In-line air bubble suspension apparatus for angiography injector fluid path

Abstract

To provide an apparatus for preventing air from delivering to a patient during injection processing.SOLUTION: A fluid path assembly for a powered fluid injector system includes a first fluid path, a second fluid path, and an air bubble suspender in the middle of the first fluid path and the second fluid path. The air bubble suspender includes: a housing; an internal chamber having a curved hemispherical interior wall defined within the housing; an inlet fluid path in fluid communication with the first fluid path and the internal chamber; and an outlet fluid path in fluid communication with the internal chamber and the second fluid path. The internal chamber is configured to create an internal fluid vortex in an injection fluid entering the internal chamber from the inlet fluid path. The internal fluid vortex forms a circular fluid vortex path along the curved hemispherical inner wall, the fluid vortex path flows across an opening of the outlet fluid path, the internal fluid vortex temporarily suspends air bubbles in a low pressure area in a center of the fluid vortex path, and delays passage of one or more air bubbles to the outlet fluid path.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 705,250, filed June 18, 2020, the disclosure of which is incorporated by reference in its entirety.

[0002] The present disclosure relates generally to fluid injector systems and associated fluid path elements for high pressure injection of medical fluids. More specifically, the present disclosure describes a fluid delivery system having at least one gas bubble suspension device. Other embodiments relate to features of the gas bubble suspension device suitable for use in fluid injection procedures. [Background technology]

[0003] In many medical diagnostic and therapeutic procedures, a medical practitioner, such as a physician, injects one or more medical fluids into a patient. Numerous injector-actuated syringes and powered fluid injectors for pressurized injection of medical fluids, such as contrast solutions (often simply referred to as "contrast media"), flushing agents such as saline or lactated Ringer's solution, and other medical fluids, have been developed for use in procedures such as cardiovascular angiography (CV), computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and other imaging procedures. Generally, these fluid injectors are designed to deliver a preset amount of fluid at a preset pressure and / or flow rate.

[0004] Typically, a fluid injector has at least one drive member, such as a piston, that connects to a syringe, for example via a connection with a plunger or an engagement feature on the proximal end wall of the syringe. The syringe may include a rigid barrel with a syringe plunger slidably disposed within the barrel. The drive member drives the plunger proximally and / or distally relative to the longitudinal axis of the barrel to draw fluid into or deliver fluid from the syringe barrel. In certain applications, such as angiography, medical fluids are injected directly into the arterial system at fluid pressures of up to 1200 psi.

[0005] During certain injection procedures at these high fluid pressures where fluid is administered directly to the cardiac system, it is essential that air is not injected simultaneously with the medical fluid as patient harm may result. Thus, new methods and devices are needed to prevent inadvertent injection of air during high pressure fluid injection procedures. Furthermore, at pressures up to 1200 psi during some CV injections, the air in the fluid path is compressed; however, if injection is stopped upon air detection, the air volume may expand rapidly due to the release of pressure. Furthermore, releasing the system compliance at the cessation of injection may allow continued fluid flow as the compliance volume is released in the absence of fluid pressure. Thus, high pressure fluid injector systems must address these phenomena when preventing inadvertent air injection. Summary of the Invention [Means for solving the problem]

[0006] In view of the above, there is a need for devices, systems, and methods for preventing air from being delivered to a patient during an injection procedure. An embodiment of the present disclosure relates to an apparatus for suspending air bubbles within a fluid path of a fluid injector system. The apparatus includes a housing, an internal chamber having a curved inner wall defined within the housing, an inlet fluid path in fluid communication with the internal chamber, the inlet fluid path extending into the chamber at a tangent to the curved inner wall, and an outlet fluid path in fluid communication with the internal chamber, the outlet fluid path being spaced from the inlet fluid path such that fluid entering the internal chamber via the inlet fluid path is directed away from the outlet fluid path. The internal chamber is configured to generate an internal fluid vortex within the injection fluid entering the internal chamber from the inlet fluid path, the internal fluid vortex at least temporarily suspending one or more air bubbles within the fluid within the internal vortex and delaying passage of the one or more air bubbles to the outlet fluid path.

[0007] In some embodiments, the outlet fluid path extends from the internal chamber in a direction perpendicular to the flow path of the fluid within the internal chamber.

[0008] In some embodiments, at least a portion of the outlet fluid path has a cross-sectional area that is greater than a cross-sectional area of ​​the inlet fluid path to reduce the fluid velocity in the outlet fluid path relative to the fluid velocity in the inlet fluid path.

[0009] In some embodiments, the outlet fluid path extends substantially parallel to the inlet fluid path, hi some embodiments, the interior chamber is at least partially spherical or hemispherical.

[0010] In some embodiments, the device further includes a recess extending radially outward from the internal chamber.

[0011] In some embodiments, the device further comprises a valve in fluid communication with the internal chamber for venting air accumulated within the internal chamber.

[0012] In some embodiments, the housing includes a first housing portion including the inlet and outlet fluid paths and a second housing portion including at least a portion of the internal chamber, wherein one of the first housing portion and the second housing portion includes a flange for receiving the other of the first housing portion and the second housing portion.

[0013] In some embodiments, the housing includes at least one reinforcing rib extending radially outward from the outlet fluid path.

[0014] In some embodiments, the apparatus further includes a screen disposed in the outlet fluid path such that fluid exiting the interior chamber passes through the screen.

[0015] In some embodiments, the housing includes a light-transmissive material configured to illuminate the gas bubble within the interior chamber.

[0016] In some embodiments, the housing includes a connector arm configured to attach to an injector housing of a fluid injector system.

[0017] In some embodiments, the apparatus further comprises an adjustable valve for altering a cross-sectional area of ​​at least one of the inlet and outlet fluid paths.

[0018] Another embodiment of the present disclosure is directed to an apparatus for suspending air bubbles within a fluid path of a fluid injector system. The apparatus includes a housing defining an internal chamber, an inlet fluid path in fluid communication with the internal chamber, an outlet fluid path in fluid communication with the internal chamber, and an extension tube in fluid communication with the inlet fluid path and extending into the internal chamber. The extension tube includes a tip spaced from the outlet fluid path such that fluid entering the internal chamber through the extension tube is directed away from the outlet fluid path.

[0019] In some embodiments, the apparatus further includes a screen dividing the internal chamber into an inlet portion and an outlet portion. The screen includes at least one opening that provides fluid communication between the inlet portion and the outlet portion. Fluid entering the internal chamber from the extension tube must flow through at least one opening in the screen to reach the outlet fluid path.

[0020] In some embodiments, a first portion of the screen adjacent the tip of the extension tube is impermeable to the fluid and a second portion of the screen adjacent the outlet fluid path includes at least one opening. In some embodiments, the screen includes a funnel defining the at least one opening, the funnel tapering from a maximum cross-sectional area adjacent the inlet portion of the internal chamber to a minimum diameter extending to the outlet portion of the internal chamber.

[0021] In some embodiments, the screen includes a hood that at least partially blocks the at least one opening such that fluid must flow around the hood to flow through the at least one opening. In some embodiments, the screen includes a mesh. In some embodiments, the at least one opening includes two or more openings arranged in an arc.

[0022] In some embodiments, the housing includes a first housing portion including a flange configured to receive the screen and a second housing portion received within the flange of the first housing portion to capture the screen between the first housing portion and the second housing portion.

[0023] In some embodiments, the inlet fluid pathway tapers from a smaller cross-sectional area to a larger cross-sectional area in the direction of fluid flow through the inlet fluid pathway to reduce the flow rate of the fluid flowing through the inlet fluid pathway.

[0024] In some embodiments, the extension tube extends parallel to an inner wall of the internal chamber, hi some embodiments, the outlet fluid path extends at an acute angle relative to the inlet fluid path.

[0025] In some embodiments, the housing includes a light-transmissive material configured to illuminate the gas bubble within the interior chamber.

[0026] In some embodiments, the housing includes a connector arm configured to attach to an injector housing of a fluid injector system.

[0027] In some embodiments, the apparatus further comprises an adjustable valve for altering a cross-sectional area of ​​at least one of the inlet and outlet fluid paths.

[0028] Another embodiment of the present disclosure relates to a fluid injector system including at least one fluid reservoir configured to inject a medical fluid and at least one air bubble suspension device in fluid communication with the at least one fluid reservoir. The at least one air bubble suspension device includes a housing defining an internal chamber, an inlet fluid path in fluid communication with the internal chamber, and an outlet fluid path in fluid communication with the internal chamber, the outlet fluid path being spaced from the inlet fluid path such that fluid entering the internal chamber via the inlet fluid path is directed away from the outlet fluid path. The fluid injector system further includes at least one air detector configured to detect one or more air bubbles in a fluid path connecting the at least one fluid reservoir to the at least one air bubble suspension device, and at least one shutoff valve downstream of the at least one air bubble suspension device and configured to move from an open position to a closed position in response to the air detector detecting one or more air bubbles in the fluid path. The internal chamber is configured to generate an internal fluid vortex within an injection fluid entering the internal chamber from the inlet fluid path, the internal fluid vortex at least temporarily suspending one or more gas bubbles within the fluid within the internal vortex and delaying passage of the one or more gas bubbles to the outlet fluid path. Features of various embodiments of an air bubble suspension device suitable for use in a fluid injector system are described herein.

[0029] In some embodiments, the gas bubble suspension device is movable between an injection position in which the outlet fluid path extends substantially vertically downward from the internal chamber such that buoyant forces of the gas bubbles in the internal chamber cause one or more gas bubbles to remain suspended within an internal fluid vortex further within the internal chamber, and a priming position in which the outlet fluid path extends substantially vertically upward from the chamber such that buoyant forces of the gas bubbles in the internal chamber cause the gas bubbles to flow from the internal fluid vortex through the outlet fluid path.

[0030] In some embodiments, the system further includes an adjustable valve for altering a cross-sectional area of ​​at least one of the inlet and outlet fluid paths.

[0031] Further aspects or embodiments of the present disclosure are described in the following numbered clauses:

[0032] Clause 1. An apparatus for suspending gas bubbles within a fluid pathway of a fluid injector system, the apparatus including: a housing; an internal chamber having a curved inner wall defined within the housing; an inlet fluid pathway in fluid communication with the internal chamber, the inlet fluid pathway extending into the chamber at a tangent to the curved inner wall; and an outlet fluid pathway in fluid communication with the internal chamber, the outlet fluid pathway being spaced from the inlet fluid pathway such that fluid entering the internal chamber via the inlet fluid pathway is directed away from the outlet fluid pathway, the internal chamber configured to generate an internal fluid vortex within an injection fluid entering the internal chamber from the inlet fluid pathway, the internal fluid vortex at least temporarily suspending one or more gas bubbles within the fluid within the internal vortex and delaying passage of the one or more gas bubbles to the outlet fluid pathway.

[0033] Clause 2. The apparatus of clause 1, wherein the outlet fluid path extends from the internal chamber in a direction perpendicular to the flow path of the fluid within the internal chamber.

[0034] Clause 3. The apparatus of clause 1 or 2, wherein at least a portion of the outlet fluid path has a cross-sectional area greater than a cross-sectional area of ​​the inlet fluid path to reduce fluid velocity in the outlet fluid path relative to fluid velocity in the inlet fluid path.

[0035] Clause 4. An apparatus as described in any one of clauses 1 to 3, wherein the outlet fluid path extends substantially parallel to the inlet fluid path.

[0036] Clause 5. An apparatus according to any one of clauses 1 to 4, wherein the internal chamber is at least partially spherical or hemispherical.

[0037] Clause 6. The apparatus of any one of clauses 1 to 5, further comprising a recess extending radially outward from the internal chamber.

[0038] Clause 7. The apparatus of any one of clauses 1 to 6, further comprising a valve in fluid communication with the internal chamber for venting air accumulated within the internal chamber.

[0039] Clause 8. The device of any one of clauses 1 to 7, wherein the housing includes a first housing portion including an inlet fluid path and an outlet fluid path, and a second housing portion including at least a portion of the internal chamber, and one of the first housing portion and the second housing portion includes a flange for receiving the other of the first housing portion and the second housing portion.

[0040] Clause 9. An apparatus as described in any one of clauses 1 to 8, wherein the housing includes at least one reinforcing rib extending radially outward from the outlet fluid path.

[0041] Clause 10. The apparatus of any one of clauses 1 to 9, further comprising a screen disposed in the outlet fluid path such that fluid exiting the internal chamber passes through the screen.

[0042] Clause 11. The device of any one of clauses 1 to 10, wherein the housing comprises a light-transmissive material configured to illuminate the gas bubble within the internal chamber.

[0043] Clause 12. The device of any one of clauses 1 to 11, wherein the housing includes a connector arm configured to attach to an injector housing of a fluid injector system.

[0044] Clause 13. An apparatus as described in any one of clauses 1 to 12, further comprising an adjustable valve for varying a cross-sectional area of ​​at least one of the inlet fluid path and the outlet fluid path.

[0045] Clause 14. An apparatus for suspending air bubbles within a fluid pathway of a fluid injector system, the apparatus including: a housing defining an internal chamber; an inlet fluid pathway in fluid communication with the internal chamber; an outlet fluid pathway in fluid communication with the internal chamber; and an extension tube in fluid communication with the inlet fluid pathway and extending into the internal chamber, the extension tube including a tip spaced from the outlet fluid pathway such that fluid entering the internal chamber through the extension tube is directed away from the outlet fluid pathway.

[0046] Clause 15. The apparatus of clause 14, further comprising a screen dividing the internal chamber into an inlet portion and an outlet portion, the screen including at least one opening providing fluid communication between the inlet portion and the outlet portion, and wherein fluid entering the internal chamber from the extension tube must flow through at least one opening in the screen to reach the outlet fluid path.

[0047] Clause 16. An apparatus as described in clause 14 or 15, wherein a first portion of the screen adjacent the tip of the extension tube is impermeable to fluid and a second portion of the screen adjacent the outlet fluid path includes at least one opening.

[0048] Clause 17. An apparatus as described in any one of clauses 14 to 16, wherein the screen includes a funnel defining at least one opening, the funnel tapering from a maximum cross-sectional area adjacent the inlet portion of the internal chamber to a minimum diameter extending into the outlet portion of the internal chamber.

[0049] Clause 18. An apparatus as described in any one of clauses 14 to 17, wherein the screen comprises a hood that at least partially blocks at least one opening such that fluid must flow around the hood to flow through the at least one opening.

[0050] Clause 19. An apparatus according to any one of clauses 14 to 18, wherein the screen comprises a mesh.

[0051] Clause 20. An apparatus according to any one of clauses 14 to 19, wherein the at least one opening comprises two or more openings arranged in an arc.

[0052] Clause 21. An apparatus as described in any one of clauses 14 to 20, wherein the housing includes a first housing part including a flange configured to receive the screen, and a second housing part received within the flange of the first housing part to capture the screen between the first housing part and the second housing part.

[0053] Clause 22. An apparatus as described in any one of clauses 14 to 21, wherein the inlet fluid pathway tapers from a smaller cross-sectional area to a larger cross-sectional area in a direction of fluid flow through the inlet fluid pathway to reduce a flow rate of the fluid flowing through the inlet fluid pathway.

[0054] Clause 23. An apparatus according to any one of clauses 14 to 22, wherein the extension tube extends parallel to the inner wall of the inner chamber.

[0055] Clause 24. An apparatus as described in any one of clauses 14 to 23, wherein the outlet fluid path extends at an acute angle to the inlet fluid path.

[0056] Clause 25. An apparatus according to any one of clauses 14 to 24, wherein the housing comprises a light-transmissive material configured to illuminate the gas bubbles within the internal chamber.

[0057] Clause 26. The device of any one of clauses 14 to 25, wherein the housing includes a connector arm configured to attach to an injector housing of a fluid injector system.

[0058] Clause 27. An apparatus as described in any one of clauses 14 to 26, further comprising an adjustable valve for varying a cross-sectional area of ​​at least one of the inlet fluid path and the outlet fluid path.

[0059] Clause 28. A medical device comprising at least one fluid reservoir configured to infuse a medical fluid, and at least one gas bubble suspension device in fluid communication with the at least one fluid reservoir, the at least one gas bubble suspension device including a housing defining an internal chamber, an inlet fluid path in fluid communication with the internal chamber, and an outlet fluid path in fluid communication with the internal chamber, the outlet fluid path being spaced from the inlet fluid path such that fluid entering the internal chamber via the inlet fluid path is directed away from the outlet fluid path. and at least one shut-off valve downstream of the at least one air bubble suspension device and configured to move from an open position to a closed position in response to the air detector detecting one or more air bubbles in the fluid path, wherein the internal chamber is configured to generate an internal fluid vortex within an injection fluid entering the internal chamber from the inlet fluid path, the internal fluid vortex at least temporarily suspending the one or more air bubbles within the fluid in the internal vortex and delaying passage of the one or more air bubbles to an outlet fluid path.

[0060] Clause 29. The fluid injector system of clause 28, wherein the bubble suspension device is movable between an injection position in which the outlet fluid path extends substantially vertically downward from the internal chamber such that buoyancy of the air bubbles in the internal chamber causes one or more air bubbles to remain suspended within an internal fluid vortex further within the internal chamber, and a priming position in which the outlet fluid path extends substantially vertically upward from the chamber such that buoyancy of the air bubbles in the internal chamber causes the air bubbles to flow from the internal fluid vortex through the outlet fluid path.

[0061] Clause 30. The fluid infuser system of clause 28 or 29, wherein the internal chamber includes at least one curved inner wall, and the inlet fluid path extends into the internal chamber at a tangent to the curved inner wall.

[0062] Clause 31. A fluid injector system as described in any one of clauses 28 to 30, wherein the outlet fluid path extends from the internal chamber in a direction substantially perpendicular to a flow path of the fluid within the internal fluid vortex within the internal chamber.

[0063] Clause 32. A fluid injector system as described in any one of clauses 28 to 31, wherein at least a portion of the outlet fluid path has a cross-sectional area greater than a cross-sectional area of ​​the inlet fluid path to reduce fluid velocity in the outlet fluid path relative to fluid velocity in the inlet fluid path.

[0064] Clause 33. A fluid infuser system according to any one of clauses 28 to 32, wherein the outlet fluid path extends substantially parallel to the inlet fluid path.

[0065] Clause 34. A fluid infuser system according to any one of clauses 28 to 33, wherein the internal chamber is at least partially spherical or hemispherical.

[0066] Clause 35. A fluid injector system as described in any one of clauses 28 to 34, wherein the bubble suspension device further includes a recess extending radially outward from the internal chamber in a direction substantially opposite the outlet fluid path.

[0067] Clause 36. The fluid injector system of any one of clauses 28 to 35, further comprising a valve on the recess and in fluid communication with the internal chamber for venting air accumulated within the recess.

[0068] Clause 37. A fluid injector system as described in any one of clauses 28 to 36, wherein the housing of the bubble suspension device includes a first housing portion including at least one of an inlet fluid path and an outlet fluid path, and a second housing portion including at least a portion of the internal chamber, and one of the first housing portion and the second housing portion includes a flange for receiving the other of the first housing portion and the second housing portion.

[0069] Clause 38. A fluid injector system as described in any one of clauses 28 to 37, wherein the housing of the bubble suspension device includes at least one reinforcing rib extending radially outward from the outlet fluid path.

[0070] Clause 39. A fluid injector system as described in any one of clauses 28 to 38, wherein the bubble suspension device further includes a screen positioned proximate to the outlet fluid path such that fluid flowing from the internal chamber passes through the screen.

[0071] Clause 40. A fluid injector system as described in any one of clauses 28 to 39, wherein one or more of the one or more gas bubbles temporarily adhere to a surface of the screen as the fluid passes through the screen.

[0072] Clause 41. A fluid injector system according to any one of clauses 28 to 40, wherein the screen includes a hydrophilic coating on at least a portion of a surface of the screen.

[0073] Clause 42. A fluid injector system as described in any of clauses 28 to 41, wherein the bubble suspension device further includes an extension tube in fluid communication with the inlet fluid pathway and extending into the internal chamber, the extension tube including a tip spaced from the outlet fluid pathway such that fluid flowing into the internal chamber through the extension tube is directed away from the outlet fluid pathway.

[0074] Clause 43. A fluid injector system as described in any one of clauses 28 to 42, wherein the screen divides the internal chamber into an inlet portion and an outlet portion, the screen including at least one opening providing fluid communication between the inlet portion and the outlet portion, and fluid flowing into the internal chamber from the inlet fluid path must flow through at least one opening in the screen to reach the outlet fluid path.

[0075] Clause 44. A fluid injector system as described in any one of clauses 28 to 43, wherein a first portion of the screen adjacent the tip of the extension tube is impermeable to fluid and a second portion of the screen adjacent the outlet fluid path includes at least one opening.

[0076] Clause 45. A fluid injector system as described in any one of clauses 28 to 44, wherein the screen includes a funnel defining at least one opening, the funnel tapering from a maximum cross-sectional area adjacent the inlet portion of the internal chamber to a minimum diameter extending into the outlet portion of the internal chamber.

[0077] Clause 46. A fluid injector system as described in any one of clauses 28 to 45, wherein the screen includes a hood that at least partially blocks at least one opening such that fluid must flow around the hood to flow through the at least one opening.

[0078] Clause 47. A fluid injector system according to any one of clauses 28 to 46, wherein the screen comprises a mesh.

[0079] Clause 48. A fluid injector system according to any one of clauses 28 to 47, wherein the at least one opening comprises two or more openings arranged in an arc.

[0080] Clause 49. A fluid injector system as described in any one of clauses 28 to 48, wherein the air bubble suspension device delays the passage of one or more air bubbles to the outlet fluid path by at least 100 milliseconds.

[0081] Clause 50. A fluid injector system as described in any one of clauses 28 to 49, wherein the housing includes a first housing portion including a flange configured to receive the screen, and a second housing portion received within the flange of the first housing portion to capture the screen between the first housing portion and the second housing portion.

[0082] Clause 51. A fluid injector system as described in any one of clauses 28 to 50, wherein the inlet fluid pathway tapers from a smaller cross-sectional area to a larger cross-sectional area in the direction of fluid flow through the inlet fluid pathway to reduce a flow rate of the fluid flowing through the inlet fluid pathway.

[0083] Clause 52. A fluid infuser system as described in any one of clauses 28 to 51, wherein the extension tube extends parallel to the inner wall of the internal chamber.

[0084] Clause 53. A fluid infuser system according to any one of clauses 28 to 52, wherein the outlet fluid path extends at an acute angle to the inlet fluid path.

[0085] Clause 54. A fluid injector system as described in any one of clauses 28 to 53, wherein the housing of the air bubble suspension device comprises a light-transmissive material configured to illuminate the air bubbles within the internal chamber.

[0086] Clause 55. A fluid injector system as described in any one of clauses 28 to 54, wherein the housing of the air bubble suspension device includes a connector arm configured for attachment to an injector housing of the fluid injector system.

[0087] Clause 56. The fluid infuser system of any one of clauses 28 to 55, further comprising an adjustable valve for varying a cross-sectional area of ​​at least one of the inlet and outlet fluid paths.

[0088] Further details and advantages of the various embodiments described in detail herein will become apparent upon consideration of the following detailed description of the various embodiments in conjunction with the accompanying drawings. [Brief description of the drawings]

[0089] [Figure 1] FIG. 1 is a perspective view of a fluid injector system according to one embodiment of the present disclosure. [Diagram 2] 1 is a schematic diagram of a fluid injector system according to one embodiment of the present disclosure. [Diagram 3]FIG. 1 is a perspective view of an air bubble suspension device according to one embodiment of the present disclosure. [Figure 4] FIG. 4 is a cross-sectional side view of the air bubble suspension device of FIG. 3 in an injection position. [Diagram 5] FIG. 4 is a side cross-sectional view of the air bubble suspension device of FIG. 3 in a priming position. [Figure 6] FIG. 2 is a cross-sectional side view of an air bubble suspension device according to one embodiment of the present disclosure. [Figure 7] FIG. 1 is a perspective view of an air bubble suspension device according to one embodiment of the present disclosure. [Figure 8] FIG. 8 is a side cross-sectional view of the air bubble suspension device of FIG. 7 in an injection position. [Figure 9] FIG. 1 is a perspective view of an air bubble suspension device according to one embodiment of the present disclosure. [Figure 10] FIG. 10 is a cross-sectional side view of the air bubble suspension device of FIG. 9 during a first period of an injection protocol. [Figure 11] FIG. 10 is a cross-sectional side view of the air bubble suspension device of FIG. 9 during a second period of the injection protocol. [Figure 12] FIG. 10 is a cross-sectional side view of the air bubble suspension device of FIG. 9 during a third period of the injection protocol. [Figure 13] FIG. 10 is a cross-sectional side view of the air bubble suspension device of FIG. 9 during a fourth period of the injection protocol. [Figure 14] FIG. 10 is a side cross-sectional view of the air bubble suspension device of FIG. 9 in a priming position. [Figure 15] FIG. 2 is a cross-sectional side view of an air bubble suspension device according to one embodiment of the present disclosure. [Figure 16] FIG. 16 is a perspective view of the air bubble suspension device of FIG. [Figure 17] FIG. 2 is a cross-sectional side view of an air bubble suspension device according to one embodiment of the present disclosure. [Figure 18] FIG. 18 is an exploded perspective view of the air bubble suspension device of FIG. 17. [Figure 19] FIG. 1 is a perspective view of a screen for an air bubble suspension device according to one embodiment of the present disclosure. [Figure 20] FIG. 1 is a perspective view of a screen for an air bubble suspension device according to one embodiment of the present disclosure. [Figure 21]FIG. 1 is a perspective view of a screen for an air bubble suspension device according to one embodiment of the present disclosure. [Figure 22] FIG. 1 is a perspective view of a screen for an air bubble suspension device according to one embodiment of the present disclosure. [Diagram 23] FIG. 1 is a perspective view of a screen for an air bubble suspension device according to one embodiment of the present disclosure. [Figure 24] FIG. 1 is a front view of a screen for an air bubble suspension device according to one embodiment of the present disclosure. [Diagram 25] FIG. 1 is a perspective view of an air bubble suspension device according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0090] DETAILED DESCRIPTION Referring to the drawings, in which like numerals refer to like parts throughout the several views, the present disclosure relates generally to an in-line air bubble suspension device for use with a fluid infuser system.

[0091] For purposes of the following description, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall refer to the present disclosure as depicted in the drawings. Spatial or directional terms such as "left", "right", "inner", "outer", "upper", "lower", etc. should not be considered limiting as the present invention may be in various alternative orientations.

[0092] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. All numbers used in the specification and claims should be understood to be modified in all instances by the term "about." The terms "approximately," "about," and "substantially" refer to a range of ±10% of the stated value.

[0093] As used herein, the term "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" means any one of A, B, and C, or any combination of two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more of A alone, or one or more of B alone, or one or more of C alone, or one or more of A and one or more of B, or one or more of A and one or more of C, or one or more of B and one or more of C, or one or more of A, B, and C. Similarly, as used herein, the term "at least two" is synonymous with "two or more." For example, the phrase "at least two of D, E, and F" means any combination of two or more of D, E, and F. For example, "at least two of D, E, and F" includes one or more of D and one or more of E, or one or more of D and one or more of F, or one or more of E and one or more of F, or all one or more of D, E, and F.

[0094] It is also to be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the following specification, are merely exemplary of the present disclosure, and therefore specific dimensions and other physical characteristics relating to the examples disclosed herein are not to be considered as limiting.

[0095] When used with respect to a component of a fluid delivery system, such as a fluid reservoir, a syringe, an air suspension device, or a fluid line, the term "distal" refers to the portion of said component closest to the patient. When used with respect to a component of an injector system, such as a fluid reservoir, a syringe, an air suspension device, or a fluid line, the term "proximal" refers to the portion of said component closest to the injector of the injector system (i.e., the portion of said component furthest from the patient). When used with respect to a component of a fluid delivery system, such as a fluid reservoir, a syringe, an air suspension device, or a fluid line, the term "upstream" refers to the direction away from the patient toward the injector of the injector system. For example, if a first component is referred to as being "upstream" of a second component, the first component is located closer to the injector than the second component. When used with respect to a component of a fluid delivery system, such as a fluid reservoir, a syringe, an air suspension device, or a fluid line, the term "downstream" refers to the direction away from the injector of the fluid delivery system toward the patient. For example, when a first component is referred to as being "downstream" of a second component, the first component is positioned closer to the patient than the second component.

[0096] As used herein, the terms "capacitance" and "impedance" are used interchangeably to refer to the volumetric expansion of injector components, such as fluid reservoirs, syringes, fluid lines, and / or other components of a fluid delivery system, as a result of pressurized fluid with such components, and / or the incorporation of mechanical slack due to forces applied to the components. Capacitance and impedance can result from high injection pressures, which can be as high as 1,200 psi in some angiography procedures, resulting in the volume of fluid retained within some of the components exceeding the desired volume selected for the injection procedure or the resting volume of the component. Additionally, the capacitance of various components, if not properly accounted for, can adversely affect the accuracy of the pressure sensors of the injector system, as volumetric expansion of components can cause an artificial reduction in the measured pressure of those components.

[0097] The terms "first," "second," and the like do not refer to a particular order or chronology, but rather to different conditions, characteristics, or elements. All documents mentioned herein are "incorporated by reference" in their entirety. 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."

[0098] It is to be understood that the present disclosure may contemplate alternative variations and step sequences unless expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the following specification, are merely exemplary embodiments of the present disclosure. Hence, specific dimensions and other physical characteristics relating to the examples disclosed herein are not to be considered as limiting.

[0099] Although the systems and devices described herein refer to angiography (CV) injection systems, other pressurized injection protocols, such as computed tomography (CT), ultrasound, positron emission tomography (PET), and magnetic resonance imaging (MRI), can also incorporate various embodiments described herein to prevent air injection.

[0100] Referring to the drawings, in which like numerals refer to like parts throughout the several views of the drawings, the present disclosure generally relates to a fluid injector system and air bubble suspension device for delaying the movement of one or more air bubbles through a fluid line toward a patient and preventing delivery of one or more air bubbles that may inadvertently occur during an injection procedure.

[0101] 1, one embodiment of a dual syringe angiography injector system 2000 is shown. The angiography injector system 2000 is configured to inject two medical fluids via a first fluid path 210A for a medical fluid, such as an imaging contrast agent for an angiography injection procedure, and a second fluid path 210B for a flushing fluid, such as saline or lactated Ringer's solution. The dual syringe angiography injector system 2000 may include an injector housing 12 having two syringe ports 15 configured to engage two syringes 10A, 10B. In some embodiments, the syringes 10A, 10B may be held within corresponding pressure jackets 17A, 17B, for example to prevent pressure-induced expansion and potential rupture of the syringes 10A, 10B.

[0102] The fluid injector system 2000 may further include at least one graphical user interface (GUI) 11 that allows an operator to view and control the status of the injection procedure. The GUI 11 may be in operative communication with a controller 900 (see FIG. 2 ), which transmits and receives commands between the GUI 11 and the fluid injector system 2000. The GUI 11 may be provided on the injector housing 12 or may be mounted remotely from the injector housing 12.

[0103] The dual syringe angiography injector system 2000 may further include at least one upstream air detector 200 associated with the fluid paths 210A,B for detecting one or more air bubbles in an air detection tube region 250 of the first fluid path 210A and the second fluid path 210B. The air detection tube region 250 may be associated with a proximal or upstream portion of the first fluid path 210A and the second fluid path 210B, for example. In some embodiments, the at least one air detector 200 may be a single module having at least one sensor operably associated with each of the first fluid path 210A and the second fluid path 210B. In some embodiments, the at least one air detector 200 may include at least two separate modules, each module operably associated with one of the first fluid path 210A and the second fluid path 210B. The at least one air detector 200 may be in operative communication with the controller 900 (see FIG. 2 ) such that the controller 900 may receive a signal from the at least one air detector 200 indicative of the detection of one or more air bubbles in one or both of the first fluid path 210A and / or the second fluid path 210B. Upon receipt of the one or more signals, the controller 900 may send a signal or command to the fluid injector system 2000 to stop the fluid injection procedure, for example, by closing one or more shutoff valves (see FIG. 2 , FIG. 215A, FIG. 215B and / or FIG. 390) downstream of the at least one air detector 200 to prevent the detected air bubbles from being injected into the patient. The at least one air detector 200 may include an ultrasonic sensor, an optical sensor, or other suitable sensor configuration configured to detect one or more air bubbles in the fluid path.

[0104] 1, the dual syringe angiography injector system 2000 may further include bulk fluid containers 19A, 19B for filling and refilling the respective syringes 10A, 10B with contrast and flushing fluid, respectively. The bulk fluid containers 19A and 19B may be in selective fluid communication with the syringes 10A and 10B via respective bulk fluid paths 216A and 216B and bulk fluid valves 215A and 215B.

[0105] Further details and examples of suitable, non-limiting power injector systems, including the syringe, pressure jacket and pressure jacket retention mechanism, tubing, shut-off valve, controller, and air detector, are described in U.S. Pat. No. 5,383,858, U.S. Pat. No. 7,553,294, U.S. Pat. No. 7,666,169, U.S. Pat. No. 8,945,051, U.S. Pat. No. 10,022,493, U.S. Pat. No. 10,507,319, and International PCT Application Nos. PCT / US2013 / 061275, PCT / US2018 / 034613, PCT / US2020 / 049885, PCT / US2021 / 035273, and PCT / US2021 / 029963, the disclosures of which are incorporated by reference in their entireties herein. Although the fluid injector system 2000 is described herein in the context of a dual syringe angiography (CV) injector, it should be understood that the fluid injector system 2000 can be adapted for single and multiple syringe configurations for any injection procedure (e.g., CT, PET, MRI, ultrasound, etc.).

[0106]

[0023] Referring now to Figure 2, there is shown a schematic diagram of the fluid injector system 2000 shown in Figure 1. The injector system 2000 includes pistons 13A, 13B respectively associated with each of the syringes 10A, 10B and their corresponding pressure jackets 17A, 17B (see Figure 1). Each of the pistons 13A, 13B is configured to drive a respective plunger 14A, 14B within the barrel of the respective syringe 10A, 10B. A controller 900 is operatively associated with the injector system 2000, for example, to actuate the pistons 13A, 13B to reciprocate the plungers 14A, 14B within the syringes 10A, 10B, thereby performing and stopping an injection procedure. In particular, the controller 900 may include at least one processor programmed or configured to operate various other components of the injector system 2000, such as the pistons 13A, 13B, and one or more shut-off valves as described herein, to capture and deliver medical fluid according to a programmed protocol for an injection procedure. The controller 900 may include a computer-readable medium, such as a memory, in which one or more injection protocols may be stored for execution by the at least one processor.

[0107] The controller 900 may be programmed or configured to execute a fill operation in which the pistons 13A, 13B associated with each syringe 10A, 10B are retracted toward the proximal ends of the syringes 10A, 10B to draw an infusion fluid F (e.g., imaging contrast and flushing fluids) from the bulk fluid containers 19A, 19B into the syringes 10A, 10B. During such a fill operation, the controller 900 may be programmed or configured to selectively actuate the bulk fluid valves 215A and 215B to establish fluid communication between the respective syringes 10A, 10B and the bulk fluid containers 19A, 19B via the bulk fluid paths 216A and 216B to control the filling of the appropriate infusion fluid F into the syringes 10A, 10B. Upon completion of the filling operation, and optionally a priming operation to remove air from syringes 10A, 10B and the various embodiments of the air bubble suspension devices described herein (e.g., by priming any such air into bulk fluid containers 19A, 19B or via a priming tube), controller 900 may be programmed or configured to selectively actuate bulk fluid valves 215A and 215B to block fluid communication between respective syringes 10A, 10B and bulk fluid containers 19A, 19B via bulk fluid paths 216A and 216B.

[0108] After the fill and priming operations, the controller 900 may be programmed or configured to execute a delivery operation in which the pistons 13A, 13B associated with one or both of the syringes 10A, 10B move toward the distal ends of the syringes to inject the injection fluid F into the first and second fluid paths 210A, 210B. The controller 900 may be programmed or configured to selectively actuate the bulk fluid valves 215A and 215B to establish fluid communication between the syringes 10A, 10B and the patient via the fluid paths 210A, 210B. The first and second fluid paths 210A, 210B eventually merge into a patient fluid line 210C that is in fluid communication with the patient's vascular system. According to various embodiments, the first fluid path 210A and the second fluid path 210B may meet at a fluid mixing connector that provides turbulent mixing of the first fluid and the second fluid, such as the fluid mixing connectors described in International PCT Application Nos. PCT / US2021 / 019507 and PCT / US2014 / 026324, the disclosures of which are incorporated herein by reference.

[0109] The controller 900 can be in operative communication with the at least one air detector 200 such that in response to the air detector 200 detecting the presence of one or more air bubbles in at least one of the first fluid path 210A and / or the second fluid path 210B, the controller 900 can deactivate the pistons 13A, 13B. The controller 900 can further be in operative communication with the at least one downstream automatic shut-off valve 390 such that the controller 900 can actuate the at least one downstream shut-off valve 390 to stop the flow of fluid through the at least one downstream shut-off valve 390 into the patient's vasculature. The at least one downstream shut-off valve 390 can be actuated by the controller 900 between various positions such as an open position in which medical fluid can flow to the patient, a closed position in which fluid flow to the patient is prevented, and a hemodynamic monitoring position in which the patient's vasculature is in fluid communication with the pressure transducers and isolated from the syringes 10A, 10B. In some embodiments, the downstream shut-off valve 390 can be a stopcock, a pinch valve, or the like. In certain embodiments, a downstream shutoff valve 390 may be associated with each of the fluid paths 210A and 210B and may be disposed before the first fluid path 210A and the second fluid path 210B join the patient fluid line 210C. Suitable examples of pinch valves and pinch valve / fluid path configurations are described in International Patent Application No. PCT / US2021 / 029963. During normal delivery operations, the controller 900 may be programmed or configured to move the downstream shutoff valve 390 to an open position to establish fluid communication between the patient and the fluid paths 210A, 210B. The controller 900 may be programmed or configured to move the downstream shutoff valve 390 to a closed position in response to air being detected by the at least one air detector 200. The movement of the pistons 13A, 13B may also be stopped in response to air being detected by the at least one air detector 200. In the stopped position, the downstream shutoff valve 390 fluidly isolates the patient from the fluid paths 210A, 210B, thereby preventing air from being insufflated into the patient.

[0110] 2, in some embodiments, the first and second fluid paths 210A, 210B may each include an air bubble suspension device 300 configured to at least temporarily interrupt or delay one or more air bubbles flowing through the fluid paths 210A, 210B. Each air bubble suspension device 300 may be provided in line with the associated fluid path 210A, 210B between the at least one air detector 200 and the downstream shutoff valve 390, such that all fluid flow through the fluid paths 210A, 210B must pass through at least one air bubble suspension device 300 to reach the patient.

[0111] In some embodiments, the controller 900 can be programmed or configured to move the bulk fluid valves 215A, 215B and / or the downstream shutoff valve 390 to a closed position in response to one or more air bubbles being detected by the at least one air detector 200 along with the simultaneous stopping of the pistons 13A, 13B. In the absence of the air bubble suspension device 300, one or more air bubbles detected by the at least one air detector 200 can travel through the fluid paths 210A, 210B at a sufficient velocity to pass through the bulk fluid valves 215A, 215B and the downstream shutoff valve 390 before the bulk fluid valves 215A, 215B and / or the downstream shutoff valve 390 reach a closed position. For example, during a high pressure (e.g., 1200 psi) CV injection procedure, it may take 60 ms to 90 ms, e.g., about 80 ms in one embodiment, for the injector system 2000 to stop the injection procedure after an air bubble has flowed into the detection region of the at least one air detector 200. The time required to stop the injection procedure may include the time required for at least one air detector 200 to communicate to the controller 900 that an air bubble has been detected, the time required for the controller 900 to communicate with the bulk fluid valves 215A, 215B and / or downstream shutoff valve 390, and the time required for the bulk fluid valves 215A, 215B and / or shutoff valve 390 to move from an open position to a closed position. At high injection pressures (e.g., 1200 psi) typical of CV injection procedures, between the detection of an air bubble and the closing of the bulk fluid valves 215A, 215B and / or downstream shutoff valve 390, an air bubble may move from 2.8 mL to 3.6 mL of volume in the fluid paths 210A, 210B over 60 to 90 milliseconds. For example, at approximately 1200 psi, an air bubble may move the equivalent of 3.2 mL over 80 milliseconds at a flow rate of 30 mL / sec in a 0.072 inch ID tubing. The distance equivalent of a 3.2 mL volume in such an embodiment would be approximately 4 feet of tubing length traveled in 80 milliseconds.Thus, even with the fast response time of at least one air detector 200, controller 900, and bulk fluid valves 215A, 215B and / or downstream shutoff valve 390, air bubbles can potentially travel a significant distance into the patient before the bulk fluid valves 215A, 215B and / or downstream shutoff valve 390 can be closed. Furthermore, due to the compressibility of gas compared to liquids, air bubble volume can decrease significantly under high injection pressures. Simply stopping the flow of fluid by stopping the pistons 13A, 13B can release the pressure on the system and allow the air bubble volume to expand. The increase in volume can move the air bubbles down the fluid path past the bulk fluid valves 215A, 215B and / or downstream shutoff valve 390 before such valves are closed.

[0112] An embodiment of the air bubble suspension device 300 of the present disclosure is configured to at least temporarily delay the flow of air bubbles in the fluid paths 210A, 210B such that the controller 900 has sufficient time to move the bulk fluid valves 215A, 215B and / or the downstream shut-off valve 390 to a closed position before the air bubbles reach the bulk fluid valves 215A, 215B and / or the downstream shut-off valve 390. As described herein, during a high pressure (e.g., 1200 psi) CV injection procedure, it may take 60 to 90 milliseconds, such as about 80 milliseconds in one embodiment, for the system 2000 to close the bulk fluid valves 215A, 215B and / or the downstream shut-off valve 390 in response to the at least one air detector 200 detecting an air bubble in the fluid paths 210A, 210B. Embodiments of the air bubble suspension device 300 can be configured to delay the flow of air bubbles for at least 60 to 90 milliseconds, such as at least 80 milliseconds in one embodiment, such that the bulk fluid valves 215A, 215B and / or downstream shut-off valve 390 can be moved to a closed position before the air bubbles reach the bulk fluid valves 215A, 215B and / or downstream shut-off valve 390. Thus, the air bubbles cannot flow into the patient downstream of the bulk fluid valves 215A, 215B and / or downstream shut-off valve 390. In some embodiments, the controller 900 is programmed or configured to move one or both of the bulk fluid valves 215A, 215B to a closed position in response to the at least one air detector 200 detecting an air bubble in the fluid path 210A, 210B. In some embodiments, the controller 900 is programmed or configured to move the downstream shut-off valve 390 to a closed position in response to the at least one air detector 200 detecting an air bubble in the fluid paths 210A, 210B. In some embodiments, the controller 900 is programmed or configured to move one or both of the bulk fluid valves 215A, 215B and the downstream shut-off valve 390 to a closed position in response to the at least one air detector 200 detecting an air bubble in the fluid paths 210A, 210B.

[0113] 3-25, features of various embodiments of a gas bubble suspension device 300 according to the present disclosure are shown. In general, embodiments of the gas bubble suspension device 300 include a housing 310 defining an internal chamber 320. The internal chamber 320 is in fluid communication with an inlet fluid path 312 and an outlet fluid path 314. The inlet fluid path 312 and the outlet fluid path 314 may be configured to be in fluid communication with associated fluid paths 210A, 210B of the fluid injector system 2000. At least one gas bubble suspension device 300 may be connected to an associated fluid path 210A, 210B such that injection fluid injected from an associated syringe 10A, 10B flows into the inlet fluid path 312, through the internal chamber 320, and out of the outlet fluid path 314. An air bubble suspension device 300 is disposed in each of the fluid paths 210A, 210B downstream of the at least one air detector 200 and upstream of the downstream shut-off valve 390 and, in some embodiments, upstream of the bulk fluid valves 215A, 215B. In this manner, air bubbles are at least temporarily suspended within the air bubble suspension device 300 for a length of time that allows for the downstream shut-off valve 390 and / or the bulk fluid valves 215A, 215B to move to a closed position and the injection procedure to cease. In some embodiments, the air bubble suspension device 300 may be configured to delay the passage of one or more air bubbles from the inlet fluid path 312 to the outlet fluid path 314 by at least 100 milliseconds.

[0114] The inlet fluid path 312 may be oriented with respect to the interior chamber 320 such that fluid flow into the interior chamber 320 generates an internal fluid vortex in the infusion fluid entering the interior chamber 320. In some embodiments, the inlet fluid path 312 may be oriented such that the infusion fluid from the inlet fluid path 312 enters the interior chamber 320 substantially tangent to the curved or hemispherical interior wall 322 of the interior chamber 320, thereby inducing the infusion fluid to flow along the interior wall 322 to generate a fluid vortex. The internal fluid vortex induces one or more gas bubbles that may be present in the infusion fluid to be temporarily retained within the fluid vortex within the interior chamber 320, thereby at least temporarily delaying the passage of the one or more gas bubbles to the outlet fluid path 314 and out of the gas bubble suspension device 300. The internal fluid vortex may define a generally circular or otherwise continuous flow path along the curved or hemispherical interior wall 322 of the interior chamber 320, thereby inducing one or more gas bubbles to be temporarily suspended in the infusion fluid within the fluid vortex. Additionally, the fluid vortex may cause one or more bubbles to coalesce into fewer larger bubbles, for example, by collision and coalescence of the small bubbles. The curved or hemispherical inner wall 322 may minimize the shear forces on the bubble or bubbles, and thus prevent the bubbles from shearing into smaller bubbles within the vortex.

[0115] In various embodiments, the internal chamber 320 can have a volume (i.e., fluid volume) sufficient to delay air bubbles up to 0.5 milliliters (mL). In such embodiments, the internal chamber 320 may have a volume (i.e., fluid volume) between 2 mL and 10 mL, in some embodiments between 2.8 mL and 3.6 mL, in some embodiments about 3.2 mL, and in some embodiments about 5.4 mL. In the embodiment shown in Figures 3-6, the internal chamber 320 may have a volume (i.e., fluid volume) of about 6.77 mL to delay air bubbles up to about 0.5 mL. In the embodiment shown in Figures 7-8, the internal chamber 320 may have a volume (i.e., fluid volume) of about 7.00 mL to delay air bubbles up to about 0.5 mL. In some embodiments, to delay air bubbles having a volume greater than 0.5 mL, the volume of the internal chamber 320 may be increased accordingly.

[0116] 3-25, the outlet fluid path 314 may be oriented with respect to the interior chamber 320 to prevent one or more gas bubbles suspended in the internal fluid vortex from easily flowing toward the outlet fluid path 314. For example, the outlet fluid path 314 may be oriented such that the fluid flow path defined by the fluid vortex is directed away from the outlet fluid path 314 or such that fluid flowing within the interior chamber 320 must change direction to enter the outlet fluid path 314 (see, e.g., FIG. 14). In some embodiments, the outlet fluid path 314 may extend substantially perpendicularly from the interior wall 322 of the interior chamber 320 such that the fluid flow within the fluid vortex passes laterally across the opening 315 of the outlet fluid path 314 (see, e.g., FIG. 4). The outlet fluid path 314 may be positioned such that in the injection position of the gas bubble suspension device 300, the outlet fluid path 314 extends at least partially downwardly from the interior chamber 320. Because air is buoyant with respect to the infusion fluid within the internal chamber 320, any air bubbles present within the internal chamber 320 are induced by their relative buoyancy to float or migrate away from the outlet fluid path 314 toward the top of the internal chamber 320. Additionally, with such a configuration of the air bubble suspension device 300, the air bubble suspension device 300 may be moved (e.g., rotated) from an injection position to a priming position (see FIG. 5 ) in which the outlet fluid path 314 extends at least partially upwardly from the internal chamber 320. In the priming position, during a priming process that removes air from the fluid lines prior to the start of a fluid infusion procedure, air bubbles present within the internal chamber 320 are induced to float toward the outlet fluid path 314, thereby allowing the air bubbles to be purged through the outlet fluid path 314 from the distal end of the associated fluid path 210A, 210B under the influence of the priming fluid flow.

[0117] With particular reference to FIGS. 3-5, one embodiment of the bubble suspension device 300 is shown. The housing 310 may be formed from a first housing portion 302 and a second housing portion 304. Forming the housing 310 from multiple portions may facilitate manufacturing by an injection molding process to form various features of the bubble suspension device 300. The bubble suspension device 300 may be made of any suitable medical grade material, such as a medical grade polymeric material capable of withstanding high fluid pressures within the bubble suspension device 300. The first housing portion 302 may include at least one of an inlet fluid path 312 and an outlet fluid path 314. In the embodiment shown in FIGS. 3-5, the first housing portion 302 includes both the inlet fluid path 312 and the outlet fluid path 314. The inlet fluid path 312 and the outlet fluid path 314 may extend substantially parallel to one another. An interior chamber 320 may be defined by the first housing portion 302 and the second housing portion 304. In the embodiment shown in Figures 3-5, the first housing portion 302 and the second housing portion 304 each partially define an internal chamber 320. As shown in Figures 4 and 5, the first housing portion 302 includes a flange 306 configured to receive an end feature 308, e.g., a lip, of the second housing portion 304. In some embodiments, the flange 306 may be provided on the second housing portion 304 and the end feature 308 may be provided on the first housing portion 302. The first housing portion 302 and the second housing portion 304 may be joined via adhesive, laser welding, ultrasonic welding, or the like. The housing 310 may include one or more reinforcing ribs 324, 325 located at various locations to provide support against high fluid pressures within the housing 310. In some angiographic (CV) procedures, the fluid pressure may be up to about 1200 psi. In some embodiments, a plurality of reinforcing ribs 324 may extend radially from at least a portion of the inlet fluid pathway 312, the first housing portion 302, the second housing portion 304, and the outlet fluid pathway 314. In some embodiments, at least one reinforcing rib 325 may extend parallel to the inlet fluid pathway 312 and / or the outlet fluid pathway 314.In certain embodiments, the connector arm 360 may further function as a stiffening mechanism for the inlet fluid pathway 312 .

[0118] 3-5, the internal chamber 320 may have a curved, hemispherical inner wall 322 to induce the injection fluid entering the internal chamber 320 to flow through an internal fluid vortex, identified in FIG. 4 by vortex flow path B. In some embodiments, the inner wall 322 of the internal chamber 320 defined by the second housing portion 304 may be substantially hemispherical or dome-shaped. As shown in FIG. 4, which illustrates the air bubble suspension device 300 shown in the injection position, the fluid inlet path 312 may extend into the internal chamber 320 substantially tangent to the inner wall 322 to generate an internal fluid vortex. The fluid inlet path 312 may have an opening 313 into the internal chamber 320 such that injection fluid flowing into the internal chamber 320 in direction A merges with injection fluid in the internal chamber 320 flowing through the fluid vortex flow path B. Thus, injection fluid flowing into the internal chamber 320 from the fluid inlet path 312 flows into the internal fluid vortex in substantially the same direction as the vortex flow path B to maintain the fluid vortex. Thus, fluid vortex channel B continues to flow within inner chamber 320 as long as injected fluid continues to be introduced into inner chamber 320 from fluid inlet path 312. Inner wall 322 may be shaped to induce recirculation of injected fluid into vortex channel B.

[0119] 4, the outlet fluid pathway 314 may extend from the interior chamber 320 substantially perpendicular to the inner wall 322 and the fluidic vortex pathway B such that the fluidic vortex pathway B flows laterally across the opening 315 of the outlet fluid pathway 314. Thus, at least a portion of the injected fluid in the fluidic vortex pathway B flows back through the opening 315 toward the opening 313 of the fluidic inlet pathway 312 to maintain the fluidic vortex.

[0120] Continuing to refer to FIG. 4 , the internal fluid vortex can suspend one or more gas bubbles 400 in the internal chamber 320 during an injection procedure performed by the fluid injector system 2000. When the injection fluid is introduced into the internal chamber 320 via the inlet fluid path 312, the gas bubbles 400 present in the incoming injection fluid move toward a low pressure region LP formed by the internal fluid vortex at the center of the fluid vortex flow path B. The injection fluid flowing through the fluid vortex flow path B at least temporarily suspends the one or more gas bubbles 400 in the low pressure region and forms a boundary that at least temporarily delays the passage of the one or more gas bubbles 400 to the outlet fluid path 314. The one or more gas bubbles 400 suspended in the low pressure region LP can coalesce to form one or more larger gas bubbles 402. The internal wall 322 can be shaped to cause a recirculation of the injection fluid into the vortex flow path B and induce the one or more gas bubbles 400 to form closer together in the vortex flow path B. Even so, during the course of injection, one or more of the larger bubbles 402 may be sheared or broken up by fluid forces into smaller bubbles 404 that may migrate out of the vortex channel B.

[0121] 4, in the infusion position, the housing 310 is oriented such that the outlet fluid path 314 extends substantially vertically downward from the internal chamber 320. Thus, the flow direction C of the infusion fluid exiting the internal chamber 320 is substantially aligned with the direction of gravity G. Because air is buoyant with respect to the infusion fluid, the buoyancy of the air bubbles 400, 402 within the internal chamber 320 induces a tendency for one or more of the air bubbles 400, 402 to rise against the direction of gravity G toward an upper region of the internal chamber 320, and thus the air bubbles 400, 402 tend to remain suspended in the internal fluid vortex within the internal chamber 320 for a longer period of time. Furthermore, even the shear air bubbles 404 that cross the boundary formed by the fluid vortex flow path B will be induced by the buoyancy to flow against the direction of gravity G, and thus further retarded from traveling through the outlet fluid path 314.

[0122] In some embodiments, at least a portion of the outlet fluid path 314 may have a cross-sectional diameter Do larger than the cross-sectional diameter Di of the inlet fluid path 312. The larger diameter Do of the outlet fluid path 314 may reduce the flow velocity in the outlet fluid path 314 of the fluid exiting the internal chamber 320. As a result, the reduced flow velocity may reduce the drag force on the air bubble 404 outside the boundary formed by the fluid vortex flow path B, such that the buoyancy force of the air bubble 404 may tend to overcome the drag force directing the air bubble 404 toward the outlet fluid path 314. As a result, the exit of the air bubble 404 from the outlet fluid path 314 may be at least temporarily delayed.

[0123] 4, in some embodiments, the diameter Di of the inlet fluid pathway 312 may be selected to control the flow rate of the infusion fluid, including the gas bubbles 400, contained within the interior chamber 320. In particular, decreasing the diameter Di increases the flow rate. The diameter Di of the inlet fluid pathway 312 may be selected to generate a relatively high flow rate, which has the effect of breaking up one or more gas bubbles 400. In some embodiments, the diameter Di of the inlet fluid pathway 312 may be approximately 3.7 mm (0.145 inches).

[0124] 5, the air bubble suspension device 300 is shown in a priming position for performing a priming or purging operation in which fluid is injected to prime / purge the air bubble suspension device 300 and associated fluid paths 210A, 210B prior to an injection procedure to remove air from the air bubble suspension device 300 and associated fluid paths 210A, 210B. In the priming position, the housing 310 is oriented such that the inlet fluid path 312 and the outlet fluid path 314 extend substantially vertically upward from the internal chamber 320. Thus, the flow direction A of the injected fluid flowing through the inlet fluid path 312 into the internal chamber 320 substantially coincides with the direction of gravity G. The diameter Di of the inlet fluid path 312 may be small enough such that the fluid flow velocity of the inlet fluid path 312 can carry the air bubble 400 against the buoyancy direction of the air bubble 400. That is, the flow velocity through diameter Di generates a drag force on one or more gas bubbles 400 sufficient to overcome the buoyant force of the gas bubbles 400, drawing them into the interior chamber 329. As a result, the one or more gas bubbles 400 are transported into the interior chamber 320 by the infusion fluid.

[0125] In the priming position, the outlet fluid path 314 also extends substantially vertically upward from the inner chamber 320 such that the flow direction C of the infusion fluid exiting the inner chamber 320 is substantially opposite the direction of gravity G. The buoyancy of the gas bubbles 400 within the inner chamber 320 causes the gas bubbles 400, 402 to rise upwardly from the internal fluid vortex through the outlet fluid path 314, acting in concert with the drag force associated with the fluid flow, thereby purging the gas bubble suspension device 300 of the gas bubbles 400.

[0126] 3-5, the air bubble suspension device 300 may include a connector arm 360 extending from the housing 310. The connector arm 360 may be configured to connect to the injector housing 12 or a fluid path or other mechanism associated with the injector (see FIGS. 1 and 2). In particular, the connector arm 360 may be configured to interface with an actuator that communicates with a controller 900 (see FIG. 2) of the fluid injector system 2000. The controller 900 may be programmed or configured to rotate the air bubble suspension device 300 between the injection and priming positions via the connector arm 360 according to an injection protocol. Alternatively, the connector arm 360 may be configured to be attached to the fluid injector system in either the injection or priming positions, and may be configured for a user to manually rotate the air bubble suspension device 300 between the injection and priming positions via the connector arm 360 to prepare the fluid injector for a fluid injection procedure, e.g., in response to a prompt by the system on a GUI.

[0127] Referring now to FIG. 6, one embodiment of the air bubble suspension device 300 is shown. The embodiment of the air bubble suspension device shown in FIG. 6 may be substantially similar to the embodiment shown in FIGS. 3-5, and only the differences therebetween are described below. The embodiment of the air bubble suspension device 300 shown in FIG. 6 may include an air purge valve 350 on the housing 310 in fluid communication with the internal chamber 320. The air purge valve 350 may be particularly disposed in fluid communication with the top region of the internal chamber 320. The air purge valve 350 may be used to evacuate the air accumulated in the internal chamber 320 after completion of the injection procedure, particularly when using a multi-patient setup for performing multiple consecutive injection sequences using multi-patient disposable sets and single-patient disposable sets. The air purge valve 350 may be set to a closed position during the performance of the injection procedure, whereby the air bubbles 400, 402 present in the injection fluid are suspended in the internal chamber 320 in the same manner as described in connection with FIGS. 3-5. Once an injection procedure is completed and before the next injection procedure is initiated, the internal fluid vortex and vortex flow path B (shown in FIG. 4) dissipate due to the lack of fluid flow into the internal chamber 320. Thus, the vortex flow path B (shown in FIG. 4) no longer presents a flow boundary to the one or more coalesced gas bubbles 402 suspended within the internal chamber 320. Thus, the one or more coalesced gas bubbles 402 can float to the top region of the internal chamber 320 adjacent the air purge valve 350. The air purge valve 350 may be moved to an open position manually by an operator or automatically by the controller 900 to allow the one or more coalesced gas bubbles 402 to exit the internal chamber 320 via the air purge valve 350, e.g., with less fluid flow into the chamber to replace the volume of purged air with fluid. In some embodiments, the outlet of the air purge valve 350 may be connected to a vacuum source, such as a hand syringe (not shown), to aid in the removal of the one or more coalesced gas bubbles 402 from the internal chamber 320. After one or more coalesced air bubbles 402 have been removed from the inner chamber 320, the air purge valve 350 may be returned to the closed position, including in a subsequent injection procedure.The air purge valve 350 may be a stopcock, a pinch valve, or the like.

[0128] 6 , in some embodiments, the air bubble suspension device 300 may include an adjustable valve 352 associated with the inlet fluid path 312 and / or an adjustable valve 354 associated with the outlet fluid path 314. The adjustable valve 352 may be configured to change the cross-sectional area of ​​the inlet fluid path 312, and the adjustable valve 354 may be configured to change the cross-sectional area of ​​the outlet fluid path 314. Reducing the cross-sectional area of ​​the inlet fluid path 312 and / or the outlet fluid path 314 increases the flow rate, whereas increasing the cross-sectional area of ​​the inlet fluid path 312 and / or the outlet fluid path 314 decreases the flow rate. In some embodiments, it may be desirable to increase the cross-sectional area of ​​the inlet fluid path 312, thereby decreasing the flow rate through the inlet fluid path 312, because a decreased flow rate is less likely to dislodge air bubbles attached to a surface of the inlet fluid path 312. In some embodiments, it may be desirable to increase the cross-sectional area of ​​the outlet fluid path 314, thereby decreasing the flow rate through the outlet fluid path 314, because the decreased flow rate is less likely to carry air bubbles 402 from a fluid vortex through the outlet fluid path 314. The adjustable valves 352, 354 may be stopcocks, pinch valves, or the like.

[0129] 7-8, an embodiment of the gas bubble suspension device 300 is shown. The embodiment of the gas bubble suspension device 300 shown in FIGS. 7-8 may be substantially similar to the embodiment shown in FIGS. 3-6, and only the differences are described below. The embodiment of the gas bubble suspension device 300 shown in FIGS. 7-8 may include a recess 326 defined in the inner wall 322 and extending radially outward from a topmost region of the inner chamber 320 substantially opposite the outlet fluid path 314. The recess 326 may receive and hold one or more gas bubbles 408. The recess 326 may be adapted to receive and hold one or more gas bubbles 408, particularly in the form of microbubbles generated by outgassing of the medical fluid. In some embodiments, an air purge valve 350, as described in connection with FIG. 6, may be disposed on the recess 326 to evacuate one or more gas bubbles 408 accumulated in the recess 326 from the recess 326.

[0130] 9-14, one embodiment of an air bubble suspension device 300 is shown. The embodiment of the air bubble suspension device 300 shown in FIGS. 9-14 may include certain common features and components with the embodiment shown in FIGS. 3-8, and any elements not specifically described in connection with FIGS. 9-14 will be understood to be substantially similar to the similar elements of the embodiment of FIGS. 3-8. In the embodiment of the air bubble suspension device 300 shown in FIGS. 9-14, the housing 310 includes a screen 328 that divides the interior chamber 320 into an inlet portion 332 and an outlet portion 334. Various embodiments of the screen 328 are described herein in connection with FIGS. 19-24. The screen 328 may be disposed proximate to the outlet fluid path 314. The screen 328 may include at least one opening 340 that provides fluid communication between the inlet portion 332 and the outlet portion 334. Infusion fluid entering the internal chamber 320 from the inlet fluid path 312 must then flow through at least one opening 340 in the screen 328 to reach the outlet fluid path 314. In some embodiments, the screen 328 may include at least one funnel-shaped opening 342 that defines the at least one opening 340. The funnel 342 may taper from a maximum cross-sectional area adjacent the inlet portion 332 of the internal chamber 320 to a minimum diameter extending into the outlet portion 334 of the internal chamber 320. In some embodiments, at least a portion of the screen 328 may have a hydrophilic coating that causes air bubbles in the infusion fluid to adhere to the screen 328 and at least temporarily delay the flow of such air bubbles to the outlet fluid path 314.

[0131] 9-14, the air bubble suspension device 300 may further include an extension tube 370 in fluid communication with the inlet fluid path 312 and extending therefrom into the interior chamber 320. The extension tube 370 may include a tip 372 passing therethrough away from the flow axis of the outlet fluid path 314 such that the infusion fluid entering the interior chamber 320 through the extension tube 370 is directed away from the outlet fluid path 314. In some embodiments, the extension tube 370 extends beyond the at least one opening 340 in the screen 328 to allow the infusion fluid entering the interior chamber 320 from the inlet fluid path 312 to enter the vortex flow path B before reaching the at least one opening 340. The inlet portion 332 of the interior chamber 320 may be at least partially hemispherical or dome shaped with the vortex flow path B flowing along the interior wall 322 of the interior chamber 320.

[0132] Continuing to refer to Figures 9-14, the inlet fluid path 312 and extension tube 370 may be oriented at an acute angle relative to the outlet fluid path 314 such that injection fluid entering the internal chamber 320 from the extension tube 370 is directed away from the opening 315 of the outlet fluid path 314.

[0133] 10-13, a sequence illustrating one embodiment of the air bubble suspension effect within the internal chamber 320 during the performance of an injection procedure is shown. Referring initially to FIG. 10, the injection fluid may flow in a direction A through the inlet fluid pathway 312 and the extension tube 370 into the internal chamber 320. One or more air bubbles 400 may be transported into the internal chamber 320 along with the injection fluid. The orientation of the extension tube 370 directs the injection fluid and the one or more air bubbles 400 into the vortex flow path B. Additionally, the buoyancy of the one or more air bubbles 400 relative to the injection fluid blocks the flow of the one or more air bubbles 400 through at least one opening 340 in the screen 328 toward the outlet fluid pathway 314.

[0134] 11, as the injection fluid flows through the vortex flow passage B, one or more gas bubbles 400 may migrate toward the low pressure region LP at the center of the vortex flow passage B, thereby becoming at least temporarily suspended within the interior chamber 320. Additionally, one or more gas bubbles 400 may coalesce into one or more larger volumes of coalesced gas bubbles 402 in the low pressure region LP, while the injection fluid and additional gas bubbles 400 continue to enter the interior chamber 320 via the extension tube 370 (see FIG. 12).

[0135] FIG. 13 illustrates the gas bubble suspension device 300 after fluid flow into the internal chamber 320 has ceased, e.g., after completion of an injection procedure. With no new injection fluid being introduced into the internal chamber 320 to maintain the internal fluid vortex, the vortex flow path B (shown in FIGS. 9-12) dissipates and no longer presents a flow boundary to the one or more coalesced gas bubbles 402 suspended within the internal chamber 320. Thus, the one or more coalesced gas bubbles 402 may float to the top region of the internal chamber 320 due to the buoyancy of the one or more coalesced gas bubbles 402 relative to the injection fluid. In some embodiments, the gas bubble suspension device 300 may include an air purge valve 350 in fluid communication with the top region of the internal chamber 320 to facilitate removal of the one or more coalesced gas bubbles 402 from the internal chamber 320 (substantially as described herein with reference to FIG. 6), e.g., between two injection procedures when a multi-patient injection sequence is used.

[0136] 9-14, the air bubble suspension device 300 can be rotated approximately 180° from the injection position shown in FIGS. 10-13 to the priming position shown in FIG. 14. In the injection position, the outlet fluid path 314 extends substantially vertically downward from the internal chamber 320. Thus, the flow direction C of the injection fluid exiting the internal chamber 320 is substantially aligned with the direction of gravity G. Because air is buoyant with respect to the injection fluid, the buoyancy of the air bubbles 400, 402 in the internal chamber 320 induces a tendency for one or more of the air bubbles 400, 402 to rise toward the upper region of the internal chamber 320 against the direction of gravity G, and thus the air bubbles 400, 402 tend to remain suspended in the internal fluid vortex within the internal chamber 320. Moreover, even air bubbles that cross the boundary formed by the fluid vortex flow path B are induced to flow through the screen 328 against the direction of gravity G, and thus are further delayed in reaching the outlet fluid path 314.

[0137] 14, the outlet fluid pathway 314 extends substantially vertically upward from the inner chamber 320 such that the flow direction C of the infusion fluid exiting the inner chamber 320 is substantially opposite the direction of gravity G. The buoyancy of the air bubbles 400, 402 within the inner chamber 320 induces the air bubbles 400, 402 to flow out of the chamber 320 through the outlet fluid pathway 314, thereby purging the air bubble suspension device 300 of air.

[0138] 9, the air bubble suspension device 300 may include a connector arm 360 extending from the housing 310. The connector arm 360 may be configured to connect to the injector housing 12 or a fluid path or other mechanism associated with the injector system 2000 (see FIGS. 1, 2). In particular, the connector arm 360 may be configured to interface with an actuator that communicates with a controller 900 (see FIG. 2) of the fluid injector system 2000. The controller 900 may be programmed or configured to rotate the air bubble suspension device 300 between the injection and priming positions via the connector arm 360 according to an injection protocol. Alternatively, the connector arm 360 may be configured to be attached to the fluid injector system in either the injection or priming positions and may be configured for a user to manually rotate the air bubble suspension device 300 between the injection and priming positions via the connector arm 360 to prepare the fluid injector for a fluid injection procedure, e.g., in response to a prompt by the system on the GUI 11.

[0139] 15 and 16, one embodiment of the air bubble suspension device 300 is shown. The embodiment of the air bubble suspension device 300 shown in FIG. 15 and FIG. 16 may include many common features and components with the various embodiments shown in FIG. 3-FIG. 13, and any element not specifically described in connection with FIG. 15 and FIG. 16 will be understood to be substantially similar to the similar element of any of the embodiments of FIG. 3-FIG. 13. In the embodiment of the air bubble suspension device 300 shown in FIG. 15 and FIG. 16, the housing 310 may be formed into a first housing portion 302 and a second housing portion 304, and the first housing portion 302 includes an inlet fluid path 312, an extension tube 370, and an outlet fluid path 314. The inlet fluid path 312 may extend at an acute angle relative to the outlet fluid path 314. The second housing portion 304 may be hemispherical or dome-shaped such that the vortex flow path B flows in a circular or other continuous manner along the inner wall 322 of the inner chamber 320. The first housing portion 302 may include a flange 306 configured to receive an end feature 308, such as a lip, of the second housing portion 304. In some embodiments, the flange 306 may be provided on the second housing portion 304 and the end feature 308 may be provided on the first housing portion 302. The first housing portion 302 and the second housing portion 304 may be joined via an adhesive, laser welding, ultrasonic welding, or the like.

[0140] 15 and 16, the extension tube 370 can extend beyond the opening 315 of the outlet fluid path 314 such that insufflated fluid entering the internal chamber 320 is directed away from the outlet fluid path 314 and into vortex channel B. Similar to the embodiment shown in FIGS. 3-13, the vortex channel B forms a boundary that at least temporarily delays the passage of one or more gas bubbles 400 suspended within the internal chamber 320 into the outlet fluid path 314. In some embodiments, the opening 315 of the outlet fluid path 314 can be positioned relative to, for example below, the extension tube 370 such that the extension tube 370 creates a flow occlusion for the fluid and / or gas bubbles 400 flowing toward the outlet fluid path 314.

[0141] In certain embodiments, the inner diameter of the inlet fluid pathway 312 may be tapered such that the proximal cross-sectional area Ap of the upstream inlet fluid pathway 312 is smaller than the distal cross-sectional area Ad of the downstream inlet fluid pathway 312. In some embodiments, the proximal cross-sectional area Ap may be substantially circular and the distal cross-sectional area Ad may be substantially elliptical or oval. In some embodiments, by increasing the downstream cross-sectional area Ad relative to the upstream cross-sectional area Ap, the fluid flow rate in the inlet fluid pathway 312 is slowed (e.g., about 0.1 mL / sec to 30 mL / sec), allowing the air bubbles 410 in the inlet fluid pathway 312 to attach to the sidewall 317 of the larger cross-sectional area Ad, for example, by surface tension. The reduction in the fluid flow rate in the inlet fluid pathway 312 due to the enlarged distal cross-sectional area Ad may not be sufficient to immediately remove the attached air bubbles 410 from the sidewall 317. That is, the force of adhesion of the bubble 410 to the sidewall 317 may be greater than the force exerted on the bubble 410 by the infusion fluid flowing through the distal cross-sectional area Ad. Thus, the bubble 410 is at least temporarily delayed from entering the interior chamber 320 and therefore delayed from exiting the fluid exit path 314. In some embodiments, the enlarged distal cross-sectional area Ad of the fluid inlet path 312 may allow the infusion fluid to flow around the bubble 410 adhered to the sidewall 317, rather than flowing into and potentially eliminating the bubble 410 adhered to the sidewall 317. In some embodiments, the enlarged distal cross-sectional area Ad of the fluid inlet path 312 may allow the bubble 410 to adhere to the sidewall 317 at least partially outside the main flow path of the infusion fluid through the fluid inlet path 312. In some embodiments, the inner surface of the fluid inlet path 312 may be configured to attract and adhere the bubble, such as by a surface treatment applied to the sidewall 317. Such features regarding different cross-sectional areas of the fluid inlet passages 312 are also applicable to other embodiments of the air bubble suspension device 300 described herein.

[0142] 15 and 16, the air bubble suspension device 300 can be rotated approximately 180° from the injection position shown in FIG. 15 to the priming position, similar to FIG. 5 or FIG. 14. In the injection position, the outlet fluid path 314 extends substantially vertically downward from the internal chamber 320. Thus, the flow direction C of the injection fluid exiting the internal chamber 320 is substantially aligned with the direction of gravity G. Because air is buoyant with respect to the injection fluid, the buoyancy of the air bubbles 400, 402 in the internal chamber 320 induces a tendency for one or more of the air bubbles 400, 402 to rise toward the upper region of the internal chamber 320 against the direction of gravity G, and thus the air bubbles 400, 402 remain suspended in the internal fluid vortex within the internal chamber 320. Moreover, even air bubbles that cross the boundary formed by the fluid vortex flow path B are induced to flow through the screen 328 against the direction of gravity G, and thus are further delayed in reaching the outlet fluid path 314.

[0143] In the priming position, the outlet fluid pathway 314 extends substantially vertically upward from the inner chamber 320 such that the flow direction C of the infusion fluid exiting the inner chamber 320 is substantially opposite the direction of gravity G. The buoyancy of the air bubbles 400, 402 within the inner chamber 320 induces the air bubbles 400, 402 to flow out of the chamber 320 through the outlet fluid pathway 314, thereby purging the air bubble suspension device 300 of air.

[0144] 15 and 16, the air bubble suspension device 300 may include a connector arm 360 extending from the housing 310. The connector arm 360 may be configured to connect to the injector housing 12 or a fluid path or other mechanism associated with the injector system 2000 (see FIGS. 1, 2). In particular, the connector arm 360 may be configured to interface with an actuator that communicates with a controller 900 (see FIG. 2) of the fluid injector system 2000. The controller 900 may be programmed or configured to rotate the air bubble suspension device 300 between the injection and priming positions via the connector arm 360 according to an injection protocol. Alternatively, the connector arm 360 may be configured to be attached to the fluid injector system in either the injection or priming positions, and may be configured for a user to manually rotate the air bubble suspension device 300 between the injection and priming positions via the connector arm 360 to prepare the fluid injector for a fluid injection procedure, e.g., in response to a prompt by the system on the GUI 11.

[0145] 17-18, one embodiment of the air bubble suspension device 300 is shown. The embodiment of the air bubble suspension device 300 shown in FIGS. 17-18 may include many common features and components with the various embodiments shown in FIGS. 3-16 and particularly FIGS. 9-14, and any element not specifically described in connection with FIGS. 17-18 is understood to be substantially similar to the similar element of any of the embodiments of FIGS. 3-16. In the embodiment of the air bubble suspension device 300 shown in FIGS. 17-18, the housing 310 may be formed by a first housing portion 302 and a second housing portion 304, the first housing portion 302 including an inlet fluid path 312, an extension tube 370, and an outlet fluid path 314. The inlet fluid path 312 may extend at an acute angle relative to the outlet fluid path 314. The second housing portion 304 may be hemispherical or dome-shaped such that the fluid vortex flow path B flows circularly or otherwise continuously along the inner wall 322 of the inner chamber 320. The first housing portion 302 may include a flange 306 configured to receive an end feature 308, such as a lip, of the second housing portion 304. In some embodiments, the flange 306 may be provided on the second housing portion 304 and the end feature 308 may be provided on the first housing portion 302. The first housing portion 302 and the second housing portion 304 may be joined via an adhesive, laser welding, ultrasonic welding, or the like.

[0146] 17-18, a screen 328 may be provided between the first housing portion 302 and the second housing portion 304. In some embodiments, the screen 328 may be received within the flange 306 such that the end feature 308 holds the screen 328 in position between the first housing portion 302 and the second housing portion 304. The screen 328 may divide the internal chamber 320 into an inlet portion 332 and an outlet portion 334. The screen 328 may include at least one opening 340 that provides fluid communication between the inlet portion 332 and the outlet portion 334 (as shown in FIGS. 19-24). Infusion fluid entering the internal chamber 320 from the inlet fluid path 312 must subsequently flow through the at least one opening 340 of the screen 328 to reach the outlet portion 334 and the outlet fluid path 314. In some embodiments, the screen 328 may have a hydrophilic coating that causes the gas bubbles 400 in the infusion fluid to adhere to the screen 328, for example, by increasing the surface tension or adhesion therebetween, thereby further retarding, at least temporarily, the flow of such adhered gas bubbles 400 toward the outlet fluid path 314. The extension tube 370 may be positioned within the inner chamber 320 such that the infusion fluid entering the inner chamber is directed away from the one or more openings 340 in the screen 328 toward the vortex flow path B. For example, the one or more openings 340 in the screen 328 may be positioned in a portion of the screen 328 proximal to the distal outlet of the extension tube 370.

[0147] 19-24, there are shown various embodiments of a screen 328 suitable for use with the embodiments of the air bubble suspension device 300 described herein in relation to Figures 9-13 and 17-18. With reference to Figure 19, the screen 328 may include a plurality of openings 340 substantially uniformly distributed on the screen 328.

[0148] 20-24, the screen 328 may include a solid portion 380 that is impermeable to fluids and air, and one or more openings 340 located outside the solid portion 380, e.g., located in a portion of the screen 328 proximal to the distal outlet of the extension tube 370 when assembled. The screen 328 may be positioned within the air bubble suspension device 300 such that the solid portion 380 is adjacent to the extension tube 370. Thus, the infusion fluid that enters the inner chamber 320 via the extension tube 370 must enter the vortex flow path B and circulate within the inner chamber 320 at least once before reaching the opening or openings 340. In the embodiment shown in FIG. 20, the solid portion 380 occupies approximately half of the screen 328, and the opening or openings 340 occupy approximately half of the screen 328. In the embodiment shown in FIG. 21, the solid portion 380 occupies a greater percentage of the screen 328 than the opening or openings 340. In some embodiments, the one or more openings 340 may be arranged in any pattern, such as a grid, an arc, or a line. In some embodiments, the one or more openings 340 may be distributed non-uniformly across the screen 328.

[0149] 22, the screen 328 includes a single opening 340 that is offset from a centerline CL of the screen 328. A solid portion 380 occupies the remainder of the screen 328. By offsetting the opening 340 from the centerline CL of the screen 328, air bubbles within the inner chamber 320 (see FIGS. 17 and 18 ) may be forced to redirect to reach and pass through the opening 340, thereby further slowing the flow of air bubbles from the air bubble suspension device 300.

[0150] 23, the screen 328 may include at least one funnel 342 that defines at least one opening 340. The funnel 342 may taper from a maximum cross-sectional area adjacent the inlet portion 332 of the internal chamber 320 to a minimum diameter extending into the outlet portion 334 of the internal chamber 320 (see FIGS. 9-14 and 17-18).

[0151] 24, in some embodiments of the screen 328, each of the one or more openings 340 may be partially blocked by a hood 344. Each hood 344 may extend from the screen 328 into the inlet portion 332 of the internal chamber 320 (see FIGS. 17-18) against the direction of fluid flow, such that the fluid in the inlet portion 332 and any associated air bubbles must flow around the hood 344 to pass through the associated opening 340. In some embodiments, the hood 344 may be configured such that the air bubbles will adhere to the hood 344, e.g., via surface tension, slowing the flow of the air bubbles from the inlet portion 332.

[0152] In all of the embodiments of the screen 328 shown in FIGS. 19-24, the screen 328 may have a hydrophilic coating that causes air bubbles in the infusion fluid to adhere to the screen 328, thereby at least temporarily slowing the flow of such air bubbles toward the outlet fluid path 314. In various embodiments, other surfaces of the interior chamber 320 may be at least partially coated with a hydrophilic coating. Additionally, any portion of the screen 328 or various features thereof may be configured to cause air bubbles to adhere to the screen 328, e.g., via surface tension, slowing the flow of air bubbles through one or more openings 340. In some embodiments, the screen 328 may be a mesh made from a material that allows air bubbles to readily adhere to its surface.

[0153] According to certain embodiments, the change in fluid pressure across the screen 328 may be substantially zero, resulting in no significant change in fluid velocity at the screen 328 that may dislodge any air bubbles attached to the screen 328. Instead, the injection fluid may be free to flow through other openings 340 or channels within the screen, instead of dislodging any air bubbles attached to the screen 328. For example, the volume of the inlet portion 332 (see FIGS. 17-18) upstream of the screen 328 may be substantially the same as the volume of the outlet portion 334 (see FIGS. 17-18) immediately downstream of the screen 328, such that there is no significant change in fluid pressure due to flow path restriction.

[0154] It should be understood that features of the various embodiments of screen 328 shown in the embodiment of Figures 19-24 may be combined with one another and still fall within the scope of the present disclosure.

[0155] 25, various embodiments of the gas bubble suspension device 300 may include a generally cylindrical housing 310 having an inlet fluid path 312 and an outlet fluid path 314 extending therefrom. The inlet fluid path 312 and the outlet fluid path 314 may be in fluid communication with opposite ends of an internal chamber 320. When an infusion fluid is introduced into the internal chamber 320 in a direction substantially tangential to the arc of the cylindrical housing 310 via the inlet fluid path 312, an internal fluid vortex is generated in the form of a spiral or helical vortex channel B that flows along the inner wall 322 of the internal chamber 320. One or more gas bubbles 400 carried by the infusion fluid move toward the low pressure region LP at the center of the vortex channel B. The infusion fluid within the vortex channel B forms a boundary that at least temporarily prevents the one or more gas bubbles 400 from flowing to the outlet fluid path 314. The length of the helical or helical vortex channel B may be proportional to the height of the housing 310. Thus, the height of the housing 310 may be proportional to the time delay in the flow of the gas bubbles 400 within the internal chamber 320. Thus, by increasing the cylindrical height of the housing 310, the suspension time of one or more gas bubbles 400 within the helical vortex flow path B may be increased.

[0156] 25, the gas bubble suspension device 300 may be rotated from the injection position to the priming position by the controller 900 (see FIG. 2) or manually by a user. In the injection position shown in FIG. 25, the gas bubble suspension device 300 may be oriented such that the outlet fluid path 314 is located below the inlet fluid path 312. In this manner, the buoyancy of the one or more gas bubbles 400 within the interior chamber 320 causes the one or more gas bubbles 400 to float upward within the interior chamber 320 against the direction of gravity G and the direction of the vortex flow path B and away from the outlet fluid path 314.

[0157] In the priming position, the air bubble suspension device 300 may be oriented, for example, by rotating the air bubble suspension device 300 approximately 180° about a horizontal axis, such that the outlet fluid path 314 is located above the inlet fluid path 312. Thus, the buoyancy of the air bubble(s) 400 within the interior chamber 320 causes the air bubble(s) 400 to float upwardly within the interior chamber 120 toward the outlet fluid path 314, thereby purging air into the interior chamber 320 under the flow of priming fluid.

[0158] The air bubble suspension device 300 may include a connector arm 360 extending from the housing 310. The connector arm 360 may be configured to connect to the injector housing 12 or a fluid path or other mechanism associated with the injector system 2000 (see Figs. 1, 2). In particular, the connector arm 360 may be configured to interface with an actuator that communicates with a controller 900 (see Fig. 2) of the fluid injector system 2000. The controller 900 may be programmed or configured to rotate the air bubble suspension device 300 between the injection and priming positions via the connector arm 360 according to an injection protocol. Alternatively, the connector arm 360 may be configured to attach to the fluid injector system in either the injection or priming positions, and may be configured to allow a user to manually rotate the air bubble suspension device 300 between the injection and priming positions via the connector arm 360 to prepare the fluid injector for an injection procedure, e.g., in response to a prompt by the system on the GUI 11.

[0159] In some embodiments, the distal surface of the housing 310 may include a protrusion 384 that extends upward into the internal chamber 320. The protrusion 384 may be approximately dome-shaped, conical, and / or Gaussian. The protrusion 384 may extend to any height within the internal chamber 320. In some embodiments, the protrusion 384 may extend up to half the height of the internal chamber 320. The protrusion 384 may be configured to extend into the low pressure region LP of the fluid vortex and impede the flow of the one or more gas bubbles 400 toward the opening 315 of the outlet fluid path 314 by preventing the one or more gas bubbles 400 in the low pressure region LP from moving downwardly beyond the protrusion 384 toward the outlet fluid path 314. Thus, the protrusion 384 further suspends the one or more gas bubbles 400 within the internal chamber 320 in conjunction with the suspension of the gas bubbles caused by the fluid vortex.

[0160] In some embodiments, the housing 310 may include a dome- or cone-shaped recess 326 extending from the proximal surface of the internal chamber 320, in a similar function to the recess 326 of FIGS. 7-8. The recess 326 may receive and retain one or more air bubbles 400 that float upwardly within the internal chamber 320 under the influence of buoyancy and remove the one or more air bubbles 400 from the vortex flow path B. The recess 326 may also be adapted to receive and retain one or more air bubbles in the form of microbubbles generated by outgassing of the medical fluid. In some embodiments, an air purge valve 350, as described in connection with FIG. 6, may be disposed in the housing 310 in fluid communication with the recess 326 such that one or more air bubbles 400 accumulated in the recess 326 may be removed from the recess 326 as described herein.

[0161] In all embodiments of the air bubble suspension device 300 described herein, the housing 310 can be constructed at least in part from a transparent or translucent light-transmitting material, such as polycarbonate, that can act as a light tube. By directing a light source toward the housing 310, one or more air bubbles 400, 402, 404, 406, 408 can be illuminated so that an operator can more easily identify the presence of air bubbles within the air bubble suspension device 300.

[0162] It should be understood that features of the various embodiments of the air bubble suspension device 300 shown in the embodiment of Figures 3-25 may be combined with one another and still be within the scope of the present disclosure.

[0163] Although various examples of the present disclosure have been provided in the foregoing description, those skilled in the art can make modifications and variations to these examples without departing from the scope and spirit of the present disclosure. For example, it should be understood that the features of the various embodiments described herein can be adapted to other embodiments described herein. Thus, the above description is intended to be illustrative rather than limiting. The above disclosure is defined by the appended claims, and all modifications to the disclosure that are within the meaning and equivalency of the claims are intended to be included within their scope. [Explanation of symbols]

[0164] 10A Syringe 10B Syringe 12 Injector housing 13A Piston 13B Piston 14A Plunger 14B Plunger 15 Syringe port 17A Pressure Jacket 17B Pressure Jacket 19A Bulk Fluid Containers 19B Bulk fluid containers 120 Inner Chamber 200 Air Detector 210A First Fluid Path 210B Second fluid path 210C Patient Fluid Line 215A Bulk Fluid Valve 215B Bulk Fluid Valve 216A Bulk Fluid Path 216B Bulk Fluid Path 250 Air Detection Tube Area 300 Air Bubble Suspension Device 302 First housing part 304 Second housing part 306 Flange 308 End Features 310 Housing 312 Inlet fluid path, fluid inlet path 313 Opening 314 Outlet fluid path, fluid outlet path 315 Opening 317 Side wall 320 Inner Chamber 322 Interior wall 324 Reinforced Rib 325 Reinforced Rib 326 Recess 328 screens 329 Inner Chamber 332 Entrance section 334 Exit part 340 Opening 342 Funnel, funnel-shaped opening 344 Food 350 Air Purge Valve 352 Adjustable Valve 354 Adjustable Valve 360 Connector Arm 370 Extension tube 372 Tip 380 Solid Part 384 Protrusion 390 Downstream shutoff valve, downstream automatic shutoff valve 400 bubbles 402 Bubbles 404 Bubbles 406 Bubbles 408 Bubbles 410 Bubbles 900 Controller 2000 Dual Syringe Angiography Injector System, Fluid Injector System

Claims

1. 1. A fluid pathway assembly for a powered fluid injector system, comprising: at least one first fluid path including an air detection region configured to interact with at least one upstream air detector; at least one second fluid path with a shut-off valve at a distal end, the shut-off valve including at least a first position providing fluid communication with a patient and at least a second position in which fluid communication with the patient is prevented; at least one air bubble suspension device intermediate said at least one first fluid path and said at least one second fluid path; Equipped with The air bubble suspension device comprises: Housing and an internal chamber having a curved hemispherical inner wall defined within the housing, the internal chamber being at least partially spherical or hemispherical; an inlet fluid pathway in fluid communication with the first fluid pathway and the interior chamber, the inlet fluid pathway extending into the interior chamber at a tangent to the curved hemispherical interior wall; an outlet fluid pathway in fluid communication with the internal chamber and the second fluid pathway, the outlet fluid pathway being spaced from the inlet fluid pathway such that injection fluid entering the internal chamber via the inlet fluid pathway is directed away from the outlet fluid pathway; Equipped with 11. The fluid pathway assembly of claim 10, wherein the internal chamber is configured to generate an internal fluid vortex within the injected fluid entering the internal chamber from the inlet fluid pathway, the internal fluid vortex forming a circular fluid vortex passage (B) along the curved hemispherical inner wall, the circular fluid vortex passage (B) flowing laterally across an opening of the outlet fluid pathway, the internal fluid vortex at least temporarily suspending one or more gas bubbles in a low pressure region in a center of the circular fluid vortex passage (B) and delaying passage of the one or more gas bubbles to the outlet fluid pathway.

2. 2. The assembly of claim 1, wherein the outlet fluid path extends from the internal chamber in a direction perpendicular to the circular fluid vortex flow path (B) of fluid within the internal chamber.

3. 2. The assembly of claim 1, wherein at least a portion of the outlet fluid path has a cross-sectional area that is greater than a cross-sectional area of ​​the inlet fluid path to reduce a fluid velocity in the outlet fluid path relative to a fluid velocity in the inlet fluid path.

4. The assembly of claim 1 , wherein the outlet fluid path extends generally parallel to the inlet fluid path.

5. The housing includes: a first housing portion including the inlet fluid path and the outlet fluid path; a second housing portion including at least a portion of the internal chamber; The assembly of claim 1 , wherein one of the first and second housing portions includes a flange for receiving an end feature of the other of the first and second housing portions.

6. The assembly of claim 5 , wherein the housing includes at least one reinforcing rib extending radially outward from at least a portion of the inlet fluid path, the outlet fluid path, the second housing portion, or the first housing portion.

7. The assembly of claim 6 , wherein the at least one reinforcing rib comprises a plurality of reinforcing ribs extending radially outward from the inlet fluid pathway, the outlet fluid pathway, the second housing portion, or the first housing portion.

8. The assembly of claim 1 , wherein the housing is made of a light-transmissive material configured to illuminate a gas bubble within the internal chamber.

9. said at least one air bubble suspension device; an injection location where the outlet fluid path extends generally vertically downward from the internal chamber such that buoyancy of the one or more gas bubbles within the internal chamber causes the one or more gas bubbles to remain suspended within the internal fluid vortex further within the internal chamber; 2. The assembly of claim 1, wherein the outlet fluid path extends generally vertically upward from the internal chamber such that the buoyancy of the one or more gas bubbles within the internal chamber causes the one or more gas bubbles to flow from the internal fluid vortex through the outlet fluid path.

10. The assembly of claim 1 , wherein the air bubble suspension device delays passage of the one or more air bubbles to the outlet fluid path by at least 100 milliseconds.

11. 2. The assembly of claim 1, wherein the shut-off valve further comprises a third location providing fluid communication between the at least one first fluid path and at least one third fluid path including a spike at a distal end thereof.

12. The assembly of claim 1 , wherein the assembly includes a pair of first fluid paths, a pair of second fluid paths, and a pair of air bubble suspension devices.

13. 13. The assembly of claim 12, wherein a first of the first pair of fluid paths, a first of the second pair of fluid paths, and a first of the pair of air bubble suspension devices are coupled at a first fluid path component of the assembly, and a second of the pair of fluid paths, a second of the second pair of fluid paths, and a second of the pair of air bubble suspension devices are coupled at a second fluid path component of the assembly.

14. 14. The assembly of claim 13, wherein the first fluid path component is configured to flow a first medical fluid from a first fluid reservoir to the patient, and the second fluid path component is configured to flow a second medical fluid from a second fluid reservoir to the patient.

15. 15. The assembly of claim 14, wherein the first fluid reservoir is a first syringe and the second fluid reservoir is a second syringe.

16. 1. A method for preventing one or more air bubbles from being injected into a patient during a power injection procedure, comprising: flowing the injection fluid through an air detection region of the fluid pathway past at least one upstream air detector; detecting one or more air bubbles in the injection fluid in the air detection region of the fluid path with the at least one upstream air detector; signaling, by the at least one air detector, to a processor that the one or more air bubbles have been detected; flowing the injection fluid and the one or more air bubbles through an air bubble suspension device distal to the air detection region; at least temporarily suspending the one or more gas bubbles in an internal fluid vortex in the injection fluid within the gas bubble suspension device; sending, by the processor, a signal to an actuator of a shut-off valve to operate the shut-off valve from a first position providing fluid communication with a patient's vascular system to a second position preventing fluid communication with the patient's vascular system; actuating the shut-off valve from the first position to the second position with the actuator to prevent the one or more gas bubbles from passing into a portion of the fluid pathway downstream of the shut-off valve; Including, wherein the air bubble suspension device delays passage of the one or more air bubbles from the air bubble suspension device for a time sufficient for the processor to activate the actuator and for the actuator to operate the shutoff valve from the first position to the second position.

17. The air bubble suspension device comprises: Housing and an internal chamber defined within the housing and having a curved, hemispherical inner wall, the internal chamber being at least partially spherical or hemispherical; an inlet fluid path in fluid communication with the air detection region of the fluid path and with the interior chamber, the inlet fluid path extending into the interior chamber at a tangent to the curved hemispherical inner wall; an outlet fluid pathway in fluid communication with the internal chamber and a second fluid pathway having the shut-off valve at a distal end, the outlet fluid pathway being spaced from the inlet fluid pathway such that injection fluid entering the internal chamber via the inlet fluid pathway is directed away from the outlet fluid pathway; Equipped with 17. The method of claim 16, wherein the internal chamber is configured to generate an internal fluid vortex within the injected fluid entering the internal chamber from the inlet fluid path, the internal fluid vortex forming a circular fluid vortex passage (B) along the curved hemispherical inner wall, the circular fluid vortex passage (B) flowing laterally across an opening of the outlet fluid path, the internal fluid vortex at least temporarily suspending the one or more gas bubbles in a low pressure region in a center of the circular fluid vortex passage (B) and delaying passage of the one or more gas bubbles to the outlet fluid path.

18. 17. The method of claim 16, wherein at least temporarily suspending the one or more gas bubbles within the internal fluid vortex within the infusion fluid comprises suspending the one or more gas bubbles within the internal fluid vortex within the infusion fluid for at least 100 milliseconds.

19. 17. The method of claim 16, further comprising pressurizing the injection fluid with a syringe and flowing the injection fluid through the at least one upstream air detector to the air detection region of the fluid pathway.

20. 17. The method of claim 16, further comprising the step of stopping, by the processor, the flow of the infusion fluid simultaneously with operating the shutoff valve from the first position to the second position by the actuator.

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