Prime tube configuration for syringe

Abstract

The perfusion tube includes a sidewall defining an interior chamber having an expandable volume, a connector associated with a proximal end of the sidewall and configured to reversibly engage an outlet of a fluid reservoir containing a medical fluid, and a closure associated with a distal end of the sidewall, the closure being permeable to air but substantially impermeable to the medical fluid. The expandable volume of the interior chamber is configured to increase as the medical fluid enters the interior chamber.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 065,095, filed August 13, 2020, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to infusion tubing for syringes and / or pumps, such as syringes used in fluid injector systems, for injecting contrast media for contrast-enhanced imaging procedures. Specifically, this disclosure relates to infusion tubing for infusing and / or purging air from a reservoir after filling it and before performing an injection protocol, wherein the infusion tubing helps determine when to purge air from the reservoir. Background Technology

[0004] Powered fluid injector systems are widely used in medical imaging procedures such as angiography, computed tomography (CT), and magnetic resonance imaging (NMR / MRI). These injector systems offer fluid delivery precision and accuracy that surpasses that of manual injectors, and further provide numerous safety features to prevent injury to the patient during the injection procedure.

[0005] Air must not be injected into the patient during certain infusion procedures. Air may be present in the syringe or reservoir of the manufacturer-packaged fluid infuser system. Additionally, air may accumulate in the syringe or reservoir during automated or manual filling of the syringe from one or more bulk fluid sources. Any air present in the volume must be purged before the infusion procedure to avoid air embolism.

[0006] For example, after the syringe is filled with fluid, a tubing kit can be connected to the syringe's discharge port, and the system can be actuated to inject air through the tubing to infuse the system until the syringe and tubing are filled with only air. While this technique effectively removes air from the tubing connected to the syringe, dispensing fluid from the end of the tubing can lead to contamination or scaling of system components and may cause spills into the infusion kit, which could be a safety hazard and require cleaning. Furthermore, in some situations, technicians may not be able to determine when the syringe has been fully infused; for example, it may be difficult to observe air in the syringe in low light or at a distance, potentially leading to the assumption that the syringe has been infused.

[0007] Therefore, a new infusion tubing configuration is needed that retains the infusion fluid and is easily observable to ensure infusion occurs before injection. Summary of the Invention

[0008] In view of the foregoing, there is a need for apparatuses, systems, and methods for improving priming of syringes and fluid injector systems. Embodiments of the present disclosure relate to a priming tube for use with a fluid injector. The priming tube includes a sidewall defining an interior chamber having an expandable volume, a connector associated with a proximal end of the sidewall and configured to reversibly engage an outlet of a fluid reservoir containing a medical fluid, and a closure associated with a distal end of the sidewall, the closure being permeable to air but substantially impermeable to the medical fluid. The expandable volume of the interior chamber is configured to increase as the medical fluid enters the interior chamber.

[0009] In some embodiments, the sidewall includes at least one bellows. Each of the at least one bellows is configured to transition from a collapsed state to an expanded state in response to an increase in fluid pressure within the interior chamber. At least one of the at least one bellows, when in the expanded state, defines a volume that is greater than a volume defined when in the collapsed state. In some embodiments, the at least one bellows is stable in both the collapsed state and the expanded state. The axial length of the sidewall, when the at least one bellows is in the expanded state, can be greater than the axial length when the at least one bellows is in the collapsed state.

[0010] In some embodiments, the sidewall includes an elastic material to expand the expandable volume in response to an increase in fluid pressure within the interior chamber.

[0011] In some embodiments, the sidewall can be configured to transition from a collapsed state to an expanded state in response to an increase in fluid pressure within the interior chamber. In the collapsed state, a distal portion of the sidewall is rolled up over a proximal portion of the sidewall. In the expanded state, the distal portion of the sidewall is at least partially unrolled from the proximal portion of the sidewall. The volume defined by the interior chamber, when the sidewall is in the expanded state, is greater than the volume defined when in the collapsed state. In some embodiments, in the collapsed state, an inner surface of the distal portion of the sidewall faces an 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 interior chamber to increase the volume of the interior chamber.

[0012] In some embodiments, the sidewall can be in a relaxed or curved configuration when no fluid is flowing through the interior chamber and in a rigid, stretched configuration when fluid flows into the interior chamber.

[0013] In some embodiments, the sidewall can be in a rolled up, coiled configuration when no fluid is flowing through the interior chamber and in an unrolled, stretched configuration when fluid flows into the interior chamber.

[0014] In some embodiments, the priming tube can further include a check valve associated with the proximal end of the sidewall and configured to prevent fluid from exiting the proximal end. In some embodiments, the closure can include a high-opening pressure valve.

[0015] In some embodiments, the closure includes a porous material. For example, the closure can define at least one aperture having a cross-sectional area sized to allow passage of air and substantially prevent passage of the medical fluid through the at least one aperture.

[0016] In some embodiments, the at least one aperture can be configured to emit an audible sound when air flows through the at least one aperture.

[0017] Other embodiments of the present disclosure relate to a priming tube for use with a fluid injection. The priming tube includes a sidewall defining an interior chamber, a connector associated with a proximal end of the sidewall and configured to reversibly engage an outlet of a fluid reservoir containing a medical fluid, and a shuttle member configured to slide within the interior chamber in response to the medical fluid flowing into the interior chamber. The sidewall can be rigid such that it does not deform in response to fluid pressure below a predetermined threshold. In some embodiments, at least one of the shuttle member and the sidewall defines an air passageway configured to allow air to flow distally through the shuttle member without causing the shuttle member to slide within the interior chamber. In some embodiments, the shuttle member can include a plug configured to form an interference fit with the outlet of the fluid reservoir such that the plug is driven out of the outlet of the fluid reservoir at a predetermined fluid pressure. The plug can have an outer diameter large enough to prevent a patient administration line from being attached to the outlet of the fluid reservoir when the plug is stuck in the outlet.

[0018] In some embodiments, the priming tube can include a cap having a proximal end configured to engage the outlet of the fluid reservoir and a distal end configured to engage the shuttle member. The shuttle member can be configured to at least partially recess within the outlet of the fluid reservoir prior to a priming operation.

[0019] In some embodiments, the priming tube further includes at least one engagement feature on the priming tube configured to hold the sidewall to the outlet of the fluid reservoir. The shuttle member can lock the at least one engagement feature to the outlet of the fluid reservoir in an initial position prior to a priming operation to prevent the priming tube from being removed from the fluid reservoir when the shuttle member is in the initial position. The at least one engagement feature can be unlocked from the outlet of the fluid reservoir to allow the priming tube to be removed when the shuttle member moves distally within the interior chamber to a second priming position. In some embodiments, the shuttle member can include a tip configured to extend distally from the distal end of the priming tube when the shuttle member moves to the second priming position.

[0020] In some embodiments, the shuttle member includes a porous material that is permeable to air and impermeable to the medical fluid. For example, the shuttle member can define at least one aperture having a cross-sectional area sized to permit passage of air and substantially prevent passage of the medical fluid

[0021] In some embodiments, the sidewall includes at least one indicator to indicate a distance traveled by the shuttle member corresponding to a fluid fill level of the internal chamber of the perfusion tube. In some embodiments, the sidewall is at least partially translucent or transparent such that the shuttle member is visible through the sidewall.

[0022] Other embodiments of the present disclosure relate to a perfusion tube for use with a fluid injector system. The perfusion tube includes a sidewall defining an internal chamber having an expandable volume, and a connector associated with a proximal end of the sidewall and configured to reversibly engage an outlet of a fluid reservoir containing a medical fluid. The sidewall is configured to transition from a collapsed state to an expanded state in response to an increase in fluid pressure within the internal chamber. In the collapsed state, a distal portion of the sidewall is rolled up on a proximal portion of the sidewall. In the expanded state, the distal portion of the sidewall is at least partially unrolled from the proximal portion of the sidewall. The volume defined by the internal chamber when the sidewall is in the expanded state is greater than when the sidewall is in the collapsed state. In the collapsed state, an inner surface of the distal portion of the sidewall can face an inner surface of the proximal portion of the sidewall.

[0023] Other embodiments of the present disclosure relate to a fluid injector system including at least one fluid reservoir configured for injection of a medical fluid and a perfusion tube. The perfusion tube includes a sidewall defining an internal chamber having an expandable volume, and a connector associated with a proximal end of the sidewall and configured to reversibly engage an outlet of the fluid reservoir. The system further includes at least one processor programmed or configured to determine a perfusion state of the perfusion tube.

[0024] In some embodiments, the at least one processor is programmed or configured to determine the perfusion state of the perfusion tube based on a measured fluid pressure in at least one of the perfusion tube and the fluid reservoir. For example, in some embodiments, the fluid injector system can further include an actuator for injection of the medical fluid from the at least one reservoir, and the at least one processor can be programmed or configured to determine the perfusion state of the perfusion tube based on a measured current draw of the actuator. The at least one processor can be programmed or configured to determine the perfusion state of the perfusion tube based on a force reading on a motor of the fluid injector associated with delivery of fluid from the fluid reservoir.

[0025] In certain embodiments, the at least one processor can be programmed or configured to determine the priming status of the priming tube based on at least one of an inflation of the priming tube and a change in shape of the priming tube. In certain embodiments, the at least one processor can be programmed or configured to determine the priming status of the priming tube based on a sound emanating from the priming tube. In some embodiments, the sidewall comprises a resilient material that causes the inflatable volume to inflate in response to an increase in fluid pressure within the internal chamber.

[0026] In some embodiments, the sidewall can comprise at least one bellows. Each of the at least one bellows is configured to transition from a collapsed state to an inflated state in response to an increase in fluid pressure within the internal chamber. The inflatable volume defined by the internal chamber is greater when at least one of the at least one bellows is in the inflated state than when in the collapsed state.

[0027] In some embodiments, the sidewall is configured to transition from a collapsed state to an inflated state in response to an increase in fluid pressure within the internal chamber. In the collapsed state, a distal portion of the sidewall is rolled up over a proximal portion of the sidewall. In the inflated state, the distal portion of the sidewall is at least partially unrolled from the proximal portion of the sidewall. The inflatable volume defined by the internal chamber is greater when the sidewall is in the inflated state than when in the collapsed state.

[0028] In some embodiments, the sidewall is in a rolled up, coiled configuration when no fluid is flowing through the internal chamber and in an unrolled, stretched configuration when fluid is flowing through the internal chamber.

[0029] Other embodiments of the present disclosure relate to a fluid injector system comprising at least one fluid reservoir configured for injection of a medical fluid, and a priming tube. The priming tube comprises a sidewall defining an internal chamber, a shuttle member slidable within the internal chamber, and a connector associated with a proximal end of the sidewall and configured to reversibly engage an outlet of the fluid reservoir. The fluid injector system further comprises at least one processor programmed or configured to determine a priming status of the priming tube. The at least one processor can be programmed or configured to determine the priming status based on a position of the shuttle member within the internal chamber.

[0030] In some embodiments, wherein the sidewall of the priming tube comprises at least one indicator corresponding to a fluid fill level of the internal chamber, and the at least one processor can be programmed or configured to determine the priming status based on a position of the shuttle member relative to the at least one indicator.

[0031] In some embodiments, the priming tube further includes a cap having a proximal end configured to engage the outlet of the fluid reservoir and a distal end configured to engage the shuttle member. The shuttle member can be configured to at least partially recess within the outlet of the fluid reservoir prior to the priming operation. In some embodiments, the priming tube further includes at least one engagement feature on the priming tube configured to retain the side wall to the outlet of the fluid reservoir. In an initial position prior to the priming operation, the shuttle member locks the at least one engagement feature to the outlet of the fluid reservoir to prevent removal of the priming tube from the fluid reservoir when the shuttle member is in the initial position. Upon distal movement of the shuttle member within the internal chamber to a second priming position, the at least one engagement feature is unlocked from the outlet of the fluid reservoir to allow removal of the priming tube.

[0032] Other aspects or examples of the present disclosure are described in the following numbered clauses:

[0033] Clause 1. A priming tube for use with a fluid injector, the priming tube comprising: a side wall defining an internal chamber having an expandable volume; a connector associated with a proximal end of the side wall and configured to reversibly engage an outlet of a fluid reservoir containing a medical fluid; and a closure associated with a distal end of the side wall, the closure being permeable to air but substantially impermeable to the medical fluid, wherein the expandable volume of the internal chamber is configured to increase as the medical fluid enters the internal chamber.

[0034] Clause 2. The priming tube of clause 1, wherein the side wall includes at least one bellows, wherein each of the at least one bellows is configured to transition from a collapsed state to an expanded state in response to an increase in fluid pressure within the internal chamber, 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 in the collapsed state.

[0035] Clause 3. The priming tube of clause 1 or 2, wherein the at least one bellows is stable in both the collapsed state and the expanded state.

[0036] Clause 4. The priming tube of any of clauses 1-3, wherein an axial length of the side wall is greater when the at least one bellows is in the expanded state than when in the collapsed state.

[0037] Clause 5. The priming tube of any of clauses 1-4, wherein the side wall includes an elastic material configured to expand the expandable volume in response to an increase in fluid pressure within the internal chamber.

[0038] Clause 6. The perfusion tube of any one of clauses 1-5, wherein the sidewall is configured to transition from the collapsed state to the expanded state in response to an increase in fluid pressure within the interior chamber, wherein in the collapsed state the distal portion of the sidewall is rolled over the proximal portion of the sidewall, wherein in the expanded state the distal portion of the sidewall is at least partially unrolled from the proximal portion of the sidewall, and wherein the volume defined by the interior chamber is greater when the sidewall is in the expanded state than when the sidewall is in the collapsed state.

[0039] Clause 7. The perfusion tube of any one of clauses 1-6, wherein in the collapsed state, an inner surface of the distal portion of the sidewall faces an inner surface of the proximal portion of the sidewall.

[0040] Clause 8. The perfusion tube of any one of clauses 1-7, wherein at least a portion of the sidewall is configured to invert in response to an increase in fluid pressure within the interior chamber to increase the volume of the interior chamber.

[0041] Clause 9. The perfusion tube of any one of clauses 1-8, wherein the sidewall is in a relaxed or curved configuration when no fluid is flowing through the interior chamber and in a rigid, stretched configuration when fluid is flowing through the interior chamber.

[0042] Clause 10. The perfusion tube of any one of clauses 1-9, wherein the sidewall is in a rolled, coiled configuration when no fluid is flowing through the interior chamber and in an unrolled, stretched configuration when fluid is flowing through the interior chamber.

[0043] Clause 11. The perfusion tube of any one of clauses 1-10, further comprising a check valve associated with the proximal end of the sidewall and configured to prevent fluid from exiting the proximal end.

[0044] Clause 12. The perfusion tube of any one of clauses 1-11, wherein the closure comprises a porous material.

[0045] Clause 13. The perfusion tube of any one of clauses 1-12, wherein the closure defines at least one aperture having a cross-sectional area sized to permit passage of air and substantially prevent passage of a medical fluid through the at least one aperture.

[0046] Clause 14. The perfusion tube of any one of clauses 1-13, wherein the at least one aperture is configured to emit an audible sound when air flows through the at least one aperture.

[0047] Clause 15. The perfusion tube of any one of clauses 1-14, wherein the closure comprises a high-opening pressure valve.

[0048] Clause 16. A priming tube for use with a fluid injection, the priming tube comprising: a sidewall defining an interior chamber; a connector associated with a proximal end of the sidewall and configured to reversibly engage an outlet of a fluid reservoir containing a medical fluid; and a shuttle member configured to slide within the interior chamber in response to the medical fluid flowing into the interior chamber.

[0049] Clause 17. The priming tube of clause 16, wherein the sidewall is rigid such that it does not deform in response to fluid pressures below a predetermined threshold.

[0050] Clause 18. The priming tube of clause 16 or 17, wherein at least one of the shuttle member and the sidewall defines an air passageway configured to allow air to flow distally through the shuttle member without causing the shuttle member to slide within the interior chamber.

[0051] Clause 19. The priming tube of any one of clauses 16-18, wherein the shuttle member comprises a plug configured to form an interference fit with the outlet of the fluid reservoir such that the plug is driven out of the outlet of the fluid reservoir at a predetermined fluid pressure.

[0052] Clause 20. The priming tube of any one of clauses 16-19, 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 when the plug is stuck in the outlet.

[0053] Clause 21. The priming tube of any one of clauses 16-20, further comprising a cap having a proximal end configured to engage the outlet of the fluid reservoir and a distal end configured to engage the shuttle member, wherein the shuttle member is configured to at least partially recess within the outlet of the fluid reservoir prior to a priming operation.

[0054] Clause 22. The priming tube of any one of clauses 16-21, further comprising at least one engagement feature on the priming tube configured to hold the sidewall to the outlet of the fluid reservoir, wherein in an initial position prior to a priming operation, the shuttle member locks the at least one engagement feature to the outlet of the fluid reservoir to prevent the priming tube from being removed from the fluid reservoir when the shuttle member is in the initial position, and wherein upon distal movement of the shuttle member within the interior chamber to a second priming position, the at least one engagement feature unlocks from the outlet of the fluid reservoir to allow the priming tube to be removed.

[0055] Clause 23. The priming tube of any one of clauses 16-22, wherein the shuttle member comprises a tip configured to extend distally from a distal end of the priming tube when the shuttle member is moved to the second priming position.

[0056] Clause 24. The perfusion tube of any of clauses 16-23, wherein the shuttle member comprises a porous material that is permeable to air and impermeable to the medical fluid.

[0057] Clause 25. The perfusion tube of any of clauses 16-24, wherein the shuttle member defines at least one aperture having a cross-sectional area sized to permit passage of air and substantially prevent passage of the medical fluid.

[0058] Clause 26. The perfusion tube of any of clauses 16-25, wherein the sidewall comprises at least one indicator to indicate a distance traveled by the shuttle member corresponding to a fluid fill level of the internal chamber of the perfusion tube.

[0059] Clause 27. The perfusion tube of any of clauses 16-24, wherein the sidewall is at least partially translucent or transparent such that the shuttle member is visible through the sidewall.

[0060] Clause 28. A perfusion tube for use with a fluid injector system, the perfusion tube comprising: a sidewall defining an internal chamber having an expandable volume; and a connector associated with a proximal end of the sidewall and configured to reversibly engage an outlet of a fluid reservoir containing a medical fluid, wherein the sidewall is configured to transition from a collapsed state to an expanded state in response to an increase in fluid pressure within the internal chamber, wherein, in the collapsed state, a distal portion of the sidewall is rolled up over a proximal portion of the sidewall, wherein, in the expanded state, the distal portion of the sidewall is at least partially unrolled from the proximal portion of the sidewall, and wherein the volume defined by the internal chamber is greater when the sidewall is in the expanded state than when the sidewall is in the collapsed state.

[0061] Clause 29. The perfusion tube of clause 28, wherein, in the collapsed state, an inner surface of the distal portion of the sidewall faces an inner surface of the proximal portion of the sidewall.

[0062] Clause 30. A fluid injector system, the fluid injector system comprising: at least one fluid reservoir configured for injection of a medical fluid; a perfusion tube comprising: a sidewall defining an internal chamber having an expandable volume; and a connector associated with a proximal end of the sidewall and configured to reversibly engage an outlet of the fluid reservoir, and at least one processor programmed or configured to determine a perfusion state of the perfusion tube.

[0063] Clause 31. The fluid injector system of clause 30, wherein the at least one processor is programmed or configured to determine the perfusion state of the perfusion tube based on a measured fluid pressure in at least one of the perfusion tube and the fluid reservoir.

[0064] Clause 32. The fluid injector system according to Clause 30 or 31 further includes an actuator for injecting medical fluid from at least one reservoir, wherein at least one processor is programmed or configured to determine the perfusion state of the perfusion tube based on a measured current consumption of the actuator.

[0065] Clause 33. A fluid injector system according to any one of Clauses 30-32, wherein at least one processor is programmed or configured to determine the infusion state of the infusion tube based on at least one of expansion and shape change of the infusion tube.

[0066] Clause 34. A fluid injector system according to any one of Clauses 30-33, wherein at least one processor is programmed or configured to determine the infusion status of the infusion tube based on sounds emitted from the infusion tube.

[0067] Clause 35. A fluid injector system according to any one of Clauses 30-34, wherein at least one processor is programmed or configured to determine the infusion state of the infusion tube based on force readings on the motor of the fluid injector associated with the delivery of fluid from the fluid reservoir.

[0068] Clause 36. A fluid injector system according to any one of Clauses 30-35, wherein the sidewall includes at least one bellows, wherein each of the at least one bellows is configured to change from a contracted state to an expanded state in response to an increase in fluid pressure within the internal chamber, wherein when at least one of the at least one bellows is in the expanded state, the expandable volume defined by the internal chamber is greater than the expandable volume when it is in the contracted state.

[0069] Clause 37. The fluid injector system according to any one of Clauses 30-36, wherein the sidewalls comprise an elastic material configured to expand the expandable volume in response to an increase in fluid pressure within the internal chamber.

[0070] Clause 38. A fluid injector system according to any one of Clauses 30-37, wherein the sidewall is configured to change 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 rolls up over the proximal portion of the sidewall, wherein in the expanded state, the distal portion of the sidewall spreads out at least partially from the proximal portion of the sidewall, and wherein the expandable volume defined by the internal chamber is greater when the sidewall is in the expanded state than the expandable volume when it is in the contracted state.

[0071] Clause 39. The fluid injector system according to any one of Clauses 30-38, wherein the sidewalls are in a rolled-up, coiled configuration when no fluid flows through the internal chamber, and in a spread-out, extended configuration when fluid flows through the internal chamber.

[0072] Clause 40. A fluid injector system comprising: at least one fluid reservoir configured for injecting a medical fluid; an infusion tube including: a sidewall defining an internal chamber; a shuttle member slidable within the internal chamber; and a connector associated with a proximal end of the sidewall and configured to reversibly engage an outlet of the fluid reservoir; and at least one processor programmed or configured to determine the infusion state of the infusion tube.

[0073] Clause 41. The fluid injector system according to Clause 40, wherein at least one processor is programmed or configured to determine the infusion state of the infusion tube based on the position of the shuttle member within the internal chamber.

[0074] Clause 42. The fluid injector system according to Clause 40 or 41, wherein the sidewall of the infusion tube includes at least one indicator corresponding to the fluid fill level of the internal chamber, and wherein at least one processor is programmed or configured to determine the infusion state of the infusion tube based on the position of the shuttle member relative to the at least one indicator.

[0075] Clause 43. The fluid injector system according to any one of Clauses 40-42, wherein the infusion tube further includes a cap having a proximal end and a distal end, the proximal end being configured to engage the outlet of the fluid reservoir, the distal end being configured to engage a shuttle member, and wherein the shuttle member is configured to be at least partially recessed within the outlet of the fluid reservoir prior to the infusion operation.

[0076] Clause 44. The fluid injector system according to any one of Clauses 40-43, wherein the infusion tube further includes at least one engagement feature on the infusion tube, the at least one engagement feature being configured to retain a sidewall to an outlet of a fluid reservoir, wherein, in an initial position prior to an infusion operation, the shuttle member locks the at least one engagement feature to the outlet of the fluid reservoir to prevent the infusion tube from being removed from the fluid reservoir when the shuttle member is in the initial position, and wherein, when the shuttle member in the internal chamber moves distally to a second infusion position, the at least one engagement feature unlocks from the outlet of the fluid reservoir to allow removal of the infusion tube.

[0077] Further details and advantages of the various examples will become clear when viewed in conjunction with the accompanying drawings and a detailed description of the various examples described herein. Attached Figure Description

[0078] Figure 1 A perspective view of a fluid injector system according to an embodiment of the present disclosure;

[0079] Figure 2A A schematic diagram of a fluid injector system according to an embodiment of the present disclosure;

[0080] Figure 2B for Figure 2A A partial schematic diagram of the fluid injector system, showing the infusion tubing attached to each syringe (for clarity, ...). Figure 2A The various components were not displayed Figure 2B middle);

[0081] Figure 3 According to embodiments of this disclosure Figure 2B A schematic diagram of the infusion tube;

[0082] Figure 4A A perspective view of the infusion tube according to an embodiment of the present disclosure;

[0083] Figure 4B for Figure 4A Exploded view of the infusion tube;

[0084] Figure 4C for Figure 4A A side cross-sectional view of the infusion tube in a contracted state;

[0085] Figure 4D for Figure 4A A side cross-sectional view of the injection pipe when it is in an expanded state;

[0086] Figure 4E for Figure 4A A graph showing the pressure change of the infusion tube over time;

[0087] Figure 5A A perspective view of the infusion tube according to an embodiment of the present disclosure;

[0088] Figure 5B for Figure 5A Exploded view of the infusion tube;

[0089] Figure 5C for Figure 5A A side cross-sectional view of the infusion tube in a contracted state;

[0090] Figure 5D for Figure 5A A side cross-sectional view of the injection tube in an expanded state;

[0091] Figure 5E for Figure 5A A graph showing the pressure change of the infusion tube over time;

[0092] Figure 6A A perspective view of the infusion tube according to an embodiment of the present disclosure;

[0093] Figure 6B for Figure 6A Exploded view of the infusion tube;

[0094] Figure 6C forFigure 6A A side cross-sectional view of the infusion tube in a contracted state;

[0095] Figure 6D for Figure 6A A side cross-sectional view of the injection pipe when it is in an expanded state;

[0096] Figure 6E for Figure 6A A graph showing the pressure change of the infusion tube over time;

[0097] Figure 7A A perspective view of the infusion tube according to an embodiment of the present disclosure;

[0098] Figure 7B for Figure 7A Exploded view of the infusion tube;

[0099] Figure 7C for Figure 7A A side cross-sectional view of the infusion tube in a contracted state;

[0100] Figure 7D for Figure 7A A side cross-sectional view of the injection pipe when it is in an expanded state;

[0101] Figure 7E for Figures 7A-7D A graph showing the pressure change of the infusion tube over time;

[0102] Figure 8A A perspective view of the infusion tube according to an embodiment of the present disclosure;

[0103] Figure 8B for Figure 8A Exploded view of the infusion tube;

[0104] Figure 8C for Figure 8A A side cross-sectional view of the infusion tube in its initial state;

[0105] Figure 8D for Figure 8A A side cross-sectional view of the injection pipe when it is in the injection state;

[0106] Figure 8E for Figure 8A A graph showing the pressure change of the infusion tube over time;

[0107] Figure 9A A perspective view of the infusion tube according to an embodiment of the present disclosure;

[0108] Figure 9B for Figure 9A Exploded view of the infusion tube;

[0109] Figure 9C forFigure 9A A side cross-sectional view of the infusion tube in its initial state;

[0110] Figure 10A A perspective view of the infusion tube according to an embodiment of the present disclosure;

[0111] Figure 10B for Figure 10A Exploded view of the infusion tube;

[0112] Figure 10C for Figure 10A A side cross-sectional view of the infusion tube;

[0113] Figure 11A A perspective view of the infusion tube according to an embodiment of the present disclosure;

[0114] Figure 11B for Figure 11A Exploded view of the infusion tube;

[0115] Figure 11C for Figure 11A A side cross-sectional view of the infusion tube in its initial state;

[0116] Figure 11D for Figure 11A A side cross-sectional view of the injection pipe when it is in the injection state;

[0117] Figure 12A A perspective view of the infusion tube according to an embodiment of the present disclosure;

[0118] Figure 12B for Figure 12A Exploded view of the infusion tube;

[0119] Figure 12C for Figure 12A A side cross-sectional view of the infusion tube in its initial state;

[0120] Figure 12D for Figure 12A A side cross-sectional view of the injection pipe when it is in the injection state;

[0121] Figure 13 A side cross-sectional view of the infusion tube according to an embodiment of the present disclosure;

[0122] Figure 14A A side view of the infusion tube according to an embodiment of the present disclosure;

[0123] Figure 14B for Figure 14A A side view of the infusion tube in a contracted state;

[0124] Figure 14C for Figure 14AA side cross-sectional view of the injection pipe when it is in the expansion and injection state;

[0125] Figure 15A A side view of the infusion tube in its initial state according to an embodiment of the present disclosure; and

[0126] Figure 15B for Figure 15A A side view of the injection pipe in the injection structure.

[0127] Referring to the accompanying drawings, wherein the same reference numerals refer to the same parts in various views, this disclosure generally relates to infusion tubing for use with a syringe in a fluid injector system. Detailed Implementation

[0128] For the purposes described below, the terms “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “horizontal,” “vertical,” and their derivatives should be used in relation to the orientation disclosed in the accompanying drawings. Spatial or directional terms, such as “left,” “right,” “inner,” “outer,” “up,” “down,” etc., should not be considered limiting, as the invention can employ various alternative orientations.

[0129] As used herein, the singular forms of “a,” “an,” and “the” include plural indicators unless the context clearly specifies otherwise. In all cases, all figures used in the specification and claims should be understood to be modified by the term “about.” The terms “approximately,” “about,” and “substantially” refer to a range of plus or minus ten percent of the specified value.

[0130] 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 any two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more individual A's; or one or more individual B's; or one or more individual C's; or one or more A's and one or more B's; or one or more A's and one or more C's; or one or more B's and one or more C's; or one or more of all A's, B's, and C's. 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 any two or more of D's, E's, and F's. For example, "at least two of D, E, and F" includes one or more D's and one or more E's; or one or more D's and one or more F's; or one or more E's and one or more F's; or one or more of all D's, E's, and F's.

[0131] It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary examples of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the examples disclosed herein should not be considered limiting.

[0132] When used relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, air levitation device, or fluid line), the term "distal" refers to the portion of the component closest to the patient. When used relative to a component of an injector system (such as a fluid reservoir, syringe, air levitation device, or fluid line), the term "proximal" refers to the portion of the component closest to the injector of the injector system (i.e., the portion of the component furthest from the patient). When used relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, air levitation device, or fluid line), the term "upstream" refers to a direction away from the patient and towards 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 relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, air levitation device, or fluid line), the term "downstream" refers to a direction towards the patient and away from the injector of the fluid delivery system. For example, if a first component is referred to as "downstream" of a second component, the first component is located closer to the patient than the second component. The terms "first," "second," etc., are not intended to refer to any specific order or sequence, but rather to different conditions, attributes, or elements. The term "at least" is synonymous with "greater than or equal to." The term "not greater than" is synonymous with "less than or equal to."

[0133] It should be understood that alternative variations and sequences of steps may be taken in this disclosure unless the opposite is expressly stated. It should also be understood that the specific apparatus and processes shown in the accompanying drawings and described in the following specification are merely exemplary aspects of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the examples disclosed herein should not be considered limiting.

[0134] While the devices, systems, and methods described herein are generally discussed 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 be incorporated into the various embodiments of the infusion tubing described herein. Furthermore, although many embodiments or infusion tubing described herein are described in detail with reference to syringes or syringe-based fluid injectors, it should be understood that other powered infusion systems, such as those incorporating pumps like peristaltic pumps, which require infusion reservoirs and / or fluid tubing kits, can be infused using the various embodiments of the infusion tubing described herein.

[0135] Referring to the accompanying drawings, wherein like reference numerals denote like parts in various views, this disclosure generally relates to the infusion tubing of a syringe for a fluid injector system. First, refer to... Figure 1 An embodiment of a dual-syringe angiography injector system 2000 is illustrated. The angiography injector system 2000 is configured to inject two medical fluids via a first fluid path 210A for a medical fluid (e.g., 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). Fluid paths 210A, 210B may be connected to corresponding outlets 16A, 16B of syringes 10A, 10B, such as nozzles. The dual-syringe angiography injector system 2000 may include an injector housing 12 having two syringe ports 15 configured to engage syringes 10A, 10B. In some embodiments, syringes 10A, 10B may be held within corresponding pressure sheaths 17A, 17B, for example, to prevent pressure-induced swelling and potential rupture of syringes 10A, 10B.

[0136] The injector system 2000 may also include at least one graphical user interface (GUI) 11 through which an operator can observe and control the status of the injection program. The GUI 11 can be integrated with the controller 900 (see...). Figures 2A-3 Operable communication, the controller 900 sends and receives commands between the GUI 11 and the fluid injector system 2000, and receives input from the GUI 11 and the fluid injector system 2000.

[0137] Continue 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 media and flushing fluid, respectively. Bulk fluid containers 19A and 19B may be selectively fluidly connected to syringes 10A and 10B via respective bulk fluid paths 216A and 216B and bulk fluid valves 215A and 215B.

[0138] In U.S. patents 5,383,858, 7,553,294, 7,666,169, 8,945,051, 10,022,493, and 10,507,319, and international PCT applications Nos. PCT / US2013 / 061275, PCT / US2018 / 034613, PCT / US2020 / 049885, PCT / US2021 / 035273, and PCT / US2021 Further details and examples of suitable non-limiting power injector systems, including syringes, pressure jackets and pressure jacket holding mechanisms, tubing, shut-off valves, controllers and air detectors, are described in PCT / 029963, PCT / US2021 / 018523, PCT / US2021 / 037623, PCT / US2021 / 037574 and PCT / US2021 / 045298, the disclosures of which are incorporated herein by reference in their entirety.

[0139] Now for reference Figure 2A , showed Figure 1 The diagram shows a fluid injector system 2000. The injector system 2000 includes pistons 13A, 13B associated with each injector 10A, 10B, and their corresponding pressure jackets 17A, 17B (see diagram). Figure 1 Each of pistons 13A, 13B is configured to drive a corresponding plunger 14A, 14B within the barrel of the corresponding syringe 10A, 10B. A controller 900 is operatively associated with the injector system 2000, for example, by actuating pistons 13A, 13B to reciprocate plunger 14A, 14B within syringes 10A, 10B, thereby executing and stopping an injection procedure. In a corresponding peristaltic pump system, the controller 900 would be configured to operate the rotor of the corresponding peristaltic pump. Specifically, the controller 900 may include at least one processor programmed or configured to actuate pistons 13A, 13B and various other components of the injector system 2000, such as one or more valves 215A, 215B, to draw in and deliver medical fluid according to a programmed scheme for the injection procedure. The controller 900 may include a computer-readable medium, such as memory, on which one or more injection schemes may be stored for execution by at least one processor.

[0140] The controller 900 can be programmed or configured to perform a filling operation during which pistons 13A, 13B associated with each syringe 10A, 10B are retracted proximally to the syringes 10A, 10B to draw injection fluid F (e.g., imaging contrast media and flushing fluid) from bulk fluid containers 19A, 19B into the syringes 10A, 10B. During this filling operation, the controller 900 can be programmed or configured to selectively actuate bulk fluid valves 215A and 215B to establish fluid communication between the respective syringes 10A, 10B and the bulk fluid containers 19A, 19B via bulk fluid paths 216A and 216B, thereby controlling the filling of syringes 10A, 10B with the appropriate injection fluid F.

[0141] The controller 900 can be programmed or configured to perform an inflation / venting operation to remove any air from syringes 10A and 10B upon completion of the filling operation. This will be combined with... Figures 3-15B The various embodiments of the injection tube 300 shown describe specific details of the injection / venting operation.

[0142] Following the filling and perfusion operations, the controller 900 may be programmed or configured to perform a delivery operation during which pistons 13A, 13B associated with one or both of syringes 10A, 10B move toward the distal end of the syringe to inject fluid F into a first fluid path 210A and a second fluid path 210B, respectively. The controller 900 may be programmed or configured to selectively actuate phase fluid valves 215A and 215B to establish fluid communication between syringes 10A, 10B and the patient via fluid paths 210A, 210B. The first fluid path 210A and the second fluid path 210B ultimately converge into a patient fluid line 210C in fluid communication with the patient's vascular system.

[0143] For reference Figure 2B The fluid injector system 2000 is shown having an infusion tube 300 attached to each syringe 10A, 10B. The infusion tube 300 can be attached to syringes 10A, 10B after a filling operation from bulk fluid containers 19A and 19B to syringes 10A, 10B and before the injection procedure. Other embodiments may be for the infusion of at least a portion of the tubing assembly during preparation of a fluid injection procedure. For example, in one embodiment, the infusion tube configuration described herein can be attached to the distal end of the tubing assembly (e.g., ...). Figure 2A(As shown), for example, a reusable portion of a tubing kit, and is used to ensure air perfusion from the syringe and the reusable portion of the tubing kit. In other embodiments, the perfusion tubing may be attached to the distal end of a newly installed individual patient tubing kit (attached to a reusable tubing kit) to ensure perfusion of the individual patient tubing kit before attachment to a patient catheter. Fluid paths 210A, 210B may be disconnected from syringes 10A, 10B to allow connection of the perfusion tubing 300. With the perfusion tubing 300 connected to syringes 10A, 10B, the fluid injector system 2000 can be actuated to perfuse / vent syringes 10A, 10B by extending pistons 13A, 13B distally to inject air from syringes 10A, 10B into the associated perfusion tubing 300. In some embodiments, the controller 900 may be programmed or configured to extend each piston 13A, 13B by a predetermined distance corresponding to a predetermined fluid volume to eject a predetermined air / fluid volume from each syringe 10A, 10B into the associated infusion tubing 300. The predetermined air / fluid volume can be selected to ensure that all (or substantially all) of the air in syringes 10A, 10B is ejected into the infusion tubing 300. For example, the predetermined air / fluid volume may be selected based on empirical data of the maximum air volume within the syringe after a filling operation. The predetermined air / fluid volume may include a safety factor to ensure that even unusually large amounts of air are completely ejected from the injector during the infusion / venting operation. Since the predetermined air / fluid volume is typically larger than the actual air volume present in syringes 10A, 10B, a certain amount of medical fluid F will be ejected into the infusion tubing 300 along with the air volume. Once the infusion operation is complete, the infusion tubing 300 can be disconnected from syringes 10A, 10B, and fluid paths 210A, 210B can be... Figure 2A The arrangement shown is reconnected to prepare for the injection procedure. The infusion tubing 300 may be configured to retain the medical fluid F after the infusion tubing 300 is disconnected from the syringes 10A, 10B to prevent spillage and leakage. In some embodiments, the infusion tubing 300 may be discarded once disconnected from the syringes 10A, 10B.

[0144] In some embodiments, the fluid injector system 2000 may include one or more infusion status sensors 910 associated with the infusion tubing 300 and / or syringes 10A, 10B. The infusion status sensor 910 may communicate with the controller 900 and may be configured to detect the infusion status based on observation and / or measurement of air and fluid in the infusion tubing 300, such as whether syringes 10A, 10B have been infused to remove all air from them. In various embodiments, the infusion status sensor 910 may include an optical sensor (e.g., a camera), a strain gauge, a microphone, an ammeter, a limit switch, a pressure sensor, or any other type of sensor capable of detecting properties of the system 2000 that can be used to determine the infusion status. Further details of the infusion status sensor 910 will be provided in the context of a specific embodiment of the infusion tubing 300 as described herein with reference to Figures 4-15B.

[0145] For reference Figure 3 In some embodiments, the infusion tube 300 may include a sidewall 310 having a proximal end 312 and a distal end 314 and defining an internal chamber 350. The proximal end 312 of the sidewall 310 may include a connector 320 configured to reversibly engage outlets 16A, 16B of an associated fluid reservoir (e.g., syringes 10A, 10B). In some embodiments, the connector 320 may include one or more engagement lugs 322 whose profiles are complementary to the internal threads of outlets 16A, 16B of syringes 10A, 10B. In some embodiments, the one or more engagement lugs 322 may be configured to release from outlets 16A, 16B of syringes 10A, 10B at a predetermined fluid pressure within the infusion tube 300. In some embodiments, the connector 320 may be a female Luer connector. In other embodiments, the connector may be the male or female portion of a connector and is configured to engage / connect with a corresponding complementary female or male connector, as described in International PCT Application No. PCT / US2021 / 018523.

[0146] In some embodiments, the infusion tubing 300 may include a closure 330 associated with the distal end 314 of the sidewall 310. The closure 330 is permeable to air but substantially impermeable to liquids, including medical fluids F. For example, according to various embodiments, the closure 330 may be a porous material, such as a material having at least one pore whose cross-sectional area allows air passage but substantially prevents the passage of medical fluid through the at least one pore. Thus, during the infusion operation of syringes 10A, 10B, air ejected from syringes 10A, 10B by pressurizing the syringe contents can flow out of the infusion tubing 300 via the closure 330, while any medical fluid F ejected from syringes 10A, 10B is retained within the internal chamber 350. Due to the difference in compressibility between gases such as air and liquids such as medical fluids F (e.g., contrast agents or saline), a significant increase in pressure buildup occurs in the infusion tubing 300 after all the air has been ejected from the syringes and the liquid has been injected into the infusion tubing 300. According to various embodiments, the pressure difference between air and liquid medical fluid can be used to determine the infusion status of the syringe. In some embodiments, the closure 330 may be made of hydrophobic medical-grade plastic, such as that produced under the trademark Gore- and Commercially available plastics typically allow the passage of gases but not liquids. In some embodiments, the closure 330 may be a solid material defining one or more orifices having a sufficient cross-sectional area to allow air to escape from the infusion 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 escape from the infusion tube 300. In some embodiments, the closure 330 may be a solid member that is impermeable to all fluids (e.g., air and medical fluids), such that all fluid injected from syringes 10A, 10B into the infusion tube 300 is retained within the internal chamber 350.

[0147] In some embodiments, the closure 330 may include an opening pressure valve, such as a high opening pressure valve, configured to open in response to a predetermined fluid pressure. Thus, the closure 330 can remain closed when pressure is built up within the infusion line 300, and the closure 330 can open at a predetermined fluid pressure to allow air and / or fluid to flow out of the infusion line 300.

[0148] In some embodiments, the internal chamber 350 may define an expandable volume. That is, the volume of the internal chamber 350 may increase as the sidewall 310 stretches, unfolds, expands, or otherwise changes shape. In such embodiments, the sidewall 310 may be made of a stretchable, foldable, and / or resilient 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 receives the volume of fluid ejected from the syringes 10A, 10B. In some embodiments, the internal chamber 350 may be configured to expand or become rigid in response to an increase in fluid pressure as fluid is ejected into the internal chamber 350.

[0149] In some embodiments, the sidewall 310 may be biased towards a contracted state, for example, the state in which the infusion tubing 300 is supplied and initially connected to syringes 10A, 10B, wherein the internal chamber 350 has a minimum volume. According to certain configurations, once the internal chamber 350 expands due to an increase in fluid pressure, this fluid pressure must be maintained; otherwise, the internal chamber 350 will tend to at least partially return to a contracted state and eject fluid back outside the connector 320. According to these configurations, a one-way valve 340, such as a check valve, may be positioned adjacent to or integral with the connector 320 of the infusion tubing 300 to prevent fluid from flowing out of the infusion tubing 300 when the fluid pressure is released, for example, when the infusion tubing 300 is disconnected from syringes 10A, 10B. Therefore, accidental spillage or leakage of medical fluid is avoided when the infusion tubing 300 is removed from the syringe.

[0150] In some embodiments, the sidewall 310 remains stable in both the contracted and expanded states because the internal chamber 350 does not bias towards either a contracted or expanded state. In such embodiments, releasing fluid pressure from the internal chamber 350, for example when the infusion tube 300 is disconnected from the syringes 10A, 10B, does not cause the internal chamber 350 to return to the contracted state. Thus, a one-way valve 340 is not required to prevent fluid backflow from the infusion tube 30. However, a one-way valve 340 may still be provided to prevent accidental fluid discharge, for example, if a technician squeezes the sidewall 310 during removal of the infusion tube 300 from the syringes 10A, 10B, or if the infusion tube 300 is accidentally tilted, causing gravity to cause fluid to flow through the connector 320.

[0151] The shape change of the sidewall 310 due to the expansion of the internal chamber 350 can be used as an indicator that the filling / venting operation of syringes 10A and 10B has been completed. The shape change of the sidewall 310 can be detected by the filling status sensor 910, and the filling status sensor 910 can send an output signal to the controller 900 indicating the filling status of syringes 10A and 10B. In other embodiments, a technician can determine the completion of the filling operation visually or audibly.

[0152] In some embodiments, the sidewall 310 may be substantially rigid, meaning that the sidewall does not deform substantially under pressure associated with the injection procedure, for example, 1200 psi for a CV procedure.

[0153] In some embodiments, the volume of the internal chamber 350 is sufficient to contain a predetermined volume of fluid ejected from the associated syringes 10A, 10B during syringe infusion / venting operations. In some embodiments, the volume defined by the internal chamber 350 can range from 5 mL to 30 mL, and in other embodiments, from 5 mL to 10 mL. In specific embodiments, this volume should be sufficient to address situations requiring more than one infusion sequence, such as when air bubbles are still observed in the system. In some embodiments, the infusion operation may include two injection sequences: a strong first flow rate with a small ejection volume to remove most of the air from the system, followed optionally by a slower second flow rate with a larger flow volume, either tapping or vibrating, to remove small air bubbles.

[0154] To perform the infusion / venting operation to expel air from syringes 10A and 10B, syringes 10A and 10B can be held in a substantially upright vertical position with outlets 16A and 16B at their highest points. Infusion of syringes 10A and 10B can be performed, for example, by moving pistons 13A and 13B distally to expel a portion of the contents of the syringes (i.e., air and medical fluid F) to expel any air from the interior of syringes 10A and 10B. In the vertical position, due to the buoyancy of the air in the medical fluid F, most of the air in syringes 10A and 10B rises to the distal end of the syringe adjacent to outlets 16A and 16B. When syringes 10A and 10B are infused, 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 infusion tube 300. During the infusion operation, air can be expelled from various internal surfaces of the syringes and the surface of the plunger to ensure that all air is infused. Examples of methods for expelling air bubbles (including microbubbles) from an internal surface or plunger surface are described in International PCT Application Publication No. WO 2019 / 204617, such as by placing the contents of a syringe under at least a partial vacuum to coalesce small air bubbles into larger air bubbles and / or by vibrating, tapping or otherwise impacting the syringe or piston / plunger assembly to expel air bubbles, the disclosure of which is incorporated herein by reference.

[0155] For reference Figures 4A-15B Various embodiments of the infusion tube 300 are illustrated. Figures 4A-15B The illustrated embodiment has the same as Figure 3 In the embodiments, components with the same reference numerals indicate similar and / or functionally equivalent components. First refer to... Figures 4A-4D An embodiment of the infusion tube 300 includes an expanding sidewall 310 having at least one bellows 316. The at least one bellows 316 is configured to expand and contract longitudinally to increase the volume of an internal chamber extending longitudinally between a proximal end 312 and a distal end 314 of the sidewall 310. The at least one bellows 316 includes alternating wider diameter portions 317 and narrower diameter portions 318 (see...). Figure 4D Initially, at least one bellows 316 is provided in a contracted state (see...). Figure 4C In this contracted state, the distance between the nearest wider diameter portion 317 and the farthest wider diameter portion 317 is minimized. Figure 4C In the contracted state, the length of the sidewall 310 is greater than that of the sidewall. Figure 4D The inflated state is short, and the internal volume of the internal chamber 350 is minimized. Therefore, in the inflated state, the volume defined by the internal chamber 350 is larger.

[0156] Continue to refer to Figures 4A-4DIn some embodiments, the closure 330 is in the form of a porous plug made of a porous hydrophobic polymer or other materials described herein, and is substantially permeable to air but impermeable to liquids, inserted or otherwise connected to the distal end 314 of the infusion tubing 300. The closure 330 may be configured to allow air or other gases to pass through the pores in the material while preventing the medical fluid F from leaving the internal chamber 350. It should be appreciated that the porous plug can be located elsewhere on the infusion tubing 300 while still allowing air to escape from the infusion tubing 300 and retaining liquid within the infusion tubing 300.

[0157] During the infusion / cleaning operation of syringes 10A and 10B, air ejected 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 air, at least one bellows 316 remains substantially unchanged in construction and is in a contracted state. As air continues to be infused, eventually some medical fluid F pushes the remaining air from syringes 10A and 10B into the infusion tube 300, and a certain amount of medical fluid F itself enters the infusion tube 300. The medical fluid F moves through at least one bellows 316 and contacts the porous plug of the closure 330, through which the medical fluid F cannot pass. Therefore, fluid pressure is established in the internal chamber 350, and at least one bellows 316 begins to expand from a compressed state to an extended state (compare). Figure 4C and Figure 4B ).

[0158] Technical experts can observe the expansion of the bellows 316 on the sidewall 310 to confirm that substantially all air has been purged from the syringes 10A and 10B, and that the syringes 10A and 10B are filled and ready for use. In some embodiments, the filling status sensor 910 (see...) Figure 2B and Figure 3The device may include a detector for image recognition, such as the camera described in U.S. Patent No. 10,201,666, the disclosure of which is incorporated herein by reference. Based on the output signal from the perfusion status sensor 910, the controller 900 may be programmed or configured to determine that the perfusion tubing 300 is in an expanded state and that the syringes 10A and 10B are perfused with air. The processor 900 may be configured to block the fluid injection procedure until it receives an indication that the syringes 10A and 10B have been successfully perfused. Once successful perfusion has been established as determined by the controller 900 and / or a technical expert, the perfusion tubing 300 may be removed and discarded according to hospital protocols, and the properly perfused patient catheter line may be fitted onto the syringes 10A and 10B. It should be noted that while the perfusion tubing embodiments described herein are for ensuring air perfusion from the syringes, various embodiments of the perfusion tubing may also be used to ensure air perfusion from the tubing kit and the syringes. According to these embodiments, the perfusion tubing may be placed at the distal end of the tubing kit (e.g., Figure 2A As shown), and used in a similar manner to determine that all air has been effectively ejected from the internal volume of the tubing kit, and in some embodiments, forming corresponding syringes and / or peristaltic pump mechanisms attached to the proximal ends of the tubing kit.

[0159] Continue to refer to Figures 4A-4D In some embodiments, each 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. A technician can use this sound as an indication that substantially all air has been expelled from the syringes 10A, 10B and that the syringes 10A, 10B are filled and ready for use. Furthermore, the filling status sensor 910 may include a microphone configured to detect sound and send a signal to a processor 900, which can then determine sequentially based on the signal that the syringes 10A, 10B have been filled. For example, a technician or the processor 900 may count the number of popping sounds corresponding to the expansion of at least one bellows 312 and correlate them with the total number of bellows features to determine when the filling tube 300 is in a fully expanded configuration.

[0160] Now refer to Figure 4E ,for Figures 4A-4DAn embodiment is illustrated in graph 400, showing the change in fluid pressure within the infusion tube 300 over time. The fluid pressure, represented by curve 402, is initially substantially constant in portion 404 because primary air is injected into the internal chamber 350 and flows through the porous material of the closure 330. As the medical fluid F enters the internal chamber 350 and causes each of at least one bellows 316 to transition from a constricted state to an expanded state, the fluid pressure then experiences several peaks 410. Specifically, because the medical fluid F cannot flow out of the distal end 314, the fluid pressure increases until the first of at least one bellows 316 transitions to an expanded state. When the first of at least one bellows 316 expands, the fluid pressure decreases due to the increased volume of the internal chamber 350 caused by the expansion of the bellows 316. As more fluid is expelled from syringes 10A, 10B into the internal chamber 350, the pressure rebuilds until another bellows 316 expands. This process continues until all bellows 316 are in an expanded state and the infusion operation is complete. After all bellows 316 are in an expanded state, the fluid pressure will rise, as shown at the tail 412 of curve 402, until the fluid flow stops.

[0161] In some embodiments, the infusion status sensor 910 may include a motor current (or motor force) sensor configured to measure the current consumption of 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. Specifically, changes in motor current may be correlated with changes in fluid pressure within the infusion tube 300, such as… Figure 4E The graph is shown below. When the last bellows 316 is in the expanded state and the motor current and fluid pressure continue to rise, the controller 900 can then stop the filling operation, indicate that the system has been filled, and proceed to the next step in the injection scheme. Alternatively, the controller 900 can determine that the system has been effectively filled after a predetermined number of bellows 316 have expanded.

[0162] For reference Figures 5A-5D An embodiment of an infusion tubing 300 including an expandable sidewall 310 is illustrated. The sidewall 310 may be made of a flexible or stretchable elastic material or a balloon that expands when a pressure difference exists between the internal chamber 350 and the environment outside the sidewall 310. The material of the sidewall 310 may be elastic because when stretched, the sidewall 310 attempts to return to its initial state. Therefore, if fluid pressure is removed from the internal chamber 350, the sidewall 310 will contract and force fluid back out of the proximal end 312 of the infusion tubing 300. A one-way valve 340 is configured to prevent backflow from the proximal end 312 when the infusion tubing 300 is disconnected from the syringe. The infusion tubing 300 is... Figures 5A-5C The non-expansion structure shown is provided.

[0163] Continue to refer to Figures 5A-5D In one embodiment, the closure 330 may be a sealing plug, which is inserted into or otherwise connected to the distal end 314 of the infusion tubing 300. The sealing plug prevents all fluid, including air and medical fluid F, from leaving the distal end 314 of the infusion tubing 300. Due to the sealing nature of the sidewall 310 caused by the one-way valve 340 and the closure 330, air and fluid are trapped in the internal chamber 350 during infusion. As air continues to be infused, eventually some of the medical fluid F pushes the remaining air into the infusion tubing 300, and the medical fluid F itself enters the internal chamber 350. As the volume of air in the sidewall 310 increases, and subsequently the volume of fluid, the pressure in the sidewall 310 increases, and the flexible, expandable wall of the sidewall 310 expands, similar to the expansion of a balloon. Specifically, as pressure builds up in the infusion tubing 300, the sidewall 310 begins to expand from… Figures 5A-5C The compressed state shown expands to Figure 5D The expansion state is shown. Once the volume of the internal chamber 350 reaches a certain size, a technician can determine that the syringes 10A and 10B have been filled and are ready for injection procedures. In some embodiments, the elastic characteristics of the sidewall 310 can be selected such that it does not expand substantially under pressurized air (due to the compressibility of the gas), but expands when liquid pressure is established in the internal chamber 350.

[0164] In other embodiments, the closure 330 may be porous, allowing air to pass through but preventing liquid from passing through. According to this embodiment, and similar to a bellows (…), Figures 4A-4E When air flows into the internal chamber 350, the elastic sidewall 310 does not expand substantially because the air flows out through the closure 330. However, when liquid medical fluid F is injected into the internal chamber 350, the elastic sidewall 310 expands and fluid pressure is established therein.

[0165] In some embodiments, the perfusion status sensor 910 may include a camera, as described herein. Figure 3 and 4A As described in -4D, in conjunction with controller 900, it is determined that syringes 10A and 10B have been infused based on the sidewall 310 being in an expanded state. (As described herein...) Figures 4A-4D The controller 900 may be programmed or configured to prevent the execution of the injection procedure until successful infusion of syringes 10A and 10B has been detected.

[0166] During removal of the infusion tubing 300 from syringes 10A and 10B, a 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 infusion tubing 300. The entire infusion tubing 300, containing air and medical fluid F, may be discarded according to hospital protocols.

[0167] For reference Figure 5E ,for Figures 5A-5D The infusion tubing 300 is illustrated in graph 500, showing the fluid pressure change over time within the infusion tubing 300. The fluid pressure, represented by curve 502, initially rises slowly in portion 504 because air, due to its compressibility, is primarily injected into the internal chamber 350 at a low slope. As the medical fluid F expels the remaining air from the syringes 10A, 10B, and some of the medical fluid F itself enters the internal chamber 350, the fluid pressure continues to rise at a greater rate. The fluid pressure may experience a transition point 506, where the sidewalls 310 undergo yielding due to expansion. Once the total expansion volume of the internal chambers 350 is nearly reached, the pressure increases at a greater rate in portion 508. In some embodiments, the infusion status sensor 910 may include a motor current (or motor force) sensor configured to measure the current consumption 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 and correlate the pressure measurement with the infusion status. Specifically, changes in motor current can be correlated with changes in fluid pressure within the injection tube 300, such as... Figure 5E As shown in the graph, the controller 900 can determine when the system has been effectively infused.

[0168] For reference Figures 6A-6D The illustration shows an embodiment of an infusion tube 300, wherein the sidewall 310 includes an expandable rolling diaphragm. The sidewall 310 is flexible or elastic, such that it can roll up or fold over itself in response to fluid pressure in the internal chamber 350. In the initially provided contracted state of the infusion tube 300, as... Figures 6A-6C As shown, the sidewall 310 is arranged such that the distal portion 313 of the sidewall 310 is rolled up or folded into the internal space defined by the proximal portion 311 of the sidewall 310. The distal portion 313 is rolled up on 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 sidewall 310 is configured to flip in response to an increase in fluid pressure within the internal chamber 350, thereby transforming the sidewall 310 to... Figure 6D The expansion position is shown. In particular, the distal portion 313 is flipped by unfolding / spreading out from the interior of the proximal portion 311, so that the sidewall 310 presents... Figure 6DThe internal chamber 350 is in an expanded state as shown. Therefore, the volume defined by the internal chamber 350 when the sidewall 310 is in an expanded state is greater than the volume when it is in a contracted state.

[0169] Continue to refer to Figures 6A-6D In this embodiment, the closure 330 may include a... Figures 4A-4D The embodiment uses a substantially similar porous material to allow air to flow through the closure 330 while retaining the medical fluid F within the internal chamber 350. During the infusion / venting operation of the syringes, air injected from syringes 10A, 10B into the infusion 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 air, the rolling diaphragm portion of the sidewall 310 remains substantially unchanged, i.e., remains in a contracted state, as air is ejected from syringes 10A, 10B. As air continues to be infused, the medical fluid F pushes the remaining air from syringes 10A, 10B into the infusion tube 300 and expels it from the porous material of the closure 330, and the medical fluid F itself enters the internal chamber 350. Due to the hydrophobic properties of the closure 330, the medical fluid F cannot leave the internal chamber 350. As the volume of the medical fluid F in the internal chamber 350 increases, the pressure in the internal chamber 350 increases, forcing the distal portion 313 to spread / unfold from the interior of the proximal portion 311, thereby pulling the sidewall 310 from... Figures 6A-6C The contraction state shown transforms into Figure 6D The expansion state shown.

[0170] Once the internal chamber 350 reaches a certain volume or the rolling diaphragm portion of the sidewall 310 reaches a specific unfolding state, such as fully unfolded, a technician can determine that substantially all air has been removed from the syringes 10A and 10B, meaning that the syringes 10A and 10B have been filled and are ready for use. In some embodiments, the filling status sensor 910 (see...) Figure 2B and Figure 3 This may include a detector for image recognition, such as the camera described in U.S. Patent No. 10,201,666. Based on the output signal from the perfusion status sensor 910, the controller 900 may be programmed or configured to determine that the perfusion tubing 300 is in an expanded state and that the syringes 10A and 10B are infused with air. The processor 900 may be configured to block the fluid injection process until it receives an indication that the syringes 10A and 10B have been successfully infused. Once the controller 900 and / or a technical expert determine that a successful perfusion has been established, the perfusion tubing 300 may be removed and discarded according to hospital protocols, and the appropriately infused patient catheter may be attached to the syringes 10A and 10B.

[0171] For reference Figure 6E ,for Figures 6A-6DThe embodiment illustrates a graph 600 showing the change in fluid pressure over time within the infusion tube 300. The fluid pressure, represented by curve 602, is initially substantially constant at portion 604 because primarily air is injected into the internal chamber 350 and flows through the porous material of the closure 330. Then, as medical fluid F enters the internal chamber 350, the fluid pressure increases until it reaches a pressure sufficient to cause the distal portion 313 of the sidewall 310 to spread out from the proximal portion 311. Then, as more fluid is expelled from the syringes 10A, 10B into the internal chamber 350, the fluid pressure continues to remain substantially constant at portion 608 and continues to cause the sidewall 310 to spread out toward an expanded state. After the sidewall 310 is in a substantially spread-out state, the volume of the internal chamber 350 is substantially maximized, and the fluid pressure substantially increases at portion 610 as fluid continues to be ejected from the syringe.

[0172] In some embodiments, the infusion status sensor 910 may include a motor current (or motor force) sensor configured to measure the current consumption of 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. Specifically, changes in motor current may be correlated with changes in fluid pressure within the infusion tube 300, such as… Figure 6E The graph is shown below.

[0173] For reference Figures 7A-7D The illustration shows an embodiment of the infusion tube 300, which includes a plurality of [unclear text - likely related to a specific type of tube]. Figures 6A-6D The embodiments share the same features, such as the rolling diaphragm sidewall 310. The main difference between these embodiments is that, in Figures 7A-7D In this embodiment, the distal end 314 of the sidewall 310 is completely sealed, preventing air from escaping from the distal end 314. As a result, all fluid ejected from the syringes 10A, 10B during the infusion / venting operation, including air and medical fluid F, remains within the internal chamber 350. Due to the compressibility of air and the incompressibility of the medical fluid, the rolling diaphragm will remain substantially rolled up when air is injected into the infusion tubing 300, but will then transition to an expanded state when fluid is injected into the internal chamber 350 and fluid pressure is established within the internal chamber 350. The infusion status can then be identified by a technician or controller 900 using input from the infusion status sensor 910, as described herein.

[0174] For reference Figure 7E ,for Figures 7A-7DThe embodiment illustrates a graph 700 showing the change in fluid pressure over time within the infusion tube 300. The fluid pressure, represented by curve 702, is initially substantially constant at portion 604 because primarily air is injected into the internal chamber 350 and flows through the porous material of the closure 330. Then, as medical fluid F enters the internal chamber 350, the fluid pressure increases until it reaches a pressure sufficient to cause the distal portion 313 of the sidewall 310 to spread out from the proximal portion 311. Then, as more fluid is expelled from syringes 10A, 10B into the internal chamber 350, the fluid pressure continues to remain substantially constant at portion 708 and continues to cause the sidewall 310 to spread out toward an expanded state. After the sidewall 310 is in a substantially spread-out state, the volume of the internal chamber 350 is substantially maximized, and the air / fluid pressure substantially increases at portion 710 as fluid continues to be ejected from syringes 10A, 10B. Therefore, Figures 7A-7D The stress behavior of the embodiment is similar to Figures 6A-6D In the embodiments, although in Figures 6A-6D In the embodiments, the presence of the porous closure 330 can at least initially reduce the pressure within the internal chamber 350, as air can escape.

[0175] refer to Figures 8A-9C The illustration shows an embodiment of an infusion tube 300 including a shuttle member 360 slidable within an internal chamber 530. According to these embodiments, the sidewall 310 may be substantially rigid and inelastic, such that the sidewall 310 does not significantly expand under normal infusion pressures below a predetermined threshold. The shuttle member 360 is configured to slide within the internal chamber 350 from proximal end 312 to distal end 314 in response to liquid ejected from syringes 10A, 10B into the infusion tube 300. The infusion tube 300 is initially provided with the shuttle member 360 adjacent to or near the proximal end 312. In some embodiments, the shuttle member 360 may be sized to frictionally engage with the sidewall 310, such that the shuttle member 360 does not accidentally disengage from the proximal end 312 until the infusion tube 300 is pressurized from syringes 10A, 10B. In some embodiments, the proximal end 312 of the sidewall 310 has a slightly reduced diameter to increase frictional engagement with the shuttle member 360 at the proximal end 312. Thus, the initial amount of fluid pressure required to drive out 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, such as Figure 9C As shown, the sidewall 310 may include an inner lip 352 to retain the shuttle member 360 adjacent to or near the proximal end 312 until the infusion tube 300 is pressurized from the syringes 10A, 10B. The lip 352 or friction fit allows the reciprocating member 360 to be prevented from being expelled under air pressure, but to be expelled and become slidable as fluid flows into the inner chamber 350.

[0176] In some embodiments, the shuttle member 360 may allow air passage to reach the distal end 314 of the infusion tube 300. In such embodiments, the shuttle member 360 may be made of a hydrophobic medical-grade plastic that, as described herein, is permeable to air but impermeable to the medical fluid F. In some embodiments, dimensional tolerances between the outer side of the shuttle member 360 and the inner side of the sidewall 310 may allow air to pass between the shuttle member 360 and the sidewall 310, but substantially prevent the medical fluid F from passing between the shuttle member 360 and the sidewall 310. In some embodiments, the shuttle member 360 may include one or more orifices having a sufficient cross-sectional area to allow air passage but substantially prevent the passage of the medical fluid F.

[0177] The closure 330 adheres to the orifice 331 at the distal end 314 of the infusion tube 300 and serves as a stop to prevent the shuttle member 360 from escaping from the distal end 314 of the infusion tube 300. The closure 330 may include an orifice 332 to allow air to exit from the distal end 314 of the infusion tube 300. Various embodiments may include a lip or protrusion at the distal end 314 of the sidewall 310 instead of the closure 330, wherein the inner diameter of the distal end 314 is smaller than the inner diameter of the sidewall 310 to prevent the shuttle member 360 from escaping from the distal end 314 of the infusion tube 300.

[0178] During the infusion / venting operation of syringes 10A and 10B, air passes through or surrounds shuttle member 360, through internal chamber 350, and exits from orifice 332 of closure member 330. In some embodiments, air may pass through or surround shuttle member 360 without substantially displacing and / or moving shuttle member 350 within internal chamber 350. As air continues to be infused, eventually some medical fluid F pushes the remaining air from syringes 10A and 10B into internal chamber 350, and medical fluid F itself enters internal chamber 350. The pressurized medical fluid F displaces shuttle member 360 from frictional engagement with sidewall 310 and causes shuttle member 360 to slide distally toward closure member 330 within internal chamber 350. As the medical fluid F continues to be injected from syringes 10A and 10B into the internal chamber 350, the shuttle member 360 may continue to slide distally until the shuttle member 360 contacts the closure member 330, and substantially all the air has been expelled from the internal chamber 350 by the pressurized medical fluid F.

[0179] Continue to refer to Figures 8A-9CThe sidewall 310 may be made of a translucent or transparent material, allowing the shuttle member 360 to be seen through it. The shuttle member 360 may be an easily visible, conspicuous color, so that movement of the shuttle member 360 along the longitudinal axis of the internal chamber 350 can be observed or detected. Once a predetermined volume of medical fluid F has entered the infusion tube 300, as evidenced by the longitudinal position of the shuttle member 360 within the internal chamber 350, a skilled technician can determine that syringes 10A and 10B have been fully infused. In some embodiments, the internal chamber 350 may be sized such that once a volume sufficient to infuse the syringes 10A and 10B with medical fluid F has been injected into the internal chamber 350, the shuttle member 360 contacts the closure 330 (e.g., Figure 8D (As shown). In such an embodiment, a technician can observe the cessation of movement of the shuttle member 360, indicating that the shuttle member 360 has engaged the closure member 330 to confirm that the syringes 10A and 10B have been fully infused.

[0180] In some embodiments, the perfusion status sensor 910 (see Figure 2B and Figure 3 This can be configured to detect the position of the shuttle component 360 within the internal chamber 350. See details... Figures 9A-9C The sidewall 310 may include one or more ribs 319 or other boundaries or indicators that a technician and / or the perfusion status sensor 910 may use as rulers to help determine the relative position and distance traveled of the shuttle member 360 within the internal chamber 350, thereby determining the volume of medical fluid F that has entered the perfusion tube 300. The perfusion status sensor 910 may include a detector for image recognition, such as the camera described in U.S. Patent No. 10,201,666. Based on the output signal from the perfusion status sensor 910, the controller 900 may be programmed or configured to determine that the shuttle member 360 has moved a sufficient distance to indicate that the syringes 10A and 10B have been perfused with air. The processor 900 may be configured to block the fluid injection procedure until it receives an indication that the syringes 10A and 10B have been successfully perfused. Once the controller 900 and / or a technical expert confirm that successful perfusion has been established, the perfusion tubing 300 can be removed and discarded according to hospital protocols, and the properly perfused patient catheter line can be attached to syringes 10A and 10B. The perfusion tubing 300 may include a one-way check valve at the proximal end to prevent fluid leakage upon removal.

[0181] In some embodiments, the size or flow characteristics of the orifice 332 of the closure 330 may be configured to produce an audible sound, such as a whistle, when air flows through the orifice 332. When the orifice 332 stops emitting sound, this indicates that substantially all air has been expelled from the internal chamber 350, and a technician can determine that syringes 10A, 10B have been filled. Optionally, the filling status sensor 910 may include a microphone configured to detect sound emanating from the orifice 332. The controller 900 may be programmed or configured to determine that syringes 10A, 10B have been filled when the orifice 332 stops emitting sound, indicating that substantially all air has been expelled from the internal chamber 350.

[0182] For reference Figure 8E ,for Figures 8A-8D The embodiment illustrates a graph 800 showing the change in fluid pressure over time within the infusion tubing 300. 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. Then, as medical fluid F enters the inner chamber 350, the fluid pressure increases until it reaches a pressure sufficient to expel the shuttle member 360 from the proximal end 314. The expulsion of the shuttle member 360 results in a spike 812 as the initial static friction between the shuttle member 360 and the sidewall 310 is overcome. The pressure can then stabilize at section 814 as the shuttle member 360 is displaced by the medical fluid F and slides along the infusion tubing 300 until it reaches the distal end 314. Once the shuttle member 360 contacts the distal end, the fluid pressure rapidly builds up in the inner chamber 350, as shown in section 816.

[0183] In some embodiments, the infusion status sensor 910 may include a motor current (or motor force) sensor configured to measure the current consumption of 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. Specifically, changes in motor current may be correlated with changes in fluid pressure within the infusion tube 300, such as… Figure 8E The graph is shown below. For example, when the pressure stabilizes at section 814 or rises sharply at section 816, the controller 900 can determine that air has been injected from the syringe and provide an indication that the injection operation is complete.

[0184] For reference Figures 10A-10CThis illustration shows one embodiment of an infusion cannula 300, wherein a sidewall 310 defines a cap 370 at a distal end 314, the cap 370 having one or more air release holes 372 and a plug retaining member 374. A shuttle member 360 in the form of a porous plug is disposed within the cap 370, and in an initial state or initial position, the infusion cannula 300 is held in the outlets 16A, 16B of syringes 10A, 10B by the plug retaining member 374. In some embodiments, the shuttle member 360 may be made of a hydrophobic medical-grade plastic, as described herein, which is permeable to air but impermeable to the medical fluid F. In some embodiments, the shuttle member 360 may be a solid material defining one or more orifices having a sufficient cross-sectional area to allow air passage but insufficient to allow the passage of the medical fluid F.

[0185] During the infusion / venting operation, air ejected from syringes 10A and 10B flows through the perforated shuttle member 360, enters the internal chamber 350, and exits from one or more air release holes 372. As air continues to be infused 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 contacts the proximal side 362 of the shuttle member 360. When the medical fluid F cannot pass through the shuttle member 360, fluid pressure builds up on the proximal side 362, causing the shuttle member 360 to move to a second infusion position and rest against the stopper retainer member 374.

[0186] In some embodiments, the controller 900 may be configured to measure fluid pressure at the proximal side 362 of the shuttle member 360. Specifically, the perfusion status sensor 910 may include a motor current (or motor force) sensor configured to measure the current consumption of the drive motor associated with pistons 13A, 13B. The controller 900 may be programmed or configured to determine the fluid pressure based on the motor current consumption. The controller 900 may be programmed or configured to determine that syringes 10A, 10B have been perfused when a predetermined fluid pressure is measured. Once the controller 900 has established successful perfusion, the perfusion tubing 300 may be removed and discarded according to hospital protocols, and an appropriately perfused patient catheter may be attached to syringes 10A, 10B. Figures 10A-10C A feature of the infusion tubing 300 shown is that the volume of the medical fluid F ejected during the infusion operation is minimized, reducing hospital waste and saving costs. Once the controller 900 has determined that the syringe has been infused, the controller can release the pressure on the pistons 13A, 13B and depressurize the fluid in the syringe to ensure that pressurized fluid is not ejected from the syringe when the infusion tubing 300 is removed.

[0187] Now for reference Figures 11A-11DThe illustration shows an embodiment of an infusion tube 300 with an indicator tab extending distally. A sidewall 310 defines a cap 370 with a receiving port 376 at a distal end 314. The sidewall 310 engages with threaded connectors of outlets 16A, 16B of syringes 10A, 10B via threaded lugs 320. A shuttle member 360 in the form of a porous plug is disposed within an internal chamber 350 and, in the initial state or position of the infusion tube 300, is retained in the outlets 16A, 16B of syringes 10A, 10B by a press fit. In some embodiments, the shuttle member 360 may be made of a hydrophobic medical-grade plastic, as described herein, which is permeable to air but impermeable to the medical fluid F. In some embodiments, the shuttle member 360 may be a solid material defining one or more orifices having a sufficient cross-sectional area to allow air passage but not a sufficient cross-sectional area to allow the passage of the medical fluid F. In some embodiments, the shuttle member 360 may be painted in a bright color for easy visibility by a technician. The shuttle member 360 includes a distally extending tip 364 axially aligned with a receiving aperture 376 of the cap 370. The diameter of the receiving aperture 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.

[0188] During the infusion / venting operation, air ejected from syringes 10A, 10B flows through the perforated shuttle member 360, enters the internal chamber 350, and exits from the receiving port 376. As air continues to be infused and purged from syringes 10A, 10B, some medical fluid F eventually pushes the remaining air out of syringes 10A, 10B through the shuttle member 360, and the medical fluid F contacts the proximal side 362 of the shuttle member 360. Because the medical fluid F cannot pass through the shuttle member 360, fluid pressure builds up on the proximal side 362, causing the shuttle member 360 to be expelled from the outlets 16A, 16B of syringes 10A, 10B to a second infusion position and rest against the cap 370. The tip 364 extends through the receiving port 376, providing an indication to the technician and / or controller 900 that the shuttle member 360 has been expelled and syringes 10A, 10B have been infused. The distal surface 367 of the shuttle member 360 can be sealingly adjacent to the inner surface surrounding the receiving port 376 to prevent any medical fluid from leaking out of the infusion tube 300 once infused.

[0189] In some embodiments, the perfusion status sensor 910 may include a detector for image recognition, such as the camera described in U.S. Patent No. 10,201,666. The perfusion status sensor 910 may be configured to detect movement and / or position of the tip 364 from an initial position to a perfusion position, in which the tip 364 is flush with or recessed within the sidewall 310 (see [link to relevant documentation]). Figure 11CAt the infusion position, the shuttle member 360 moves to the distal end 314 of the infusion tube 300, and the tip 364 extends distally through the receiving hole 376. In some embodiments, the infusion status sensor 910 may include a limit switch contacted by the tip 364 when the shuttle member 360 moves to the distal end 314 of the infusion tube 300.

[0190] Based on the output signal from the perfusion status sensor 910, the controller 900 can be programmed or configured to determine that the shuttle member 360 has moved to the distal end 314 of the perfusion tubing 300, indicating that the syringes 10A and 10B have been perfused. The processor 900 can be configured to block the fluid injection process until it receives an indication that the syringes 10A and 10B have been successfully perfused. Once the controller 900 and / or a technical expert determine that a successful perfusion has been established, the perfusion tubing 300 can be removed and discarded according to hospital protocols, and the appropriately perfused patient catheter can be fitted onto the syringes 10A and 10B.

[0191] For reference Figures 12A-12C The embodiment of the injection tube 300 and Figures 11A-11D The embodiments are similar, and the main differences will be discussed. Figures 12A-12C In the illustrated embodiment, the engagement lug 322 is disposed on the deflectable arm 324 of the connector 320. In some embodiments, the engagement lug 322 may include a tab that engages with a corresponding groove 378 in the outlets 16A, 16B of the syringes 10A, 10B. The proximal end of the shuttle member 360 includes a wall 368 of at least a partial circumference surrounding the outer circumference of the outlets 16A, 16B, and engages the deflectable arm 324 (e.g., at the initial position of the infusion tube 300) at the deflectable arm 324. Figure 12C (As shown), to prevent the arm 324 from deflecting inward. The engagement of the circumferential wall 368 with the deflectable arm 324 reversibly locks the engagement lug 322 of the infusion tube 300 into the corresponding groove 378 of the outlets 16A, 16B of the syringes 10A, 10B, and prevents the connector 320 of the infusion tube 300 from being manually removed from the outlets 16A, 16B of the syringes 10A, 10B when the shuttle member 360 is sealed in the outlets 16A, 16B. As previously described, the shuttle member 360 is permeable to air but impermeable to liquid, so when fluid pressure is established, the shuttle member 360 is driven out from the outlets 16A, 16B. When the shuttle member 360 moves distally to the infusion position, the circumferential wall 368 is driven out from between the outer circumference of the outlets 16A, 16B and the deflectable arm 324 (as shown). Figure 12DAs shown, the arm 324 is allowed to deflect radially inward, allowing the engagement lug 322 to be released from the slot 378. The infusion tube 300 can then be removed from the syringes 10A and 10B. Therefore, the arrangement of the circumferential wall 368 and the deflectable arm 324 forces a technician to perform an infusion operation on syringes 10A and 10B before the infusion tube 300 can be removed, thus ensuring that the syringes are infused before the injection procedure can proceed (i.e., by removing the infusion tube 300). As previously stated, a technician and / or processor 900 can determine the system's status (infused or uninfused) by extending the tip 364 through the receiving hole 376 and by enabling the technician to remove the infusion tube 300.

[0192] In some embodiments, the engagement lug 322 of the connector 320 may be configured to automatically release from the slot 378 of the outlets 16A, 16B of the syringes 10A, 10B at a predetermined fluid pressure corresponding to the fluid pressure when the syringes 10A, 10B are fully infused. Therefore, the release of the infusion tube 300 from the syringes 10A, 10B indicates that the syringes 10A, 10B have been infused and are ready for injection. In some embodiments, the connector 320 may be configured to be non-manually removable from the outlets 16A, 16B of the syringes 10A, 10B, thereby forcing a technician to perform an infusion operation to automatically release the infusion tube 300 from the syringes 10A, 10B. The syringes 10A, 10B may be oriented such that when the engagement lug 322 is released from the outlets 16A, 16B of the syringes 10A, 10B, the infusion tube 300 falls into a waste container. After the infusion tubing 300 has been released, the appropriate patient catheter line can be attached to syringes 10A and 10B.

[0193] For reference Figure 13An embodiment of an infusion tube 300 is shown, comprising an inner cap 380 fitted onto an inner nozzle 55 of an outlet 16A, 16B of syringes 10A, 10B. The cap 380 is constructed and / or arranged to be recessed into the outlets 16A, 16B such that the cap 380 cannot be manually removed from the inner nozzle 55 before the syringe is infused, and can only be removed by the infusion operation. Therefore, the infusion procedure cannot be performed without initial infusion and final removal of the cap 380. For example, the inner cap 380 may be recessed into the outlets 16A, 16B by a frictional fit, making it impossible for the inner cap 380 to be removed intentionally or unintentionally with ordinary effort. In some embodiments, the inner cap 380 may include a proximal post 382 inserted into at least a portion of the inner nozzle 55 of the syringes 10A, 10B. The proximal post 382 may help maintain the inner cap 380 in proper position on the inner nozzle 55 by a press fit or a frictional fit. In some embodiments, the inner cap 380 may be made of a hydrophobic medical-grade plastic that, as described herein, is permeable to air but impermeable to the medical fluid F. In some embodiments, the inner cap 380 may be a solid material defining one or more pores having a sufficient cross-sectional area to allow air passage but not a sufficient cross-sectional area to allow the medical fluid F passage.

[0194] According to some embodiments, the shuttle member 360 may be disposed within and slide within the internal chamber 350 of the infusion tube 300, and the shuttle member 360 is sufficiently tightly fitted with the sidewall 310 to prevent the medical fluid F from flowing between the shuttle member 360 and the sidewall 310. In some embodiments, the shuttle member 360 may include fingers 366 configured to engage the cap 380. In some embodiments, the shuttle member 360 may be made of a hydrophobic medical-grade plastic, as described herein, which is permeable to air but impermeable to the medical fluid F. In some embodiments, the shuttle member 360 may be a solid material defining one or more orifices having a sufficient cross-sectional area to allow air passage but not sufficient cross-sectional area to allow the medical fluid F passage. The distal end 314 of the sidewall 310 has at least one opening to allow air to flow through the cap 380 and the shuttle member 360 to exit the infusion tube 300.

[0195] During the infusion operation, air ejected from syringes 10A and 10B flows through or around the inner cap 380 and shuttle member 360, enters the internal chamber 350, and exits from the distal end 314 of the infusion tube 300. As air continues to be infused and purged from syringes 10A and 10B, some of the medical fluid F eventually pushes the remaining air in syringes 10A and 10B through the inner cap 380, and the medical fluid F contacts the proximal surface or proximal post 382 of the inner cap 380. Since the medical fluid F cannot pass through the cap 380, fluid pressure builds up until the inner cap 380 is expelled from the nozzle 55. As more fluid F is injected into the infusion tube 300, the inner cap 380 then slides distally within the internal chamber 350 under the force of the medical fluid F. The inner cap 380 further engages the shuttle member 360 within the internal chamber 350 and pushes it toward the distal end 314.

[0196] and combination Figures 8A-9C Similar to the embodiments discussed, the shuttle member 360 and / or inner cap 380 may be a bright color, and the sidewall 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. A technician and / or controller 900 may determine that syringes 10A and 10B have been infused based on the position of the shuttle member 360 and / or the visibility of the inner cap 380 within the internal chamber 350, in a manner consistent with this document. Figures 8A-9C The discussion methods were basically the same.

[0197] In some embodiments, syringes 10A and 10B may be provided with a pre-positioned inner cap 380. This inner cap 380 helps maintain sterility inside the syringe 380. Furthermore, as described herein, due to the non-manually removable interface between the inner cap 380 and the inner nozzle 55, the inner cap 380 can be easily removed only during the infusion operation, thereby ensuring that syringes 10A and 10B are infused before connection to the patient's catheter and minimizing the occurrence of unintentional air injection during the infusion procedure.

[0198] For reference Figures 14A-14C The illustration shows an embodiment including an expandable infusion tube 300. Similar to the one described herein... Figures 4A-4D In the discussed embodiments, a closure 330 in the form of a sealing plug may be inserted into or otherwise adhered to the distal end 314 of the infusion tubing 300. The closure 330 prevents all fluids, including air and medical fluids F, from leaving the distal end 314 of the infusion tubing 300. In some embodiments, the sidewalls 300 may be made of a material that can be in an expanded state (e.g., Figure 14A (As shown) is blow-molded and then converted into a shrinkage or compression state (e.g. Figure 14B(As shown), this is the state of the infusion tube 300. When in the contracted state, the sidewall 310 itself collapses at least partially, minimizing the volume of the internal chamber 350. Figure 14A As shown, embodiments of the infusion tube 300 are typically formed into an elliptical shell during manufacturing, although other molded shapes are also conceivable. After manufacturing, a portion of the sidewall 310 is flipped so that the opposing faces of the sidewalls 310 are in contact with or close together. As shown, the sidewall 310 thus... Figure 14B The infusion tube 300 is formed into a semi-elliptical shell in its contracted state. 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 recover, causing the sidewall 310 to expand and increase the volume of the internal chamber 350. In some embodiments, the infusion tube 300 may further include a one-way valve 340 that prevents backflow from the internal chamber 350 out of the proximal end 312 of the infusion tube 300.

[0199] according to Figures 14A-14C Operation and connection of the infusion tube 300 in the embodiment Figures 5A-5C The described embodiments are similar. Due to the sealing nature of the sidewalls 310 and the closure 330, air is trapped in the internal chamber 350 during the infusion operation. As air continues to be infused, some of the medical fluid F eventually pushes the remaining air into the infusion tube 300, and the medical fluid F itself enters the internal chamber 350. As the volume of air and medical fluid F in the internal chamber 350 increases, the sidewalls 310 flip to accommodate the increased fluid volume and corresponding pressure. Once the volume of the internal chamber 350 reaches a certain size, a skilled technician can determine that the syringes 10A, 10B have been infused and are ready for the injection procedure. In some embodiments, the infusion status sensor 910 may include a camera, as described herein. Figures 4A-4D The controller 900, in conjunction with the controller, determines that syringes 10A and 10B have been infused based on the sidewall 310 being in an expanded state. As described herein, at least... Figures 4A-4D The controller 900 may be programmed or configured to prevent the execution of the injection procedure until successful infusion of syringes 10A and 10B has been detected.

[0200] During removal of the infusion tubing 300 from syringes 10A and 10B, a one-way valve 340 prevents pressurized air and fluid in the internal chamber 150 from being released from the proximal end 312 of the infusion tubing 300. The entire infusion tubing 300, containing air and medical fluid F, can be discarded according to hospital protocols.

[0201] For reference Figure 15A and 15B In some embodiments of the infusion tube 300, the sidewall 310 may be naturally in a bent, soft, or relaxed state or configuration, similar toFigure 15A The flat tube shown. When fluid pressure is established in the internal chamber 350, for example when medical fluid F flows through the sidewall 310, the fluid pressure causes the sidewall 310 to straighten / stretch and expand into a tubular shape, as... Figure 15B As shown. In some embodiments, the sidewall 310 may become substantially rigid in response to fluid flow through the internal chamber 350. In other embodiments, the sidewall 310 may be in a flat, rolled-up, or coiled state when there is no fluid flow in the internal chamber 350. When fluid flows through the internal chamber 350, the sidewall 310 may transform into a stretched, expanded shape due to fluid pressure. The closure 330 attached to the distal end 314 of the sidewall 310 is permeable to air but impermeable to the medical fluid F, as described herein. Figures 4A-4D As described herein, a technician and / or processor 900 can visually determine when the infusion tube 300 is in the straightened position. Figure 15B The controller 900 can determine that the infusion operation has been completed and the next step of the fluid injection procedure can be performed. In some embodiments, the closure 300 may define a flow characteristic to induce an audible sound as air passes through the closure 330. When the orifice 332 stops emitting sound, this indicates that substantially all air has been expelled from the internal chamber 350, and a technician can determine that syringes 10A, 10B have been infused. Optionally, the infusion status sensor 910 may include a microphone configured to detect sound emanating from the orifice 332. The controller 900 may be programmed or configured to determine that syringes 10A, 10B have been infused when the closure 330 stops emitting sound, indicating that substantially all air has been expelled from the internal chamber 350. Once the controller 900 and / or a technician have determined that a successful infusion has been established, the infusion tubing 300 can be removed and discarded according to hospital protocols, and an appropriately infused patient catheter line can be attached to syringes 10A, 10B.

[0202] While various examples of this disclosure have been provided in the foregoing description, those skilled in the art can make modifications and alterations to these examples without departing from the scope and spirit of this disclosure. For example, it should be understood that features of the various embodiments herein can be applied to other embodiments described herein. Therefore, the description is intended to be illustrative rather than limiting. The disclosure is defined by the appended claims, and all changes to the disclosure falling within the meaning and equivalents of the claims are to be included within their scope.

Claims

1. An infusion tube for use with a fluid injector, the infusion tube comprising: Sidewalls that define an internal chamber having an expandable volume; A connector associated with the proximal end of the sidewall and configured to reversibly engage the outlet of a fluid reservoir containing medical fluid; as well as A closure associated with the distal end of the sidewall, the closure being permeable to air but impermeable to the medical fluid. The expandable volume of the internal chamber is configured to increase as the medical fluid enters the internal chamber.

2. The infusion tube according to claim 1, wherein, The sidewall includes at least one bellows, wherein each of the at least one bellows is configured to change from a contracted state to an expanded state in response to an increase in fluid pressure within the internal cavity. Wherein, when at least one of the at least one bellows is in the expanded state, the volume defined by the internal chamber is greater than the volume when it is in the contracted state.

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

4. The infusion tube according to claim 2, wherein, When the at least one bellows is in the expanded state, the axial length of the sidewall is greater than the axial length when it is in the contracted state.

5. The injection tube according to claim 1, wherein, The sidewalls include an elastic material configured to expand the expandable volume in response to an increase in fluid pressure within the internal cavity.

6. The infusion tube according to claim 1, wherein, The sidewalls are configured to change from a contracted state to an expanded state in response to an increase in fluid pressure within the internal cavity. In the contracted state, the distal portion of the sidewall rolls up onto the proximal portion of the sidewall. In the expanded state, the distal portion of the sidewall at least partially extends from the proximal portion of the sidewall, and When the sidewall is in the expanded state, the volume defined by the internal cavity is greater than the volume when it is in the contracted state.

7. The infusion tube according to claim 1, wherein, When no fluid flows through the internal chamber, the sidewalls are in a relaxed or bent configuration, while when fluid flows through the internal chamber, the sidewalls are in a rigid, extended configuration.

8. The infusion tube according to claim 1, wherein, When no fluid flows through the internal chamber, the sidewalls are in a rolled-up, coiled configuration, while when fluid flows through the internal chamber, the sidewalls are in a spread-out, extended configuration.

9. The infusion tube according to claim 1 or 2 further includes a check valve associated with a proximal end of the sidewall and configured to prevent fluid from flowing out of the proximal end.

10. The infusion tube according to claim 1 or 2, wherein the closure comprises a porous material.

11. The infusion tube according to claim 1 or 2, wherein, The closure defines at least one hole, the size of which allows air to pass through and prevents medical fluid from passing through the at least one hole.

12. The infusion tube according to claim 11, wherein, The at least one hole is configured to produce an audible sound when air flows through it.

13. The infusion tube according to claim 1 or 2, wherein the closure includes a high-opening-pressure valve.

14. An infusion tube for use with a fluid injector system, the infusion tube comprising: Sidewalls that define an internal chamber having an expandable volume; as well as A connector, associated with the proximal end of the sidewall, is configured to reversibly engage the outlet of a fluid reservoir containing medical fluid. The sidewalls are configured to change from a contracted state to an expanded state in response to an increase in fluid pressure within the internal cavity. In the contracted state, the distal portion of the sidewall rolls up onto the proximal portion of the sidewall, while in the expanded state, the distal portion of the sidewall at least partially unfolds from the proximal portion of the sidewall. When the sidewall is in the expanded state, the volume defined by the internal cavity is greater than the volume when it is in the contracted state.

15. A fluid injector system, the fluid injector system comprising: At least one fluid reservoir configured for injecting medical fluids; Infusion tube, the infusion tube comprising: Sidewalls that define an internal chamber having an expandable volume; A connector, associated with the proximal end of the sidewall and configured to reversibly engage the outlet of the at least one fluid reservoir; and A closure associated with the distal end of the sidewall, the closure being permeable to air but impermeable to the medical fluid; and At least one processor, the at least one processor being programmed or configured to determine the infusion state of the infusion tubing; and The expandable volume of the internal chamber is configured to increase as the medical fluid enters the internal chamber.

16. The fluid injector system of claim 15, wherein, The at least one processor is programmed or configured to determine the filling state of the filling tube based on the measured fluid pressure in at least one of the filling tube and the at least one fluid reservoir.

17. The fluid injector system of claim 15 or 16, 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 perfusion state of the perfusion tube based on a measured current consumption of the actuator.

18. The fluid injector system of claim 15 or 16, wherein the at least one processor is programmed or configured to determine the infusion state of the infusion tube based on at least one of the expansion of the infusion tube and the shape change of the infusion tube.

19. The fluid injector system of claim 15 or 16, wherein the at least one processor is programmed or configured to determine the infusion state of the infusion tube based on sound emitted from the infusion tube.

20. The fluid injector system of claim 15 or 16, wherein the at least one processor is programmed or configured to determine the infusion state of the infusion tube based on force readings on the motor of the fluid injector associated with the delivery of fluid from the at least one fluid reservoir.

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