Fluid mixing kit

Abstract

A fluid mixing apparatus for mixing a first injected fluid and a second injected fluid includes a first fluid inlet, a second fluid inlet, a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet, and an outlet port in fluid communication with the mixing chamber. The first fluid inlet is configured to direct a first injected fluid in a first direction and has a first redirecting surface. The second fluid inlet is configured to direct a second injected fluid in a second direction along an axis different from the first direction and has a second redirecting surface. The mixing chamber is configured to mix the first injection fluid and the second fluid together. A mixture of the first injection fluid and the second injection fluid exits the fluid mixing device through the outlet port.

Description

[0001] This application is a divisional application of the Chinese national phase application of PCT international patent application PCT / US2021 / 019507, with an application date of February 25, 2021. The application number of the Chinese national phase application is 202180017411.X.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Application No. 62 / 982,995, filed on February 28, 2020, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure relates to a fluid mixing device for use with a fluid delivery tubing set configured for use with a power fluid injector. The present disclosure also relates to a fluid delivery tubing set having the fluid mixing device. Background Art

[0005] In many medical diagnostic and treatment procedures, a medical practitioner, such as a physician or radiologist, uses a powered fluid injector system to inject one or more fluids into a patient. In recent years, several powered fluid injectors for pressurized injection of fluids have been developed for use in procedures such as angiography (CV), computed tomography (CT), molecular imaging (such as PET imaging), and magnetic resonance imaging (MRI). In these imaging procedures, a first injection fluid, such as a contrast agent, can be used to highlight certain internal organs, portions of the circulatory system, or portions of the body during the imaging procedure. At the same time, a second injection fluid, such as saline or a similar flushing agent, can be used to ensure complete injection of a bolus of contrast agent and / or to adjust the concentration of the contrast agent. In some procedures, it may be desirable to deliver a mixture of the first injection fluid and the second injection fluid.

[0006] When delivering a mixture of a first injection fluid and a second injection fluid, it is desirable to fully mix the two fluids prior to injection into a patient. However, because the first injection fluid and the second injection fluid typically have different physical properties, such as specific gravity and / or viscosity, the two fluids may not be fully mixed prior to entering the patient's vascular system, resulting in reduced image quality. Therefore, there is a need in the art for an improved fluid delivery system that facilitates mixing of two or more injection fluids prior to injection into a patient. Summary of the invention

[0007] These needs and other needs may be met by the non-limiting embodiments described herein, which are directed to improved fluid mixing devices and fluid delivery tubing sets including the same.

[0008] In some non-limiting embodiments of the present disclosure, a fluid mixing device for mixing a first injection fluid and a second injection fluid may include a first fluid inlet configured to guide the first injection fluid in a first direction. The first fluid inlet may have a first redirecting surface. The fluid mixing device may also include a second fluid inlet configured to guide the second injection fluid in a second direction. The second fluid inlet may have a second redirecting surface. The fluid mixing device may also include a mixing chamber that is fluidly connected to the first fluid inlet and the second fluid inlet and has a third redirecting surface. The mixing chamber may be configured to mix the first injection fluid and the second injection fluid. The fluid mixing device may also include an outlet port that is fluidly connected to the mixing chamber and is distal to the first fluid inlet and the second fluid inlet. The first redirecting surface may be configured to redirect the first injection fluid in a first different direction different from the first direction to enter the mixing chamber along the first different direction, and the second redirecting surface may be configured to redirect the second injection fluid in a second different direction different from the second direction to enter the mixing chamber along the second different direction. The first different direction and the second different direction may be selected so that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber to turbulently mix the first injection fluid and the second injection fluid in the mixing chamber. The mixture of the first injection fluid and the second injection fluid may exit the fluid mixing device through the outlet port.

[0009] In some non-limiting embodiments of the present disclosure, the fluid mixing device may further include at least one of a first check valve in the first fluid inlet and a second check valve in the second fluid inlet. The first fluid inlet and the second fluid inlet may have a non-circular cross-sectional shape, and the first check valve and the second check valve have a circular cross-sectional shape.

[0010] In some non-limiting embodiments of the present disclosure, the first fluid inlet and the second fluid inlet may have a first inlet port and a second inlet port, respectively. The first redirection surface and the second redirection surface may be located distally relative to the first inlet port and the second inlet port, respectively. The third redirection surface may be located proximally relative to the outlet port, the first redirection surface, and the second redirection surface.

[0011] In some non-limiting embodiments of the present disclosure, the mixing chamber may further include a first inlet, wherein the first inlet of the mixing chamber is distal to the third redirection surface. The first redirection surface may be located distal to the first fluid inlet and at least partially faces the first inlet of the mixing chamber. The mixing chamber may further include a second inlet, wherein the second inlet of the mixing chamber is distal to the third redirection surface. The second redirection surface may be located distal to the second fluid inlet and at least partially faces the second inlet of the mixing chamber.

[0012] In some non-limiting embodiments of the present disclosure, at least one of the first redirection surface and the second redirection surface may be substantially concave and have a radius of curvature greater than or equal to 90°. At least one of the first redirection surface and the second redirection surface may be substantially concave and have a radius of curvature greater than or equal to 150°. The third redirection surface may have a substantially concave surface facing the outlet port. The radius of curvature of the concave surface may be greater than or equal to 90°. The radius of curvature of the concave surface may be greater than or equal to 150°.

[0013] In some non-limiting embodiments of the present disclosure, the first check valve may have a first end engaged with a first inlet port on a first fluid inlet and a second end engaged with a first stop element proximal to a first redirection surface. The second check valve may have a first end engaged with a second inlet port on a second fluid inlet and a second end engaged with a second stop element proximal to a second redirection surface. The first check valve and the second check valve may be reversibly compressed between the first end and the second end in response to a first fluid pressure of a first injection fluid flowing through the first inlet port and a second fluid pressure of a second injection fluid flowing through the second fluid port, respectively. The first stop element and the second stop element may have a sharp proximal end. The first inlet port and the second inlet port may have tapered end surfaces.

[0014] In some non-limiting embodiments of the present disclosure, the axis of the outlet port may be parallel to the axis of the first fluid inlet and the axis of the second fluid inlet. The axis of the outlet port may extend between the axis of the first fluid inlet and the axis of the second fluid inlet. The axis of the first fluid inlet may be parallel to and deviate from the axis of the second fluid inlet, and the axis of the outlet port may be substantially perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet. The axis of the first fluid inlet may be substantially perpendicular to the axis of the second fluid inlet, and the outlet port may have an axis substantially parallel to and coincident with one of the axes of the first fluid inlet and the second fluid inlet. The axis of the first fluid inlet may be at an angle between 130° and 165° relative to the axis of the second fluid inlet, and the outlet port may have an axis at an angle of less than 70° relative to one of the axes of the first fluid inlet and the second fluid inlet.

[0015] In some non-limiting embodiments of the present disclosure, each of the first redirection surface and the second redirection surface can be concave and face the fluid flow direction of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively. At least one of the first fluid inlet, the second fluid inlet, and the outlet port can have at least partially spiral rifling on at least a portion of the inner surface of at least one of the first fluid inlet, the second fluid inlet, and the outlet port for generating a corresponding fluid vortex for at least one of the first injection fluid, the second injection fluid, and a mixture of the first injection fluid and the second injection fluid.

[0016] In some non-limiting embodiments of the present disclosure, the outlet port may have at least one baffle member or mixing member disposed in an interior surface thereof.

[0017] In some non-limiting embodiments of the present disclosure, the outlet port may also include a pressure isolation valve integrated therewith.

[0018] The pressure isolation valve may have a first lumen in fluid communication with the outlet port, a second lumen configured for connection to a pressure transducer, and a valve member located between the first lumen and the second lumen, wherein the valve member is configured to isolate the second lumen from the outlet port during a fluid injection procedure.

[0019] In some non-limiting embodiments of the present disclosure, the connector element may be disposed outside or inside at least one of the first fluid inlet, the second fluid inlet, and the outlet port.

[0020] In some non-limiting embodiments of the present disclosure, a fluid delivery tubing kit for delivering a fluid from a fluid injector to a patient may include: a first inlet tube configured to deliver a first injection fluid; a second inlet tube configured to deliver a second injection fluid; an outlet tube configured to deliver a mixture of the first injection fluid and the second injection fluid to the patient; and a fluid mixing device. The fluid mixing device may include a first fluid inlet configured to guide the first injection fluid in a first direction. The first fluid inlet may have a first redirecting surface. The fluid mixing device may also include a second fluid inlet configured to guide the second injection fluid in a second direction. The second fluid inlet may have a second redirecting surface. The fluid mixing device may also include a mixing chamber that is fluidly connected to the first fluid inlet and the second fluid inlet and has a third redirecting surface. The mixing chamber may be configured to mix the first injection fluid and the second fluid. The fluid mixing device may also include an outlet port that is fluidly connected to the mixing chamber and is distal to the first fluid inlet and the second fluid inlet. The first redirecting surface can be configured to redirect the first injection fluid in a first different direction different from the first direction to enter the mixing chamber along the first different direction, and the second redirecting surface can be configured to redirect the second injection fluid in a second different direction different from the second direction to enter the mixing chamber along the second different direction. The first different direction and the second different direction can be selected so that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber to turbulently mix the first injection fluid and the second injection fluid in the mixing chamber. The mixture of the first injection fluid and the second injection fluid can exit the fluid mixing device through the outlet port.

[0021] In some non-limiting embodiments of the present disclosure, a method for turbulently mixing a first injection fluid and a second injection fluid to form a substantially uniform mixture of the first injection fluid and the second injection fluid may include contacting a fluid flow of the first injection fluid with a first concave redirection surface associated with a first fluid inlet. The method may also include redirecting the fluid flow of the first injection fluid to a first different direction, wherein the first different direction flows at an angle in the range of 90-175° to the fluid flow direction of the first injection fluid and toward a third concave redirection surface in a mixing chamber. The method may also include contacting a fluid flow of the second injection fluid with a second concave redirection surface associated with a second fluid inlet. The method may also include redirecting the fluid flow of the second injection fluid to a second different direction, wherein the second different direction flows at an angle in the range of 90-175° to the fluid flow direction of the second injection fluid and toward a third concave redirection surface in the mixing chamber. The method may also include turbulently mixing the first injection fluid and the second injection fluid in a mixing chamber to form a mixture of the first injection fluid and the second injection fluid when the first injection fluid and the second injection fluid contact the third concave redirection surface; and redirecting the mixture of the first injection fluid and the second injection fluid through an outlet port of the mixing chamber.

[0022] Various other non-limiting embodiments of the present disclosure are listed in one or more of the following clauses:

[0023] Item 1. A fluid mixing device for mixing a first injection fluid and a second injection fluid, the fluid mixing device comprising: a first fluid inlet configured to direct the first injection fluid in a first direction, the first fluid inlet having a first redirection surface; a second fluid inlet configured to direct the second injection fluid in a second direction, the second fluid inlet having a second redirection surface; a mixing chamber fluidly connected to the first fluid inlet and the second fluid inlet and having a third redirection surface, the mixing chamber configured to mix the first injection fluid and the second injection fluid; and an outlet port fluidly connected to the mixing chamber and distal to the first fluid inlet and the second fluid inlet, wherein the first redirection surface is configured to redirect the first injection fluid in a first different direction different from the first direction to enter the mixing chamber along the first different direction, and the second redirection surface is configured to redirect the second injection fluid in a second different direction different from the second direction to enter the mixing chamber along the second different direction, wherein the first different direction and the second different direction are selected so that the first injection fluid and the second injection fluid contact the third redirection surface of the mixing chamber to turbulently mix the first injection fluid and the second injection fluid in the mixing chamber, and wherein a mixture of the first injection fluid and the second injection fluid exits the fluid mixing device through the outlet port.

[0024] Clause 2. The fluid mixing device of Clause 1, further comprising at least one of a first check valve in the first fluid inlet and a second check valve in the second fluid inlet.

[0025] Clause 3. The fluid mixing device of Clause 2, wherein the first fluid inlet and the second fluid inlet have a non-circular cross-sectional shape, and wherein the first check valve and the second check valve have a circular cross-sectional shape.

[0026] Clause 4. A fluid mixing device according to any one of clauses 1 to 3, wherein the first fluid inlet and the second fluid inlet have a first inlet port and a second inlet port, respectively, wherein the first redirection surface and the second redirection surface are located distally relative to the first inlet port and the second inlet port, respectively, and wherein the third redirection surface is located proximally relative to the outlet port, the first redirection surface, and the second redirection surface.

[0027] Clause 5. A fluid mixing device according to any one of clauses 1 to 4, wherein the mixing chamber further comprises a first inlet, wherein the first inlet of the mixing chamber is distal to the third redirection surface, and wherein the first redirection surface is distal to the first fluid inlet and at least partially faces the first inlet of the mixing chamber.

[0028] Clause 6. A fluid mixing device according to any one of clauses 1 to 5, wherein the mixing chamber further comprises a second inlet, wherein the second inlet of the mixing chamber is distal to the third redirection surface, and wherein the second redirection surface is distal to the second fluid inlet and at least partially faces the second inlet of the mixing chamber.

[0029] Clause 7. The fluid mixing device of any of Clauses 1 to 6, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature greater than or equal to 90°.

[0030] Clause 8. The fluid mixing device of any of Clauses 1 to 6, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature greater than or equal to 150°.

[0031] Clause 9. The fluid mixing device of any one of clauses 1 to 8, wherein the third redirecting surface has a substantially concave surface facing the outlet port.

[0032] Clause 10. The fluid mixing device of Clause 9, wherein the radius of curvature of the concave surface is greater than or equal to 90°.

[0033] Clause 11. The fluid mixing device of Clause 9, wherein the radius of curvature of the concave surface is greater than or equal to 150°.

[0034] Clause 12. A fluid mixing device according to any one of Clauses 2 to 11, wherein the first check valve has a first end engaged with a first inlet port on a first fluid inlet and a second end engaged with a first stop element proximate to a first redirection surface, wherein the second check valve has a first end engaged with a second inlet port on a second fluid inlet and a second end engaged with a second stop element proximate to a second redirection surface, and wherein the first check valve and the second check valve are reversibly compressed between the first end and the second end in response to a first fluid pressure of a first injected fluid flowing through the first inlet port and a second fluid pressure of a second injected fluid flowing through the second fluid port, respectively.

[0035] Clause 13. The fluid mixing device of Clause 12, wherein the first stop element and the second stop element have sharp proximal ends.

[0036] Clause 14. The fluid mixing device of any one of clauses 1 to 13, wherein the first inlet port and the second inlet port have tapered end surfaces.

[0037] Clause 15. The fluid mixing device of any one of clauses 1 to 14, wherein an axis of the outlet port is parallel to an axis of the first fluid inlet and an axis of the second fluid inlet.

[0038] Clause 16. The fluid mixing device of Clause 15, wherein an axis of the outlet port extends between an axis of the first fluid inlet and an axis of the second fluid inlet.

[0039] Clause 17. A fluid mixing device according to any one of clauses 1 to 14, wherein the axis of the first fluid inlet is parallel to and offset from the axis of the second fluid inlet, and wherein the axis of the outlet port is substantially perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet.

[0040] Clause 18. A fluid mixing device according to any one of clauses 1 to 14, wherein the axis of the first fluid inlet is substantially perpendicular to the axis of the second fluid inlet, and wherein the outlet port has an axis substantially parallel to and coincident with one of the axes of the first fluid inlet and the second fluid inlet.

[0041] Clause 19. A fluid mixing device according to any one of clauses 1 to 14, wherein the axis of the first fluid inlet is at an angle between 130° and 165° relative to the axis of the second fluid inlet, and wherein the outlet port has an axis that is at an angle of less than 70° relative to the axis of the first fluid inlet and one of the axes of the second fluid inlet.

[0042] Clause 20. A fluid mixing device according to any one of clauses 1 to 19, wherein each of the first redirection surface and the second redirection surface is concave and faces the fluid flow direction of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

[0043] Item 21. A fluid mixing device according to any one of items 1 to 20, wherein at least one of the first fluid inlet, the second fluid inlet and the outlet port has at least partially spiral rifling on at least a portion of the inner surface of at least one of the first fluid inlet, the second fluid inlet and the outlet port, for generating corresponding fluid vortices for at least one of the first injection fluid, the second injection fluid and the mixture of the first injection fluid and the second injection fluid.

[0044] Clause 22. A fluid mixing device according to any one of clauses 1 to 21, wherein the outlet port has at least one baffle member or mixing member disposed in an inner surface thereof.

[0045] Clause 23. The fluid mixing device of any one of clauses 1 to 22, wherein the outlet port further comprises a pressure isolation valve integrated therewith.

[0046] Clause 24. A fluid mixing device according to Clause 23, wherein the pressure isolation valve includes a housing having a first lumen connected to the outlet port fluid, a second lumen configured for connecting to a pressure transducer, and a valve member located between the first lumen and the second lumen, wherein the valve member is configured to isolate the second lumen from the outlet port during a fluid injection process.

[0047] Clause 25. The fluid mixing device of any one of Clauses 1 to 24, further comprising a connector element located on the exterior or interior of at least one of the first fluid inlet, the second fluid inlet, and the outlet port.

[0048] Item 26. A fluid delivery circuit kit for delivering fluid from a fluid injector to a patient, the fluid delivery circuit kit comprising: a first inlet tube configured to deliver a first injection fluid; a second inlet tube configured to deliver a second injection fluid; an outlet tube configured to deliver a mixture of the first injection fluid and the second injection fluid to the patient; and a fluid mixing device comprising: a first fluid inlet coupled to the first inlet tube and configured to direct the first injection fluid in a first direction, the first fluid inlet having a first redirecting surface; a second fluid inlet coupled to the second inlet tube and configured to direct the second injection fluid in a second direction, the second fluid inlet having a second redirecting surface; a mixing chamber fluidly connected to the first fluid inlet and the second fluid inlet and having a third redirecting surface, the mixing chamber being configured to mix a first injection fluid and a second fluid; and an outlet port coupled to the outlet tube and in fluid communication with a mixing chamber, wherein the first redirection surface is configured to redirect the first injection fluid in a first different direction different from the first direction to enter the mixing chamber along the first different direction, and the second redirection surface is configured to redirect the second injection fluid in a second different direction different from the second direction to enter the mixing chamber along the second different direction, wherein the first different direction and the second different direction are selected so that the first injection fluid and the second injection fluid contact a third redirection surface of the mixing chamber to turbulently mix the first injection fluid and the second injection fluid together in the mixing chamber, and wherein a mixture of the first injection fluid and the second injection fluid exits the fluid mixing device through the outlet port.

[0049] Clause 27. The fluid delivery tubing kit of Clause 26, further comprising at least one of a first check valve in the first fluid inlet and a second check valve in the second fluid inlet.

[0050] Clause 28. The fluid delivery tubing kit of Clause 26 or 27, wherein the first fluid inlet and the second fluid inlet have a non-circular cross-sectional shape, and wherein the first check valve and the second check valve have a circular cross-sectional shape.

[0051] Clause 29. A fluid delivery circuit kit according to any one of clauses 26 to 28, wherein the first fluid inlet and the second fluid inlet have a first inlet port and a second inlet port, respectively, wherein the first redirection surface and the second redirection surface are located distally relative to the first inlet port and the second inlet port, respectively, and wherein the third redirection surface is located proximally relative to the outlet port, the first redirection surface, and the second redirection surface.

[0052] Clause 30. A fluid delivery tubing kit according to any one of clauses 26 to 29, wherein the mixing chamber further comprises a first inlet, wherein the first inlet of the mixing chamber is distal to the third redirection surface, and wherein the first redirection surface is located distal to the first fluid inlet and at least partially faces the first inlet of the mixing chamber.

[0053] Clause 31. A fluid delivery tubing kit according to any one of clauses 26 to 30, wherein the mixing chamber further comprises a second inlet, wherein the second inlet of the mixing chamber is distal to the third redirection surface, and wherein the second redirection surface is located distal to the second fluid inlet and at least partially faces the second inlet of the mixing chamber.

[0054] Clause 32. The fluid delivery tubing set of any of Clauses 26 to 31, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature greater than or equal to 90°.

[0055] Clause 33. The fluid delivery tubing set of any of Clauses 26 to 32, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature greater than or equal to 150°.

[0056] Clause 34. The fluid delivery tubing set of any one of Clauses 26 to 33, wherein the third redirecting surface has a substantially concave surface facing the outlet port.

[0057] Clause 35. The fluid delivery tubing kit of Clause 34, wherein the radius of curvature of the concave surface is greater than or equal to 90°.

[0058] Clause 36. The fluid delivery tubing kit of Clause 34, wherein the radius of curvature of the concave surface is greater than or equal to 150°.

[0059] Clause 37. A fluid delivery tubing kit according to any one of clauses 26-36, wherein the first check valve has a first end engaged with a first inlet port on a first fluid inlet and a second end engaged with a first stop element proximal to a first redirection surface, wherein the second check valve has a first end engaged with a second inlet port on a second fluid inlet and a second end engaged with a second stop element proximal to a second redirection surface, and wherein the first check valve and the second check valve are reversibly compressed between the first end and the second end in response to a first fluid pressure of a first injection fluid flowing through the first inlet port and a second fluid pressure of a second injection fluid flowing through the second fluid port, respectively.

[0060] Clause 38. The fluid delivery tubing set of Clause 37, wherein the first stop element and the second stop element have sharpened proximal ends.

[0061] Clause 39. The fluid delivery tubing set of any one of Clauses 26 to 38, wherein the first inlet port and the second inlet port have tapered end surfaces.

[0062] Clause 40. The fluid delivery tubing set of any one of Clauses 26 to 39, wherein an axis of the outlet port is parallel to an axis of the first fluid inlet and an axis of the second fluid inlet.

[0063] Clause 41. The fluid delivery tubing kit of Clause 40, wherein an axis of the outlet port extends between an axis of the first fluid inlet and an axis of the second fluid inlet.

[0064] Clause 42. The fluid delivery tubing kit of any of clauses 26 to 39, wherein the axis of the first fluid inlet is parallel to and offset from the axis of the second fluid inlet, and wherein the axis of the outlet port is substantially perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet.

[0065] Clause 43. A fluid delivery tubing kit according to any of clauses 26 to 39, wherein the axis of the first fluid inlet is substantially perpendicular to the axis of the second fluid inlet, and wherein the outlet port has an axis that is substantially parallel to and coincident with one of the axis of the first fluid inlet and the axis of the second fluid inlet.

[0066] Clause 44. A fluid delivery tubing kit according to any one of clauses 22 to 39, wherein the axis of the first fluid inlet is at an angle between 130° and 165° relative to the axis of the second fluid inlet, and wherein the outlet port has an axis that is at an angle of less than 70° relative to the axis of the first fluid inlet and one of the axes of the second fluid inlet.

[0067] Clause 45. A fluid delivery tubing kit according to any one of clauses 26 to 44, wherein each of the first redirection surface and the second redirection surface is concave and faces the direction of fluid flow of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

[0068] Item 46. A fluid delivery tubing kit according to any one of items 26 to 45, wherein at least one of the first fluid inlet, the second fluid inlet, and the outlet port has at least partially spiral rifling on at least a portion of the inner surface of at least one of the first fluid inlet, the second fluid inlet, and the outlet port, for generating corresponding fluid vortices for at least one of the first injection fluid, the second injection fluid, and a mixture of the first injection fluid and the second injection fluid.

[0069] Clause 47. The fluid delivery tubing set of any of Clauses 26 to 46, wherein the outlet port has at least one baffle member or mixing member disposed in an interior surface thereof.

[0070] Clause 48. The fluid delivery tubing set of any one of Clauses 26 to 47, wherein the outlet port further comprises a pressure isolation valve integrated therewith.

[0071] Item 49. A fluid delivery circuit kit according to Item 48, wherein the pressure isolation valve includes a first lumen connected to the outlet port fluid, a second lumen configured for connection to a pressure transducer, and a valve member located between the first lumen and the second lumen, wherein the valve member is configured to isolate the second lumen from the outlet port during a fluid injection process.

[0072] Clause 50. The fluid delivery tubing set of any of Clauses 26 to 49, further comprising a connector element located on the exterior or interior of at least one of the first fluid inlet, the second fluid inlet, and the outlet port.

[0073] Item 51. A method for turbulently mixing a first injection fluid and a second injection fluid to form a substantially uniform mixture of the first injection fluid and the second injection fluid, the method comprising: contacting a fluid flow of the first injection fluid with a first concave redirection surface associated with a first fluid inlet; redirecting the fluid flow of the first injection fluid to a first different direction, wherein the first different direction flows at an angle in the range of 90-175° to the fluid flow direction of the first injection fluid and toward a third concave redirection surface in a mixing chamber; contacting a fluid flow of the second injection fluid with a second concave redirection surface associated with a second fluid inlet; redirecting the fluid flow of the second injection fluid to a second different direction, wherein the second different direction flows at an angle in the range of 90-175° to the fluid flow direction of the second injection fluid and toward the third concave redirection surface in the mixing chamber; turbulently mixing the first injection fluid and the second injection fluid in the mixing chamber when the first injection fluid and the second injection fluid contact the third concave redirection surface to form a mixture of the first injection fluid and the second injection fluid; and redirecting the mixture of the first injection fluid and the second injection fluid through an outlet port of the mixing chamber.

[0074] Clause 52. The method of Clause 51, further comprising at least one of a first check valve in the first fluid inlet and a second check valve in the second fluid inlet.

[0075] Clause 53. The method of Clause 52, wherein the first fluid inlet and the second fluid inlet have a non-circular cross-sectional shape, and wherein the first check valve and the second check valve have a circular cross-sectional shape.

[0076] Clause 54. A method according to any one of clauses 51 to 53, wherein the first fluid inlet and the second fluid inlet have a first inlet port and a second inlet port, respectively, wherein the first redirection surface and the second redirection surface are located distally relative to the first inlet port and the second inlet port, respectively, and wherein the third redirection surface is located proximally relative to the outlet port, the first redirection surface, and the second redirection surface.

[0077] Clause 55. A method according to any one of clauses 51 to 54, wherein the mixing chamber further comprises a first inlet, wherein the first inlet of the mixing chamber is distal to the third redirection surface, and wherein the first redirection surface is distal to the first fluid inlet and at least partially faces the first inlet of the mixing chamber.

[0078] Clause 56. A method according to any one of clauses 51 to 55, wherein the mixing chamber further comprises a second inlet, wherein the second inlet of the mixing chamber is distal to the third redirection surface, and wherein the second redirection surface is distal to the second fluid inlet and at least partially faces the second inlet of the mixing chamber.

[0079] Clause 57. The method of any one of Clauses 51 to 56, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature greater than or equal to 90°.

[0080] Clause 58. The method of any of Clauses 51 to 57, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature greater than or equal to 150°.

[0081] Clause 59. The method of any one of clauses 51 to 58, wherein the third redirecting surface has a substantially concave surface facing the outlet port.

[0082] Clause 60. The method of Clause 59, wherein the radius of curvature of the concave surface is greater than or equal to 90°.

[0083] Clause 61. The method of Clause 59, wherein the radius of curvature of the concave surface is greater than or equal to 150°.

[0084] Clause 62. A method according to any one of clauses 51 to 61, wherein the first check valve has a first end engaged with a first inlet port on a first fluid inlet and a second end engaged with a first stop element proximate to a first redirection surface, wherein the second check valve has a first end engaged with a second inlet port on a second fluid inlet and a second end engaged with a second stop element proximate to a second redirection surface, and wherein the first check valve and the second check valve are reversibly compressed between the first end and the second end in response to a first fluid pressure of a first injection fluid flowing through the first inlet port and a second fluid pressure of a second injection fluid flowing through the second fluid port, respectively.

[0085] Clause 63. The method of clause 62, wherein the first stop element and the second stop element have sharp proximal ends.

[0086] Clause 64. The method of any one of Clauses 51 to 63, wherein the first inlet port and the second inlet port have tapered end surfaces.

[0087] Clause 65. The method of any one of Clauses 51 to 64, wherein an axis of the outlet port is parallel to an axis of the first fluid inlet and an axis of the second fluid inlet.

[0088] Clause 66. The method of Clause 65, wherein an axis of the outlet port extends between an axis of the first fluid inlet and an axis of the second fluid inlet.

[0089] Clause 67. The method of any of clauses 51 to 64, wherein the axis of the first fluid inlet is parallel to and offset from the axis of the second fluid inlet, and wherein the axis of the outlet port is substantially perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet.

[0090] Clause 68. The method of any of clauses 51 to 64, wherein the axis of the first fluid inlet is substantially perpendicular to the axis of the second fluid inlet, and wherein the outlet port has an axis substantially parallel to and coincident with one of the axis of the first fluid inlet and the axis of the second fluid inlet.

[0091] Clause 69. A method according to any one of clauses 51 to 64, wherein the axis of the first fluid inlet is at an angle between 130° and 165° relative to the axis of the second fluid inlet, and wherein the outlet port has an axis that is at an angle of less than 70° relative to the axis of the first fluid inlet and one of the axes of the second fluid inlet.

[0092] Clause 70. The method of any one of clauses 51 to 69, wherein each of the first redirection surface and the second redirection surface is concave and faces a direction of fluid flow of a first injection fluid in the first fluid inlet and a second injection fluid in the second fluid inlet, respectively.

[0093] Item 71. A method according to any one of items 51 to 70, wherein at least one of the first fluid inlet, the second fluid inlet, and the outlet port has at least partially spiral rifling on at least a portion of the inner surface of at least one of the first fluid inlet, the second fluid inlet, and the outlet port, for generating corresponding fluid vortices for at least one of the first injection fluid, the second injection fluid, and a mixture of the first injection fluid and the second injection fluid.

[0094] Clause 72. The method of any one of Clauses 51 to 71, wherein the outlet port has at least one baffle member or mixing member disposed in an interior surface thereof.

[0095] Clause 73. The method of any one of clauses 51 to 72, wherein the outlet port further comprises a pressure isolation valve integrated therewith.

[0096] Clause 74. A method according to clause 73, wherein the pressure isolation valve comprises a first lumen connected to the outlet port fluid, a second lumen configured for connecting to a pressure transducer, and a valve member located between the first lumen and the second lumen, wherein the valve member is configured to isolate the second lumen from the outlet port during a fluid injection process.

[0097] Clause 75. The method of any of Clauses 51 to 74, further comprising a connector element located on the exterior or interior of at least one of the first fluid inlet, the second fluid inlet, and the outlet port.

[0098] Further details and advantages of the various examples described in detail herein will become apparent after reading the following detailed description of the various embodiments in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0099] Figure 1 is a perspective view of a fluid injector system according to some embodiments of the present disclosure;

[0100] Figure 2 To be able to Figure 1 a perspective view of a portion of a fluid delivery tubing kit for use with a fluid injector system;

[0101] Figure 3 For use Figure 2 a cross-sectional view of a fluid mixing device of a fluid delivery tubing kit;

[0102] Figure 4 for Figure 3 A plan view of a distal end of a fluid mixing device;

[0103] Figure 5 for Figure 3 A plan view of a proximal end of a fluid mixing device;

[0104] Figure 6 For along Figure 4 The line AA in Figure 3-5 A cross-sectional view of a fluid mixing device;

[0105] Figure 7 is a cross-sectional view of a fluid mixing device according to another embodiment of the present disclosure;

[0106] Figure 8 is a cross-sectional view of a fluid mixing device according to another embodiment of the present disclosure;

[0107] Fig. 9 is a cross-sectional view of a fluid mixing device according to another embodiment of the present disclosure;

[0108] Fig.10 is a top view of a fluid mixing device according to another embodiment;

[0109] Fig.11 for Fig.10 A side view of the fluid mixing device shown;

[0110] Fig.12 For along Fig.11 The BB line in Figure 10-11 A cross-sectional view of a fluid mixing device;

[0111] Fig.13 is a perspective view of a fluid mixing device according to another embodiment;

[0112] Fig.14 for Fig.13 A side view of the fluid mixing device shown;

[0113] Fig.15 For along Fig.14 The line CC in Figure 13-14 A cross-sectional view of a fluid mixing device;

[0114] Fig.16 is a top view of a fluid mixing device according to another embodiment of the present disclosure;

[0115] Fig.17 for Fig.16 A top view of the fluid mixing device shown;

[0116] Fig.18 For along Fig.17The line DD in Figure 16-17 A cross-sectional view of a fluid mixing device;

[0117] Figure 19-21 is a cross-sectional view of a fluid mixing device according to a further embodiment of the present disclosure;

[0118] Fig. 22 is a perspective view of a fluid mixing device according to another embodiment;

[0119] Fig.23 for Fig. 22 An exploded view of the fluid mixing device shown;

[0120] Fig.24A For along Fig. 22 The line EE in Figure 22-23 A cross-sectional view of a fluid mixing device, wherein the check valve is shown in a closed position;

[0121] Fig. 24B For along Fig. 22 The line EE in Figure 22-23 A cross-sectional view of a fluid mixing device, wherein the check valve is shown in an open position;

[0122] Fig.25 For along Fig. 22 The line FF in Figure 22-23 A cross-sectional view of a fluid mixing device;

[0123] Fig.26 For along Fig.25 The line GG in Fig.25 A cross-sectional view of a fluid inlet of a fluid mixing device shown;

[0124] Fig. 27 For along Fig.25 The line HH in Fig.25 A cross-sectional view of a fluid inlet of a fluid mixing device shown;

[0125] Fig.28 is a perspective view of a fluid mixing device coupled to a pressure isolation valve according to another embodiment;

[0126] Fig.29 for Fig.28 An exploded view of the fluid mixing device shown; and

[0127] Fig.30 For along Fig.28 The line II in Figure 28-29 Cross-sectional view of a fluid mixing device. DETAILED DESCRIPTION

[0128] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall be related to the disclosure of the orientation in the accompanying drawings.

[0129] Spatial or directional terms, such as "left", "right", "inner", "outer", "upper", "lower", etc., are not to be considered limiting as the disclosure may assume various alternative orientations.

[0130] In all cases, all numbers used in the specification and claims are to be understood as modified by the term “about.” The terms “approximately,” “about,” and “substantially” refer to a range of plus or minus ten percent of the stated value.

[0131] Unless otherwise specified, all ranges or ratios disclosed herein should be understood to encompass the starting and ending values ​​and any and all subranges or subratios contained therein. For example, a specified range or ratio of "1 to 10" should be considered to include any and all subranges or subratios between (inclusive of) a minimum value of 1 and a maximum value of 10; that is, all subranges or subratios start with a minimum value of 1 or greater and end with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent averages over the specified ranges and / or ratios.

[0132] The terms "first", "second", etc. are not intended to refer to any particular order or sequence, but rather to different conditions, properties or elements.

[0133] All documents mentioned herein are "incorporated by reference" in their entirety.

[0134] The term "at least" is synonymous with "greater than or equal to."

[0135] 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" refers to 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; or one or more individual B; or one or more individual C; or one or more A and one or more B; or one or more A and one or more C; or one or more B and one or more C; or one or more all of A, B, and C. Similarly, as used herein, the term "at least two" is synonymous with "two or more." For example, the phrase "at least two of D, E, and F" means any combination of any two or more of D, E, and F. For example, "at least two of D, E, and F" includes one or more D and one or more E; or one or more D and one or more F; or one or more E and one or more F; or one or more all of D, E, and F.

[0136] The words "comprising" and "including" etc. do not exclude the presence of elements or steps other than those listed in any claim or the entire specification. In this specification, "comprising" means "including", and "comprising" means "comprising".

[0137] As used herein, the term "parallel" or "substantially parallel" refers to the relative angle between two objects (if extended to a theoretical intersection), such as an elongated object and including a reference line, i.e., from 0° to 5°, or from 0° to 3°, or from 0° to 2°, or from 0° to 1°, or from 0° to 0.5°, or from 0° to 0.25°, or from 0° to 0.1°, including the recited values.

[0138] As used herein, the terms "perpendicular", "transverse", "substantially perpendicular" or "substantially transverse" mean that the relative angle between two objects at their actual or theoretical intersection is 85° to 90°, or 87° to 90°, or 88° to 90°, or 89° to 90°, or 89.5° to 90°, or 89.75° to 90°, or 89.9° to 90°, including the recited values.

[0139] 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 the present disclosure. Therefore, specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered as limiting.

[0140] When used with respect to a component of a fluid injector system, such as a fluid reservoir, syringe, or fluid line, the term "distal" refers to the portion of the component that is closest to the patient. When used with respect to a component of a fluid injector system, such as a fluid reservoir, syringe, or fluid line, the term "proximal" refers to the portion of the component that is closest to the injector of the fluid injector system (i.e., the portion of the component that is farthest from the patient). When used with respect to a component of a fluid injector system, such as a fluid reservoir, syringe, or fluid line, the term "upstream" refers to a direction away from the patient and toward the injector of the fluid 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 along the fluid path than the second component. When used with respect to a component of a fluid injector system, such as a fluid reservoir, syringe, or fluid line, the term "downstream" refers to a direction toward the patient and away from the injector of the fluid injector 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 along the fluid path than the second component.

[0141] Although this disclosure primarily refers to MEDRAD ®The present disclosure is described with reference to the Stellant CT injection system, but it will be apparent to one of ordinary skill in the art that the present disclosure may be applied to a variety of injection systems, including their associated disposables (e.g., syringes, tubing, etc.), such as disposables designed for CT, CV, MR, PET, ultrasound, and other medical injectors configured to inject two or more medical fluids. In certain embodiments, the fluid mixing device may be adapted for use with tubing associated with angiographic injectors. Examples of such injection systems include the MEDRAD provided by Bayer HealthCare LLC, Indianola, PA ® Salient CT injection system, MEDRAD ® Stellant FLEX CT injection system, MEDRAD ® Centargo CT injection system, MEDRAD ® MRXperion MR injection system, MEDRAD ® Avanta Infusion System and MEDRAD ® Mark 7 Arterion Infusion System.

[0142] Reference Figure 1 A non-limiting example of a fluid injector system 100 according to the present disclosure includes at least one fluid reservoir, such as at least one syringe 12 having a reciprocating plunger 14, at least one piston connectable to the plunger 14, and a fluid control module (not shown). The fluid injector system 100 can be configured as a computed tomography (CT) contrast injector system, a magnetic resonance imaging (MRI) contrast injector system, or a vascular angiography (CV) contrast injector system. The at least one syringe 12 is generally adapted to interface with at least one component of the system (e.g., a syringe port 13). The fluid injector system 100 is generally configured to deliver at least one fluid F to a patient from at least one syringe 12 during an injection process. The fluid injector system 100 is configured to releasably receive at least one syringe 12, and at least one syringe 12 is to be filled with at least one fluid F (such as a contrast medium, a saline solution, Ringer's lactate, or any desired medical fluid). The system can be a multi-syringe injector, in which several syringes can be oriented side by side or in another spatial relationship and are separately actuated by corresponding pistons associated with the injector. The at least one syringe 12 may be oriented in any manner, such as upright, inverted, or positioned at any angle.

[0143] Continue to refer Figure 1, the injector system 100 can be a dual syringe fluid injector system used during a medical procedure to inject at least two injection fluids F1 and F2 into the patient's vascular system by driving the plungers 14 of the corresponding syringes 12 with a drive member such as a piston (not shown). Alternatively, one or both syringes of the dual-head fluid injector system can be replaced with a pump, such as a peristaltic pump, without departing from the scope of the present disclosure. The first injection fluid F1 and the second injection fluid F2 can be a suitable contrast imaging agent and a flushing fluid, respectively. The piston can be configured to engage the plunger 14. When engaged, such as during a fluid delivery operation, the at least one piston can move the plunger 14 toward the distal end 19 of the at least one syringe 12, and retract the plunger 14 toward the proximal end 11 of the at least one syringe 12, such as during a filling operation of filling the syringe 12.

[0144] According to various embodiments, the tubing set 17 (e.g., first and second fluid conduits 17a, 17b, configured to be connected to the corresponding first and second syringes 12 and the common administration line 20) can be in fluid communication with the outlet port of each syringe 12 to allow each syringe to be in fluid communication with a catheter or other fluid delivery device to deliver the fluid F from each syringe 12 to a vascular access location. The first and second fluid conduits 17a, 17b can be connected to the common administration line 20 via a fluid mixing device 40 according to various embodiments of the present disclosure. Figure 1 The fluid injector system 100 shown in FIG. 1 is an open system in that there are no valves configured to isolate the syringes 12 from each other and from at least a portion of the tubing set 17. However, it should be understood that a valve may be added distal to the syringe 12 to isolate the syringe 12 from at least a portion of the tubing set 17. Figure 1 The fluid injector system 100 is converted into a closed system.

[0145] In order to accurately and effectively administer a certain volume of contrast agent during the imaging process, many injection schemes require dual-flow administration, that is, a mixture of contrast agent and saline is administered to the patient at the same time. However, because contrast agent and flushing fluid (saline) generally have different physical properties, such as specific gravity, viscosity and / or surface tension properties, the two solutions may not be completely mixed before entering the patient's vascular system, resulting in reduced image quality. For example, in some cases where inefficient mixing has occurred, a laminar flow of a less viscous but faster-flowing fluid may pass through a more viscous but slower-flowing fluid. Although Y-connectors and T-connectors for connecting two fluid conduits to a common administration line are known, conventional Y-connectors and T-connectors may not provide adequate mixing of the two fluids. Turbulent mixing can improve the mixing efficiency between viscous contrast agents and less viscous saline. An example of a connector with a turbulent mixing chamber is described in U.S. Patent No. 9,555,379, the disclosure of which is incorporated herein by reference. The present disclosure describes novel fluid mixing devices that provide improved mixing of viscous and less viscous fluids for contrast enhanced imaging procedures.

[0146] Figure 2 According to some non-limiting embodiments of the present disclosure, a dual-head injector (e.g. Figure 1 1 is a perspective view of a portion of a fluid delivery circuit kit 202 for use with the fluid injector system 100 in place of the circuit kit 17. As shown, the fluid delivery circuit kit 202 includes a first inlet line 217a, a second inlet line 217b, an outlet line 220, and a fluid mixing device 240. The first inlet line 217a and the second inlet line 217b are configured to deliver a first injection fluid and a second injection fluid to the fluid mixing device 240, respectively. In an example embodiment, the first injection fluid and the second injection fluid are a contrast medium solution and a physiological saline solution, respectively. In addition, the outlet line 220 is configured to deliver a mixture of the first injection fluid and the second injection fluid from the fluid mixing device 240 to a patient or other downstream fluid path components (e.g., an infusion circuit).

[0147] As will be understood herein, the fluid mixing device 240 is configured to mix the first injection fluid and the second injection fluid. Figure 3 , 4 , 5 and 6 respectively show a top view, a left side view, a right side view and a cross-sectional view of the fluid mixing device 240. Figure 6As shown, the fluid mixing device 240 has a body defining a first fluid inlet 242 and a second fluid inlet 244, each of which is configured to direct a corresponding one of a first injection fluid and a second injection fluid in a corresponding first direction 248 and a second direction 250. As shown, the second direction 250 is along an axis 276 that is different from the first direction 248. In some embodiments, the axis of the first direction 248 and the axis of the second direction 250 can be substantially parallel. In other embodiments, the axis of the first direction 248 can be at an acute angle or an obtuse angle relative to the second direction 250.

[0148] Continue to refer Figure 6 , the first fluid inlet 242 and the second fluid inlet 244 have corresponding first redirection surfaces 252 and second redirection surfaces 254. In some embodiments, one or both of the first redirection surface 252 and the second redirection surface 254 are concave facing the first fluid inlet 242 and the second fluid inlet 244, respectively, to redirect the flow of the fluid. In addition, the fluid mixing device 240 also has a mixing chamber 256 that is fluidly connected to the first fluid inlet 242 and the second fluid inlet 244 through a first mixing chamber inlet 270 and a second mixing chamber inlet 272, and an outlet port 246 that is fluidly connected to the mixing chamber 256. The mixing chamber 256 is configured to turbulently mix the redirected first injection fluid and the second injection fluid together, for example, by turbulent mixing when impacting the third redirection surface 262 in the mixing chamber 256.

[0149] More specifically, the first redirecting surface 252 and the second redirecting surface 254 are configured to redirect the first fluid and the second fluid entering the first fluid inlet 242 and the second fluid inlet 244, respectively, to enter the mixing chamber 256 through the first mixing chamber inlet 270 and the second mixing chamber inlet 272, and the first injection fluid and the second injection fluid can then be turbulently mixed in the mixing chamber 256. Before entering the mixing chamber 256, the first injection fluid and the second injection fluid flow through the first fluid inlet 242 and the second fluid inlet 244, respectively, independently. When the first fluid and the second fluid flow through the first fluid inlet 242 and the second fluid inlet 244, respectively, the first fluid and the second fluid contact the corresponding first redirecting surface 252 and the second redirecting surface 254 at the distal ends of the first fluid inlet 242 and the second fluid inlet 244, respectively. The first redirecting surface 252 and the second redirecting surface 254 are configured to redirect the first injection fluid and the second injection fluid in corresponding first different directions 258 and second different directions 260 that are different from the corresponding first directions 248 and the second directions 250. Due to this deflection, the first injection fluid and the second injection fluid enter the mixing chamber 256 through the first mixing chamber inlet 270 and the second mixing chamber inlet 272 along the corresponding first different direction 258 and the second different direction 260, in which the two fluids turbulently contact each other. The first different direction 258 and the second different direction 260 are selected so that the first injection fluid and the second injection fluid contact the third redirection surface 262 at the proximal end of the mixing chamber 256 to turbulently mix the first injection fluid and the second injection fluid together in the mixing chamber 256. In some embodiments, the third redirection surface 262 can have a concave end facing the outlet port 246.

[0150] After mixing, the mixture of the first injection fluid and the second injection fluid exits the fluid mixing device 240 in a direction along the third axis 278 through the outlet port 246 at the distal end of the fluid mixing device 240. In some embodiments, the third axis 278 can be parallel to one or both of the first axis 274 and the second axis 276. In other embodiments, the third axis 278 can be arranged at an acute angle or an obtuse angle relative to both the first axis 274 and the second axis 276.

[0151] Continue to refer Figure 6 The first fluid inlet 242 and the second fluid inlet 244 each have a corresponding first inlet port 264 and a second inlet port 266, configured to be attached to the first fluid pipeline and the second fluid pipeline (such as Figure 2). In some embodiments, the first and second fluid lines can be removably or non-removably connected to the first and second inlet ports 264, 266. In embodiments where the first and second fluid lines are non-removably connected to the first and second inlet ports 264, 266, the first and second fluid lines can be connected to the first and second inlet ports 264, 266 by solvent bonding, laser welding, or other attachment methods.

[0152] like Figure 6 As shown, the first redirection surface 252 and the second redirection surface 254 are located distally relative to the first inlet port 264 and the second inlet port 266, respectively, and the third redirection surface 262 is located proximally relative to the outlet port 246 and the first redirection surface 252 and the second redirection surface 254. In an example embodiment, the first redirection surface 252 and the second redirection surface 254 are located closer to the outlet port 246 than the third redirection surface 262 and the outlet port 246. In addition, the first redirection surface 252 and the second redirection surface 254 may be formed at the distal ends of the corresponding first fluid inlet 242 and the second fluid inlet 244, and each of the first redirection surface 252 and the second redirection surface 254 at least partially faces the corresponding first mixing chamber inlet 270 and the second mixing chamber inlet 272 of the mixing chamber 256, respectively.

[0153] Continue to refer Figure 6, at least one of the first redirection surface 252 and the second redirection surface 254 may have a concave surface. The concave configuration may improve the redirection characteristics of the surface having turbulence while eliminating corners where bubbles may gather or temporarily suspend during the perfusion operation process. In some embodiments, each of the first redirection surface 252 and the second redirection surface 254 may have a radius of curvature greater than or equal to 90°, and greater than or equal to 150° in other embodiments. For example, in a particular embodiment, each of the first redirection surface 252 and the second redirection surface 254 may have a radius of curvature from 80° to 160°. In some embodiments, each of the first redirection surface 252 and the second redirection surface 254 may have a radius of curvature between 90° and 180°. Therefore, the injection fluid from each of the inlet lines 217a and 217b contacts the rounded redirection surfaces 252 and 254, which causes the first injection fluid and the second injection fluid to change flow direction. In some embodiments, the rounded redirection surfaces 252 and 254 can change the flow direction of the first injection fluid and the second injection fluid by an angle of 90° to 150°, respectively, toward different directions 258 and 260 and into the mixing chamber 256. As a result, the fluids double back in the mixing chamber 256 and interact, for example, turbulent mixing, combined with further redirection by the third redirection surface 262. After the fluids are mixed into a uniform solution, the flow direction of the fluid mixture along the third axis 278 is redirected again by the radius of the third redirection surface 262, resulting in the mixture of the first injection fluid and the second injection fluid flowing down along a single outlet line 220. In some embodiments, the third redirection surface 262 can have a radius of curvature greater than or equal to 90°, more preferably greater than or equal to 150°. In some embodiments, the third redirection surface 262 can have a radius of curvature between 90° and 180°. Although known mixing devices (not shown) include some vortexes of the injection fluids, various conventional mixing devices may still suffer from density separation, for example, a higher density fluid swirls outside of a lower density fluid, which prevents adequate mixing of the first fluid and the second fluid. In contrast, the fluid mixing device 240 produces a substantially homogeneous mixture of the first injection fluid and the second injection fluid during the turbulent mixing process.

[0154] According to various embodiments, the first redirection surface 252 and the second redirection surface 254 may include concave redirection surfaces that face the direction of flow in the first fluid inlet 242 and the second fluid inlet 244, respectively. Figure 6As shown, the first fluid inlet 242, the second fluid inlet 244, and the outlet port 246 all have corresponding axes 274, 276, and 278. In some embodiments, the third axis 278 of the outlet port 246 can be located between the first axis 274 and the second axis 276 of the first fluid inlet 242 and the second fluid inlet 244, respectively. In other embodiments, the third axis 278 of the outlet port 246 can be located above or below the first axis 274 and the second axis 276 of the first fluid inlet 242 and the second fluid inlet 244, respectively. In other embodiments, the third axis 278 of the outlet port 246 can be coaxial with one of the first axis 274 and the second axis 276 of the first fluid inlet 242 and the second fluid inlet 244. In other embodiments, the first different direction 258 and the second different direction 260 of the fluid entering the mixing chamber 256 can be angled toward each other at an angle of 0 to 90 degrees, so that the first fluid and the second fluid directly impact each other and turbulently mix.

[0155] In operation, a first injection fluid enters the first fluid inlet 242, and a second injection fluid enters the second fluid inlet 244, each from a corresponding one of the first inlet line 217a and the second inlet line 217b (eg, Figure 2254). The first injection fluid and the second injection fluid then pass through the respective first fluid inlet 242 and the second fluid inlet 244 until they reach the first redirection surface 252 and the second redirection surface 254. When the first injection fluid engages the first redirection surface 252, the first fluid is redirected into the mixing chamber 256 in a direction 258. Similarly, when the second injection fluid engages the second redirection surface 254 through the first mixing chamber inlet 270, the second fluid is redirected into the mixing chamber 256 in a direction 260. At this point, the first injection fluid and the second injection fluid, which have been redirected into the mixing chamber 256 through the second mixing chamber inlet 272, are turbulently mixed together by the flow of the first and second fluids impacting each other and the third redirection surface 262 in the mixing chamber 256. The mixture of the first injection fluid and the second injection fluid simultaneously engages the third redirection surface 262, at which point it is redirected through the outlet port 246 and into the outlet line 220 to be delivered to a patient or other downstream fluid path component. According to various embodiments, the first fluid and the second fluid can be at least partially redirected to flow in opposite directions, such as one flowing in a clockwise direction and the other flowing in a counterclockwise direction in the mixing chamber 256, so that the flows of the first fluid and the second fluid join and impact each other to produce turbulent mixing. For example, when the two fluids interact within the mixing chamber 256, the inertial changes associated with the impact of one fluid flowing in a clockwise flow direction and the other fluid flowing in a counterclockwise flow direction result in a turbulent mixed solution of the first fluid and the second fluid. Depending on the mixing ratio and flow rate of the first injection fluid and the second injection fluid, the first injection fluid and the second injection fluid can be mixed only in the mixing chamber 256, or mixed in the mixing chamber 256 and in the region of at least one of the first redirection surface 252 and the second redirection surface 254.

[0156] Figure 7 2 is a cross-sectional view of another embodiment of a fluid mixing device 340 according to another example of the present disclosure, wherein at least one of the first fluid inlet 342, the second fluid inlet 344, and the outlet port 346 includes a spiral "rifling" pattern on an inner surface to further direct and rotate the corresponding fluid flow in the inlet and / or outlet and increase turbulent mixing of the first fluid and the second fluid. The pattern may include one or more at least partially spiral protrusions or depressions that are recessed into or protrude from the inner surface of at least one of the first fluid inlet 342, the second fluid inlet 344, and the outlet port 346. The pattern imparts rotation to the fluid flow within the corresponding fluid path. Figure 7In the example of the embodiment of the present invention, the first fluid inlet 342, the second fluid inlet 344 and the outlet port 346 each have at least partially spiral portions 343, 345 and 347, which are used to generate corresponding fluid vortices for at least one of the first injection fluid, the second injection fluid and the mixture of the first injection fluid and the second injection fluid when the corresponding fluid flows through the channel. The spiral portion in one of the inlet or outlet can have the same or different direction of directionality (clockwise or counterclockwise), and can have a different size or pitch than the spiral portion in other parts of the mixing device 340. Although the first fluid inlet 342, the second fluid inlet 344 and the outlet port 346 each have spiral portions 343, 345 and 347, it should be understood that any number of the aforementioned areas can be provided with spiral portions without departing from the scope of the disclosed concept. By having spiral portions 343, 345 and 347, mixing can be further improved. It should be understood that the function of the fluid mixing device 340 in other aspects is the same as the above-mentioned fluid mixing device 240.

[0157] In another embodiment of the fluid mixing device 440 of the present disclosure, Figure 8 As shown, the outlet port 446 of the fluid mixing device 440 can have one or more baffle members or mixing members 447 located therein. The baffle members 447 can advantageously further improve the mixing of the first injection fluid and the second injection fluid. It should be understood that the function of the fluid mixing device 440 is otherwise the same as the fluid mixing device 240 described above. In other embodiments, the fluid mixing device can include one or more baffle members or mixing members in one or both of the first fluid inlet and the second fluid inlet.

[0158] Fig. 9Another example of a fluid mixing device 540 according to another embodiment of the present disclosure is shown. As shown, the fluid mixing device 540 may include a first valve 543 in a first fluid inlet 542, and the first valve 543 is configured to prevent the second injection fluid from flowing back into the first fluid inlet 542 and the fluid line 217a. In addition, the fluid mixing device 540 may include a second valve 545 in a second fluid inlet 544, and the second valve 545 is configured to prevent the first injection fluid from flowing back into the second fluid inlet 544 and the fluid line 217b. Under the typical injection pressure of the fluid injection process, when the pressure of one fluid in the upstream fluid path and the fluid inlet is greater than the pressure of another fluid in the upstream other fluid path and the other fluid inlet, the fluid under greater pressure flows back into the fluid path of lower pressure, which may cause the undesirable mixing of the fluid in the upstream fluid path or other upstream components of the fluid injection system. Due to the undesirable mixing of the two fluids before the controlled mixing in the fluid mixing device, this may result in an inaccurate dose of the contrast agent, and may result in reduced image quality and exposure of the patient to unnecessary excess contrast agent. Otherwise, the function of the fluid mixing device 540 is the same as the fluid mixing device 240 .

[0159] In another embodiment of the fluid mixing device 640 of the present disclosure, as Figure 10-12 As shown, the first direction 648 ( Fig.12 ) is parallel to the second direction 650 ( Fig.12 ), which is opposite to the second direction 650 and deviates from the second direction 650. In addition, as shown in the figure, the outlet port 646 of the fluid mixing device 640 has an axis 678 that is substantially perpendicular to the first direction 648 and the second direction 650. Therefore, the fluid mixing device 640 provides indirect mixing of the two fluids, rather than frontal mixing. For example, the first direction 648 and the second direction 646 promote the direct collision of the streamlines of half of the pipe cross-sectional diameter and the indirect mixing of the streamlines of the other half. That is, due to the deviation of the two opposite fluid directions 648 and 650, half direct mixing and half indirect mixing occur in the fluid mixing area.

[0160] In another embodiment of the fluid mixing device 740 of the present disclosure, Figure 13-15As shown, the first direction 748 is substantially perpendicular to the second direction 750. In addition, the outlet port 746 of the fluid mixing device 740 can have an axis 778 that is substantially parallel to and coincident with the axis 774 of the first fluid inlet 742. In an alternative embodiment, the fluid mixing device 740 (not shown) can have an axis 778 of the outlet port 746 that is substantially parallel to and coincident with the axis of the second fluid inlet 744. At least one notch 745 can be provided between two of the first fluid inlet 742, the second fluid inlet 744, and the outlet port 746. The notch 745 can be provided to save material in the transition region between two of the first fluid inlet 742, the second fluid inlet 744, and the outlet port 746 to facilitate molding of the fluid mixing device 740. According to these embodiments, the perpendicular collision of the flow paths of the first fluid and the second fluid in the fluid mixing device 740 can produce turbulent mixing of the two fluids and limit and / or disrupt any laminar flow of one fluid relative to the other fluid.

[0161] In another embodiment of the fluid mixing device 840 of the present disclosure, Figure 16-18 As shown, the first direction 848 can be at an angle between 130° and 165° relative to the second direction 850. In addition, the outlet port 846 of the fluid mixing device 840 can have an axis 878 that is at an angle of less than 70° relative to the first direction 848. In an alternative embodiment of the fluid mixing device 840 (not shown), the outlet port 846 can have an axis 878 that is at an angle of less than 70° relative to the second direction 850. According to these embodiments, the angled but substantially opposite flow of the flow paths of the first fluid and the second fluid in the fluid mixing device 840 can produce turbulent mixing of the two fluids and limit and / or disrupt any laminar flow of one fluid relative to the other fluid.

[0162] Other examples of fluid mixing devices 940A, 940B, and 940C according to various embodiments of the present disclosure are described in Figure 19-21 According to these embodiments, the fluid mixing devices 940A, 940B, and 940C have a T-shaped 90-degree connector design with one or more deviated fluid paths to enhance mixing of the first fluid and the second fluid. Fig.19 The fluid mixing device 940A includes a first fluid inlet 942A and a second fluid inlet 944A for the first fluid and the second fluid, respectively, and a fluid outlet 946A. Fig.19As shown, the first fluid flow axis 948A is offset from both the second fluid flow axis 950A and the fluid outlet flow axis 978A. Fluid mixing occurs at least in the fluid mixing region 980A, where the offset fluid streamlines of the first fluid along the axis 948A interact with the fluid streamlines of the second fluid along the axis 950A to produce turbulent mixing in the fluid mixing region 980A, which can be further enhanced by the offset of the outlet flow axis 978A to the fluid outlet 946A.

[0163] refer to Fig. 20 The fluid mixing device 940B includes a first fluid inlet 942B and a second fluid inlet 944B for the first fluid and the second fluid, respectively, and a fluid outlet 946B. The fluid mixing device 940B also includes a turbulent mixing chamber 956B, in which further turbulent mixing can occur. Fig. 20 As can be seen in the first fluid flow axis 948B, the first fluid flow axis 948B is offset from both the second fluid flow axis 950B and the fluid outlet flow axis 978B. Fluid mixing occurs at least in the fluid mixing region 980B, where the fluid mixing chamber 956B and the offset fluid streamlines of the first fluid along the axis 948B interact with the fluid streamlines of the second fluid line along the axis 950B to produce turbulent mixing in the fluid mixing region 980B, which can be further enhanced by the offset of the outlet flow axis 978B to the fluid outlet 946B.

[0164] refer to Fig.21 The fluid mixing device 940C includes a first fluid inlet 942C and a second fluid inlet 944C for the first fluid and the second fluid, respectively, and a fluid outlet 946C. The fluid mixing device 940C also includes a turbulent mixing chamber 956C in which further turbulent mixing can occur. Fig.21 944C, particularly on the side of the flow path opposite the second fluid inlet 944C. Fluid mixing occurs at least in a fluid mixing region 980C where the fluid mixing chamber 956C and the fluid streamlines of the first fluid along axis 948C interact with the fluid streamlines of the second fluid line along axis 950C to produce turbulent mixing in the fluid mixing region 980C, which can be further enhanced by the deviation of the outlet flow axis 978C from the fluid outlet 946C.

[0165] Fig. 22 FIG. 1 is a perspective view of a fluid mixing device 1040 according to some non-limiting embodiments of the present disclosure. The fluid mixing device 1040 can be used as part of a fluid delivery tubing kit, such as Figure 2, wherein the fluid mixing device 1040 is connected to a pair of fluid inlet and outlet lines. Fig. 22 As shown, the fluid mixing device 1040 has a body defining a first fluid inlet 1042 and a second fluid inlet 1044, each of which is configured to direct a corresponding one of a first injection fluid and a second injection fluid. The fluid mixing device 1040 also has an outlet port 1046, which is configured to deliver a mixture of the first injection fluid and the second injection fluid from the fluid mixing device 1040 to a patient or other downstream fluid path component.

[0166] refer to Fig.23 , Fig.23 yes Fig. 22 1040 is an exploded perspective view of a fluid mixing device 1040, which has a body 1041 with a first portion 1043 and a second portion 1045. In some embodiments, the first portion 1043 and the second portion 1045 can be manufactured separately and connected together to form the body 1041 of the fluid mixing device 1040. Desirably, the first portion 1043 and the second portion 1045 are connected together in a non-removable manner, such as by an adhesive, welding (e.g., laser welding or ultrasonic welding), friction fit, solvent gluing, or other non-removable connection mechanism. In some embodiments, the first portion 1043 and the second portion 1045 can be removably connected together.

[0167] Continue to refer Fig.23 The first portion 1043 defines a portion of the first fluid inlet 1042 and the second fluid inlet 1044, and has a receiving cavity 1047 for receiving a check valve 1049 in each of the first fluid inlet 1042 and the second fluid inlet 1044. The second portion 1045 has a corresponding inner cavity 1051 (such as Fig.24A As shown in FIG. 1 ), the inner cavity 1051 is configured to receive the first portion 1043 including the check valve 1049. The second portion of the first fluid inlet 1042 and the second fluid inlet 1044 is defined by the inner cavity 1051 of the second portion 1045 (as shown in FIG. 1 ). Figures 24A-24B Once the first portion 1043 including the check valve 1049 is inserted into the second portion 1045, the first portion 1043 and the second portion 1045 may be joined together at one or more contact points between the first portion 1043 and the second portion 1045.

[0168] Each check valve 1049 can be configured to prevent backflow of the first injection fluid and the second injection fluid during an injection process in which the fluid pressures in the corresponding first and second conduits that deliver the first and second injection fluids to the fluid mixing device 1040 are not equal. The check valve 1049 can be made of a compressible material, such as an elastic polymer, which can be compressed under the pressurized flow of the fluid from an expanded state to a compressed state. The compressible material can be appropriately selected to provide an appropriate stiffness so that the check valve opens at a selected fluid pressure. The check valve 1049 can also be used to isolate the fluid injector system to avoid suppressing the hemodynamic blood pressure signal, as described herein with reference to Figure 28-30 As discussed. In some embodiments, when the fluid mixing device 1040 is configured for multi-patient use, the check valve 1049 can be used to isolate contamination between patients. In addition, after the injection of the first injection fluid and the second injection fluid is stopped (e.g., due to the release of the accumulated volume or the "expansion" of the fluid injector component under pressure), the check valve 1049 prevents the first injection fluid and the second injection fluid from "dripping" to the outlet.

[0169] refer to Figures 24A-24B , which shows the Fig. 22 In the cross-sectional plan view of the fluid mixing device 1040 taken along line F-F shown in FIG, a check valve 1049 is shown located in a receiving cavity 1047 of each of the first fluid inlet 1042 and the second fluid inlet 1044 of the first portion 1043. The receiving cavity 1047 of each valve 1049 is aligned with the direction of fluid flow through each of the first fluid inlet 1042 and the second fluid inlet 1044. Each check valve 1049 has a proximal end 1053, which is configured to be closed when the check valve 1049 is in a closed position ( Fig.24A ) contacts the corresponding sealing surfaces 1055 on the first fluid inlet 1042 and the second fluid inlet 1044 in the first portion 1043, and is configured to contact the corresponding sealing surfaces 1055 on the first fluid inlet 1042 and the second fluid inlet 1044 in the first portion 1043 when the check valve 1049 is in the open position ( Fig. 24B) is spaced apart from the sealing surface 1055 on the first fluid inlet 1042 and the second fluid inlet 1044 in the first portion 1043. Each check valve 1049 also has a distal end 1057 that engages with a stop element 1059 located within each of the first fluid inlet 1042 and the second fluid inlet 1044. In some embodiments, each stop element 1059 can be a support structure that is connected to the inner side wall of the corresponding first fluid inlet 1042 and the second fluid inlet 1044 downstream of the check valve 1049 and is configured to prevent movement of the distal end 1057 of the check valve 1049, thereby allowing the check valve 1049 to compress when pressure is applied to the proximal end 1053. In some embodiments, each stop element 1059 can have a sharp proximal end 1071 that is configured to reduce the contact area with the check valve 1049, thereby allowing greater compression of the check valve 1049 between its proximal end 1053 and distal end 1057 at lower fluid pressures. For example, under pressure, the distal end 1057 can be compressed and molded around the sharp proximal end 1061 of the stop element 1059, thereby allowing the outer circumference of the proximal end 1053 to be more easily released from the sealing surface 1055. In this way, the sharp stop element 1059 allows for reduced pressure drop by allowing easier opening during injection compared to a stop element with a flat support surface. In some embodiments, the stop element 1059 is made of a silicone material.

[0170] During the injection process, the first injection fluid and the second injection fluid are pushed through the first fluid inlet 1042 and the second fluid inlet 1044 under pressure, causing the first fluid and the second fluid to engage with the respective proximal ends 1053 of the check valve 1049. Initially, the proximal ends 1053 engage the sealing surfaces 1055 ( Fig.24A ), to prevent the first injection fluid and the second injection fluid from passing through the check valve 1049. As the fluid pressure builds up, the force on the proximal end 1053 of the check valve 1049 increases. Due to the compressible nature of each check valve 1049, the proximal end 1053 is pushed in the distal direction, thereby creating a gap between the proximal end 1053 of the check valve 1049 and the sealing surface 1055 on the first portion 1043. Fig. 24BAs shown, such a gap is formed only when sufficient fluid pressure P is applied on the proximal end 1053, such as during a typical injection process. As described herein, the pressurized first injection fluid and the second injection fluid then travel around the corresponding check valve 1049 and through the fluid mixing device 1040. During the injection process, if the pressure of one of the first injection fluid and the second injection fluid is higher than the pressure of the other of the first injection fluid and the second injection fluid, the check valve 1049 in the fluid inlet with the lower pressure can be closed to prevent fluid from flowing back in the upstream direction, such as due to the back pressure of the higher pressure fluid on the distal end 1055 of the lower pressure check valve 1049. After the injection process is completed, the elastic properties of each check valve 1049 cause the check valve 1049 to expand axially so that the proximal end 1053 engages the sealing surface 1055 on the first portion 1043 to prevent additional fluid from flowing through the check valve 1049. In this way, after the injection process is completed, any excess fluid is prevented from flowing through the fluid mixing device 1040. In addition, any backflow of one fluid to the other fluid path is prevented.

[0171] refer to Fig.25 , and continue to refer to Figures 24A-24B Each check valve 1049 is sized such that its outer diameter is slightly smaller than the receiving cavity 1047 (eg, Figures 24A-24B ) and the corresponding inner cavity 1051 of the second portion 1045 of the body 1043 (as shown Fig.26 1049). In this way, the fluid can bypass the body of each check valve 1049 and pass through the channel 1060. In some embodiments, the channel 1060 can have a non-circular cross-section and the check valve 1049 can have a circular cross-section. In this way, when the check valve 1049 is in the open position, the channel 1060 defines a flow path for the first injection fluid and the second injection fluid to flow around the corresponding check valve 1049.

[0172] In some embodiments, Fig.26 As shown, the channel 1060 can have a grooved cross-section with one or more grooves 1061. In embodiments where the channel 1060 has multiple grooves 1061, the grooves 1061 can be spaced apart from each other at equal or unequal intervals around the perimeter of the channel 1060. The number of grooves 1061, the radial depth and / or the circumferential width of the grooves 1061 can be selected based on the desired flow rate of the first fluid and the second fluid through the channel 1061 when the corresponding check valve 1049 is in the open position.

[0173] Each check valve 1049 is desirably an elastic member that is at least partially compressible in the longitudinal direction when subjected to fluid pressure. The check valve 1049 in the first fluid inlet 1042 may be the same or different than the check valve 1049 in the second fluid inlet 1044. In some embodiments, the opening pressure of each check valve 1049 may be selected based on the characteristics of the fluid injector and / or the characteristics of the first injection fluid and the second injection fluid, such as fluid viscosity, and the temperature range, flow rate range, and pressure range into which the first injection fluid and the second injection fluid are to be injected.

[0174] refer to Fig. 27 , around the sealing surface 1055 (such as Fig.24A The shape of the inlet opening 1065 of the embodiment shown in FIG. 1060 may be similar to that of the channel 1060 (as shown in FIG. Fig.25 The inlet opening 1065 may have a taper 1067 that tapers radially inward in a direction from the proximal end toward the distal end of the fluid mixing device 1040. The cross-sectional shape of the inlet opening 1065 is selected to achieve a low pressure drop and a lower opening pressure of the check valve 1049.

[0175] refer to Figures 24A-24B , it will be appreciated that the fluid mixing device 1040 produces a turbulent mixing of the first fluid and the second fluid, similar to the fluid mixing device 240 described herein. Figures 24A-24B As shown, the first fluid inlet 1042 and the second fluid inlet 1044 have corresponding first redirection surfaces 1052 and second redirection surfaces 1054. In addition, the fluid mixing device 1040 also has a mixing chamber 1056 in fluid communication with the first fluid inlet 1042 and the second fluid inlet 1044, and an outlet port 1046 in fluid communication with the mixing chamber 1056. The mixing chamber 1056 is configured to turbulently mix the first injection fluid and the second injection fluid together.

[0176] Continue to refer Figures 24A-24B The first redirecting surface 1052 and the second redirecting surface 1054 are configured to redirect the first fluid and the second fluid entering the first fluid inlet 1042 and the second fluid inlet 1044, respectively, into the mixing chamber 1056, where the first injection fluid and the second injection fluid can then undergo turbulent mixing. Figure 6As discussed, the first redirecting surface 1052 and the second redirecting surface 1054 are configured to redirect the first injection fluid and the second injection fluid in corresponding first different directions and second different directions, which are different from the corresponding first direction and second direction in which the first injection fluid and the second injection fluid flowed before contacting the first redirecting surface 1052 and the second redirecting surface 1054. Due to this deflection, the first injection fluid and the second injection fluid enter the mixing chamber 1056 along the corresponding first different direction and the second different direction, and contact the third redirecting surface 1062 at the proximal end of the mixing chamber 1056 to turbulently mix the first injection fluid and the second injection fluid together in the mixing chamber 1056. After mixing, the mixture of the first injection fluid and the second injection fluid exits the fluid mixing device 1040 via the outlet port 1046 at the distal end of the fluid mixing device 1040.

[0177] refer to Fig.25 The outlet port 1046 may have a connection element 1070 configured to allow the outlet port 1046 to be connected to an outlet line (such as Figure 2 ) is removably connected to the outlet line 220 shown in . The connecting element 1070 can be a male Luer lock that is configured to be removably connected to a corresponding female Luer lock on the proximal end of the outlet line 220. In some embodiments, the connecting element 1070 can be a female Luer lock that is configured to be removably connected to a corresponding male Luer lock on the proximal end of the outlet line 220. In other embodiments, for example, the fluid path connectors described in International PCT Application Nos. PCT / US2021 / 018523 and PCT / US2016 / 063448, the disclosures of which are incorporated by reference. In this way, the fluid mixing device 1040 can be removably connected to the outlet line 220, thereby allowing the fluid mixing device 1040 to be used with multiple patients, for example, if one or more check valves are connected upstream of the connector on the outlet port 1046.

[0178] In another embodiment of the present disclosure, Figure 28-30As shown, the fluid mixing device 1140 has a body 1141 defining a first fluid inlet 1142 and a second fluid inlet 1144, each of which is configured to guide a corresponding one of a first injection fluid and a second injection fluid. The body of the fluid mixing device 1140 also includes an outlet port 1146, which is configured to deliver a mixture of the first injection fluid and the second injection fluid to an outlet pipeline (not shown). The body 1141 has a first portion 1143 and a second portion 1145 that are irremovably or removably connected together. A check valve 1149 is disposed in a passage 1155 of each of the first fluid inlet 1142 and the second fluid inlet 1144 (as shown in FIG. 1 ). Fig.29 ), and is configured to open under pressure to allow the first injection fluid and the second injection fluid to flow to the outlet port 1146. Figure 28-30 The structure and function of the fluid mixing device 1140 shown in FIG. Figure 22-27 The structure and function of the described fluid mixing device 1040 are substantially the same. Therefore, only the relative differences between the two embodiments will now be discussed.

[0179] refer to Figure 28-30 , the outlet port 1146 may have a pressure isolation valve 1150 configured to allow a pressure transducer to be connected to the fluid path so that a hemodynamic blood pressure signal reading can be obtained during fluid delivery. The pressure isolation valve 1150 isolates the high pressure fluid injector system from interfering with the low pressure measurement of the hemodynamic blood pressure signal.

[0180] The pressure isolation valve 1150 includes a housing 1152, which may be a unitary structure or preferably a housing 1152. Fig.29 The housing 1152 is a two-piece housing including a first portion 1152a and a second portion 1152b that are adapted to be connected together to form the housing 1150. The first and second portions 1152a, 1152b are preferably formed to be non-removably engaged with each other. Non-limiting examples of suitable pressure isolation valves are described in U.S. Patent Nos. 6,866,654, 7,611,503, 8,919,384, and 8,992,489, the disclosures of which are incorporated by reference.

[0181] refer to Fig.30, a first portion 1152a of the housing 1152 defines a high pressure lumen 1154, which forms the high pressure side of the pressure isolation valve 1150. The high pressure lumen 1154 is in fluid communication with the outlet port 1146. A second portion 1152b of the housing 1152 defines a low pressure lumen 1156, which generally forms the low pressure side of the pressure isolation valve 1150. The second portion 1152b of the housing 1152 also includes a pressure isolation port 1158 to which a pressure transducer (not shown) can be connected. The structure forming the pressure isolation port 1158 can terminate in a Luer connector or other suitable medical connector for connecting a pressure transducer to the pressure isolation port 1158.

[0182] The first and second portions 1152a, 1152b of the housing 1152 can define an internal chamber 1160 that is generally in fluid communication with the high pressure lumen 1154 and the low pressure lumen 1156. An internal valve member 1162 is located in the internal chamber 1160 and is biased to a normally open position, wherein the high pressure lumen 1154 is in fluid communication with the low pressure lumen 1156. The valve member 1162 is also generally adapted to isolate the low pressure lumen 1156 once the fluid pressure in the high pressure lumen 1154 reaches a preset pressure. The low pressure lumen 1156 also includes a flow activation port 1164 having a flow activation valve 1166, which is generally adapted to activate a small flow around the valve member 1162 so that the valve member 1162 is substantially operated to a closed position upon flow activation.

[0183] Although various embodiments of a fluid mixing device for mixing two injected fluids have been described herein, similar fluid mixing devices having three or even four total fluid inlets, each having a corresponding redirecting surface, wherein the fluid inlets are in fluid communication with a mixing chamber similar to that described herein, fall within the scope of the present disclosure.

[0184] Although various embodiments of a fluid mixing device and a patient fluid delivery circuit kit are provided in the foregoing description, modifications and changes may be made to these examples by those skilled in the art without departing from the scope and spirit of the present disclosure. Therefore, the foregoing description is intended to be illustrative rather than limiting. The above disclosure herein is defined by the appended claims, and all changes to the disclosure that fall within the meaning and equivalent scope of the claims are included within the scope of the claims.

Claims

1. A fluid delivery tubing kit for delivering fluid from a fluid injector to a patient, the fluid delivery tubing kit comprising: a first inlet tube configured to deliver a first injection fluid; a second inlet tube configured to deliver a second injection fluid; an outlet tube configured to deliver a mixture of the first insufflation fluid and the second insufflation fluid to the patient; and Fluid mixing equipment, comprising: a first fluid inlet coupled to the first inlet tube and configured to direct the first injection fluid in a first direction, the first fluid inlet having a first redirecting surface; a second fluid inlet coupled to the second inlet tube and configured to direct the second injection fluid in a second direction, the second fluid inlet having a second redirecting surface; a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and having a third redirection surface, the mixing chamber being configured to mix the first injection fluid and the second injection fluid, wherein the mixing chamber comprises a first inlet distal to the third redirection surface and a second inlet distal to the third redirection surface, wherein the first redirection surface is distal to the first fluid inlet and at least partially faces the first inlet of the mixing chamber, and wherein the second redirection surface is distal to the second fluid inlet and at least partially faces the second inlet of the mixing chamber; and an outlet port coupled to the outlet tube and in fluid communication with the mixing chamber, wherein the first redirecting surface is configured to redirect the first injection fluid in a first different direction different from the first direction to enter the mixing chamber along the first different direction, and wherein the second redirecting surface is configured to redirect the second injection fluid in a second different direction different from the second direction to enter the mixing chamber along the second different direction, wherein the first different direction and the second different direction are selected so that the first injection fluid and the second injection fluid contact a third redirecting surface of the mixing chamber to turbulently mix the first injection fluid and the second injection fluid together in the mixing chamber, and Wherein a mixture of the first injection fluid and the second injection fluid exits the fluid mixing device through the outlet port. 2 . The fluid delivery tubing kit of claim 1 , further comprising at least one of a first check valve in the first fluid inlet and a second check valve in the second fluid inlet.

3. The fluid delivery tubing kit of claim 2, wherein: The first fluid inlet and the second fluid inlet have a non-circular cross-sectional shape, and wherein the first check valve and the second check valve have a circular cross-sectional shape.

4. The fluid delivery tubing kit according to any one of claims 1 to 3, wherein: The first fluid inlet and the second fluid inlet have a first inlet port and a second inlet port, respectively, wherein the first redirection surface and the second redirection surface are located distally relative to the first inlet port and the second inlet port, respectively, and wherein the third redirection surface is located proximally relative to the outlet port, the first redirection surface and the second redirection surface.

5. The fluid delivery tubing kit according to any one of claims 1 to 3, wherein: At least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature greater than or equal to 90°.

6. The fluid delivery tubing kit according to any one of claims 1 to 3, wherein: At least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature greater than or equal to 150°.

7. The fluid delivery tubing kit according to any one of claims 1 to 3, wherein: The third redirecting surface has a substantially concave surface facing the outlet port.

8. The fluid delivery tubing kit of claim 7, wherein: The curvature radius of the concave surface is greater than or equal to 90°.

9. The fluid delivery tubing kit of claim 7, wherein: The curvature radius of the concave surface is greater than or equal to 150°.

10. The fluid delivery tubing kit of claim 2, wherein: The first check valve has a first end engaged with a first inlet port on the first fluid inlet and a second end engaged with a first stop element proximate to the first redirection surface, wherein the second check valve has a first end engaged with a second inlet port on the second fluid inlet and a second end engaged with a second stop element proximate to the second redirection surface, and wherein the first check valve and the second check valve are reversibly compressed between the first end and the second end in response to a first fluid pressure of the first injection fluid flowing through the first inlet port and a second fluid pressure of the second injection fluid flowing through the second fluid port, respectively.

11. The fluid delivery tubing kit of claim 10, wherein: The first stop element and the second stop element have sharp proximal ends.

12. The fluid delivery tubing kit according to claim 10 or 11, wherein: The first inlet port and the second inlet port have tapered end surfaces.

13. The fluid delivery tubing set according to any one of claims 1 to 3, wherein: The axis of the outlet port is parallel to the axis of the first fluid inlet and the axis of the second fluid inlet.

14. The fluid delivery tubing kit of claim 13, wherein: An axis of the outlet port extends between an axis of the first fluid inlet and an axis of the second fluid inlet.

15. The fluid delivery tubing set according to any one of claims 1 to 3, wherein: Each of the first redirecting surface and the second redirecting surface is concave and faces a fluid flow direction of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

16. The fluid delivery tubing set according to any one of claims 1 to 3, wherein: At least one of the first fluid inlet, the second fluid inlet, and the outlet port has at least partially spiral rifling on at least a portion of an inner surface of at least one of the first fluid inlet, the second fluid inlet, and the outlet port, for generating a corresponding fluid vortex for at least one of the first injection fluid, the second injection fluid, and a mixture of the first injection fluid and the second injection fluid.

17. The fluid delivery tubing set according to any one of claims 1 to 3, wherein: The outlet port has at least one baffle member or mixing member disposed in an interior surface thereof.

18. The fluid delivery tubing set according to any one of claims 1 to 3, wherein: The outlet port also includes a pressure isolation valve integrated therewith.

19. The fluid delivery tubing set of any one of claims 1 to 3, further comprising a connector element located on the exterior or interior of at least one of the first fluid inlet, the second fluid inlet, and the outlet port.

20. The fluid delivery tubing kit of claim 18, wherein: The pressure isolation valve includes a housing having a first lumen in fluid communication with the outlet port, a second lumen configured for connection to a pressure transducer, and a valve member located between the first lumen and the second lumen, wherein the valve member is configured to isolate the second lumen from the outlet port during a fluid injection process.

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