through the closure 330 at the distal end 314. Due to the compressibility of the air, the configuration of at least one bellows 316 remains substantially unchanged and in a contracted state. As the air continues to be primed, eventually some medical fluid F pushes the remaining air from syringes 10A and 10B into the priming tube 300, and some amount of medical fluid F itself enters the priming tube 300. The medical fluid F moves through at least one bellows 316 and comes into contact with the porous plug of the closure 330, but the medical fluid F cannot pass through it. As a result, the fluid pressure in the internal chamber 350 increases, and at least one bellows 316 begins to expand from a compressed state to an extended state (compare Figure 4C with Figure 4B).

[0108] The expansion of the bellows 316 in the side wall 310 can be visualized by an engineer to confirm that substantially all air has been purged from syringes 10A, 10B and that syringes 10A, 10B are primed and ready for use. In some embodiments, the priming state sensor 910 (see Figures 2B and 3) may include an image recognition detector, such as a camera, as described in U.S. Patent No. 10,201,666, whose disclosure is incorporated herein by reference. Based on the output signal from the priming state sensor 910, the controller 900 may be programmed or configured to determine that the priming tube 300 is expanded and that the air in syringes 10A, 10B is primed. The processor 900 may be configured to prevent the fluid injection procedure until it receives an indicator that syringes 10A, 10B are properly primed. Once successful priming is established, as determined by the controller 900 and / or technician, the priming tube 300 may be removed and discarded in accordance with hospital protocols, and the properly primed patient catheter line may be installed in syringes 10A, 10B. While the priming tube embodiments described herein are used to ensure priming of air from syringes, it should be noted that various embodiments of priming tubes may also be used to ensure priming of air from tubing sets and syringes. According to these embodiments, the priming tube may be positioned at the distal end of a tubing set (as shown in Figure 2A) and may be used in a similar manner to determine that all air has been effectively removed from the internal volume of the tubing set, and, in certain embodiments, to form a corresponding (one or more) syringe and / or (one or more) peristaltic pump mechanism attached to the (one or more) proximal end of the tubing set.

[0109] Continuing to refer to Figures 4A to 4D, in some embodiments, each of the bellows 316 may be configured to emit an audible sound, such as a popping sound, when transitioning from a contracted state to an expanded state. The technician can use the sound as an indicator that substantially all the air has been purged from syringes 10A and 10B and that syringes 10A and 10B are primed and ready for use. In addition, the priming state sensor 910 may include a microphone configured to detect the sound and transmit a signal to the processor 900, which can determine, based on the signal, that syringes 10A and 10B are primed. For example, the technician or the processor 900 can count the number of popping sounds corresponding to the expansion of at least one bellows 316 to determine when the primed tube 300 is in a fully expanded configuration and relate this to the total number of bellows functional units.

[0110] Referring here to Figure 4E, a graph 400 is shown illustrating the fluid pressure in the prime tube 300 over time for embodiments of Figures 4A to 4D. The fluid pressure, represented by curve 402, is initially substantially constant in section 404, as primarily air is injected into the internal chamber 350 and flows through the porous material of the closure 330. Subsequently, the fluid pressure experiences several peaks 410 as the medical fluid F enters the internal chamber 350 and transitions each of the at least one bellows 316 from a contracted state to an expanded state. Specifically, since the medical fluid F cannot flow out from the distal end 314, the fluid pressure rises until the first of the at least one bellows 316 transitions to an expanded state. Once the first of the at least one bellows 316 expands, the fluid pressure decreases due to the increase in the volume of the internal chamber 350 resulting from the expansion of the bellows 316. As more fluid is discharged into the internal chamber 350 from syringes 10A, 10B, the pressure rises again until another of the bellows 316 expands. This process continues until all of the bellows 316 are in the expanded state and the priming operation is complete. After all of the bellows 316 are in the expanded state, the fluid pressure rises, as shown by the tail section 412 of curve 402, until the fluid flow stops.

[0111] In some embodiments, the priming state sensor 910 may include a motor current (or motor force) sensor configured to measure the flow of current in the drive motor associated with the pistons 13A, 13B. The controller 900 may be programmed or configured to detect changes in fluid pressure based on changes in motor current. Specifically, changes in motor current may correlate with changes in fluid pressure in the priming tube 300, as shown in the graph in Figure 4E. When the motor current, and thus the fluid pressure, continues to rise after the last bellows 316 has expanded, the controller 900 may stop the priming operation and indicate that the system is primed and can proceed to the next step in the injection protocol. Alternatively, after a predetermined number of bellows 316 have expanded, the controller 900 may determine that the system is effectively primed.

[0112] Referring here to Figures 5A to 5D, one embodiment of the prime tube 300 including an expandable side wall 310 is shown. The side wall 310 may be made of a flexible or expandable elastomer material or balloon that expands when there is a pressure difference between the inner chamber 350 and the environment outside the side wall 310. The material of the side wall 310 may be elastic in that, when stretched, the side wall 310 will try to return to its initial state. Thus, when the fluid pressure is removed from the inner chamber 350, the side wall 310 contracts, pushing the fluid back out from the proximal end 312 of the prime tube 300. A one-way valve 340 is provided to prevent backflow from the proximal end 312 when the prime tube 300 is detached from the syringe. The prime tube 300 is provided in a non-expandable configuration as shown in Figures 5A to 5C.

[0113] Continuing to refer to Figures 5A to 5D, in one embodiment, the closure 330 may be a sealing plug inserted into or otherwise connected to the distal end 314 of the prime tube 300. The sealing plug can prevent all fluid, including both air and medical fluid F, from escaping from the distal end 314 of the prime tube 300. Due to the sealed nature of the side wall 310 by the one-way valve 340 and the closure 330, the air and liquid are trapped within the internal chamber 350 during the priming operation. As the air continues to be primed, eventually some of the medical fluid F pushes the remaining air into the prime tube 300, and the medical fluid F itself enters the internal chamber 350. As the volume of air and subsequent fluid in the side wall 310 increases, the pressure in the side wall 310 increases, and the flexible, expandable wall of the side wall 310 expands, similar to the inflation of a balloon. Specifically, as the pressure increases within the prime tube 300, the side wall 310 begins to expand from the compressed state shown in Figures 5A-5C to the expanded state shown in Figure 5D. When the volume of the internal chamber 350 reaches a certain size, the technician can determine that the syringes 10A and 10B are primed and ready for injection. In certain embodiments, the elastic properties of the side wall 310 can be selected such that, due to the compressibility of gases, it does not expand substantially under pressurized air, but expands as the hydraulic pressure increases within the internal chamber 350.

[0114] In another embodiment, the closure 330 may be porous so that air can pass through but liquid is impermeable. In this embodiment, similar to the bellows (Figures 4A-4E), the elastomer sidewall 310 does not substantially expand even if such air flows into the internal chamber 350, as air flows out through the closure 330. However, when the liquid medical fluid F is injected into the internal chamber 350, the elastomer sidewall 310 expands, and the fluid pressure increases within it.

[0115] In some embodiments, the priming state sensor 910 may include a camera, as described herein in relation to Figures 3 and 4A-4D, in conjunction with a controller 900 for determining whether syringes 10A and 10B are being primed based on the sidewall 310 being in an expanded state. As described herein in relation to Figures 4A-4D, the controller 900 may be programmed or configured to prevent the execution of the injection procedure until successful priming of syringes 10A and 10B is detected.

[0116] During the removal of the prime tube 300 from syringes 10A and 10B, the one-way valve 340 prevents pressurized air and / or fluid in the internal chamber 350 from being released from the proximal end 312 of the prime tube 300. The entire prime tube 300 containing air and medical fluid F can be disposed of according to hospital protocols.

[0117] Referring here to Figure 5E, a graph 500 is shown showing the fluid pressure in the prime tube 300 over time for the prime tubes of Figures 5A–5D. The fluid pressure, represented by curve 502, initially rises slowly in section 504, with a low gradient, mainly as air is injected into the internal chamber 350, due to the compressibility of air. The fluid pressure continues to rise at a faster rate as the medical fluid F pushes out the remaining air from syringes 10A, 10B and some of the medical fluid F itself enters the internal chamber 350. The fluid pressure may experience a transition point 506 where the sidewalls 310 experience yielding due to the expansion of the sidewalls 310. As the full expanded volume of the internal chamber 350 approaches, the pressure rises at an even faster rate in section 508. In some embodiments, the priming state sensor 910 may include a motor current (or motor force) sensor configured to measure the flow of current in the drive motor associated with pistons 13A, 13B. The controller 900 may be programmed or configured to detect changes in fluid pressure based on changes in motor current and to associate the pressure measurements with the priming state. Specifically, changes in motor current can correlate with changes in fluid pressure within the priming tube 300, as shown in Figure 5E, allowing the controller 900 to determine when the system is effectively primed.

[0118] Referring here to Figures 6A to 6D, one embodiment of the prime tube 300 is shown, which includes a rolling diaphragm body with an expanding side wall 310. The side wall 310 is flexible or elastic so that it can be rolled up or folded over itself in response to the fluid pressure in the internal chamber 350. In the contracted state in which the prime tube 300 is initially provided, as shown in Figures 6A to 6C, the side wall 310 is positioned such that the distal portion 313 of the side wall 310 is rolled up or folded over within the internal space defined by the proximal portion 311 of the side wall 310. The distal portion 313 is rolled up over the proximal portion 311 such that the inner surface 323 of the distal portion 313 faces the inner surface 321 of the proximal portion 311. At least a portion of the distal portion 313 of the side wall 310 is configured to invert in response to an increase in fluid pressure within the internal chamber 350 in order to move the side wall 310 to the expanded position shown in Figure 6D. Specifically, the distal portion 313 inverts by unfolding / opening from the inside of the proximal portion 311 so that the side wall 310 takes the expanded state shown in Figure 6D. As a result, the volume defined by the internal chamber 350 is greater when the side wall 310 is in the expanded state than when it is in the contracted state.

[0119] Continuing to refer to Figures 6A to 6D, the closure 330 in this embodiment may include substantially the same porous material as in the embodiments of Figures 4A to 4D to allow air to pass through the closure 330 while retaining the medical fluid F in the internal chamber 350. During the priming / purging operation of the syringes, the air injected from syringes 10A and 10B into the priming tube 300 passes through the internal chamber 350 and exits through the porous material of the closure 330 at the distal end 314. Due to the compressibility of the air, the rolling diaphragm portion of the side wall 310 remains substantially unchanged, i.e., contracted, as the air is discharged from syringes 10A and 10B. As the air continues to prime, the medical fluid F pushes the remaining air from syringes 10A and 10B into the priming tube 300, pushing it out of the porous material of the closure 330, and the medical fluid F itself enters the internal chamber 350. Due to the hydrophobicity of the closure 330, the medical fluid F cannot escape the internal chamber 350. As the volume of the medical fluid F in the internal chamber 350 increases, the pressure inside the internal chamber 350 increases, causing the distal portion 313 to expand from inside the proximal portion 311, thus transitioning the side wall 310 from the contracted state shown in Figures 6A to 6C to the expanded state shown in Figure 6D.

[0120] When the volume of the internal chamber 350 reaches a certain size, or when the rolling diaphragm portion of the side wall 310 reaches a certain deployed state, for example, fully deployed, the technician can determine that substantially all air has been purged from syringes 10A, 10B, which means that syringes 10A, 10B are primed and ready for use. In some embodiments, the priming state sensor 910 (see Figures 2B and 3) may include an image recognition detector, such as a camera, as described in U.S. Patent No. 10,201,666. Based on the output signal from the priming state sensor 910, the controller 900 may be programmed or configured to determine that the priming tube 300 is in an expanded state and that the air in syringes 10A, 10B is primed. The processor 900 may be configured to prevent the fluid injection procedure until it receives an indicator that syringes 10A, 10B are properly primed. Once successful priming is established, as determined by the controller 900 and / or technician, the primed tube 300 may be removed and discarded in accordance with hospital protocols, and the properly primed patient catheter line may be placed in syringes 10A and 10B.

[0121] Referring here to Figure 6E, a graph 600 is shown illustrating the fluid pressure in the prime tube 300 over time for embodiments of Figures 6A to 6D. The fluid pressure, represented by curve 602, is initially substantially constant in section 604 as air is injected into the inner chamber 350 and flows through the porous material of the closure 330. The fluid pressure then increases as the medical fluid F enters the inner chamber 350 until it reaches a pressure sufficient to unfold the distal portion 313 of the side wall 310 from the proximal portion 311. The fluid pressure then remains substantially constant in section 608 as more fluid is discharged into the inner chamber 350 from syringes 10A and 10B, continuing to unfold the side wall 310 toward the expanded state. After the side wall 310 is substantially expanded, the volume of the inner chamber 350 is substantially minimized, and the fluid pressure increases substantially in section 610 as the fluid continues to be discharged from the syringes.

[0122] In some embodiments, the priming state sensor 910 may include a motor current (or motor force) sensor configured to measure the current flow of the drive motor associated with the pistons 13A, 13B. The controller 900 may be programmed or configured to detect changes in fluid pressure based on changes in motor current. Specifically, changes in motor current may correlate with changes in fluid pressure within the priming tube 300, as shown in the graph in Figure 6E.

[0123] Referring here to Figures 7A to 7D, one embodiment of the prime tube 300 is shown, which includes many of the same functional parts as the embodiments in Figures 6A to 6D, such as the rolling diaphragm sidewall 310. The main difference between these embodiments is that in the embodiments of Figures 7A to 7D, the distal end 314 of the sidewall 310 is completely sealed so that air cannot escape from the distal end 314. As a result, all fluid, including both air and medical fluid F, discharged from syringes 10A and 10B during the priming / purging operation is retained within the internal chamber 350. Due to the compressibility of air and the incompressibility of medical fluid, the rolling diaphragm remains substantially rolled when air is discharged into the prime tube 300, but then transitions to an expanded state as the fluid is discharged into the internal chamber 350 and the fluid pressure within the internal chamber 350 increases. The primed state can then be recognized by a technician or by a controller 900 using input from the priming state sensor 910, as described herein.

[0124] Referring here to Figure 7E, a graph 700 is shown illustrating the fluid pressure in the prime tube 300 over time for embodiments of Figures 7A to 7D. The fluid pressure, represented by curve 702, is initially substantially constant in section 704 as air is injected into the inner chamber 350 and flows through the porous material of the closure 330. The fluid pressure then increases as the medical fluid F enters the inner chamber 350 until it reaches a pressure sufficient to unfold the distal portion 313 of the side wall 310 from the proximal portion 311. The fluid pressure then remains substantially constant in section 708 as more fluid is discharged into the inner chamber 350 from syringes 10A and 10B, continuing to unfold the side wall 310 toward the expanded state. After the side wall 310 is substantially expanded, the volume of the inner chamber 350 is substantially minimized, and the air / fluid pressure increases substantially in section 710 as fluid continues to be discharged from syringes 10A and 10B. Therefore, the pressure behavior in the embodiments shown in Figures 7A to 7D is the same as in the embodiments shown in Figures 6A to 6D, except that the presence of the porous closure 330 in the embodiments shown in Figures 6A to 6D allows air to escape, thus reducing the pressure in the internal chamber 350 at least initially.

[0125] Referring to Figures 8A to 9C, embodiments of the prime tube 300 are shown, including a shuttle member 360 that is slidable within the internal chamber 350. According to these embodiments, the sidewall 310 may be substantially rigid and inelastic so as not to expand under normal priming pressure below a predetermined threshold. The shuttle member 360 is configured to slide within the internal chamber 350 from the proximal end 312 to the distal end 314 in response to the liquid being discharged from the syringes 10A, 10B into the prime tube 300. The shuttle member 360 is initially provided adjacent to or near the proximal end 312 in the prime tube 300. In some embodiments, the shuttle member 360 may be sized to have a friction fit with the sidewall 310 so as not to inadvertently dislodge the shuttle member 360 from the proximal end 312 until the prime tube 300 is pressurized from the syringes 10A, 10B. In some embodiments, the proximal end 312 of the side wall 310 has a slightly reduced diameter to increase the friction fit with the shuttle member 360 at the proximal end 312. Thus, the initial amount of fluid pressure required to dislodge the shuttle member 360 is greater than the fluid pressure required to move the shuttle member 360 the remaining distance to the distal end 314. In some embodiments, as shown in Figure 9C, the side wall 310 may include an internal lip 352 to hold the shuttle member 360 adjacent to or near the proximal end 312 until the prime tube 300 is pressurized from syringes 10A, 10B. The lip 352 or friction fit may be such that the shuttle member 360 does not dislodge under pneumatic pressure but dislodges and becomes slidable when fluid flows into the internal chamber 350.

[0126] In some embodiments, the shuttle member 360 can allow air to pass to the distal end 314 of the prime tube 300. In such embodiments, the shuttle member 360 may be made of a hydrophobic medical-grade plastic, as described herein, that is permeable to air but impermeable to the medical fluid F. In some embodiments, the dimensional tolerance between the outside of the shuttle member 360 and the inside of the side wall 310 may be such that air can pass between the shuttle member 360 and the side wall 310, but the medical fluid F cannot substantially pass between the shuttle member 360 and the side wall 310. In some embodiments, the shuttle member 360 may include one or more openings having a cross-sectional area sufficient to allow air to pass through but substantially prevent the passage of the medical fluid F.

[0127] The closure 330 is bonded to the opening 332 at the distal end 314 of the prime tube 300 and can function as a stop to prevent the shuttle member 360 from being discharged from the distal end 314 of the prime tube 300. The closure 330 may include an opening 332 to allow air to exit the distal end 314 of the prime tube 300. Various embodiments may include a lip or projection at the distal end 314 of the side wall 310 instead of the closure 330, and the inner diameter of the distal end 314 is smaller than the inner diameter of the side wall 310 to prevent the shuttle member 360 from being discharged from the distal end 314 of the prime tube 300.

[0128] During the priming / purging operation of syringes 10A and 10B, air passes through or around the shuttle member 360, through the internal chamber 350, and exits through the opening 332 of the closure 330. In some embodiments, the air can pass through or around the shuttle member 360 without substantially dislodging and / or moving the shuttle member 360 within the internal chamber 350. As the air continues to prime, some of the medical fluid F eventually pushes the remaining air from syringes 10A and 10B into the internal chamber 350, and the medical fluid F itself enters the internal chamber 350. The pressurized medical fluid F disengages the shuttle member 360 from friction fit with the side wall 310, causing the shuttle member 360 to slide distally toward the closure 330 within the internal chamber 350. As the medical fluid F continues to be injected into the internal chamber 350 from syringes 10A and 10B, the shuttle member 360 can continue to slide distally until it comes into contact with the closure 330 and is pushed out of the internal chamber 350 by the medical fluid F, which has been pressurized and contains virtually all of the air.

[0129] Continuing to refer to Figures 8A to 9C, the side wall 310 may be made of a translucent or transparent material so that the shuttle member 360 is visible through the side wall 310. The shuttle member 360 may be a conspicuous color that is easily visible so that the movement of the shuttle member 360 along the longitudinal axis of the internal chamber 350 can be observed or detected. Once a predetermined amount of medical fluid F has entered the priming tube 300, as evidenced by the longitudinal position of the shuttle member 360 within the internal chamber 350, the technician can determine that the syringes 10A and 10B have been fully primed. In some embodiments, the internal chamber 350 may be sized such that the shuttle member 360 contacts the closure 330 (as shown in Figure 8D) once a sufficient amount of medical fluid F to prime the syringes 10A and 10B has been discharged into the internal chamber 350. In such embodiments, the cessation of movement of the shuttle member 360, indicating that the shuttle member 360 has engaged with the closure 330, can be observed by an engineer to establish that the syringes 10A and 10B have been fully primed.

[0130] In some embodiments, the priming state sensor 910 (see Figures 2B and 3) may be configured to detect the position of the shuttle member 360 within the internal chamber 350. Referring particularly to Figures 9A–9C, the side wall 310 may include one or more ribs 319 or other boundaries or indicators that can be used by technicians and / or the priming state sensor 910 as a scale to help determine the relative position and distance traveled of the shuttle member 360 within the internal chamber 350, and thus the amount of medical fluid F that has entered the priming tube 300. The priming state sensor 910 may include an image recognition detector, such as a camera, as described in U.S. Patent No. 10,201,666. Based on the output signal from the priming state sensor 910, the controller 900 may be programmed or configured to determine that the shuttle member 360 has traveled a sufficient distance to indicate that the syringes 10A, 10B have been primed with air. The processor 900 may be configured to prevent the fluid injection procedure until it receives an indicator that the syringes 10A, 10B have been successfully primed. Once successful priming is established, as determined by the controller 900 and / or technician, the primed tube 300 may be removed and discarded according to hospital protocols, and a properly primed patient catheter line may be placed in syringes 10A, 10B. The primed tube 300 may include a one-way check valve at its proximal end to prevent fluid leakage after removal.

[0131] In some embodiments, the opening 332 of the closure 330 may be sized to produce an audible sound, such as a whistle, when air flows through the opening 332, or may have a flow function configured to do so. A technician can determine that the syringes 10A, 10B have been primed when the opening 332 stops producing sound, which indicates that substantially all the air has been expelled from the internal chamber 350. Alternatively, the priming state sensor 910 may include a microphone configured to detect sound emitted from the opening 332. The controller 900 may be programmed or configured to determine that the syringes 10A, 10B have been primed when the opening 332 stops producing sound, which indicates that substantially all the air has been expelled from the internal chamber 350.

[0132] Referring here to Figure 8E, a graph 800 is shown illustrating the fluid pressure in the prime tube 300 over time for embodiments of Figures 8A to 8D. The fluid pressure, represented by curve 802, is initially substantially constant in section 804, as primarily air is injected into the inner chamber 350 and flows through or around the shuttle member 360. The fluid pressure then increases as the medical fluid F enters the inner chamber 350 until it reaches a pressure sufficient to dislodge the shuttle member 360 from its proximal end 312. The dislodgement of the shuttle member 360 can cause a pressure spike 812 once the initial static friction between the shuttle member 360 and the side wall 310 is overcome. The pressure then stabilizes in section 814 as the shuttle member 360 slides along the prime tube 300 until it is displaced by the medical fluid F and reaches its distal end 314. Once the shuttle member 360 contacts the distal end, the fluid pressure rises rapidly within the inner chamber 350, as shown by section 816.

[0133] In some embodiments, the priming state sensor 910 may include a motor current (or motor force) sensor configured to measure the flow of current in the drive motor associated with the pistons 13A, 13B. The controller 900 may be programmed or configured to detect changes in fluid pressure based on changes in motor current. Specifically, changes in motor current may correlate with changes in fluid pressure in the priming tube 300, as shown in the graph in Figure 8E. For example, when the pressure stabilizes in section 814 or rises dramatically in section 816, the controller 900 may determine that air has been primed from the syringe and provide an indicator that the priming operation is complete.

[0134] Referring here to Figures 10A to 10C, one embodiment of the prime tube 300 is shown in which a side wall 310 defines a cap 370 at a distal end 314 having one or more air vents 372 and a plug retaining member 374. A shuttle member 360 in the form of a porous plug is provided within the cap 370 and is held by the plug retaining member 374 at the outlets 16A and 16B of the syringes 10A and 10B in the initial state or position of the prime tube 300. In some embodiments, the shuttle member 360 may be made from a hydrophobic medical-grade plastic, such as those described herein, which is permeable to air but impermeable to the medical fluid F. In some embodiments, the shuttle member 360 may be made of a solid material that defines one or more openings having a cross-sectional area sufficient to allow the passage of air but insufficient to allow the passage of the medical fluid F.

[0135] During the priming / purging operation, air discharged from syringes 10A and 10B passes through the porous shuttle member 360, flows into the internal chamber 350, and exits through one or more air release holes 372. As the air continues to be primed and purged from syringes 10A and 10B, some medical fluid F eventually pushes the remaining air out of syringes 10A and 10B through the shuttle member 360, and the medical fluid F comes into contact with the proximal surface 362 of the shuttle member 360. Since the medical fluid F cannot pass through the shuttle member 360, the fluid pressure rises against the proximal surface 362, moving the shuttle member 360 to a second primed position and compressing it against the plug retaining member 374.

[0136] In some embodiments, the controller 900 may be configured to measure fluid pressure at the proximal surface 362 of the shuttle member 360. Specifically, the priming state sensor 910 may include a motor current (or motor force) sensor configured to measure the flow of current in a drive motor associated with pistons 13A, 13B. The controller 900 may be programmed or configured to determine the fluid pressure based on the flow of motor current. The controller 900 may be programmed or configured to determine that syringes 10A, 10B have been primed when a predetermined fluid pressure is measured. Once successful priming is established by the controller 900, the priming tube 300 may be removed and discarded according to hospital protocols, and a properly primed patient catheter line may be installed in syringes 10A, 10B. One feature of the priming tube 300 shown in Figures 10A to 10C is that the amount of medical fluid F discharged during the priming operation is minimized, reducing hospital waste and saving costs. When the controller 900 determines that the syringe has been primed, the controller can release the pressure on the pistons 13A and 13B and depressurize the fluid in the syringe to ensure that the pressurized fluid is not discharged from the syringe when the prime tube 300 is removed.

[0137] Referring here to Figures 11A to 11D, one embodiment of the prime tube 300 having an indicator tab extending distally is shown. The side wall 310 defines a cap 370 at the distal end 314 having a receiving opening 376. The side wall 310 engages with threaded connectors at the outlets 16A and 16B of the syringes 10A and 10B by threaded lugs 322. A shuttle member 360 in the form of a porous plug is provided within the internal chamber 350, and in the initial state or position of the prime tube 300, the shuttle member 360 is held at the outlets 16A and 16B of the syringes 10A and 10B by press-fitting. In some embodiments, the shuttle member 360 may be made from a hydrophobic medical-grade plastic, such as those described herein, which is permeable to air but impermeable to the medical fluid F. In some embodiments, the shuttle member 360 may be made of a solid material that defines one or more openings having a cross-sectional area sufficient to allow air to pass through, but insufficient to allow medical fluid F to pass through. In certain embodiments, the shuttle member 360 may be colored in a conspicuous color so that it is easily visible to technicians. The shuttle member 360 includes a distally extending tip 364 that is axially aligned with the receiving opening 376 of the cap 370. The diameter of the receiving opening 376 may be slightly larger than the diameter of the distally extending tip 364 to allow air to pass through the space between the diameters.

[0138] During the priming / purging operation, air discharged from syringes 10A and 10B passes through the porous shuttle member 360, flows into the internal chamber 350, and exits through the receiving opening 376. As the air continues to be primed and purged from syringes 10A and 10B, some medical fluid F eventually pushes the remaining air out of syringes 10A and 10B through the shuttle member 360, and the medical fluid F comes into contact with the proximal surface 362 of the shuttle member 360. Since the medical fluid F cannot pass through the shuttle member 360, the fluid pressure rises against the proximal surface 362, moving the shuttle member 360 from the outlets 16A and 16B of syringes 10A and 10B to the second primed position and compressing it against the cap 370. The tip 364 extends through the receiving opening 376, providing the technician and / or controller 900 with an indication that the shuttle member 360 has been removed and the syringes 10A and 10B have been primed. The distal surface 367 of the shuttle member 360 can be sealed against the inner surface surrounding the receiving opening 376 to prevent the medical fluid from escaping from the priming tube 300 after priming.

[0139] In some embodiments, the priming state sensor 910 may include an image recognition detector, such as a camera, as described in U.S. Patent No. 10,201,666. The priming state sensor 910 may be configured to detect the movement and / or position of the tip 364 from an initial position (see Figure 11C) where the tip 364 is coplanar with or recessed in the side wall 310, to a priming position (see Figure 11D) where the shuttle member 360 moves to the distal end 314 of the prime tube 300 and the tip 364 extends distally through the receiving opening 376. In some embodiments, the priming state sensor 910 may include a limit switch that is contacted by the tip 364 when the shuttle member 360 moves to the distal end 314 of the prime tube 300.

[0140] Based on the output signal from the priming status sensor 910, the controller 900 may be programmed or configured to determine that the shuttle member 360 has moved to the distal end 314 of the priming tube 300, indicating that the syringes 10A and 10B have been primed. The processor 900 may be configured to prevent the fluid injection procedure until it receives an indicator that the syringes 10A and 10B have been successfully primed. Once successful priming is established, as determined by the controller 900 and / or the technician, the priming tube 300 may be removed and discarded according to hospital protocols, and a properly primed patient catheter line may be placed in the syringes 10A and 10B.

[0141] Referring here to Figures 12A to 12C, one embodiment of the prime tube 300 is similar to the embodiments in Figures 11A to 11D, and the main differences will be described. In the embodiments shown in Figures 12A to 12C, an engagement lug 322 is provided on the deflectable arm 324 of the connector 320. In some embodiments, the engagement lug 322 may include tabs that fit into corresponding slots 378 of the outlets 16A and 16B of the syringes 10A and 10B. The proximal end of the shuttle member 360 includes at least a partially circumferential wall 368 that surrounds the outer circumference of the outlets 16A and 16B and engages with the deflectable arm 324 in the initial position of the prime tube 300 (shown in Figure 12C) to prevent inward deflection of the arm 324. The engagement of the peripheral wall 368 with the deflectable arm 324 locks the engagement lug 322 of the prime tube 300 into the corresponding slot 378 of the outlets 16A and 16B of the syringes 10A and 10B, preventing manual removal of the connector 320 of the prime tube 300 from the outlets 16A and 16B of the syringes 10A and 10B when the shuttle member 360 is sealed inside the outlets 16A and 16B. As previously mentioned, since the shuttle member 360 is permeable to air and impermeable to liquid, the shuttle member 360 will detach from the outlets 16A and 16B as the fluid pressure increases. As the shuttle member 360 moves distally to the prime position, the peripheral wall 368 disengages from between the outer circumference of the outlets 16A, 16B and the deflectable arm 324 (as shown in Figure 12D), allowing the arm 324 to deflect radially inward so that the engagement lug 322 can be released from the slot 378. The prime tube 300 can then be removed from the syringes 10A, 10B. Thus, the arrangement of the peripheral wall 368 and the deflectable arm 324 compels the technician to perform a priming operation on the syringes 10A, 10B before the prime tube 300 can be removed from the syringes 10A, 10B, ensuring that the syringes are primed before the injection procedure can proceed (i.e., by removal of the prime tube 300).As described above, the technician and / or processor 900 can determine the state of the system (whether it is primed or not) by the tip 364 extending through the receiving opening 376 and by the technician who can remove the prime tube 300.

[0142] In some embodiments, the engagement lug 322 of the connector 320 may be configured to automatically release from the slot 378 of the outlet 16A, 16B of the syringes 10A, 10B at a predetermined fluid pressure corresponding to the fluid pressure at which the syringes 10A, 10B are fully primed. Thus, the release of the priming tube 300 from the syringes 10A, 10B indicates that the syringes 10A, 10B are primed and ready for the injection protocol. In some embodiments, the connector 320 may be configured not to be manually removable from the outlet 16A, 16B of the syringes 10A, 10B, thereby forcing the technician to perform a priming operation to automatically release the priming tube 300 from the syringes 10A, 10B. The syringes 10A, 10B may be oriented so that the priming tube 300 falls into the waste container when the engagement lug 322 releases from the outlet 16A, 16B of the syringes 10A, 10B. A properly primed catheter line may be placed in syringes 10A and 10B after the prime tube 300 has been opened.

[0143] Referring here to Figure 13, one embodiment of a priming tube 300 is shown, which includes an inner cap 380 that fits onto the inner nozzles 55 of the outlets 16A, 16B of syringes 10A, 10B. The cap 380 is configured and / or positioned to be recessed within the outlets 16A, 16B so that it cannot be manually removed from the inner nozzles 55 before the syringes are primed, and can only be removed by the priming operation. Thus, the injection procedure cannot be performed without initial priming and the resulting removal of the cap 380. For example, the inner cap 380 may be recessed within the outlets 16A, 16B by friction fitting so that a person cannot intentionally or inadvertently remove the inner cap 380 with normal effort. In some embodiments, the inner cap 380 may include a proximal post 382 that is inserted into at least a portion of the inner nozzles 55 of syringes 10A, 10B. The proximal post 382 can help hold the inner cap 380 in place on the inner nozzle 55 via press-fit or friction fit. In some embodiments, the inner cap 380 may be made from a hydrophobic medical-grade plastic, such as those described herein, which is permeable to air but impermeable to the medical fluid F. In some embodiments, the inner cap 380 may be made of a solid material that defines one or more openings having a cross-sectional area sufficient to allow the passage of air but insufficient to allow the passage of the medical fluid F.

[0144] In certain embodiments, the shuttle member 360 may be slidably located within the internal chamber 350 of the prime tube 300 and have a fit with the side wall 310 that is tight enough to prevent the medical fluid F from flowing between the shuttle member 360 and the side wall 310. In some embodiments, the shuttle member 360 may include fingers 366 configured to engage with the cap 380. In some embodiments, the shuttle member 360 may be made from a hydrophobic medical-grade plastic, such as those described herein, that is permeable to air but impermeable to the medical fluid F. In some embodiments, the shuttle member 360 may be made of a solid material that defines one or more openings having a cross-sectional area sufficient to allow the passage of air but insufficient to allow the passage of the medical fluid F. The distal end 314 of the side wall 310 has at least one opening to allow air flowing between the cap 380 and the shuttle member 360 to exit the prime tube 300.

[0145] During the priming operation, air expelled from syringes 10A and 10B passes through or around the inner cap 380 and shuttle member 360, flows into the inner chamber 350, and exits from the distal end 314 of the priming tube 300. As the air continues to be primed and purged from syringes 10A and 10B, eventually some medical fluid F pushes the remaining air out of syringes 10A and 10B through the inner cap 380 and comes into contact with the proximal surface or proximal post 382 of the inner cap 380. Since the medical fluid F cannot pass through the cap 380, the fluid pressure increases until the inner cap 380 detaches from the nozzle 55. The inner cap 380 then slides distally within the inner chamber 350 under the force of the medical fluid F as more fluid F is injected into the priming tube 300. The inner cap 380 further engages with the shuttle member 360 in the inner chamber 350 and pushes toward the distal end 314.

[0146] Similar to the embodiments described in relation to Figures 8A to 9C, the shuttle member 360 and / or inner cap 380 may be a conspicuous color and the side wall 310 may be at least partially transparent or translucent so that the shuttle member 360 and / or inner cap 380 are visible within the internal chamber 350. The technician and / or controller 900 can determine that the syringes 10A, 10B have been primed based on the visibility of the position of the shuttle member 360 and / or inner cap 380 within the internal chamber 350, in substantially the same manner as described herein in relation to Figures 8A to 9C.

[0147] In some embodiments, the syringes 10A and 10B may already have an inner cap 380 provided in place. Thus, the inner cap 380 can help maintain sterility inside the syringes 10A and 10B. Furthermore, as described herein, the non-manually removable interface between the inner nozzle 55 and the inner cap 380 allows the inner cap 380 to be easily removed only by a priming operation, thereby ensuring that the syringes 10A and 10B are primed before catheter line connection and minimizing the occurrence of unintended air injection during the infusion procedure.

[0148] Referring here to Figures 14A–14C, one embodiment of the prime tube 300 including an expandable body is shown. Similar to the embodiments described herein in relation to Figures 4A–4D, a closure 330 in the form of a sealing plug may be inserted into or otherwise bonded to the distal end 314 of the prime tube 300. The closure 330 can prevent all fluids, including air and medical fluid F, from escaping from the distal end 314 of the prime tube 300. In some embodiments, the sidewall 310 may be made of a material that is blow-molded in an expanded state (shown in Figure 14A) and then converted to a contracted or compressed state (shown in Figure 14B), which is the state in which the prime tube 300 is supplied. When in the contracted state, the sidewall 310 collapses at least partially onto itself so as to minimize the volume of the internal chamber 350. As shown in Figure 14A, one embodiment of the prime tube 300 is generally molded as an ellipsoidal shell during manufacturing, although other molded shapes are also conceivable. After manufacturing, a portion of the sidewall 310 is inverted so that opposing surfaces of the sidewall 310 are in contact with or close to each other. Thus, the illustrated sidewall 310 is formed as a semi-ellipsoidal shell in the contracted state shown in Figure 14B. When the pressure inside the internal chamber 350 exceeds the pressure of the external environment and the compressive pressure of the contracted sidewall 310, at least a portion of the sidewall 310 is configured to return to an expanded state, increasing the volume of the internal chamber 350. In some embodiments, the prime tube 300 may further include a one-way valve 340 to prevent backflow from the internal chamber 350 returning from the proximal end 312 of the prime tube 300.

[0149] The priming tube 300 according to the embodiments in Figures 14A to 14C operates similarly to the embodiments described in relation to Figures 5A to 5C. Due to the sealed nature of the sidewall 310 and closure 330, air is trapped within the inner chamber 350 during the priming operation. As the air continues to be primed, some of the medical fluid F eventually pushes the remaining air into the priming tube 300, and the medical fluid F itself enters the inner chamber 350. As the amount of air and medical fluid F in the inner chamber 350 increases, the sidewall 310 inverts to adapt to the increased fluid volume and corresponding pressure. Once the volume of the inner chamber 350 reaches a certain size, the technician can determine that the syringes 10A and 10B are primed and ready for injection. In some embodiments, the priming state sensor 910 may include a camera, as described herein in relation to Figures 4A to 4D, in conjunction with a controller 900 for determining whether syringes 10A and 10B are being primed based on the sidewall 310 being in an expanded state. At least as described herein in relation to Figures 4A to 4D, the controller 900 may be programmed or configured to prevent the execution of the injection procedure until successful priming of syringes 10A and 10B is detected.

[0150] During the removal of the prime tube 300 from syringes 10A and 10B, the one-way valve 340 prevents pressurized air and fluid in the internal chamber 350 from being released from the proximal end 312 of the prime tube 300. The entire prime tube 300 containing air and medical fluid F can be disposed of according to hospital protocols.

[0151] Referring here to Figures 15A and 15B, in some embodiments of the prime tube 300, the sidewall 310 may, naturally, be bent, loose, or flared, similar to a flattened tube as shown in Figure 15A. When the fluid pressure increases within the inner chamber 350, such as when the medical fluid F flows through the sidewall 310, the fluid pressure causes the sidewall 310 to straighten / stretch and expand into the tube shape as shown in Figure 15B. In some embodiments, the sidewall 310 can become substantially rigid in response to the fluid flow through the inner chamber 350. In another embodiment, the sidewall 310 may be flattened, coiled, or coiled when there is no fluid flow through the inner chamber 350. The sidewall 310 can transition to a straight, expanded shape due to the fluid pressure when the fluid flows through the inner chamber 350. The closure 330, connected to the distal end 314 of the side wall 310, may be permeable to air but impermeable to the medical fluid F, as described in relation to Figures 4A–4D of this specification. As described herein, the technician and / or processor 900 can visually determine when the priming tube 300 is straight (Figure 15B) and determine that the priming operation is complete, and proceed to the next step in the fluid injection procedure. In some embodiments, the closure 330 can define a flow function for inducing an audible sound as air passes through the closure 330. The technician can determine that the syringes 10A, 10B have been primed when the opening 332 stops emitting sound, indicating that substantially all air has been expelled from the internal chamber 350. Alternatively, the priming state sensor 910 may include a microphone configured to detect sound emitted from the opening 332. The controller 900 may be programmed or configured to determine that syringes 10A and 10B have been primed when closure 330 stops emitting sound, which indicates that substantially all air has been expelled from the internal chamber 350.Once successful priming is established, as determined by the controller 900 and / or technician, the primed tube 300 may be removed and discarded in accordance with hospital protocols, and the properly primed patient catheter line may be placed in syringes 10A and 10B.

[0152] Various examples of the present disclosure have been provided in the foregoing description, but those skilled in the art can modify and change these examples without departing from the scope and spirit of the present disclosure. For example, it should be understood that features of various embodiments of this specification may be adapted to other embodiments described herein. Accordingly, this description is intended to be illustrative rather than restrictive. This disclosure is defined by the appended claims, and all changes to this disclosure that are included in the meaning and scope of the equivalents of the claims should be included within that scope. [Explanation of symbols]

[0153] 10A Syringe 10B Syringe 11. Graphical User Interface (GUI) 12 Injector housing 13A Piston 13B Piston 14A Plunger 14B Plunger 15 Syringe Port 16A Exit 16B Exit 17A Pressure Jacket 17B Pressure Jacket 19A Bulk fluid container 19B Bulk fluid container 55 nozzles 210A Fluid path 210B Fluid path 210C Patient Fluid Line 215A Bulk Fluid Valve 215B Bulk Fluid Valve 216A Bulk fluid path 216B Bulk fluid pathway 300 Prime Tubes 310 Side wall 311 Proximal portion 312 Proximal end 313 Distal portion 314 Distal end 316 Bellows 317 Wide-diameter section 318 Narrow section 319 Rib 320 connector 322 Engagement lug 323 Inner self 324 Deflectable Arm 330 Closure 332 Opening 340 One-way valve 350 Internal Chamber 352 Internal Lip 360 Shuttle Components 362 Proximal surface 364 Tip 366 Fingers 367 Distal surface 368 Peripheral wall 370 Cap 372 Air vents 374 Plug retaining member 376 Receptor opening 378 slots 380 Cap 382 Proximal Post 400 graphs 402 curve Section 404 410 Peak 412 Tail Section 500 graphs 502 curve Section 504 506 Transition Point Section 508 600 graphs 602 curve Section 604 Section 608 Section 610 700 graphs 702 curve Section 704 Section 708 Section 710 800 graphs 802 curve Section 804 812 Spikes Section 814 Section 816 900 Controllers, Processors 910 Priming State Sensor 2000 Dual Syringe Angiography Injector System, Fluid Injector System

Claims

1. A prime tube for use with a fluid injector, wherein the prime tube is Side walls defining an internal chamber having an expandable volume, A connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of a fluid reservoir containing medical fluid, A closure associated with the distal end of the side wall, wherein the closure is permeable to air and substantially impermeable to the medical fluid, Equipped with, A primed tube in which the expandable volume of the internal chamber is configured to increase as the medical fluid enters the internal chamber.

2. The side wall comprises at least one bellows, each of which is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber. The prime tube according to claim 1, wherein the volume defined by the internal chamber is greater when at least one of the at least one bellows is in the expanded state than when it is in the contracted state.

3. The prime tube according to claim 1 or 2, wherein the at least one bellows is stable in both the contracted and expanded states.

4. The prime tube according to any one of claims 1 to 3, wherein the axial length of the side wall is greater when the at least one bellows is in an expanded state than when it is in a contracted state.

5. The prime tube according to claim 1, wherein the side wall comprises an elastomer material configured to expand the expandable volume in response to an increase in fluid pressure within the internal chamber.

6. The side wall is configured to transition from a contracted state to an expanded state in response to an increase in the fluid pressure within the internal chamber. In the contracted state, the distal portion of the side wall is wrapped around the proximal portion of the side wall. In the expanded state, the distal portion of the side wall is at least partially extended from the proximal portion of the side wall. The prime tube according to claim 1, wherein the volume defined by the internal chamber is greater when the side wall is in the expanded state than when it is in the contracted state.

7. The prime tube according to claim 6, wherein, in the contracted state, the inner surface of the distal portion of the side wall faces the inner surface of the proximal portion of the side wall.

8. The prime tube according to claim 6 or 7, wherein at least a portion of the side wall is configured to invert in response to an increase in fluid pressure within the internal chamber in order to increase the volume of the internal chamber.

9. The prime tube according to claim 1, wherein the side wall is in a relaxed or bent configuration when there is no fluid flow through the internal chamber, and is in a rigid, extended configuration when fluid flows through the internal chamber.

10. The prime tube according to claim 1, wherein the side wall is in a coiled configuration when there is no fluid flow through the internal chamber, and in an unfolded configuration when fluid flows through the internal chamber.

11. The prime tube according to any one of claims 1 to 10, further comprising a check valve associated with the proximal end of the side wall and configured to prevent fluid from flowing out from the proximal end.

12. The prime tube according to any one of claims 1 to 9, wherein the closure comprises a porous material.

13. The prime tube according to any one of claims 1 to 9, wherein the closure defines at least one opening, the at least one opening having a cross-sectional area of ​​a size that allows the passage of air and substantially prohibits the passage of medical fluid through the at least one opening.

14. The prime tube according to claim 13, wherein the at least one opening is configured to produce an audible sound when air flows through the at least one opening.

15. The closure comprises a high-crack pressure valve, according to any one of claims 1 to 9.

16. A prime tube for use with a fluid injector, wherein the prime tube is Side walls defining the internal chamber, A connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of a fluid reservoir containing medical fluid, A shuttle member configured to slide within the internal chamber in response to the flow of the medical fluid into the internal chamber, Prime Tube, equipped with [feature].

17. The prime tube according to claim 16, wherein the side wall is rigid so as not to deform in response to a fluid pressure below a predetermined threshold.

18. The prime tube according to claim 16 or 17, wherein at least one of the shuttle member and the side wall defines an air passage configured to allow air to flow distally beyond the shuttle member without causing the shuttle member to slide within the internal chamber.

19. The prime tube according to any one of claims 16 to 18, wherein the shuttle member comprises a plug, the plug is configured to form an interlocking fit with the outlet of the fluid reservoir such that the plug disengages from the outlet of the fluid reservoir at a predetermined fluid pressure.

20. The prime tube according to claim 19, wherein the plug has an outer diameter large enough to prevent a patient administration line from being attached to the outlet of the fluid reservoir while the plug is in the outlet.

21. The cap further comprises a proximal end configured to engage with the outlet of the fluid reservoir and a distal end configured to engage with the shuttle member, The priming tube according to any one of claims 16 to 20, wherein the shuttle member is configured to be at least partially recessed within the outlet of the fluid reservoir before the priming operation.

22. The outlet of the fluid reservoir further comprises at least one engaging function on the prime tube configured to hold the side wall, The shuttle member, in its initial position before the priming operation, engages the at least one engaging function with the outlet of the fluid reservoir to prevent the removal of the prime tube from the fluid reservoir while the shuttle member is in the initial position. The prime tube according to any one of claims 16 to 21, wherein when the shuttle member moves distally within the internal chamber to a second prime position, the at least one engaging function is released from the outlet of the fluid reservoir to allow the prime tube to be removed.

23. The prime tube according to claim 22, wherein the shuttle member has a tip configured to extend distally from the distal end of the prime tube when the shuttle member is moved to the second prime position.

24. The prime tube according to any one of claims 16 to 23, wherein the shuttle member comprises a porous material that is permeable to air and substantially impermeable to the medical fluid.

25. The prime tube according to any one of claims 16 to 24, wherein the shuttle member defines at least one opening having a cross-sectional area of ​​a size that allows the passage of air and substantially prohibits the passage of medical fluid.

26. The prime tube according to any one of claims 16 to 25, wherein the side wall comprises at least one indicator for indicating the distance the shuttle member has traveled, corresponding to the fluid filling level of the internal chamber of the prime tube.

27. The prime tube according to any one of claims 16 to 24, wherein the side wall is at least partially translucent or transparent so that the shuttle member is visible through the side wall.

28. A prime tube for use with a fluid injector system, wherein the prime tube is Side walls defining an internal chamber having an expandable volume, A connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of a fluid reservoir containing medical fluid, Equipped with, The side wall is configured to transition from a contracted state to an expanded state in response to an increase in the fluid pressure within the internal chamber. In the contracted state, the distal portion of the side wall is wrapped over the proximal portion of the side wall, and in the expanded state, the distal portion of the side wall is at least partially unfolded from the proximal portion of the side wall. A prime tube in which the volume defined by the internal chamber is greater when the side wall is in the expanded state than when it is in the contracted state.

29. The prime tube according to claim 28, wherein, in the contracted state, the inner surface of the distal portion of the side wall faces the inner surface of the proximal portion of the side wall.

30. A fluid reservoir configured to inject medical fluids, Side walls defining an internal chamber having an expandable volume, and A connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of the fluid reservoir. A prime tube equipped with, At least one processor programmed or configured to determine the priming state of the prime tube A fluid injector system equipped with the following features.

31. The fluid injector system according to claim 30, wherein the at least one processor is programmed or configured to determine the priming state of the prime tube based on the measured fluid pressure of at least one of the prime tube and the fluid reservoir.

32. The fluid injector system according to claim 30 or 31, further comprising an actuator for injecting the medical fluid from the at least one reservoir, wherein the at least one processor is programmed or configured to determine the priming state of the prime tube based on the measured current flow of the actuator.

33. The fluid injector system according to any one of claims 30 to 32, wherein the at least one processor is programmed or configured to determine the priming state of the prime tube based on at least one of the expansion of the prime tube and a change in the shape of the prime tube.

34. The fluid injector system according to any one of claims 30 to 33, wherein the at least one processor is programmed or configured to determine the priming state of the prime tube based on sound emitted from the prime tube.

35. The fluid injector system according to any one of claims 30 to 34, wherein the at least one processor is programmed or configured to determine the priming state of the priming tube based on a reading of the force of a motor of a fluid injector associated with delivering fluid from the fluid reservoir.

36. The side wall comprises at least one bellows, Each of the at least one bellows is configured to transition from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber. The fluid injector system according to any one of claims 30 to 35, wherein the expandable volume defined by the internal chamber is greater when at least one of the at least one bellows is in the expanded state than when it is in the contracted state.

37. The fluid injector system according to any one of claims 30 to 35, wherein the side wall comprises an elastomer material configured to expand the expandable volume in response to an increase in the fluid pressure in the internal chamber.

38. The side wall is configured to transition from a contracted state to an expanded state in response to an increase in the fluid pressure within the internal chamber. In the contracted state, the distal portion of the side wall is wrapped over the proximal portion of the side wall, and in the expanded state, the distal portion of the side wall is at least partially unfolded from the proximal portion of the side wall. The fluid injector system according to any one of claims 30 to 35, wherein the expandable volume defined by the internal chamber is greater when the side wall is in the expanded state than when it is in the contracted state.

39. The fluid injector system according to any one of claims 30 to 35, wherein the side wall is in a coiled configuration when there is no fluid flow through the internal chamber, and is in an unfolded configuration when fluid flows through the internal chamber.

40. A fluid reservoir configured to inject medical fluids, Side walls defining the internal chamber, A shuttle member that can slide within the internal chamber, and A connector associated with the proximal end of the side wall and configured to reversibly engage with the outlet of the fluid reservoir. A prime tube equipped with, At least one processor programmed or configured to determine the priming state of the prime tube A fluid injector system equipped with the following features.

41. The fluid injector system according to claim 40, wherein the at least one processor is programmed or configured to determine the priming state of the prime tube based on the position of the shuttle member in the internal chamber.

42. The fluid injector system according to claim 40 or 41, wherein the side wall of the prime tube is provided with at least one indicator corresponding to the fluid filling level of the internal chamber, and the at least one processor is programmed or configured to determine the priming state of the prime tube based on the position of the shuttle member relative to the at least one indicator.

43. The fluid injector system according to any one of claims 40 to 42, wherein the priming tube further comprises a cap having a proximal end configured to engage with the outlet of the fluid reservoir and a distal end configured to engage with the shuttle member, the shuttle member being configured to be at least partially recessed in the outlet of the fluid reservoir before the priming operation.

44. The prime tube further comprises at least one engaging portion on the prime tube configured to hold the side wall at the outlet of the fluid reservoir, The fluid injector system according to any one of claims 40 to 42, wherein the shuttle member engages the at least one engaging function at the outlet of the fluid reservoir to prevent the removal of the prime tube from the fluid reservoir when the shuttle member is in the initial position before the priming operation, and the at least one engaging function is released from the outlet of the fluid reservoir to allow the removal of the prime tube when the shuttle member moves distally within the internal chamber to a second prime position.

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