RU2830618C1 - Fluid mixing kit - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: fluid mixing device for mixing the first injection fluid and the second injection fluid includes a first fluid inlet, second fluid inlet, mixing chamber in fluid communication with first and second fluid inlets and an outlet branch pipe in hydrodynamic communication with the mixing chamber. First fluid inlet is configured to move the first injection fluid in a first direction and has a first redirecting surface. Second fluid inlet is configured to move the second injection fluid in a second direction oriented along a different axis from the first direction, and has a second redirecting surface. Mixing chamber is configured to mix the first injection fluid and the second injection fluid. Mixture of the first injection fluid and the second injection fluid exits the fluid mixing device through the outlet branch pipe.

EFFECT: disclosed is a fluid mixing kit.

17 cl, 30 dwg

Description

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Application No. 62/982,995, filed February 28, 2020, the contents of which are incorporated herein by reference in their entirety.

PREREQUISITES FOR THE CREATION OF THE INVENTION

Field of invention

[0002] The present invention relates to fluid mixing devices for use with fluid delivery pipe assemblies adapted for use with power-driven fluid injectors. The disclosure of the present invention also relates to fluid delivery pipe assemblies having the above-mentioned fluid mixing devices.

State of the art

[0003] In many diagnostic and therapeutic procedures, a healthcare practitioner, such as a physician or radiologist, injects one or more fluids into a patient using a powered fluid injector system. In recent years, many powered fluid injector systems have been developed for injection of fluids under pressure for use in procedures such as angiography (CT), computed tomography (CT), molecular imaging (e.g., positron emission tomography), and magnetic resonance imaging (MRI). In these imaging procedures, a first injection fluid, such as a contrast medium, is used to highlight certain internal organs, parts of the circulatory system, or parts of the body during imaging. At the same time, a second injection fluid, such as a saline solution or similar flushing agent, is used to ensure a complete bolus injection of the contrast medium and/or to adjust the concentration of the contrast medium. In some procedures, there is a need to deliver a mixture of a first injection fluid and a second injection fluid.

[0004] When delivering a mixture of a first injection fluid and a second injection fluid, it is desirable that the two fluids are well mixed before being injected into a patient. However, since the first and second injection fluids typically have different physical properties, such as specific gravity and/or viscosity, the two fluids are not always thoroughly mixed before entering the patient's vascular system, resulting in poor image quality. Accordingly, there is a need in the art for improved fluid delivery systems that provide mixing of two or more injection fluids before injection into a patient.

BRIEF DESCRIPTION OF THE INVENTION

[0005] These and other needs can be met by the non-limiting embodiments described by the authors, aimed at improving the devices for mixing fluids and the sets of pipes for supplying fluids including them.

[0006] In some non-limiting embodiments of the present invention, a fluid mixing device for mixing a first injection fluid and a second injection fluid is configured to include a first fluid inlet configured to move the first injection fluid in a first direction. The first fluid inlet may have a first redirecting surface. The fluid mixing device is also configured to include a second fluid inlet configured to move the second injection fluid in a second direction. The second fluid inlet may have a second redirecting surface. The fluid mixing device is also configured to include a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and with a third redirecting surface. The mixing chamber is configured to mix the first injection fluid with the second injection fluid. The device for mixing fluids is also designed with the possibility of including an outlet branch pipe in hydrodynamic communication with the mixing chamber and distal to the first fluid inlet and the second fluid inlet. The first redirecting surface is configured to redirect the first injection fluid in the first modified direction, different from the first direction, for entering the mixing chamber in the first modified direction, and the second redirecting surface is configured to redirect the second injection fluid in the second modified direction, different from the second direction, for entering the mixing chamber in the second modified direction. The first modified direction and the second modified direction are selected so that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber for vortex mixing of the first injection fluid and the second injection fluid in the mixing chamber. The possibility of the mixture of the first injection fluid and the second injection fluid exiting the device for mixing fluids through the outlet branch pipe is provided.

[0007] In some non-limiting embodiments of the present invention, the fluid mixing device is also designed to 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 are provided with the possibility of having a non-circular cross-sectional shape, and the first check valve and the second check valve are provided with the possibility of having a circular cross-sectional shape.

[0008] In some non-limiting embodiments of the present invention, the first fluid inlet and the second fluid inlet are configured to have a first inlet nozzle and a second inlet nozzle, respectively. The first redirecting surface and the second redirecting surface are distal to the first inlet nozzle and the second inlet nozzle, respectively. The third redirecting surface is proximal to the outlet nozzle, the first redirecting surface, and the second redirecting surface.

[0009] In some non-limiting embodiments of the present invention, the mixing chamber is also designed to include a first inlet, wherein the first inlet of the mixing chamber is located distal to the third redirecting surface. The first redirecting surface is located distal to the first fluid inlet and at least partially faces the first inlet into the mixing chamber. The mixing chamber is also designed to include a second inlet, wherein the second inlet of the mixing chamber is located distal to the third redirecting surface. The second redirecting surface is located distal to the second fluid inlet and at least partially faces the second inlet into the mixing chamber.

[0010] In some non-limiting embodiments of the present invention, at least one of the first redirecting surface and the second redirecting surface is configured to be substantially concave with a radius of curvature of 90° or more. At least one of the first redirecting surface and the second redirecting surface is configured to be substantially concave with a radius of curvature of 150° or more. The third redirecting surface is configured to be substantially concave and faces the outlet nozzle. A concave surface having a radius of curvature of 90° or more is possible. A concave surface having a radius of curvature of 150° or more is possible.

[0011] In some non-limiting embodiments of the present invention, the first check valve is configured to have a first end in engagement with a first inlet port on the first fluid inlet and a second end in engagement with a first stop element located proximal to the first redirecting surface. The second check valve is configured to have a first end in engagement with a second inlet port on the second fluid inlet and a second end in engagement with a second stop element located proximal to the second redirecting surface. The first check valve and the second check valve are configured to be reversibly compressed between the first end and the second end in response to a first pressure of the first injection fluid flowing through the first inlet port and a second pressure of the second injection fluid flowing through the second fluid port, respectively. The first stop element and the second stop element are configured to have a pointed proximal end. The first inlet pipe and the second inlet pipe are designed with the possibility of having a conical end surface.

[0012] In some non-limiting embodiments of the present invention, the outlet nozzle is configured to have an axis parallel to the axis of the first fluid inlet and the axis of the second fluid inlet. The axis of the outlet nozzle is provided to pass between the axis of the first fluid inlet and the axis of the second fluid inlet. There is a possibility of a parallel orientation of the axis of the first fluid inlet relative to the axis of the second fluid inlet and offset relative to it, and the outlet nozzle is configured to have an axis generally perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet. There is a possibility of a perpendicular orientation of the axis of the first fluid inlet relative to the axis of the second fluid inlet, and the outlet nozzle is configured to have an axis generally parallel and coinciding with one of the axes that include the axis of the first fluid inlet and the axis of the second fluid inlet. It is possible to orient the axis of the first fluid inlet at an angle of 130° to 165° relative to the axis of the second fluid inlet, and the outlet pipe is designed with the possibility of having an axis at an angle of less than 70° relative to one of the axes, which include the axis of the first fluid inlet and the axis of the second fluid inlet.

[0013] In some non-limiting embodiments of the present invention, a configuration is possible in which each of the first redirecting surface and the second redirecting surface has a concave shape and faces in the direction of flow 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 elements, which include the first fluid inlet, the second fluid inlet and the outlet, is configured to have at least a partial helical cut on at least a portion of the inner surface of at least one of the elements, which include the first fluid inlet, the second fluid inlet and the outlet, to create a corresponding vortex in 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.

[0014] In some non-limiting embodiments of the present invention, the outlet pipe is configured to have at least one diverting element or mixing element located on its inner surface.

[0015] In some non-limiting embodiments of the present invention, the outlet port is also designed to include an excess pressure valve associated therewith.

[0016] The excess pressure valve is configured to have a first lumen in fluid communication with the outlet pipe, a second lumen configured to communicate with the pressure transducer, and a valve element between the first lumen and the second lumen, wherein the valve element is configured to isolate the second lumen from the outlet pipe during the fluid injection procedure.

[0017] In some non-limiting embodiments of the present invention, it is possible to provide a connecting element outside or inside at least one of the first fluid inlet, the second fluid inlet, and the outlet.

[0018] In some non-limiting embodiments of the present invention, a fluid delivery tube assembly for delivering a fluid from a fluid injector to a patient is configured to 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 is configured to include a first fluid inlet configured to move the first injection fluid in a first direction. The first fluid inlet is configured to have a first redirecting surface. The fluid mixing device is also configured to include a second fluid inlet configured to move the second injection fluid in the second direction. The second fluid inlet may have a second redirecting surface. The device for mixing fluids is also designed with the possibility of including a mixing chamber in a hydrodynamic communication with the first fluid inlet and the second fluid inlet and with the presence of a third redirecting surface. The mixing chamber is configured to mix the first injection fluid and the second injection fluid. The device for mixing fluids is also designed with the possibility of including an outlet pipe in a hydrodynamic communication with the mixing chamber and distal to the first fluid inlet and the second fluid inlet. The first redirecting surface is configured to redirect the first injection fluid in the first changed direction, different from the first direction, to enter the mixing chamber in the first changed direction, and the second redirecting surface is configured to redirect the second injection fluid in the second changed direction, different from the second direction, to enter the mixing chamber in the second changed direction. The first changed direction and the second changed direction are selected so that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber for vortex mixing of the first injection fluid and the second injection fluid in the mixing chamber. It is possible for the mixture of the first injection fluid and the second injection fluid to exit the device for mixing fluids through the outlet branch pipe.

[0019] In some non-limiting embodiments of the present invention, a method of vortex mixing a first injection fluid and a second injection fluid to form a substantially homogeneous mixture of the first injection fluid and the second injection fluid includes contacting a fluid flow of the first injection fluid with a first concave redirecting surface associated with a first fluid inlet. The method also includes redirecting the fluid flow of the first injection fluid to a first changed direction, wherein the first changed direction is at an angle of 90-175° relative to the direction of the fluid flow of the first injection fluid and in the direction of a third concave redirecting surface in the mixing chamber. The method also includes contacting a fluid flow of the second injection fluid with a second concave redirecting surface associated with the second fluid inlet. The method also includes the possibility of redirecting the fluid flow of the second injection fluid to a second changed direction, wherein the second changed direction is at an angle of 90-175° relative to the direction of the fluid flow of the second injection fluid and in the direction of the third concave redirecting surface in the mixing chamber. The method also includes the possibility of vortex mixing of the first injection fluid and the second injection fluid in the mixing chamber after contact of the first injection fluid and the second injection fluid with the third concave redirecting 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 the outlet branch pipe of the mixing chamber.

[0020] Various other non-limiting embodiments of the present invention are set forth in one or more of the following:

[0021] 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 move the first injection fluid in a first direction, wherein the first fluid inlet has a first redirection surface; a second fluid inlet configured to move the second injection fluid in a second direction, wherein the second fluid inlet has a second redirection surface; a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and having a third redirection surface, wherein the mixing chamber is configured to mix the first injection fluid and the second injection fluid; and an outlet pipe in fluid communication with the mixing chamber and located distally of 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 modified direction different from the first direction to enter the mixing chamber in the first modified direction, and the second redirection surface is configured to redirect the second injection fluid in a second modified direction different from the second direction to enter the mixing chamber in a second modified direction, wherein the first modified direction and the second modified direction are selected so that the first injection fluid and the second injection fluid contact the third redirection surface of the mixing chamber for vortex mixing of the first injection fluid and the second injection fluid in the mixing chamber, and wherein the mixture of the first injection fluid and the second injection fluid exits the fluid mixing device through the outlet pipe.

[0022] Item 2. The device for mixing fluids according to item 1, further comprising at least one of shut-off valves, which include a first shut-off valve in the first fluid inlet and a second shut-off valve in the second fluid inlet.

[0023] Item 3. The fluid mixing device of item 2, wherein the first fluid inlet and the second fluid inlet have a non-circular cross-sectional shape, and the first shut-off valve and the second shut-off valve have a circular cross-sectional shape.

[0024] Item 4. The fluid mixing device according to one of items 1-3, wherein the first fluid inlet and the second fluid inlet have a first inlet nozzle and a second inlet nozzle, respectively, wherein the first redirecting surface and the second redirecting surface are located distal to the first inlet nozzle and the second inlet nozzle, respectively, and the third redirecting surface is located proximal to the outlet nozzle, the first redirecting surface and the second redirecting surface.

[0025] Item 5. A device for mixing fluids according to one of items 1-4, wherein the mixing chamber also includes a first inlet, wherein the first inlet of the mixing chamber is located distal to the third redirecting surface, and the first redirecting surface is located distal to the first inlet for the fluid and at least partially faces the first inlet into the mixing chamber.

[0026] Item 6. A device for mixing fluids according to one of items 1-5, wherein the mixing chamber also includes a second inlet, wherein the second inlet of the mixing chamber is located distal to the third redirecting surface, and the second redirecting surface is located distal to the second inlet for the fluid and at least partially faces the second inlet into the mixing chamber.

[0027] Item 7. A device for mixing fluids according to one of items 1-6, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature of 90° or more.

[0028] Item 8. A device for mixing fluids according to one of items 1-6, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature of 150° or more.

[0029] Item 9. A device for mixing fluid media according to one of items 1-8, wherein the third redirecting surface has a surface of a substantially concave shape and faces the outlet pipe.

[0030] Item 10. The device for mixing fluid media according to item 9, wherein the concave surface has a radius of curvature of 90° or more.

[0031] Item 11. The device for mixing fluid media according to item 9, wherein the concave surface has a radius of curvature of 150° or more.

[0032] Item 12. The fluid mixing device of any one of items 2-11, wherein the first check valve has a first end in engagement with a first inlet port on the first fluid inlet and a second end in engagement with a first stop element located proximal to the first redirecting surface, wherein the second check valve has a first end in engagement with a second inlet port on the second fluid inlet and a second end in engagement with a second stop element located proximal to the second redirecting surface, and the first check valve and the second check valve are configured to reversibly compress between the first end and the second end in response to a first pressure of the first injection fluid flowing through the first inlet port and a second pressure of the second injection fluid flowing through the second fluid port, respectively.

[0033] Item 13. The fluid mixing device of item 12, wherein the first stop member and the second stop member have a pointed proximal end.

[0034] Item 14. A device for mixing fluid media according to one of items 1-13, wherein the first inlet pipe and the second inlet pipe have a conical end surface.

[0035] Item 15. A device for mixing fluids according to one of items 1-14, wherein the outlet pipe has an axis parallel to the axis of the first fluid inlet and the axis of the second fluid inlet.

[0036] Item 16. The fluid mixing device of item 15, wherein the axis of the outlet pipe extends between the axis of the first fluid inlet and the axis of the second fluid inlet.

[0037] Item 17. A fluid mixing device according to one of items 1-14, wherein the axis of the first fluid inlet is parallel and offset with respect to the axis of the second fluid inlet, and the outlet pipe has an axis generally perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet.

[0038] Item 18. A device for mixing fluids according to one of items 1-14, wherein the axis of the first fluid inlet is generally perpendicular to the axis of the second fluid inlet, and the outlet pipe has an axis that is generally parallel to and coincides with one of the axes that include the axis of the first fluid inlet and the axis of the second fluid inlet.

[0039] Item 19. A device for mixing fluids according to one of items 1-14, wherein the axis of the first fluid inlet is oriented at an angle of from 130° to 165° relative to the axis of the second fluid inlet, and the outlet pipe has an axis at an angle of less than 70° relative to one of the axes that include the axis of the first fluid inlet and the axis of the second fluid inlet.

[0040] Item 20. The fluid mixing device according to one of items 1-19, wherein each of the first redirecting surface and the second redirecting surface has a concave shape and faces in the direction of flow of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

[0041] Item 21. The fluid mixing device according to one of items 1-20, wherein at least one of the first fluid inlet, the second fluid inlet and the outlet has at least a partial helical groove 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, to create a corresponding vortex in 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.

[0042] Item 22. A device for mixing fluid media according to one of items 1-21, wherein the outlet pipe has at least one deflecting element or mixing element located on its inner surface.

[0043] Item 23. A device for mixing fluid media according to one of items 1-22, wherein the outlet pipe also includes an excess pressure valve combined therewith.

[0044] Item 24. The fluid mixing device of item 23, wherein the excess pressure valve includes a housing having a first lumen in fluid communication with the outlet pipe and a second lumen configured to communicate with a pressure transducer, and a valve element between the first lumen and the second lumen, wherein the valve element is configured to isolate the second lumen from the outlet pipe during the fluid pumping procedure.

[0045] Item 25. A device for mixing fluids according to one of items 1-24, further comprising a connecting element outside or inside at least one of the elements, which include the first fluid inlet, the second fluid inlet and the outlet.

[0046] Item 26. A fluid delivery tube assembly for delivering a fluid from a fluid injector to a patient, wherein the fluid delivery tube assembly includes: 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 connected to the first inlet tube and configured to move the first injection fluid in a first direction, wherein the first fluid inlet has a first redirection surface; a second fluid inlet connected to the second inlet tube and configured to move the second injection fluid in a second direction, wherein the second fluid inlet has a second redirection surface; a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and having a third redirecting surface, wherein the mixing chamber is configured to mix the first injection fluid and the second fluid; and an outlet pipe connected to the outlet pipe and in fluid communication with the mixing chamber, wherein the first redirection surface is configured to redirect the first injection fluid in a first modified direction different from the first direction, to enter the mixing chamber in the first modified direction, and the second redirection surface is configured to redirect the second injection fluid in a second modified direction different from the second direction, to enter the mixing chamber in a second modified direction, wherein the first modified direction and the second modified direction are selected so that the first injection fluid and the second injection fluid contact the third redirection surface of the mixing chamber for vortex mixing of the first injection fluid and the second injection fluid in the mixing chamber, and wherein the mixture of the first injection fluid and the second injection fluid exits the device for mixing fluids through the outlet pipe.

[0047] Item 27. The fluid supply pipe assembly of item 26, further comprising at least one of shut-off valves, which include a first shut-off valve in a first fluid inlet and a second shut-off valve in a second fluid inlet.

[0048] Item 28. The fluid supply pipe assembly of item 26 or 27, wherein the first fluid inlet and the second fluid inlet have a non-circular cross-sectional shape, and the first shut-off valve and the second shut-off valve have a circular cross-sectional shape.

[0049] Item 29. A fluid supply pipe assembly according to one of items 26-28, wherein the first fluid inlet and the second fluid inlet have a first inlet nozzle and a second inlet nozzle, respectively, wherein the first redirecting surface and the second redirecting surface are located distal to the first inlet nozzle and the second inlet nozzle, respectively, and the third redirecting surface is located proximal to the outlet nozzle, the first redirecting surface and the second redirecting surface.

[0050] Item 30. A set of pipes for supplying a fluid according to one of items 26-29, wherein the mixing chamber also includes a first inlet, wherein the first inlet of the mixing chamber is located distal to the third redirecting surface, and the first redirecting surface is located distal to the first inlet for the fluid and at least partially faces the first inlet into the mixing chamber.

[0051] Item 31. A set of pipes for supplying a fluid according to one of items 26-30, wherein the mixing chamber also includes a second inlet, wherein the second inlet of the mixing chamber is located distal to the third redirecting surface, and the second redirecting surface is located distal to the second inlet for the fluid and at least partially faces the second inlet into the mixing chamber.

[0052] Item 32. A fluid supply pipe assembly according to one of items 26-31, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature of 90° or more.

[0053] Item 33. A fluid supply pipe assembly according to one of items 26-32, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature of 150° or more.

[0054] Item 34. A set of pipes for supplying a fluid medium according to one of items 26-33, wherein the third redirecting surface has a surface of a substantially concave shape and faces the outlet nozzle.

[0055] Item 35. A fluid supply pipe assembly according to item 34, wherein the concave surface has a radius of curvature of 90° or more.

[0056] Item 36. A set of pipes for supplying a fluid according to item 34, wherein the surface of the concave shape has a radius of curvature of 150° or more.

[0057] Item 37. The fluid delivery pipe assembly of any one of items 26-36, wherein the first shut-off valve has a first end engaged with a first inlet port on the first fluid inlet opening and a second end engaged with a first stop member located proximal to the first redirecting surface, wherein the second shut-off valve has a first end engaged with a second inlet port on the second fluid inlet opening and a second end engaged with a second stop member located proximal to the second redirecting surface, and the first shut-off valve and the second shut-off valve are configured to reversibly compress between the first end and the second end in response to a first pressure of the first injection fluid flowing through the first inlet port and a second pressure of the second injection fluid flowing through the second fluid port, respectively.

[0058] Item 38. A fluid supply pipe assembly according to item 37, wherein the first stop member and the second stop member have a pointed proximal end.

[0059] Item 39. A set of pipes for supplying a fluid medium according to one of items 26-38, wherein the first inlet branch pipe and the second inlet branch pipe have a conical end surface.

[0060] Item 40. A fluid supply pipe assembly according to one of items 26-39, wherein the outlet pipe has an axis parallel to the axis of the first fluid inlet and the axis of the second fluid inlet.

[0061] Item 44. The fluid supply pipe assembly of item 40, wherein the axis of the outlet pipe extends between the axis of the first fluid inlet and the axis of the second fluid inlet.

[0062] Item 42. A fluid supply pipe assembly according to one of items 26-39, wherein the axis of the first fluid inlet is parallel and offset with respect to the axis of the second fluid inlet, and the outlet pipe has an axis generally perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet.

[0063] Item 43. A fluid supply pipe assembly according to one of items 26-39, wherein the axis of the first fluid inlet is generally perpendicular to the axis of the second fluid inlet, and the outlet pipe has an axis that is generally parallel to and coincident with one of the axes that include the axis of the first fluid inlet and the axis of the second fluid inlet.

[0064] Item 44. A fluid supply pipe assembly according to one of items 22-39, wherein the axis of the first fluid inlet is oriented at an angle of 130° to 165° relative to the axis of the second fluid inlet, and the outlet pipe has an axis at an angle of less than 70° relative to one of the axes that include the axis of the first fluid inlet and the axis of the second fluid inlet.

[0065] Item 45. A fluid supply pipe assembly according to one of items 26-44, wherein each of the first redirecting surface and the second redirecting surface has a concave shape and faces in the direction of flow of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

[0066] Item 46. A fluid delivery pipe assembly according to one of items 26-45, wherein at least one of the first fluid inlet, the second fluid inlet and the outlet has at least a partial helical thread 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, to create a corresponding vortex in 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.

[0067] Item 47. A set of pipes for supplying a fluid medium according to one of items 26-46, wherein the outlet branch pipe has at least one diverting element or mixing element located on its inner surface.

[0068] Item 48. A set of pipes for supplying a fluid medium according to one of items 26-47, wherein the outlet branch also includes an excess pressure valve associated therewith.

[0069] Item 49. The fluid delivery pipe assembly of Item 48, wherein the excess pressure valve includes a first lumen in fluid communication with the outlet pipe, a second lumen configured to communicate with the pressure transducer, and a valve element between the first lumen and the second lumen, wherein the valve element is configured to isolate the second lumen from the outlet pipe during the fluid injection procedure.

[0070] Item 50. A fluid supply pipe assembly according to one of items 26-49, further comprising a connecting element outside or inside at least one of the first fluid inlet, the second fluid inlet and the outlet.

[0071] Item 51. A method of vortex mixing a first injection fluid and a second injection fluid to form a substantially homogeneous mixture of the first injection fluid and the second injection fluid, the method comprising: contacting a fluid stream of the first injection fluid with a first concave redirecting surface associated with a first fluid inlet; redirecting the fluid stream of the first injection fluid to a first modified direction, the first modified direction being at an angle of 90-175° relative to the direction of fluid stream of the first injection fluid and in a direction of a third concave redirecting surface in a mixing chamber; contacting the fluid stream of the second injection fluid with a second concave redirecting surface associated with the second fluid inlet; redirecting the fluid flow of the second injection fluid to a second changed direction, wherein the second changed direction is at an angle of 90-175° relative to the direction of the fluid flow of the second injection fluid and in the direction of a third concave redirecting surface in the mixing chamber; vortex mixing the first injection fluid and the second injection fluid in the mixing chamber after contact of the first injection fluid and the second injection fluid with the third concave redirecting 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 nozzle of the mixing chamber.

[0072] Item 52. The method of item 51, further comprising at least one of the shut-off valves, which include a first shut-off valve in the first fluid inlet and a second shut-off valve in the second fluid inlet.

[0073] Item 53. The method of item 52, wherein the first fluid inlet and the second fluid inlet have a non-circular cross-sectional shape, and the first shut-off valve and the second shut-off valve have a circular cross-sectional shape.

[0074] Item 54. The method of one of items 51-53, wherein the first fluid inlet and the second fluid inlet have a first inlet nozzle and a second inlet nozzle, respectively, wherein the first redirecting surface and the second redirecting surface are located distal to the first inlet nozzle and the second inlet nozzle, respectively, and the third redirecting surface is located proximal to the outlet nozzle, the first redirecting surface and the second redirecting surface.

[0075] Paragraph 55. The method of one of paragraphs 51-54, wherein the mixing chamber further includes a first inlet, wherein the first inlet of the mixing chamber is located distal to the third redirecting surface, and the first redirecting surface is located distal to the first fluid inlet and at least partially faces the first inlet into the mixing chamber.

[0076] Paragraph 56. The method according to one of paragraphs 51-55, wherein the mixing chamber also includes a second inlet, wherein the second inlet of the mixing chamber is located distal to the third redirecting surface, and the second redirecting surface is located distal to the second fluid inlet and at least partially faces the second inlet into the mixing chamber.

[0077] Item 57. The method of one of items 51-56, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature of 90° or more.

[0078] Item 58. The method of one of items 51-57, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature of 150° or more.

[0079] Item 59. The method according to one of items 51-58, wherein the third redirecting surface has a surface of substantially concave shape and faces towards the outlet nozzle.

[0080] Item 60. The method of item 59, wherein the concave surface has a radius of curvature of 90° or more.

[0081] Item 61. The method of item 59, wherein the concave surface has a radius of curvature of 150° or more.

[0082] Item 62. The method of any one of items 51-61, wherein the first check valve has a first end in engagement with a first inlet port on the first fluid inlet opening and a second end in engagement with a first stop element located proximal to the first redirecting surface, wherein the second check valve has a first end in engagement with a second inlet port on the second fluid inlet opening and a second end in engagement with a second stop element located proximal to the second redirecting surface, and the first check valve and the second check valve are configured to reversibly compress between the first end and the second end in response to a first pressure of the first injection fluid flowing through the first inlet port and a second pressure of the second injection fluid flowing through the second fluid port, respectively.

[0083] Item 63. The method of item 62, wherein the first stop member and the second stop member have a pointed proximal end.

[0084] Item 64. The method according to one of items 51-63, wherein the first inlet pipe and the second inlet pipe have a conical end surface.

[0085] Item 65. The method of one of items 51-64, wherein the outlet nozzle has an axis parallel to the axis of the first fluid inlet and the axis of the second fluid inlet.

[0086] Item 66. The method of item 65, wherein the axis of the outlet nozzle extends between the axis of the first fluid inlet and the axis of the second fluid inlet.

[0087] Item 67. The method of one of items 51-64, wherein the axis of the first fluid inlet is parallel and offset with respect to the axis of the second fluid inlet, and the outlet nozzle has an axis generally perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet.

[0088] Item 68. The method of one of items 51-64, wherein the axis of the first fluid inlet is generally perpendicular to the axis of the second fluid inlet, and the outlet nozzle has an axis that is generally parallel to and coincident with one of the axes that include the axis of the first fluid inlet and the axis of the second fluid inlet.

[0089] Item 69. The method according to one of items 51-64, wherein the axis of the first fluid inlet is oriented at an angle of from 130° to 165° relative to the axis of the second fluid inlet, and the outlet nozzle has an axis at an angle of less than 70° relative to one of the axes that include the axis of the first fluid inlet and the axis of the second fluid inlet.

[0090] Item 70. The method according to one of items 51-69, wherein each of the first redirecting surface and the second redirecting surface has a concave shape and faces in the direction of flow of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

[0091] Paragraph 71. The method of any one of paragraphs 51-70, wherein at least one of the first fluid inlet, the second fluid inlet and the outlet has at least a partial helical groove 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, to create a corresponding vortex in 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.

[0092] Item 72. The method according to one of items 51-71, wherein the outlet pipe has at least one diverting element or mixing element located on its inner surface.

[0093] Item 73. The method according to one of items 51-72, wherein the outlet pipe also includes an excess pressure valve associated therewith.

[0094] Item 74. The method of item 73, wherein the excess pressure valve includes a first lumen in fluid communication with the outlet pipe, a second lumen configured to communicate with the pressure transducer, and a valve element between the first lumen and the second lumen, wherein the valve element is configured to isolate the second lumen from the outlet pipe during the fluid injection procedure.

[0095] Item 75. The method according to one of items 51-74, further comprising a connecting element outside or inside at least one of the first fluid inlet, the second fluid inlet, and the outlet.

[0096] Further details and advantages of the various embodiments described in detail by the authors will become apparent from the detailed description of the various examples presented below in connection with the accompanying figures.

BRIEF DESCRIPTION OF THE FIGURES

[0097] FIG. 1 is a perspective view of a fluid injector system in accordance with some embodiments of the present invention;

[0098] FIG. 2 is a perspective view of a portion of a fluid delivery tube assembly usable with the fluid injector system of FIG. 1;

[0099] FIG. 3 is a side view of a fluid mixing apparatus for the fluid supply pipe assembly of FIG. 2;

[00100] FIG. 4 is a plan view of the distal end of the fluid mixing device of FIG. 3;

[00101] FIG. 5 is a plan view of the proximal end of the fluid mixing device of FIG. 3;

[00102] FIG. 6 is a sectional view of the fluid mixing device of FIGURES 3-5 along line A - A of FIG. 4;

[00103] FIG. 7 is a cross-sectional view of a fluid mixing device according to another embodiment of the present invention;

[00104] FIG. 8 is a cross-sectional view of a fluid mixing device according to another embodiment of the present invention;

[00105] FIG. 9 is a cross-sectional view of a fluid mixing device according to another embodiment of the present invention;

[00106] FIG. 10 is a top view of a fluid mixing apparatus according to another embodiment;

[00107] FIG. 11 is a side view of the fluid mixing apparatus shown in FIG. 10;

[00108] FIG. 12 is a sectional view of the fluid mixing device of FIGURES 10-11 along line B - B of FIG. 11;

[00109] FIG. 13 is a perspective view of a fluid mixing apparatus according to another embodiment;

[00110] FIG. 14 is a side view of the fluid mixing apparatus shown in FIG. 13;

[00111] FIG. 15 is a cross-sectional view of the fluid mixing device of FIGURES 13-14, along line C-C in FIG. 14;

[00112] FIG. 16 is a top view of a fluid mixing apparatus in accordance with another embodiment of the present invention;

[00113] FIG. 17 is a top view of the fluid mixing apparatus shown in FIG. 16;

[00114] FIG. 18 is a cross-sectional view of the fluid mixing device of FIGURES 16-17, taken along line D - D of FIG. 17;

[00115] FIGURES 19-21 are cross-sectional views of fluid mixing devices in accordance with other embodiments of the present invention;

[00116] FIG. 22 is a perspective view of a fluid mixing apparatus according to another embodiment;

[00117] FIG. 23 is an exploded view of the fluid mixing apparatus shown in FIG. 22;

[00118] FIG. 24A is a cross-sectional view of the fluid mixing apparatus of FIGURES 22-23, taken along line E-E of FIG. 22, with the shut-off valve shown in the closed position;

[00119] FIG. 24B is a cross-sectional view of the fluid mixing apparatus of FIGURES 22-23, taken along line E-E of FIG. 22, with the shut-off valve shown in the open position;

[00120] FIG. 25 is a cross-sectional view of the fluid mixing device of FIGURES 22-23, along line F - F of FIG. 22;

[00121] FIG. 26 is a cross-sectional view of a fluid inlet of the fluid mixing device shown in FIG. 25 along line G - G of FIG. 25;

[00122] FIG. 27 is a cross-sectional view of the fluid inlet of the fluid mixing device shown in FIG. 25 along line H-H of FIG. 25;

[00123] FIG. 28 is a perspective view of a fluid mixing device coupled to an excess pressure valve according to another embodiment;

[00124] FIG. 29 is an exploded view of the fluid mixing apparatus shown in FIG. 28; and

[00125] FIG. 30 is a cross-sectional view of the fluid mixing device of FIGURES 28-29, taken along line I - I of FIG. 28.

DETAILED DESCRIPTION OF THE INVENTION

[00126] For the purposes of the description provided below, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives refer to the description in its orientation shown in the figures.

[00127] Terms relating to spatial location or direction, such as "left", "right", "inner", "outer", "above", "below", etc., should not be construed as limiting, since the invention provides for the possibility of various alternative orientations.

[00128] All numbers used in the description and claims are to be understood as adjusted by the term "about." The terms "approximately," "about," and "essentially" mean a range of plus or minus ten percent from the stated value.

[00129] Unless otherwise stated, all ranges or ratios disclosed by the authors should be understood to encompass the initial and final values, and any subranges or partial ratios encompassed. For example, a stated range or ratio of "1 to 10" should be understood to include any and all subranges or partial ratios between (inclusive) the minimum value of 1 and the maximum value of 10; that is, all subranges or partial ratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less. The ranges and/or ratios disclosed by the authors represent average values within the stated range and/or ratio.

[00130] The terms "first," "second," and the like, do not refer to any particular order or chronology, but to different conditions, properties, or elements.

[00131] All documents cited by the authors are "incorporated by reference" in their entirety.

[00132] The term "at least" is synonymous with the term "equal or greater".

[00133] As used herein, the term "at least one of" is synonymous with the term "one or more of." For example, the phrase "at least one of A, B, and C" means any one of A, B, and C, or any combination of any two or more of A, B, and C. For example, "at least one of A, B, and C" includes one or more of A only; or one or more of B only; or one or more of C only; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C. Similarly, as used herein, the term "at least two of" is synonymous with the term "two or more of." 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 of D and one or more of E; or one or more of D and one or more of F; or one or more of E and one or more of F; or one or more of all of D, E, and F.

[00134] The words "comprising" and "comprising" and other similar words do not exclude the presence of elements or steps other than those listed in any claim or in the description as a whole. As used in the description, "comprising" means "includes" and "comprising" means "including."

[00135] As used herein, the terms "parallel" or "substantially parallel" mean a relative angle between two objects (if extended to a point of theoretical intersection), such as oblong objects, including imaginary lines, that is, 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°, inclusive of the values indicated.

[00136] As used herein, the terms "perpendicular," "transverse," "substantially perpendicular," or "substantially transverse" mean a relative angle between two objects at an actual or theoretical intersection point that is between 85° and 90°, or between 87° and 90°, or between 88° and 90°, or between 89° and 90°, or between 89.5° and 90°, or between 89.75° and 90°, or between 89.9° and 90°, including the values stated.

[00137] It should also be understood that the specific devices and processes shown in the accompanying figures and described in the description below are merely typical examples of the disclosure of the invention. Thus, specific dimensions and other physical characteristics concerning the examples described by the authors should not be considered as limiting.

[00138] With respect to a component of a fluid injector system, such as a fluid reservoir, a syringe, or a fluid conduit, the term "distal" refers to the portion of said component closest to a patient. With respect to a component of a fluid injector system, such as a fluid reservoir, a syringe, or a fluid conduit, the term "proximal" refers to the portion of said component closest to the injector of the fluid injector system (i.e., the portion of said component farthest from the patient). With respect to a component of a fluid injector system, such as a fluid reservoir, a syringe, or a fluid conduit, the term "upstream" refers in a direction away from the patient and toward the injector of the fluid injector system. For example, if a first component is listed as "upstream" with respect to a second component, then the first component is located closer to the injector along the flow path than the second component. When applied to a component of a fluid injector system, such as a fluid reservoir, syringe, or fluid tubing, the term "downstream" refers to the direction toward the patient and away from the injector of the fluid injector system. For example, if a first component is listed as "downstream" relative to a second component, then the first component is located closer to the patient along the flow path than the second component.

[00139] Although the disclosure of the present invention is described primarily with respect to the MEDRAD® Stellant computed tomography injection system, one skilled in the art will appreciate that the disclosure of the present invention is applicable to various injection systems, including associated consumables (e.g., syringes, tubing, etc.), such as those intended for CT, CTA, MRI, PET, ultrasound, and other medical injectors configured to inject two or more medical fluids. In certain embodiments, it is possible to adapt a fluid mixing device for use with a tubing associated with an angiographic injector. Examples of such injection systems include the MEDRAD® Salient CT Injection System, the MEDRAD® Stellant FLEX CT Injection System, the MEDRAD® Centargo CT Injection System, the MEDRAD® MRXperion MR Injection System, the MEDRAD® Avanta Injection System, and the MEDRAD® Mark 7 Arterion Injection System, all available from Bayer HealthCare LLC, Indianola, Pennsylvania, USA.

[00140] As shown in FIG. 1, a non-limiting example of a fluid injector system 100 according to the disclosure of the present invention includes at least one fluid reservoir, such as at least one syringe 12 having a reciprocating plunger 14, at least one piston connected to the plunger 14, and a fluid flow control module (not shown). It is possible to configure the fluid injector system 100 as a contrast injection system for computed tomography (CT), a contrast injection system for magnetic resonance imaging (MRI), or a contrast injection system for angiography (CTAE). The at least one syringe 12 is generally adapted to mate with at least one component of the system, such as a syringe inlet 13. The fluid injector system 100 is generally configured to deliver at least one fluid F from at least one syringe 12 into the patient's body during an injection procedure. The fluid injector system 100 is configured to receive in a removable mode at least one syringe 12, which is filled with at least one fluid F, such as a contrast medium, a saline solution, Ringer's lactate, or any desired medical fluid. It is possible to design the system as an injector with several syringes, with a possible orientation of several syringes side by side or in another spatial relationship and with separate actuation by corresponding pistons associated with the injector. It is possible to orient at least one syringe 12 in any direction, for example, up, down, or at any angle.

[00141] Also shown in FIG. 1 is a possible design of the injector system 100 as a dual-syringe fluid injector system that is used during a medical procedure to administer at least two injection fluids F1 and F2 into a patient's vascular system by actuating the plungers 14 of the respective syringes 12 using a drive member such as a piston (not shown). Alternatively, it is possible to replace one or both syringes of the dual fluid injector system with a pump such as a peristaltic pump without departing from the scope of the disclosure of the present invention. The first and second injection fluids F1 and F2 are a respective contrast imaging agent and a flushing fluid, respectively. There is a possibility of configuring the piston for engagement with the plunger 14. After engagement, at least one piston moves the plunger 14 in the direction of the distal end 19 of at least one syringe 12, for example, during the operation of feeding a fluid, and also retracts the plunger 14 in the direction of the proximal end 11 of at least one syringe 12, for example, during the operation of filling the syringe 12.

[00142] According to various embodiments, a design is possible in which the set of tubes 17 (e.g., the first and second fluid conduits 17a and 17b configured to connect to the respective first and second syringes 12 and the common inlet line 20) is in fluid communication with the outlet nozzle of each syringe 12 to bring each syringe into fluid communication with a catheter or other fluid delivery device for delivering fluid F from each syringe 12 to the vascular access site. A design is possible in which the first and second fluid conduits 17a and 17b are connected to the common inlet line 20 by a fluid mixing device 40 in accordance with various embodiments of the present invention. The fluid injector system 100 shown in FIG. 1, is an open system due to the absence of valves configured to isolate the syringes 12 from each other and from at least a portion of the tube set 17. However, it should be understood that it is possible to add valves located distal to the syringes 12 to convert the fluid injector system 100 of FIG. 1 into a closed system.

[00143] In order to accurately and efficiently deliver volumes of contrast medium during an imaging procedure, many injection protocols require dual-stream administration, i.e., the simultaneous delivery of a mixture of contrast medium and saline to a patient. However, because the contrast medium and the rinsing fluid (saline) typically have different physical properties, such as specific gravity, viscosity, and/or surface tension, the two solutions are not always adequately mixed before entering the patient's vasculature, resulting in poor image quality. For example, in certain cases where inefficient mixing occurs, a laminar flow of a less viscous, faster-flowing fluid may pass by a more viscous, slower-flowing fluid. Although Y-connectors and T-connectors are known in the art for connecting two fluid lines to a common inlet line, traditional Y-connectors and T-connectors do not always provide sufficient mixing of the two fluids. Vortex mixing can improve the mixing efficiency between a viscous contrast medium and a less viscous saline solution. Examples of connectors having vortex mixing chambers are described in U.S. Patent No. 9,555,379, the disclosure of which is incorporated herein by reference. The disclosure of the present invention describes new fluid mixing devices that provide improved mixing of viscous and less viscous fluids for contrast-enhanced imaging procedures.

[00144] FIG. 2 is a perspective view of a portion of a fluid delivery tube set 202 that is used with a dual-head injector, such as the fluid injector system 100 of FIG. 1, instead of the tube set 17, according to some non-limiting embodiments of the present invention. As shown in the figure, the fluid delivery tube set 202 includes a first inlet line 217a, a second inlet line 217b, an outlet line 220, and a fluid mixing device 240. The first and second inlet lines 217a and 217b are configured to deliver first and second injection fluids, respectively, to the fluid mixing device 240. In one embodiment, the first and second injection fluids are a contrast media solution and a saline solution, respectively. In addition, the outlet line 220 is configured to deliver a mixture of the first and second injection fluids from the fluid mixing device 240 to the patient's body or to a downstream component of the flow path (e.g., the main pipe).

[00145] As will be understood by those skilled in the art, the fluid mixing device 240 is configured to mix the first and second injection fluids. FIGURES 3, 4, 5 and 6 show a top view, a left view, a right view and a section, respectively, of the fluid mixing device 240. As shown in FIG. 6, the fluid mixing device 240 has a housing that defines first and second fluid inlets 242 and 244, each of which is configured to move the respective first and second injection fluids in a respective first and second directions 248 and 250. As shown in the figure, the second direction 250 is oriented along a different axis 276 than the first direction 248. In certain embodiments, a design is possible in which the axis of the first direction 248 and the axis of the second direction 250 are substantially parallel. In other embodiments, the orientation of the axis of the first direction 248 may be at an acute or obtuse angle relative to the second direction 250.

[00146] Also shown in FIG. 6 is that the first and second fluid inlets 242 and 244 have corresponding first and second redirection surfaces 252 and 254. In certain embodiments, one or both of the first and second redirection surfaces 252 and 254 are concave and facing the first and second fluid inlets 242 and 244, respectively, to redirect the flow of fluid. In addition, the device 240 for mixing fluids also has a mixing chamber 256 in fluid communication with the first and second inlet openings 242 and 244 for fluids through the first and second inlet openings 270 and 272 of the mixing chamber, and an outlet pipe 246 in fluid communication with the mixing chamber 256. The mixing chamber 256 is designed with the possibility of vortex mixing of the redirected first and second injection fluids, for example by vortex mixing with impact on the third redirecting surface 262 in the mixing chamber 256.

[00147] In more detail, the first and second redirection surfaces 252 and 254 are configured to redirect the first fluid and the second fluid, entering through the first and second inlet openings 242 and 244 for fluids, respectively, into the mixing chamber 256 through the first and second inlet openings 270 and 272 of the mixing chamber, where the possibility of vortex mixing of the first and second injection fluids is provided. Before entering the mixing chamber 256, the first and second injection fluids independently flow from each other through the first and second inlet openings for fluids 242, 244, respectively. When the first and second fluids flow through the first and second fluid inlets 242, 244, respectively, the first and second fluids contact the corresponding first and second redirection surfaces 252, 254 at the distal ends of the first and second fluid inlets 242, 244, respectively. The first and second redirection surfaces 252 and 254 are configured to redirect the first and second injection fluids in the corresponding first and second modified directions 258 and 260, different from the corresponding first and second directions 248 and 250. As a result of this deviation, the first and second injection fluids enter the mixing chamber 256 through the first and second inlets 270 and 272 of the mixing chamber along the corresponding first and second modified directions 258 and 260, where the two fluids enter into a vortex contact with each other. The first and second changed directions 258 and 260 are selected so that the first and second injection fluids contact the third redirection surface 262 at the proximal end of the mixing chamber 256 for vortex mixing of the first and second injection fluids in the mixing chamber 256. In some embodiments, the third redirection surface 262 is configured to have a concave end and faces the outlet nozzle 246.

[00148] After mixing, the mixture of the first and second injection fluids exits the fluid mixing device 240 through the outlet nozzle 246 at the distal end of the fluid mixing device 240 in the direction of the third axis 278. In some embodiments, a design is possible in which the third axis 278 is parallel to one or both of the first and second axes 274, 276. In other embodiments, a design is possible in which the third axis 278 is oriented at an acute or obtuse angle relative to the first and second axes 274, 276.

[00149] Also shown in FIG. 6, both the first and second fluid inlet openings 242 and 244 have corresponding first and second inlet nozzles 264 and 266 configured to respectively connect to a first fluid conduit and a second fluid conduit (shown in FIG. 2). In some embodiments, the pipeline for the first fluid and the pipeline for the second fluid are configured to be detachably or permanently connected to the first and second inlet nozzles 264, 266. In embodiments in which the pipeline for the first fluid and the pipeline for the second fluid are permanently connected to the first and second inlet nozzles 264, 266, it is possible to connect the pipeline for the first fluid and the pipeline for the second fluid to the first and second inlet nozzles 264, 266 by adhesive bonding with a solvent, laser welding, or using other means of connection.

[00150] As shown in FIG. 6, the first and second redirecting surfaces 252 and 254 are located distally of the first and second inlet nozzles 264 and 266, respectively, and the third redirecting surface 262 is located proximally of the outlet nozzle 246 and the first and second redirecting surfaces 252 and 254. In one embodiment, the first and second redirecting surfaces 252 and 254 are located closer to the outlet nozzle 246 compared to the position of the third redirecting surface 262 and the outlet nozzle 246. In addition, a design is possible in which the first and second redirecting surfaces 252 and 254 are formed at the distal end of the corresponding first and second fluid inlet openings 242 and 244, and each of the first and second redirecting surfaces 252 and 254 at least partially faces the corresponding first and second inlet nozzles openings 270 and 272 of the mixing chamber into the mixing chamber 256, respectively.

[00151] Also in FIG. 6, it is shown that at least one of the first and second redirecting surfaces 252 and 254 is configured to have a concave surface. The configuration of the concave surface improves the redirecting nature of the vortex flow surface, while eliminating corners in which air bubbles may form or temporarily hang during the primary pouring operation. In some embodiments, each of the first and second redirecting surfaces 252 and 254 is configured to have a radius of curvature of 90° or more, and in other embodiments 150° or more. For example, in particular embodiments, each of the first and second redirecting surfaces 252 and 254 is configured to have a radius of curvature from 80° to 160°. In some embodiments, each of the first and second redirecting surfaces 252 and 254 is configured to have a radius of curvature from 90° to 180°. Accordingly, the injection fluid from each of the inlet lines 217a and 217b contacts the rounded redirecting surfaces 252 and 254, which causes a change in the direction of flow of the first and second injection fluids. In some embodiments, the rounded redirecting surfaces 252 and 254 are capable of changing the direction of flow of the first and second injection fluids, respectively, by an angle in the range from 90° to 150° towards the changed directions 258 and 260 and into the mixing chamber 256. In fact, the fluids move in a tangled path and interact with each other, for example, undergo vortex mixing, in the mixing chamber 256 in combination with further redirection under the action of the third redirecting surface 262. After mixing the fluids to a homogeneous solution, the mixture of fluids is again redirected by the radius of the third redirecting surface 262 along the flow direction of the third axis 278, as a result of which the mixture of the first and second injection fluids flows along a single outlet line 220. In some embodiments, the third redirecting surface 262 is configured to have a radius of curvature of 90° or more, more preferably 150° or more. In some embodiments, the third redirecting surface 262 is configured to have a radius of curvature from 90° to 180°. Although known mixing devices (not shown) include some swirl of the injection fluids, in various traditional mixing devices, it is still possible to separate by density, for example, a fluid of greater density swirls outside of a fluid of lesser density, which prevents proper mixing of the first and second fluids. The device 240 for mixing fluids, in contrast to the above-mentioned devices, creates a substantially homogeneous mixture of the first and second injection fluids in the swirl mixing process.

[00152] According to various embodiments, the first and second redirection surfaces 252 and 254 are designed to include concave redirection surfaces facing in the direction of flow in the first fluid inlet 242 and the second fluid inlet 244, respectively. In addition, as shown in FIG. 6, the first fluid inlet 242, the second fluid inlet 244 and the outlet 246 have corresponding axes 274, 276 and 278. In some embodiments, the third axis 278 of the outlet 246 is located between the first and second axes 274 and 276 of the first and second fluid inlets 242 and 244, respectively. In other embodiments, the third axis 278 of the outlet pipe 246 is located above or below the first and second axes 274 and 276 of the first and second inlet openings 242 and 244 for fluids, respectively. In other embodiments, the third axis 278 of the outlet pipe 246 is coaxial with the first or second axis 274 and 276 of the first and second inlet openings 242 and 244 for fluids. In other embodiments, the first and second changed directions 258 and 260 of the fluids entering the mixing chamber 256 are oriented relative to each other at an angle from 0 to 90 degrees so that the first and second fluids directly collide with each other and are subjected to vortex mixing.

[00153] In operation, a first injection fluid is supplied to a first fluid inlet 242 and a second injection fluid is supplied to a second fluid inlet 244, each of a respective first and second inlet lines 217a and 217b (shown in FIG. 2). The first and second injection fluids then pass through the respective first and second fluid inlets 242 and 244 until they reach the first and second redirection surfaces 252 and 254. When the first injection fluid contacts the first redirection surface 252, the first fluid is redirected in the direction 258 into the mixing chamber 256. Similarly, when the second injection fluid contacts the second redirection surface 254 through the first inlet 270 of the mixing chamber, the second fluid is redirected in the direction 260 into the mixing chamber 256. At this point, the first and second injection fluids, having been redirected into the mixing chamber 256 through the second inlet 272 of the mixing chamber, are subjected to vortex mixing under the action of the flow of the first and second fluids colliding with each other and the third redirection surface 262 in the mixing chamber 256. The mixture of the first and second injection fluids simultaneously contacts the third redirecting surface 262, after which it is redirected through the outlet nozzle 246 into the outlet line 220 for delivery to the patient or another downstream component. According to various embodiments, it is possible to at least partially redirect the first and second fluids so that they flow in opposite directions, for example, so that one flows in a clockwise direction and the other flows in a counterclockwise direction in the mixing chamber 256, so that the streams of the first and second fluids interlock and collide "on opposite courses" to create a vortex mixing. For example, the change of inertia associated with the collision of one fluid flowing in a clockwise direction of flow and another fluid flowing in a counterclockwise direction of flow results in the formation of a solution of the first and second fluids subjected to vortex mixing, since the two fluids interact in the mixing chamber 256. Depending on the mixing ratio and the flow rate of the first and second injection fluids, there is a possibility of mixing the first and second injection fluids only in the mixing chamber 256 or in the mixing chamber 256 and in the area of at least one of the first redirecting surface 252 and the second redirecting surface 254.

[00154] FIG. 7 is a cross-sectional view of another embodiment of a fluid mixing device 340 according to another example of the disclosure of the present invention, in which at least one of the components, which include the first fluid inlet 342, the second fluid inlet 344 and the outlet 346, includes a helical "rifled" structure on the inner surface for further directing and rotating the corresponding fluid flow at the inlet and/or outlet and increasing the vortex mixing of the first and second fluids. The structure can include one or more at least partially helical protrusions or recesses cut into the inner surface or protruding from the inner surface of at least one of the first fluid inlet 342, the second fluid inlet 344 and the outlet 346. This structure provides for the rotation of the fluid flow within the corresponding fluid flow path. In the example of FIG. 7, the first fluid inlet 342, the second fluid inlet 344 and the outlet 346 have at least a partially spiral-shaped portion 343, 345 and 347 for creating a corresponding vortex in at least one of the first injection fluid, the second injection fluid and the mixture of the first and second injection fluids, respectively, when the corresponding fluids flow through the channels. The spiral-shaped portion at the inlet or outlet allows for the possibility of direction (clockwise or counterclockwise) in the same or changed direction and the possibility of having different sizes or pitch as the spiral-shaped portion in other parts of the mixing device 340. Although the first and second fluid inlets 342 and 344 and the outlet pipe 346 have spiral-shaped portions 343, 345 and 347, it will be clear to those skilled in the art that any number of the above-mentioned sections with a spiral-shaped portion are possible without deviating from the scope of the disclosed concept. Due to the presence of the spiral-shaped portions 343, 345 and 347, there is a favorable possibility of further improving the mixing. It will be appreciated by those skilled in the art that the fluid mixing device 340 otherwise functions in the same manner as the fluid mixing device 240 discussed above.

[00155] In another embodiment of the fluid mixing device 440 according to the present invention, as shown in FIG. 8, the outlet nozzle 446 of the fluid mixing device 440 is configured to have one or more diverting elements or mixing elements 447 located inside it. Thanks to the diverting element 447, there is an advantageous possibility of further improving the mixing of the first and second injection fluids. Those skilled in the art will understand that the fluid mixing device 440 otherwise functions in the same way as the fluid mixing device 240 discussed above. In other embodiments, the fluid mixing device is designed to include one or more diverting elements or a mixing element in one or both of the first and second fluid inlets.

[00156] FIG. 9 shows another example of a fluid mixing device 540 according to another embodiment of the present invention. As shown in the figure, the fluid mixing device 540 is designed to include a first valve 543 in the first fluid inlet 542, which is configured to prevent a backflow of the second injection fluid into the first fluid inlet 542 and the fluid conduit 217a. In addition, the fluid mixing device 540 is designed to include a second valve 545 in the second fluid inlet 544, which is configured to prevent a backflow of the first injection fluid into the second fluid inlet 544 and the fluid conduit 217b. Under the pumping pressure characteristic of a fluid injection procedure, when the pressure of one fluid in an upstream flow line and fluid inlet exceeds the pressure of another fluid in an upstream other flow line and another fluid inlet, the backflow of the fluid under higher pressure into the lower flow line of the fluid under pressure may result in an undesirable mixing of the fluids in the upstream flow line or other upstream components of the fluid injection system. As a result, inaccurate dosing of the contrast medium may result due to the undesirable mixing of the two fluids prior to controlled mixing in the fluid mixing device, which leads to deterioration in image quality and unnecessary exposure of the patient to the contrast medium. Otherwise, the fluid mixing device 540 functions in the same manner as the fluid mixing device 240.

[00157] In another embodiment of the fluid mixing device 640 according to the present invention, as shown in FIGURES 10-12, the first direction 648 (FIG. 12) is parallel, oppositely directed and offset relative to the second direction 650 (FIG. 12). In addition, as shown in the figure, the outlet nozzle 646 of the fluid mixing device 640 has an axis 678 that is generally perpendicular to the first and second directions 648 and 650. Accordingly, the fluid mixing device 640 provides for indirect, rather than counter-directional mixing of two fluids. For example, the first direction 648 and the second direction 646 promote direct collision of flow lines in one half of the cross-sectional diameter of the pipes and indirect mixing in the other half of the flow lines. That is, due to the displacement of two opposite directions 648 and 650 of the fluid flow, in the mixing zone of the fluids, half direct mixing and half indirect mixing occurs.

[00158] In another embodiment of the fluid mixing device 740 according to the present invention, as shown in FIGURES 13-15, the first direction 748 is generally perpendicular to the second direction 750. Furthermore, the outlet nozzle 746 of the fluid mixing device 740 is configured to have an axis 778 that is generally parallel and coincident with the axis 774 of the first fluid inlet 742. In an alternative embodiment, the fluid mixing device 740 (not shown) is configured to have an axis 778 of the outlet nozzle 746 that is generally parallel and coincident with the axis of the second fluid inlet 744. A design is possible in which at least one recess 745 is provided between the first fluid inlet 742, the second fluid inlet 744 and an outlet nozzle 746. The recess 745 is provided to allow for a material saving in the transition zone between the first fluid inlet 742, the second fluid inlet 744 and the outlet nozzle 746 to facilitate casting 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 is capable of creating a vortex mixing of the two fluids and restricting and/or interrupting any laminar flow of one fluid relative to the other fluid.

[00159] In another embodiment of the fluid mixing device 840 according to the present invention, as shown in FIGURES 16-18, the first direction 848 can be oriented at an angle of from 130° to 165° relative to the second direction 850. In addition, the outlet 846 of the fluid mixing device 840 is configured to have an axis 878 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 846 is configured to have an axis 878 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 first fluid and the second fluid in the fluid mixing device 840 is capable of creating a vortex mixing of the two fluids and limiting and/or interrupting any laminar flow of a fluid relative to another fluid.

[00160] Other examples of fluid mixing devices 940A, 940B and 940C according to various embodiments of the present invention are shown in FIGS. 19-21. According to these embodiments, fluid mixing device 940A, 940B and 940C have a 90-degree T-shaped connector design having one or more offset flow paths to enhance mixing of the first fluid and the second fluid. As shown first in FIG. 19, 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. As shown in FIG. 19, the first fluid flow axis 948A is offset from both the second fluid flow axis 950A and the outlet flow axis 978A. Mixing of the fluids occurs at least in the fluid mixing zone 980A, where the offset fluid flow lines of the first fluid along the axis 948A interact with the fluid flow lines of the second fluid pipeline along the axis 950A to create a vortex mixing in the fluid mixing zone 980A, with the possibility of enhancing it by offsetting the outlet flow axis 978A toward the fluid outlet 946A.

[00161] As shown in 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 fluid vortex mixing chamber 956B in which vortex mixing is possible. As can be seen in FIG. 20, the first fluid flow axis 948B is offset relative to the second fluid flow axis 950B and the fluid outlet axis 978B. Mixing of fluids occurs at least in fluid mixing zone 980B, where fluid mixing chamber 956B and offset fluid flow lines of the first fluid along axis 948B interact with fluid flow lines of the second fluid pipeline along axis 950B to create vortex mixing in fluid mixing zone 980B, with the possibility of enhancing it by offsetting fluid outlet axis 978B toward fluid outlet 946B.

[00162] As shown in 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 fluid vortex mixing chamber 956C, in which further vortex mixing is provided. As can be seen in FIG. 21, the flow axis 948C of the first fluid is offset from the fluid outlet axis 978C, in particular, on the side of the flow path opposite the second fluid inlet 944C. Mixing of fluids occurs at least in fluid mixing zone 980C, where fluid mixing chamber 956C and fluid flow lines for the first fluid along axis 948C interact with fluid flow lines for the second fluid along axis 950C to create vortex mixing in fluid mixing zone 980C, with the possibility of enhancing it by shifting axis 978C of the outlet flow toward outlet 946C of the fluid.

[00163] FIG. 22 is a perspective view of a fluid mixing device 1040 according to some non-limiting embodiments of the present invention. The fluid mixing device 1040 may be used as part of a fluid delivery pipe set, such as the fluid delivery pipe set 202 shown in FIG. 2, wherein the fluid mixing device is connected to a pair of fluid inlet lines and an outlet line. As shown in FIG. 22, the fluid mixing device 1040 has a housing defining first and second fluid inlet openings 1042 and 1044, each of which is configured to move a respective of the first and second injection fluids. The fluid mixing device 1040 also has an outlet nozzle 1046 configured to deliver a mixture of the first and second injection fluids from the fluid mixing device 1040 to the patient's body or another downstream component.

[00164] As shown in FIG. 23, which is an exploded perspective view of the fluid mixing device 1040 shown in FIG. 22, the fluid mixing device 1040 has a body 1041 with a first portion 1043 and a second portion 1045. In some embodiments, a design is possible in which the first portion 1043 and the second portion 1045 are made separately and connected to form the body of the fluid mixing device 1040. Preferably, the first portion 1043 and the second portion 1045 are connected in a non-removable mode, such as by adhesive, welding (e.g., laser welding or ultrasonic welding), friction fit, solvent bonding, or using another non-removable connection mechanism. In some embodiments, it is possible to connect the first portion 1043 and the second portion 1045 in a removable mode.

[00165] FIG. 23 also shows that the first portion 1043 defines a portion of the first and second fluid inlets 1042 and 1044 and has a receiving seat 1047 for receiving a check valve 1049 in each of the first and second fluid inlets 1042 and 1044. The second portion 1045 has a corresponding internal cavity 1051 (shown in FIG. 24A) configured to receive the first portion 1043, including the check valves 1049. The second portion of the first and second fluid inlets 1042 and 1044 is defined by the internal cavity 1051 of the second portion 1045 (shown in FIGS. 24A-24B). Once the first portion 1043, including the shut-off valves 1049, enters the second portion 1045, the first portion 1043 and the second portion 1045 may be connected at one or more contact points between the first portion 1043 and the second portion 1045.

[00166] A design is possible in which each check valve 1049 is configured to prevent backflow of the first and second injection fluids during injection procedures when the fluid pressures in the respective first and second pipes through which the first and second injection fluids are supplied to the fluid mixing device 1040 are not equal. It is possible to make the check valves 1049 from a compressible material, such as an elastomeric polymer that is compressible under the action of a compressed fluid flow from an expanded state to a compressed state. The compressible material is selected accordingly to provide an appropriate rigidity such that the check valve opens at a selected fluid pressure. The check valves 1049 are also used to protect the fluid injector system from damping the hemodynamic blood pressure signal, as discussed by the authors with reference to FIGURES 28-30. In some embodiments, the check valves 1049 are used to protect against the transfer of contamination from patient to patient when the fluid mixing device 1040 is configured for use by multiple patients. In addition, the check valves 1049 prevent the first and second injection fluids from "leaking" to the outlet after the injection of the first and second injection fluids has ceased, such as due to the release of accumulated capacity or "swelling" of components of the pressurized fluid injector.

[00167] Referring to FIGURES 24A-24B, which show a cross-sectional plan view of the fluid mixing device 1040 along the line F-F shown in FIG. 22, shut-off valves 1049 are shown located in a receptacle 1047 of each of the first and second fluid inlets 1042 and 1044 of the first portion 1043. The receptacle 1047 for each valve 1049 is in line with the direction of flow of the fluid through each of the first and second fluid inlets 1042 and 1044. Each check valve 1049 has a proximal end 1053 configured to be in contact with a corresponding sealing surface 1055 on the first and second fluid inlets 1042 and 1044 in the first portion 1043 when the check valve 1049 is in the closed position (FIG. 24A), and configured to be spaced from the sealing surface 1055 on the first and second fluid inlets 1042 and 1044 in the first portion 1043 when the check valve 1049 is in the open position (FIG. 24B). Each check valve 1049 also has a distal end 1057 engaged with a stop member 1059 that is located within each of the first and second fluid inlets 1042 and 1044. In some embodiments, each stop member 1059 is a support structure associated with the inner side wall of the respective first second inlet openings 1042, 1044 for fluid downstream of the check valve 1049 and configured to prevent movement of the distal end 1057 of the check valve 1049, which allows the check valve 1049 to be compressed when a pressure force is applied to the proximal end 1053. In some embodiments, each stop member 1059 is configured to have a pointed proximal end 1071, which is configured to reduce the contact area with the check valve 1049, which allows for greater compression of the check valve 1049 between its proximal and distal ends 1053 and 1057 at a lower fluid pressure. For example, under pressure, it is possible to compress the distal end 1057 and mold it around the pointed proximal end 1061 of the stop element 1059, which makes it easier to remove the outer periphery of the proximal end 1053 from the sealing surface 1055. Thus, the pointed stop element 1059 provides the ability to reduce the pressure drop through the ability to open more easily during injections compared to stop elements with a flat supporting surface. In some embodiments, the stop element 1059 is made of silicone material.

[00168] During the injection procedure, the first and second injection fluids are forced under pressure through the first and second fluid inlets 1042 and 1044 such that the first and second fluids come into contact with the respective proximal ends 1053 of the check valves 1049. Initially, the proximal ends 1053 engage with the sealing surface 1055 on the first portion 1043 (FIG. 24A) to block the passage of the first and second injection fluids passing through the check valve 1049. As fluid pressure is generated, the force acting on the proximal end 1053 of the check valves 1049 increases. Due to the compressible nature of each check valve 1049, the proximal end 1053 is forced to move in the distal direction, thereby creating a gap between the proximal end 1053 of the check valves 1049 and the sealing surface 1055 on the first portion 1043. As shown in FIG. 24B, such a gap is formed only when sufficient fluid pressure P is applied to the proximal end 1053, such as during a typical injection procedure. The pressurized first and second injection fluids then move around the respective check valves 1049 and through the fluid mixing device 1040, as described by the authors. During the injection procedure, if the pressure of one of the first and second injection fluids exceeds the pressure of the other of the first and second injection fluids, it is possible to close the check valve 1049 on the inlet for the fluid with the lower pressure to prevent a backflow of the fluid in the upstream direction, for example, due to the counter pressure of the fluid under high pressure at the distal end 1055 of the check valve 1049 with the lower pressure. After the injection procedure is completed, the elastic nature of each check valve 1049 causes the check valve 1049 to expand in the axial direction, so that the proximal end 1053 contacts the sealing surface 1055 on the first part 1043 to prevent the flow of additional fluid through the check valve 1049. In this way, it is ensured that the flow of any excess fluid through the device 1040 for mixing fluids is prevented after the injection procedure is completed. In addition, any backflow of one fluid into another flow line is prevented.

[00169] As shown in FIG. 25, as well as in FIGS. 24A-24B, each check valve 1049 is sized such that its outer diameter is slightly smaller than the inner diameter of the channel 1060 defined by the receiving seat 1047 of the first part 1043 (shown in FIGS. 23A-24B) and the corresponding internal cavity 1051 of the second part 1045 of the housing 1043 (shown in FIG. 26). Thus, it is possible for fluid to pass around the housing of each check valve 1049 and through the channel 1060. In some embodiments, the channel 1060 is configured to have a non-circular cross-section, and the check valve 1049 is configured to have a circular cross-section. Thus, channel 1060 defines a flow path for the first and second injection fluids around the respective check valves 1049 when check valve 1049 is in the open position.

[00170] In some embodiments, as shown in FIG. 26, the channel 1060 is configured to have a grooved cross-section with one or more grooves 1061. In embodiments in which the channel 1060 has a plurality of grooves 1061, the grooves 1061 are configured to be separated from each other by equal or different intervals along the perimeter of the channel 1060. The number of grooves 1061, the radial depth and/or the circumferential width of the grooves 1061 are selected depending on the desired flow rate of the first and second fluids through the channel 1061 when the corresponding check valves 1049 are in the open position.

[00171] Each check valve 1049 is preferably an elastomeric member that is at least partially compressible in the longitudinal direction when exposed to fluid pressure. The check valve 1049 in the first fluid inlet 1042 is the same as or different from the check valve 1049 in the second fluid inlet 1044. In some embodiments, the opening pressure of each check valve 1049 is selected based on the characteristics of the fluid injector and/or the characteristics of the first and second injection fluids, such as the viscosity of the fluid, and the temperature range, the flow rate range, and the pressure range at which it is possible to introduce the first and second injection fluids.

[00172] FIG. 27 shows that the inlet opening 1065 surrounding the sealing surface 1055 (shown in FIG. 24A) is configured to have a shape corresponding to the shape of the channel 1060 (shown in FIG. 25). The inlet opening 1065 is configured to have a narrowing 1067 directed radially inward from the proximal end to the distal end of the fluid mixing device 1040. The cross-sectional shape of the inlet opening 1065 is selected so as to achieve a low pressure drop and a lower opening pressure for the check valve 1049.

[00173] Upon review of FIGURES 24A-24B, it will be appreciated by those skilled in the art that fluid mixing device 1040 creates a vortex mixing of the first and second fluids similar to fluid mixing device 240 discussed above. As shown in FIGURES 24A-24B, the first and second inlet openings 1042 and 1044 for fluids have corresponding first and second redirection surfaces 1052 and 1054. In addition, the device 1040 for mixing fluids also has a mixing chamber 1056 in fluid communication with the first and second inlet openings 1042 and 1044 for fluids and an outlet nozzle 1046 in fluid communication with the mixing chamber 1056. The mixing chamber 1056 is configured to vortex mix the first and second injection fluids.

[00174] Also shown in FIGURES 24A-24B, the first and second redirection surfaces 1052 and 1054 are configured to redirect the first fluid and the second fluid entering through the first and second fluid inlets 1042 and 1044, respectively, into the mixing chamber 1056, where the first and second injection fluids are configured to be vortex-mixed. As discussed by the authors with reference to FIG. 6, the first and second redirecting surfaces 1052 and 1054 are configured to redirect the first and second injection fluids in respective first and second modified directions, different from the respective first and second directions in which the first and second injection fluids flow before contacting the first and second redirecting surfaces 1052 and 1054. Due to this deviation, the first and second injection fluids enter the mixing chamber 1056 in respective first and second modified directions and contact the third redirecting surface 1062 at the proximal end of the mixing chamber 1056 for vortex mixing the first and second injection fluids in the mixing chamber 1056. After mixing, the mixture of the first and second injection fluids exits the fluid mixing device 1040 through the outlet nozzle 1046 at the distal end of the fluid mixing device 1040.

[00175] As shown in FIG. 25, the outlet pipe 1046 is configured to have a connector 1070 configured to allow the outlet pipe 1046 to be removably connected to an outlet conduit, such as the outlet line 220 shown in FIG. 2. The connector 1070 is a luer lock configured to be removably connected to a corresponding female luer lock member at the proximal end of the outlet line 220. In some embodiments, the connector 1070 is a female luer lock member configured to be removably connected to a corresponding luer lock member at the proximal end of the outlet line 220. In other embodiments, current path connectors such as those described in International PCT Application Nos. PCT/US2021/018523 and PCT/US2016/063448 are used, the disclosures of which are incorporated herein by reference. Thus, it is possible to connect the fluid mixing device 1040 in a removable mode to the outlet line 220, which allows the fluid mixing device 1040 to be used for multiple patients, for example, if one or more shut-off valves are attached upstream of the connector on the outlet nozzle 1046.

[00176] In another embodiment of the present invention, as shown in FIGURES 28-30, the fluid mixing device 1140 has a housing 1141 defining first and second fluid inlet openings 1142 and 1144, each of which is configured to move a respective of the first and second injection fluids. The housing of the fluid mixing device 1140 also includes an outlet nozzle 1146 configured to deliver a mixture of the first and second injection fluids to an outlet pipeline (not shown). The housing 1141 has a first portion 1143 and a second portion 1145, which are connected to each other in a non-removable mode or in a removable mode. The check valve 1149 is located in the channel 1155 of each of the first and second inlet openings 1142 and 1144 for fluids (shown in FIG. 29) and is configured to open under pressure to allow the first and second injection fluids to flow toward the outlet nozzle 1146. The structure and functionality of the fluid mixing device 1140 shown in FIGS. 28-30 are essentially identical to the structure and functionality of the fluid mixing device 1040 described with reference to FIGS. Accordingly, only relative differences between the two embodiments are discussed herein.

[00177] As shown in FIGURES 28-30, the outlet port 1146 is configured to have an overpressure valve 1150 configured to allow the pressure transducer to be connected to the flow line so as to allow the hemodynamic blood pressure signal data to be obtained during the delivery of the fluid. The overpressure valve 1150 protects the high-pressure fluid injector system from interference with the low-pressure measurement of the hemodynamic blood pressure signal.

[00178] The excess pressure valve 1150 includes a body 1152 formed as a one-piece structure or, preferably, a multi-piece structure, as shown in FIG. 29. For example, the body 1152 is a two-piece body including a first portion 1152a and a second portion 1152b adapted to be connected together to form the body 1150. The first and second portions 1152a, 1152b are preferably formed to be permanently engaged with each other. Non-limiting examples of suitable excess pressure valves are described in U.S. Patent Nos. 6,866,654; 7,611,503; 8,919,384 and 8,992,489, the contents of which are incorporated by reference.

[00179] As shown in FIG. 30, the first portion 1152a of the housing 1152 defines a high-pressure lumen 1154, forming a high-pressure side of the excess-pressure valve 1150. The high-pressure lumen 1154 is in fluid communication with the outlet pipe 1146. The second portion 1152b of the housing 1152 defines a low-pressure lumen 1156, as a whole forming a low-pressure side of the excess-pressure valve 1150. The second portion 1152b of the housing 1152 also includes a positive-pressure port 1158, to which a pressure transducer (not shown) can be connected. The structure forming the positive-pressure port 1158 ends with a Luer connector or other suitable medical connector for connecting the pressure transducer to the positive-pressure port 1158.

[00180] A design is possible in which the first and second parts 1152a, 1152b of the housing 1152 define an internal chamber 1160, which as a whole is in fluid communication with the high-pressure lumen 1154 and the low-pressure lumen 1156. An internal valve element 1162 is located in the internal chamber 1160 and is biased toward a normally open position, wherein the high-pressure lumen 1154 is in fluid communication with the low-pressure lumen 1156. The valve element 1162 as a whole is also adapted to isolate the low-pressure lumen 1156 immediately after the pressure of the fluid in the high-pressure lumen 1154 reaches a predetermined value. The low pressure lumen 1156 also includes a flow initiation port 1164 having a flow initiation valve 1166 generally adapted to initiate a small flow around the valve member 1162 such that the valve member 1162 functions to a closed position substantially after the flow is initiated.

[00181] Although the inventors have described various embodiments of fluid mixing devices for mixing two injection fluids, similar fluid mixing devices with three or even four fluid inlets, each having corresponding redirection surfaces, are possible, in which the fluid inlets are in fluid communication with the mixing chamber similar to that described by the inventors. Such fluid mixing devices are encompassed within the scope of the disclosure of the present invention.

[00182] Although the above description provides various embodiments of fluid mixing devices and tube assemblies for delivering fluid to a patient, modifications and changes in these examples can be made by those skilled in the art without departing from the scope and spirit of the disclosure. Accordingly, the above description is intended to be illustrative and not restrictive. The above disclosure is defined by the appended claims, and all changes in the disclosure that come within the meaning and equivalence of the claims are intended to be embraced within their scope.

Claims (35)

1. A device for mixing fluids, intended for mixing a first injection fluid and a second injection fluid and comprising: - a first fluid inlet configured to move the first injection fluid in a first direction, wherein the first fluid inlet has a first redirection surface; - a second fluid inlet configured to move the second injection fluid in a second direction, wherein the second fluid inlet has a second redirection surface; - a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and having a third redirection surface, wherein the mixing chamber is configured to mix the first injection fluid and the second injection fluid; and - an outlet pipe in fluid communication with the mixing chamber and located distal to the first fluid inlet and the second fluid inlet, wherein the first fluid inlet and the second fluid inlet have a first inlet nozzle and a second inlet nozzle, respectively, wherein the first redirecting surface and the second redirecting surface are located distal to the first inlet nozzle and the second inlet nozzle, respectively, and the third redirecting surface is located proximal to the outlet nozzle, the first redirecting surface and the second redirecting surface, wherein the first redirecting surface is configured to redirect the first injection fluid in a first modified direction different from the first direction to enter the mixing chamber in the first modified direction, and the second redirecting surface is configured to redirect the second injection fluid in a second modified direction different from the second direction to enter the mixing chamber in a second modified direction, wherein the first modified direction and the second modified direction are selected such that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber for vortex mixing of the first injection fluid and the second injection fluid in the mixing chamber, and wherein the mixture of the first injection fluid and the second injection fluid exits the fluid mixing device through the outlet pipe. 2. The device for mixing fluids according to claim 1, also comprising at least one of the shut-off valves, which include a first shut-off valve in the first inlet opening for the fluid and a second shut-off valve in the second inlet opening for the fluid. 3. The device for mixing fluids according to claim 1, wherein the mixing chamber also includes a first inlet, wherein the first inlet of the mixing chamber is located distal to the third redirecting surface, and the first redirecting surface is located distal to the first inlet for the fluid and at least partially faces the first inlet into the mixing chamber. 4. The device for mixing fluids according to claim 1, wherein the mixing chamber also includes a second inlet, wherein the second inlet of the mixing chamber is located distal to the third redirecting surface, and the second redirecting surface is located distal to the second inlet for the fluid and at least partially faces the second inlet into the mixing chamber. 5. The device for mixing fluid media according to claim 1, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature of 90° or more. 6. The device for mixing fluid media according to claim 1, wherein at least one of the first redirecting surface and the second redirecting surface is substantially concave and has a radius of curvature of 150° or more. 7. A device for mixing fluid media according to claim 1, wherein the third redirecting surface has a surface of essentially a concave shape and faces the outlet pipe. 8. A device for mixing fluid media according to claim 7, wherein the concave surface has a radius of curvature of 90° or more. 9. A device for mixing fluid media according to claim 7, wherein the concave surface has a radius of curvature of 150° or more. 10. The fluid mixing device of claim 2, wherein the first shut-off valve has a first end in engagement with a first inlet port on the first fluid inlet and a second end in engagement with a first stop element located proximal to the first redirecting surface, wherein the second shut-off valve has a first end in engagement with a second inlet port on the second fluid inlet and a second end in engagement with a second stop element located proximal to the second redirecting surface, and the first shut-off valve and the second shut-off valve are configured to reversibly compress between the first end and the second end in response to a first pressure of the first injection fluid flowing through the first inlet port and a second pressure of the second injection fluid flowing through the second fluid port, respectively. 11. A device for mixing fluids according to claim 1, wherein the outlet pipe has an axis parallel to the axis of the first inlet opening for the fluid and the axis of the second inlet opening for the fluid. 12. The device for mixing fluids according to claim 11, wherein the axis of the outlet pipe passes between the axis of the first inlet opening for the fluid and the axis of the second inlet opening for the fluid. 13. The fluid mixing device according to claim 1, wherein each of the first redirecting surface and the second redirecting surface has a concave shape and faces in the direction of flow of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively. 14. The fluid mixing device according to claim 1, wherein at least one of the first fluid inlet, the second fluid inlet and the outlet has at least a partial helical groove 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, to create a corresponding vortex in 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. 15. A device for mixing fluid media according to claim 1, wherein the outlet pipe also includes an excess pressure valve combined with it. 16. A device for mixing fluids according to claim 15, wherein the excess pressure valve includes a housing having a first lumen in fluid communication with the outlet pipe, and a second lumen configured to communicate with the pressure transducer, and a valve element between the first lumen and the second lumen, wherein the valve element is configured to isolate the second lumen from the outlet pipe during the procedure of pumping the fluid. 17. A set of tubes for delivering a fluid from a fluid injector to a patient's body, wherein the set of tubes for delivering a fluid comprises: - a first inlet pipe configured to deliver a first injection fluid; - a second inlet pipe 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's body; and - a device for mixing fluid media, including: - a first fluid inlet connected to the first inlet pipe and configured to move the first injection fluid in a first direction, wherein the first fluid inlet has a first redirection surface; - a second fluid inlet connected to the second inlet pipe and configured to move the second injection fluid in a second direction, wherein the second fluid inlet has 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, wherein the mixing chamber is configured to mix the first injection fluid and the second injection fluid; and - an outlet pipe connected to the outlet pipe and in hydrodynamic communication with the mixing chamber, wherein the first fluid inlet and the second fluid inlet have a first inlet nozzle and a second inlet nozzle, respectively, wherein the first redirecting surface and the second redirecting surface are located distal to the first inlet nozzle and the second inlet nozzle, respectively, and the third redirecting surface is located proximal to the outlet nozzle, the first redirecting surface and the second redirecting surface, wherein the first redirecting surface is configured to redirect the first injection fluid in a first modified direction different from the first direction to enter the mixing chamber in the first modified direction, and the second redirecting surface is configured to redirect the second injection fluid in a second modified direction different from the second direction to enter the mixing chamber in a second modified direction, wherein the first modified direction and the second modified direction are selected such that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber for vortex mixing of the first injection fluid and the second injection fluid in the mixing chamber, and wherein the mixture of the first injection fluid and the second injection fluid exits the fluid mixing device through the outlet pipe.

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