Fluid mixing set

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

BACKGROUND OF THE DISCLOSURE

Field of the Disclosure

The present disclosure is related to fluid mixing devices for use with fluid delivery tubing sets configured for use with powered fluid injectors. The present disclosure is also related to fluid delivery tube sets having said fluid mixing devices.

Description of Related Art

In many medical diagnostic and therapeutic procedures, a medical practitioner, such as a physician or radiologist, injects a patient with one or more fluids using a powered fluid injector system. In recent years, a number of powered fluid injector systems for pressurized injection of fluids have been developed for use in procedures such as angiography (CV), computed tomography (CT), molecular imaging (such as PET imaging), and magnetic resonance imaging (MRI). In these imaging procedures, a first injection fluid, such as a contrast agent, may be used to highlight certain internal organs, portions of the circulatory system, or portions of the body during an imaging process. Meanwhile, a second injection fluid, such as saline or a similar flushing agent, may be used to ensure complete injection of the bolus of the contrast agent and/or adjust the concentration of the contrast agent. In some procedures, it may be desirable to deliver a mixture of the first injection fluid and the second injection fluid.

When delivering a mixture of the first injection fluid and the second injection fluid, it is desirable for the two fluids to be mixed well before injection into the patient. However, because the first and second injection fluids typically have different physical properties, for example specific gravity and/or viscosity, the two fluids may not be thoroughly mixed prior to entering the patient's vascular system, leading to reduced image quality. Accordingly, there is a need in the art for improved fluid delivery systems that promote mixing of two or more injection fluids prior to injection into the patient.

SUMMARY OF THE DISCLOSURE

These needs and others may be met by the non-limiting embodiments described herein, which are directed to an improved fluid mixing devices and fluid delivery tube sets including the same.

In some non-limiting embodiments of the present disclosure, a fluid mixing device for mixing a first injection fluid and a second injection fluid may include a first fluid inlet configured to conduct the first injection fluid in a first direction. The first fluid inlet may have a first redirecting surface. The fluid mixing device further may include a second fluid inlet configured to conduct the second injection fluid in a second direction. The second fluid inlet may have a second redirecting surface. The fluid mixing device further may include a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and having a third redirecting surface. The mixing chamber may be configured to mix the first injection fluid and the second injection fluid. The fluid mixing device further may include an outlet port in fluid communication with the mixing chamber and distal to the first fluid inlet and the second fluid inlet. The first redirecting surface may be configured to redirect the first injection fluid in a first different direction from the first direction to enter the mixing chamber along the first different direction, and the second redirecting surface may be configured to redirect the second injection fluid in a second different direction from the second direction to enter the mixing chamber along the second different direction. The first different direction and the second different direction may be selected so that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber to turbulently mix the first injection fluid and second injection fluid in the mixing chamber. A mixture of the first injection fluid and the second injection fluid may exit the fluid mixing device through the outlet port.

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

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

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

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

In some non-limiting embodiments of the present disclosure, the first check valve may 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 proximal to the first redirecting surface. The second check valve may 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 proximal to the second redirecting surface. The first check valve and the second check valve may be reversibly compressible between the first end and the second end in response to first fluid pressure of the first injection fluid flowing through the first inlet port and a second fluid pressure of the second injection fluid flowing through the second fluid port, respectively. The first stop element and the second stop element may have a pointed proximal end. The first inlet port and the second inlet port may have a tapered end surface.

In some non-limiting embodiments of the present disclosure, the outlet port may have an axis parallel to an axis of the first fluid inlet and an axis of the second fluid inlet. The axis of the outlet port may extend between the axis of the first fluid inlet and the axis of the second fluid inlet. An axis of the first fluid inlet may be parallel to and offset from an axis of the second fluid inlet, and the outlet port may have an axis generally perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet. An axis of the first fluid inlet may be generally perpendicular to an axis of the second fluid inlet, and the outlet port may have an axis generally parallel and coincidental to one of the axis of the first fluid inlet and the axis of the second fluid inlet. An axis of the first fluid inlet may be at an angle of between 130° and 165° with respect to an axis of the second fluid inlet, and the outlet port may have an axis at an angle less than 70° with respect to one of the axis of the first fluid inlet and the axis of the second fluid inlet.

In some non-limiting embodiments of the present disclosure, each of the first redirecting surface and the second redirecting surface may be concave-shaped and face a direction of fluid flow of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively. At least one of the first fluid inlet, the second fluid inlet, and the outlet port may have an at least partially helical-shaped rifling on at least a portion of an inner surface of the at least one of the first fluid inlet, the second fluid inlet, and the outlet port for creating a corresponding fluid vortex for at least one of the first injection fluid, the second injection fluid, and the mixture of the first injection fluid and the second injection fluid.

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

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

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

In some non-limiting embodiments of the present disclosure, a connector element may be provided on an exterior or an interior of at least one of the first fluid inlet, the second fluid inlet, and the outlet port.

In some non-limiting embodiments of the present disclosure, a fluid delivery tube set for delivering fluid from a fluid injector to a patient may include: a first inlet tube configured to deliver a first injection fluid; a second inlet tube configured to deliver a second injection fluid; an outlet tube configured to deliver a mixture of the first injection fluid and the second injection fluid to a patient; and a fluid mixing device. The fluid mixing device may include a first fluid inlet configured to conduct the first injection fluid in a first direction. The first fluid inlet may have a first redirecting surface. The fluid mixing device further may include a second fluid inlet configured to conduct the second injection fluid in a second direction. The second fluid inlet may have a second redirecting surface. The fluid mixing device further may include a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and having a third redirecting surface. The mixing chamber may be configured to mix the first injection fluid and the second injection fluid. The fluid mixing device further may include an outlet port in fluid communication with the mixing chamber and distal to the first fluid inlet and the second fluid inlet. The first redirecting surface may be configured to redirect the first injection fluid in a first different direction from the first direction to enter the mixing chamber along the first different direction, and the second redirecting surface may be configured to redirect the second injection fluid in a second different direction from the second direction to enter the mixing chamber along the second different direction. The first different direction and the second different direction may be selected so that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber to turbulently mix the first injection fluid and the second injection fluid in the mixing chamber. A mixture of the first injection fluid and the second injection fluid may exit the fluid mixing device through the outlet port.

In some non-limiting embodiments of the present disclosure, a method for turbulently mixing a first injection fluid and a second injection fluid to form a substantially homogeneous mixture of the first injection fluid and the second injection fluid may include contacting a fluid flow of the first injection fluid with a first concave redirecting surface associated with a first fluid inlet. The method further may include redirecting the fluid flow of the first injection fluid to a first different direction, wherein the first different direction flows at an angle ranging from 90-175° from a fluid flow direction of the first injection fluid and towards a third concave redirecting surface in a mixing chamber. The method further may include contacting a fluid flow of the second injection fluid with a second concave redirecting surface associated with a second fluid inlet. The method further may include redirecting the fluid flow of the second injection fluid to a second different direction, wherein the second different direction flows at an angle ranging from 90-175° from a fluid flow direction of the second injection fluid and towards the third concave redirecting surface in the mixing chamber. The method further may include turbulently mixing the first injection fluid and the second injection fluid in the mixing chamber upon 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 port of the mixing chamber.

Various other non-limiting embodiments of the present disclosure are recited in one or more of the following clauses:

Clause 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 conduct the first injection fluid in a first direction, the first fluid inlet having a first redirecting surface; a second fluid inlet configured to conduct the second injection fluid in a second direction, the second fluid inlet having a second redirecting surface; a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and having a third redirecting surface, the mixing chamber configured to mix the first injection fluid and the second injection fluid; and an outlet port in fluid communication with the mixing chamber and distal to the first fluid inlet and the second fluid inlet, wherein the first redirecting surface is configured to redirect the first injection fluid in a first different direction from the first direction to enter the mixing chamber along the first different direction, and the second redirecting surface is configured to redirect the second injection fluid in a second different direction from the second direction to enter the mixing chamber along the second different direction, wherein the first different direction and the second different direction are selected so that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber to turbulently mix the first injection fluid and the second injection fluid in the mixing chamber, and wherein a mixture of the first injection fluid and the second injection fluid exits the fluid mixing device through the outlet port.

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

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

Clause 4. The fluid mixing device of any one of clauses 1 to 3, wherein the first fluid inlet and the second fluid inlet have a first inlet port and a second inlet port, respectively, wherein the first redirecting surface and second redirecting surface are positioned distally relative to the first inlet port and second inlet port, respectively, and wherein the third redirecting surface is positioned proximally relative to the outlet port, the first redirecting surface, and the second redirecting surface.

Clause 5. The fluid mixing device of any one of clauses 1 to 4, wherein the mixing chamber further comprises a first inlet, wherein the first inlet of the mixing chamber is distal to the third redirecting surface, and wherein the first redirecting surface is positioned distal to the first fluid inlet and at least partially faces the first inlet to the mixing chamber.

Clause 6. The fluid mixing device of any one of clauses 1 to 5, wherein the mixing chamber further comprises a second inlet, wherein the second inlet of the mixing chamber is distant to the third redirecting surface, and wherein the second redirecting surface is positioned distal to the second fluid inlet and at least partially faces the second inlet to the mixing chamber.

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

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

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

Clause 10. The fluid mixing device of clause 9, wherein the concave-shaped surface has a radius of curvature of greater than or equal to 90°.

Clause 11. The fluid mixing device of clause 9, wherein the concave-shaped surface has a radius of curvature of greater than or equal to 150°.

Clause 12. The fluid mixing device of any one of clauses 2 to 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 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 proximal to the second redirecting surface, and wherein the first check valve and the second check valve are reversibly compressible between the first end and the second end in response to first fluid pressure of the first injection fluid flowing through the first inlet port and a second fluid pressure of the second injection fluid flowing through the second fluid port, respectively.

Clause 13. The fluid mixing device of clause 12, wherein the first stop element and the second stop element have a pointed proximal end.

Clause 14. The fluid mixing device of clause any one of clauses 1 to 13, wherein the first inlet port and the second inlet port have a tapered end surface.

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

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

Clause 17. The fluid mixing device of any one of clauses 1 to 14, wherein an axis of the first fluid inlet is parallel to and offset from an axis of the second fluid inlet, and wherein the outlet port has an axis generally perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 18. The fluid mixing device of any one of clauses 1 to 14, wherein an axis of the first fluid inlet is generally perpendicular to an axis of the second fluid inlet, and wherein the outlet port has an axis generally parallel and coincidental to one of the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 19. The fluid mixing device of any one of clauses 1 to 14, wherein an axis of the first fluid inlet is at an angle of between 130° and 165° with respect to an axis of the second fluid inlet, and wherein the outlet port has an axis at an angle less than 70° with respect to one of the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 20. The fluid mixing device of any one of clauses 1 to 19, wherein each of the first redirecting surface and the second redirecting surface are concave-shaped and face a direction of fluid flow of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

Clause 21. The fluid mixing device of any one of clauses 1 to 20, wherein at least one of the first fluid inlet, the second fluid inlet, and the outlet port has an at least partially helical-shaped rifling on at least a portion of an inner surface of the at least one of the first fluid inlet, the second fluid inlet, and the outlet port for creating a corresponding fluid vortex for at least one of the first injection fluid, the second injection fluid, and the mixture of the first injection fluid and the second injection fluid.

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

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

Clause 24. The fluid mixing device of clause 23, wherein the pressure isolation valve comprises a housing having a first lumen in fluid communication with the outlet port, a second lumen configured for connecting to a pressure transducer, and a valve member between the first lumen and the second lumen, wherein the valve member is configured for isolating the second lumen from the outlet port during a fluid injection procedure.

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

Clause 26. A fluid delivery tube set for delivering fluid from a fluid injector to a patient, the fluid delivery tube set comprising: a first inlet tube configured to deliver a first injection fluid; a second inlet tube configured to deliver a second injection fluid; an outlet tube configured to deliver a mixture of the first injection fluid and the second injection fluid to a patient; and a fluid mixing device comprising: a first fluid inlet coupled to the first inlet tube and configured to conduct the first injection fluid in a first direction, the first fluid inlet having a first redirecting surface; a second fluid inlet coupled to the second inlet tube and configured to conduct the second injection fluid in second direction, the second fluid inlet having a second redirecting surface; a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and having a third redirecting surface, the mixing chamber configured to mix the first injection fluid and the second fluid; and an outlet port coupled to the outlet tube and in fluid communication with the mixing chamber, wherein the first redirecting surface is configured to redirect the first injection fluid in a first different direction from the first direction to enter the mixing chamber along the first different direction, and the second redirecting surface is configured to redirect the second injection fluid in a second different direction from the second direction to enter the mixing chamber along the second different direction, wherein the first different direction and the second different direction are selected so that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber to turbulently mix the first injection fluid and the second injection fluid together in the mixing chamber, and wherein a mixture of the first injection fluid and the second injection fluid exits the fluid mixing device via the outlet port.

Clause 27. The fluid delivery tube set of clause 26, further comprising at least one of a first check valve in the first fluid inlet; and a second check valve in the second fluid inlet.

Clause 28. The fluid delivery tube set of clause 26 or 27, wherein the first fluid inlet and the second fluid inlet have a non-circular cross-sectional shape, and wherein the first check valve and the second check valve have a circular cross-sectional shape.

Clause 29. The fluid delivery tube set of any one of clauses 26 to 28, wherein the first fluid inlet and the second fluid inlet have a first inlet port and a second inlet port, respectively, wherein the first redirecting surface and second redirecting surface are positioned distally relative to the first inlet port and second inlet port, respectively, and wherein the third redirecting surface is positioned proximally relative to the outlet port, the first redirecting surface, and the second redirecting surface.

Clause 30. The fluid delivery tube set of any one of clauses 26 to 29, wherein the mixing chamber further comprises a first inlet, wherein the first inlet of the mixing chamber is distal to the third redirecting surface, and wherein the first redirecting surface is positioned distal to the first fluid inlet and at least partially faces the first inlet to the mixing chamber.

Clause 31. The fluid delivery tube set of any one of clauses 26 to 30, wherein the mixing chamber further comprises a second inlet, wherein the second inlet of the mixing chamber is distal to the third redirecting surface, and wherein the second redirecting surface is positioned distal to the second fluid inlet and at least partially faces the second inlet to the mixing chamber.

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

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

Clause 34. The fluid delivery tube set of any of clauses 26 to 33, wherein the third redirecting surface has a substantially concave-shaped surface facing the outlet port.

Clause 35. The fluid delivery tube set of clause 34, wherein the concave-shaped surface has a radius of curvature of greater than or equal to 90°.

Clause 36. The fluid delivery tube set of clause 34, wherein the concave-shaped surface has a radius of curvature of greater than or equal to 150°.

Clause 37. The fluid delivery tube set of any of clauses 26-36, 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 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 proximal to the second redirecting surface, and wherein the first check valve and the second check valve are reversibly compressible between the first end and the second end in response to a first fluid pressure of the first injection fluid flowing through the first inlet port and a second fluid pressure of the second injection fluid flowing through the second fluid port, respectively.

Clause 38. The fluid delivery tube set of clause 37, wherein the first stop element and the second stop element have a pointed proximal end.

Clause 39. The fluid delivery tube set of any of clauses 26 to 38, wherein the first inlet port and the second inlet port have a tapered end surface.

Clause 40. The fluid delivery tube set of any one of clauses 26 to 39, wherein the outlet port has an axis parallel to an axis of the first fluid inlet and an axis of the second fluid inlet.

Clause 44. The fluid delivery tube set of clause 40, wherein the axis of the outlet port extends between the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 42. The fluid delivery tube set of any one of clauses 26 to 39, wherein an axis of the first fluid inlet is parallel to and offset from an axis of the second fluid inlet, and wherein the outlet port has an axis generally perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 43. The fluid delivery tube set of any one of clauses 26 to 39, wherein an axis of the first fluid inlet is generally perpendicular to an axis of the second fluid inlet, and wherein the outlet port has an axis generally parallel and coincidental to one of the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 44. The fluid delivery tube set of any one of clauses 22 to 39, wherein an axis of the first fluid inlet is at an angle of between 130° and 165° with respect to an axis of the second fluid inlet, and wherein the outlet port has an axis at an angle less than 70° with respect to one of the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 45. The fluid delivery tube set of any one of clauses 26 to 44, wherein each of the first redirecting surface and the second redirecting surface are concave-shaped and face a direction of fluid flow of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

Clause 46. The fluid delivery tube set of any one of clauses 26 to 45, wherein at least one of the first fluid inlet, the second fluid inlet, and the outlet port has an at least partially helical-shaped rifling on at least a portion of an inner surface of the at least one of the first fluid inlet, the second fluid inlet, and the outlet port for creating a corresponding fluid vortex for at least one of the first injection fluid, the second injection fluid, and the mixture of the first injection fluid and the second injection fluid.

Clause 47. The fluid delivery tube set of any one of clauses 26 to 46, wherein the outlet port has at least one baffle member or mixing member disposed in an inner surface thereof.

Clause 48. The fluid delivery tube set of any one of clauses 26 to 47, wherein the outlet port further comprises a pressure isolation valve integrated therewith.

Clause 49. The fluid delivery tube set of clause 48, wherein the pressure isolation valve comprises a first lumen in fluid communication with the outlet port, a second lumen configured for connecting to a pressure transducer, and a valve member between the first lumen and the second lumen, wherein the valve member is configured for isolating the second lumen from the outlet port during a fluid injection procedure.

Clause 50. The fluid delivery tube set of any of clauses 26 to 49, further comprising a connector element on an exterior or an interior of at least one of the first fluid inlet, the second fluid inlet, and the outlet port.

Clause 51. A method for turbulently 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 flow of the first injection fluid with a first concave redirecting surface associated with a first fluid inlet; redirecting the fluid flow of the first injection fluid to a first different direction, wherein the first different direction flows at an angle ranging from 90-175° from a fluid flow direction of the first injection fluid and towards a third concave redirecting surface in a mixing chamber; contacting a fluid flow of the second injection fluid with a second concave redirecting surface associated with a second fluid inlet; redirecting the fluid flow of the second injection fluid to a second different direction, wherein the second different direction flows at an angle ranging from 90-175° from a fluid flow direction of the second injection fluid and towards the third concave redirecting surface in the mixing chamber; turbulently mixing the first injection fluid and the second injection fluid in the mixing chamber upon 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 port of the mixing chamber.

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

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

Clause 54. The method of any one of clauses 51 to 53, wherein the first fluid inlet and the second fluid inlet have a first inlet port and a second inlet port, respectively, wherein the first redirecting surface and second redirecting surface are positioned distally relative to the first inlet port and second inlet port, respectively, and wherein the third redirecting surface is positioned proximally relative to the outlet port, the first redirecting surface, and the second redirecting surface.

Clause 55. The method of any one of clauses 51 to 54, wherein the mixing chamber further comprises a first inlet, wherein the first inlet of the mixing chamber is distal to the third redirecting surface, and wherein the first redirecting surface is positioned distal to the first fluid inlet and at least partially faces the first inlet to the mixing chamber.

Clause 56. The method of any one of clauses 51 to 55, wherein the mixing chamber further comprises a second inlet, wherein the second inlet of the mixing chamber is distal to the third redirecting surface, and wherein the second redirecting surface is positioned distal to the second fluid inlet and at least partially faces the second inlet to the mixing chamber.

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

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

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

Clause 60. The method of clause 59, wherein the concave-shaped surface has a radius of curvature of greater than or equal to 90°.

Clause 61. The method of clause 59, wherein the concave-shaped surface has a radius of curvature of greater than or equal to 150°.

Clause 62. The method of any of clauses 51 to 61, 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 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 proximal to the second redirecting surface, and wherein the first check valve and the second check valve are reversibly compressible between the first end and the second end in response to a first fluid pressure of the first injection fluid flowing through the first inlet port and a second fluid pressure of the second injection fluid flowing through the second fluid port, respectively.

Clause 63. The method of clause 62, wherein the first stop element and the second stop element have a pointed proximal end.

Clause 64. The method of any of clauses 51 to 63, wherein the first inlet port and the second inlet port have a tapered end surface.

Clause 65. The method of any one of clauses 51 to 64, wherein the outlet port has an axis parallel to an axis of the first fluid inlet and an axis of the second fluid inlet.

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

Clause 67. The method of any one of clauses 51 to 64, wherein an axis of the first fluid inlet is parallel to and offset from an axis of the second fluid inlet, and wherein the outlet port has an axis generally perpendicular to the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 68. The method of any one of clauses 51 to 64, wherein an axis of the first fluid inlet is generally perpendicular to an axis of the second fluid inlet, and wherein the outlet port has an axis generally parallel and coincidental to one of the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 69. The method of any one of clauses 51 to 64, wherein an axis of the first fluid inlet is at an angle of between 130° and 165° with respect to an axis of the second fluid inlet, and wherein the outlet port has an axis at an angle less than 70° with respect to one of the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 70. The method of any one of clauses 51 to 69, wherein each of the first redirecting surface and the second redirecting surface are concave-shaped and face a direction of fluid flow of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

Clause 71. The method of any one of clauses 51 to 70, wherein at least one of the first fluid inlet, the second fluid inlet, and the outlet port has an at least partially helical-shaped rifling on at least a portion of an inner surface of the at least one of the first fluid inlet, the second fluid inlet, and the outlet port for creating a corresponding fluid vortex for at least one of the first injection fluid, the second injection fluid, and the mixture of the first injection fluid and the second injection fluid.

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

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

Clause 74. The method of clause 73, wherein the pressure isolation valve comprises a first lumen in fluid communication with the outlet port, a second lumen configured for connecting to a pressure transducer, and a valve member between the first lumen and the second lumen, wherein the valve member is configured for isolating the second lumen from the outlet port during a fluid injection procedure.

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

Further details and advantages of the various embodiments described in detail herein will become clear upon reviewing the following detailed description of the various examples in conjunction with the accompanying drawing figures.

DETAILED DESCRIPTION OF THE DISCLOSURE

For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the disclosure as it is oriented in the drawing figures.

Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the disclosure can assume various alternative orientations.

All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. The terms “approximately”, “about”, and “substantially” mean a range of plus or minus ten percent of the stated value.

Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or sub-ratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios 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 herein represent the average values over the specified range and/or ratio.

The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

All documents referred to herein are “incorporated by reference” in their entirety.

The term “at least” is synonymous with “greater than or equal to”.

As used herein, the term “at least one of” is synonymous with “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 alone; or one or more B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C. Similarly, as used herein, the term “at least two of” is synonymous with “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.

The word “comprising” and “comprises”, and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. In the present specification, “comprises” means “includes” and “comprising” means “including”.

As used herein, the terms “parallel” or “substantially parallel” mean a relative angle as between two objects (if extended to theoretical intersection), such as elongated objects and including reference 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 recited values.

As used herein, the terms “perpendicular”, “transverse”, “substantially perpendicular”, or “substantially transverse” mean a relative angle as between two objects at their real or theoretical intersection is from 85° to 90°, or from 87° to 90°, or from 88° to 90°, or from 89° to 90°, or from 89.5° to 90°, or from 89.75° to 90°, or from 89.9° to 90°, inclusive of the recited values.

It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary examples of the disclosure. Hence, specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered as limiting.

When used in relation to a component of a fluid injector system such as a fluid reservoir, a syringe, or a fluid line, the term “distal” refers to a portion of said component nearest to a patient. When used in relation to a component of a fluid injector system such as a fluid reservoir, a syringe, or a fluid line, the term “proximal” refers to a portion of said component nearest to the injector of the fluid injector system (i.e., the portion of said component farthest from the patient). When used in relation to a component of a fluid injector system such as a fluid reservoir, a syringe, or a fluid line, the term “upstream” refers to a direction away from the patient and towards the injector of the fluid injector system. For example, if a first component is referred to as being “upstream” of a second component, the first component is located nearer to the injector along the fluid path than the second component is to the injector. When used in relation to a component of a fluid injector system such as a fluid reservoir, a syringe, or a fluid line, the term “downstream” refers to a direction towards the patient and away from the injector of the fluid injector system. For example, if a first component is referred to as being “downstream” of a second component, the first component is located nearer to the patient along the fluid path than the second component is to the patient.

Although the present disclosure is described primarily in reference to the MEDRAD® Stellant CT Injection System, it will be apparent to persons of ordinary skill in the art that the present disclosure can be applied to a variety of injection systems inclusive of their associated disposables (e.g., syringes, tubing, etc.), such as those designed for CT, CV, MR, PET, ultrasound, and other medical injectors configured to inject two or more medical fluids. In certain embodiments, the fluid mixing device may be suited for use with tubing associated with an angiography injector. Examples of such injection systems include the MEDRAD® Salient CT Injection System, MEDRAD® Stellant FLEX CT Injection System, MEDRAD® Centargo CT Injection System, MEDRAD® MRXperion MR Injection System, MEDRAD® Avanta Injection System, and MEDRAD® Mark 7 Arterion Injection System offered by Bayer HealthCare LLC, Indianola, Pa.

Referring now toFIG.1, a non-limiting example of a fluid injector system100in accordance with the present disclosure includes at least one fluid reservoir, such as at least one syringe12having a reciprocally-movable plunger14, at least one piston connectable to the plunger14, and a fluid control module (not pictured). The fluid injector system100may be configured as a computed tomography (CT) contrast injector system, a magnetic resonance imaging (MRI) contrast injector system, or an angiographic (CV) contrast injector system. The at least one syringe12is generally adapted to interface with at least one component of the system, such as a syringe port13. The fluid injector system100is generally configured to deliver at least one fluid F from the at least one syringe12to a patient during an injection procedure. The fluid injector system100is configured to releasably receive the at least one syringe12, which is to be filled with at least one fluid F, such as a contrast media, saline solution, Ringer's lactate, or any desired medical fluid. The system may be a multi-syringe injector, wherein several syringes may be oriented side-by-side or in another spatial relationship and are separately actuated by respective pistons associated with the injector. The at least one syringe12may be oriented in any manner such as upright, downright, or positioned at any degree angle.

With continued reference toFIG.1, the injector system100may be a dual syringe fluid injector system used during a medical procedure to inject the at least two injection fluids F1and F2into the vasculature system of a patient by driving plungers14of respective syringes12with a drive member, such as a piston (not shown). Alternatively, one or both of the syringes of the dual head fluid injector system may be replaced with a pump, such as a peristaltic pump, without deviating from the scope of the present disclosure. The first and second injection fluids F1and F2may be a suitable contrast imaging agent and a flushing fluid, respectively. The piston may be configured to engage the plunger14. Upon engagement, the at least one piston may move the plunger14toward the distal end19of the at least one syringe12, for example during a fluid delivery operation, as well as retracting the plunger14toward the proximal end11of the at least one syringe12, for example during a filling operation to fill the syringe12.

According to various embodiments, a tubing set17(e.g., first and second fluid conduits17aand17bconfigured for connecting to respective first and second syringes12and common administration line20) may be in fluid communication with an outlet port of each syringe12to place each syringe in fluid communication with a catheter or other fluid delivery device for delivering the fluid F from each syringe12to the a vascular access site. The first and second fluid conduits17aand17bmay be connected to the common administration line20by a fluid mixing device40according to various embodiments of the present disclosure. The fluid injector system100shown inFIG.1is an open system do to the lack of valves configured of isolating the syringes12from one another and from at least a portion of the tubing set17. However, it is to be understood that valves may be added distally of the syringes12to convert the fluid injector system100ofFIG.1to a closed system.

For accurate and efficient administration of volumes of contrast agent during an imaging procedure, many injection protocols require a dual flow administration, i.e., where a mixture of both contrast agent and saline are administered concurrently to the patient. However, because the contrast and the flushing fluid (saline) typically have different physical properties, for example specific gravity, viscosity, and/or surface tension properties, the two solutions may not be thoroughly mixed prior to entering the patient's vascular system leading to reduced image quality. For example, in certain cases where inefficient mixing has occurred, laminar flow of the less viscous faster flowing fluid may occur past the more viscous, slower flowing fluid. While Y-connectors and T-connectors for connecting two fluid conduits to a common administration line are known, conventional Y-connectors and T-connectors may not provide sufficient mixing of the two fluids. Turbulent mixing may improve the efficiency of mixing between the viscous contrast agent and less viscous saline. Examples of connectors having turbulent mixing chambers are described in U.S. Pat. No. 9,555,379, the disclosure of which is incorporated herein by reference. The present disclosure describes new fluid mixing devices that provide improved mixing of viscous and less viscous fluids for contrast enhanced imaging procedures.

FIG.2is a perspective view of a portion of a fluid delivery tube set202that may be used with a dual-head injector, such as the fluid injector system100ofFIG.1in place of the tubing set17, according to some non-limiting embodiments of the present disclosure. As shown, the fluid delivery tube set202includes a first inlet line217a, a second inlet line217b, an outlet line220, and a fluid mixing device240. The first and second inlet lines217aand217bare configured to deliver first and second injection fluids, respectively, to the fluid mixing device240. In one example embodiment, the first and second injection fluids are a contrast media solution and a saline solution, respectively. Furthermore, the outlet line220is configured to deliver a mixture of the first and second injection fluids from the fluid mixing device240to a patient or other downstream fluid path component (e.g., a prime tube).

As will be appreciated herein, the fluid mixing device240is configured to mix the first and second injection fluids.FIGS.3,4,5, and6show top, left, right, and cross-section views, respectively, of the fluid mixing device240. As shown inFIG.6, the fluid mixing device240has a body defining first and second fluid inlets242and244, each of which is configured to conduct a corresponding one of the first and second injection fluids in a corresponding first and second direction248and250. As shown, the second direction250is along a different axis276from the first direction248. In certain embodiments, the axis of the first direction248and the axis of the second direction250may be substantially parallel. In other embodiments, the axis of the first direction248may be angled at an acute or an obtuse angle relative to the second direction250.

With continuing reference toFIG.6, the first and second fluid inlets242and244have corresponding first and second redirecting surfaces252and254. In certain embodiments, one or both of the first and second redirecting surfaces252and254are concave-shaped facing the first and second fluid inlets242and244, respectively, to redirect the flow of fluid. Moreover, the fluid mixing device240further has a mixing chamber256in fluid communication with the first and second fluid inlets242and244through first and second mixing chamber inlets270and272, and an outlet port246in fluid communication with the mixing chamber256. The mixing chamber256is configured to turbulently mix the redirected first and second injection fluids together, for example by turbulently mixing with impact against a third redirecting surface262in mixing chamber256.

More specifically, the first and second redirecting surfaces252and254are configured to redirect a first fluid and a second fluid entering the first and second fluid inlets242and244, respectively, into the mixing chamber256through first and second mixing chamber inlets270and272, where the first and second injection fluids can then be turbulently mixed. Prior to entering the mixing chamber256, the first and second injection fluids independently flow through the first and second fluid inlets242,244, respectively. As the first and second fluids flow through the first and second fluid inlets242,244, respectively, the first and second fluids contact the respective first and second redirecting surfaces252,254at distal ends of the first and second fluid inlets242,244, respectively. The first and second redirecting surfaces252and254are configured to redirect the first and second injection fluids in a corresponding first and second different direction258and260that is different than the corresponding first and second directions248and250. Due to this deflection, the first and second injection fluids enter the mixing chamber256through first and second mixing chamber inlets270and272along the corresponding first and second different directions258and260where the two fluids come into turbulent contact with one another. The first and second different directions258and260are selected so that the first and second injection fluids contact a third redirecting surface262at a proximal end of the mixing chamber256to turbulently mix the first and second injections fluids together in the mixing chamber256. In some embodiments, the third redirecting surface262may have a concave-shaped end facing the outlet port246.

After mixing, the mixture of the first and second injection fluids exits the fluid mixing device240via the outlet port246at a distal end of the fluid mixing device240in a direction along a third axis278. In some embodiments, the third axis278may be parallel with one or both of the first and second axes274,276. In other embodiments, the third axis278may be arranged at an acute or obtuse angle relative to both of the first and second axes274,276.

With continued reference toFIG.6, the first and second fluid inlets242and244each have corresponding first and second inlet ports264and266, configured to respectively attach to a first fluid tubing and a second fluid tubing (shown inFIG.2). In some embodiments, the first fluid tubing and the second fluid tubing may be removably or non-removably connectable to the first and second inlet ports264,266. In embodiments where the first fluid tubing and the second fluid tubing are non-removably connectable to the first and second inlet ports264,266, the first fluid tubing and the second fluid tubing may be connected to the first and second inlet ports264,266by solvent bonding, laser welding, or other attachment means.

As shown inFIG.6, the first and second redirecting surfaces252and254are positioned distally relative to the first and second inlet ports264and266, respectively, and the third redirecting surface262is positioned proximally relative to the outlet port246, and the first and second redirecting surfaces252and254. In one example embodiment, the first and second redirecting surfaces252and254are positioned closer to the outlet port246compared to the position of the than the third redirecting surface262and the outlet port246. Furthermore, the first and second redirecting surfaces252and254may be formed at a distal end of the corresponding first and second fluid inlets242and244, and each of the first and second redirecting surfaces252and254at least partially face the corresponding first and second mixing chamber inlets270and272to the mixing chamber256, respectively.

With continued reference toFIG.6, at least one of the first and second redirecting surfaces252and254may have a concave surface. Concave surface configuration may improve the redirecting nature of the surface with turbulent flow while eliminating corners in which air bubbles may collect or be temporarily suspended during a priming operation. In some embodiments, each of the first and second redirecting surfaces252and254may have a radius of curvature greater than or equal to 90°, and in other embodiments being greater than or equal to 150°. For example, in particular embodiments, each of the first and second redirecting surfaces252and254may have a radius of curvature of from 80° to 160°. In some embodiments, each of the first and second redirecting surfaces252and254may have a radius of curvature between 90° and 180°. Accordingly, the injection fluid from each of the inlet lines217aand217bcontacts the radiused redirecting surfaces252and254, which causes the first and second injection fluids to change the flow direction. In some embodiments, the radiused redirecting surfaces252and254may change the flow direction of the first and second injection fluids, respectively, by an angle ranging from 90° to 150° toward different directions258and260and into the mixing chamber256. As such, the fluids double back and interact with each other, e.g., turbulently mix, in the mixing chamber256in combination with further redirection by the third redirecting surface262. After the fluids mix to a homogenous solution, the mixture of fluids is redirected again by the radius of the third redirecting surface262along a flow direction of the third axis278causing the mixture of the first and second injection fluid to flow down the single outlet line220. In some embodiments, the third redirecting surface262may have a radius of curvature greater than or equal to 90°, more preferably being greater than or equal to 150°. In some embodiments, the third redirecting surface262may have a radius of curvature between 90° and 180°. While known mixing devices (not shown) include some swirling of the injection fluids, various conventional mixing devices may still suffer from a density separation, e.g., higher density fluid spinning to the outside of the lower density fluid, which prevents thorough mixing of the first and second fluids. The fluid mixing device240, by way of contrast, produces a substantially homogeneous mixture of the first and second injection fluids during the turbulent mixing process.

According to various embodiments, the first and second redirecting surfaces252and254may include concave-shaped redirecting surfaces that face directions of flow in the first fluid inlet242and the second fluid inlet244, respectively. Additionally, as shown inFIG.6, the first fluid inlet242, the second fluid inlet244, and the outlet port246all have corresponding axes274,276, and278. In some embodiments, the third axis278of the outlet port246may be positioned between the first and second axes274and276of the first and second fluid inlets242and244, respectively. In other embodiments, the third axis278of the outlet port246may be positioned above or below the first and second axes274and276of the first and second fluid inlets242and244, respectively. In other embodiments, the third axis278of the outlet port246may be coaxial with one of the first and second axes274and276of the first and second fluid inlets242and244. In other embodiments, the first and second different direction258and260of the fluids entering the mixing chamber256may be angled toward each other with a 0 degree to 90 degree angle so that the first and second fluids directly impact each other and turbulently mix.

In operation, the first injection fluid enters the first fluid inlet242and the second injection fluid enters the second fluid inlet244, each from a corresponding one of the first and second inlet lines217aand217b(shown inFIG.2). The first and second injection fluids then pass through the respective first and second fluid inlets242and244until they reach the first and second redirecting surfaces252and254. When the first injection fluid engages the first redirecting surface252, the first fluid is redirected in the direction258into the mixing chamber256. Similarly, when the second injection fluid engages the second redirecting surface254through first mixing chamber inlet270, the second fluid is redirected in the direction260into the mixing chamber256. At this point, the first and second injection fluids, by having been redirected into the mixing chamber256through the second mixing chamber inlet272, are turbulently mixed together by the flow of the first and second fluids impacting each other and the third redirecting surface262in the mixing chamber256. The mixture of the first and second injection fluids is simultaneously engaged with the third redirecting surface262, upon which time it is redirected through the outlet port246and into the outlet line220, in order to be delivered to the patient or other downstream fluid path component. According to various embodiments, the first and second fluids may be at least partially redirected to flow in opposite directions, such as one flowing in a clockwise direction and the other flowing in a counter-clockwise direction in the mixing chamber256such that the flow of the first and second fluids engage and impact each other head on to create turbulent mixing. For example, the change of inertia associated with the impact of one fluid flowing in a clockwise flow direction and the other fluid flowing in a counterclockwise flow direction results in a turbulently mixed solution of the first and second fluid as the two fluids interact within mixing chamber256. Depending on the mixing ratio and flow rates of the first and second injection fluids, the first and second injection fluids may mix solely in the mixing chamber256, or in the mixing chamber256and in the area of at least one of first redirecting surface252and second redirecting surface254.

FIG.7is a section view of another embodiment of the fluid mixing device340, according to another example of the present disclosure where at least one of the first fluid inlet342, the second fluid inlet344, and the outlet port346include a helical “rifling” pattern on an inner surface to further direct and rotate the respective fluid flow in the inlet and/or outlet and increase turbulent mixing of the first and second fluids. The pattern may include one or more at least partially helical protrusions or indentations recessed into the inner surface or protruding from the inner surface of at least one of the first fluid inlet342, the second fluid inlet344, and the outlet port346. The pattern imparts a rotation of the flow of the fluid within the corresponding fluid path. In the example ofFIG.7, the first fluid inlet342, the second fluid inlet344, and the outlet port346each have an at least partially helical-shaped portion343,345, and347for generating a corresponding fluid vortex for at least one of the first injection fluid, the second injection fluid, and the mixture of the first and second injection fluids, respectively, as the respective fluids flow through the channels. The helical-shaped portion in one of the inlets or outlet may have directionality (clockwise or counterclockwise) in the same or different direction and may have different dimensions or pitch as the helical-shaped portion in the other portions of the mixing device340. Although the first and second fluid inlets342and344and the outlet port346each have helical-shaped portions343,345, and347, it will be appreciated that any number of the aforementioned regions may be provided with a helical-shaped portion, without departing from the scope of the disclosed concept. By having the helical-shaped portions343,345, and347, mixing may advantageously be further improved. It will be appreciated that the fluid mixing device340otherwise functions the same as the fluid mixing device240discussed above.

In another embodiment of a fluid mixing device440of the present disclosure, as shown inFIG.8, the outlet port446of the fluid mixing device440may have one or more baffle members or mixing members447located on an interior thereof. The baffle member447may advantageously further improve mixing of the first and second injection fluids. It will be appreciated that the fluid mixing device440otherwise functions the same as the fluid mixing device240, discussed above. In other embodiments, the fluid mixing device may include one or more baffle member or mixing member in one or both of the first and second fluid inlets.

FIG.9shows yet a further example of a fluid mixing device540, in accordance with another embodiment of the present disclosure. As shown, the fluid mixing device540may include a first valve543in the first fluid inlet542configured to prevent backflow of the second injection fluid into the first fluid inlet542and fluid line217a. Furthermore, the fluid mixing device540may include a second valve545in the second fluid inlet544configured to prevent backflow of the first injection fluid into the second fluid inlet544and fluid line217b. Under the injection pressures typical of a fluid injection procedure, when the pressure of one fluid in the upstream fluid path and fluid inlet is greater than the pressure of the other fluid in the upstream other fluid path and other fluid inlet, backflow of the fluid under greater pressure into the lower pressure fluid path may result in undesired mixing of the fluids in the upstream fluid path or other upstream components of the fluid injection system. This may lead to inaccurate dosing of contrast agent due to the undesired mixing of the two fluid prior to the controlled mixing in the fluid mixing device and may lead to decreased image quality and exposure of the patient to unnecessary excess contrast agent. Otherwise, the fluid mixing device540functions the same as the fluid mixing device240.

In another embodiment of a fluid mixing device640of the present disclosure, as shown inFIGS.10-12, the first direction648(FIG.12) is parallel to, in the opposite direction from, and offset from the second direction650(FIG.12). Furthermore, as shown, the outlet port646of the fluid mixing device640has an axis678generally perpendicular to the first and second directions648and650. Accordingly, the fluid mixing device640provides indirect instead of head-on mixing of the two fluids. For example, the first direction648and the second direction646facilitate a direct collision of stream lines of one-half the diameter of the tubing cross-section and indirect mixing of the other one-half of the stream lines. That is, because of the offset of the two opposing fluid directions648and650, half direct mixing and half indirect mixing occurs in the fluid mixing region.

In yet another embodiment of a fluid mixing device740of the present disclosure, as shown inFIGS.13-15, the first direction748is generally perpendicular to the second direction750. Moreover, the outlet port746of the fluid mixing device740may have an axis778generally parallel and coincidental to an axis774of the first fluid inlet742. In an alternative embodiment, fluid mixing device740(not shown) may have an axis778of an outlet port746generally parallel and coincidental to an axis of a second fluid inlet744. At least one notch745may be provided between two of the first fluid inlet742, the second fluid inlet744, and the outlet port746. The notch745may be provided to conserve material in a transition area between two of the first fluid inlet742, the second fluid inlet744, and the outlet port746to facilitate molding of the fluid mixing device740. According to these embodiments, the perpendicular collision of the flow paths of the first fluid and the second fluid in the fluid mixing device740may create turbulent mixing of the two fluids and limit and/or disrupt any laminar flow of one fluid relative to the other fluid.

In yet another embodiment of a fluid mixing device840of the present disclosure, as shown inFIGS.16-18, the first direction848may be at an angle of between 130° and 165° with respect to the second direction850. Additionally, the outlet port846of the fluid mixing device840may have an axis878at an angle less than 70° with respect to the first direction848. In an alternative embodiment, fluid mixing device840(not shown), the outlet port846may have an axis878at an angle less than 70° with respect to second direction850. According to these embodiments, the angled but substantially opposite flow of the flow paths of the first fluid and the second fluid in fluid mixing device840may create turbulent mixing of the two fluids and limit and/or disrupt any laminar flow of one fluid relative to the other fluid.

Other examples of fluid mixing devices940A,940B, and940C, in accordance with various embodiments of the present disclosure, are shown inFIGS.19-21. According to these embodiments, the fluid mixing device940A,940B, and940C has a T-shaped 90 degree connector design having one or more offset fluid paths to enhance mixing of the first fluid and the second fluid. Referring first toFIG.19, fluid mixing device940A includes a first fluid inlet942A and a second fluid inlet944A for a first fluid and a second fluid respectively, and a fluid outlet946A. As can be seen inFIG.19the first fluid flow axis948A is offset from both the second fluid flow axis950A and the fluid outlet flow axis978A. Fluid mixing occurs at least in fluid mixing region980A where offset fluid flow lines of the first fluid along axis948A interact with fluid flow lines of the second fluid line along axis950A to create a turbulent mixing in fluid mixing region980A, which may be further enhanced by the offset of the outlet flow axis978A to the fluid outlet946A.

Referring toFIG.20, fluid mixing device940B includes a first fluid inlet942B and a second fluid inlet944B for a first fluid and a second fluid respectively, and a fluid outlet946B. The fluid mixing device940B also includes a turbulent fluid mixing chamber956B where further turbulent mixing may occur. As can be seen inFIG.20the first fluid flow axis948B is offset from both the second fluid flow axis950B and the fluid outlet flow axis978B. Fluid mixing occurs at least in fluid mixing region980B where the fluid mixing chamber956B and the offset fluid flow lines of the first fluid along axis948B interact with fluid flow lines of the second fluid line along axis950B to create a turbulent mixing in fluid mixing region980B, which may be further enhanced by the offset of the outlet flow axis978B to fluid outlet946B.

Referring toFIG.21, fluid mixing device940C includes a first fluid inlet942C and a second fluid inlet944C for a first fluid and a second fluid respectively, and a fluid outlet946C. The fluid mixing device940C also includes a turbulent fluid mixing chamber956C where further turbulent mixing may occur. As can be seen inFIG.21the first fluid flow axis948C is offset from and the fluid outlet flow axis978C, particularly on the side of the flow path opposite the second fluid inlet944C. Fluid mixing occurs at least in fluid mixing region980C where the fluid mixing chamber956C and the fluid flow lines of the first fluid along axis948C interact with fluid flow lines of the second fluid line along axis950C to create a turbulent mixing in fluid mixing region980C, which may be further enhanced by the offset of the outlet flow axis978C to the fluid outlet946C.

FIG.22is a perspective view of a fluid mixing device1040according to some non-limiting embodiments of the present disclosure. The fluid mixing device1040may be used as part of a fluid delivery tube set, such as the fluid delivery tube set202shown inFIG.2, wherein the fluid mixing device1040is connected to a pair of fluid inlet lines and an outlet line. As shown inFIG.22, the fluid mixing device1040has a body defining first and second fluid inlets1042and1044, each of which is configured to conduct a corresponding one of the first and second injection fluids. The fluid mixing device1040further has an outlet port1046that is configured for delivering a mixture of the first and second injection fluids from the fluid mixing device1040to the patient or other downstream fluid path component.

With reference toFIG.23, which is an exploded perspective view of the fluid mixing device1040shown inFIG.22, the fluid mixing device1040has a body1041with a first portion1043and a second portion1045. In some embodiments, the first portion1043and the second portion1045may be manufactured separately and are connected together to form the body1041of the fluid mixing device1040. Desirably, the first portion1043and the second portion1045are connected together in a non-removable manner, such as by adhesive, welding (e.g., laser welding or ultrasonic welding), friction fit, solvent gluing, or other non-removable connection mechanism. In some embodiments, the first portion1043and the second portion1045may be removably connected together.

With continued reference toFIG.23, the first portion1043defines a portion of the first and second fluid inlets1042and1044, and has a receiving cavity1047for receiving a check valve1049in each of the first and second fluid inlets1042and1044. The second portion1045has a corresponding inner cavity1051(shown inFIG.24A) that is configured to receive the first portion1043, including the check valves1049. A second part of the first and second fluid inlets1042and1044is defined by the inner cavity1051of the second portion1045(shown inFIGS.24A-24B). Once the first portion1043, including the check valves1049, is inserted into the second portion1045, the first portion1043and the second portion1045may be joined together at one or more contact points between the first portion1043and the second portion1045.

Each check valve1049may be configured to prevent backflow of the first and second injection fluids during injection procedures where fluid pressures in the respective first and second tubes delivering the first and second injection fluids to the fluid mixing device1040are not equal. The check valves1049may be made from a compressible material, such as an elastomeric polymer, that may be compressed under the pressurized flow of the fluid from an expanded state to a compressed state. The compressible material may be selected as appropriate to provide the appropriate stiffness so that the check valve opens at a selected fluid pressure. The check valves1049may also be used to isolate the fluid injector system from dampening a hemodynamic blood pressure signal, as discussed herein with reference toFIGS.28-30. In some embodiments, the check valves1049may be used to isolate contamination from patient to patient when the fluid mixing device1040is configured for multi-patient use. Furthermore, the check valves1049prevent “dribbling” of the first and second injection fluids to the outlet after the injection of first and second injection fluids ceases, such as due to release of built-up capacitance or “swelling” of the fluid injector components under pressure.

With reference toFIGS.24A-24B, which show a cross-sectional plan view of the fluid mixing device1040taken along line F-F shown inFIG.22, the check valves1049are shown positioned in the receiving cavity1047of each of the first and second fluid inlets1042and1044of the first portion1043. The receiving cavity1047for each valve1049is aligned with a direction of fluid flow through each of the first and second fluid inlets1042and1044. Each check valve1049has a proximal end1053that is configured to be in contact with a corresponding sealing face1055on the first and second fluid inlets1042and1044in the first portion1043when the check valve1049is in a closed position (FIG.24A), and that is configured to be spaced apart from the sealing face1055on the first and second fluid inlets1042and1044in the first portion1043when the check valve1049is in an open position (FIG.24B). Each check valve1049further has a distal end1057that is engaged with a stop element1059positioned within each of the first and second fluid inlets1042and1044. In some embodiments, each stop element1059may be a support structure that is connected to an inner sidewall of the respective first and second fluid inlet1042,1044downstream of the check valve1049and is configured to prevent movement of the distal end1057of the check valve1049, thus allowing the check valve1049to compress when subject to a pressure force on the proximal end1053. In some embodiments, each stop element1059may have a pointed proximal end1071that is configured to reduce the contact area with the check valve1049, thereby allowing for a greater compression of the check valve1049between its proximal and distal ends1053and1057at a lower fluid pressure. For example, under pressure, the distal end1057may compress and mold around the pointed proximal end1061of the stop element1059allowing the outer circumference of the proximal end1053to more readily release from the sealing face1055. In this manner, the pointed stop element1059allows for decreased pressure drops by allowing easier opening during injections compared to stop elements with a flat supporting surface. In some embodiments, stop element1059is made from a silicone material.

During an injection procedure, the first and second injection fluids are urged under pressure through the first and second fluid inlets1042and1044such that the first and second fluids engage respective proximal ends1053of the check valves1049. Initially, the proximal ends1053engage the sealing face1055on the first portion1043(FIG.24A) to block the passage of the first and second injection fluids past the check valve1049. As the fluid pressure builds, the force on the proximal end1053of the check valves1049increases. Due to the compressible nature of each check valve1049, the proximal end1053is urged in the distal direction, thereby creating a gap between the proximal end1053of the check valves1049and the sealing face1055on the first portion1043. As shown inFIG.24B, such a gap is formed only when sufficient fluid pressure P is imparted on the proximal end1053, such as, for example, during a typical injection procedure. The pressurized first and second injection fluids then travel around the respective check valves1049and through the fluid mixing device1040, as described herein. During the injection procedure, if the pressure of one of the first and second injection fluids is higher than the pressure of the other of the first and second injection fluids, the check valve1049in the fluid inlet with the lower pressure may close to prevent a backflow of the fluid in an upstream direction, for example due to the back pressure of the higher pressure fluid on the distal end1055of the lower pressure check valve1049. After the injection procedure is completed, the resilient nature of each check valve1049causes the check valve1049to expand axially such that the proximal end1053engages the sealing face1055on the first portion1043to prevent additional fluid from flowing past the check valve1049. In this manner, any excess fluid is prevented from flowing through the fluid mixing device1040after the completion of the injection procedure. Further, any backflow of one fluid into the other fluid path is prevented.

With reference toFIG.25, and with continued reference toFIGS.24A-24B, each check valve1049is dimensioned such that its outer diameter is slightly smaller than an inner diameter of a channel1060defined by the receiving cavity1047of the first portion1043(shown inFIGS.23A-24B) and the corresponding inner cavity1051of the second portion1045of the body1043(shown inFIG.26). In this manner, fluid may pass around the body of each check valve1049and through the channel1060. In some embodiments, the channel1060may have a non-circular cross-section and the check valve1049may have a circular cross-section. In this manner, the channel1060defines a flow path for the first and second injection fluids to flow around the respective check valves1049, when the check valve1049is in the open position.

In some embodiments, as shown inFIG.26, the channel1060may have a fluted cross-section with one or more flutes1061. In embodiments where the channel1060has a plurality of flutes1061, the flutes1061may be spaced apart from each other at equal or unequal spacing about a perimeter of the channel1060. The number of flutes1061, the radial depth, and/or the circumferential width of the flutes1061may be selected based on a desired flow rate of the first and second fluids through the channel1061when the respective check valves1049are in the open position.

Each check valve1049is desirably an elastomeric part that is at least partially compressible in a longitudinal direction when acted upon by fluid pressure. The check valve1049in the first fluid inlet1042may be the same or different compared to the check valve1049in the second fluid inlet1044. In some embodiments, the opening pressure of each check valve1049may be selected based on the characteristics of the fluid injector, and/or the characteristics of the first and second injection fluids, such as the fluid viscosity, and the temperature range, flow rate range, and the pressure range at which the first and second injections fluids will be injected.

With reference toFIG.27, an inlet opening1065surrounding the sealing face1055(shown inFIG.24A) may have a shape that corresponds to the shape of the channel1060(shown inFIG.25). The inlet opening1065may have a taper1067that tapers radially inward in a direction from the proximal end toward the distal end of the fluid mixing device1040. The cross-sectional shape of the inlet opening1065is chosen to achieve a low pressure drop and a lower opening pressure for the check valve1049.

With reference toFIGS.24A-24B, it will be appreciated that the fluid mixing device1040creates turbulent mixing of the first and second fluids similar to the fluid mixing device240, discussed herein. As shown inFIGS.24A-24B, the first and second fluid inlets1042and1044have corresponding first and second redirecting surfaces1052and1054. Moreover, the fluid mixing device1040further has a mixing chamber1056in fluid communication with the first and second fluid inlets1042and1044and an outlet port1046in fluid communication with the mixing chamber1056. The mixing chamber1056is configured to turbulently mix the first and second injection fluids together.

With continued reference toFIGS.24A-24B, the first and second redirecting surfaces1052and1054are configured to redirect a first fluid and a second fluid entering the first and second fluid inlets1042and1044, respectively, into the mixing chamber1056, where the first and second injection fluids can then be turbulently mixed. As discussed herein with reference toFIG.6, the first and second redirecting surfaces1052and1054are configured to redirect the first and second injection fluids in a corresponding first and second different directions that are different than the corresponding first and second directions in which the first and second injection fluids flow prior to contacting the first and second redirecting surfaces1052and1054. Due to this deflection, the first and second injection fluids enter the mixing chamber1056along the corresponding first and second different directions and contact a third redirecting surface1062at a proximal end of the mixing chamber1056to turbulently mix the first and second injections fluids together in the mixing chamber1056. After mixing, the mixture of the first and second injection fluids exits the fluid mixing device1040via the outlet port1046at a distal end of the fluid mixing device1040.

With reference toFIG.25, the outlet port1046may have a connection element1070configured for permitting removable connection of the outlet port1046with outlet tubing, such as the outlet line220shown inFIG.2. The connection element1070may be a male luer lock that is configured to removably connect with a corresponding female luer lock on the proximal end of the outlet line220. In some embodiments, the connection element1070may be a female luer lock that is configured to removably connect with a corresponding male luer lock on the proximal end of the outlet line220. In other embodiments, fluid path connectors such as described in International PCT Application Nos. PCT/US2021/018523 and PCT/US2016/063448, the disclosures of which are incorporated by this reference. In this manner, the fluid mixing device1040can be removably connected to an outlet line220to thereby permit the use of the fluid mixing device1040with multiple patients, for example if one or more check valves are attached upstream of the connector on the outlet port1046.

In another embodiment of the present disclosure, as shown inFIGS.28-30, a fluid mixing device1140having a body1141defining first and second fluid inlets1142and1144, each of which is configured to conduct a corresponding one of the first and second injection fluids. The body of the fluid mixing device1140further includes an outlet port1146configured for delivering a mixture of the first and second injection fluids to outlet tubing (not shown). The body1141with a first portion1143and a second portion1145that are non-removably or removably connected together. A check valve1149is disposed in a channel1155of each of the first and second fluid inlets1142and1144(shown inFIG.29) and is configured to be opened under pressure to permit a flow of the first and second injection fluids toward the outlet port1146. The structure and functionality of the fluid mixing device1140shown inFIGS.28-30is substantially identical to the structure and functionality of the fluid mixing device1040described herein with reference toFIGS.22-27. Accordingly, only the relative differences between the two embodiments will now be discussed.

With reference toFIGS.28-30, the outlet port1146may have a pressure isolation valve1150configured to allow for connecting a pressure transducer to the fluid path so that hemodynamic blood pressure signal readings may be obtained during fluid delivery. The pressure isolation valve1150isolates the high pressure fluid injector system from interfering with a low pressure measurement of a hemodynamic blood pressure signal.

The pressure isolation valve1150includes a housing1152, which may be a unitary structure or, preferably, a multi-piece structure as shown inFIG.29. For example, the housing1152is a two-piece housing including a first portion1152aand a second portion1152b, which are adapted to connect together to form the housing1150. The first and second portions1152a,1152bare preferably formed for non-removable engagement with each other. Non-limiting examples of suitable pressure isolation valves are described in U.S. Pat. Nos. 6,866,654; 7,611,503; 8,919,384; and 8,992,489, the disclosures of which are incorporated by reference.

With reference toFIG.30, the first portion1152aof the housing1152defines a high pressure lumen1154, which forms a high pressure side of the pressure isolation valve1150. The high-pressure lumen1154is in fluid communication with the outlet port1146. The second portion1152bof the housing1152defines a low pressure lumen1156, which generally forms a low pressure side of the pressure isolation valve1150. The second portion1152bof the housing1152further includes a pressure isolation port1158to which a pressure transducer (not shown) may be connected. The structure forming pressure isolation port1158may terminate in a luer connector or other suitable medical connector for connecting a pressure transducer to the pressure isolation port1158.

The first and second portions1152a,1152bof the housing1152may define an internal chamber1160generally in fluid communication with the high pressure lumen1154and the low pressure lumen1156. An internal valve member1162is located in the internal chamber1160and is biased to a normally open position, wherein the high pressure lumen1154is in fluid communication with the low pressure lumen1156. The valve member1162is generally further adapted to isolate the low pressure lumen1156once fluid pressure in the high pressure lumen1154reaches a preset pressure. The low pressure lumen1156further includes a flow initiating port1164having a flow initiating valve1166that is generally adapted to initiate a small flow around the valve member1162such that the valve member1162operates to a closed position substantially upon flow initiation.

While various embodiments of fluid mixing devices for mixing two injection fluids have been described herein, similar fluid mixing devices with three or even four total fluid inlets, each having corresponding redirecting surfaces, where the fluid inlets are in fluid communication with a mixing chamber similar to as described herein. Such fluid mixing devices fall within the scope of the present disclosure.

While various embodiments of fluid mixing devices and patient fluid delivery tube sets were provided in the foregoing description, those skilled in the art may make modifications and alterations to these examples without departing from the scope and spirit of the disclosure. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The disclosure described hereinabove is defined by the appended claims, and all changes to the disclosure that fall within the meaning and the range of equivalency of the claims are to be embraced within their scope.