Fluid path connector for medical fluid delivery

Abstract

A fluid path connector for a medical fluid delivery system, the fluid path connector comprising a first connector element and a second connector element, the first connector element comprising a body, a first lumen, a first flexible leg, and a second flexible leg, the second connector element comprising a body defining an undercut, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel, wherein the first flexible leg comprises a first flange and the second flexible leg comprises a second flange, and wherein, upon engagement of the first connector element with the second connector element, the first flange and the second flange engage with the undercut of the body of the second connector element to prevent disengagement of the first connector element and the second connector element.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 705,251, filed June 18, 2020, and U.S. Provisional Patent Application No. 62 / 979,584, filed February 21, 2020, the disclosure of each of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to connectors, syringes, and syringe and connector systems for use in fluid delivery systems, and more particularly to connectors, syringes, and syringe and connector systems for use in medical fluid delivery systems in which one or more fluids are delivered to a patient under time constraints. Background Technology

[0004] In many medical procedures, such as drug delivery, it is necessary to inject fluids into a patient. During diagnostic and therapeutic procedures, various types of fluids can be injected into a patient, such as contrast media (often simply referred to as "contrast") and / or saline. In some medical procedures (such as angiography, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), nuclear medicine, and positron emission tomography (PET)), it is necessary to deliver fluids under high pressure in a timed manner, such as for contrast procedures. Injectors suitable for these applications typically use relatively large-volume syringes and are capable of producing relatively high flow rates.

[0005] Medical personnel are working under increasingly challenging time and physical constraints. Therefore, there is a strong desire to fill syringes or other fluid containers and connect and disconnect fluid delivery system components as quickly as possible. However, filling large syringes with fluids such as contrast media or saline is often a time-consuming process. Conventional syringes have a distal opening, which is typically used to fill the syringe's interior with fluid. The size of this distal opening significantly limits the filling rate. Furthermore, because conventional syringes are usually transported with the plunger in the fully retracted position, filling the syringe first requires moving the plunger to the distal end of the syringe to expel air and begin the fluid filling process. Since the cost of many medical procedures, such as diagnostic imaging, increases with duration, any delay can significantly increase costs.

[0006] Furthermore, in many such fluid delivery systems, it is necessary to form fluid connections between individual fluid path components. For example, it may be necessary to connect an injector-driven infusion tube to a flexible plastic tubing, which in turn connects to a spike connected to a bulk fluid source or a catheter inserted into the patient's body. A commonly used connector in the medical field is a Luer connector or Luer lock. A Luer connector consists of a male connector or component and a female connector or component. The male and female components are typically connected by a friction fit or a radially inwardly projecting thread attached to the female component, which mates with one or more radially outwardly extending flanges on the male Luer component to create a leak-free connection.

[0007] Many fluid connectors used in medical procedures, including Luer connectors, have defects, the most significant of which include fragility, breakage (e.g., due to overtightening), and difficulty in forming a connection, such as requiring time to rotate one or both connectors. Because healthcare professionals face increasingly difficult time and physical constraints during various medical procedures, many fluid path components must often be connected and / or disconnected in a relatively short time under pressure and / or emergency conditions. This can lead to overtightening of Luer connectors, which can compromise the structural integrity of the connector or even cause connector components to break, resulting in leaks and potential air ingress. For many conventional connector configurations, there are no indications (audible or visual) to the user that the connector is properly assembled and does not require further tightening. Furthermore, the cumulative tolerances between male and female components due to variations in the manufacturing process can compromise the seal between the male and female components of a Luer connector. Additionally, in some procedures such as angiography, very high fluid pressures (up to 1200 psi) are used to inject fluid. High pressure can cause conventional Luer connectors to disconnect, for example, by loosening the Luer connector, or by reducing friction between connector components when the male and / or female connectors are wetted.

[0008] Healthcare professionals must connect and / or disconnect fluid delivery systems within a relatively short timeframe and under pressure and / or emergency conditions. Therefore, there is a need to develop syringe adapters configured for filling syringes and / or delivering medical fluids to patients. These adapters feature durable syringe and connector interfaces that allow for simple and quick connection or disconnection without leakage, breakage, or accidental disconnection. Summary of the Invention

[0009] In one example of this disclosure, a fluid path connector for a medical fluid delivery system may include: a first connector element including a body, a first lumen, a first flexible leg, and a second flexible leg; and a second connector element including a body defining an undercut, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel, wherein the first flexible leg includes a first flange, and the second flexible leg includes a second flange, wherein, when the first connector element engages with the second connector element, the first flange and the second flange engage with the undercut of the body of the second connector element to prevent disengagement of the first connector element and the second connector element, and wherein, the sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element engage with each other.

[0010] In another example of this disclosure, the first connector element and the second connector element are each in fluid communication with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tubing kit, and a bulk fluid container. The first flange and the second flange are each angled inward toward the longitudinal axis of the first connector element. The first flange and the second flange are each at an angle of 45-75 degrees relative to the longitudinal axis of the first connector element. The first connector element includes a first actuating arm associated with a first flexible leg and a second actuating arm associated with a second flexible leg, wherein, when an inwardly pointing pressure is applied to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move outward relative to the body of the second connector element to disengage the first flange and the second flange from the undercut, thereby allowing the first connector element and the second connector element to disengage. At least one of the first flexible leg and the second flexible leg includes at least one reinforcing rib. When the first connector element and the second connector element are connected to each other, the first connector element and the second connector element are configured to withstand a fluid pressure of at least 800 psi in the fluid path. The first connector element also includes a support base extending from the body between the first and second flexible legs, wherein the support base is configured to reduce deflection of the body due to fluid pressure exerted by fluid moving through the fluid path. The support base includes at least one reinforcing rib to reduce deflection of the body due to fluid pressure exerted by fluid moving through the fluid path. The sealing element is one of: an elastic O-ring, an overmolded sealing surface, and a quadrilateral ring. The channel is sized such that when the first and second connector elements engage and disengage from each other, at least one sealing element moves in opposite directions within the channel along the longitudinal axis of the second connector element. At least one sealing element moves between a first position and a second position, in which at least one sealing element seals the fluid channel defined in the second connector element to prevent fluid from flowing through the second connector element, and in the second position, at least one sealing element moves out of the fluid channel to allow fluid to flow through the second connector element. At least one of the first and second connector elements also includes a skirt surrounding the body of the first and second connector elements. The skirt extends beyond the distal end of the body of at least one of the first and second connector elements. At least one aperture is defined in the skirt for the second connector element. At least one of the first and second connector elements further includes a fluid path adapter configured to connect at least one of the first and second connector elements to a fluid delivery element. The first connector element includes a slidable sleeve configured to lock the first and second flexible arms when the first connector element engages with the second connector element.

[0011] In another example of this disclosure, a medical fluid delivery system includes: a syringe including a proximal end, a distal end, and a sidewall extending from the proximal end to the distal end; a fluid delivery member; and a fluid path connector including: a first connector element including a body, a first lumen, a first flexible leg, and a second flexible leg; and a second connector element including a body defining an undercut, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel, wherein the first connector element is fluidly connected to the fluid delivery member, wherein the second connector element is fluidly connected to the distal end of the syringe, wherein the first flexible leg includes a first flange, and the second flexible leg includes a second flange, wherein, when the first connector element engages with the second connector element, the first flange and the second flange engage with the undercut of the body of the second connector element to prevent disengagement of the first connector element and the second connector element, and wherein the sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element engage with each other.

[0012] In another example of this disclosure, the first connector element and the second connector element are each in fluid communication with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tubing kit, and a bulk fluid container. The first flange and the second flange are each angled inward toward the longitudinal axis of the first connector element. The first flange and the second flange are each at an angle of 45-75 degrees relative to the longitudinal axis of the first connector element. The first connector element includes a first actuating arm associated with a first flexible leg and a second actuating arm associated with a second flexible leg, wherein, when an inwardly pointing pressure is applied to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move outward relative to the body of the second connector element to disengage the first flange and the second flange from the undercut, thereby allowing the first connector element and the second connector element to disengage. At least one of the first flexible leg and the second flexible leg includes at least one reinforcing rib. When the first connector element and the second connector element are connected to each other, the first connector element and the second connector element are configured to withstand a fluid pressure of at least 800 psi in the fluid path. The first connector element further includes a support base extending from the body between the first flexible leg and the second flexible leg, wherein the support base is configured to reduce deflection of the body due to fluid pressure exerted by fluid moving through the fluid path. The support base includes at least one reinforcing rib to reduce deflection of the body due to fluid pressure exerted by fluid moving through the fluid path. The channel is sized such that when the first connector element and the second connector element engage and disengage from each other, a sealing element moves in opposite directions within the channel along the longitudinal axis of the second connector element. At least one of the first connector element and the second connector element further includes a skirt surrounding the body of the first connector element and the body of the second connector element. The skirt extends beyond the distal end of the body of at least one of the first connector element and the second connector element. At least one aperture is defined in the skirt for the second connector element. At least one of the first connector element and the second connector element further includes a fluid path adapter configured to connect at least one of the first connector element and the second connector element to a fluid delivery element. The first connector element includes a slidable sleeve configured to lock the first flexible arm and the second flexible arm when the first connector element engages with the second connector element.

[0013] In another example of this disclosure, a fluid path connector for a medical fluid delivery system includes: a first connector element including a body defining a first undercut, a first flexible leg, and a second flexible leg; and a second connector element including a body defining a second undercut, a third flexible leg, and a fourth flexible leg, wherein the first flexible leg includes a first flange, the second flexible leg defines a second flange, the third flexible leg includes a third flange, and the fourth flexible leg defines a fourth flange, and wherein, when the first connector element engages with the second connector element, the first flange and the second flange are linked to the second undercut of the body of the second connector element, and the third flange and the fourth flange are linked to the first undercut of the body of the first connector element to ensure that the first connector element and the second connector element are prevented from disengaging from each other.

[0014] In another example of this disclosure, the first flange and the second flange are each angled inward toward the longitudinal axis of the first connector element, and the third flange and the fourth flange are each angled inward toward the longitudinal axis of the second connector element. The first flange and the second flange each form an angle of 45-75 degrees relative to the longitudinal axis of the first connector element, and the third flange and the fourth flange each form an angle of 45-75 degrees relative to the longitudinal axis of the second connector element. The first connector element further includes a first actuating arm and a second actuating arm, and the second connector element further includes a third actuating arm and a fourth actuating arm, wherein, when an inwardly pointing pressure is applied to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move outward relative to the body of the second connector element to allow disengagement of the first connector element and the second connector element, and wherein, when an inwardly pointing pressure is applied to the third actuating arm and the fourth actuating arm, the third flexible leg and the fourth flexible leg move outward relative to the body of the second connector element to allow disengagement of the first connector element and the second connector element. At least one of the first, second, third, and fourth actuating arms includes at least one reinforcing rib. When the first and second connector elements are connected to each other, the first and second connector elements are configured to withstand a fluid pressure of at least 800 psi.

[0015] The following clauses also set forth further features of this disclosure:

[0016] Clause 1: A fluid path connector for a medical fluid delivery system, the fluid path connector comprising: a first connector element including a body, a first lumen, a first flexible leg, and a second flexible leg; and a second connector element including a body defining an undercut, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel, wherein the first flexible leg includes a first flange, and the second flexible leg includes a second flange, wherein, when the first connector element engages with the second connector element, the first flange and the second flange engage with the undercut of the body of the second connector element to prevent disengagement of the first connector element and the second connector element, and wherein the sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element engage with each other.

[0017] Clause 2: A fluid path connector according to Clause 1, wherein the first connector element and the second connector element are each in fluid communication with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tubing kit, and a bulk fluid container.

[0018] Clause 3: A fluid path connector according to Clause 1 or 2, wherein the first flange and the second flange are each angled inward toward the longitudinal axis of the first connector element.

[0019] Clause 4: A fluid path connector according to any one of Clauses 1-3, wherein the first flange and the second flange are each at an angle of 45-75 degrees relative to the longitudinal axis of the first connector element.

[0020] Clause 5: A fluid path connector according to any one of Clauses 1-4, wherein the first connector element includes a first actuating arm associated with a first flexible leg and a second actuating arm associated with a second flexible leg, and wherein, when an inwardly pointing pressure is applied to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move outward relative to the body of the second connector element to disengage the first flange and the second flange from the undercut, thereby allowing the first connector element and the second connector element to disengage.

[0021] Clause 6: The fluid path connector according to Clause 5, wherein at least one of the first flexible leg and the second flexible leg includes at least one reinforcing rib.

[0022] Clause 7: A fluid path connector according to any one of Clauses 1-6, wherein when the first connector element and the second connector element are connected to each other, the first connector element and the second connector element are configured to withstand a fluid pressure of at least 800 psi in the fluid path.

[0023] Clause 8: A fluid path connector according to any one of Clauses 1-7, wherein the first connector element further includes a support base extending from the body between the first flexible leg and the second flexible leg, and wherein the support base is configured to reduce deflection of the body due to fluid pressure exerted by fluid moving through the fluid path.

[0024] Clause 9: The fluid path connector according to Clause 8, wherein the support base includes at least one reinforcing rib to reduce the deflection of the body due to the fluid pressure exerted by the fluid moving through the fluid path.

[0025] Clause 10: A fluid path connector according to any one of Clauses 1-9, wherein the sealing element is one of the following: a resilient O-ring, an overmolded sealing surface, and a quadrilateral ring.

[0026] Clause 11: A fluid path connector according to any one of Clauses 1-10, wherein the channel is sized such that when the first connector element and the second connector element engage and disengage from each other, at least one sealing element moves in opposite directions within the channel along the longitudinal axis of the second connector element.

[0027] Clause 12: A fluid path connector according to any one of Clauses 1-11, wherein at least one sealing element moves between a first position and a second position, wherein in the first position, at least one sealing element seals a fluid passage defined in a second connector element to prevent fluid from flowing through the second connector element, and in the second position, at least one sealing element moves out of the fluid passage to allow fluid to flow through the second connector element.

[0028] Clause 13: A fluid path connector according to any one of Clauses 1-12, wherein at least one of the first connector element and the second connector element further includes a skirt surrounding the body of the first connector element and the body of the second connector element.

[0029] Clause 14: A fluid path connector according to Clause 13, wherein the skirt extends beyond the distal end of the body of at least one of the first connector element and the second connector element.

[0030] Clause 15: A fluid path connector according to Clause 13 or 14, wherein at least one hole is defined in a skirt for a second connector element.

[0031] Clause 16: A fluid path connector according to any one of Clauses 1-15, wherein at least one of the first connector element and the second connector element further comprises a fluid path adapter configured to connect at least one of the first connector element and the second connector element to a fluid delivery element.

[0032] Clause 17: A fluid path connector according to any one of Clauses 1-16, wherein the first connector element includes a sliding sleeve configured to lock the first flexible arm and the second flexible arm when the first connector element engages with the second connector element.

[0033] Clause 18. A medical fluid delivery system comprising: a syringe including a proximal end, a distal end, and a sidewall extending from the proximal end to the distal end; a fluid delivery member; and a fluid path connector comprising: a first connector element including a body, a first lumen, a first flexible leg, and a second flexible leg; and a second connector element including a body defining an undercut, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel, wherein the first connector element is fluidly connected to the fluid delivery member, wherein the second connector element is fluidly connected to the distal end of the syringe, wherein the first flexible leg includes a first flange, and the second flexible leg includes a second flange, wherein, when the first connector element engages with the second connector element, the first flange and the second flange engage with the undercut of the body of the second connector element to prevent disengagement of the first connector element and the second connector element, and wherein the sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element engage with each other.

[0034] Clause 19: A medical fluid delivery system pursuant to Clause 18, wherein a first connector element and a second connector element are each in fluid communication with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tubing kit, and a bulk fluid container.

[0035] Clause 20: A medical fluid delivery system according to Clause 18 or 19, wherein the first flange and the second flange are each angled inward toward the longitudinal axis of the first connector element.

[0036] Clause 21: A medical fluid delivery system according to any one of Clauses 18-20, wherein the first flange and the second flange are each at an angle of 45-75 degrees relative to the longitudinal axis of the first connector element.

[0037] Clause 22: A medical fluid delivery system according to any one of Clauses 18-21, wherein the first connector element includes a first actuating arm associated with a first flexible leg and a second actuating arm associated with a second flexible leg, and wherein, when an inwardly pointing pressure is applied to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move outward relative to the body of the second connector element to disengage the first flange and the second flange from the undercut, thereby allowing the first connector element and the second connector element to disengage.

[0038] Clause 23: A medical fluid delivery system pursuant to Clause 22, wherein at least one of the first flexible leg and the second flexible leg includes at least one reinforcing rib.

[0039] Clause 24: A medical fluid delivery system according to any one of Clauses 18-23, wherein when the first connector element and the second connector element are connected to each other, the first connector element and the second connector element are configured to withstand a fluid pressure of at least 800 psi in the fluid path.

[0040] Clause 25: A medical fluid delivery system according to any one of Clauses 18-24, wherein the first connector element further includes a support base extending from the body between the first flexible leg and the second flexible leg, and

[0041] The support base is configured to reduce the deflection of the body caused by the fluid pressure exerted by the fluid moving through the fluid path.

[0042] Clause 26: A medical fluid delivery system pursuant to Clause 25, wherein the support base includes at least one reinforcing rib to reduce deflection of the body due to fluid pressure exerted by fluid moving through the fluid path.

[0043] Clause 27: A medical fluid delivery system according to any one of Clauses 18-26, wherein the channel is sized such that when the first connector element and the second connector element engage and disengage from each other, the sealing element moves in opposite directions within the channel along the longitudinal axis of the second connector element.

[0044] Clause 28: A medical fluid delivery system according to any one of Clauses 18-27, wherein at least one of the first connector element and the second connector element further includes a skirt surrounding the body of the first connector element and the body of the second connector element.

[0045] Clause 29: A medical fluid delivery system pursuant to Clause 28, wherein the skirt extends beyond the distal end of the body of at least one of the first connector element and the second connector element.

[0046] Clause 30: A medical fluid delivery system pursuant to Clause 28 or 29, wherein at least one aperture is defined in a skirt for a second connector element.

[0047] Clause 31: A medical fluid delivery system according to any one of Clauses 18-30, wherein at least one of the first connector element and the second connector element further includes a fluid path adapter configured to connect at least one of the first connector element and the second connector element to the fluid delivery element.

[0048] Clause 32: A medical fluid delivery system according to any one of Clauses 18-31, wherein the first connector element includes a slidable sleeve configured to lock the first flexible arm and the second flexible arm when the first connector element engages with the second connector element.

[0049] Clause 33. A fluid path connector for a medical fluid delivery system, the fluid path connector comprising:

[0050] The first connector element includes a body defining a first undercut, a first flexible leg, and a second flexible leg; and

[0051] The second connector element includes a body defining a second undercut, a third flexible leg, and a fourth flexible leg.

[0052] The first flexible leg includes a first flange, the second flexible leg defines a second flange, the third flexible leg includes a third flange, and the fourth flexible leg defines a fourth flange.

[0053] Specifically, when the first connector element engages with the second connector element, the first flange and the second flange are linked to the second undercut of the body of the second connector element, and the third flange and the fourth flange are linked to the first undercut of the body of the first connector element, to ensure that the first connector element and the second connector element do not disengage from each other.

[0054] Clause 34: The fluid path connector according to Clause 33, wherein the first flange and the second flange are each angled inward toward the longitudinal axis of the first connector element, and

[0055] The third and fourth flanges are angled inward toward the longitudinal axis of the second connector element.

[0056] Clause 35: A fluid path connector according to Clause 33 or 34, wherein the first flange and the second flange are each at an angle of 45-75 degrees relative to the longitudinal axis of the first connector element, and

[0057] The third and fourth flanges are each at an angle of 45-75 degrees relative to the longitudinal axis of the second connector element.

[0058] Clause 36: A fluid path connector according to any one of Clauses 33-35, wherein the first connector element further comprises a first actuating arm and a second actuating arm.

[0059] The second connector element also includes a third actuator arm and a fourth actuator arm.

[0060] Specifically, when an inward pressure is applied to the first and second actuating arms, the first and second flexible legs move outward relative to the body of the second connector element to allow the first and second connector elements to disengage.

[0061] Specifically, when an inwardly pointing pressure is applied to the third and fourth actuating arms, the third and fourth flexible legs move outward relative to the body of the second connector element to allow the first and second connector elements to disengage.

[0062] Clause 37: A fluid path connector according to Clause 36, wherein at least one of the first actuating arm, the second actuating arm, the third actuating arm, and the fourth actuating arm includes at least one reinforcing rib.

[0063] Clause 38: A fluid path connector according to any one of Clauses 33-37, wherein when the first connector element and the second connector element are connected to each other, the first connector element and the second connector element are configured to withstand a fluid pressure of at least 800 psi. Attached Figure Description

[0064] Figure 1 This is a perspective view of a fluid path connector assembly associated with a syringe, as shown in the disconnected position, according to an example of this disclosure.

[0065] Figure 2 It is in the disconnected position. Figure 1 Side view of the fluid path connector assembly;

[0066] Figure 3 It is in the connection position. Figure 1 A three-dimensional view of the fluid path connector assembly;

[0067] Figure 4 It is in the connection position. Figure 1 Side view of the fluid path connector assembly;

[0068] Figure 5A yes Figure 1 A cross-sectional view of the fluid path connector assembly;

[0069] Figure 5B yes Figure 1 A cross-sectional view of the fluid path connector assembly;

[0070] Figure 6A yes Figure 1 A cross-sectional view of the fluid path connector assembly, showing the splitter included in the second connector element;

[0071] Figure 6B yes Figure 1A cross-sectional view of the fluid path connector assembly, showing the splitter included in the second connector element;

[0072] Figure 6C It is with Figure 6A A perspective view of the second connector element of the shunt;

[0073] Figure 7 This is a perspective view of a fluid path connector assembly according to another example of this disclosure, shown in the disconnected position;

[0074] Figure 8 It is in the disconnected position. Figure 7 Side view of the fluid path connector assembly;

[0075] Figure 9 It is in the connection position. Figure 7 A three-dimensional view of the fluid path connector assembly;

[0076] Figure 10 It is in the connection position. Figure 7 Side view of the fluid path connector assembly;

[0077] Figure 11 yes Figure 7 A perspective view of the fluid path connector assembly, in which the locking skirt is fully locked;

[0078] Figure 12 yes Figure 7 A side view of the fluid path connector assembly, in which the locking skirt is fully locked;

[0079] Figure 13 This is a perspective view of a connector element including a reinforcing member, according to an example of this disclosure;

[0080] Figure 14 yes Figure 13 Side view of the connector element;

[0081] Figure 15 This is a perspective view of a connector element including a reinforcing member according to another example of this disclosure;

[0082] Figure 16 yes Figure 15 Side view of the connector element;

[0083] Figure 17 This is a perspective view of a connector element including a reinforcing member according to another example of this disclosure;

[0084] Figure 18 yes Figure 17 Side view of the connector element;

[0085] Figure 19 This is a perspective view of a connector element including a reinforcing member according to another example of this disclosure;

[0086] Figure 20 yes Figure 19 Side view of the connector element;

[0087] Figure 21 This is a perspective view of a connector element including a reinforcing member according to another example of this disclosure;

[0088] Figure 22 yes Figure 21 Side view of the connector element;

[0089] Figure 23 This is a perspective view of a connector element including a reinforcing member according to another example of this disclosure;

[0090] Figure 24 yes Figure 23 Side view of the connector element;

[0091] Figure 25 This is a perspective view of a connector element including a reinforcing member according to another example of this disclosure;

[0092] Figure 26 yes Figure 25 Side view of the connector element;

[0093] Figure 27 This is a perspective view of a fluid path connector assembly associated with a syringe, according to an example of this disclosure, shown in the disconnected position;

[0094] Figure 28 yes Figure 27 A perspective view of a fluid path connector assembly shown in a connected position;

[0095] Figure 29 yes Figure 27 A side view of a fluid path connector assembly in the connected position;

[0096] Figure 30 yes Figure 27 A cross-sectional view of a fluid path connector assembly shown connected to a cover;

[0097] Figure 31 This is a perspective view of a fluid path connector assembly associated with a syringe and a filling spike, according to another example of this disclosure, the fluid path connector assembly being shown in the disconnected position;

[0098] Figure 32 yes Figure 31 A perspective view of a fluid path connector assembly in a connected position;

[0099] Figure 33A yes Figure 31 A three-dimensional view of the fluid path connector assembly;

[0100] Figure 33B This is a perspective view of an example of a fluid path connector assembly according to another example of this disclosure;

[0101] Figure 33C yes Figure 33B A cross-sectional view of the fluid path connector assembly;

[0102] Figure 34 This is a cross-sectional view of a fluid path connector assembly and cap according to another example of this disclosure;

[0103] Figure 35 yes Figure 34 A cross-sectional view of the fluid path connector assembly;

[0104] Figure 36 This is a perspective view of a fluid path connector assembly associated with a syringe and tubing kit, according to another example of this disclosure;

[0105] Figure 37 yes Figure 36 A cross-sectional view of the fluid path connector assembly;

[0106] Figure 38 This is a cross-sectional view of a fluid path connector assembly associated with a syringe and spike assembly, according to another example of this disclosure, showing the fluid path connector assembly in the disconnected position;

[0107] Figure 39 yes Figure 38 A cross-sectional view of a fluid path connector assembly shown in the connected position;

[0108] Figure 40 yes Figure 38 A three-dimensional view of the fluid path connector spike assembly;

[0109] Figure 41 It is in the open position. Figure 38 A cross-sectional view of the fluid path connector spike assembly;

[0110] Figure 42 It is in the closed position. Figure 38 A cross-sectional view of the fluid path connector spike assembly;

[0111] Figure 43This is a perspective view of a fluid path connector assembly associated with a syringe and spike assembly, according to another example of this disclosure;

[0112] Figure 44 yes Figure 43 A cross-sectional view of the fluid path connector assembly;

[0113] Figure 45 yes Figure 43 A three-dimensional view of the fluid path connector spike assembly;

[0114] Figure 46 yes Figure 43 A cross-sectional view of the fluid path connector spike assembly;

[0115] Figure 47 This is a side view of a fluid path connector assembly associated with a syringe and tubing kit, according to another example of this disclosure;

[0116] Figure 48 yes Figure 47 A three-dimensional view of the fluid path connector assembly;

[0117] Figure 49 yes Figure 47 Side view of the fluid path connector assembly;

[0118] Figure 50 This is a perspective view of a fluid path connector assembly associated with a syringe, according to another example of this disclosure;

[0119] Figure 51 yes Figure 50 A cross-sectional view of the fluid path connector assembly;

[0120] Figure 52 This is a perspective view of a connector element according to another example of this disclosure;

[0121] Figure 53 yes Figure 52 Side view of the connector element;

[0122] Figure 54 This is a perspective view of a fluid path connector assembly associated with a syringe, according to an example of this disclosure, the fluid path connector assembly including... Figure 52 Connector components;

[0123] Figure 55 yes Figure 54 A cross-sectional view of the fluid path connector assembly;

[0124] Figure 56 This is a cross-sectional view of a fluid path connector assembly according to another example of this disclosure;

[0125] Figure 57This is a cross-sectional view of a fluid path connector element associated with a syringe, according to another example of this disclosure;

[0126] Figure 58 For being in the disconnected position Figure 56 A three-dimensional view of the fluid path connector assembly;

[0127] Figure 59 yes Figure 58 A perspective view of a fluid path connector assembly shown in a connected position;

[0128] Figure 60 It is a 90-degree rotation around the longitudinal axis. Figure 56 A cross-sectional view of a fluid path connector assembly shown in the connected position;

[0129] Figure 61 This is a cross-sectional view of a fluid path connector assembly according to another example of this disclosure, shown in the disconnected position; and

[0130] Figure 62 yes Figure 61 A cross-sectional view of a fluid path connector assembly shown in the connected position. Detailed Implementation

[0131] The illustrations generally show preferred and non-limiting aspects of the systems and methods of this disclosure. While the description presents various aspects of the apparatus, it should not be construed as limiting this disclosure in any way. Furthermore, modifications, concepts, and applications of various aspects of this disclosure will be interpreted by those skilled in the art as encompassing, but not limited to, the illustrations and descriptions provided herein.

[0132] The following description is provided to enable those skilled in the art to make and use the aspects intended for implementing this disclosure. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of this disclosure. Furthermore, for the purposes described below, the terms “end,” “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “transverse,” “longitudinal,” and their derivatives should be used in connection with this disclosure, as they are oriented in the accompanying drawings. The term “proximal” in relation to the injection tube generally refers to the axial or longitudinal direction toward the end of the syringe closest to the injector and opposite to the direction toward the patient. The term “distal” in relation to the injection tube generally refers to the axial or longitudinal direction away from the injector and toward the patient. The term “proximal” in relation to the tubing kit generally refers to the axial or longitudinal direction toward the end of the tubing kit closest to the syringe and opposite to the direction toward the patient. The term “distal” in relation to the tubing kit generally refers to the axial or longitudinal direction away from the syringe and toward the patient. The term "radial" and related terms generally refer to a direction perpendicular to the longitudinal axis of the syringe. However, it should be understood that various alternative variations and sequences of steps may be taken in this disclosure unless the opposite is expressly specified. It should also be understood that the specific apparatus and processes shown in the accompanying drawings and described in the following specification are merely exemplary aspects of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the aspects disclosed herein should not be considered limiting.

[0133] Figure 1 -6 illustrates a fluid path connector assembly 10 associated with a syringe 16 according to an example of this disclosure. The fluid path connector assembly 10 may include a first connector element 12 and a second connector element 14 configured to connect to each other to form a liquid tight seal between a first fluid container and a second fluid container or fluid delivery device. In one example of this disclosure, the first connector element 12 may be operatively connected to the syringe 16. The first connector element 12 may be operatively connected to the distal end of the syringe 16. In one example of this disclosure, the first connector element 12 may be welded (e.g., laser welded) or otherwise bonded to the distal end of the syringe 16. In some examples of this disclosure, the second connector element 14 may be connected to a catheter kit, a fluid delivery line, a fluid spike assembly, or any medical fluid container with an opening. In one example of this disclosure, the inner surface of the distal tip of the syringe 16 may include a plurality of ribs 17 that form a profile within the syringe 16 utilizing the Coanda effect of fluid flowing through the syringe 16, as... Figures 6A-6CThe diverter 53 assembly is shown. As used herein, the Coanda effect is the tendency of liquid flow to be drawn towards nearby curved or angled surfaces as it flows along a surface. Therefore, as fluid enters syringe 16 through the connector element, it contacts diverter 53 and is directed towards the inner wall of the discharge neck of syringe 16 to contact the multiple ribs 17. As the liquid flows along the distal tips of the ribs of syringe 16, it is naturally drawn to the inner surface of the tapered distal end of syringe 16, rather than dripping from the edges of the distal tips of the ribs. The liquid then flows down the tubular sidewalls of syringe 16, eventually accumulating at the bottom of syringe 16, filling syringe 16 from the bottom up as air escapes from syringe 16 through the flow controller and connecting tube. This flow along the inner surface of syringe 16 helps reduce turbulence as liquid fills syringe 16, which helps reduce the formation of air bubbles during filling. Furthermore, diverter 53 and ribs 17 allow for faster filling of syringe 16, thereby reducing the duration of the fluid injection process. Further features and advantages of this Coanda effect are described in WO2017 / 091643, the contents of which are incorporated herein by reference in their entirety. It should be noted that, although... Figure 1 The accompanying drawings illustrate a syringe 16 having a first connector element 12 and a second connector element 14, the second connector element 14 being connected to a catheter tubing kit, fluid delivery line, fluid spike assembly, or any medical fluid container with an opening, but the positions of the first connector element 12 and the second connector element 14 may be interchanged without departing from the spirit of this disclosure. Generally, the positions of the first connector element 12 and the second connector element 14 may be interchanged in various configurations without departing from the spirit of this disclosure.

[0134] In some examples of this disclosure, the first connector element 12 may include a body 18, a first lumen 19 extending through the body 18, a first leg 20, and a second leg 22, wherein a support base 76 connects the first leg 20 and the second leg 22. The first leg 20 and the second leg 22 may be integrally formed with the body 18. Figure 1 As shown in Figure 6, the first leg 20 and the second leg 22 can extend distally from the body 18 relative to the distal end of the syringe 16. In one example of this disclosure, the first leg 20 and the second leg 22 are made of a material such that they can pivot where the legs 20, 22 meet the support base 76 to allow the distal ends of the first leg 20 and the second leg 22 to move radially outward in a direction relative to the longitudinal axis 24 of the first connector element 12. In one example of this disclosure, the first leg 20 and the second leg 22 may be made of a rigid material with a flexible pivot point to allow the first leg 20 and the second leg 22 to move radially outward in a direction relative to the longitudinal axis 24 of the first connector element 12.

[0135] In some examples of this disclosure, the first connector element 12 may further include a first actuating arm 26 and a second actuating arm 28 extending from the body 18 in a direction opposite to that of the first leg 20 and the second leg 22. The first actuating arm 26 and the second actuating arm 28 may be integrally formed with the body 18 and the first leg 20 and the second leg 22. During operation of the fluid path connector assembly 10, the first actuating arm 26 and the second actuating arm 28 are configured to be pushed radially inward toward each other by an operator to move the first leg 20 and the second leg 22 radially outward away from each other. Pressure on the first actuating arm 26 and the second actuating arm 28 forces the first leg 20 and the second leg 22 away from each other. In one embodiment of this disclosure, at least one of the first actuating arm 26 and the second actuating arm 28 may include a plurality of clamping ribs 30 to assist in clamping the first actuating arm 26 and the second actuating arm 28 during operation of the first connector element 12. In some examples of this disclosure, the first connector element 12 may further include a support portion 32 that extends from the body 18 in the same direction as the first actuating arm 26 and the second actuating arm 28 (i.e., toward the body of the syringe 16), such as Figure 1 As shown in Figure 6, the support portion 32 can be integrally formed with the body 18 and can define a channel configured to receive the distal end of the syringe 16. The support portion 32 can be connected to the distal end of the syringe 16, for example by threaded engagement, adhesive bonding, or welding. When the first connector element 12 is operatively connected to the syringe 16, and further, when the first actuating arm 26 and the second actuating arm 28 are pressed inward against each other to actuate the first connector element 12, the support portion 32 provides a stabilizing effect for the first connector element 12.

[0136] According to various examples of this disclosure, each of the first leg 20 and the second leg 22 may respectively include a first flange 34 and a second flange 36, configured to engage a portion of the second connector element 14, as described herein, to facilitate easy connection of the first connector element 12 and the second connector element 14 in a manner that withstands pressures associated with a pressurized fluid injection process without disconnection, and to form a fluid-tight seal between the first lumen 19 of the first connector element 12 and the second lumen 47 of the second connector element 14. In some examples of this disclosure, at least a portion 38, 40 of each flange 34, 36 may be angled inward relative to the longitudinal axis 24 of the first connector element 12, respectively. In one example of this disclosure, portions 38, 40 of the flanges 34, 36 may be angled at 60 degrees to the longitudinal axis 24 of the first connector element 12, wherein the angled portions are angled toward the proximal end of the syringe 16, as... Figure 1-6 is shown. In other examples of this disclosure, portions 38, 40 of flanges 34, 36 may form an angle ranging from 45 degrees to 75 degrees with the longitudinal axis 24 of the first connector element 12. In another example of this disclosure, portions 38, 40 of flanges 34, 36 may form an angle ranging from 55 degrees to 65 degrees with the longitudinal axis 24 of the first connector element 12. In one example of this disclosure, portions 38, 40 of flanges 34, 36 may point toward the distal end of syringe 16, such that portions 38, 40 of flanges 34, 36 extend toward the proximal end of syringe 16. Under fluid injection pressure, the angled portions 38, 40 of flanges 34, 36 may push the first leg 20 and the second leg 22 in a radially inward direction, thereby increasing the strength of the connection force between the first connector element 12 and the second connector element 14 during pressurized injection and making it less likely to break. As described below, the distal surfaces 42, 44 of flanges 34, 36 may be inclined or beveled to aid in receiving the second connector element 14. Surfaces 42, 44 may be angled inward toward the longitudinal axis 24 of the first connector element 12. In one example of this disclosure, the outer edge of each surface 42, 44 may be inclined inward toward the inner edge of each surface 42, 44, while also inward and toward the actuator arms 26, 28. During the insertion of the second connector element 14 into the first connector element 12, the beveled or inclined surfaces 42, 44 cause the first leg 20 and the second leg 22 to bend radially outward, and then once the body 46 of the second connector element 14 passes the flanges 34, 36, the first leg 20 and the second leg 22 spring back in the radially inward direction, thereby engaging the first connector element 12 with the second connector element 14.

[0137] According to various embodiments of this disclosure, each of the legs 20, 22 may further include at least one reinforcing member 45a, 45b. According to various embodiments, the reinforcing members 45a, 45b may be disposed along at least a portion of the outer surface of the legs 20, 22. In some embodiments, the reinforcing members 45a, 45b may extend the entire length of the legs 20, 22. The reinforcing members 45a, 45b may be integrally formed with the legs 20, 22, for example, on the outer surface of the legs 20 or 22. The reinforcing members 45a, 45b may be made of a material similar to that of the legs 20, 22 and the first connector element 12, for example, by co-molding the legs 20, 22 with the corresponding reinforcing members 45a, 45b. In other embodiments, the reinforcing members 45a, 45b may be made of a different material than that of the legs 20, 22 and the first connector element 12 to increase the strength of the legs 20, 22. Reinforcing members 45a and 45b may be provided on legs 20 and 22 to increase the rigidity of legs 20 and 22 while still allowing legs 20 and 22 to retain sufficient flexibility to move inward and outward during the connection and disconnection of the first connector element 12 and the second connector element 14. In one example of this disclosure, reinforcing members 45a and 45b may be strips of material extending along at least a portion of the length of legs 20 and 22 and extending outward from the outer surface of legs 20 and 22, for example, substantially perpendicular to the outer surface of legs 20 and 22. After the first connector element 12 and the second connector element 14 have been connected, reinforcing members 45a and 45b may be configured to help maintain the connection between legs 20 and 22 and the second connector element 14, for example by further reducing outward bending or stretching of legs 20 and 22 during the pressurized injection process. Due to the high fluid pressure between the first connector element 12 and the second connector element 14, in some embodiments, the first connector element 12 and the second connector element 14 may have a tendency to bend radially outward from each other. Therefore, the reinforcing members 45a and 45b help ensure that the legs 20 and 22 do not move outward under these high fluid pressures, thereby preventing the first connector element 12 from disconnecting from the second connector element 14.

[0138] Referring again to Figures 5 and 6, a second connector element 14 is described in detail according to some examples of this disclosure. The second connector element 14 may include a body 46 having a second lumen 47 extending therethrough, the second lumen 47 being configured for connection to a first connector element 12 and providing fluid communication with a first lumen 19 of the first connector element 12. In one example of this disclosure, the body 46 is configured to be substantially cylindrical. When the first connector element 12 and the second connector element 14 are connected, the body 46 may be configured to be held between legs 20, 22 of the first connector element 12. The body 46 may define at least one aperture 48, 50 extending through an outer skirt 51 surrounding an outer surface near a proximal end of the body 46. The outer skirt 51 may, for example, help maintain the sterility of the internal fluid path by preventing unintentional contact and contamination of the internal fluid path by a technician during manipulation of the connector assembly. In one example of this disclosure, the body 46 defines two apertures 48, 50 extending therethrough. In one example of this disclosure, the second connector element 12 may further include an attachment member 52 extending from the body 46. The attachment member 52 may be configured to allow a tubing kit, spike assembly, or fluid container to be attached to the second connector element 12. In one example of this disclosure, the attachment member 52 may be configured to allow a frictional engagement with the tubing kit, spike assembly, or fluid container. The tubing kit, spike assembly, or fluid container may be welded (laser welded) or otherwise bonded to the attachment member 52. It should also be understood that the attachment member 52 may be configured for any other type of connection, including threaded connections or Luer lock connections. In one example of this disclosure, the second connector element 14 may further include at least one support member 54, 56 extending from the body 46 in the same direction as the attachment member 52 and at least partially around the attachment member 52. The support members 54, 56 are configured to prevent bending of bends in the attached fluid path element and further provide a clamping surface for an operator to hold the second connector element 14 when using it. In one example of this disclosure, the second connector element 14 includes two support members 54, 56.

[0139] In various examples of this disclosure, the second connector element 14 may further include a support base 60 extending from the body 46 in a direction opposite to that of the attachment member 52. As described herein, a skirt 51 may extend around the support base 60. In one example of this disclosure, the support base 60 may be configured to insert into an opening in the distal tip of a syringe 16 to connect a syringe 16 attached to the first connector element 12 to a tubing kit, spike assembly, or fluid container attached to the second connector element 14. It is also contemplated that the support base 60 may be configured to receive the distal tip of the syringe 16. In one example of this disclosure, the support base 60 may define at least one circumferential channel 62, which may be configured to receive at least one sealing element 64. In one example of this disclosure, the at least one sealing element 64 may be at least one O-ring, a molded sealing surface overlaid on the outer surface of the support base 60, a quadrilateral ring, or any other dynamic seal. In one example of this disclosure, when the first connector element 12 and the second connector element 14 are connected, at least one sealing element 64 is configured to establish a fluid tight seal between the support base 60 and the distal tip of the syringe 16. By using the sealing element 64, fluid leakage from the fluid path connector assembly 10 is prevented as fluid flows between the syringe 16 connected to the first connector element 12 and the tubing or fluid container connected to the second connector element 14. As the second connector element 14 is pulled away from the first connector element 12, the support base 60 is pulled out of the distal tip of the syringe 16. As the support base 60 is pulled out of the distal tip of the syringe 16, the sealing element 64 continues to maintain a fluid tight seal between the support base 60 and the distal tip of the syringe 16 until the support base 60 is completely removed from the distal tip of the syringe 16. In one example of this disclosure, the fluid path connector assembly 10 may include two sealing elements disposed on the support base 60 of the second connector element 14. By providing multiple sealing elements, the sterility of the fluid path connector assembly 10 is improved.

[0140] In one example of this disclosure, the body 46 of the second connector element 14 may also define an undercut 66 on its proximal surface, for example, in the form of a groove or channel having an externally angled wall that is complementary to the angled surfaces of the flanges 34, 36. The undercut 66 may be configured to receive portions 38, 40 of the first flange 34 and the second flange 36 of the first connector element 12 to ensure that the first connector element 12 and the second connector element 14 remain connected during use of the fluid path connector assembly 10. In one example of this disclosure, the undercut 66 may be formed as a channel in at least a portion of the body 46. The undercut 66 may have an inclined surface extending from the outer surface of the body 46 toward the second lumen 47 of the second connector element 14 toward the inner surface of the body 46. In one example of this disclosure, the undercut 66 may extend around the entire circumference of the body 46. It is also contemplated that the undercut 66 may be provided only on a portion of the circumference of the body 46. In one example of this disclosure, the inclined surface of the undercut 66 may substantially correspond to the inclined surfaces of corresponding portions 38, 40 of the first flange 34 and the second flange 36 of the first connector element 12. The inclined surface of the undercut 66 may extend at an angle relative to the longitudinal axis of the second connector element 14, which corresponds to the longitudinal axis 24 of the first connector element 12. In one example of this disclosure, the inclined surface of the undercut 66 extends at an angle of 60 degrees relative to the longitudinal axis of the second connector element 14. In other examples of this disclosure, the inclined surface of the undercut 66 may form an angle ranging from 45 degrees to 75 degrees with respect to the longitudinal axis of the second connector element 14. In yet another example of this disclosure, the inclined surface of the undercut 66 may form an angle ranging from 55 degrees to 65 degrees with respect to the longitudinal axis of the second connector element 14. In one example of this disclosure, the inclined surface of the undercut 66 is inclined inwardly from one end of the body 46 near the attachment member 52 toward the end of the body 46 near the support base 60.

[0141] Continue to refer to Figure 1Section -6 details methods for connecting and disconnecting the fluid connector system 10. In one example of this disclosure, a first connector element 12 may be operatively connected to a syringe 16. In one example, the first connector element 12 is soldered to a distal end, and more specifically, to the distal tip of the syringe 16. The distal tip of the syringe 16 may be received in a support portion 32 of the first connector element 12. In one example of this disclosure, a second connector element 14 may be operatively connected to a tubing kit, spike assembly, or fluid container. The tubing kit, spike assembly, fluid container, or other fluid path component may be connected to an attachment portion 52 of the second connector element 14. According to various examples, connector assembly 10 can be configured to provide a user with visual and / or audible signals indicating that connector assembly 10 is properly engaged. For example, during the connection of first connector element 12 and second connector element 14, an audible "click" sound can be heard when the first flange 34 and second flange 36 of the first connector element 12 pass through the body of the second connector element 14 and when the first flange 34 and second flange 36 engage the undercut 66, indicating that the two connector elements are engaged. Furthermore, the user can visually inspect whether the first flange 34 and second flange 36 are engaged with the undercut 66, thereby indicating that connector assembly 10 is ready for use. As described herein, although the drawings generally illustrate an embodiment where the first connector element 12 is associated with a syringe and the second connector element 14 is associated with some other fluid path component, the relative positions of the first connector element 12 and the second connector element 14 may be interchanged without departing from the intent of this disclosure.

[0142] In one example of this disclosure, after the syringe 16 has been connected to the first connector element 12 and the tubing kit / spiked assembly / fluid container has been connected to the second connector element 14, the first connector element 12 and the second connector element 14 can move toward each other to connect. As the second connector element 14 moves toward the first connector element 12, the body 46 of the second connector element 14 can engage with the inclined surfaces 42, 44 of the first flexible leg 20 and the second flexible leg 22 of the first connector element 12. Since the diameter of the body 46 of the second connector element 14 can be larger than the opening defined by the legs 20, 22 of the first connector element 12, the body 46 of the second connector element 14 can force the legs 20, 22 to move outward when the body 46 pushes against the inclined surfaces 42, 44. At some point, the legs 20, 22 will be pushed outward enough to allow the body 46 of the second connector element 14 to move past the legs 20, 22 to be received within the first connector element 12. It is also envisioned that the actuator arms 26 and 28 can be pressed inward simultaneously to move the legs 20 and 22 outward, thereby receiving the second connector element 14 within the first connector element 12, while applying a small engagement force to the second connector element 14, or without having to press the body 46 of the second connector element 14 against the inclined surfaces 42 and 44 of the legs 20 and 22. The actuator arms 26 and 28 can then be released after the body 46 of the second connector element 14 has been received within the first connector element 12.

[0143] In one example of this disclosure, after the body 46 of the second connector element 14 moves past the legs 20, 22, the legs 20, 22 can be configured to move inward toward each other to their original rest position. As the legs 20, 22 move inward, the flanges 34, 36 of the legs 20, 22 move into place to engage with the undercut 66 of the body 46 of the second connector element 14. An audible "click" or other noise can be heard at this time, indicating that the connector assembly 10 is engaged. In one example of this disclosure, the first connector element 12 can be moved relative to the second connector element 14 (see FIG. 5) before fluid is transmitted through the fluid path connector assembly 10. When the body 46 of the second connector element 14 moves into the first connector element 12, the support base 60 of the second connector element 14 is inserted into the distal tip of the syringe 16 to form a fluid tight seal using the sealing member 64. As fluid is transmitted through the fluid path connector assembly 10, the second connector element 14 can move away from the syringe 16 due to the fluid pressure exerted by the fluid through the fluid path connector assembly 10. To prevent the second connector element 14 from disengaging from the first connector element 12, as the second connector element 14 moves away from the syringe 16, the flanges 34, 36 of the first connector element 12 actively engage with the undercut 66 of the second connector element 14 to prevent disengagement (see FIG. 6). Due to the angled surfaces of the flanges 34, 36 and the undercut 66, under pressurized conditions, as the second connector element 14 moves away from the first connector element 12, the interaction between the angled surfaces 38, 40 of the flanges 34, 36 of the first connector element 12 and the inclined surface of the undercut 66 of the second connector element 14 causes the first flexible leg 20 and the second flexible leg 22 to be pulled radially inward, increasing the engagement force of the fluid connector system 10 and preventing disengagement under relatively high fluid pressures. In one example of this disclosure, the fluid path connector assembly 10 can withstand pressures greater than 800 psi or even up to 1200 psi, which can be used during angiography imaging procedures.

[0144] In one example of this disclosure, after fluid has been transferred through the fluid path connector assembly 10, such as after the imaging process is completed, the first connector element 12 and the second connector element 14 are ready to disconnect from each other. In one example of this disclosure, the actuator arms 26, 28 of the first connector element 12 can be pressed inward toward each other by an operator. As the actuator arms 26, 28 move inward, the legs 20, 22 of the first connector element 12 move outward away from each other. As the legs 20, 22 move away from each other, the diameter of the opening defined by the legs 20, 22 increases to allow the body 46 of the second connector element 14 to be pulled out from the first connector element 12. Once the body 46 of the second connector element 14 has been removed from the first connector element 12, the operator can release the actuator arms 26, 28 to allow the legs 20, 22 to move backward toward each other.

[0145] refer to Figure 7-12 In one example of this disclosure, the first connector element 12 may further include a movable locking sleeve 70 disposed on the outer surface of the body 18 of the first connector element 12. In one example of this disclosure, the locking sleeve 70 may generally be received around the first connector element 12. The locking sleeve 70 is slidable along the longitudinal axis 24 of the first connector element 12 along the outer surface of the body 18. The locking sleeve 70 defines a through channel with a diameter larger than the diameter of the body 18. The profile of the inner surface of the through channel may substantially match the outer profile of the first connector element 12, thus allowing the locking sleeve 70 to move along the first connector element 12. In one example of this disclosure, the locking sleeve 70 may include at least a partially circumferential flange 72 that facilitates movement of the locking sleeve 70 along the first connector element 12.

[0146] like Figure 7-10 As shown, in the first unlocked position, the locking sleeve 70 is positioned distally around the outer circumference of the first connector element 12. In some examples, the locking sleeve 70 may surround the actuator arms 26, 28, forcing them radially inward into the open position. After the second connector element 14 has engaged with the first connector element 12, the locking sleeve 70 may slide along the first connector element 12 toward the legs 20, 22. The locking sleeve 70 slides along the legs 20, 22 until it is positioned in the second locked position around the outer circumference of the legs 20, 22. Figure 11 and 12As shown, when positioned in the second locked position, the locking sleeve 70 helps prevent the legs 20, 22 from moving outward relative to each other under the high fluid pressure experienced during fluid transmission through the fluid path connector assembly 10, thereby preventing disconnection of the connector 10. After fluid has been transmitted through the fluid path connector assembly 10, the locking sleeve 70 can slide rearward toward the body 18 of the first connector element 12 to allow the legs 20, 22 to move outward relative to each other, thereby allowing the first connector element 12 and the second connector element 14 to disconnect from each other. In one example of this disclosure, it is also contemplated that the locking sleeve 70 can slide along the first connector element 12 to cover the actuator arms 26, 28, thereby forcing the actuator arms 26, 28 to move inward toward each other to move the legs 20, 22 outward away from each other. When the locking sleeve 70 is positioned on the actuator arms 26, 28, the locking sleeve 70 can be used to open the legs 20, 22 to allow the second connector element 14 to be inserted into or removed from the first connector element 12.

[0147] refer to Figure 13-26 According to several examples of this disclosure, several different types of reinforcing features of the first connector element 12 are disclosed. In these figures, the first connector element 12 is shown having proximal attachments for tubing kits or spike assemblies; however, it should be noted that these same reinforcing features can be used on the first connector element 12 when associated with the syringe 16 (see [reference]). Figure 1 -6). It should be understood that these reinforcing features can be used in conjunction with the reinforcing members 45a, 45b of the first connector element 12. The following reinforcing features are provided to help prevent the legs 20, 22 from moving outward relative to each other under the high fluid pressures experienced by the fluid path connector assembly 10. Figure 13 and 14As shown in one example of this disclosure, at least one reinforcing member 74 may extend from a support base 76 disposed on the body 18 of the first connector element 12. The support base 76 may be provided to allow the first connector element 12 to be connected to a tubing kit or syringe 16. For example, the reinforcing feature 74 strengthens the support base 76 when under high pressure during an injection process. In some embodiments, under high fluid pressure, the support base 76 may bend or deform due to the fluid pressure applied to it. In some embodiments, the support base 76 may bend outward a distance that allows the sealing member 64 (e.g., O-ring 64) to move and / or deform and lose the fluid tight seal between the first connector element 12 and the second connector element 14. The reinforcing member 74 may extend from the support base 76 toward the actuating arms 26, 28. The reinforcing member 74 may be configured to help prevent the actuating arms 26, 28 from moving too far inward toward each other. For example, the reinforcing member 74 can be configured to function as a stop member that limits the distance by which the actuator arms 26, 28 can be pressed inward toward each other. In this example of the present disclosure, the first connector element 12 can be configured to withstand a fluid pressure greater than 652 psi. Figure 15 and 16 As shown, according to one example of this disclosure, the reinforcing member 74 may extend from one end near the support base 76 to the opposite end near the support base 76 to provide further support for the body 18 of the first connector element 12, thereby preventing deflection or bending of the support base 76 of the body 16. According to these examples of this disclosure, the first connector element 12 may be configured to withstand a fluid pressure greater than 887 psi when the reinforcing member 74 according to various embodiments is present. (Refer to...) Figure 17 and 18 According to one example of this disclosure, the reinforcing member 80 may also extend along the longitudinal axis of the support base 76, thereby providing further rigidity to the support base 76 and the body 16 of the first connector element 12. (Refer to...) Figure 19 and 20 According to one example of this disclosure, the reinforcing member 74 may also include another reinforcing member 82 extending perpendicularly to the reinforcing member 74, for example, configured in an "I-beam" shape. In this example of the disclosure, the first connector element 12 may be configured to withstand a fluid pressure greater than 1,156 psi.

[0148] refer to Figure 21 and 22According to one example of this disclosure, the reinforcing members 45a and 45b may be increased in height to further increase the rigidity or stiffness of the legs 20 and 22. By increasing the height of the reinforcing members 45a and 45b, additional material is provided on the legs 20 and 22 to help prevent the legs 20 and 22 from bending relative to each other and / or moving outward under high fluid pressure. For example, the increase in the stiffness of the beams such as the legs 20 and 22 can be determined by Equation 1:

[0149] Stiffness = (b*h) 3 Equation 1, where b is the width of the beam and h is the height. In this example of the present disclosure, the first connector element 12 can be configured to withstand fluid pressures greater than 933 psi. (See reference...) Figure 23 and 24 According to one example of this disclosure, one or more reinforcing members 78 may also be provided on the body 18 of the first connector element 12 to help prevent deflection or bending of the body 18 when the first connector element 12 is subjected to high fluid pressure. For example, as Figure 23 and 24 As shown, the support base 76 can be strengthened by thickening it, for example, by increasing the thickness in the mold or by bonding individual reinforcing members 78 to the support base 76. Figure 25 and 26 As shown, the reinforcing member 8 may include a vertical feature located at the center of the reinforcing member 74. According to various embodiments, the first connector element 12 may include one or more of the reinforcing members 74, 78, 80, and 82 described herein. Figure 25 and 26 An example of this disclosure is shown in which all reinforcing members 74, 78, 80, 82 can be disposed on a single connector element. In this example of this disclosure, the first connector element 12 can be configured to withstand fluid pressures up to or greater than 1,377 psi.

[0150] refer to Figure 27-29In another example of this disclosure, a fluid path connector assembly 100 is shown and described in detail. The fluid path connector assembly 100 may include a first connector element 102 and a second connector element 104. The first connector element 102 is operatively connected to a syringe 16, while the second connector element 104 is operatively connected to a tubing kit, spike assembly, or fluid container. In one example of this disclosure, the first connector element 102 and the second connector element 104 are substantially similar to the first connector element 12 described above in conjunction with the fluid path connector assembly 10. The first connector element 102 may include a body 106 having a first undercut 126, a first actuating arm 108, a second actuating arm 110, a first leg 112, and a second leg 114. The second connector element 104 may include a body 116 having a second undercut 128, a first actuating arm 118, a second actuating arm 120, a first leg 122, and a second leg 124. The first connector element 102 and the second connector element 104 can be joined together in the vertical direction such that the flexible legs 112 and 114 of the first connector element 102 are perpendicular to the flexible legs 122 and 124 of the second connector element 104, so as to interact with the second undercut 128 and the first undercut 126 respectively, thereby connecting the first connector element 102 and the second connector element 104. The first actuating arm 108 and the second actuating arm 110 can be pressed inward to open the first connector element 102, and the first actuating arm 118 and the second actuating arm 120 can be pressed inward to open the second connector element 104.

[0151] In one example of this disclosure, the body 106 of the first connector element 102 may define an undercut 126, and the body 116 of the second connector element 104 may define an undercut 128. Undercuts 126 and 128 are disposed on the first connector element 102 and the second connector element 104 to help lock the first connector element 102 and the second connector element 104 and operably connect the first connector element 102 and the second connector element 104 to each other, thereby forming a fluid-tight seal for the fluid path connector assembly 100. Figure 30 As shown, in one example of this disclosure, the second connector element 104 may include a support base 130 including at least one sealing member 132 to form a fluid tight seal with the distal tip of the syringe 16, as described in a similar manner to the second connector element 14 described above. The second connector element may include a removable cap 131 for, for example, maintaining sterility during transport and preventing contamination of the syringe. Upon connection, the legs 112, 114 of the first connector element 102 are configured to engage and lock therein with the undercut 128 of the second connector element 104, and the legs 122, 124 of the second connector element 104 are configured to engage and lock therein with the undercut 126 of the first connector element 102.

[0152] Return to reference Figure 27-29 During the connection of the first connector element 102 and the second connector element 104, the first connector element 102 and the second connector element 104 may move toward each other. As the first connector element 102 and the second connector element 104 move toward each other, the legs 112, 114 of the first connector element 102 contact the bottom surface of the undercut 128 of the second connector element 104, causing the legs 112, 114 to separate. In a similar manner, as the first connector element 102 and the second connector element 104 move toward each other, the legs 122, 124 of the second connector element 104 contact the bottom surface of the undercut 126 of the first connector element 102, causing the legs 122, 124 to separate. As the first connector element 102 and the second connector element 104 are further pushed toward each other, the legs 112, 114 of the first connector element 102 move past the undercut 128 of the second connector element 104 and engage with the undercut 128. Similarly, when the first connector element 102 and the second connector element 104 are further pushed toward each other, the legs 122, 124 of the second connector element 104 move past the undercut 126 of the first connector element 102 and engage with the undercut 126. To disconnect the fluid path connector assembly 100, the actuating arms 108, 110 of the first connector element 102 and the actuating arms 118, 120 of the second connector element 104 are pressed inward toward each other to allow the legs 112, 114, 122, 124 to move outward, thereby allowing the first connector element 102 and the second connector element 104 to be pulled apart.

[0153] refer to Figure 31-3 3. According to various examples of this disclosure, a fluid path connector assembly 140 is shown and described, configured to attach a spike adapter member 146 for inserting a body fluid bottle or saline bag for imaging to a syringe 16. The fluid path connector assembly 140 is substantially similar to the fluid path connector assembly 10 described above and operates in a similar manner, but with some modifications. The fluid path connector assembly 140 may include a first connector element 142 and a second connector element 144, which can be connected to the spike adapter member 146, for example, by threaded attachment or by welding (laser welding) or other adhesive methods. The first connector element 142 may be substantially similar to the first connector elements 12, 102 described herein. The second connector element 144 may be substantially similar to the second connector element 14 described herein, but with some modifications for connection to the spike adapter member 146.

[0154] In one example of this disclosure, the second connector element 144 may include a spike adapter member 146 configured to allow a bulk fluid container to be connected to the second connector element 144, for example, for filling a syringe with contrast agent or saline. The spike adapter member 146 may include a body 148, a support base 150, and a cap 152 covering the spike member 155 (see [link to documentation]). Figure 33C The connector 150 includes a vent 154 defined within the body 148 to allow for pressure equalization. In one example of this disclosure, the connecting member 150 may be a threaded member threadedly connected to the connecting member 156 on the second connector element 144. Figure 33A In one example of this disclosure, the connecting members 150, 156 may be a threaded or friction-fit Luer lock connection system. Figure 33B and 33C In another example of this disclosure, the connecting member 150 may be a male connector member 151, which may be laser-welded or otherwise bonded to a female connecting member 153 on the second connector element 144. In another example of this disclosure, a spike adapter member 146 may be welded to the second connector element 144. The spike adapter member 146 may be operatively connected to the second connector element 144 such that the second connector element 144 can be fluidly connected to a fluid bag or bulk fluid or container using the spike member 155, rather than connecting the second connector element 144 to a tubing kit similar to the second connector element 14 described herein. The spike member 155 may be used to tap the fluid bag or container to allow fluid transfer from the syringe 16 to or from the fluid bag or container to the syringe 16. In one example of this disclosure, a vent 154 may be provided to allow pressure equalization as fluid is transferred from the container or bag through the spike adapter member 146. In various embodiments, the second connector element 144 may include a shunt XX as described herein to allow fluid to flow into the syringe under the Coanda effect, thereby accelerating syringe filling and reducing the air bubbles.

[0155] refer to Figure 34 and 35In another example of this disclosure, a fluid path connector assembly 160 and a syringe are shown and described in detail. The fluid path connector assembly 160 may include a cap element 162 configured to provide protection against contamination at the distal tip of the syringe 16. In one example of this disclosure, the cap element 162 is configured to prevent dust and associated microorganisms from contacting and contaminating the distal tip of the syringe 16, for example, during packaging, transport, and assembly. The cap element 162 may include a body 164 defining a channel for receiving the distal tip of the syringe 16. The distal tip of the cap element 162 may include a recess 166 configured to extend into an opening at the distal tip of the syringe 16 when the cap element 162 is positioned on the syringe 16. In one example of this disclosure, the recess 166 may be configured to prevent dust or contaminating fluid or objects from entering the distal tip of the syringe 16. In one example of this disclosure, the cap element 162 may include a circumferential locking protrusion 168 disposed on an inner surface at the proximal end of the cap element 162. A locking protrusion 168 (e.g., as part of a flexible locking arm 186 on the cap) may be configured to removably lock with an undercut 170 defined in the distal tip of the syringe 16. In one example of this disclosure, the proximal end of the cap element 162 may be divided into a plurality of locking arms, each including a locking protrusion 168 at one end. In one example of this disclosure, a circumferential channel 172 may be defined in the distal tip of the syringe 16. The circumferential channel 172 may be configured to receive at least one sealing member 174, which may be configured to form a fluid-tight seal with the inner surface of the cap element 162 when the cap element 162 is positioned on the distal tip of the syringe 16. In one example of this disclosure, the sealing member 174 may be a resilient O-ring, an overmolded sealing surface, a quadrilateral ring, or any other dynamic seal.

[0156] refer to Figure 36 and 37In one example of this disclosure, a fluid path connector assembly 180 is shown and described in detail. In one example of this disclosure, the fluid path connector assembly 180 may include a cap element 182 configured to provide fluid communication between a tubing kit and the distal tip of a syringe 16. The cap element 182 may include a body 184 defining a channel for receiving the distal tip of the syringe 16 and one or more fluid paths for filling and delivering medical fluid. In one example of this disclosure, the body 184 may include at least one locking arm 186 configured to actively engage with the distal tip of the syringe 16 to lock the cap element 182 to the syringe 16. In one example of this disclosure, the body 184 may include two locking arms 186. The locking arms 186 may be flexible, so that they may move outward relative to each other as the cap element 182 slides over the distal tip of the syringe 16. The locking arm 186 may include a locking protrusion 188 disposed on its inner surface to actively engage with an undercut 190 defined in the distal tip of the syringe 16. In one example of this disclosure, as the cap element 182 slides along the distal tip of the syringe 16 in a proximal direction, the locking arm 186 is forced radially outward by a flange 192 defined on the distal tip of the syringe 16. After the locking arm 186 has passed the flange 192 of the syringe 16, the locking arms 186 are biased to move rearward toward each other, thereby actively locking the locking protrusion 188 with the undercut 190 of the syringe 16. According to various embodiments, after the locking protrusion 188 engages with the undercut 190, the cap element 182 can be nonremovably locked to the syringe. According to this embodiment, a technician can easily attach the cap element 182 to the syringe without requiring the threaded engagement of conventional Luer components or a stronger connection engagement compared to friction-fit components. In some embodiments, the cap element 182 may produce an audible "click" when locked to the syringe tip, and / or the locking arm 186 may be flush with the outer surface of the cap element 182 when locked to the syringe tip. Thus, the user will have at least one auditory or visual cue that the cap element 182 is securely engaged with the syringe 16.

[0157] Continue to refer to Figure 36 and Figure 37In one example of this disclosure, the cap element 182 may further include a fluid transfer member 194 configured to guide fluid from the syringe 16 to a tubing kit or fluid container. The fluid transfer member 194 may include at least one fluid inlet port 196 that may be fluidly connected to the tubing kit, spike assembly, or fluid container. In one example of this disclosure, the fluid transfer member 194 may include two fluid ports, one for filling the syringe 16 with fluid and the other for delivering fluid from the syringe 16.

[0158] refer to Figure 38-42 According to another example of this disclosure, a fluid path connector assembly 200 is shown and described in detail. Although this embodiment is shown as a rolling diaphragm type syringe (see, for example, International PCT Publication No. WO2016 / 172467, the disclosure of which is incorporated herein by reference in its entirety), the fluid connector assembly 200 is also within the scope of this disclosure when used with other types of syringes. The fluid path connector assembly 200 may include a connector element 202 and a spike member 204, the spike member 204 directly ( Figures 43-46 ) or via intermediate piping kit ( Figure 38-42 The connector element 202 is fluidly connected to the connector element 202. The connector element 202 can be operatively connected to the fluid container 206 via spikes 204, 252. In one example of this disclosure, the connector element 202 can be fluidly connected to the spike member 204 using a transfer kit 208. Figure 38 A connector element 202 disconnected from the fluid container 206 is shown. To connect the connector element 202 to the fluid container 206, the inclined surface 210 on the connector element 202 and the inclined surface 212 on the fluid container 206 interact as the two elements are pushed towards each other and come into contact. Due to this interaction between the connector element 202 and the fluid container 206, a plurality of supports 210 on the connector element 202 are allowed to bend, such that a pair of flexible legs 212, 214 are opened wide enough to engage with a retaining lip 216 on a collar 218 of the fluid container 206. It should be understood that the fluid container 206 can be any number of containers known in the art, such as bottles, syringes, or rolling diaphragm syringes disclosed in WO2016 / 172467, WO2015 / 164783, WO2016 / 069711, and 62 / 730,228, the disclosures of which are incorporated herein by reference in their entirety.

[0159] Connector element 202 is connected to transfer kit 208 to guide fluid between spike members 204 through transfer kit 208 and into fluid container 206. Connector element 202 includes at least two flexible legs 212, 214 that, when pressure is applied near the top of each flexible leg, will cause latches 220, 222 on the flexible legs 212, 214 to move laterally and outward relative to each other, allowing connector element 202 to be removed from fluid container 206, syringe, cap, or adapter to which connector element 202 is connected. Connector element 202 may also include ribs 224, 226 and sealing member 228 for sealing. In one example of this disclosure, sealing member 228 may be an O-ring, an overmolded sealing surface, a quadrilateral ring, or any other dynamic seal.

[0160] refer to Figure 41 and 42 A valve member 230 may be provided in connector element 202. Valve member 230 may include a spring 232 that allows valve spool 234 to remain open (e.g., ...). Figure 41 (as shown) or in contact with the valve seat 236 of the rod 238 of the connector element 202 (e.g.) Figure 42 (As shown). When valve spool 234 is in the open position, fluid is allowed to flow around it and into the fluid path. When valve spool 234 is in the closed position, fluid flow then stops. Figure 41 and 42 As shown, the tip of the diverter 240 contacts the valve spool 234 and then pushes it to the open position. While the valve spool 234 is still in contact with the valve seat 236 and the fluid passage is closed, an operator can insert the spike member 204 into the bulk fluid container without the risk of leakage until the fluid path is fully established. Once the connector element 202 has been connected to the fluid container 206, syringe, cap, or adapter containing the diverter 240, the valve member 230 will open and fluid will be allowed to flow through it. A fluid diverter or other contact member for the valve spool 234 can be incorporated into any number of devices to disengage the valve spool 234 from the valve seat 236 and complete the fluid path. The presence of the diverter 240 allows fluid to flow along the inner surface of the fluid container 206, which receives fluid via the Coanda effect as described herein. Other such filling methods and adapters have been described, for example, in WO2017 / 091643, the disclosure of which is incorporated herein by reference.

[0161] refer to Figures 43-46According to one example of this disclosure, connector element 250 is shown and described in detail. Connector element 250 can be directly fluidly connected to spike member 252 and fluid container 254. In one example of this disclosure, connector element 250 is substantially similar to connector element 202 described above, but does not include valve core 234, so fluid flow is unrestricted regardless of whether connector element 250 is attached to a device with a fluid splitter or other contact member. However, as those skilled in the art will understand, a valve including valve core and valve seat can be incorporated into connector element 250 similar to connector element 202 described above.

[0162] refer to Figure 45 and Figure 46 According to one example of this disclosure, connector element 250 may be connected to spike member 252. The connection between connector element 250 and spike member 252 may occur by friction mating, solvent bonding, adhesive bonding or any other connection method known in the art.

[0163] refer to Figures 47-49 According to one example of this disclosure, a connector element 260 associated with a piping kit 262 is shown and described in detail. Connector element 260 can be fluidly connected to both the fluid path piping kit 262 and the fluid container 264. In this example of connector element 260, a valve core is not included, so fluid flow is unrestricted regardless of whether connector element 260 is attached to a device with a fluid splitter or other contact member. However, as those skilled in the art will understand, a valve including a valve core and seat can be incorporated into connector element 260 similar to connector element 202 described above. Connector element 260 can be connected to fluid path piping kit 262 by friction mating, solvent bonding, adhesive bonding, or other connection methods known in the art.

[0164] refer to Figure 50 and 51 According to one example of this disclosure, connector element 270 is shown and described in detail. Connector element 270 can be directly connected to fluid container 272. In this example of connector element 270, a valve core is not included, so fluid flow is unrestricted regardless of whether connector element 270 is attached to a device with a fluid splitter or other contact member. However, as those skilled in the art will understand, a valve including a valve core and valve seat can be incorporated into connector element 270 similar to connector element 202 described above.

[0165] refer to Figures 52-55According to one example of this disclosure, connector element 280 is shown and described in detail. Connector element 280 can be fluidly connected to connector element 282. In one example of this disclosure, first connector element 280 can be connected to second connector element 284 disposed on fluid container 282. In order to connect connector element 280 to fluid container 282, inclined surface 286 on connector element 280 interacts with inclined surface 288 on second connector element 284 of fluid container 282 when the two elements are pushed toward each other and come into contact. Due to this interaction between connector element 280 and second connector element 284, a plurality of supports 290 on connector element 280 are allowed to bend such that a pair of flexible legs 292, 294 are opened wide enough to engage with retaining lip 296 on collar 298 of second connector element 284. It should be understood that fluid container 282 can be any number of containers known in the art, such as bottles, syringes or rolling diaphragm syringes disclosed in WO2016 / 172467, WO2015 / 164783, WO2016 / 069711 and 62 / 730,228.

[0166] Connector element 280 may include a male connector element 300 surrounded by a cylindrical skirt 302. The male connector element 300 may include a sealing member 304 and may be recessed within the skirt 302. The recess at the tip of the male connector element 300 may, for example, help maintain the sterility of the male connector element 300 by preventing unintentional contact and contamination between the surface of the male connector element 300 and the corresponding female connector element. In other embodiments, connector element 280 may include a skirt surrounding the recessed female connector element. In one example, male connector element 290 is received at the distal end of fluid container 282, and a fluid tight seal is formed between the male connector element 290 and the inner surface of fluid container 282 using the sealing member 304.

[0167] refer to Figure 56According to one example of this disclosure, a fluid path connector assembly 310 is shown and described in detail. The fluid path connector assembly 310 may include a first connector element 312 and a second connector element 314. In this example, the second connector element 314 may be integrally molded to the distal end of a fluid container (e.g., a syringe). The first connector element 312 may be fitted into a circumferential gap between the syringe tip and the inner surfaces of the second connector element 314. Because the first connector element 312 is fitted into the distal end of the syringe, a skirt of the first connector element 312 can fit into the circumferential gap and can prevent fluid leakage during fluid injection. The circumferential gap may also collect fluid that may drip from the distal tip of the syringe or from the fluid path connector assembly 310 during the disconnection of the first connector element 312 from the syringe.

[0168] refer to Figure 57 According to one example of this disclosure, a connector element 320 is shown and described in detail. The connector element 320 may include a threaded inner surface 322 that engages with a corresponding external threaded surface on the distal tip of a syringe. The connector element 320 may thread-engage the syringe tip to lock the connector element 320 to the syringe tip. In some examples, the connector element 320 may include a first locking member, such as a ratchet assembly at the proximal end of the connector element 320, which engages with and locks a second locking member (such as a protrusion or pawl at the proximal end of the threads on the syringe tip). In other examples, the positions of the first and second locking members may be reversed. In some examples, when the connector element 320 thread-engages the threads of the syringe tip, once the connector element 320 is thread-engaged to the syringe tip, the first ratchet locking member may engage and lock with the second locking member. In some examples, the force of the connection may vary depending on the torque applied during the threading process and the tightness required for a particular injection process (e.g., the fluid injection pressure used).

[0169] refer to Figures 58-60 According to an example of this disclosure, a fluid path connector assembly 330 is shown and described in detail. This fluid path connector assembly 330 can be used to connect two parts of a piping kit (not shown) in a fluidly tight manner. The fluid path connector assembly 330 may include a male connector element 332 attachable to one end of a first piping kit and a female connector element 334 attachable to one end of a second piping kit. The male connector element 332 may include flexible legs 336, 338 for forming a positive locking engagement with a retaining lip 340 on a collar 342 of the female connector element 334. Each of the male connector element 332 and the female connector element 334 may include piping kit connector elements 344, 346 for connection to the respective piping kit.

[0170] The various examples of fluid connector assemblies described herein are suitable for use with medical fluid injectors, such as powered CT fluid injector systems, powered MR fluid injector systems, and powered CV angiography injector systems. The fluid connector assemblies are suitable for high-pressure injection processes and can exhibit increased connection forces between connector elements during high-pressure injection processes, such as those involving CV injection processes with fluid pressures up to 1200 psi or CT or MR injection processes with fluid pressures up to 400 psi.

[0171] refer to Figure 61 and 62 According to one example of this disclosure, a fluid path connector assembly 350 is shown and described in detail. The fluid path connector assembly 350 may include a first connector element 352 and a second connector element 354, which are operatively connectable to each other to form a fluid tight seal between a syringe and a tubing kit or fluid container. In one example of this disclosure, the first connector element 352 is substantially similar to the first connector element 12 described above, and the second connector element 354 is substantially similar to the second connector element 14 described above. However, in this example of the fluid path connector assembly 350, the second connector element 354 may include additional features for forming a fluid tight seal between the second connector element 354 and the fluid container, while preventing fluid flow through the second connector element 354 when disconnected. A movable sealing member 356 may be disposed on a connecting member 358 of the second connector element 354. In one example of this disclosure, the sealing member 356 may be a resilient O-ring or a slidable sealing element. The connecting member 358 may define a circumferential fluid channel 360 and a circumferential groove 362 in its outer surface. The sealing member 354 can be retained in either the circumferential fluid channel 360 or the circumferential groove 362. The sealing member 354 can be provided to form a fluid-tight seal between the connecting element 358 and the distal tip of the syringe. In one example of this disclosure, the sealing member 354 can slide and / or roll between the circumferential fluid channel 360 and the circumferential groove 362 of the connecting member 358 during the removal and insertion of the second connector member 354 and the first connector member 352, respectively.

[0172] Continue to refer to Figure 61 and Figure 62 The operation of the fluid path connector assembly 350 according to an example of this disclosure is shown and described in detail. Figure 61The fluid path connector assembly 350 is shown in the disconnected position. In the disconnected position, the sealing member 356 can be retained in the circumferential fluid passage 360, sealing the circumferential fluid passage 360 ​​so that fluid cannot pass through the second connector element 354 to any bulk container or piping assembly to which the second connector element 354 can be connected. When the sealing member 356 is retained in the circumferential fluid passage 360 ​​when the fluid path connector assembly 350 is in the disconnected position, the sealing member 356 prevents fluid leakage from the second connector element 354 when connected to a bulk fluid container. This prevents fluid leakage from the bulk fluid container through the second connector assembly 354 when the user disconnects the second connector element 354 from the first connector element 352 after filling the syringe 366 with fluid.

[0173] refer to Figure 62 The fluid path connector assembly 350 is shown in the connected position, with the first connector element 352 and the second connector element 354 connected to each other. During the connection process, a connecting member 358 is inserted into the first connector element 352. As the connecting member 358 is inserted into the first connector element 352, the sealing member 356 can frictionally engage with the inner surface of the distal tip 364 of the syringe 366. As the connecting member 358 is further inserted into the first connector element 352, the sealing member 356 continues to slide along the inner surface of the distal tip 364 of the syringe 366. The sliding movement of the sealing member 356 along the inner surface of the distal tip 364 of the syringe 366 generates frictional force, causing the sealing member 356 to roll or slide from the circumferential fluid channel 360 into the circumferential groove 362. Once the sealing member 356 is positioned in the circumferential groove 362, the circumferential fluid channel 360 is opened, thereby allowing fluid to flow from the second connector element 354 through the circumferential fluid channel 360 to the first connector element 352 and into the syringe 366. After the syringe 366 has been filled, the fluid path connector assembly 350 can be disconnected. As the second connector element 354 is pulled away from the first connector element 352, the sealing member 356 is pulled along the inner surface of the distal tip 364 of the syringe 366. As the sealing member 356 is pulled along the inner surface of the distal tip 364 of the syringe 366, frictional forces can cause the sealing member 356 to roll or slide from the circumferential groove 362 into the circumferential fluid passage 360, thereby sealing the circumferential fluid passage 360 ​​when the fluid path connector assembly 350 is moved to the disconnected position. In one example of this disclosure, a spiked member or tubing assembly may be connected to the second connector element 354 to transfer fluid from a bulk fluid source to the syringe 366.

[0174] While various examples of this disclosure have been provided in the foregoing description, modifications and alterations can be made to these examples by those skilled in the art without departing from the scope and spirit of this disclosure. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The foregoing disclosure is defined herein by the appended claims, and all changes to the meaning and equivalent scope of this disclosure falling within the claims are included within the scope of the claims.

Claims

1. A fluid path connector for a medical fluid delivery system, the fluid path connector comprising: The first connector element includes a body, a first cavity, a first flexible leg, a second flexible leg, a first actuating arm associated with the first flexible leg, and a second actuating arm associated with the second flexible leg; and The second connector element includes a body defining a circumferentially undercut surface, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel. The first flexible leg includes a first flange, and the second flexible leg includes a second flange, wherein the first flange and the second flange each form an angle of 45-75 degrees relative to the longitudinal axis of the first connector element. Specifically, when the first connector element and the second connector element are engaged, the first flange and the second flange engage with the circumferentially undercut inclined surface of the body of the second connector element to prevent the first connector element and the second connector element from disengaging. Specifically, when an inward pressure is applied to the first and second actuating arms, the first and second flexible legs move outward relative to the body of the second connector element, causing the first and second flanges to disengage from the circumferential undercut, thereby allowing the first and second connector elements to disengage. The at least one sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element are engaged with each other.

2. The fluid path connector according to claim 1, wherein, The first connector element and the second connector element are each configured to be in fluid communication with a fluid delivery element selected from the group consisting of a syringe, a spike member, a fluid tubing kit, and a bulk fluid container.

3. The fluid path connector according to claim 1, wherein, The first flange and the second flange are each angled inward toward the longitudinal axis of the first connector element.

4. The fluid path connector according to claim 1, wherein, At least one of the first flexible leg and the second flexible leg includes at least one reinforcing rib.

5. The fluid path connector according to claim 1, wherein, When the first connector element and the second connector element are connected to each other, the connection between the first connector element and the second connector element is configured to withstand a fluid pressure of at least 800 psi in the fluid path.

6. The fluid path connector according to claim 1, in, The first connector element further includes a support base extending from the body between the first flexible leg and the second flexible leg, and The support base is configured to reduce the deflection of the body caused by the fluid pressure exerted by the fluid in the fluid path.

7. The fluid path connector according to claim 6, wherein, The support base includes at least one support base reinforcing rib to reduce the deflection of the body due to the fluid pressure exerted by the fluid in the fluid path.

8. The fluid path connector according to claim 1, wherein, The at least one sealing element is selected from a group consisting of a flexible O-ring, a molded sealing surface, and a quadrilateral ring.

9. The fluid path connector according to claim 1, wherein, At least one of the first connector element and the second connector element further includes a skirt surrounding the body of the first connector element and the body of the second connector element.

10. The fluid path connector according to claim 9, wherein, The skirt extends beyond the distal end of the body of at least one of the first connector element and the second connector element.

11. The fluid path connector of claim 9, wherein when the skirt is on the second connector element, at least one hole is defined in the skirt.

12. The fluid path connector according to claim 2, wherein, At least one of the first connector element and the second connector element further includes a fluid path adapter configured to connect the first connector element and the second connector element to the fluid delivery element.

13. The fluid path connector of claim 1, wherein during the engagement process, when the first flange of the first flexible leg and the second flange of the second flexible leg pass through the circumferential undercut of the second connector, the first flange of the first flexible leg and the second flange of the second flexible leg each bend radially outward and return to an unbent position to contact and engage the circumferential undercut of the second connector element, thereby engaging the first connector element with the second connector element, and At the joint position, the first lumen and the second lumen are in fluid communication.

14. The fluid path connector of claim 13, wherein the first connector and the second connector are irreversibly engaged when the first flange and the second flange of the first connector element engage the circumferential undercut of the second connector element.

15. Medical fluid delivery systems, including: A syringe, comprising a proximal end, a distal end, and a sidewall extending from the proximal end to the distal end; Fluid delivery components; and Fluid path connector, including: The first connector element includes a body, a first cavity, a first flexible leg, and a second flexible leg; and The second connector element includes a body defining a circumferentially undercut surface, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel. The first connector element is fluidly connected to one of the fluid delivery component and the distal end of the syringe. The second connector element is fluidly connected to another of the fluid delivery components and the distal end of the syringe. The first flexible leg includes a first flange, and the second flexible leg includes a second flange, wherein the first flange and the second flange each form an angle of 45-75 degrees relative to the longitudinal axis of the first connector element. Specifically, when the first connector element and the second connector element are engaged, the first flange and the second flange engage with the circumferentially undercut inclined surface of the body of the second connector element to prevent the first connector element and the second connector element from disengaging. The at least one sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element are engaged with each other.

16. The medical fluid delivery system according to claim 15, wherein, The first connector element and the second connector element are each configured to be in fluid communication with a fluid path element selected from the group consisting of a syringe, a spike member, a fluid tubing kit, and a bulk fluid container.

17. A fluid path connector for a medical fluid delivery system, the fluid path connector comprising: A first connector element includes a body having a support base, a first cavity, a first flexible leg having a first actuating arm, and a second flexible leg having a second actuating arm, wherein at least one of the first flexible leg and the second flexible leg includes at least one reinforcing rib; and The second connector element includes a body defining a circumferentially undercut surface, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel. The first flexible leg includes a first flange, and the second flexible leg includes a second flange. The first flange and the second flange each form an inward angle of 45-75 degrees relative to the longitudinal axis of the first connector element. Specifically, when the first connector element and the second connector element are engaged, the first flange and the second flange engage with the circumferentially undercut inclined surface of the body of the second connector element to prevent the first connector element and the second connector element from disengaging. Specifically, when an inward pressure is applied to the first and second actuating arms, the first and second flexible legs move outward relative to the body of the second connector element, causing the first and second flanges to disengage from the circumferential undercut, thereby allowing the first and second connector elements to disengage. The at least one sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element are engaged with each other.

18. The fluid path connector according to claim 17, wherein, When the first connector element and the second connector element are connected to each other, the connection between the first connector element and the second connector element is configured to withstand a fluid pressure of at least 800 psi in the fluid path.

19. A fluid path connector for a medical fluid delivery system, the fluid path connector comprising: The first connector element includes a body, a first cavity, a first flexible leg, and a second flexible leg; and The second connector element includes a body defining a circumferentially undercut surface, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel. The first flexible leg includes a first flange, and the second flexible leg includes a second flange, wherein the first flange and the second flange each form an angle of 45-75 degrees relative to the longitudinal axis of the first connector element. During the engagement process, as the first flange of the first flexible leg and the second flange of the second flexible leg pass through the circumferential undercut of the second connector, the first flange of the first flexible leg and the second flange of the second flexible leg each bend radially outward and return to an unbent position to contact and engage the inclined surface of the circumferential undercut of the second connector element, thereby engaging the first connector element with the second connector element. Specifically, when the first connector element and the second connector element are engaged, the first flange and the second flange are circumferentially undercut into the body of the second connector element to prevent the first connector element and the second connector element from disengaging. The at least one sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element are engaged with each other. At the joint position, the first lumen and the second lumen are in fluid communication.

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