In-line air bubble suspension device for angiographic injector fluid path

Abstract

An apparatus (300) for suspending gas bubbles in a fluid path of a fluid injector system includes an interior chamber (320) having a curved inner wall (322) defined within an outer housing (310), an inlet fluid passage in fluid communication with the interior chamber, and an outlet fluid passage in fluid communication with the interior chamber. The inlet fluid passage extends into the chamber tangentially to the curved inner wall, and the outlet fluid passage is spaced apart from the inlet fluid passage such that fluid flowing into the interior chamber via the inlet fluid passage is directed away from the outlet fluid passage. The interior chamber is configured to generate an internal fluid vortex in an injection fluid entering the interior chamber from the inlet fluid passage, and wherein the internal fluid vortex causes one or more gas bubbles in the fluid to at least temporarily suspend in the internal vortex and delay passage of the one or more gas bubbles to the outlet fluid passage.

Description

[0001] Cross-references to related applications

[0002] 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 herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to fluid injector systems and associated fluid path elements for high-pressure injection of medical fluids. More specifically, this disclosure describes a fluid delivery system having at least one bubble suspension device. Other embodiments relate to features of a bubble suspension device suitable for fluid injection procedures. Background Technology

[0004] In many medical diagnostic and treatment procedures, medical practitioners (such as internists) administer one or more medical fluids to patients. Various injector-actuated syringes and powered fluid injectors have been developed for pressurized injection of medical fluids, such as contrast solutions (often simply referred to as "contrast"), irrigants (such as saline or Ringer's lactate), and other medical fluids, for use in procedures such as cardiovascular angiography (CV), computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and other imaging processes. Generally, these fluid injectors are designed to deliver a predetermined amount of fluid at a preset pressure and / or flow rate.

[0005] Typically, a fluid injector has at least one actuating member, such as a piston, connected to the syringe, for example, via an engagement feature on the proximal wall of a plunger or injection tube. The syringe may include a rigid barrel in which the syringe plunger is slidably disposed. The actuating member drives the plunger in a proximal and / or distal direction relative to the longitudinal axis of the barrel to draw fluid into or deliver fluid from the syringe barrel. In some applications, such as angiography, medical fluids are injected directly into the arterial system at fluid pressures up to 1200 psi.

[0006] During certain infusion procedures, at these high fluid pressures, fluid is injected directly into the cardiac system, and it is crucial to prevent air from being injected along with the medical fluid, as this could harm the patient. Therefore, new methods and devices are needed to prevent accidental air injection during high-pressure fluid infusion procedures. Furthermore, during some CV infusions, air in the fluid path is compressed at pressures up to 1200 psi; however, if the injection is stopped upon detecting air, the air volume may rapidly expand due to pressure release. Additionally, releasing system compliance upon cessation of infusion can lead to continuous fluid flow due to the release of compliant volume in the absence of fluid pressure. Therefore, high-pressure fluid infusion systems must address these phenomena in preventing accidental air injection. Summary of the Invention

[0007] In view of the above, there is a need for devices, systems, and methods for preventing air delivery to the patient during an injection procedure. Embodiments of this disclosure relate to an apparatus for suspending air bubbles in the 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 passage in fluid communication with the internal chamber, extending tangentially to the curved inner wall into the chamber; and an outlet fluid passage in fluid communication with the internal chamber, spaced apart from the inlet fluid passage such that fluid flowing into the internal chamber via the inlet fluid passage is diverted away from the outlet fluid passage. The internal chamber is configured to generate internal fluid vortices in the injected fluid entering the internal chamber from the inlet fluid passage, wherein the internal fluid vortices suspend one or more air bubbles in the fluid at least temporarily and delay the passage of one or more air bubbles to the outlet fluid passage.

[0008] In some embodiments, the outlet fluid passage extends from the internal chamber in a direction perpendicular to the flow path of the fluid within the internal chamber.

[0009] In some embodiments, at least a portion of the outlet fluid passage has a cross-sectional area larger than that of the inlet fluid passage, so as to reduce the fluid velocity in the outlet fluid passage relative to the fluid velocity in the inlet fluid passage.

[0010] In some embodiments, the outlet fluid passage extends substantially parallel to the inlet fluid passage.

[0011] In some embodiments, the internal chamber is at least partially spherical or hemispherical.

[0012] In some embodiments, the device further includes a recess extending radially outward from the internal chamber.

[0013] In some embodiments, the device further includes a valve in fluid communication with the internal chamber for discharging air accumulated in the internal chamber.

[0014] In some embodiments, the housing includes: a first housing portion including an inlet fluid passage and an outlet fluid passage; and a second housing portion including at least a portion of an internal chamber. 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.

[0015] In some embodiments, the housing includes at least one reinforcing rib extending radially outward from the outlet fluid passage.

[0016] In some embodiments, the device further includes a filter screen disposed in the outlet fluid passage, such that fluid flowing out of the internal chamber passes through the filter screen.

[0017] In some embodiments, the housing includes a light-transmitting material configured to illuminate bubbles in the internal chamber.

[0018] In some embodiments, the housing includes a connector arm configured for attachment to an injector housing of a fluid injector system.

[0019] In some embodiments, the device further includes an adjustable valve for changing the cross-sectional area of ​​at least one of the inlet fluid passage and the outlet fluid passage.

[0020] Other embodiments of this disclosure relate to an apparatus for suspending air bubbles in a fluid path of a fluid injector system. The apparatus includes: a housing defining an internal chamber; an inlet fluid passage in fluid communication with the internal chamber; an outlet fluid passage in fluid communication with the internal chamber; and an extension tube in fluid communication with the inlet fluid passage and extending into the internal chamber. The extension tube includes a tip spaced apart from the outlet fluid passage, such that fluid flowing into the internal chamber via the extension tube is directed away from the outlet fluid passage.

[0021] In some embodiments, the device further includes a filter screen dividing the internal chamber into an inlet portion and an outlet portion. The filter screen includes at least one hole that provides fluid communication between the inlet portion and the outlet portion. Fluid flowing into the internal chamber from the extension tube must pass through at least one hole in the screen tube to reach the outlet fluid passage.

[0022] In some embodiments, a first portion of the filter screen adjacent to the tip of the extension tube is impermeable to fluid, and a second portion of the filter screen adjacent to the outlet fluid passage includes at least one pore. In some embodiments, the filter screen includes a funnel defining at least one pore, the funnel tapering gradually from a maximum cross-sectional area at the inlet portion adjacent to the internal chamber to a minimum diameter at the outlet portion extending into the internal chamber.

[0023] In some embodiments, the filter screen includes a cover that at least partially blocks at least one orifice, such that fluid must flow around the cover to pass through the at least one orifice. In some embodiments, the filter screen includes a mesh. In some embodiments, the at least one orifice includes two or more orifices arranged in an arcuate pattern.

[0024] In some embodiments, the housing includes: a first housing portion including a flange configured to receive a filter; and a second housing portion received within the flange of the first housing portion to capture the filter between the first housing portion and the second housing portion.

[0025] In some embodiments, the inlet fluid passage gradually tapers from a smaller cross-sectional area to a larger cross-sectional area in the direction in which the fluid flows through the inlet fluid passage, in order to reduce the flow rate of the fluid flowing through the inlet fluid passage.

[0026] In some embodiments, the extension tube extends parallel to the inner wall of the internal chamber. In some embodiments, the outlet fluid passage extends at an acute angle relative to the inlet fluid passage.

[0027] In some embodiments, the housing includes a light-transmitting material configured to illuminate bubbles in the internal chamber.

[0028] In some embodiments, the housing includes a connector arm configured for attachment to a fluid injector system.

[0029] In some embodiments, the device further includes an adjustable valve for changing the cross-sectional area of ​​at least one of the inlet fluid passage and the outlet fluid passage.

[0030] Other embodiments of this disclosure relate to a fluid injection system including at least one fluid reservoir configured to inject a medical fluid and at least one bubble suspending device in fluid communication with the at least one fluid reservoir. The at least one bubble suspending device includes: a shell defining an internal chamber; an inlet fluid passage in fluid communication with the internal chamber; and an outlet fluid passage in fluid communication with the internal chamber, spaced apart from the inlet fluid passage such that fluid flowing into the internal chamber via the inlet fluid passage is diverted away from the outlet fluid passage. The fluid injector system also includes at least one air detector configured to detect one or more bubbles in a fluid path connecting the at least one fluid reservoir to the at least one bubble suspending device; and at least one shut-off valve located downstream of the at least one bubble suspending device and configured to move from an open position to a closed position in response to the air detector detecting one or more bubbles in the fluid path. The internal chamber is configured to generate an internal fluid vortex in the injected fluid entering the internal chamber from the inlet fluid passage, and wherein the internal fluid vortex suspends one or more bubbles in the fluid at least temporarily within the internal vortex and delays the passage of one or more bubbles to the outlet fluid passage. Features of various embodiments of bubble suspending devices suitable for use with fluid injector systems are described herein.

[0031] In some embodiments, the bubble levitation device can be moved between: an injection position, in which the outlet fluid passage extends substantially vertically downward from the internal chamber, such that the buoyancy of the bubbles in the internal chamber further causes one or more bubbles to remain suspended in the internal fluid vortex within the internal chamber; and a filling position, in which the outlet fluid passage extends substantially vertically upward from the chamber, such that the buoyancy of the bubbles in the internal chamber causes the bubbles to flow from the internal fluid vortex through the outlet fluid passage.

[0032] In some embodiments, the system further includes an adjustable valve for changing the cross-sectional area of ​​at least one of the inlet fluid passage and the outlet fluid passage.

[0033] Other aspects or examples of this disclosure are described in the following numbered clauses:

[0034] Clause 1. An apparatus for suspending air bubbles in a fluid path of a fluid injector system, the apparatus comprising: a housing; an internal chamber having a curved inner wall defined within the housing; an inlet fluid passage in fluid communication with the internal chamber, the inlet fluid passage extending tangentially to the curved inner wall into the chamber; and an outlet fluid passage in fluid communication with the internal chamber, the outlet fluid passage being spaced apart from the inlet fluid passage such that fluid flowing into the internal chamber via the inlet fluid passage is directed away from the outlet fluid passage, wherein the internal chamber is configured to generate an internal fluid vortex in the injected fluid entering the internal chamber from the inlet fluid passage, and wherein the internal fluid vortex suspends one or more air bubbles in the fluid at least temporarily in the internal vortex and delays the passage of one or more air bubbles to the outlet fluid passage.

[0035] Clause 2. The apparatus according to Clause 1, wherein the outlet fluid passage extends from the internal chamber in a direction perpendicular to the flow path of the fluid within the internal chamber.

[0036] Clause 3. The apparatus according to Clause 1 or 2, wherein at least a portion of the outlet fluid passage has a cross-sectional area greater than that of the inlet fluid passage, so as to reduce the fluid velocity in the outlet fluid passage relative to the fluid velocity in the inlet fluid passage.

[0037] Clause 4. The apparatus according to any one of Clauses 1-3, wherein the outlet fluid passage extends substantially parallel to the inlet fluid passage.

[0038] Clause 5. The device according to any one of Clauses 1-4, wherein the internal chamber is at least partially spherical or hemispherical.

[0039] Clause 6. The device according to any one of Clauses 1-5 further includes a recess extending radially outward from the internal chamber.

[0040] Clause 7. The apparatus according to any one of Clauses 1-6 further includes a valve in fluid communication with the internal chamber for discharging air accumulated in the internal chamber.

[0041] Clause 8. The device according to any one of Clauses 1-7, wherein the housing comprises: a first housing portion including an inlet fluid passage and an outlet fluid passage; and a second housing portion including at least a portion of an 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.

[0042] Clause 9. The device according to any one of Clauses 1-8, wherein the housing includes at least one reinforcing rib extending radially outward from the outlet fluid passage.

[0043] Clause 10. The apparatus according to any one of Clauses 1-9 further includes a filter screen disposed in the outlet fluid passage such that fluid flowing out of the internal chamber passes through the filter screen.

[0044] Clause 11. The device according to any one of Clauses 1-10, wherein the housing comprises a light-transmitting material configured to illuminate bubbles in the internal chamber.

[0045] Clause 12. The device according to any one of Clauses 1-11, wherein the housing includes a connector arm configured for attachment to an injector housing of a fluid injector system.

[0046] Clause 13. The apparatus according to any one of Clauses 1-12 further includes an adjustable valve for changing the cross-sectional area of ​​at least one of the inlet fluid passage and the outlet fluid passage.

[0047] Clause 14. A device for suspending air bubbles in a fluid path of a fluid injector system, the device comprising: a housing defining an internal chamber; an inlet fluid passage in fluid communication with the internal chamber; an outlet fluid passage in fluid communication with the internal chamber; and an extension tube in fluid communication with the inlet fluid passage and extending into the internal chamber, the extension tube including a tip spaced apart from the outlet fluid passage such that fluid flowing into the internal chamber via the extension tube is directed away from the outlet fluid passage.

[0048] Clause 15. The apparatus according to Clause 14 further includes a filter screen dividing the internal chamber into an inlet portion and an outlet portion, wherein the filter screen includes at least one hole providing fluid communication between the inlet portion and the outlet portion, and wherein fluid flowing into the internal chamber from the extension tube must pass through at least one hole of the screen tube to reach the outlet fluid passage.

[0049] Clause 16. The apparatus according to Clause 14 or 15, wherein a first portion of the filter screen adjacent to the tip of the extension tube is impermeable to fluid, and wherein a second portion of the filter screen adjacent to the outlet fluid passage includes at least one hole.

[0050] Clause 17. The apparatus according to any one of Clauses 14-16, wherein the filter screen includes a funnel defining at least one orifice, the funnel tapering gradually from a maximum cross-sectional area adjacent to the inlet portion of the inner chamber to a minimum diameter extending into the outlet portion of the inner chamber.

[0051] Clause 18. The apparatus according to any one of Clauses 14-17, wherein the filter screen includes a shroud that at least partially blocks at least one orifice, such that fluid must flow around the shroud to flow through at least one orifice.

[0052] Clause 19. The apparatus according to any one of Clauses 14-18, wherein the filter screen comprises a mesh.

[0053] Clause 20. The apparatus according to any one of Clauses 14-19, wherein at least one aperture comprises two or more apertures arranged in an arcuate pattern.

[0054] Clause 21. The device according to any one of Clauses 14-20, wherein the housing comprises: a first housing portion including a flange configured to receive a filter screen; and a second housing portion received within the flange of the first housing portion to capture the filter screen between the first housing portion and the second housing portion.

[0055] Clause 22. The apparatus according to any one of Clauses 14-21, wherein the inlet fluid passage gradually tapers from a smaller cross-sectional area to a larger cross-sectional area in the direction in which the fluid flows through the inlet fluid passage, so as to reduce the flow velocity of the fluid flowing through the inlet fluid passage.

[0056] Clause 23. The device according to any one of Clauses 14-22, wherein the extension tube extends parallel to the inner wall of the internal chamber.

[0057] Clause 24. The apparatus according to any one of Clauses 14-23, wherein the outlet fluid passage extends at an acute angle relative to the inlet fluid passage.

[0058] Clause 25. The device according to any one of Clauses 14-24, wherein the housing comprises a light-transmitting material configured to illuminate bubbles in the internal chamber.

[0059] Clause 26. The device according to any one of Clauses 14-25, wherein the housing includes a connector arm configured for attachment to an injector housing of a fluid injector system.

[0060] Clause 27. The apparatus according to any one of Clauses 14-26 further includes an adjustable valve for changing the cross-sectional area of ​​at least one of the inlet fluid passage and the outlet fluid passage.

[0061] Clause 28. A fluid injector system comprising: at least one fluid reservoir configured for injecting a medical fluid; at least one bubble suspending device in fluid communication with the at least one fluid reservoir; the at least one bubble suspending device comprising: a housing defining an internal chamber; an inlet fluid passage in fluid communication with the internal chamber; and an outlet fluid passage in fluid communication with the internal chamber, the outlet fluid passage being spaced apart from the inlet fluid passage such that fluid flowing into the internal chamber via the inlet fluid passage is diverted away from the outlet fluid passage; at least one air detector configured to detect one or more bubbles in a fluid path connecting the at least one fluid reservoir to the at least one bubble suspending device; and at least one shut-off valve located downstream of the at least one bubble suspending device and configured to move from an open position to a closed position in response to the air detector detecting one or more bubbles in the fluid path, wherein the internal chamber is configured to generate an internal fluid vortex in the injected fluid entering the internal chamber from the inlet fluid passage, and wherein the internal fluid vortex suspends one or more bubbles in the fluid at least temporarily and delays the passage of one or more bubbles to the outlet fluid passage.

[0062] Clause 29. The fluid injector system according to Clause 28, wherein the bubble suspending device is movable between: an injection position, in which the outlet fluid passage extends substantially vertically downward from the internal chamber, such that the buoyancy of the bubbles in the internal chamber further causes one or more bubbles to remain suspended in the internal fluid vortex within the internal chamber; and a filling position, in which the outlet fluid passage extends substantially vertically upward from the chamber, such that the buoyancy of the bubbles in the internal chamber causes the bubbles to flow from the internal fluid vortex through the outlet fluid passage.

[0063] Clause 30. The fluid injector system according to Clause 28 or 29, wherein the internal chamber includes at least one curved inner wall, wherein the inlet fluid passage extends into the internal chamber in a manner tangential to the curved inner wall.

[0064] Clause 31. The fluid injector system according to any one of Clauses 28-30, wherein the outlet fluid passage extends from the internal chamber in a direction substantially perpendicular to the flow path of the fluid in the internal fluid vortex within the internal chamber.

[0065] Clause 32. The fluid injector system according to any one of Clauses 28-31, wherein at least a portion of the outlet fluid passage has a cross-sectional area greater than that of the inlet fluid passage to reduce the fluid velocity in the outlet fluid passage relative to the fluid velocity in the inlet fluid passage.

[0066] Clause 33. A fluid injector system according to any one of Clauses 28-32, wherein the outlet fluid passage extends substantially parallel to the inlet fluid passage.

[0067] Clause 34. The fluid injector system according to any one of Clauses 28-33, wherein the internal chamber is at least partially spherical or hemispherical.

[0068] Clause 35. The fluid injector system according to any one of Clauses 28-34, wherein the bubble suspension device further includes a recess extending radially outward from the internal chamber in a direction substantially opposite to the outlet fluid passage.

[0069] Clause 36. The fluid injector system according to any one of Clauses 28-35 further includes a valve located on the recess and in fluid communication with the internal chamber for discharging air accumulated in the recess.

[0070] Clause 37. The fluid injector system according to any one of Clauses 28-36, wherein the housing of the bubble suspending device comprises: a first housing portion including at least one of an inlet fluid passage and an outlet fluid passage; and a second housing portion including at least a portion of an 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.

[0071] Clause 38. The fluid injector system according to any one of Clauses 28-37, wherein the housing of the bubble suspension device includes at least one reinforcing rib extending radially outward from the outlet fluid passage.

[0072] Clause 39. The fluid injector system according to any one of Clauses 28-38, wherein the bubble suspension device further includes a filter screen disposed proximal to the outlet fluid passage, such that fluid flowing out of the internal chamber passes through the filter screen.

[0073] Clause 40. A fluid injector system according to any one of Clauses 28-39, wherein, as fluid passes through a filter screen, one or more of one or more air bubbles temporarily adhere to the surface of the filter screen.

[0074] Clause 41. The fluid injector system according to any one of Clauses 28-40, wherein the filter screen includes a hydrophilic coating on at least a portion of the surface of the filter screen.

[0075] Clause 42. The fluid injector system according to any one of Clauses 28-41, wherein the bubble suspension device further comprises an extension tube in fluid communication with the inlet fluid passage and extending into the inner chamber, the extension tube including a tip spaced apart from the outlet fluid passage, such that fluid flowing into the inner chamber via the extension tube is directed away from the outlet fluid passage.

[0076] Clause 43. The fluid injector system according to any one of Clauses 28-42, wherein a filter divides an internal chamber into an inlet portion and an outlet portion, wherein the filter includes at least one hole providing fluid communication between the inlet portion and the outlet portion, and wherein fluid flowing into the internal chamber from the inlet fluid passage must flow through at least one hole of the filter to reach the outlet fluid passage.

[0077] Clause 44. The fluid injector system according to any one of Clauses 28-43, wherein a first portion of the filter screen adjacent to the tip of the extension tube is impermeable to fluid, and wherein a second portion of the filter screen adjacent to the outlet fluid passage includes at least one hole.

[0078] Clause 45. The fluid injector system according to any one of Clauses 28-44, wherein the filter screen includes a funnel defining at least one orifice, the funnel tapering gradually from a maximum cross-sectional area adjacent to the inlet portion of the internal chamber to a minimum diameter extending into the outlet portion of the internal chamber.

[0079] Clause 46. A fluid injector system according to any one of Clauses 28-45, wherein the filter screen includes a shroud that at least partially blocks at least one orifice, such that fluid must flow around the shroud to flow through at least one orifice.

[0080] Clause 47. The fluid injector system according to any one of Clauses 28-46, wherein the filter screen comprises a mesh.

[0081] Clause 48. A fluid injector system according to any one of Clauses 28-47, wherein at least one orifice comprises two or more orifices arranged in an arcuate pattern.

[0082] Clause 49. A fluid injector system according to any one of Clauses 28-48, wherein the bubble suspension device delays the passage of one or more bubbles to the outlet fluid path by at least 100 milliseconds.

[0083] Clause 50. A fluid injector system according to any one of Clauses 28-49, wherein the housing comprises: a first housing portion including a flange configured to receive a filter screen; and a second housing portion received within the flange of the first housing portion to capture the filter screen between the first housing portion and the second housing portion.

[0084] Clause 51. The fluid injector system according to any one of Clauses 28-50, wherein the inlet fluid passage gradually tapers from a smaller cross-sectional area to a larger cross-sectional area in the direction in which the fluid flows through the inlet fluid passage, so as to reduce the flow velocity of the fluid flowing through the inlet fluid passage.

[0085] Clause 52. The fluid injector system according to any one of Clauses 28-51, wherein the extension tube extends parallel to the inner wall of the internal chamber.

[0086] Clause 53. The fluid injector system according to any one of Clauses 28-52, wherein the outlet fluid passage extends at an acute angle relative to the inlet fluid passage.

[0087] Clause 54. The fluid injector system according to any one of Clauses 28-53, wherein the housing of the bubble suspending device includes a light-transmitting material configured to illuminate the bubbles in the internal chamber.

[0088] Clause 55. The fluid injector system according to any one of Clauses 28-54, wherein the housing of the bubble suspension device includes a connector arm configured for attachment to the injector housing of the fluid injector system.

[0089] Clause 56. The fluid injector system according to any one of Clauses 28-55 further includes an adjustable valve for changing the cross-sectional area of ​​at least one of the inlet fluid passage and the outlet fluid passage.

[0090] The further details and advantages of the various examples described in this article will become clear after reading the following detailed description of the various examples in conjunction with the accompanying drawings.

[0091] Further details and advantages of the various examples described herein will become clear by reading the following detailed description of various examples in conjunction with the accompanying drawings. Attached Figure Description

[0092] Figure 1 This is a perspective view of a fluid injector system according to an embodiment of the present disclosure;

[0093] Figure 2 This is a schematic diagram of a fluid injector system according to an embodiment of the present disclosure;

[0094] Figure 3 This is a perspective view of a bubble levitation device according to an embodiment of the present disclosure;

[0095] Figure 4 yes Figure 3 A cross-sectional side view of the bubble suspension device at the injection position;

[0096] Figure 5 yes Figure 3 A cross-sectional side view of the bubble suspension device at the injection position;

[0097] Figure 6 This is a cross-sectional side view of a bubble levitation device according to an embodiment of the present disclosure;

[0098] Figure 7This is a perspective view of a bubble levitation device according to an embodiment of the present disclosure;

[0099] Figure 8 yes Figure 7 A cross-sectional side view of the bubble suspension device at the injection position;

[0100] Figure 9 This is a perspective view of a bubble levitation device according to an embodiment of the present disclosure;

[0101] Figure 10 yes Figure 9 A cross-sectional side view of the bubble suspension device during the first time interval of the injection scheme;

[0102] Figure 11 yes Figure 9 A cross-sectional side view of the bubble suspension device during the second time interval of the injection scheme;

[0103] Figure 12 yes Figure 9 A cross-sectional side view of the bubble suspension device during the third time interval of the injection scheme;

[0104] Figure 13 yes Figure 9 A cross-sectional side view of the bubble suspension device during the fourth time interval of the injection scheme;

[0105] Figure 14 yes Figure 9 A cross-sectional side view of the bubble suspension device at the injection position;

[0106] Figure 15 This is a cross-sectional side view of a bubble levitation device according to an embodiment of the present disclosure;

[0107] Figure 16 yes Figure 15 A perspective view of a bubble levitation device;

[0108] Figure 17 This is a cross-sectional side view of a bubble levitation device according to an embodiment of the present disclosure;

[0109] Figure 18 yes Figure 17 Exploded perspective view of the bubble suspension device;

[0110] Figure 19 This is a perspective view of a filter screen for a bubble suspending device according to an embodiment of the present disclosure;

[0111] Figure 20 This is a perspective view of a filter screen for a bubble suspending device according to an embodiment of the present disclosure;

[0112] Figure 21This is a perspective view of a filter screen for a bubble suspending device according to an embodiment of the present disclosure;

[0113] Figure 22 This is a perspective view of a filter screen for a bubble suspending device according to an embodiment of the present disclosure;

[0114] Figure 23 This is a perspective view of a filter screen for a bubble suspending device according to an embodiment of the present disclosure;

[0115] Figure 24 This is a front view of a filter screen for a bubble suspending device according to an embodiment of the present disclosure; and

[0116] Figure 25 This is a perspective view of a bubble levitation device according to an embodiment of the present disclosure.

[0117] Referring to the accompanying drawings, wherein the same reference numerals refer to the same parts in various views, this disclosure generally relates to an online bubble suspension device for use with a fluid injector system. Detailed Implementation

[0118] For the purposes described below, the terms “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “horizontal,” “vertical,” and their derivatives should be used in relation to the orientation disclosed in the accompanying drawings. Spatial or directional terms, such as “left,” “right,” “inner,” “outer,” “up,” “down,” etc., should not be considered limiting, as the invention can employ various alternative orientations.

[0119] As used herein, the singular forms of “a,” “an,” and “the” include plural indicators unless the context clearly specifies otherwise. In all cases, all figures used in the specification and claims should be understood to be modified by the term “about.” The terms “approximately,” “about,” and “substantially” refer to a range of plus or minus ten percent of the specified value.

[0120] As used herein, the term "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" means any one of A, B, and C, or any combination of any two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more individual A's; or one or more individual B's; or one or more individual C's; or one or more A's and one or more B's; or one or more A's and one or more C's; or one or more B's and one or more C's; or one or more of all A's, B's, and C's. Similarly, as used herein, the term "at least two" is synonymous with "two or more." For example, the phrase "at least two of D, E, and F" means any combination of any two or more of D's, E's, and F's. For example, "at least two of D, E, and F" includes one or more D's and one or more E's; or one or more D's and one or more F's; or one or more E's and one or more F's; or one or more of all D's, E's, and F's.

[0121] It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary examples of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the examples disclosed herein should not be considered limiting.

[0122] When used relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, air levitation device, or fluid line), the term "distal" refers to the portion of the component closest to the patient. When used relative to a component of an injector system (such as a fluid reservoir, syringe, air levitation device, or fluid line), the term "proximal" refers to the portion of the component closest to the injector of the injector system (i.e., the portion of the component furthest from the patient). When used relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, air levitation device, or fluid line), the term "upstream" refers to a direction away from the patient and towards the injector of the injector system. For example, if a first component is referred to as "upstream" of a second component, the first component is located closer to the injector than the second component. When used relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, air levitation device, or fluid line), the term "downstream" refers to a direction towards the patient and away from the injector of the fluid delivery system. For example, if a first component is referred to as "downstream" of a second component, the first component is located closer to the patient than the second component.

[0123] As used herein, the terms “capacitance” and “impedance” are used interchangeably to refer to the volumetric expansion of injector components (e.g., fluid reservoirs, syringes, fluid lines, and / or other components of the fluid delivery system) due to the pressurized fluid in these components and / or due to mechanical relaxation absorbed by forces applied to the components. Capacitance and impedance can be caused by high injection pressures, which in some angiography procedures can be on the order of 1,200 psi, and may result in a fluid volume held within a portion of the component exceeding the amount selected for the injection procedure or the component's resting volume. Furthermore, without proper consideration, the capacitance of various components can adversely affect the accuracy of pressure sensors in the injector system because the volumetric expansion of components causes an artificial decrease in the measured pressure of these components.

[0124] The terms “first,” “second,” etc., are not intended to refer to any particular order or sequence, but rather to different conditions, properties, or elements. All documents mentioned herein are incorporated herein 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.”

[0125] It should be understood that alternative variations and sequences of steps may be taken in this disclosure unless the opposite is expressly stated. It should also be understood that the specific apparatus and processes shown in the accompanying drawings and described in the following specification are merely exemplary aspects of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the examples disclosed herein should not be considered limiting.

[0126] While the systems and apparatus 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), may also be incorporated into the various embodiments described herein for preventing air injection.

[0127] Referring to the accompanying drawings, wherein like reference numerals refer to like parts in their various views, this disclosure generally relates to fluid injector systems and bubble suspension devices for delaying the movement of one or more bubbles toward a patient through a fluid line and preventing the delivery of one or more bubbles that may occur unintentionally during an injection procedure.

[0128] First refer to Figure 1An embodiment of a dual-syringe angiography injector system 2000 is illustrated. The angiography injector system 2000 is configured to inject two medical fluids via a first fluid path 210A for a medical fluid (e.g., an imaging contrast medium for angiography injection procedures) and a second fluid path 210B for a flushing fluid (such as saline or Ringer's lactate). 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, syringes 10A, 10B may be held within corresponding pressure sheaths 17A, 17B, for example to prevent pressure-induced swelling and potential rupture of syringes 10A, 10B.

[0129] The injector system 2000 may also include at least one graphical user interface (GUI) 11 through which an operator can observe and control the status of the injection program. The GUI 11 can be integrated with the controller 900 (see...). Figure 2 Operable communication is possible, with controller 900 sending and receiving commands between GUI 11 and fluid injector system 2000. GUI 11 can be mounted on injector housing 12 or mounted remotely from injector housing 12.

[0130] The dual-injector angiography injector system 2000 may further include at least one upstream air detector 200 associated with fluid paths 210A, B, for detecting one or more air bubbles within an air detection conduit region 250 of the first fluid path 210A and the second fluid path 210B. The air detection conduit region 250 may, for example, be associated with a proximal or upstream portion of the first fluid path 210A and the second fluid path 210B. In some embodiments, the at least one air detector 200 may be a single module having at least one sensor operatively 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 distinct modules, each operatively associated with one of the first fluid path 210A and the second fluid path 210B. The at least one air detector 200 may be associated with a controller 900 (see...). Figure 2 Operable to communicate, such that controller 900 can receive from at least one air detector 200 a signal indicating 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 receiving the signal(s), controller 900 can send a signal or command to fluid injector 2000 to stop the fluid injection procedure, for example, by closing one or more shut-off valves downstream of at least one air detector 200 (see...). Figure 2(215A, 215B and / or 390) to prevent detected air bubbles from being injected into the patient. The at least one air detector 200 may include an ultrasonic sensor and an optical sensor, or other suitable sensor device, configured to detect one or more air bubbles within the fluid path.

[0131] Continue to refer to Figure 1 The dual-syringe angiography injector system 2000 may further include bulk fluid containers 19A and 19B for filling and refilling the respective syringes 10A and 10B with imaging contrast media and flushing fluid, respectively. Bulk fluid containers 19A and 19B may be selectively fluidly connected to syringes 10A and 10B via respective bulk fluid paths 216A and 216B and bulk fluid valves 215A and 215B.

[0132] Further details and examples of suitable non-limiting power injector systems, including syringes, pressure jackets and pressure jacket retaining mechanisms, tubing, shut-off valves, controllers, and air detectors, are described in U.S. Patents 5,383,858, 7,553,294, 7,666,169, 8,945,051, 10,022,493, and 10,507,319, and international PCT applications PCT / US2013 / 061275, PCT / US2018 / 034613, PCT / US2020 / 049885, PCT / US2021 / 035273, and PCT / US2021 / 029963, and the disclosures thereof are incorporated herein by reference in their entirety. Although the fluid injection system 2000 is described herein in the context of a dual-injector angiography (CV) injector, it should be understood that the fluid injection system 2000 can be adapted to single-injector and multi-injector configurations for any injection procedure (e.g., CT, PET, MRI, ultrasound, etc.).

[0133] Now for reference Figure 2 , showed Figure 1 The diagram shows a fluid injector system 2000. The injector system 2000 includes pistons 13A, 13B associated with each injector 10A, 10B, and their corresponding pressure jackets 17A, 17B (see diagram). Figure 1Each of pistons 13A, 13B is configured to drive a corresponding plunger 14A, 14B within the barrel of the corresponding syringe 10A, 10B. A controller 900 is operatively associated with the injector system 2000, for example, by actuating pistons 13A, 13B to reciprocate plunger 14A, 14B within syringes 10A, 10B, thereby executing and stopping an injection procedure. Specifically, the controller 900 may include at least one processor programmed or configured to actuate pistons 13A, 13B and various other components of the injector system 2000, such as one or more shut-off valves, as described herein, to draw in and deliver medical fluid according to a programmed scheme for the injection procedure. The controller 900 may include a computer-readable medium, such as memory, on which one or more injection schemes may be stored for execution by at least one processor.

[0134] The controller 900 can be programmed or configured to perform a filling operation during which pistons 13A, 13B associated with each syringe 10A, 10B are retracted proximally towards the syringes 10A, 10B to draw injection fluid F (e.g., imaging contrast media and flushing fluid) from bulk fluid containers 19A, 19B into the syringes 10A, 10B. During this filling operation, the controller 900 can be programmed or configured to selectively actuate bulk fluid valves 215A and 215B to establish fluid communication between the respective syringes 10A, 10B and bulk fluid containers 19A, 19B via bulk fluid paths 216A and 216B, thereby controlling the filling of syringes 10A, 10B with the appropriate injection fluid F. When the filling operation is completed and the infusion operation that optionally removes any air from the syringes 10A, 10B and the various embodiments of the bubble suspension device described herein (e.g., by infusing any such air back into the bulk fluid containers 19A, 19B or through the infusion tube), the controller 900 can be programmed or configured to selectively actuate the bulk fluid valves 215A and 215B to block the fluid communication between the respective syringes 10A, 10B and the bulk fluid containers 19A, 19B via the bulk fluid paths 216A and 216B.

[0135] Following the filling and infusion operations, the controller 900 may be programmed or configured to perform a delivery operation during which pistons 13A, 13B associated with one or both of syringes 10A, 10B move toward the distal end of the syringe to inject fluid F into a first fluid path 210A and a second fluid path 210B. The controller 900 may be programmed or configured to selectively actuate phase fluid valves 215A and 215B to establish fluid communication between syringes 10A, 10B and the patient via fluid paths 210A, 210B. The first fluid path 210A and the second fluid path 210B ultimately converge into a patient fluid line 210C in fluid communication with the patient's vascular system. According to various embodiments, the first fluid path 210A and the second fluid path 210B may converge at a fluid mixing connector that provides turbulent mixing of the first and second fluids, such as the fluid mixing connectors described in International PCT Applications No. PCT / US2021 / 019507 and PCT / US2014 / 026324, the disclosures of which are incorporated herein by reference.

[0136] The controller 900 is operatively communicable with at least one air detector 200, such that the controller 900 can stop actuation of pistons 13A, 13B 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 is also operatively communicable with at least one downstream automatic shut-off valve 390, such that the controller 900 can actuate at least one downstream shut-off valve 390 to prevent fluid from flowing through at least one downstream shut-off valve 390 and into the patient's vascular system. The at least one downstream shut-off valve 390 can be actuated by the controller 900 in various positions, such as an open position where medical fluid can flow to the patient, a closed position where fluid flow to the patient is prevented, and a hemodynamic monitoring position where the patient's vascular system is in fluid communication with a pressure sensor and isolated from syringes 10A, 10B. In some embodiments, the downstream shut-off valve 390 may be a stop valve, a pinch valve, etc. In some embodiments, the downstream shut-off valve 390 may be associated with each of fluid paths 210A and 210B and may be located before the first fluid path 210A and the second fluid path 210B merge into the patient fluid line 210C. Suitable examples of pinch valves and pinch valve / fluid path configurations are described in International PCT Application No. PCT / US2021 / 029963. During normal delivery operation, the controller 900 may be programmed or configured to move the downstream shut-off valve 390 to the open position to establish fluid communication between the patient and fluid paths 210A, 210B. The controller 900 may also be programmed or configured to move the downstream shut-off valve 390 to the closed position in response to air being detected by at least one air detector 200. Movement of pistons 13A, 13B may also stop in response to air being detected by at least one air detector 200. In the stopped position, the downstream shut-off valve 390 fluidly isolates the patient from fluid paths 210A, 210B, thereby preventing air from being injected into the patient.

[0137] Continue to refer to Figure 2 In some embodiments, each of the first fluid path 210A and the second fluid path 210B may include a bubble suspending device 300 configured to at least temporarily suspend or delay one or more bubbles flowing through fluid paths 210A, 210B. Each bubble suspending device 300 may be arranged in a straight line with the associated fluid path 210A, 210B between at least one air detector 200 and a downstream shut-off valve 390, such that all fluid flowing through fluid paths 210A, 210B must pass through at least one bubble suspending device 300 to reach the patient.

[0138] In some embodiments, the controller 900 may be programmed or configured to move the bulk fluid valves 215A, 215B and / or the downstream shut-off valve 390 to a closed position in response to the detection of one or more bubbles by at least one air detector 200 and the accompanying cessation of pistons 13A, 13B. Without the bubble levitation device 300, one or more bubbles detected by at least one air detector 200 may travel through fluid paths 210A, 210B at sufficient speed to flow through the bulk fluid valves 215A, 215B and / or the downstream shut-off valve 390 before they reach the closed position. For example, during a high-pressure (e.g., 1200 psi) CV injection procedure, the injector system 2000 may require 60 to 90 milliseconds (e.g., approximately 80 milliseconds in one embodiment) to stop the injection procedure after bubbles have flowed into the detection area of ​​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 with the controller 900 that a bubble has been detected; the time required for the controller 900 to communicate with the bulk fluid valves 215A, 215B and / or the downstream shut-off valve 390; and the time required for the bulk fluid valves 215A, 215B and / or the shut-off valve 390 to move from the open position to the closed position. At typical high injection pressures (e.g., 1200 psi) in a CV injection procedure, a bubble can move from a volume of 2.8 mL to 3.6 mL in fluid paths 210A, 210B within 60 to 90 milliseconds between bubble detection and closure of the bulk fluid valves 215A, 215B and / or the downstream shut-off valve 390. For example, at approximately 1200 psi, a bubble can travel a distance corresponding to 3.2 mL in 80 milliseconds at a flow rate of 30 mL / s in a 0.072-inch inner diameter tubing. In such an embodiment, the equivalent distance of a 3.2 ml volume could be approximately 4 feet of tubing traveled during an 80 millisecond period. Therefore, even if at least one air detector 200, controller 900, and bulk fluid valves 215A, 215B, and / or downstream shut-off valve 390 have a fast response time, the bubble could potentially travel a considerable distance and enter the patient's body before the bulk fluid valves 215A, 215B, and / or downstream shut-off valve 390 can close. Furthermore, due to the compressibility of gases compared to liquids, the bubble volume decreases significantly at high injection pressures. Pressure on the system can only be released by stopping fluid flow through stop pistons 13A, 13B, allowing the bubble volume to expand. The increased volume allows the bubble to move down the fluid path, past the bulk fluid valves 215A, 215B, and / or downstream shut-off valve 390, before these valves close.

[0139] Embodiments of the bubble levitation device 300 of this disclosure are configured to at least temporarily delay bubble flow in 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 the closed position before the 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, the system 2000 may close the bulk fluid valves 215A, 215B and / or the downstream shut-off valve 390 in response to at least one air detector 200 detecting bubbles in fluid paths 210A, 210B, which may take 60 milliseconds to 90 milliseconds, for example, approximately 80 milliseconds in one embodiment. Embodiments of the bubble suspending device 300 may be configured to delay the flow of bubbles by at least 60 to 90 milliseconds, for example, at least 80 milliseconds in one embodiment, such that the body fluid valves 215A, 215B and / or the downstream shut-off valve 390 can be moved to a closed position before the bubbles can reach the body fluid valves 215A, 215B and / or the downstream shut-off valve 390. This prevents the bubbles from flowing downstream of the body fluid valves 215A, 215B and / or the downstream shut-off valve 390 and entering the patient's body. In some embodiments, the controller 900 is programmed or configured to move one or both of the body fluid valves 215A, 215B to a closed position in response to at least one air detector 200 detecting bubbles in the fluid paths 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 at least one air detector 200 detecting bubbles 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 at least one air detector 200 detecting air bubbles in fluid paths 210A, 210B.

[0140] refer to Figure 3-25Features of various embodiments of a bubble levitation device 300 are shown according to this disclosure. Typically, embodiments of the bubble levitation device 300 include a housing 310 defining an internal chamber 320. The internal chamber 320 is in fluid communication with an inlet fluid passage 312 and an outlet fluid passage 314. The inlet fluid passage 312 and the outlet fluid passage 314 may be configured to be in fluid communication with associated fluid paths 210A, 210B of a fluid injector system 2000. At least one bubble levitation device 300 may be connected to the associated fluid paths 210A, 210B such that injection fluid injected from the associated syringes 10A, 10B flows into the inlet fluid passage 312, through the internal chamber 320, and out of the outlet fluid passage 314. The bubble levitation device 300 is located downstream of at least one air detector 200 and upstream of a downstream shut-off valve 390 (and in some embodiments, upstream of bulk fluid valves 215A, 215B) in each of the fluid paths 210A, 210B. In this manner, the bubbles are at least temporarily suspended in the bubble suspension device 300 for a period of time to allow the downstream shut-off valve 390 and / or the bulk fluid valves 215A, 215B to move to the closed position and stop the injection process. In some embodiments, the bubble suspension device 300 may be configured to delay the passage of one or more bubbles from the inlet fluid passage 312 to the outlet fluid passage 314 by at least 100 milliseconds.

[0141] The inlet fluid passage 312 may be oriented relative to the inner chamber 320 such that fluid flowing into the inner chamber 320 generates an internal fluid vortex within the injected fluid entering the inner chamber 320. In some embodiments, the inlet fluid passage 312 may be oriented such that the injected fluid from the inlet fluid passage 312 enters the inner chamber 320 substantially tangentially to the curved or hemispherical inner wall 322 of the inner chamber 320, thereby causing the injected fluid to flow along the inner wall 322 to generate a fluid vortex. The internal fluid vortex causes one or more bubbles that may be present in the injected fluid to be temporarily retained in the fluid vortex within the inner chamber 320, thereby at least temporarily delaying the passage of one or more bubbles to the outlet fluid passage 314 and their exit from the bubble suspension device 300. The internal fluid vortex may define a generally circular or other continuous flow path along the curved or hemispherical inner wall 322 of the inner chamber 320, causing one or more bubbles in the injected fluid to be temporarily suspended in the fluid vortex. Furthermore, the fluid vortex may cause one or more bubbles to coalesce into a smaller number of larger bubbles, for example, through the collision and coalescence of smaller bubbles. The curved or hemispherical inner wall 322 can minimize the shear force on one or more bubbles, thereby preventing the bubbles from shearing into smaller bubbles in the vortex.

[0142] In various embodiments, the internal chamber 320 may have a volume (i.e., fluid capacity) sufficient to delay bubbles up to 0.5 ml (mL). In such embodiments, the internal chamber 320 may have a volume (i.e., fluid capacity) between 2 mL and 10 mL, between 2.8 mL and 3.6 mL in some embodiments, approximately 3.2 mL in some embodiments, and approximately 5.4 mL in some embodiments. Figure 3-6 In the illustrated embodiment, the internal chamber 320 may have a volume of approximately 6.77 ml (i.e., fluid capacity) for delaying bubbles up to approximately 0.5 ml. Figure 7-8 In the illustrated embodiment, the internal chamber 320 may have a volume of approximately 7.00 mL (i.e., fluid capacity) for delaying bubbles up to approximately 0.5 mL in size. In some embodiments, the volume of the internal chamber 320 may be increased accordingly to delay bubbles with a volume greater than 0.5 mL.

[0143] Continue to refer to Figure 3-25 In the various embodiments shown, the outlet fluid passage 314 may be oriented relative to the internal chamber 320 to prevent one or more air bubbles suspended in the internal fluid vortex from easily flowing to the outlet fluid passage 314. For example, the outlet fluid passage 314 may be oriented such that the fluid flow path defined by the fluid vortex is directed away from the outlet fluid passage 314, or such that fluid flowing within the internal chamber 320 must change direction to enter the outlet fluid passage 314 (e.g., see...). Figure 14 In some embodiments, the outlet fluid passage 314 may extend substantially perpendicularly from the inner wall 322 of the inner chamber 320, such that fluid flowing in the fluid vortex passes laterally through the opening 315 of the outlet fluid passage 314 (e.g., see...). Figure 4 The outlet fluid passage 314 can be arranged such that, at the injection position of the bubble levitation device 300, the outlet fluid passage 314 extends at least partially downward from the inner chamber 320. Since air is buoyant relative to the injected fluid in the inner chamber 320, any bubbles present in the inner chamber 320 are propelled away from the outlet fluid passage 314 and float or migrate toward the top of the inner chamber 320 by their relative buoyancy. Furthermore, with this configuration of the bubble levitation device 300, the bubble levitation device 300 can be moved (e.g., rotated) from the injection position to the filling position, where the outlet fluid passage 314 extends at least partially upward from the inner chamber 320 (see...). Figure 5 At the infusion location, during the infusion procedure in which air is removed from the fluid line before the fluid injection procedure begins, air bubbles present in the internal chamber 320 are induced to float toward the outlet fluid passage 314, such that, under the influence of the infusion fluid flow, the air bubbles can be removed from the distal ends of the associated fluid paths 210A, 210B through the outlet fluid passage 314.

[0144] Specific reference Figure 3-5 An embodiment of the bubble levitation device 300 is illustrated. The housing 310 can be formed from a first housing portion 302 and a second housing portion 304. Forming the housing 310 from multiple portions facilitates manufacturing via injection molding processes to form various features of the bubble levitation device 300. The bubble levitation device 300 can be made of any suitable medical-grade material, such as a medical-grade polymeric material capable of withstanding high fluid pressures within the bubble levitation device 300. The first housing portion 302 may include at least one of an inlet fluid passage 312 and an outlet fluid passage 314. Figure 3-5 In the illustrated embodiment, the first housing portion 302 includes both an inlet fluid passage 312 and an outlet fluid passage 314. The inlet fluid passage 312 and the outlet fluid passage 314 may extend substantially parallel to each other. The internal chamber 320 may be defined by the first housing portion 302 and the second housing portion 304. Figure 3-5 In the illustrated embodiment, each of the first housing portion 302 and the second housing portion 304 partially defines the internal chamber 320. Figure 4 and 5 As shown, the first housing portion 302 includes 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 disposed on the second housing portion 304, and the end feature 308 may be disposed on the first housing portion 302. The first housing portion 302 and the second housing portion 304 may be joined by adhesives, laser welding, ultrasonic welding, etc. The housing 310 may include one or more reinforcing ribs 324, 325 located at different positions to provide support against high fluid pressures within the housing 310. In some angiography (CV) procedures, fluid pressures may be as high as approximately 1200 psi. In some embodiments, a plurality of reinforcing ribs 324 may extend radially from at least a portion of the inlet fluid passage 312, the first housing portion 302, the second housing portion 304, and the outlet fluid passage 314. In some embodiments, at least one reinforcing rib 325 may extend parallel to the inlet fluid passage 312 and / or the outlet fluid passage 314. In some embodiments, the connector arm 360 may additionally serve as a reinforcing feature of the inlet fluid passage 314.

[0145] Continue to refer to Figure 3-5 The internal chamber 320 may have a curved hemispherical inner wall 322 to cause the injected fluid entering the internal chamber 320 to flow in an internal fluid vortex. Figure 4 The vortex path B is used to identify this. In some embodiments, the inner wall 322 of the internal cavity 320 defined by the second housing portion 304 may be substantially hemispherical or dome-shaped. Figure 4 As shown, a bubble levitation device 300 in the injection position is illustrated. A fluid inlet passage 312 extends into an internal cavity 320 substantially tangential to the inner wall 322 to generate an internal fluid vortex. The fluid inlet passage 312 may have an opening 313 leading to the internal cavity 320, such that injected fluid flowing into the internal cavity 320 in direction A merges with injected fluid flowing in the internal cavity 320 in the fluid vortex flow path B. The injected fluid flowing into the internal cavity 320 from the fluid inlet passage 312 thus enters the internal fluid vortex in substantially the same direction as the vortex flow path B to maintain the fluid vortex. Therefore, as long as the injected fluid continues to be introduced into the internal cavity 320 from the fluid inlet passage 312, the fluid vortex path B flows continuously within the internal cavity 320. The inner wall 322 may be shaped to facilitate the recirculation of the injected fluid into the vortex path B.

[0146] Continue to refer to Figure 4 The outlet fluid passage 314 can extend from the internal chamber 320 substantially perpendicular to the inner wall 322 and the fluid vortex flow path B, such that the fluid vortex flow path B flows laterally through the opening 315 of the outlet fluid passage 314. In this way, at least some of the injected fluid in the fluid vortex flow path B flows through the opening 315 and returns toward the opening 313 of the fluid inlet path 312 to maintain the fluid vortex.

[0147] Continue to refer to Figure 4 During the injection procedure performed by the fluid injector system 2000, internal fluid vortices can suspend one or more bubbles 400 within the internal chamber 320. As the injection fluid is introduced into the internal chamber 320 via the inlet fluid passage 312, any bubbles 400 present in the incoming injection fluid migrate toward the low-pressure region LP formed by the internal fluid vortex at the center of the fluid vortex flow path B. The injection fluid flowing in the fluid vortex flow path B forms a boundary that at least temporarily suspends one or more bubbles 400 within the low-pressure region and at least temporarily delays the passage of one or more bubbles 400 toward the outlet fluid passage 314. One or more bubbles 400 suspended in the low-pressure region LP can coalesce to form one or more larger bubbles 402. The inner wall 322 can be shaped to promote the recirculation of the injection fluid into the vortex flow path B and to promote the formation of a more compact structure of one or more bubbles 400 within the vortex flow path B. Even so, during the injection process, one or more larger bubbles 402 may be fluidly sheared or broken into smaller bubbles 404, which may migrate outside the eddy flow path B.

[0148] Continue to refer to Figure 4At the injection position, the outer casing 310 is oriented such that the outlet fluid passage 314 extends substantially vertically downward from the inner chamber 320. Thus, the flow direction C of the injected fluid exiting the inner chamber 320 is substantially aligned with the direction of gravity G. Because air is buoyant relative to the injected fluid, the buoyancy of the bubbles 400, 402 in the inner chamber 320 causes one or more bubbles 400, 402 to tend to rise towards the upper region of the inner chamber 320 opposite to the direction of gravity G, thus the bubbles 400, 402 tend to remain suspended in the internal fluid vortex within the inner chamber 320 for a longer period. Furthermore, even shear bubbles 404 crossing the boundary formed by the fluid vortex flow path B are also buoyed and tend to flow opposite to the direction of gravity G, and are therefore further delayed in their movement through the outlet fluid passage 314.

[0149] In some embodiments, at least a portion of the outlet fluid passage 314 may have a cross-sectional diameter Do larger than the cross-sectional diameter Di of the inlet fluid passage 312. The larger diameter Do of the outlet fluid passage 314 reduces the flow velocity of the fluid exiting the internal chamber 320 at the outlet fluid passage 314. This reduced flow velocity thus decreases the drag force on the bubble 404 outside the boundary formed by the fluid vortex flow path B, allowing the buoyancy of the bubble 404 to tend to overcome the drag force propelling the bubble 404 toward the outlet fluid passage 314. As a result, the bubble 404 may be at least temporarily delayed from exiting the outlet fluid passage 314.

[0150] Continue to refer to Figure 4 In some embodiments, the diameter Di of the inlet fluid passage 312 can be selected to control the flow rate of the injected fluid (including the bubbles 400 contained therein) into the internal chamber 320. In particular, decreasing the diameter Di increases the flow rate. The diameter Di of the inlet fluid passage 312 can be selected to produce a relatively high flow rate, which has the effect of crushing one or more bubbles 400. In some embodiments, the diameter Di of the inlet fluid passage 312 can be approximately 3.7 mm (0.145 inches).

[0151] Refer again Figure 5The bubble levitation device 300 is shown in a priming position for performing a priming or purging operation, wherein prior to the priming procedure, fluid is injected to prim / purify the bubble levitation device 300 and associated fluid paths 210A, 210B to remove any air from the bubble levitation device 300 and associated fluid paths 210A, 210B. In the priming position, the housing 310 is oriented such that the inlet fluid passage 312 and the outlet fluid passage 314 extend substantially vertically upward from the inner chamber 320. Thus, the flow direction A of the injected fluid flowing into the inner chamber 320 through the inlet fluid passage 312 is substantially aligned with the direction of gravity G. The diameter Di of the inlet fluid passage 312 can be small enough that the fluid velocity in the inlet fluid passage 312 can carry the bubble 400 against the direction of buoyancy of the bubble 400. That is, the flow velocity through the diameter Di generates a sufficient drag force on one or more bubbles 400 to overcome the buoyancy of the bubble 400 and drag the bubble into the inner chamber 329. As a result, one or more bubbles 400 are injected into the fluid and delivered to the internal chamber 320.

[0152] At the injection position, the outlet fluid passage 314 also extends approximately vertically upward from the internal chamber 320, such that the flow direction C of the injected fluid flowing out of the internal chamber 320 is approximately opposite to the direction of gravity G. The buoyancy of the bubbles 400 in the internal chamber 320 causes the bubbles 400 and 402 to float upward from the internal fluid vortex through the outlet fluid passage 314, working in conjunction with the drag associated with the fluid flow, thereby removing the bubbles 400 from the bubble suspension device 300.

[0153] Continue to refer to Figure 3-5 The bubble levitation device 300 may include a connector arm 360 extending from the housing 300. The connector arm 360 may be configured for connection to the injector housing 12 or other features associated with the flow path or injector (see [link to relevant documentation]). Figure 1-2 Specifically, connector arm 360 can be configured to engage with an actuator that is connected to the controller 900 of the fluid injector system 2000 (see...). Figure 2 Communication. The controller 900 can be programmed or configured to rotate the bubble levitation device 300 between an injection position and a filling position via the connector arm 360 according to the injection scheme. Optionally, the connector arm 360 can be configured to attach to the fluid injector system at either the injection or filling position, and can be configured for a user to manually rotate the bubble levitation device 300 between the injection and filling positions via the connector arm 360, for example, in response to system prompts on the GUI, to prepare the fluid injector for a fluid injection procedure.

[0154] Now for reference Figure 6 An embodiment of the bubble levitation device 300 is shown. Figure 6The embodiment of the bubble levitation device shown can be substantially similar to Figure 3-5 The embodiments shown are examples, and the differences between them will be discussed below. Figure 6 An embodiment of the bubble levitation device 300 shown may include an air purging valve 350 on the housing 310, which is in fluid communication with the internal chamber 320. The air purging valve 350 may be specifically configured to be in fluid communication with the uppermost region of the internal chamber 320. The air purging valve 350 can be used to purge air accumulated in the internal chamber 320, particularly after the completion of an infusion procedure, when performing multiple sequential infusion sequences using a multi-patient setup, with both multi-patient and single-patient disposable kits. The air purging valve 350 can be set to a closed position during the infusion procedure, allowing any bubbles 400, 402 present in the infused fluid to dissolve. Figure 3-5 The fluid is suspended in the same manner as described in the internal chamber 320. Upon completion of the injection procedure and before the start of subsequent injection procedures, the internal fluid vortex and vortex path B (as described) Figure 4 As shown, the vortex dissipates because no fluid flows into the internal chamber 320. Thus, the vortex path B ( Figure 4 (As shown) no longer provides a flow boundary for one or more coalesced bubbles 402 suspended in the internal chamber 320. One or more coalesced bubbles 402 can therefore float to the uppermost region of the adjacent air purge valve 350 in the internal chamber 320. The air purge valve 350 can be manually moved to the open position by the operator or automatically by the controller 900, allowing one or more coalesced bubbles 402 to flow out of the internal chamber 320 via the air purge valve 350, for example, by a low-flow-rate fluid into the chamber to replace the volume of purged air with fluid. In some embodiments, the outlet of the air purge valve 350 can be connected to a vacuum source, such as a manual syringe (not shown), to assist in removing one or more coalesced bubbles 402 from the internal chamber 320. After one or more coalesced bubbles 402 have been removed from the internal chamber 320, the air purge valve 350 can return to the closed position, preparing for a subsequent injection procedure. The air purge valve 350 can be a stop valve, a pinch valve, etc.

[0155] Continue to refer to Figure 6In some embodiments, the bubble levitation device 300 may include an adjustable valve 352 associated with the inlet fluid passage 312 and / or an adjustable valve 354 associated with the outlet fluid passage 314. The adjustable valve 352 may be configured to change the cross-sectional area of ​​the inlet fluid passage 312, and the adjustable valve 354 may be configured to change the cross-sectional area of ​​the outlet fluid passage 314. Decreasing the cross-sectional area of ​​the inlet fluid passage 312 and / or the outlet fluid passage 314 increases the flow rate, while increasing the cross-sectional area of ​​the inlet fluid passage 312 and / or the outlet fluid passage 314 decreases the flow rate. In some embodiments, it may be desirable to increase the cross-sectional area of ​​the inlet fluid passage 312 to reduce the flow rate through the inlet fluid passage 312, because a reduced flow rate is less likely to dislodge bubbles adhering to the surface of the inlet fluid passage 312. In some embodiments, it may be desirable to increase the cross-sectional area of ​​the outlet fluid passage 314 to reduce the flow rate through the outlet fluid passage 314, because a reduced flow rate is less likely to carry bubbles from the fluid vortex 402 through the outlet fluid passage 314. Adjustable valves 352 and 354 can be plug valves, pinch valves, etc.

[0156] Now for reference Figure 7-8 An embodiment of the bubble levitation device 300 is shown. Figure 7-8 The embodiment of the bubble levitation device 300 shown can be substantially similar to Figure 3-6 The embodiments shown are different from those described below, and only the differences will be discussed. Figure 7-8 An embodiment of the bubble levitation device 300 shown may include a recess 326 defined in an inner wall 322, extending radially outward from the uppermost region of an internal chamber 320 substantially opposite to an outlet fluid passage 314. The recess 326 may accommodate and retain one or more bubbles 408. The recess 326 may be particularly adapted to accommodate and retain one or more bubbles 408 in the form of microbubbles generated by the degassing action of a medical fluid. In some embodiments, such as combining Figure 6 The described air purging valve 350 can be provided on the recess 326 so that one or more air bubbles 408 accumulated in the recess 326 can be discharged from the recess 326.

[0157] Now for reference Figure 9-14 An embodiment of the bubble levitation device 300 is shown. Figure 9-14 The embodiment of the bubble levitation device 300 shown may include, with Figure 3-8 The embodiments shown have several common features and components, and are not combined. Figure 9-14 Any element specifically described should be understood to be substantially similar to Figure 3-8 Similar elements to those in the embodiments. In Figure 9-14In the embodiment of the bubble levitation device 300 shown, the housing 310 includes a filter 328 that divides the internal chamber 320 into an inlet portion 332 and an outlet portion 334. (This is in conjunction with...) Figure 19-24 Various embodiments of filter 328 are described. Filter 328 may be disposed proximal to outlet fluid passage 314. Filter 328 may include at least one orifice 340 providing fluid communication between inlet portion 332 and outlet portion 334. Injected fluid flowing into the inner chamber 320 from inlet fluid passage 312 must subsequently flow through at least one orifice 340 of filter 328 to reach outlet fluid passage 314. In some embodiments, filter 328 may include at least one funnel-shaped orifice 342 defining at least one orifice 340. The funnel 342 may taper from a maximum cross-sectional area adjacent to the inlet portion 332 of the inner chamber 320 to a minimum diameter extending into the outlet portion 334 of the inner chamber 320. In some embodiments, at least a portion of filter 328 may have a hydrophilic coating that causes air bubbles in the injected fluid to adhere to filter 328 and at least temporarily delays the flow of such air bubbles toward outlet fluid passage 314.

[0158] Continue to refer to Figure 9-14 The bubble levitation device 300 may further include an extension tube 370 in fluid communication with and extending from the inlet fluid passage 312 into the inner chamber 320. The extension tube 370 may include a tip 372 spaced apart from and passing through the flow axis of the outlet fluid passage 314, such that injected fluid flowing into the inner chamber 320 via the extension tube 370 is directed away from the outlet fluid passage 314. In some embodiments, the extension tube 370 may extend through at least one orifice 340 in the filter screen 328, such that injected fluid flowing into the inner chamber 320 from the inlet fluid passage 312 flows into the vortex path B before reaching the at least one orifice 340. The inlet portion 332 of the inner chamber 320 may be at least partially hemispherical or dome-shaped, wherein the vortex path B flows along the inner wall 322 of the inner chamber 320.

[0159] Continue to refer to Figure 9-14 The inlet fluid passage 312 and the extension tube 370 can be oriented at an acute angle relative to the outlet fluid passage 314, such that the injected fluid entering the inner chamber 320 from the extension tube 370 is guided away from the opening 315 of the outlet fluid passage 314.

[0160] Reference Figure 10-13 The sequence of embodiments illustrating the bubble suspension effect within the internal chamber 320 during the injection procedure is shown. First, refer to... Figure 10The injected fluid can flow into the internal chamber 320 along direction A through the inlet fluid passage 312 and the extension pipe 370. One or more bubbles 400 can be conveyed into the internal chamber 320 along with the injected fluid. The orientation of the extension pipe 370 guides the injected fluid and one or more bubbles 400 into the vortex flow path B. Furthermore, the buoyancy of one or more bubbles 400 relative to the injected fluid prevents one or more bubbles from flowing through at least one hole 340 in the filter screen 328 toward the outlet fluid passage 314.

[0161] Now for reference Figure 11 As the injected fluid flows through the vortex path B, one or more bubbles 400 can migrate toward the low-pressure region LP at the center of the vortex path B, thus becoming at least temporarily suspended within the internal chamber 320. Furthermore, one or more bubbles 400 can coalesce in the low-pressure region LP into one or more larger coalesced bubbles 402, while the injected fluid and additional bubbles 400 continue to enter the internal chamber 320 via the extension tube 370 (see...). Figure 12 ).

[0162] Figure 13 The bubble levitation device 300 is shown after the fluid flow into the internal chamber 320 has stopped (e.g., after the injection procedure is completed). Since no new injection fluid is introduced into the internal chamber 320 to maintain the internal fluid vortex, the vortex flow path B ( Figure 9-12 The bubble levitation device 300 dissipates and no longer provides a flow boundary for one or more coalesced bubbles 402 suspended in the internal chamber 320. Due to the buoyancy of the one or more coalesced bubbles 402 relative to the injected fluid, the one or more coalesced bubbles 402 can therefore float to the uppermost region of the internal chamber 320. In some embodiments, the bubble levitation device 300 may include an air purging valve 350 (substantially as illustrated herein) in fluid communication with the uppermost region of the internal chamber 320. Figure 6 (as described above), so as to remove one or more aggregated bubbles 402 from the internal chamber 320 between two injection procedures, for example, when using a multi-patient injection sequence.

[0163] Continue to refer to Figure 9-14 The bubble levitation device 300 can... Figure 10-13 The injection position shown is rotated approximately 180° to Figure 14The injection position is shown. At the injection position, the outlet fluid passage 314 extends substantially vertically downward from the internal chamber 320. Thus, the flow direction C of the injected fluid flowing out of the internal chamber 320 is substantially aligned with the direction of gravity G. Since air is buoyant relative to the injected fluid, the buoyancy of the bubbles 400, 402 in the internal chamber 320 causes one or more bubbles 400, 402 to tend to float towards the upper region of the internal chamber 320 opposite to the direction of gravity G, thus the bubbles 400, 402 tend to remain suspended in the internal fluid vortex within the internal chamber 320. Furthermore, even bubbles that cross the boundary formed by the fluid vortex flow path B are prompted to flow in the direction opposite to gravity G and pass through the filter screen 328, thereby further delaying their arrival at the outlet fluid passage 314.

[0164] At the infusion site, such as Figure 14 As shown, the outlet fluid passage 314 extends approximately vertically upward from the inner chamber 320, such that the flow direction C of the injected fluid flowing out of the inner chamber 320 is approximately opposite to the direction of gravity G. The buoyancy of the bubbles 400 and 402 in the inner chamber 320 causes the bubbles 400 and 402 to flow from the chamber 320 through the outlet fluid passage 314, thereby removing air from the bubble suspension device 300.

[0165] refer to Figure 9 The bubble levitation device 300 may include a connector arm 360 extending from the housing 300. The connector arm 360 may be configured for connection to the injector housing 12 or other features associated with the flow path or injector system 2000 (see [link to relevant documentation]). Figure 1-2 Specifically, connector arm 360 can be configured to engage with an actuator that is connected to the controller 900 of the fluid injector system 2000 (see...). Figure 2 Communication. The controller 900 can be programmed or configured to rotate the bubble levitation device 300 between an injection position and a filling position via the connector arm 360 according to the injection scheme. Optionally, the connector arm 360 can be configured to connect to the fluid injector system at either the injection or filling position, and can be configured for a user to manually rotate the bubble levitation device 300 between the injection and filling positions via the connector arm 360, for example, in response to system prompts on the GUI 11, to prepare the fluid injector for a fluid injection procedure.

[0166] Now for reference Figure 15 and 16 An embodiment of the bubble levitation device 300 is shown. Figure 15 and 16 The illustrated embodiment of the bubble levitation device 300 may include many similar devices. Figure 3-13 The various embodiments shown have the same features and components, and are not combined. Figure 15 and 16Any element specifically described should be understood to be related to Figure 3-13 Similar elements in any embodiment are substantially similar. Figure 15 and 16 In an embodiment of the bubble levitation device 300 shown, a housing 310 may be formed on a first housing portion 302 and a second housing portion 304, wherein the first housing portion 302 includes an inlet fluid passage 312, an extension tube 370, and an outlet fluid passage 314. The inlet fluid passage 312 may extend at an acute angle relative to the outlet fluid passage 314. The second housing portion 304 may be hemispherical or dome-shaped, such that the vortex path B flows along the inner wall 322 of the inner chamber 320 in a circular or other continuous manner. 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 disposed on the second housing portion 304, and the end feature 308 may be disposed on the first housing portion 302. The first housing portion 302 and the second housing portion 304 may be joined by adhesives, laser welding, ultrasonic welding, etc.

[0167] Continue to refer to Figure 15 and Figure 16 The extension tube 370 can extend beyond the opening 315 of the outlet fluid passage 314, allowing the injected fluid flowing into the internal chamber 320 to be guided away from the outlet fluid passage 314 into the vortex path B. As... Figure 3-13 In the illustrated embodiment, the vortex path B creates a boundary that at least temporarily delays the passage of one or more bubbles 400 suspended in the internal chamber 320 to the outlet fluid passage 314. In some embodiments, the opening 315 of the outlet fluid passage 314 may be positioned relative to the extension tube 370, for example, below the extension tube 370, such that the extension tube 370 obstructs the flow of fluid and / or bubbles 400 toward the outlet fluid passage 314.

[0168] In some embodiments, the inner diameter of the inlet fluid passage 312 may be tapered, such that the proximal cross-sectional area Ap of the upstream inlet fluid passage 312 is smaller than the distal cross-sectional area Ad of the downstream inlet fluid passage 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 passage 312 (e.g., between approximately 0.1 mL / s and 30 mL / s) may be slowed, thereby allowing bubbles 410 in the inlet fluid passage 312 to adhere, for example, to the sidewall 317 of the larger cross-sectional area Ad by surface tension. The reduction in fluid flow rate in the inlet fluid passage 312 caused by the enlarged distal cross-sectional area Ad may not be sufficient to immediately repel the adhered bubbles 410 from the sidewall 317. That is, the adhesion force of the bubbles 410 to the sidewall 317 may be greater than the force exerted on the bubbles 410 by the injected fluid flowing through the distal cross-sectional area Ad. Thus, the bubble 410 is at least temporarily delayed inflow into the internal chamber 320, and therefore delayed outflow from the fluid outlet path 314. In some embodiments, the enlarged distal cross-sectional area Ad of the fluid inlet path 312 may allow the injected fluid to flow around the bubble 410 adhered to the sidewall 317, rather than flowing into and potentially displacing the bubble 410 adhered to the sidewall 317. In some embodiments, the enlarged distal cross-sectional area Ad of the fluid inlet passage 312 may allow the bubble 410 to adhere to the sidewall 317 at least partially outside the main flow path of the injected fluid through the fluid inlet passage 312. In some embodiments, the inner surface of the fluid inlet passage 312 may be configured to attract and adhere bubbles, for example, by a surface treatment applied to the sidewall 317. These characteristics regarding the different cross-sectional areas of the fluid inlet passage 312 also apply to other embodiments of the bubble levitation device 300 described herein.

[0169] Continue to refer to Figure 15 and Figure 16 The bubble levitation device 300 can... Figure 15 The injection position shown is rotated approximately 180° to the perfusion position, similar to... Figure 5 or Figure 14At the injection position, the outlet fluid passage 314 extends substantially vertically downward from the internal chamber 320. Thus, the flow direction C of the injected fluid exiting the internal chamber 320 is substantially aligned with the direction of gravity G. Because air is buoyant relative to the injected fluid, the buoyancy of the bubbles 400, 402 in the internal chamber 320 causes one or more bubbles 400, 402 to tend to float in the upper region of the internal chamber 320 opposite to the direction of gravity G, thus keeping the bubbles 400, 402 suspended in the internal fluid vortex within the internal chamber 320. Furthermore, even bubbles crossing the boundary formed by the fluid vortex flow path B are encouraged to flow in the direction opposite to gravity G and pass through the filter screen 328, further delaying their arrival at the outlet fluid passage 314.

[0170] At the injection position, the outlet fluid passage 314 extends approximately vertically upward from the internal chamber 320, such that the flow direction C of the injected fluid exiting the internal chamber 320 is approximately opposite to the direction of gravity G. The buoyancy of the bubbles 400 and 402 in the internal chamber 320 causes the bubbles 400 and 402 to flow from the chamber 320 through the outlet fluid passage 314, thereby removing air from the bubble suspension device 300.

[0171] Continue to refer to Figure 15 and 16 The bubble levitation device 300 may include a connector arm 360 extending from the housing 300. The connector arm 360 may be configured for connection to the injector housing 12 or other features associated with the flow path or injector system 2000 (see [link to relevant documentation]). Figure 1-2 Specifically, connector arm 360 can be configured to engage with an actuator that is connected to the controller 900 of the fluid injector system 2000 (see...). Figure 2 Communication. The controller 900 can be programmed or configured to rotate the bubble levitation device 300 between an injection position and a filling position via the connector arm 360 according to the injection scheme. Optionally, the connector arm 360 can be configured to attach to the fluid injector system at either the injection or filling position, and can be configured for a user to manually rotate the bubble levitation device 300 between the injection and filling positions via the connector arm 360, for example, in response to system prompts on the GUI 11, to prepare the fluid injector for a fluid injection procedure.

[0172] Now for reference Figure 17-18 An embodiment of the bubble levitation device 300 is shown. Figure 17-18 The embodiment of the bubble levitation device 300 shown may include, with Figure 3-16 in particular Figure 9-14 The various embodiments shown share many common features and components, and are not combined. Figure 17-18 Any element specifically described should be understood to be substantially similar to Figure 3-16Similar elements in any embodiment. Figure 17-18 In an embodiment of the bubble levitation device 300 shown, the outer shell 310 may be formed of a first outer shell portion 302 and a second outer shell portion 304, wherein the first outer shell portion 302 includes an inlet fluid passage 312, an extension tube 370, and an outlet fluid passage 314. The inlet fluid passage 312 may extend at an acute angle relative to the outlet fluid passage 314. The second outer shell portion 304 may be hemispherical or dome-shaped, such that the fluid vortex path B flows along the inner wall 322 of the inner chamber 320 in a circular or other continuous manner. The first outer shell portion 302 may include a flange 306 configured to receive an end feature 308, such as a lip, of the second outer shell portion 304. In some embodiments, the flange 306 may be disposed on the second outer shell portion 304, and the end feature 308 may be disposed on the first outer shell portion 302. The first outer shell portion 302 and the second outer shell portion 304 may be joined by adhesives, laser welding, ultrasonic welding, etc.

[0173] Continue to refer to Figure 17-18 A filter screen 328 can be disposed between the first housing portion 302 and the second housing portion 304. In some embodiments, the filter screen 328 can be received within a flange 306 such that an end feature 308 holds the filter screen 328 in place between the first housing portion 302 and the second housing portion 304. The filter screen 328 can divide the internal chamber 320 into an inlet portion 332 and an outlet portion 334. The filter screen 328 may include at least one aperture 340 (e.g., ...). Figure 19-24 As shown, it provides fluid communication between inlet portion 332 and outlet portion 334. Injected fluid flowing into the internal chamber 320 from the inlet fluid passage 312 must subsequently flow through at least one orifice 340 of the filter screen 328 to reach the outlet portion 334 and the outlet fluid passage 314. In some embodiments, the filter screen 328 may have a hydrophilic coating that, for example, induces air bubbles 400 in the injected fluid to adhere to the filter screen 328 by increasing surface tension or the adhesive forces between them, thereby at least temporarily further delaying the flow of such adhered air bubbles 400 toward the outlet fluid passage 314. An extension tube 370 may be positioned within the internal chamber 320 such that injected fluid entering the internal chamber is directed toward a vortex path B and away from one or more orifices 340 of the filter screen 328. For example, one or more orifices 340 of the filter screen 328 may be located on a portion of the filter screen 328 near the distal outlet of the extension tube 370.

[0174] Now for reference Figure 19-24 Various embodiments of filter 328 are shown, which are applicable to the present document. Figure 9-13 Embodiments of the bubble levitation device 300 described in pp. 17-18. (See also...) Figure 19The filter screen 328 may include a plurality of holes 340 that are substantially uniformly distributed on the filter screen 328.

[0175] Next reference Figure 20-24 The filter 328 may include a solid portion 380 impermeable to fluid and air, and one or more holes 340 located outside the solid portion 380, for example, on a portion of the filter 328 near the distal outlet of the extension tube 370 during assembly. The filter 328 may be positioned within the bubble suspension device 300 such that the solid portion 380 is adjacent to the extension tube 370. Injected fluid entering the internal chamber 320 via the extension tube 370 must therefore enter the vortex path B and circulate at least once within the internal chamber 320 before reaching one or more holes 340. Figure 20 In the illustrated embodiment, the solid portion 380 occupies approximately half of the filter screen 328, and one or more holes 340 occupy approximately half of the filter screen 328. Figure 21 In the illustrated embodiment, the solid portion 380 occupies a larger proportion of the filter 328 than the one or more holes 340 occupy. In some embodiments, the one or more holes 340 can be arranged in any pattern, such as a grid, arc, or straight lines. In some embodiments, the one or more holes 340 can be non-uniformly distributed on the filter 328.

[0176] exist Figure 22 In the illustrated embodiment, filter 328 includes a single hole 340 offset from the centerline CL of filter 328. A solid portion 380 occupies the remainder of filter 328. Offsetting the hole 340 from the centerline CL of filter 328 forces the internal chamber 320 (see...) Figure 17-18 The bubbles in the bubble suspension device 300 change direction so that they can reach and pass through the hole 340, thereby further delaying the flow of the bubbles out of the bubble suspension device 300.

[0177] Next reference Figure 23 The filter 328 may include at least one funnel 342 defining at least one orifice 340. The funnel 342 may taper from the maximum cross-sectional area of ​​the inlet portion 332 adjacent to the internal chamber 320 to the minimum diameter extending into the outlet portion 334 of the internal chamber 320 (see...). Figure 9-14 (and 17-18).

[0178] Next reference Figure 24 In some embodiments of filter 328, each of one or more holes 340 may be partially blocked by a cover 344. Each cover 344 may extend from filter 328 into the inlet portion 332 of the inner chamber 320 (see...). Figure 17-18And opposite to the direction of fluid flow, such that the fluid in the inlet portion 332 and any associated bubbles must flow around the shroud 344 to pass through the associated orifice 340. In some embodiments, the shroud 344 may be configured such that bubbles adhere to the shroud 344, for example by surface tension, to delay the flow of bubbles out of the inlet portion 332.

[0179] exist Figure 19-24 In all embodiments of the filter 328 shown, the filter 328 may have a hydrophilic coating that causes air bubbles in the injected fluid to adhere to the filter 328, thereby at least temporarily delaying the flow of such air bubbles toward the outlet fluid passage 314. In various embodiments, other surfaces of the internal chamber 320 may be at least partially coated with a hydrophilic coating. Furthermore, any portion of the filter 328 or various features thereof may be configured such that air bubbles adhere to the filter 328, for example by surface tension, to delay the flow of air bubbles through one or more orifices 340. In some embodiments, the filter 328 may be a mesh, for example made of a material that readily allows air bubbles to adhere to its surface.

[0180] According to some embodiments, the change in fluid pressure through filter 328 can be substantially zero, resulting in no significant change in fluid velocity at filter 328, which could potentially dislodge any air bubbles adhering to filter 328. Conversely, the injected fluid can flow freely through other holes 340 or paths in the filter, rather than dislodge any air bubbles adhering to filter 328. For example, the inlet portion 332 upstream of filter 328 (see...) Figure 17-18 The volume of the filter can be compared with that of the outlet section 334 located directly downstream of the filter 328 (see...). Figure 17-18 The volumes of the fluids are basically the same, so that the fluid pressure will not change significantly due to flow path restrictions.

[0181] It should be understood that Figure 19-24 Features of various embodiments of the filter 328 shown in the embodiments can be combined with each other and still fall within the scope of this disclosure.

[0182] Now for reference Figure 25Various embodiments of the bubble levitation device 300 may include a generally cylindrical housing 310 from which an inlet fluid passage 312 and an outlet fluid passage 314 extend. The inlet fluid passage 312 and the outlet fluid passage 314 may be in fluid communication with opposite ends of an internal chamber 320. When injected fluid is introduced into the internal chamber 320 via the inlet fluid passage 312 in a direction substantially tangential to the arc of the cylindrical housing 310, an internal fluid vortex is generated in the form of a spiral or helical vortex flow path B flowing along the inner wall 322 of the internal chamber 320. One or more bubbles 400 carried by the injected fluid migrate toward a low-pressure region LP at the center of the vortex path B. The injected fluid in the vortex path B forms a boundary that at least temporarily prevents one or more bubbles 400 from flowing toward the outlet fluid passage 314. The length of the spiral or helical vortex path B may be proportional to the height of the housing 310. Therefore, the height of the housing 310 may be proportional to the time during which the flow of the bubbles 400 within the internal chamber 320 is delayed. Therefore, increasing the cylindrical height of the outer shell 310 can lead to an increase in the suspension time of one or more bubbles 400 in the helical vortex path B.

[0183] Continue to refer to Figure 25 The bubble levitation device 300 can be controlled by the controller 900 (see...) Figure 2 (Or, the user can manually rotate the device from the injection position to the infusion position.) Figure 25 As shown in the injection position, the bubble levitation device 300 can be oriented such that the outlet fluid passage 314 is positioned below the inlet fluid passage 312. In this way, the buoyancy of one or more bubbles 400 within the internal chamber 320 causes one or more bubbles 400 to float upward within the internal chamber 320, opposite to the direction of gravity G and the direction of the vortex path B, and away from the outlet fluid passage 314.

[0184] At the injection position, the bubble levitation device 300 can be oriented such that the outlet fluid passage 314 is positioned above the inlet fluid passage 312, for example, by rotating the bubble levitation device 300 about 180° around a transverse axis. In this way, the buoyancy of one or more bubbles 400 in the internal chamber 320 causes one or more bubbles 400 to float upwards toward the outlet fluid passage 314 within the internal chamber 120, thereby purging air from the internal chamber 320 under the flow of the injection fluid.

[0185] The bubble levitation device 300 may include a connector arm 360 extending from the housing 300. The connector arm 360 may be configured for connection to the injector housing 12 or other features associated with the flow path or injector system 2000 (see [link to relevant documentation]). Figure 1-2 Specifically, connector arm 360 can be configured to engage with an actuator that is connected to the controller 900 of the fluid injector system 2000 (see...). Figure 2Communication. The controller 900 can be programmed or configured to rotate the bubble levitation device 300 between an injection position and a filling position via the connector arm 360 according to the injection scheme. Optionally, the connector arm 360 can be configured to attach to the fluid injector system at either the injection or filling position, and can be configured for a user to manually rotate the bubble levitation device 300 between the injection and filling positions via the connector arm 360, for example, in response to system prompts on the GUI 11, to prepare the fluid injector for the injection procedure.

[0186] In some embodiments, the distal surface of the housing 300 may include a protrusion 384 extending upward into the internal chamber 320. The protrusion 384 may be approximately dome-shaped, conical, and / or Gaussian surface. The protrusion 384 may extend to any height within the internal chamber 320. In some embodiments, the protrusion 384 may extend to half the height of the internal chamber 320. The protrusion 384 may be configured to block the flow of one or more bubbles 400 toward the opening 315 of the outlet fluid passage 314 by extending into the low-pressure region LP of the fluid vortex and preventing one or more bubbles 400 in the low-pressure region LP from moving downward toward the outlet fluid path 314 through the protrusion 384. Therefore, the protrusion 384 further suspends one or more bubbles 400 simultaneously with the bubble suspension provided by the fluid vortex within the internal chamber 320.

[0187] In some embodiments, the housing 300 may include a dome-shaped or conical recess 326 extending from the proximal surface of the internal chamber 320, which functions similarly to... Figure 7-8 The recess 326 can accommodate and retain one or more bubbles 400 that float upwards in the internal chamber 320 under the influence of buoyancy, to remove one or more bubbles 400 from the vortex path B. The recess 326 can also be adapted to accommodate and retain one or more bubbles in the form of microbubbles generated by the degassing action of the medical fluid. In some embodiments, such as in combination Figure 6 The air purging valve 350 may be disposed on the housing 300 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.

[0188] In all embodiments of the bubble levitation device 300 described herein, the housing 310 may be at least partially constructed of a transparent or translucent light-transmitting material, such as polycarbonate, which can act as a light pipe. By directing a light source to the housing 310, one or more bubbles 400, 402, 404, 406, 408 can be illuminated, making it easier for an operator to identify the presence of bubbles in the bubble levitation device 300.

[0189] It should be understood that Figure 3-25Features of various embodiments of the bubble levitation device 300 shown in the embodiments can be combined with each other and still fall within the scope of this disclosure.

[0190] While various examples of this disclosure have been provided in the foregoing description, those skilled in the art can make modifications and alterations to these examples without departing from the scope and spirit of this disclosure. For example, it should be understood that features of the various embodiments described herein can be applied to other embodiments described herein. Therefore, the foregoing description is intended to be illustrative rather than limiting. The disclosure described above is defined by the appended claims, and all changes to the disclosure falling within the meaning and equivalent scope of the claims are to be included within their scope.

Claims

1. An apparatus for suspending air bubbles in a fluid path of a fluid injector system, the apparatus comprising: a housing; an interior chamber having a curved hemispherical inner wall defined within the housing, wherein the interior chamber is at least partially spherical or hemispherical; an inlet fluid passageway in fluid communication with the interior chamber, the inlet fluid passageway extending into the interior chamber tangentially to the curved hemispherical inner wall; and an outlet fluid passageway in fluid communication with the interior chamber, the outlet fluid passageway being spaced apart from the inlet fluid passageway such that fluid injected into the interior chamber via the inlet fluid passageway is directed away from the outlet fluid passageway, wherein the interior chamber is configured to create an internal fluid vortex in the fluid injected into the interior chamber from the inlet fluid passageway, and wherein the internal fluid vortex defines a circular fluid vortex flow path (B) along the curved hemispherical inner wall, wherein the circular fluid vortex flow path (B) traverses an opening of the outlet fluid passageway, and wherein the internal fluid vortex at least temporarily suspends the one or more air bubbles in a low pressure region in a center of the circular fluid vortex flow path (B) and delays passage of the one or more air bubbles to the outlet fluid passageway. The outlet fluid passageway extends from the interior chamber in a direction perpendicular to the circular fluid vortex flow path (B) of fluid within the interior chamber.

2. The apparatus of claim 1, wherein, At least a portion of the outlet fluid passageway has a cross-sectional area that is greater than a cross-sectional area of the inlet fluid passageway to reduce a fluid velocity in the outlet fluid passageway relative to a fluid velocity in the inlet fluid passageway.

3. The apparatus of claim 1, wherein, The outlet fluid passageway extends substantially parallel to the inlet fluid passageway.

4. The apparatus of claim 1, wherein, The housing comprises:

5. The apparatus of claim 1, wherein, a first housing portion including the inlet fluid passageway and the outlet fluid passageway; and a second housing portion including at least a portion of the interior chamber, wherein one of the first housing portion and the second housing portion includes a flange for accommodating an end feature of the other of the first housing portion and the second housing portion. The housing includes at least one reinforcing rib extending radially outward from at least one of the inlet fluid passageway, the outlet fluid passageway, the second housing portion, or the first housing portion.

6. The apparatus of claim 5, wherein, 7. The apparatus of claim 1, further comprising a screen disposed in the outlet fluid passageway such that the fluid exiting the interior chamber passes through the screen. The housing includes a light transmissive material configured to illuminate the air bubbles in the interior chamber.

8. The apparatus of claim 1, wherein, 9. The apparatus of claim 1, further comprising: an extension tube in fluid communication with the inlet fluid passageway and extending into the interior chamber, the extension tube including a tip spaced apart from the outlet fluid passageway such that fluid injected into the interior chamber via the extension tube is directed away from the outlet fluid passageway.

10. The apparatus of claim 9, further comprising a screen dividing the interior chamber into an inlet portion and an outlet portion, ​ wherein The filter screen includes at least one aperture that provides fluid communication between the inlet portion and the outlet portion, and wherein fluid flowing from the extension tube into the interior chamber must flow through the at least one aperture of the filter screen to reach the outlet fluid passageway.

11. The apparatus of claim 10, wherein, A first portion of the filter screen adjacent the tip of the extension tube is fluid impermeable, and wherein a second portion of the filter screen adjacent the outlet fluid passageway includes the at least one aperture.

12. The device of claim 9, wherein the housing includes: a first housing portion including a flange configured to receive a filter screen; and a second housing portion having an end feature received within the flange of the first housing portion to capture the filter screen between the first housing portion and the second housing portion. The inlet fluid passageway tapers from a smaller cross-sectional area to a larger cross-sectional area in a direction of fluid flow through the inlet fluid passageway to reduce a flow rate of fluid flowing through the inlet fluid passageway.

13. The apparatus of claim 9, wherein, The extension tube extends parallel to an interior wall of the interior chamber.

14. The apparatus of claim 9, wherein, The housing includes a light transmissive material configured to illuminate the air bubbles in the interior chamber.

15. The apparatus of claim 9, wherein, 16. A fluid injector system, comprising: at least one fluid reservoir configured for injection of a medical fluid; 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 including: a housing defining an interior chamber, wherein the interior chamber has a curved hemispherical interior wall and wherein the interior chamber is at least partially spherical or hemispherical; an inlet fluid passageway in fluid communication with the interior chamber, wherein the inlet fluid passageway extends into the interior chamber tangentially to the curved hemispherical interior wall; an outlet fluid passageway in fluid communication with the interior chamber, the outlet fluid passageway spaced apart from the inlet fluid passageway such that injection fluid flowing into the interior chamber via the inlet fluid passageway is directed away from the outlet fluid passageway; at least one upstream air detector configured to detect one or more air bubbles in an air detection tubing region connecting the at least one fluid reservoir to the at least one air bubble suspension device; 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 at least one upstream air detector detecting the one or more air bubbles in the air detection tubing region, ​ wherein the interior chamber is configured to create an internal fluid vortex in the injected fluid entering the interior chamber from the inlet fluid passageway, and wherein the internal fluid vortex defines a circular fluid vortex flow path (B) along the curved hemispherical inner wall, wherein the circular fluid vortex flow path (B) flows laterally through the opening of the outlet fluid passageway, and wherein the internal fluid vortex causes the one or more gas bubbles in a low pressure region in the injected fluid to at least temporarily suspend in the center of the circular fluid vortex flow path (B) and delays the one or more gas bubbles from passing to the outlet fluid passageway.

17. The fluid injector system of claim 16, wherein, The at least one bubble suspension device is movable between: an injection position in which the outlet fluid passageway extends substantially vertically downward from the interior chamber such that the buoyancy of the one or more gas bubbles in the interior chamber further causes the one or more gas bubbles to remain suspended in the internal fluid vortex in the interior chamber; and a perfusion position in which the outlet fluid passageway extends substantially vertically upward from the interior chamber such that the buoyancy of the one or more gas bubbles in the interior chamber causes the one or more gas bubbles to flow from the internal fluid vortex through the outlet fluid passageway. The outlet fluid passageway extends from the interior chamber in a direction that is substantially perpendicular to the circular fluid vortex flow path (B) of fluid in the internal fluid vortex within the interior chamber.

18. The fluid injector system of claim 16, wherein, The outlet fluid passageway extends substantially parallel to the inlet fluid passageway.

19. The fluid injector system of claim 16, wherein, The outlet fluid passageway extends substantially parallel to the inlet fluid passageway.

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