MX2022010694A

Fluid mixing set.

Abstract

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 guide the second injection fluid in a direction along an axis different from the first direction and has a second redirecting surface. The mixing chamber is configured to mix the first injection fluid and the second fluid with each other. The mixture of the first injection fluid and the second injection fluid exits the fluid mixing device through the outlet port.

MX2022010694A, drawing sheet 1 — Sheet 1 of 19

Term

14.4 yearsleft in the term

Expires 25 February 2041.

51 claims: 20 independent, 31 dependent

1
Un dispositivo para mezcla de fluidos para mezclar un primer fluido de inyección y un segundo fluido de inyección, el dispositivo para mezcla de fluidos comprende:una primera entrada de fluido configurada para conducir el primer fluido de inyección en una primera dirección, la primera entrada de fluido tiene una primera superficie de redireccionamiento;una segunda entrada de fluido configurada para conducir el segundo fluido de Inyección en una segunda dirección, la segunda entrada de fluido tiene una segunda superficie de redireccionamiento;una cámara de mezclado en comunicación fluidacon la primera entrada de fluido y la segunda entrada de fluido y que tiene una tercera superficie de redireccionamiento, la cámara de mezclado configurada para mezclar el primer fluido de inyección y el segundo fluido de inyección;y un puerto de salida en comunicación fluida con la cámara de mezclado y distal a la primera entrada de fluido y la segunda entrada de fluido;donde la primera superficie de redireccionamiento está configurada para redireccionar el primer fluido de inyección en una primera dirección diferente de la primera d irección para ingresar a la cámara de mezclado a lo largo de la primera dirección diferente, y la segunda superficie de redireccionamiento está configurada para redireccionar el segundo fluido de inyección en una segunda dirección diferente de la segunda dirección para ingresar a la cámara de mezclado a lo largo de la segunda dirección diferente, donde la primera dirección diferente y la segunda dirección diferente están seleccionadas de modo que el primer fluido de inyección y el segundo fluido de inyección contactan la tercera superficie de redireccionamiento de la cámara de mezclado para mezclar por turbulencia el primer fluido de inyección y el segundo fluido de inyección en la cámara de mezclado, y donde una mezcla del primer fluido de inyección y el segundo fluido de inyección sale del dispositivo para mezcla de fluidos a través del puerto de salida.
2
El dispositivo para mezcla de fluidos de la reivindicación 1, que además comprende al menos una entre una primera válvula de control en la primera entrada de fluido, y una segunda válvula de control en la segunda entrada de fluido. Ln/zznz/E/YiAi
3
El dispositivo para mezcla de fluidos de la reivindicación 2, donde la primera entrada de fluido y la segunda entrada de fluido tienen una forma no circular en un corte transversal, y donde la primera válvula de control y la segunda válvula de control tienen una forma circular en un corte transversal.
4
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 3, donde la primera entrada de fluido y la segunda entrada de fluido tienen un primer puerto de entrada y un segundo puerto de entrada, respectivamente, donde la primera superficie de redireccionamiento y la segunda superficie de redireccionamiento están posicionadas distalmente en relación con el primer puerto de entrada y el segundo puerto de entrada, respectivamente, y donde la tercera superficie de redireccionamiento está posicionada proximalmente en relación con el puerto de salida, la primera superficie de redireccionamiento, y la segunda superficie de redireccionamiento.
5
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 4, donde la cámara de mezclado además comprende una primera entrada, donde la primera entradade la cámara de mezclado es distal a la tercera superficie de redireccionamiento, y donde la primera superficie de redireccionamiento está en posición distal a la primera entrada de fluido y al menos parcialmente enfrentada con la primera entrada a la cámara de mezclado.
6
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 5, donde la cámara de mezclado además comprende una segunda entrada, donde la segunda entrada de la cámara de mezclado es distal a la tercera superficie de redireccionamiento, y donde la segunda superficie de redireccionamiento está en posición distal a la segunda entrada de fluido y al menos parcialmente enfrentadacon la segunda entrada a la cámara de mezclado.
7
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 6, donde al menos una de la primera superficie de redireccionamiento y la segunda superficie de redireccionamiento es sustancialmente cóncava y tiene un radio de curvatura mayor o igual a 90°.
8
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 6, donde al menos una de la primera superficie de redireccionamiento y la segunda superficie de redireccionamiento es sustancialmente cóncava y tiene un radio de curvatura mayor o igual a 150°.
9
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 8, donde la tercera superficie de redireccionamiento tiene una superficie con forma sustancialmente cóncava enfrentada al puerto de salida. Ln/zznz/E/YiAi
10
El dispositivo para mezcla de fluidos de la reivindicación 9, donde la superficie con forma cóncava tiene un radio de curvatura mayor o igual a 90°.
11
El dispositivo para mezcla de fluidos de la reivindicación 9, donde la superficie con forma cóncava tiene un radio de curvatura mayor o igual a 150°.
12
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 2 a 11, donde la primera válvula de control tiene un primer extremo acoplado con un primer puerto de entrada en la primera entrada de fluido y un segundo extremo acoplado con un primer elemento de parada proximal a la primera superficie de redireccionamiento, donde la segunda válvula de control tiene un primer extremo acoplado con un segundo puerto de entrada en la segunda entrada de fluido y un segundo extremo acoplado con un segundo elemento de parada proximal a la segunda superficie de redireccionamiento, y donde la primera válvula de control y la segunda válvula de control se pueden comprimir de forma reversible entre el primer extremo y el segundo extremo en respuesta a la primera presión de fluido del primer fluido de inyección que fluye a través del primer puerto de entrada y una segunda presión de fluido del segundo fluido de inyección que fluye a través del segundo puerto de fluido, respectivamente.
13
El dispositivo para mezcla de fluidos de la reivindicación 12, donde el primer elemento de parada y el segundo elemento de parada tienen un extremo proximal puntiagudo.
14
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 13, donde el primer puerto de entrada y el segundo puerto de entrada tienen una superficie de extremo troncocónica.
15
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 14, donde el puerto de salida tiene un eje paralelo a un eje de la primera entrada de fluido y un eje de la segunda entrada de fluido.
16
El dispositivo para mezcla de fluidos de la reivindicación 15, donde el eje del puerto de salida se extiende entre el eje de la primera entrada de fluido y el eje de la segunda entrada de fluido.
17
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 14, donde un eje de la primera entrada de fluido es paralelo y está desplazado de un eje de la segunda entrada de fluido, y donde el puerto de salida tiene un eje generalmente perpendicular al eje de la primera entrada de fluido y el eje de la segunda entrada de fluido. Ln/zznz/E/YiAi
18
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 14, donde un eje de la primera entrada de fluido es generalmente perpendicular a un eje de la segunda entrada de fluido, y donde el puerto de salida tiene un eje generalmente paralelo y coincidente con uno entre el eje de la primera entrada de fluido y el eje de la segunda entrada de fluido.
19
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 14, donde un eje de la primera entrada de fluido tiene una inclinación entre 130° y 165° en relación con un eje de la segunda entrada de fluido, y donde el puerto de salida tie ne un eje con una inclinación menor a 70° con respecto a uno entre el eje de la primera entrada de fluido y el eje de la segundaentrada de fluido.
20
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 19, donde cada una de la primera superficie de redireccionamiento y la segunda superficie de redireccionamiento tiene forma cóncava y está orientada en dirección del flujo de fluido del primer fluido de inyección en la primera entrada de fluido y el segundo fluido de inyección en la segunda entrada de fluido, respectivamente.
21
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 20, donde al menos uno entre la primera entrada de fluido, la segundaentrada de fluido, y el puerto de salida tiene un estriado con forma al menos parcialmente helicoidal en al menos una porción de una superficie interior del al menos uno entre la primera entrada de fluido, la segunda entrada de fluido, y el puerto de salida para crear un correspondiente vórtice de fluido para al menos uno entre el primer fluido de inyección, el segundo fluido de inyección, y la mezcla del primer fluido de inyección y el segundo fluido de inyección.
22
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 21, donde el puerto de salida tiene al menos un elemento deflector o elemento de mezclado dispuesto en una superficie internade este.
23
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 22, donde el puerto de salida además comprende una válvula aisladora de presión integrada con este.
24
El dispositivo para mezcla de fluidos de la reivindicación 23, donde la válvula aisladora de presión comprende un alojamiento que tiene una primera luz en comunicación fluida con el puerto de salida, una segunda luz configurada para conectarse con un transductor de presión, y un elemento frRQn ίη/ΖΖΠΖ/Ε/ΥΙΛΙ de válvula entre la primera luz y la segunda luz, donde el elemento de válvula está configurado para aislar la segunda luz del puerto de salida durante un procedimiento de inyección de fluido.
25
El dispositivo para mezcla de fluidos de cualquiera de las reivindicaciones 1 a 24, que además comprende un elemento conector en un exterior o interior de al menos uno entre la primera entrada de fluido, la segundaentrada de fluido y el puerto de salida.
26
Un conjunto de tubos para suministro de fluidos para suministrar fluidos desde un inyector de fluidos a un paciente, el conjunto de tubos para suministro de fluidos comprende:un primer tubo de entrada configurado para suministrar un primer fluido de inyección;un segundo tubo de entrada configurado para suministrar un segundo fluido de inyección;un tubo de salida configurado para suministrar una mezcla del primer fluido de inyección y el segundo fluido de inyección a un paciente;y el dispositivo para mezcla de fluidos según cualquiera de las reivindicaciones 1 a 24
27
Un método para mezclar por turbulencia un primer fluido de inyección y un segundo fluido de inyección para formar una mezcla sustancialmente homogénea del primer fluido de inyección con el segundo fluido de inyección, el método comprende:poner en contacto un flujo de fluido del primer fluido de inyección con una primera superficie cóncava de redireccionamiento asociada con una primera entrada de fluido;redireccionar el flujo de fluido del primer fluido de inyección hacia una primera dirección diferente, donde la primera dirección diferente fluye con unainclinación dentro del rango de 90 -175° desde una dirección de flujo de fluido del primer fluido de inyección y hacia una tercera superficie cóncava de redireccionamiento en una cámara de mezclado;poner en contacto un flujo de fluido del segundo fluido de inyección con una segunda superficie cóncava de redireccionamiento asociada con una segunda entrada de fluido;redireccionar el flujo de fluido del segundo fluido de inyección hacia una segunda dirección diferente, donde la segunda dirección diferente fluye con unainclinación dentro del rango de 90-175° desde una dirección de flujo de fluido del segundo fluido de inyección y hacia la tercera superficie cóncava de redireccionamiento en la cámara de mezclado;mezclar por turbulencia el primer fluido de inyección y el segundo fluido de inyección en la cámara de mezclado luego del contacto del primer fluido de inyección y el segundo fluido de inyección con la tercera superficie cóncava de redireccionamiento para formar una mezcla del primer fluido de inyección y el segundo fluido de inyección;y redireccionar la mezcla del primer fluido de inyección y el segundo fluido de inyección a través de un puerto de salida de la cámara de mezclado. Ln/zznz/E/YiAi
28
El método de la reivindicación 27, que además comprende al menos una entre una primera válvula de control en la primera entrada de fluido, y una segunda válvula de control en la segunda entrada de fluido.
29
El método de la reivindicación 28, donde la primera entrada de fluido y la segunda entrada de fluido tienen una forma no circular en un corte transversal, y donde la primera válvula de control y la segunda válvula de control tienen una forma circular en un corte transversal.
30
El método de cualquiera de las reivindicaciones 27 a 29, donde la primera entrada de fluido y la segunda entrada de fluido tienen un primer puerto de entrada y un segundo puerto de entrada, respectivamente, donde la primera superficie de redireccionamiento y la segunda superficie de redireccionamiento están posicionadas distalmente en relación con el primer puerto de entrada y el segundo puerto de entrada, respectivamente, y donde la tercera superficie de redireccionamiento está posicionada proximalmente en relación con el puerto de salida, la primera superficie de redireccionamiento, y la segunda superficie de redireccionamiento.
31
El método de cualquiera de las reivindicaciones 27 a 330, donde la cámara de mezclado además comprende una primera entrada, donde la primera entrada de la cámara de mezclado es distal a la tercera superficie de redireccionamiento, y donde la primera superficie de redireccionamiento está en posición distal a la primera entrada de fluido y al menos parcialmente enfrentada con la primera entrada a la cámara de mezclado.
32
El método de cualquiera de las reivindicaciones 27 a 31, donde la cámara de mezclado además comprende una segunda entrada, donde la segunda entrada de la cámara de mezclado es distal a la tercera superficie de redireccionamiento, y donde la segunda superficie de redireccionamiento está en posición distal a la segunda entrada de fluido y al menos parcialmente enfrentadacon la segunda entrada a la cámara de mezclado.
33
El método de cualquiera de las reivindicaciones 27 a 32, donde al menos una de la primera superficie de redireccionamiento y la segunda superficie de redireccionamiento es sustancialmente cóncava y tiene un radio de curvatura mayor o igual a 90°.
34
El método de cualquiera de las reivindicaciones 27 a 33, donde al menos una de la primera superficie de redireccionamiento y la segunda superficie de redireccionamiento es sustancialmente cóncava y tiene un radio de curvatura mayor o igual a 150°. bAan Ln/zznz/E/YiAi Ln/zznz/E/YiAi
35
El método de cualquiera de las reivindicaciones 27 a 34, donde la tercera superficie de redireccionamiento tiene una superficie con forma sustancialmente cóncava enfrentada al puerto de salida.
36
El método de la reivindicación 35, donde la superficie con forma cóncava tiene un radio de curvatura mayor o igual a 90°.
37
El método de la reivindicación 35, donde la superficie con forma cóncava tiene un radio de curvatura mayor o igual a 150°.
38
El método de cualquiera de las reivindicaciones 27 a 37, donde la primera válvula de control tiene un primer extremo acoplado con un primer puerto de entrada en la primera entrada de fluido y un segundo extremo acoplado con un primer elemento de parada proximal a la primera superficie de redireccionamiento, donde la segunda válvula de control tiene un primer extremo acoplado con un segundo puerto de entrada en la segunda entrada de fluido y un segundo extremo acoplado con un segundo elemento de parada proximal a la segunda superficie de redireccionamiento, y donde la primera válvula de control y la segunda válvula de control se pueden comprimir de forma reversible entre el primer extremo y el segundo extremo en respuesta a una primera presión de fluido del primer fluido de inyección que fluye a través del primer puerto de entrada y una segunda presión de fluido del segundo fluido de inyección que fluye a través del segundo puerto de fluido, respectivamente.
39
El método de la reivindicación 38, donde el primer elemento de parada y el segundo elemento de parada tienen un extremo proximal puntiagudo.
40
El método de cualquiera de las reivindicaciones 27 a 39, donde el primer puerto de entrada y el segundo puerto de entrada tienen una superf ¡cíe de extremo troncocónica.
41
El método de cualquiera de las reivindicaciones 27 a 40, donde el puerto de salida tiene un eje paralelo a un eje de la primera entrada de fluido y un eje de la segunda entrada de fluido.
42
El método de la reivindicación 41, donde el eje del puerto de salida se extiende entre el eje de la primera entrada de fluido y el eje de la segunda entrada de fluido.
43
El método de cualquiera de las reivindicaciones 27 a 40, donde un eje de la primera entrada de fluido es paralelo y está desplazado de un eje de la segunda entrada de fluido, y donde el puerto de salida tiene un eje generalmente perpendicular al eje de la primera entrada de fluido y el eje de la segunda entrada de fluido.
44
El método de cualquiera de las reivindicaciones 27 a 40, donde un eje de la primera entrada de fluido es generalmente perpendicular a un eje de la segunda entrada de fluido, y donde el puerto de salida tiene un eje generalmente paralelo y coincidente con uno entre el eje de la primera entrada de fluido y el eje de la segunda entrada de fluido.
45
El método de cualquiera de las reivindicaciones 27 a 40, donde un eje de la primera entrada de fluido tiene una inclinación entre 130° y 165° en relación con un eje de la segunda entrada de fluido, y donde el puerto de salida tiene un eje con una inclinación menor a 70° con respecto a uno entre el eje de la primera entrada de fluido y el eje de la segunda entrada de fluido.
46
El método de cualquiera de las reivindicaciones 27 a 45, donde cada una de la primera superficie de redireccionamiento y la segunda superficie de redireccionamiento tiene forma cóncava y está orientada en dirección del flujo de fluido del primer fluido de inyección en la primera entrada de fluido y el segundo fluido de inyección en la segunda entrada de fluido, respectivamente.
47
El método de cualquiera de las reivindicaciones 27 a 46, donde al menos uno entre la primera entrada de fluido, la segunda entrada de fluido, y el puerto de salida tiene un estriado con forma al menos parcialmente helicoidal en al menos una porción de una superficie interior del al menos uno entre la primera entrada de fluido, la segunda entrada de fluido, y el puerto de salida para crear un correspondiente vórtice de fluido para al menos uno entre el primer fluido de inyección, el segundo fluido de inyección, y la mezcla del primer fluido de inyección y el segundo fluido de inyección.
48
El método de cualquiera de las reivindicaciones 27 a 46, donde el puerto de salida tiene al menos un elemento deflector o elemento de mezclado dispuesto en una superficie internade este.
49
El método de cualquiera de las reivindicaciones 27 a 48, donde el puerto de salida además comprende una válvula aisladora de presión integrada con este.
50
El método de la reivindicación 49, donde la válvula aisladora de presión comprende una primera luz en comunicación fluida con el puerto de salida, una segunda luz configurada para conectarse con un transductor de presión, y un elemento de válvula entre la primera luz y la segunda luz, donde el elemento de válvula está configurado para aislar la segunda luz del puerto de salida durante un procedimiento de inyección de fluido. Ln/zznz/E/YiAi
51
El método de cualquiera de las reivindicaciones 27 a 50, que además comprende un elemento conectar en un exterior o interior de al menos uno entre la primera entrada de fluido, la segunda entrada de fluido y el puerto de salida.

Independent claims51

201 paragraphs in 7 sections, as filed

FLUID MIXING KIT

This application claims priority over United States Provisional Application No. 62/982,995, filed on February 28, 2020, the disclosure of which is incorporated herein by reference in its entirety.

DISCLOSURE BACKGROUND

The present disclosure relates to fluid mixing devices for use with fluid delivery tube assemblies configured for use with fluid injectors. The present disclosure also relates to fluid delivery tube assemblies having such fluid mixing devices.

In many medical diagnostic and therapeutic procedures, a medical professional, such as a physician or radiologist, injects a patient with one or more fluids using an electromechanical fluid injection system. In recent years, a number of electromechanical fluid injection systems have been developed for use in procedures such as angiography (CV), computed tomography (CT), molecular imaging (such as PET (positron emission tomography)), 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 employed to ensure complete injection of the contrast agent bolus and/or adjust the concentration of the contrast agent. In some processes it may be desirable to supply a mixture of the first injection fluid and the second injection fluid.

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

Ln/zznz/E/YiAi

SUMMARY OF THE DISCLOSURE

These and other needs can be met with the non-limiting embodiments described herein, which are directed to improved fluid mixing devices and fluid delivery tube assemblies that include such devices.

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 redirection surface. The fluid mixing device may further include a second fluid inlet configured to conduct the second injection fluid in a second direction. The second fluid inlet may have a second redirection surface. The fluid mixing device may further include a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and have a third redirecting surface. The mixing chamber may be configured to mix the first injection fluid and the second injection fluid. The fluid mixing device may further 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 direction different from the first direction to enter the mixing chamber along the first different direction, and the second redirecting surface may be configured to redirect the second injection fluid in a second direction different from the second direction to enter the mixing chamber along the second different direction. The first different direction and the second different direction can be selected such that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber to turbulence mix the first injection fluid and the second fluid. injection into 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 may further include at least one of a first control valve at the first fluid inlet, and a second control valve at the second fluid inlet. The first fluid inlet and the second fluid inlet may have a non-circular shape in cross section, and the first control valve and the second control valve may have a circular shape in cross section.

In some non-limiting embodiments of the present disclosure, the first fluid inlet and the second fluid inlet may have a first inlet port and a second inlet port, respectively. The first redirection surface and the second redirection surface

Ln/zznz/E/YiAi redirection may be positioned distally relative to the first input port and the second input port, respectively. The third redirecting surface may be positioned proximally relative to the exit port, the first redirecting surface, and the second redirecting surface.

In some non-limiting embodiments of the present disclosure, the mixing chamber may further include a first inlet, where 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 face the first inlet to the mixing chamber. The mixing chamber may further include a second inlet, where the second inlet to 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 face 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 greater than or equal to 90°. The concave-shaped surface may have a radius of curvature greater than or equal to 150°.

In some non-limiting embodiments of the present disclosure, the first control valve may have a first end coupled with a first inlet port of the first fluid inlet and a second end coupled with a first stop element proximal to the first surface of redirection. The second control valve may have a first end engaged with a second inlet port at the second fluid inlet and a second end engaged with a second stop element proximal to the second redirecting surface. The first control valve and the second control 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. The first stop member and the second stop member may have a pointed proximal end. The first inlet port and the second inlet port may have a frustoconical 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.

Ln/zznz/E/YiAi fluid. 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. fluent. An axis of the first fluid inlet may be generally parallel to an axis of the second fluid inlet, and the outlet port may have an axis generally parallel and coincident with one of the axes of the first fluid inlet and the axis of the second fluid inlet. An axis of the first fluid inlet may have an inclination between 130° and 165° with respect to an axis of the second fluid inlet, and the outlet port may have an inclination of less than 70° with respect to one between 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 redirection surface and the second redirection surface may be concave in shape and oriented in the direction of fluid flow of the first injection fluid at 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 groove on at least a portion of an interior surface of the at least one of the first fluid inlet. , the second fluid inlet, and the outlet port to create a corresponding fluid vortex for at least one of the first injection fluid, the second injection fluid, and mixing 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 def reader element or mixing element disposed on an internal surface thereof.

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

The pressure isolating valve may have a first lumen in fluid communication with the outlet port, a second lumen configured to connect with a pressure transducer, and a valve element between the first lumen and the second lumen, where the valve element It is configured to isolate the second lumen of 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 set of fluid delivery tubes for delivering fluid from a fluid injector to a patient may include: a first inlet tube configured to deliver a first fluid injection; a second inlet tube configured to supply 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 redirection surface. The fluid mixing device may further include a second fluid inlet configured to conduct the second injection fluid in a second direction. The second fluid inlet may have a second redirection surface. The fluid mixing device may further include a mixing chamber in fluid communication with the first fluid inlet and the second fluid inlet and have a third redirecting surface. The mixing chamber may be configured to mix the first injection fluid and the second injection fluid. The fluid mixing device may further 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 direction different from the first direction to enter the mixing chamber along the first different direction, and the second redirecting surface may be configured to redirect the second injection fluid in a second direction different from the second direction to enter the mixing chamber along the second different direction. The first different direction and the second different direction can be selected such that the first injection fluid and the second injection fluid contact the third redirecting surface of the mixing chamber to turbulence 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 of turbulent 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 flow of fluid of the first injection fluid with a first concave redirection surface associated with a first fluid inlet. The method may further include redirecting the fluid flow of the first injection fluid to a first different direction, where the first different direction flows with an inclination within the range of 90-175° from a fluid flow direction of the first injection fluid and towards a third concave redirection surface in a mixing chamber. The method may further include contacting a fluid flow of the second injection fluid with a second concave redirection surface associated with a second fluid inlet. The method may also include

Ln/zznz/E/YiAi redirect the fluid flow of the second injection fluid to a second different direction, where the second different direction flows with an inclination within the range of 90-175° from a fluid flow direction of the second injection fluid. injection and towards the third concave redirection surface in the mixing chamber. The method may further include swirl mixing the first injection fluid and the second injection fluid in the mixing chamber after contacting 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 listed in one or more of the clauses below:

Clause 1. A fluid mixing device for mixing a first injection fluid and a second injection fluid, the fluid mixing device comprises: a first fluid inlet configured to conduct the first injection fluid in a first direction, the first fluid inlet fluid has a first redirection surface; a second fluid inlet configured to conduct the second injection fluid in a second direction, the second fluid inlet having 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, 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 redirection surface is configured to redirect the first injection fluid in a first direction different 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 direction different from the second direction to enter the mixing chamber along the second different direction, wherein the first different direction and the second different direction are selected such that the first injection fluid and the second injection fluid contact the third redirection surface of the mixing chamber to turbulence 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 control valve at the first fluid inlet, and a second control valve at the second fluid inlet.

Ln/zznz/E/YiAi

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

Clause 4. The fluid mixing device of any 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 the second redirecting surface are positioned distally relative to the first inlet port and the second inlet port, respectively, and wherein the third redirecting surface is positioned proximally relative to the exit port, the first redirecting surface, and the second redirecting surface.

Clause 5. The fluid mixing device of any 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 distal to the first fluid inlet and at least partially facing the first inlet to the mixing chamber.

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

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

Clause 8. The fluid mixing device of any of clauses 1 to 6, wherein at least one of the first redirection surface and the second redirection 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, where the concave-shaped surface has a radius of curvature greater than or equal to 90°.

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

Clause 12. The fluid mixing device of any of clauses 2 to 11, wherein the first control valve has a first end coupled with a first inlet port

Ln/zznz/E/YiAi at the first fluid inlet and a second end coupled with a first stop member proximal to the first redirecting surface, wherein the second control valve has a first end coupled with a second inlet port at the second fluid inlet and a second end coupled with a second stop element proximal to the second redirecting surface, and wherein the first control valve and the second control valve are reversibly compressible between the first end and the second end in response to the 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 member and the second stop member have a pointed proximal end.

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

Clause 15. The fluid mixing device of any 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 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 a 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 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 coincident with one between the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 19. The fluid mixing device of any of clauses 1 to 14, wherein an axis of the first fluid inlet has an inclination between 1 30° and 165° relative to an axis of the second fluid inlet, and where the outlet port has an axis with an inclination of less than 70° with respect to one between the axis of the first fluid inlet and the axis of the second fluid inlet.

Ln/zznz/E/YiAi

Clause 20. The fluid mixing device of any of clauses 1 to 19, wherein each of the first redirection surface and the second redirection surface has a concave shape and is oriented in the direction of fluid flow of the first injection fluid in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

Clause 21. The fluid mixing device of any of clauses 1 to 20, wherein at least one of the first fluid inlet, the second fluid inlet, and the outlet port has a groove with at least partially helical shape in at least one portion of an interior 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 of clauses 1 to 21, wherein the outlet port has at least one def reader element or mixing element disposed on an internal surface thereof.

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

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

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

Clause 26. A set of tubes for supplying fluids from a fluid injector to a patient, the set of tubes for supplying fluids comprises: a first inlet tube configured to supply a first injection fluid; a second inlet tube configured to supply a second injection fluid; an outer 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 with the first inlet tube and configured to conduct the first injection fluid in a first direction, the first fluid inlet having a first redirection surface; a second fluid inlet coupled to the second inlet tube and 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

Ln/zznz/E/YiAi the second injection fluid; and an outlet port coupled with 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 direction different 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 direction different from the second direction to enter the mixing chamber along the second different direction, wherein the first different direction and the second different direction are selected such that the first injection fluid and the second injection fluid contact the third redirection surface of the mixing chamber to mix by turbulence the first injection fluid and the second fluid injection into 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 27. The fluid supply tube assembly of clause 26, further comprising at least one of a first control valve at the first fluid inlet, and a second control valve at the second fluid inlet.

Clause 28. The fluid supply tube assembly of clause 26 or 27, wherein the first fluid inlet and the second fluid inlet have a non-circular shape in cross section, and where the first control valve and the second Control valve have a circular shape in cross section.

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

Clause 30. The fluid supply tube assembly of any 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 distal to the first fluid inlet and at least partially facing the first inlet to the mixing chamber.

Clause 31. The fluid supply tube assembly of any 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 distal to the second fluid inlet and at least partially facing the second inlet to the mixing chamber.

Ln/zznz/E/YiAi

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

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

Clause 34. The fluid supply tube assembly of any of clauses 26 to 33, wherein the third redirection surface has a substantially concave shaped surface facing the outlet port.

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

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

Clause 37. The fluid supply tube assembly of any of clauses 26-36, wherein the first control valve has a first end coupled with a first inlet port at the first fluid inlet and a second end coupled with a first element stop proximal to the first redirection surface, wherein the second control valve has a first end coupled with a second inlet port at the second fluid inlet and a second end coupled with a second stop element proximal to the second redirecting surface, and wherein the first control valve and the second control 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 supply tube assembly of clause 37, wherein the first stop member and the second stop member have a pointed proximal end.

Clause 39. The fluid supply tube assembly of any of clauses 26 to 38, wherein the first inlet port and the second inlet port have a frusto-conical end surface.

Clause 40. The fluid supply tube assembly of any 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 supply tube assembly 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.

Ln/zznz/E/YiAi

Clause 42. The fluid supply tube assembly of any 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 where 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 supply tube assembly of any 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 where the outlet port has a axis generally parallel and coincident with one between the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 44. The fluid supply tube assembly of any of clauses 22 to 39, wherein an axis of the first fluid inlet has an inclination between 130° and 165° relative to an axis of the second fluid inlet, and where the outlet port has an axis with an inclination of less than 70° with respect to one between the axis of the first fluid inlet and the axis of the second fluid inlet.

Clause 45. The fluid supply tube assembly of any of clauses 26 to 44, wherein each of the first redirection surface and the second redirection surface has a concave shape and is oriented in the direction of fluid flow of the first fluid injection in the first fluid inlet and the second injection fluid in the second fluid inlet, respectively.

Clause 46. The set of fluid supply tubes of any of clauses 26 to 45, where at least one between the first fluid inlet, the second fluid inlet, and the outlet port has a groove with at least partially helical shape in at least at least a portion of an interior 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 supply tube assembly of any of clauses 26 to 46, wherein the outlet port has at least one def reader element or mixing element disposed on an internal surface thereof.

Clause 48. The fluid supply tube assembly of any of clauses 26 to 47, wherein the outlet port further comprises a pressure isolating valve integrated therewith.

Clause 49. The fluid supply tubing assembly of clause 48, wherein the pressure isolating valve comprises a first lumen in fluid communication with the outlet port, a second lumen configured to connect with a pressure transducer, and a member

Ln/zznz/E/YiAi of valve between the first lumen and the second lumen, wherein the valve element is configured to isolate the second lumen from the outlet port during a fluid injection procedure.

Clause 50. The fluid supply tube assembly of any of clauses 26 to 49, further comprising a connecting element on an exterior or interior of at least one of the first fluid inlet, the second fluid inlet and the port of exit.

Clause 51. A method for turbulence 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 toward a first different direction, wherein the first different direction flows with an inclination within the range of 90-175° from a fluid flow direction of the first injection fluid and toward 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 toward a second different direction, wherein the second different direction flows with an inclination within the range of 90-175° from a fluid flow direction of the second injection fluid and toward the third concave redirecting surface in the mixing chamber; turbulence mixing the first injection fluid and the second injection fluid in the mixing chamber after contacting 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 control valve at the first fluid inlet, and a second control valve at 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 shape in cross section, and where the first control valve and the second control valve have a circular shape in a cross section.

Clause 54. The method of any of clauses 51 to 53, wherein the first fluid inlet and the second fluid inlet have a first inlet port and a second inlet port, respectively, wherein the first redirection surface and the second redirection surface They are positioned distally relative to the first entry port and the second entry port, respectively, and wherein the third redirection surface ίη/ζζηζ/Ε/γίΛΐ is positioned proximally relative to the output port, the first redirection surface, and the second redirection surface.

Clause 55. The method of any 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 in position distal to the first fluid inlet and at least partially facing the first inlet to the mixing chamber.

Clause 56. The method of any 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 in position distal to the second fluid inlet and at least partially facing the second inlet to the mixing chamber.

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

Clause 58. The method of any of clauses 51 to 57, where at least one of the first redirection surface and the second redirection 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 redirection surface has a substantially concave shaped surface facing the exit port.

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

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

Clause 62. The method of any of clauses 51 to 60, wherein the first control valve has a first end engaged with a first inlet port at the first fluid inlet and a second end engaged with a first stop element proximal to the first surface redirection, wherein the second control valve has a first end engaged with a second inlet port at the second fluid inlet and a second end engaged with a second stop member proximal to the second redirecting surface, and wherein the first control valve and the second control 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.

Ln/zznz/E/YiAi

Clause 74. The method of clause 73, wherein the pressure isolating valve comprises a first lumen in fluid communication with the outlet port, a second lumen configured to connect with a pressure transducer, and a valve element between the first lumen and the second lumen, where the valve member is configured to isolate 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 interior of at least one of the first fluid inlet, the second fluid inlet, and the outlet port.

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

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a fluid injector system according to some embodiments of the present disclosure.

FIG. 2 is a perspective view of a portion of a fluid delivery tube assembly that may be used with the fluid injector system of FIG. 1.

FIG. 3 is a profile view of the fluid mixing device for the fluid delivery tube assembly of FIG. 2.

FIG. 4 is a plan view of a distal end of the fluid mixing device of FIG. 3.

FIG. 5 is a plan view of a proximal end of the fluid mixing device of FIG. 3.

FIG. 6 is a cross-sectional view of the fluid mixing device of FIGS. 3-5, taken along line A - A in FIG. 4.

FIG. 7 is a cross-sectional view of a fluid mixing device according to another embodiment of the present disclosure.

FIG. 8 is a cross-sectional view of a fluid mixing device according to another embodiment of the present disclosure.

FIG. 9 is a cross-sectional view of a fluid mixing device according to another embodiment of the present disclosure.

FIG. 10 is a top view of a fluid mixing device according to another embodiment.

FIG. 11 is a side view of the fluid mixing device shown in FIG. 10.

FIG. 12 is a cross-sectional view of the fluid mixing device of FIGS. 10-11, taken along line B - B in FIG. eleven.

ίη/ζζηζ/Ε/γίΛΐ

FIG. 13 is a perspective view of a fluid mixing device according to another embodiment.

FIG. 14 is a side view of the fluid mixing device shown in FIG. 13.

FIG. 15 is a cross-sectional view of the fluid mixing device of FIGS. 13-14, taken along line C - C in FIG. 14.

FIG. 16 is a top view of a fluid mixing device according to another embodiment of the present disclosure.

FIG. 17 is a top view of the fluid mixing device shown in FIG. 16.

FIG. 18 is a cross-sectional view of the fluid mixing device of FIGS. 16-17, taken along line D - D in FIG. 17.

FIGS. 19-21 are a cross-sectional view of fluid mixing devices according to additional embodiments of the present disclosure.

FIG. 22 is a perspective view of a fluid mixing device according to another embodiment.

FIG. 23 is an exploded view of a fluid mixing device shown in FIG. 22.

FIG. 24A is a cross-sectional view of the fluid mixing device of FIGS. 22-23, taken along line E - E in FIG. 22, with a control valve shown in the closed position.

FIG. 24B is a cross-sectional view of the fluid mixing device of FIGS. 22-23, taken along line E - E in FIG. 22, with a control valve shown in the open position.

FIG. 25 is a cross-sectional view of the fluid mixing device of FIGS. 22-23, taken along line F - F in FIG. 22.

FIG. 26 is a cross-sectional view of a fluid inlet of the fluid mixing device shown in FIG. 25, taken along line G - G in FIG. 25.

FIG. 27 is a cross-sectional view of a fluid inlet of the fluid mixing device shown in FIG. 25, taken along the line Η - H in FIG. 25.

FIG. 28 is a perspective view of a fluid mixing device coupled with a pressure isolating valve according to another embodiment.

FIG. 29 is an exploded view of a fluid mixing device shown in FIG. 28.

FIG. 30 is a cross-sectional view of the fluid mixing device of FIGS. 28-29, taken along line I - I in FIG. 28.

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DETAILED DESCRIPTION OF THE DISCLOSURE

Hereinafter, for the purposes of the description, the expressions “higher”, “lower”, “right”, “left”, “vertical”, “horizontal”, “upper”, “lower”, “lateral”, "longitudinal", and its derivatives will relate to the disclosure as oriented in the figure drawings.

Spatial or directional terms, such as “left,” “right,” “inside,” “outside,” “up,” “down,” and the like, are not to be considered limiting since the disclosure may assume several alternative orientations.

All numbers used in the specification and claims are to be understood as modified in all cases by the expression “approximately”. 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 deemed to encompass the initial and final values and any subranges or subproportions included therein. For example, an indicated range or ratio of “1 to 10” should be understood to include all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subproportions that begin with a minimum value of 1 or more and end with a maximum value of 10 or less. The ranges and/or ratios disclosed herein represent the average values across the disclosed range and/or ratio.

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

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

The expression “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 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 A, B, and C. Similarly, as used herein, the expression “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 D, E and F.

The expressions “comprises” and “comprising”, and the like, do not exclude the presence of elements or steps other than those enumerated in any claim or in the specification.

Ln/zznz/E/YiAi descriptive as a whole. In the present specification, “comprises” means “includes” and “comprising” means “which includes.”

As used herein, the terms "parallel" or "substantially parallel" mean a relative angle between two objects (if extended to the theoretical intersection), such as elongated objects and including reference lines, that is, from 0° to 5either, or from 0eitherUntil 3either, or from 0either up to 2either, or from 0either up to 1°, or from 0either up to 0.5, or from 0either up to 0.25°, or from 0either up to 0.1°, inclusive of the mentioned values.

As used herein, the terms “perpendicular,” “transverse,” “substantially perpendicular,” or “substantially transverse” mean a relative angle such as between two objects at their actual or theoretical intersection is 85° to 90° or 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° , including the mentioned values.

It is also to be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the specification below, are merely examples of the exemplary disclosure. Therefore, the specific dimensions and other physical characteristics related to the examples disclosed herein are not to be considered limiting.

When used in connection with 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 such component closest to a patient. When used in connection with 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 closest to the injector of the injector system. of fluids (that is, the portion of said component furthest from the patient). When used in connection with 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 toward the injector system. of fluids. For example, if a first component is referred to as being “upstream” of a second component, the first component is located closer to the injector along the fluid path than the second component is to the injector. When used in connection with 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 directed toward the patient and away from the injector of the system. fluid injector. For example, if a first component is referred to as being “downstream” of a second component, the first component is located closer to the patient along the fluid path than the second component is to the patient.

While the present disclosure is described primarily with reference to the Stellant CT MEDRAD® injection system, it will be apparent to those of ordinary skill in the art that the present disclosure can be applied to a variety of injection systems.

Ln/zznz/E/YiAi including their associated disposables (e.g., syringes, tubes, etc.), such as those designed for CT, VC, MRI, PET, ultrasound, and other medical injectors configured to inject two or more medical fluids . In certain embodiments, the fluid mixing device may be suitable for use with tubing associated with an angiography injector. Examples of such injection systems include the Salient CT MEDRAD® injection system, the Stellant FLEX CT MEDRAD® injection system, the Centargo CT MEDRAD® injection system, the MRXperion MR MEDRAD® injection system, the Avanta injection system. MEDRAD®, and the Mark 7 Arterion MEDRAD® Injection System offered by Bayer Healthcare LLC, Indianola, PA.

Referring now to FIG. 1, a non-limiting example of a fluid injector system 100 according to the present disclosure includes at least one fluid reservoir, such as at least one syringe 12 having a reciprocating plunger 14, at least one piston connectable with the plunger 14, and a control fluid module (not shown). The fluid injector system 100 may be configured as a contrast injector system for computed tomography (CT), a contrast injector system for magnetic resonance imaging (MRI), or an angiographic contrast injector system (VC). The at least one syringe 12 is generally adapted to form an interface with at least one component of the system, such as a port of a syringe 13. The fluid injector system 100 is generally configured to deliver at least one fluid F from at least one syringe 12 to a patient during an injection procedure. The fluid injector system 100 is configured to receive and be able to release the at least one syringe 12, which is to be filled with at least one fluid F, such as a contrast medium, saline, Ringer's lactate, or any fluid desired doctor. The system may be a multiple syringe injector, where various syringes may be oriented side by side or in other spatial relationship and are actuated separately by respective pistons associated with the injector. The at least one syringe 12 may be oriented in any manner such as upward, downward, or positioned at any angle.

Continuing with reference to FIG. 1, the injector system 100 may be a dual syringe fluid injector system used during a medical procedure to inject the at least two injection fluids F1 and F2 into the vascular system of a patient by actuating the plungers 14 of respective syringes 12 with a drive element, such as a piston (not shown). Alternatively, one or both syringes of the dual-head fluid injector system may be replaced with a pump, such as a peristaltic pump, without departing from the scope of the present disclosure. The first and second injection fluids F1 and F2 may be a suitable imaging contrast agent and a wash fluid, respectively. The piston may be configured to flush the plunger 14. Upon engagement, the at least one piston may displace the plunger 14 toward the distal end 19 of the at least one syringe 12, for example, during a fluid delivery operation, as well as retract the plunger 14 toward the proximal end frRQn ίη/ΖΖΠΖ/Ε/ΥΙΛΙ of the at least one syringe 12, for example during a filling operation to fill the syringe 12.

According to various embodiments, a set of tubes 17 (e.g., the first and second fluid conduits 17a and 17b configured to connect respectively with the first and second syringe 12 and a common administration line 20) may be in fluid communication with an outlet port of each syringe 12 to bring each syringe into communication fluid with a catheter or other fluid delivery device to deliver fluid F from each syringe 12 to the vascular access site. The first and second fluid conduits 17a and 17b may be connected to the common administration line 20 by a fluid mixing device 40 in accordance with various embodiments of the present disclosure. The fluid injector system 100 shown in FIG. 1 is an open system due to the lack of valves configured to isolate the syringes 12 from each other and from at least a portion of the tube assembly 17. However, it is to be understood that distal valves can be added to the syringes 12 to convert the fluid injector system 100 of FIG. 1 in a closed system.

For accurate and efficient delivery of contrast agent volumes during an imaging procedure, many protocols require dual-flow delivery, that is, where a mixture of both the contrast agent and saline is administered to the patient. concurrently. However, because the contrast and flushing fluid (saline) generally have different physical properties, e.g., specific gravity, viscosity, and/or surface tension properties, the two solutions may not be completely mixed before enter the patient's vascular system, leading to reduced image quality. For example, in certain cases, when efficient mixing does not occur, the laminar flow of the less viscous fluid may flow faster than the more viscous fluid, which flows more slowly. While Y-connectors and T-connectors connecting two fluid conduits to a common delivery line are known, conventional Y-connectors and T-connectors may not provide sufficient mixing of the two fluids. Turbulence mixing can improve the mixing efficiency between the viscous contrast agent and the less viscous saline solution. Examples of connectors having turbulent mixing chambers are described in US Patent 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. 2 is a perspective view of a portion of a fluid delivery tube assembly 202 that can be used with a dual-head injector, such as the fluid injector system 100 of FIG. 1 instead of the tube assembly 17, according to some non-limiting embodiments of the present disclosure. As shown, the water supply tube assembly

Ln/zznz/E/YiAi fluids 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 They are configured to supply a first and a second injection fluid, respectively, to the fluid mixing device 240. In an exemplary embodiment, the first and second injection fluids are a contrast medium solution and a saline solution, respectively. Likewise, the outlet line 220 is configured to supply a mixture of the first and second injection fluids from the fluid mixing device 240 to a patient or other component of the downstream fluid path (e.g., a main tube). .

As will be appreciated herein, the fluid mixing device 240 is configured to mix the first and second injection fluids. FIGS. 3, 4, 5 and 6 show top, left, right and cross-sectional views, respectively, of the fluid mixing device240. As seen in FIG. 6, the fluid mixing device 240 has a body defining a first and a second fluid inlet 242 and 244, each of which is configured to conduct a corresponding first and second fluid for injection in a corresponding first and second direction 248 and 250. As shown, the second direction 250 is along a different axis 276 than the first direction 248. In certain embodiments, the first direction axis 248 and the second direction axis 250 may be substantially parallel. In other embodiments, the axis of the first direction 248 may have an inclination that forms an acute angle or an obtuse angle relative to the second direction 250.

Continuing with reference to FIG. 6, 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 in shape and face the first and second fluid inlets 242 and 244, respectively, to redirect fluid flow. Likewise, the fluid mixing device 240 further has a mixing chamber 256 in fluid communication with the first and second fluid inlets 242 and 244 through the first and second mixing chamber inlets 270 and 272, and an outlet port 246 in fluid communication with the mixing chamber 256. The mixing chamber 256 is configured to turbulence mix between the first and second injection fluids, for example, turbulence mixing with impact collapsing third redirecting surface 262 into a mixing chamber 256.

More specifically, the first and second redirecting surfaces 252 and 254 are configured to redirect a first fluid and a second fluid entering through the first and second inlets 242 and 244, respectively, into the mixing chamber 256 through the first and second inlet of the mixing chamber 270 and 272, where the first and second injection fluid can be mixed by turbulence. Before entering the mixing chamber 256, the first and second injection fluids flow independently through the first and second inlets.

Ln/zznz/E/YiAi of fluid 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 respective first and second redirecting surfaces 252, 254 at 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 fluid in a corresponding different first and second direction 258 and 260 that is different from the corresponding first and second direction 248 and 250. Due to this deflection, the first and second injection fluids enter the mixing chamber 256 through the first and second mixing chamber inlets 270 and 272 along corresponding first and second different directions 258 and 260. where the two fluids come into turbulent contact with each other. The first and second different directions 258 and 260 are selected such that the first and second injection fluids contact a third redirecting surface 262 at a proximal end of the mixing chamber 256 to turbulence mix the first and second fluids together. the second injection fluid 256. In some embodiments, the third redirecting surface 262 may have a concave-shaped end facing the outlet port 246.

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

Continuing with reference to FIG. 6, each of the first and second fluid inlets 242 and 244 have corresponding first and second inlet ports 264 and 266, configured to respectively engage a first fluid tube and a second fluid tube (shown in FIG. 2) . In some embodiments, the first fluid tube and the second fluid tube may be removably or non-removably connected to the first and second inlet ports 264, 266. In embodiments, where the first fluid tube and the second fluid tube can be non-removably connected to the first and second inlet ports 264, 266, the first fluid tube and the second fluid tube can be connected to the first and second inlet ports 264, 266 by solvent bonding, laser welding, or other bonding means.

As shown in FIG. 6, the first and second redirecting surfaces 252 and 254 are positioned distally relative to the first and second inlet ports 264 and 266, respectively, and the third redirecting surface 262 is positioned proximally relative to the inlet port. exit 246, and the first and second redirection surfaces 252 and 254. In an exemplary embodiment, the first and second redirection surfaces 252 and 254 are positioned near the exit port 246 in

Ln/zznz/E/YiAi comparison with the position of the third redirection surface and output port 246. Likewise, the first and second redirection surfaces 252 and 254 may be formed at a distal end of the corresponding first and second fluid inlets 242 and 244, and each of the first and second redirection surfaces 252 and 254 at least partially facing corresponding first and second inlets of mixing chamber 270 and 272 to mixing chamber 256, respectively.

Continuing with reference to FIG. 6, at least one of the first and second redirection surfaces 252 and 254 may have a concave surface. The concave configuration of the surface can improve the redirecting nature of the surface with turbulent flow while eliminating corners in which bubbles can collect or be temporarily suspended during a purging operation. In some embodiments, each of the first and second redirection surfaces 252 and 254 may have a radius of curvature greater than or equal to 90°, and in other embodiments may be greater than or equal to 150°. For example, in particular embodiments, each of the first and second redirection surfaces 252 and 254 may have a radius of curvature between 80° and 160°. In some embodiments, each of the first and second redirection surfaces 252 and 254 may have a radius of curvature between 90° and 180°. Accordingly, the injection fluid from each of the inlet lines 217a and 217b contacts the curved redirection surfaces 252 and 254, causing the flow direction of the first and second injection fluid to change. In some embodiments, the curved redirecting surfaces 252 and 254 can change the flow direction of the first and second injection fluid, respectively, with an angle between 90 ° and 150 ° towards different directions 258 and 260 and towards the mixing chamber 256. Therefore, the fluids are stirred by interacting with each other, for example, by mixing by turbulence, in the mixing chamber 256 in combination with the additional redirection of the third redirection surface 262. After the fluids are mixed forming a homogeneous solution, the fluid mixture is redirected again by the curve of the third redirection surface 262 along a flow direction of the third axis 278 causing the mixture of the first and the second Injection fluid flows downward through the single outlet line 220. In some embodiments, the third redirecting surface 262 may have a radius of curvature greater than or equal to 90°, more preferably greater than or equal to 150°. In some embodiments, the third redirecting surface 262 may have a radius of curvature between 90° and 180°. While some known mixing devices (not shown) include swirling injection fluids, various mixing devices can still undergo density separation, e.g., fluid with higher density spinning away from fluid with lower density. density, which prevents complete mixing of the first fluid and the second fluid. The fluid mixing device 240, on the other hand, produces a mixture substantially

Homogeneous Ln/zznz/E/YiAi of the first and second injection fluid during the turbulence mixing process.

According to various embodiments, the first and second redirection surfaces 252 and 254 may include concave-shaped redirection surfaces facing the fluid directions at the first fluid inlet 242 and the second fluid inlet 244, respectively. Furthermore, as shown in FIG. 6, the first fluid inlet 242, the second fluid inlet 244, and the outlet port 246 all have corresponding shafts 274, 276 and 278. In some embodiments, the third shaft 278 of the outlet port 246 may be positioned between the first and second shafts 274 and 276 of the first and second fluid inlets 242 and 244, respectively. In other embodiments, the third shaft 278 of the outlet port 246 may be positioned above or below the first and second shafts 274 and 276 of the first and second fluid inlets 242 and 244, respectively. In other embodiments, the third shaft 278 of the outlet port 246 may be coaxial with one of the first and second shafts 274 and 276 of the first and second fluid inlets 242 and 244. In other embodiments, the first and second different directions 258 and 260 of the fluids entering the mixing chamber 256 may have an inclination relative to each other forming an angle of 0 degrees to 90 degrees so that the first and second fluids directly impact each other and are mixed by turbulence.

In operation, the first injection fluid enters through the first fluid inlet 242 and the second injection fluid enters through the second fluid inlet 244, each from the corresponding first and second inlet lines 217a and 217b (see FIG. 2). . The first and second injection fluids then pass through the respective first and second fluid inlets 242 and 244 until reaching the first and second redirection surfaces 252 and 254. When the first injection fluid contacts the first injection fluid 252, the first fluid is redirected in direction 258 toward the mixing chamber 256. Similarly, when the second injection fluid contacts the second redirection surface 254 Through the first inlet to the mixing chamber 270, the second fluid is redirected in the direction 260 of the mixing chamber 256. At this point, the first and second injection fluids, having been redirected to the mixing chamber 256 through the second inlet to the mixing chamber 272, are mixed together by turbulence due to the impact of the flow of the first and second injection fluids. of the second fluid and the third redirection surface 262 in the mixing chamber 256. The mixture of the first and second injection fluid simultaneously contacts the third redirecting surface 262, after which it is redirected through the outlet port 246 and towards the outlet line 220, to be delivered to the patient or to another downstream component of the pathway. According to various embodiments, the first and second fluids may be at least partially redirected to flow in opposite directions, such as one flowing clockwise and another flowing counterclockwise in the mixing chamber frRQn Ln/Zznz/E /YIAI

256 in such a way that the flow of the first and second fluids come into contact and impact head-on to mix by turbulence. For example, the change in inertia associated with the impact of one fluid flowing clockwise and the other fluid flowing counterclockwise results in a turbulence-mixed solution of the first and second fluids when both fluids interact in the mixing chamber 256. Depending on the mixing ratio and the flow rates of the first and second injection fluids, the first and second injection fluids may be mixed only in the mixing chamber 256, or in the mixing chamber 256 and in the area of at least one of the first redirection surface 252 and the second redirection surface 254.

FIG. 7 is a sectional view of another embodiment of the fluid mixing device 340, according to another example of the present disclosure, where at least one of the first fluid inlet 342, the second fluid inlet 344, and the port outlet 346 include a helical "flute" pattern on an interior surface to give more rotation and direction to the respective fluid flow at the inlet and/or outlet and increase turbulence mixing of the first and second fluids. The pattern may include one or more protruding or at least partially helical slits indented into or projecting from the interior surface of at least one of the first fluid inlet 342, the second fluid inlet 344, and the outlet port 346. The pattern imparts a rotation of the fluid flow within the corresponding fluid path. In the example of FIG. 7, each of the first fluid inlet 342, the second fluid inlet 344, and the outlet port 346 have an at least partially helical portion 343, 345, and 347 to generate a corresponding fluid vortex for at least one of the first injection fluid and the second injection fluid, and the mixture of the first and the second injection fluid, respectively, when the respective fluids flow through the channels. The helical portion at one of the inlets or outlet may be oriented (clockwise or counterclockwise) in the same or different direction and may have different dimensions or fluting than the helical portion at other portions of the mixing device 34O. Although each one of the first and second fluid inlet 342 and 344 and the outlet port 346 have helical portions 343,345 and 347, It will be appreciated that any number of the aforementioned regions may be provided with a helical portion, without departing from the scope of the disclosed concept. By having helical portions 343, 345 and 347, mixing can be even advantageously improved. It will be appreciated that the fluid mixing device 340 otherwise functions in the same manner as the fluid mixing device 240 discussed above.

In another embodiment of a fluid mixing device 440 of the present disclosure, as shown in FIG. 8, the outlet port 446 of the fluid mixing device 440 may have one or more deflector elements or mixing elements 447 located therein. The deflector element 447 can advantageously improve the mixing of the first and second

Ln/zznz/E/YiAi injection fluid. It will be appreciated that the fluid mixing device 440 otherwise functions in the same manner as the fluid mixing device 240 discussed above. In other embodiments, the fluid mixing device may include one or more reader elements or mixing elements at one or both of the first and second fluid inlets.

FIG. 9 shows a further example of a fluid mixing device 540, according to another embodiment of the present disclosure. As shown, the fluid mixing device 540 may include a first valve 543 at the first fluid inlet 542 configured to prevent backflow of the second injection fluid into the first fluid inlet 542 and fluid line 217a. Likewise, the fluid mixing device 540 may include a second valve 545 at the second fluid inlet 544 configured to prevent reflux of the first injection fluid into the first second fluid inlet 544 and fluid line 217b. At typical injection pressures 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 another fluid inlet, Reflux of the higher pressure fluid into the lower pressure fluid path may result in unwanted mixing of fluids in the upstream fluid path or other upstream components of the fluid injection system. This can lead to inaccurate dosing of the contrast agent due to unwanted mixing of the two fluids prior to controlled mixing in the fluid mixing device and can lead to reduced image quality and exposure of the patient to excess unnecessary contrast agent. Otherwise, the fluid mixing device 540 functions the same as the fluid mixing device 240.

In another embodiment of a fluid mixing device 640 of the present disclosure, as shown in FIGS. 10-12, the first direction 648 (FIG. 12) is parallel, in the opposite direction and offset from the second direction 650 (FIG. 12). Also, as shown, the outlet port 646 of the fluid mixing device 640 has an axis 678 generally perpendicular to the first and second directions 648 and 650. Accordingly, the fluid mixing device 640 provides indirect mixing instead of head-to-head mixing of the two fluids. For example, the first direction 648 and the second direction 646 facilitate a direct collision of the streamlines of half the diameter of the cross section of the tube and the indirect mixing of the other half of the streamlines. That is, due to the displacement of the two opposite fluid directions 648 and 650, direct mixing and indirect mixing occur in one half of the fluid mixing region.

In yet another embodiment of a fluid mixing device 740 of the present disclosure, as shown in FIGS. 13-15, the first direction 748 is generally perpendicular to the second direction 750. Likewise, the outlet port 746 of the fluid mixing device 740 may have an axis 778 generally parallel and coincident with an axis 774 of

Ln/zznz/E/YiAi the first fluid inlet 742. In an alternative embodiment, the fluid mixing device 740 (not shown) may have an axis 778 of an outlet port 746 generally parallel and coincident with an axis of a second fluid inlet 744. At least one notch 745 may be provided between two of the first fluid inlet 742, the second fluid inlet 744 and the outlet port 746. The notch 745 may be provided to retain material in a transition area between the two of the first fluid inlet 742, the second fluid inlet 744, and the outlet port 746 to facilitate molding of the fluid mixing device 740. According to these realizations, The perpendicular collision of the fluid pathways of the first fluid and the second fluid in the fluid mixing device 740 can create turbulent mixing of the two fluids and limit and/or break any laminar flow of one fluid relative to the other fluid.

In yet another embodiment of a fluid mixing device 840 of the present disclosure, as shown in FIGS. 16-18, the first direction 848 may have an inclination between 130° and 165° with respect to the second direction 850. Additionally, the outlet port 846 of the fluid mixing device 840 may have an axis 878 with a smaller inclination. of 70° with respect to the first direction 848. In an alternative embodiment, fluid mixing device 840 (not shown), outlet port 846 may have an axis 878 with an inclination of less than 70° with respect to the second direction 850. According to these embodiments, the inclined but substantially opposing flow of the fluid paths of the first fluid and the second fluid in the fluid mixing device 840 can create turbulent mixing of the two fluids and limit and/or break any flow. laminar of one fluid in relation to the other fluid.

Other examples of fluid mixing devices 940A, 940B, and 940C, in accordance with various embodiments of the present disclosure, are shown in FIGS. 19-21. In accordance with these embodiments, the fluid mixing device 940A, 940B and 940C has a 90 degree T-shaped connecting design with one or more offset fluid paths to improve mixing of the first fluid and the second fluid. With reference to FIG. 19, the fluid mixing device 940A includes a first fluid inlet 942A and a second fluid inlet 944A for a first fluid and a second fluid respectively, and a fluid outlet 946A. As can be seen in FIG. 19, the first fluid flow axis 948A is offset from the second fluid flow axis 950A and the fluid output flow axis 978A. Fluid mixing occurs at least in the fluid mixing region 980A where the displaced fluid flow lines of the first fluid along the axis 948A interact with the fluid flow lines of the second fluid line along along the axis 950A to create turbulent mixing in the fluid mixing region 980A, which can be further improved by moving the outlet flow axis 978A toward the fluid outlet 946A.

With reference to FIG. 20, the fluid mixing device 940B includes a first fluid inlet 942B and a second fluid inlet 944B for a first fluid and a second fluid.

Ln/zznz/E/YiAi fluid respectively, and a 946B fluid outlet. The fluid mixing device 940B also includes a swirl fluid mixing chamber 956B where additional swirl mixing can occur. As can be seen in FIG. 20, the first fluid flow axis 948B is offset from the second fluid flow axis 950B and the fluid output flow axis 978B. Fluid mixing occurs at least in the fluid mixing region 980B where the fluid mixing chamber 956B and the displaced fluid flow lines of the first fluid along the axis 948B interact with the fluid flow lines of the second fluid line along the axis 950B to create turbulent mixing in the fluid mixing region 980B, which can be further improved by shifting the outlet flow shaft 978B toward the fluid outlet 946B.

With reference to FIG. 21, the fluid mixing device 940C includes a first fluid inlet 942C and a second fluid inlet 944C for a first fluid and a second fluid respectively, and a fluid outlet 946C. The fluid mixing device 940C also includes a swirl fluid mixing chamber 956C where additional swirl mixing can occur. As can be seen in FIG. 21, the first fluid flow axis 948C is offset from [sic] and the outlet fluid flow axis 978C, particularly on the side of the flow path opposite the second fluid inlet 944C. Fluid mixing occurs at least in the fluid mixing region 980C where the fluid mixing chamber 956C and the displaced fluid flow lines of the first fluid along the axis 948C interact with the fluid flow lines of the second fluid line along axis 950C to create turbulent mixing in fluid mixing region 980C, which can be further improved by shifting the outlet flow shaft 978C toward the fluid outlet 946C.

FIG. 22 is a perspective view of a fluid mixing device 1040 in accordance with some non-limiting embodiments of the present disclosure. The fluid mixing device 1040 may be used as part of a fluid supply tube assembly, such as the fluid supply tube assembly 202 shown in FIG. 2, where the fluid mixing device 1040 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 body defining a first and a second fluid inlet 1042 and 1044, each of which is configured to conduct a corresponding first and second fluid for injection. The fluid mixing device 1040 further has an outlet port 1046 that is configured to deliver a mixture of the first and second injection fluids from the fluid mixing device 1040 to the patient or other component of the downstream fluid path. .

With reference to 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

In embodiments, the first portion 1043 and the second portion 1045 may be manufactured separately and are connected to each other to form the body 1041 of the fluid mixing device 1040. It is desirable that the first portion 1043 and the second portion 1045 be connected in a non-removable manner, such as by adhesive, welding (for example, laser welding or ultrasonic welding), friction fit, solvent bonding or other non-removable connection mechanism. removable. In some embodiments, the first portion 1043 and the second portion 1045 may be removably connected to each other.

Continuing with reference to FIG. 23, the first portion 1043 defines a portion of the first and second fluid inlets 1042 and 1044, and has a receiving cavity 1047 to receive a control valve 1049 in each of the first and second fluid inlets 1042 and 1044 The second portion 1045 has a corresponding interior cavity 1051 (shown in FIG. 24A) that is configured to receive the first portion 1043, including the control valves 1049. A second portion of the first and second fluid inlets 1042 and 1044 is defined by the interior cavity 1051 of the second portion 1045 (shown in FIGS. 24A-24B). Once the first portion 1043, including the control valves 1049, are inserted into the second portion 1045, the first portion 1043 and the second portion 1045 may be joined at one or more contact points between the first portion 1043 and the second. portion 1045.

Each control valve 1049 may be configured to prevent backflow of the first and second injection fluids during injection procedures where the fluid pressures respectively in the first and second tubes supplying the first and second injection fluids to the fluid mixing device 1040 are not the same. The control valves 1049 may be made of a compressible material, such as an elastomeric polymer, which can be compressed under pressurized flow of fluid from an expanded state to a compressed state. The compressible material can be selected as appropriate to provide the appropriate rigidity so that the control valve opens at a selected fluid pressure. Control valves 1049 may also be used to isolate the fluid injector system from interfering with a hemodynamic blood pressure signal, as set forth herein with reference to FIGS. 28-30. In some embodiments, control valves 1049 may be used to isolate contamination from one patient to another patient when the fluid mixing device 1040 is configured for use with multiple patients. Likewise, the control valves 1049 prevent "dripping" of the first and second injection fluids toward the outlet after injection of the first and second injection fluids has ceased, such as due to the release of accumulated capacity or "bulging." ” of the components of the fluid under pressure injector.

Referring to FIGS. 24A-24B, which show a cross-sectional plan view of the fluid mixing device 1040 taken along the line F - F shown in FIG. 22, the control valves 1049 are shown positioned in the receiving cavity 1047 of each of

Ln/zznz/E/YiAi the first and second fluid inlets 1042 and 1044 and of the first portion 1043. The receiving cavity 1047 of each valve 1049 is aligned with a direction of fluid flow through each of the first and second fluid inlet 1042 and 1044. Each control valve 1049 has a proximal end 1053 that is configured to contact a corresponding sealing face 1055 at the first and second fluid inlets 1042 and 1044 at the first portion 1043 when the control valve 1049 is in a position closed (FIG. 24A), and which is configured to separate from the sealing face 1055 at the first and second fluid inlets 1042 and 1044 at the first portion 1043 when the control valve 1049 is in an open position (FIG. 24B). Each control valve 1049 further has a distal end 1057 that is coupled with a stop element 1059 positioned within each of the first and second fluid inlets 1042 and 1044. In some embodiments, each stop element 1059 may be a support structure that is connected to an interior side wall of the respective first and second fluid inlet 1042, 1044 downstream of the control valve 1049 and is configured to prevent displacement of the distal end 1057 of the control valve 1049, thus allowing the control valve 1049 to be compressed when subjected to a pressure force at the proximal end 1053. In some embodiments, each stop member 1059 may have a pointed proximal end 1071 that is configured to reduce the contact area with the control valve 1049, thereby allowing greater compression of the control valve 1049 between its proximal and distal end 1053. and 1057 with a lower fluid pressure. For example, under pressure, the distal end 1057 may compress and mold around the pointed proximal end 1061 of the stop member 1059 allowing the outer circumference of the proximal end 1053 to be more easily released from the sealing surface 1055. In this way, the Pointed stop element 1059 allows reduced pressure drops by facilitating opening during injections compared to stop elements with a flat support surface. In some embodiments, the stop element 1059 is made of a silicone material.

During an 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 contact the respective proximal ends 1053 of control valves 1049. Initially, the proximal ends 1053 contact the sealing face 1055 in the first portion 1043 (FIG. 24A) to block the passage of the first and second injection fluid through the control valve 1049. As fluid pressure builds , increases the force on the proximal end 1053 of the control valves 1049. Due to the compressible nature of each control valve 1049, the proximal end 1053 is urged in the distal direction, whereby a gap is created between the proximal end 1053 of the control valves 1049 and the sealing face 1055 in the first portion 1043. As shown in FIG. 24B, such a gap is formed only when sufficient fluid pressure P is imparted onto the proximal end 1053, such as, for example, during a typical injection procedure. The first and second pressurized injection fluids then travel around the respective control valves 1049 and through the fluid mixing device 1040, as described herein. During the injection procedure, if the pressure of one of the first and second injection fluids is greater than the pressure of the other first and second injection fluids, the control valve 1049 at the lower pressure fluid inlet may be closed to prevent reflux of fluid in an upstream direction, for example, due to back pressure of the higher pressure fluid on the distal end 1055 of the lower pressure control valve 1049. Once the injection procedure is completed, the resilient nature of each control valve 1049 causes the control valve 1049 to expand axially such that the proximal end 1053 joins the sealing face 1055 at the first portion 1043 to prevent the passage of additional fluid through the control valve 1049. This prevents any excess fluid from flowing through the fluid mixing device 1040 after the injection procedure is completed. Likewise, any reflux of a fluid into the other fluid path is prevented.

With reference to FIG. 25 and continuing with reference to FIGS. 24A-24B, each control valve 1049 is sized such that the outer diameter is slightly smaller than an inner diameter of a channel 1060 defined by the receiving cavity 1047 of the first portion 1043 (shown in FIGS. 23A -24B) and the corresponding interior cavity 1051 of the second portion 1045 of the body 1043 (shown in FIG. 26). In this manner, fluid may pass around the body of each control valve 1049 and through channel 1060. In some embodiments, channel 1060 may have a non-circular cross section and control valve 1049 may have a circular cross section. In this way, channel 1060 defines a flow path for the first and second injection fluids to flow around the respective control valves 1049, when the control valve 1049 is in the open position.

In some embodiments, as shown in FIG. 26, the channel 1060 may have a channeled cross section with one or more channels 1061. In embodiments where the channel 1060 has a plurality of channels 1061, the channels 1061 may be spaced from each other with equal or unequal spacing around a perimeter of the channel 1060. The number of channels 1061, the radial depth, and/or the circumferential width of the channels 1061 can be selected based on the desired flow rate of the first and second fluid through the channel 1061 when the respective control valves 1049 are in the position open.

It is desirable that each control valve 1049 be an elastomeric part that is at least partially compressible in a longitudinal direction when actuated by fluid pressure. The control valve 1049 at the first fluid inlet 1042 may be the same or different compared to the control valve 1049 at the second fluid inlet 1044. In some embodiments, the opening pressure of each control valve 1049 may be selected over the

Ln/zznz/E/YiAi 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 the first and second injection fluids will be injected.

With reference to FIG. 27, an inlet opening 1065 surrounding the sealing face 1055 (shown in FIG. 24A) may have a shape that corresponds to the shape of the channel 1060 (shown in FIG. 25). The inlet opening 1065 may have a taper 1067 that slopes radially inward in a direction from the proximal end toward the distal end of the fluid mixing device 1040. The cross-sectional shape of the inlet opening 1065 is selected to achieve a low depression drop and a low opening pressure for the control valve 1049.

With reference to FIGS. 24A-24B, it will be appreciated that the fluid mixing device 1040 creates turbulent mixing of the first and second fluids similar to the fluid mixing device 240 set forth herein. As shown in FIGS. 24A-24B, the first and second fluid inlets 1042 and 1044 have corresponding first and second redirection surfaces 1052 and 1054. Likewise, the fluid mixing device 1040 further has a mixing chamber 1056 in fluid communication with the first and second fluid inlets 1042 and 1044 and an outlet port 1046 in fluid communication with the mixing chamber 1056. The mixing chamber 1056 is configured to swirl mix the first and second injection fluids with each other.

Continuing with reference to FIGS. 24A-24B, the first and second redirection surfaces 1052 and 1054 are configured to redirect a first fluid and a 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 fluid can then be mixed by turbulence. As set forth herein 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 corresponding first and second different directions that are different from the corresponding first and second different directions in which the first and second injection fluids flow. the second injection fluid before contacting the first and second redirection surfaces 1052 and 1054. Due to this deflection, the first and second injection fluids enter the mixing chamber 1056 along corresponding first and second different directions and contact a third redirecting surface 1062 at a proximal end of the mixing chamber 1056 to turbulence mix the first and second injection fluids with each other in the mixing chamber 1056. After mixing, the mixture of the first and second injection fluid exits the fluid mixing device 1040 through the outlet port 1046 at a distal end of the fluid mixing device 1040.

Ln/zznz/E/YiAi

With reference to FIG. 25, the outlet port 1046 may have a connection member 1070 configured to allow removable connection of the outlet port 1046 to the outlet tubes, such as the outlet line 220 shown in FIG. 2. The connecting element 1070 may be a male luer lock that is configured to removably connect with a corresponding female luer lock at the proximal end of the exit line 220. In some embodiments, the connecting element 1070 may be a female luer lock that is configured to removably connect with a corresponding male luer lock at the proximal end of the outlet line 220. In other embodiments, fluid path connectors such as such as those described in PCT International Applications No. PCT/US2021/018523 and PCT/US2016/063448, the disclosures of which are incorporated herein by reference. In this way, the fluid mixing device 1040 can be removably connected to an outlet line 220 to allow use of the fluid mixing device 1040 with multiple patients, for example, if one or more control valves are connected upstream of the connector at output port 1046.

In another embodiment of the present disclosure, as shown in FIGS. 28-30, a fluid mixing device 1140 has a body 1141 that defines a first and a second inlet 1142 and 1144, each of which is configured to conduct a corresponding first and second fluid for injection. The body of the fluid mixing device 1140 further includes an outlet port 1146 configured to supply a mixture of the first and second injection fluids to outlet tubes (not shown). The body 1141 with a first portion 1143 and a second portion 1145 that are connected to each other in a removable or non-removable manner. A control valve 1149 is disposed in a channel 1155 of each of the first and second fluid inlets 1142 and 1144 (shown in FIG. 29) and is configured to be open under pressure to allow a flow of the first and the second injection fluid towards the outlet port 1146. The structure and functionality of the fluid mixing device 1140 shown in FIGS. 28-30 are substantially identical to the structure and functionality of the fluid mixing device 1040 described herein with reference to FIGS. 22-27. Therefore, only the relative differences between the two embodiments will be discussed below.

With reference to FIGS. 28-30, the outlet port 1146 may have a pressure isolating valve 1150 configured to allow a pressure transducer to be connected to the fluid path so that readings of hemodynamic blood pressure signals can be obtained during fluid delivery. The pressure isolator valve 1150 isolates the injector system from high pressure fluids so that it does not interfere with a low pressure measurement of a hemodynamic blood pressure signal.

ίη/ζζηζ/Ε/γίΛΐ

The pressure isolating valve 1150 includes a housing 1152, which may be a unitary structure or, preferably, a multi-piece structure as shown in FIG. 29. For example, housing 1152 is a two-piece housing that includes a first portion 1152a and a second portion 1152b, which are adapted to connect together to form housing 1150. The first and second portions 1152a, 1152b are preferably formed to engage together in a non-removable manner. Non-limiting examples of suitable pressure isolating valves are described in US Patent Nos. 6,866,654, 7,611,503, 8,919,384 and 8,992,489, the disclosures of which are incorporated by reference.

With reference to FIG. 30, the first portion 1152a of the housing 1152 defines a high pressure lumen 1154, which forms a high pressure side of the pressure isolating valve 1150. The high pressure lumen 1154 is in fluid communication with the outlet port 1146. The Second portion 1152b of housing 1152 defines a low pressure lumen 1156, which generally forms a low pressure side of the pressure isolating valve 1150. The second portion 1152b of the housing 1152 further includes a depression isolation port 1158 to which a pressure transducer can be connected (not shown). The structure forming the pressure isolation port 1158 may terminate in a luer connector or other medical connector suitable for connecting a pressure transducer to the pressure isolation port 1158.

The first and second portions 1152a, 1152b of the housing 1152 may define an internal chamber 1160 generally 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 tends to a normally open position, where the high pressure lumen 1154 is in fluid communication with the low pressure lumen 1156. The valve member 1162 is generally further adapted to isolate the low pressure lumen 1156 once the fluid pressure in the high pressure lumen 1154 reaches a predetermined pressure. The low pressure lumen 1156 further includes a flow initiation port 1164 having a flow initiation valve 1166 that is generally adapted to initiate a small flow around the valve element 1162 such that the valve element 1162 operates toward a position substantially closed at the beginning of the flow.

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

While various embodiments of fluid mixing devices and patient fluid delivery tubing assemblies were provided in the preceding description, those skilled in the art may make modifications and alterations to these examples without departing from the scope.

Ln/zznz/E/YiAi or the spirit of disclosure. Accordingly, the preceding description is intended to be illustrative rather than restrictive. The disclosure described above is defined by the appended claims, and all changes to the disclosure that fall within the meaning and range of equivalence of the claims are to be considered within their scope.

Contents7

41 members in 26 offices

This recordMember, by publication datePriority claim16 more offices are in the list below

Priority claims3

Priority claims
Document	Office	Kind	Date
62982995	United States of America	–	2020-02-28
202062982995	United States of America	P	2020-02-28
2021019507	United States of America	W	2021-02-25

Members41

Family members, oldest first
Document	Office	Kind
CA3173295A1	Canada	A1	2021-09-02
WO2021173743A1	World Intellectual Property Organization (WIPO)	A1	2021-09-02
AU2021227677A1	Australia	A1	2022-09-15
CR20220391A	Costa Rica	A	2022-09-15
BR112022014253A2	Brazil	A2	2022-09-20
MX2022010694AThis record	Mexico	A	2022-09-26
IL295599A	Israel	A	2022-10-01
CN115175726A	China	A	2022-10-11
KR20220147599A	Republic of Korea	A	2022-11-03
CO2022011741A2	Colombia	A2	2022-11-18
EP4110452A1	European Patent Office (EPO)	A1	2023-01-04
US2023063649A1	United States of America	A1	2023-03-02
JP2023515625A	Japan	A	2023-04-13
CL2022002331A1	Chile	A1	2023-04-21
US11712552B2	United States of America	B2	2023-08-01
US2023293874A1	United States of America	A1	2023-09-21
PH12022552286A1	Philippines	A1	2023-12-18
IL295599B1	Israel	B1	2024-05-01
US12070568B2	United States of America	B2	2024-08-27
IL295599B2	Israel	B2	2024-09-01
CN115175726B	China	B	2024-09-24
EP4110452B1	European Patent Office (EPO)	B1	2024-10-16
US2024408371A1	United States of America	A1	2024-12-12
CN119158432A	China	A	2024-12-20
LT4110452T	Lithuania	T	2025-01-10
DK4110452T3	Denmark	T3	2025-01-13
PT4110452T	Portugal	T	2025-01-14
FI4110452T3	Finland	T3	2025-01-17
HRP20241714T1	Croatia	T1	2025-02-14
RS66407B1	Serbia	B1	2025-02-28
ES3003561T3	Spain	T3	2025-03-10
SI4110452T1	Slovenia	T1	2025-03-31
EP4537889A2	European Patent Office (EPO)	A2	2025-04-16
HUE069993T2	Hungary	T2	2025-04-28
PL4110452T3	Poland	T3	2025-04-28
JP7684324B2	Japan	B2	2025-05-27
EP4537889A3	European Patent Office (EPO)	A3	2025-07-16
JP2025107474A	Japan	A	2025-07-17
KR20250116782A	Republic of Korea	A	2025-08-01
AU2021227677B2	Australia	B2	2025-09-11
ZA202409850B	South Africa	B	2025-09-25

Fluid mixing set.

Abstract

Term

FLUID MIXING KIT

DISCLOSURE BACKGROUND

SUMMARY OF THE DISCLOSURE

BRIEF DESCRIPTION OF THE DRAWINGS

DETAILED DESCRIPTION OF THE DISCLOSURE

Priority claims3

Members41

Numbers

Titles2

Classification

Abstract

Term

FLUID MIXING KIT

MUTUAL REFERENCE WITH RELATED REQUEST

DISCLOSURE BACKGROUND

DESCRIPTION OF THE RELATED TECHNIQUE

SUMMARY OF THE DISCLOSURE

BRIEF DESCRIPTION OF THE DRAWINGS

DETAILED DESCRIPTION OF THE DISCLOSURE

Priority claims3

Members41

Numbers

Titles2

Classification