Fluid path connectors for medical fluid delivery

Abstract

To provide a fluid path connector for a medical fluid delivery system.SOLUTION: The fluid path connector includes: a first connector element comprising a body, a first lumen, a first flexible leg, and a second flexible leg; and a 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. The first flexible leg comprises a first flange, and the second flexible leg comprises a second flange. 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.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 705,251, filed Jun. 18, 2020, and U.S. Provisional Patent Application No. 62 / 979,584, filed Feb. 21, 2020, the disclosures of each of which are hereby incorporated by reference in their entireties.

[0002] The present disclosure relates to connectors, syringes, and syringe - connector systems for use in fluid delivery systems, and more particularly to connectors, syringes, and syringe - connector systems for use in medical fluid delivery systems for delivering one or more fluids to a patient under time constraints.

Background Art

[0003] In many medical procedures such as drug delivery, it is desirable to inject a liquid into a patient. During diagnostic and therapeutic procedures, various types of liquids such as contrast media (often simply referred to as "contrast agents") and / or saline can be injected into the patient. 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 a liquid such as a contrast agent under high pressure and on time. Injectors suitable for these applications typically use relatively large - volume syringes and can produce relatively high flow rates.

[0004] Medical practitioners are working under increasingly stringent time and physical constraints. Therefore, it is desirable to fill syringes or other liquid containers, as well as attach and detach components of fluid delivery systems, as quickly as possible. However, filling a large syringe with a liquid such as a contrast medium or saline is typically a time-consuming process. Conventional syringes have a distal opening typically used to fill the interior of the syringe. The size of this distal opening places a significant constraint on the filling rate. Further, conventional syringes are typically shipped with the plunger fully retracted, so in order to fill the syringe, air must first be expelled from the syringe and the plunger moved to the distal end of the syringe to initiate the liquid filling process. Since the cost of many medical procedures, such as diagnostic imaging, increases in relation to the time required, delays can significantly increase costs.

[0005] Further, in many such fluid delivery systems, it is necessary to form fluid connections between separate fluid path components. For example, it may be necessary to connect a syringe driven by an injector to a flexible plastic tube connected to a spike connected to a bulk fluid source or to a catheter inserted into a patient. Common connectors used in the medical field are luer connectors or luer locks. A luer connector includes a male connector or member and a female connector or member. The male and female members are typically connected by a friction fit to create a leak-free connection or by engaging a radially inwardly projecting thread attached to the female member with one or more radially outwardly extending flanges located on the male luer member.

[0006] A number of fluid connectors for use in medical procedures, such as luer connectors, are fragile, prone to breakage (e.g., by over-tightening), and exhibit numerous drawbacks, such as difficulty in forming connections, for example, by requiring time to rotate one or both connectors. Healthcare providers are increasingly subject to stringent time and physical constraints during various medical procedures and thus must very frequently connect and / or disconnect a number of fluid path elements in a relatively short time under stressful and / or emergency conditions. This can lead to over-tightening of luer connectors, compromising the structural integrity of the connectors, even causing cracks in the connector components, leading to the possibility of air leakage and ingress. In many conventional connector configurations, there is no indication (audible or visual) to inform the user that the connector is properly assembled and further tightening is not required. In addition, the seal between the male and female members of a luer connector can be compromised by the accumulation of tolerances between the male and female members due to variations in the manufacturing process. Further, in certain procedures such as angiography, very high fluid pressures (up to 1200 psi) are used to inject fluid. High pressure can lead to separation of conventional luer connectors, for example, if the male and / or female connectors are wet and the friction between the connector components is reduced, causing the luer threading to loosen.

[0007] Healthcare providers must connect and / or disconnect a fluid delivery system in a relatively short time under stressful and / or emergency conditions. Thus, it is desirable to develop a syringe adapter configured to fill a syringe and / or deliver medical fluid to a patient, having a durable syringe-connector interface that allows for easy and rapid connection or disconnection and does not leak, break, or unintentionally separate. SUMMARY OF THE INVENTION

[0008] In one example of the present disclosure, a fluid path connector for a medical fluid delivery system includes a first connector element including a body, a first lumen, a first flexible leg, and a second flexible leg, and a second connector element defining an undercut and including a body, a second lumen, a channel defined in the body, and at least one seal element disposed within the channel. The first flexible leg includes a first flange, and the second flexible leg includes a second flange. When the first connector element and the second connector element are engaged, the first flange and the second flange engage with the undercut of the body of the second connector element to prevent separation of the first connector element and the second connector element. The seal element is configured to define a seal that prevents fluid leakage 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.

[0009] In another example of the present disclosure, the first connector element and the second connector element each communicate with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tube set, and a bulk fluid container. The first flange and the second flange each slope inwardly toward the longitudinal axis of the first connector element. The first flange and the second flange each slope at an angle of 45 to 75 degrees with respect to the longitudinal axis of the first connector element. The first connector element includes a first operating arm associated with a first flexible leg and a second operating arm associated with a second flexible leg. When an inward pressure is applied to the first operating arm and the second operating arm, the first flexible leg and the second flexible leg move outwardly relative to the body of the second connector element to disengage the first flange and the second flange from the undercut, enabling separation of the first connector element and the second connector element. 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 in the fluid path of at least 800 psi. 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 moving through the fluid path. The support base includes at least one reinforcing rib for reducing the deflection of the body caused by the fluid pressure exerted by the fluid moving through the fluid path. The seal element is one of an elastomeric O-ring, a sealed surface by overmolding, and a quad ring. The channel is dimensioned such that when the first connector element and the second connector element are engaged with each other and separated, at least one seal element moves in opposite directions within the channel along the longitudinal axis of the second connector element.At least the seal element moves between a first position in which at least one seal member seals a fluid channel defined in a second connector element to prevent fluid from flowing through the second connector element, and a second position in which at least one seal member moves away from the fluid channel to allow fluid to flow through 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 opening 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 and second flexible arms when the first connector element engages the second connector element.

[0010] In another example of the present disclosure, a medical fluid delivery system includes a syringe having 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. The fluid path connector includes a first connector element including a body, a first lumen, a first flexible leg, and a second flexible leg, and a second connector element defining an undercut in the body, a second lumen, a channel defined in the body, and at least one seal element disposed in the channel. The first connector element is fluidly connected to the fluid delivery member, the second connector element is fluidly connected to the distal end of the syringe, the first flexible leg includes a first flange, the second flexible leg includes a second flange, and when the first connector element and the second connector element are engaged, the first flange and the second flange engage the undercut in the body of the second connector element to prevent separation of the first connector element and the second connector element. The seal element is configured to define a seal that prevents fluid leakage 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.

[0011] In another example of the present disclosure, the first connector element and the second connector element each communicate with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tube set, and a bulk fluid container. The first flange and the second flange each slope inwardly toward the longitudinal axis of the first connector element. The first flange and the second flange each slope at an angle of 45 to 75 degrees with respect to the longitudinal axis of the first connector element. The first connector element includes a first operating arm associated with a first flexible leg and a second operating arm associated with a second flexible leg. When an inward pressure is applied to the first operating arm and the second operating arm, the first flexible leg and the second flexible leg move outwardly relative to the body of the second connector element to disengage the first flange and the second flange from the undercut, enabling separation of the first connector element and the second connector element. 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 in the fluid path of at least 800 psi. The first connector element further includes a support base extending from the body between the first flexible leg and the second flexible leg, the support base being configured to reduce the deflection of the body caused by the fluid pressure exerted by the fluid moving through the fluid path. The support base includes at least one reinforcing rib for reducing the deflection of the body caused by the fluid pressure exerted by the fluid moving through the fluid path. The channel is dimensioned such that when the first connector element and the second connector element are engaged with and separated from each other, the seal 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 opening 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 and second flexible arms when the first connector element engages the second connector element.

[0012] In another example of the present 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. The first flexible leg includes a first flange, the second flexible leg defines a second flange, the third flexible leg includes a third flange, the fourth flexible leg defines a fourth flange, and when the first connector element engages the second connector element, the first flange and the second flange couple to the second undercut of the body of the second connector element, and the third flange and the fourth flange couple to the first undercut of the body of the first connector element to ensure prevention of separation of the first connector element and the second connector element from each other.

[0013] In another example of the present disclosure, the first flange and the second flange each incline inwardly toward the longitudinal axis of the first connector element, and the third flange and the fourth flange each incline inwardly toward the longitudinal axis of the second connector element. The first flange and the second flange each incline at 45 to 75 degrees with respect to the longitudinal axis of the first connector element, and the third flange and the fourth flange each incline at 45 to 75 degrees with respect to the longitudinal axis of the second connector element. The first connector element further includes a first operating arm and a second operating arm, the second connector element further includes a third operating arm and a fourth operating arm, and when inward pressure is applied to the first operating arm and the second operating arm, the first flexible leg and the second flexible leg move outwardly with respect to the body of the second connector element to enable separation of the first connector element and the second connector element. When inward pressure is applied to the third operating arm and the fourth operating arm, the third flexible leg and the fourth flexible leg move outwardly with respect to the body of the second connector element to enable separation of the first connector element and the second connector element. At least one of the first operating arm, the second operating arm, the third operating arm, and the fourth operating arm 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.

[0014] The following clauses also enumerate further features of the present disclosure.

[0015] Clause 1. A fluid path connector for a medical fluid delivery system, comprising a first connector element having a body, a first lumen, a first flexible leg, and a second flexible leg, and a second connector element having an undercut-defined body, a second lumen, a channel defined in the body, and at least one seal element disposed in the channel, wherein the first flexible leg comprises a first flange, the second flexible leg comprises a second flange, and when the first connector element and the second connector element are engaged, the first flange and the second flange engage with the undercut of the body of the second connector element to prevent separation of the first connector element and the second connector element, and the seal element is configured to define a seal that prevents fluid leakage 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.

[0016] Clause 2. The fluid path connector according to Clause 1, wherein the first connector element and the second connector element each communicate with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tube set, and a bulk fluid container.

[0017] Clause 3. The fluid path connector according to Clause 1 or 2, wherein the first flange and the second flange each incline inwardly toward the longitudinal axis of the first connector element.

[0018] Clause 4. The fluid path connector according to any one of Clauses 1 to 3, wherein the first flange and the second flange each incline at 45 to 75 degrees with respect to the longitudinal axis of the first connector element.

[0019] Clause 5. The first connector element includes a first operating arm associated with the first flexible leg portion and a second operating arm associated with the second flexible leg portion. When an inward pressure is applied to the first operating arm and the second operating arm, the first flexible leg portion and the second flexible leg portion move outward relative to the body of the second connector element, separating the first flange and the second flange from the undercut, enabling separation of the first connector element and the second connector element. The fluid path connector according to any one of Clauses 1 to 4.

[0020] Clause 6. The fluid path connector according to Clause 5, wherein at least one of the first flexible leg portion and the second flexible leg portion includes at least one reinforcing rib.

[0021] Clause 7. 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 in the fluid path of at least 800 psi. The fluid path connector according to any one of Clauses 1 to 6.

[0022] Clause 8. The first connector element further includes a support base extending from the body between the first flexible leg portion and the second flexible leg portion. 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. The fluid path connector according to any one of Claims 1 to 7.

[0023] Clause 9. The fluid path connector according to Clause 8, wherein the support base includes at least one reinforcing rib for reducing the deflection of the body caused by the fluid pressure exerted by the fluid moving through the fluid path.

[0024] Clause 10. The sealing element is one of an elastomeric O-ring, a sealed surface by overmolding, and a quad ring. The fluid path connector according to any one of Clauses 1 to 9.

[0025] Clause 11. The channel is dimensioned such that when the first connector element and the second connector element are engaged with and separated from each other, at least one sealing element moves in opposite directions within the channel along the longitudinal axis of the second connector element. The fluid path connector according to any one of Clauses 1 to 10.

[0026] Clause 12. The at least one sealing element moves between a first position where at least one sealing member seals a fluid channel defined in the second connector element to prevent fluid from flowing through the second connector element, and a second position where at least one sealing member moves away from the fluid channel to allow fluid to flow through the second connector element. The fluid path connector according to any one of Clauses 1 to 11.

[0027] Clause 13. At least one of the first connector element and the second connector element further comprises a skirt surrounding the body of the first connector element and the body of the second connector element. The fluid path connector according to any one of Clauses 1 to 12.

[0028] Clause 14. The skirt extends beyond the distal end of the body of at least one of the first connector element and the second connector element. The fluid path connector according to Clause 13.

[0029] Clause 15. At least one opening is defined in the skirt for the second connector element. The fluid path connector according to Clause 13 or 14.

[0030] Clause 16. 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. The fluid path connector according to any one of Clauses 1 to 15.

[0031] Clause 17. The fluid path connector according to any one of Clauses 1 to 16, wherein the first connector element comprises a slidable sleeve configured to lock the first and second flexible arms when the first connector element engages the second connector element.

[0032] Clause 18. A medical fluid delivery system comprising a syringe having 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, the fluid path connector comprising a body, a first lumen, a first flexible leg, and a second flexible leg, a first connector element, and a body defining an undercut, a second lumen, a channel defined in the body, and at least one seal element disposed in the channel, a second connector element, wherein the first connector element is fluidly connected to the fluid delivery member, the second connector element is fluidly connected to the distal end of the syringe, the first flexible leg comprises a first flange, the second flexible leg comprises a second flange, and when the first connector element engages the second connector element, the first flange and the second flange engage the undercut of the body of the second connector element to prevent separation of the first connector element and the second connector element, and the seal element is configured to define a seal that does not leak fluid 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 each other.

[0033] Clause 19. The medical fluid delivery system according to Clause 18, wherein the first connector element and the second connector element each communicate with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tube set, and a bulk fluid container.

[0034] Clause 20. The medical fluid delivery system according to clause 18 or 19, wherein the first flange and the second flange each incline inwardly toward the longitudinal axis of the first connector element.

[0035] Clause 21. The medical fluid delivery system according to any one of clauses 18 to 20, wherein the first flange and the second flange each incline at 45 to 75 degrees with respect to the longitudinal axis of the first connector element.

[0036] Clause 22. The first connector element includes a first operating arm associated with the first flexible leg and a second operating arm associated with the second flexible leg. When an inward pressure is applied to the first operating arm and the second operating arm, the first flexible leg and the second flexible leg move outwardly with respect to the body of the second connector element, separating the first flange and the second flange from the undercut and enabling separation of the first connector element and the second connector element. The medical fluid delivery system according to any one of clauses 18 to 21.

[0037] Clause 23. The medical fluid delivery system according to clause 22, wherein at least one of the first flexible leg and the second flexible leg includes at least one reinforcing rib.

[0038] Clause 24. 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 in the fluid path of at least 800 psi. The medical fluid delivery system according to any one of clauses 18 to 23.

[0039] Clause 25. The first connector element further comprises a support base extending from the body between the first flexible leg and the second flexible leg, the support base being configured to reduce the deflection of the body due to the fluid pressure exerted by the fluid moving through the fluid path, the medical fluid delivery system according to any one of clauses 18 to 24.

[0040] Clause 26. The support base comprises at least one reinforcing rib for reducing the deflection of the body due to the fluid pressure exerted by the fluid moving through the fluid path, the medical fluid delivery system according to clause 25.

[0041] Clause 27. The channel is dimensioned such that when the first connector element and the second connector element are engaged with each other and when separated, the sealing element moves in opposite directions within the channel along the longitudinal axis of the second connector element, the medical fluid delivery system according to any one of clauses 18 to 26.

[0042] Clause 28. At least one of the first connector element and the second connector element further comprises a skirt surrounding the body of the first connector element and the body of the second connector element, the medical fluid delivery system according to any one of clauses 18 to 27.

[0043] Clause 29. The skirt extends beyond the distal end of the body of at least one of the first connector element and the second connector element, the medical fluid delivery system according to clause 28.

[0044] Clause 30. At least one opening is defined in the skirt for the second connector element, the medical fluid delivery system according to clause 28 or 29.

[0045] Clause 31. The medical fluid delivery system according to any one of Clauses 18 to 30, 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.

[0046] Clause 32. The fluid path connector according to any one of Clauses 18 to 31, wherein the first connector element comprises a slidable sleeve configured to lock the first and second flexible arms when the first connector element engages the second connector element.

[0047] Clause 33. A fluid path connector for a medical fluid delivery system, comprising a first connector element having a body defining a first undercut, a first flexible leg, and a second flexible leg, and a second connector element having a body defining a second undercut, a third flexible leg, and a fourth flexible leg, wherein the first flexible leg comprises a first flange, the second flexible leg defines a second flange, the third flexible leg comprises a third flange, the fourth flexible leg defines a fourth flange, and when the first connector element engages the second connector element, the first flange and the second flange engage the second undercut of the body of the second connector element, and the third flange and the fourth flange engage the first undercut of the body of the first connector element to securely prevent separation of the first connector element and the second connector element from each other.

[0048] Clause 34. The fluid path connector according to Clause 33, wherein the first flange and the second flange are each inclined inwardly toward the longitudinal axis of the first connector element, and the third flange and the fourth flange are each inclined inwardly toward the longitudinal axis of the second connector element.

[0049] Clause 35. Each of the first flange and the second flange is inclined at 45 to 75 degrees with respect to the longitudinal axis of the first connector element, and each of the third flange and the fourth flange is inclined at 45 to 75 degrees with respect to the longitudinal axis of the second connector element. The fluid path connector according to clause 33 or 34.

[0050] Clause 36. The first connector element further includes a first operating arm and a second operating arm, the second connector element further includes a third operating arm and a fourth operating arm, and when an inward pressure is applied to the first operating arm and the second operating arm, the first flexible leg and the second flexible leg move outward with respect to the body of the second connector element, enabling separation of the first connector element and the second connector element. When an inward pressure is applied to the third operating arm and the fourth operating arm, the third flexible leg and the fourth flexible leg move outward with respect to the body of the second connector element, enabling separation of the first connector element and the second connector element. The fluid path connector according to any one of claims 33 to 35.

[0051] Clause 37. The fluid path connector according to clause 36, wherein at least one of the first operating arm, the second operating arm, the third operating arm, and the fourth operating arm includes at least one reinforcing rib.

[0052] Clause 38. 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. The fluid path connector according to any one of clauses 33 to 37.

Brief Description of the Drawings

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[0054] The figures generally show preferred (but not necessarily limiting) aspects of the systems and methods of the present disclosure. The description presents various aspects of the apparatus, but should in no way be construed as limiting the present disclosure. Further, modifications, concepts, and applications of aspects of the present disclosure will be understood by those skilled in the art to be included in, but not limited to, the examples and descriptions provided herein.

[0055] The following description is provided to enable those skilled in the art to make and use the aspects contemplated and described for the implementation of the present disclosure. However, various modifications, equivalents, variations, and alternative forms will still be readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternative forms are intended to be encompassed within the spirit and scope of the present disclosure. Further, for the purposes of the following description, the terms "end," "upper," "lower," "right," "left," "vertical," "horizontal," "upper part," "lower part," "lateral," "longitudinal," and their derivatives shall relate to the present disclosure as oriented in the drawings. The term "proximal" with respect to a syringe generally refers to the axial or longitudinal direction towards the end that is closest to the injector in the syringe and opposite to the tube leading towards the patient. The term "distal" with respect to a syringe refers to the axial or longitudinal direction away from the injector and towards the patient. The term "proximal" with respect to a tubing set generally refers to the axial or longitudinal direction towards the end that is closest to the syringe in the tubing set and opposite to the injection member leading towards the patient. The term "distal" with respect to a tubing set refers to the axial or longitudinal direction away from the syringe and towards the patient's injection member. 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 the present disclosure may present various alternative variations and sequences of steps unless otherwise specifically stated. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary aspects of the present disclosure. Accordingly, the specific dimensions and other physical characteristics relating to the aspects disclosed herein should not be regarded as limitations.

[0056] Figures 1 - 6 illustrate a fluid path connector assembly 10 according to an example of the present disclosure associated with a syringe 16. The fluid path connector assembly 10 can include a first connector element 12 and a second connector element 14 configured to connect to each other to form a seal that does not leak liquid between a first fluid container and a second fluid container or a fluid delivery device. In an example of the present disclosure, the first connector element 12 may be operably connected to the syringe 16. The first connector element 12 may be operably connected to the distal end of the syringe 16. In an example of the present disclosure, the first connector element 12 may be welded (e.g., laser welded) or otherwise adhered to the distal end of the syringe 16. In some examples of the present disclosure, the second connector element 14 may be connected to a catheter tube set, a fluid delivery line, a fluid spike assembly, or any medical fluid container having an opening. In an example of the present disclosure, the inner surface of the distal tip of the syringe 16 may include a plurality of ribs 17 that form a contour within the syringe 16 that utilizes the Coanda effect with respect to the fluid passing through the syringe 16 in combination with a flow diverter 53, as shown in FIGS. 6A - 6C. As used herein, the Coanda effect is the tendency for the flow of a liquid to be attracted to a nearby surface when the liquid flows along a curved or angled surface. Thus, when fluid enters the syringe 16 through the connector element, the fluid contacts the flow diverter 53, is deflected towards the inner wall of the discharge neck of the syringe 16, and contacts the plurality of ribs 17. Instead of dripping from the edge of the ribbed distal tip of the syringe 16, the liquid is naturally attracted to the inner surface of the conical distal end of the syringe 16 as it flows along the ribbed distal tip of the syringe 16. The liquid then flows down the tubular sidewall of the syringe 16 and ultimately accumulates at the bottom of the syringe 16, filling the syringe 16 from the bottom upwards as air escapes from the syringe 16 through the flow controller and the connector tube. This flow along the inner surface of the syringe 16 helps to reduce turbulence as the liquid fills the syringe 16 and aids in reducing the formation of air bubbles during filling of the syringe 16.Furthermore, the flow diverter 53 and the rib 17 enable more rapid filling of the syringe 16, and thus reduce the time required for the fluid injection process. Further features and advantages of this Coanda effect are described in WO 2017 / 091643 pamphlet, the disclosure of which is incorporated herein by reference in its entirety. FIGS. 1 and the other figures show a syringe 16 having a first connector element 12 with a second connector element 14 connected to a catheter tube set, a fluid delivery line, a fluid spike assembly, or any medical fluid container having an opening, but it should be noted that the position of the first connector element 12 with the second connector element 14 can be exchanged without departing from the spirit of the present disclosure. Generally, the position of the first connector element 12 with the second connector element 14 in various configurations can be exchanged without departing from the spirit of the present disclosure.

[0057] In some examples of the present disclosure, the first connector element 12 can include a body 18, a first lumen 19 extending through the body 18, a first leg 20, and a second leg 22, and can have a support base 76 connected to the first leg 20 and the second leg 22. The first and second legs 20, 22 may be integrally formed with the body 18. The first and second legs 20, 22 may extend distally from the body 18 in a distal direction with respect to the distal end of the syringe 16 as shown in FIGS. 1-6. In an example of the present disclosure, the first and second legs 20, 22 are made of a material such that they can pivot at the location where the legs 20, 22 meet the support base 76 to enable the distal ends of the first and second legs 20, 22 to move radially outwardly in a direction with respect to the longitudinal axis 24 of the first connector element 12. In an example of the present disclosure, the first and second legs 20, 22 may be made of a rigid material with a flexible pivot point to enable the first and second legs 20, 22 to move radially outwardly in a direction with respect to the longitudinal axis 24 of the first connector element 12.

[0058] In some examples of the present disclosure, the first connector element 12 can further include a first operating arm 26 and a second operating arm 28 that extend from the body 18 in a direction opposite to the first and second legs 20, 22. The first and second operating arms 26, 28 may be integrally formed with the body 18 and the first and second legs 20, 22. During operation of the fluid path connector assembly 10, the first and second operating arms 26, 28 are configured to be radially inwardly pressed toward each other by an operator to move the first and second legs 20, 22 radially outwardly away from each other. Due to the pressure applied to the first and second operating arms 26, 28, the first and second legs 20, 22 move away from each other. In one embodiment of the present disclosure, at least one of the first and second operating arms 26, 28 can include a plurality of gripping ribs 30 to assist in gripping the first and second operating arms 26, 28 when handling the first connector element 12. In some examples of the present disclosure, the first connector element 12 can include a support portion 32 that extends from the body 18 in the same direction as the first and second operating arms 26, 28, i.e., toward the body of the syringe 16, as shown in FIGS. 1-6. The support portion 32 may 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 screwing, adhesion, or welding. The support portion 32 provides a stabilizing effect on the first connector element 12 when the first connector element 12 is operably connected to the syringe 16 and when the first and second operating arms 26, 28 are pressed inwardly toward each other to operate the first connector element 12.

[0059] According to various examples of the present disclosure, each of the first and second legs 20, 22 is configured to withstand the pressure associated with the pressurized fluid injection procedure without separating as described herein and to form a seal that does not leak fluid between the first lumen 19 of the first connector element 12 and the second lumen 47 of the second connector element 14, and may each include a first flange 34 and a second flange 36 configured to engage a portion of the second connector element 14 for facilitating connection of the first connector element 12 to the second connector element 14. In some examples of the present disclosure, at least a portion 38, 40 of each flange 34, 36 may be inclined inwardly with respect to the longitudinal axis 24 of the first connector element 12. In one example of the present disclosure, a portion 38, 40 of the flanges 34, 36 can be inclined 60 degrees from the longitudinal axis 24 of the first connector element 12, and the inclined portion is inclined toward the proximal end of the syringe 16 as shown in FIGS. 1-6. In other examples of the present disclosure, a portion 38, 40 of the flanges 34, 36 can be inclined in the range of 45 degrees to 75 degrees from the longitudinal axis 24 of the first connector element 12. In another example of the present disclosure, a portion 38, 40 of the flanges 34, 36 can be inclined in the range of 55 degrees to 65 degrees from the longitudinal axis 24 of the first connector element 12. In one example of the present disclosure, a portion 38, 40 of the flanges 34, 36 may face toward the distal end of the syringe 16 such that the portions 38, 40 of the flanges 34, 36 extend toward the proximal end of the syringe 16. Under the fluid injection pressure, the inclined portions 38, 40 of the flanges 34, 36 can push the first and second legs 20, 22 in a radially inward direction, increasing the strength of the connection force between the first connector element 12 and the second connector element 14 during pressurized injection and making separation less likely to occur. The most distal surfaces 42, 44 of the flanges 34, 36 may be sloped or chamfered to assist in receiving the second connector element 14 as described below. The surfaces 42, 44 may be inclined inwardly toward the longitudinal axis 24 of the first connector element 12. In one example of the present disclosure, the outer edges of each of the surfaces 42, 44 may slope inwardly and toward the operating arms 26, 28, and slope inwardly to the inner edges of each of the surfaces 42, 44.The chamfered surface or sloped surface 42, 44 causes the first and second legs 20, 22 to deflect radially outward when the second connector element 14 is inserted into the first connector element 12. Then, once the body 46 of the second connector element 14 has passed through the flanges 34, 36, the first and second legs 20, 22 snap back in the radially inward direction to engage the first connector element 12 with the second connector element 14.

[0060] According to various examples of the present disclosure, each of the legs 20, 22 can further include at least one reinforcing member 45a, 45b. According to various examples, the reinforcing members 45a, 45b may be provided along at least a portion of the outer surface of the legs 20, 22. In certain examples, the reinforcing members 45a, 45b may extend over 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 leg 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 molding the legs 20, 22 and the respective reinforcing members 45a, 45b simultaneously. In other examples, the reinforcing members 45a, 45b may be made of a material different from that of the legs 20, 22 and the first connector element 12 to increase the strength of the legs 20, 22. The reinforcing members 45a, 45b can be provided on the legs 20, 22 such that while adding rigidity to the legs 20, 22, the legs 20, 22 still retain sufficient flexibility to move inwardly and outwardly during the connection and separation of the first connector element 12 and the second connector element 14. In an example of the present disclosure, the reinforcing members 45a, 45b may extend along at least a portion of the length of the legs 20, 22 and be strips of material that project outwardly from the outer surface of the legs 20, 22, for example, substantially perpendicular to the outer surface of the legs 20, 22. After the first and second connector elements 12, 14 are connected, the reinforcing members 45a, 45b may be configured to assist in maintaining the connection of the legs 20, 22 to the second connector element 14, for example, by further reducing the outward deflection or elongation of the legs 20, 22 during a pressure injection procedure. In certain embodiments, due to the high fluid pressure between the first and second connector elements 12, 14, the first and second connector elements 12, 14 may tend to deflect radially outwardly from each other. Thus, the reinforcing members 45a, 45b help to prevent the separation of the first connector element 12 from the second connector element 14 by ensuring that the legs 20, 22 do not move outwardly even under these high fluid pressures.

[0061] Continuing to refer to FIGS. 5 and 6, according to some examples of the present disclosure, the second connector element 14 will be described in detail. The second connector element 14 can include a body 46 through which a second lumen 47 is formed that is connected to the first connector element 12 and configured to communicate with the first lumen 19 of the first connector element 12. In one example of the present disclosure, the body 46 is configured to be substantially cylindrical in shape. When the first and second connector elements 12, 14 are connected, the body 46 may be configured to be held between the legs 20, 22 of the first connector element 12. The body 46 can define at least one opening 48, 50 that extends through an outer skirt 51 that surrounds the outer surface of the proximal end of the body 46. The outer skirt 51 can help maintain the sterility of the fluid path, for example, by preventing a technician from inadvertently touching and contaminating the inner fluid path during operation of the connector assembly. In one example of the present disclosure, the body 46 defines two openings 48, 50 that extend through the body 46. In one example of the present disclosure, the second connector element 12 can further include an attachment member 52 that extends from the body 46. The attachment member 52 may be configured to enable connection of a tube set, spike assembly, or fluid container to the second connector element 12. In one example of the present disclosure, the attachment member 52 may be configured to allow for a friction fit with a tube set, spike assembly, or fluid container. The tube set, spike assembly, or fluid container may be welded (laser welded) or adhered to the attachment member 52 by other means. It should also be apparent 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 the present disclosure, the second connector element 14 can further include at least one support member 54, 56 that extends at least partially around the attachment member 52 in the same direction as the attachment member 52 from the body 46. The support members 54, 56 are configured to prevent bending of the bend of the attached fluid path element and to provide a gripping surface for the operator to grip when using the second connector element 14. In one example of the present disclosure, the second connector element 14 includes two support members 54, 56.

[0062] In various examples of the present disclosure, the second connector element 14 can further include a support base 60 that extends in a direction opposite to the attachment member 52 from the body 46. The skirt 51 can extend around the support base 60 as described herein. In an example of the present disclosure, the support base 60 is configured to be inserted into an opening at the distal tip of the syringe 16 to connect the syringe 16 attached to the first connector element 12 to a tube set, a spike assembly, or a fluid container attached to the second connector element 14. Further, it is considered that the support base 60 may be configured to receive the distal tip of the syringe 16. In an example of the present disclosure, the support base 60 can define at least one circumferential groove 62 that is configured to receive at least one seal element 64. In an example of the present disclosure, the at least one seal element 64 can be at least one O-ring, a seal surface by overmolding formed on the outer surface of the support base 60, a quad ring, or any other dynamic seal. In an example of the present disclosure, when the first and second connector elements 12, 14 are connected, the at least one seal element 64 is configured to establish a seal that does not leak fluid between the support base 60 and the distal tip of the syringe 16. By using this seal element 64, when fluid passes between the syringe 16 connected to the first connector element 12 and the tube set or fluid container connected to the second connector element 14, the fluid cannot leak from the fluid path connector assembly 10. When the second connector element 14 is pulled away from the first connector element 12, the support base 60 is pulled out from the distal tip of the syringe 16. When the support base 60 is pulled out from the distal tip of the syringe 16, the seal member 64 continues to hold a seal that does not leak fluid 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 an example of the present disclosure, the fluid path connector assembly 10 may include two seal members provided on the support base 60 of the second connector element 14. By providing a plurality of seal members, the sterility of the fluid path connector assembly 10 is improved.

[0063] In an example of the present disclosure, the body 46 of the second connector element 14 can further define an undercut 66 in the form of a groove or channel having an outer inclined wall with an angle complementary to the inclined surfaces of the flanges 34, 36 on its proximal surface. The undercut 66 can be configured to receive portions 38, 40 of the first and second flanges 34, 36 of the first connector element 12 to ensure that the first and second connector elements 12, 14 remain connected during use of the fluid path connector assembly 10. In an example of the present 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 towards the second lumen 47 of the second connector element 14 to the inner surface of the body 46. In an example of the present disclosure, the undercut 66 may extend across the entire circumference of the body 46. Further, it is also conceivable that the undercut 66 may be provided only on a portion of the circumference of the body 46. In an example of the present disclosure, the inclined surface of the undercut 66 may substantially correspond to the inclined surfaces of the corresponding portions 38, 40 of the first and second flanges 34, 36 of the first connector element 12. The inclined surface of the undercut 66 may extend obliquely with respect to the longitudinal axis of the second connector element 14 corresponding to the longitudinal axis 24 of the first connector element 12. In an example of the present disclosure, the inclined surface of the undercut 66 extends at an angle of 60 degrees with respect to the longitudinal axis of the second connector element 14. In other examples of the present disclosure, the inclined surface of the undercut 66 can be inclined in the range of 45 degrees to 75 degrees from the longitudinal axis of the second connector element 14. In another example of the present disclosure, the inclined surface of the undercut 66 can be inclined in the range of 55 degrees to 65 degrees from the longitudinal axis of the second connector element 14. In an example of the present disclosure, the inclined surface of the undercut 66 is inclined inwardly from the end of the body 46 proximate to the mounting member 52 towards the end of the body 46 proximate to the support base 60.

[0064] With continued reference to FIGS. 1-6, a method of connecting and disconnecting the fluid connector system 10 will be described in detail. In one example of the present disclosure, the first connector element 12 may be operably connected to the syringe 16. In one example, the first connector element 12 is welded to the distal end of the syringe 16, more specifically to the distal tip. The distal tip of the syringe 16 may be received in the support portion 32 of the first connector element 12. In one example of the present disclosure, the second connector element 14 may be operably connected to a tube set, a spike assembly, or a fluid container. The tube set, spike assembly, fluid container, or other fluid path component may be connected to the attachment portion 52 of the second connector element 14. According to various examples, the connector assembly 10 may be configured to provide a visual and / or audible signal to the user indicating that the connector assembly 10 is properly engaged. For example, upon connection of the first connector element 12 and the second connector element 14, when the first and second flanges 34, 36 of the first connector element 12 pass through the body of the second connector element 14, an audible click sound can be heard indicating that the two connector elements are engaged when the first and second flanges 34, 36 engage the undercut 66. Further, the user can visually confirm that the first and second flanges 34, 36 are engaged with the undercut 66 and thus the connector assembly 10 is ready for use. As described herein, the figures generally show embodiments in which the first connector element 12 is associated with a syringe and the second connector element 14 is associated with some other fluid path component, but the relative positions of the first connector element 12 and the second connector element 14 may be interchanged without departing from the intent of the present disclosure.

[0065] In one example of the present disclosure, after the syringe 16 is connected to the first connector element 12 and the tubing set / spike assembly / fluid container is connected to the second connector element 14, the first and second connector elements 12, 14 can be moved toward each other for connection. As the second connector element 14 is moved toward the first connector element 12, the body 46 of the second connector element 14 can engage the inclined surfaces 42, 44 of the first and second flexible legs 20, 22 of the first connector element 12. Since the diameter of the body 46 of the second connector element 14 may 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 move the legs 20, 22 outward when the body 46 presses against the inclined surfaces 42, 44. At a particular point in time, the legs 20, 22 are pushed far enough outward so that the legs 20, 22 can be moved past to receive the body 46 of the second connector element 14 within the first connector element 12. At the same time, it is contemplated that the operating arms 26, 28 can be pushed inward to move the legs 20, 22 outward to receive the second connector element 14 within the first connector element 12, such that less engagement force needs to be applied to the second connector element 14, or that it is not necessary to press the body 46 of the second connector element 14 against the inclined surfaces 42, 44 of the legs 20, 22. Thereafter, the operating arms 26, 28 may be released after the body 46 of the second connector element 14 has been received within the first connector element 12.

[0066] In an example of the present disclosure, after the body 46 of the second connector element 14 passes through the legs 20, 22, the legs 20, 22 may be configured to move inwardly toward each other to their original rest position. When the legs 20, 22 move inwardly, the flanges 34, 36 of the legs 20, 22 move to a position where they engage with the undercut 66 of the body 46 of the second connector element 14. At this point, an audible click sound or other noise indicating the engagement of the connector assembly 10 can be heard. In an example of the present disclosure, the first connector element 12 may be movable relative to the second connector element 14 before fluid is conveyed through the fluid path connector assembly 10 (see FIG. 5). 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 and forms a seal using the seal member 64 to prevent fluid leakage. When fluid is conveyed through the fluid path connector assembly 10, due to the fluid pressure exerted by the fluid passing through the fluid path connector assembly 10, the second connector element 14 may move away from the syringe 16. To prevent separation of the second connector element 14 from the first connector element 12, when the second connector element 14 moves in a direction away from the syringe 16, the flanges 34, 36 of the first connector element 12 securely engage with the undercut 66 of the second connector element 14 to prevent separation of the first and second connector elements 12, 14 (see FIG. 6). Due to the inclined surfaces of the flanges 34, 36 and the undercut 66, under pressurized conditions, when the second connector element 14 moves away from the first connector element 12, the interaction between the inclined 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 pulls the first and second flexible legs 20, 22 radially inward, increases the engagement force of the fluid connector system 10, and prevents separation under relatively high fluid pressure. In an example of the present disclosure, the fluid path connector assembly 10 can withstand pressures exceeding 800 psi, and even up to a maximum of 1200 psi, which can be used during angiography procedures.

[0067] In an example of the present disclosure, after the fluid has been carried through the fluid path connector assembly 10, for example, after the completion of the imaging procedure, the first and second connector elements 12, 14 are in a state where they can be separated from each other. In an example of the present disclosure, an operator can push the operating arms 26, 28 of the first connector element 12 inward toward each other. As the operating arms 26, 28 move inward, the legs 20, 22 of the first connector element 12 move outward away from each other. When the legs 20, 22 move away from each other, the diameter of the opening defined by the legs 20, 22 increases, and the body 46 of the second connector element 14 can be pulled out from the first connector element 12. When the body 46 of the second connector element 14 is removed from the first connector element 12, the operator releases the operating arms 26, 28, and the legs 20, 22 can move back toward each other.

[0068] Referring to FIGS. 7-12, in an example of the present disclosure, the first connector element 12 may further include a movable locking sleeve 70 provided on the outer surface of the body 18 of the first connector element 12. In an example of the present 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 on the outer surface of the body 18. The locking sleeve 70 defines a through-channel having a diameter larger than the diameter of the body 18. The inner surface of the through-channel may be contoured to substantially match the outer contour of the first connector element 12 so that the locking sleeve 70 can move along the first connector element 12. In an example of the present disclosure, the locking sleeve 70 may include at least a partially circumferential flange 72 that helps in moving the locking sleeve 70 along the first connector element 12.

[0069] As shown in FIGS. 7-10, in the first unlock position, the locking sleeve 70 is disposed distally surrounding the outer periphery of the first connector element 12. In a particular example, the locking sleeve 70 surrounds the operating arms 26, 28 and can radially inwardly push them to the open position. After the second connector element 14 engages the first connector element 12, the locking sleeve 70 can be slid along the first connector element 12 toward the legs 20, 22. The locking sleeve 70 slides along the legs 20, 22 until the locking sleeve 70 is located at a second locking position around the outer periphery of the legs 20, 22. As shown in FIGS. 11 and 12, when located at the second locking position, the locking sleeve 70 serves to prevent separation of the connector 10 by preventing the legs 20, 22 from moving outwardly relative to each other under the high fluid pressure that occurs when fluid is carried through the fluid path connector assembly 10. After the fluid has been carried through the fluid path connector assembly 10, the locking sleeve 70 can be slid again toward the body 18 of the first connector element 12 to allow the legs 20, 22 to move outwardly relative to each other, enabling separation of the first and second connector elements 12, 14 from each other. In an example of the present disclosure, it is contemplated that by sliding the locking sleeve 70 along the first connector element 12 so as to cover the operating arms 26, 28, the operating arms 26, 28 can be moved inwardly toward each other and the legs 20, 22 can be moved outwardly away from each other. When the locking sleeve 70 is positioned on the operating arms 26, 28, the locking sleeve 70 can be used to open the legs 20, 22 so that the second connector element 14 can be inserted into and removed from the first connector element 12.

[0070] Referring to FIGS. 13 - 26, in accordance with some examples of the present disclosure, several different types of reinforcement mechanisms for a first connector element 12 are disclosed. In these figures, a first connector element 12 having a proximal attachment portion for a tube set or spike assembly is shown, but it should be noted that these same reinforcement mechanisms can also be used for the first connector element 12 (see FIGS. 1 - 6) when associated with a syringe 16. It should be understood that these reinforcement mechanisms may be used in conjunction with the reinforcement members 45a, 45b of the first connector element 12. The reinforcement mechanisms described below are provided to help prevent the legs 20, 22 from moving outwardly relative to each other under the high fluid pressure to which the fluid path connector assembly 10 is subjected. As shown in FIGS. 13 and 14, in one example of the present disclosure, at least one reinforcement member 74 may extend from a support base 76 provided on the body 18 of the first connector element 12. The support base 76 may be provided to enable the first connector element 12 to be connected to a tube set or syringe 16. The reinforcement mechanism 74 reinforces, for example, the strength of the support base 76 when under high pressure during an injection procedure. In certain embodiments, under high fluid pressure, the support base 76 may bend or deform due to the fluid pressure applied to the support base 76. In certain embodiments, the support base 76 may bend outwardly, for example, to a distance where a seal member 64, such as an O - ring 64, moves and / or deforms and the seal that prevents fluid leakage between the first connector member 12 and the second connector member 14 may be lost. The reinforcement member 74 may extend from the support base 76 towards the operating arms 26, 28. The reinforcement member 74 may be configured to assist in preventing the operating arms 26, 28 from moving significantly inwardly towards each other. For example, the reinforcement member 74 may be configured to act as a stopper member that limits the distance by which the operating arms 26, 28 can be pushed inwardly towards each other. In this example of the present disclosure, the first connector element 12 may be configured to withstand a fluid pressure exceeding 652 psi.As shown in FIGS. 15 and 16, according to an example of the present disclosure, the reinforcing member 74 extends from near one end of the support base 76 to near the opposite end of the support base 76, adding additional support to the body 18 of the first connector element 12 and preventing deflection or bending of the body 18 with respect to the support base 76. According to these examples of the present disclosure, the first connector element 12 may be configured to withstand a fluid pressure exceeding 887 psi when the reinforcing member 74 according to various embodiments is present. Referring to FIGS. 17 and 18, according to an example of the present disclosure, the reinforcing member 80 may also provide additional rigidity to the support base 76 and the body 18 of the first connector element 12 by extending along the longitudinal axis of the support base 76. Referring to FIGS. 19 and 20, according to an example of the present disclosure, the reinforcing member 74 may also include an additional reinforcing member 82 extending perpendicular to the reinforcing member 74 in a configuration such as an "I-beam". In this example of the present disclosure, the first connector element 12 may be configured to withstand a fluid pressure exceeding 1,156 psi.

[0071] Referring to FIGS. 21 and 22, according to an example of the present disclosure, the height of the reinforcing members 45a, 45b can be increased to add additional rigidity or stiffness to the legs 20, 22. By increasing the height of the reinforcing members 45a, 45b, additional material is provided to the legs 20, 22 to help prevent the legs 20, 22 from bending outwardly and / or moving relative to each other under high fluid pressure. For example, the improvement in the rigidity of a beam such as the legs 20, 22 can be determined by Equation 1. Rigidity = (b * h3) / 12 ··· Equation 1 Here, b is the width of the beam and h is the height. In this example of the present disclosure, the first connector element 12 may be configured to withstand a fluid pressure exceeding 933 psi. Referring to FIGS. 23 and 24, according to an example of the present disclosure, one or more reinforcing members 78 may be provided on the body 18 of the first connector element 12 to assist in preventing the body 18 from deflecting or bending when the first connector element 12 is exposed to a high fluid pressure. For example, as shown in FIGS. 23 and 24, the support base 76 can be reinforced by thickening the support base 76, for example, by increasing the thickness within the mold or by adhering a separate reinforcing member 78 to the support base 76. As shown in FIGS. 25 and 26, the reinforcing member 80 can include a central vertical mechanism 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, 82 described herein. FIGS. 25 and 26 show an example of the present disclosure in which all of the reinforcing members 74, 78, 80, 82 may be provided on a single connector element. In this example of the present disclosure, the first connector element 12 may be configured to withstand a fluid pressure of 1,377 psi or more.

[0072] Referring to FIGS. 27-29, in another example of the present disclosure, a fluid path connector assembly 100 is shown and described in detail. The fluid path connector assembly 100 can include a first connector element 102 and a second connector element 104. The first connector element 102 may be operably connected to the syringe 16, while the second connector element 104 may be operably connected to a tube set, a spike assembly, or a fluid container. In an example of the present disclosure, the first and second connector elements 102, 104 are substantially similar to the first connector element 12 described above in relation to the fluid path connector assembly 10. The first connector element 102 can include a body 106 having a first undercut 126, a first operating arm 108, a second operating arm 110, a first leg 112, and a second leg 114. The second connector element 104 can include a body 116 having a second undercut 128, a first operating arm 118, a second operating arm 120, a first leg 122, and a second leg 124. The first connector element 102 and the second connector element 104 can be brought closer to each other in a vertical orientation such that the flexible legs 112, 114 of the first connector element 102 and the flexible legs 122, 124 of the second connector element 104 are perpendicular and interact with the second and first undercuts 128, 126, respectively, in order to connect the first and second connector members 102, 104. The first and second operating arms 108, 110 can be pushed inward to open the first connector element 102, and the first and second operating arms 118, 120 can be pushed inward to open the second connector element 104.

[0073] In an example of the present disclosure, the body 106 of the first connector element 102 can define an undercut 126, and the body 116 of the second connector element 104 can define an undercut 128. The undercuts 126, 128 are provided on the first and second connector elements 102, 104 to assist in fixedly and operably connecting the first and second connector elements 102, 104 to each other to form a seal that does not leak fluid for the fluid path connector assembly 100. As shown in FIG. 30, in an example of the present disclosure, the second connector element 104 can include a support base 130 that includes at least one seal member 132 for forming a fluid-tight seal with the distal tip of the syringe 16, as described in a manner similar to the second connector element 14 described above. The second connector element can include a removable cap 131 for maintaining sterility and preventing contamination of the syringe, for example, during transportation. Upon connection, the legs 112, 114 of the first connector element 102 are configured to engage with the undercut 128 of the second connector element 104 and be locked to the undercut 128, and the legs 122, 124 of the second connector element 104 are configured to engage with the undercut 126 of the first connector element 102 and be locked to the undercut 126.

[0074] Referring again to FIGS. 27 - 29, when connecting the first connector element 102 and the second connector element 104, the first and second connector elements 102, 104 can be moved towards each other. As the first and second connector elements 102, 104 are moved towards 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, and the legs 112, 114 are spread apart. In a similar manner, as the first and second connector elements 102, 104 are moved towards 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, and the legs 122, 124 are spread apart. When the first and second connector elements 102, 104 are further pushed towards 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 in a snap - fit manner. Similarly, when the first and second connector elements 102, 104 are further pushed towards 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 in a snap - fit manner. To enable the legs 112, 114, 122, 124 to be moved outwardly so that the first and second connector elements 102, 104 can be separated for the fluid - path connector assembly 100, the operating arms 108, 110 of the first connector element 102 and the operating arms 118, 120 of the second connector element 104 are pushed inwardly towards each other, respectively.

[0075] Referring to FIGS. 31-33, a fluid path connector assembly 140 configured to attach a spike adapter member 146 for piercing a bulk fluid bottle of a contrast agent or saline bag to a syringe 16 is shown and described in accordance with various examples of the present disclosure. The fluid path connector assembly 140 is substantially similar to the fluid path connector assembly 10 described above, with some modifications, and functions in a similar manner. The fluid path connector assembly 140 can include a first connector element 142 and a second connector element 144 that may be connected to the spike adapter member 146, for example, by threading, or by welding (laser welding) or other adhesive means. 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.

[0076] In one example of the present disclosure, the second connector element 144 can include a spike adapter member 146 configured to enable connection of a bulk fluid container to the second connector element 144, for example, to fill a syringe with contrast agent or saline. The spike adapter member 146 can include a body 148, a connection member 150, a cap 152 that covers the spike member 155 (see FIG. 33C), and a vent 154 that allows for pressure equalization defined within the body 148. In one example of the present disclosure, the connection member 150 can be a threaded member that is threadedly connected to a connection member 156 on the second connector element 144. In one example of the present disclosure shown in FIG. 33A, the connection members 150, 156 can be a luer lock connection system with threading or a friction fit. In another example of the present disclosure shown in FIGS. 33B and 33C, the connection member 150 can be a male connector member 151 that is laser welded or otherwise adhesively connected to a female connection member 153 on the second connector element 144. In another example of the present disclosure, the spike adapter member 146 can be welded to the second connector element 144. The spike adapter member 146 can be operably connected to the second connector element 144 such that, instead of connecting the second connector element 144 to a tube set as described herein for the second connector element 14, the second connector element 144 can be fluidly connected to a fluid bag or bulk fluid or container using the spike member 155. The spike member 155 can be used to provide an access port to the fluid bag or container and enable fluid movement between the syringe 16 and the fluid bag or container. In one example of the present disclosure, the vent 154 can be provided such that air pressure can be equalized when fluid is carried from the container or bag through the spike adapter member 146. In various embodiments, the second connector element 144 can include a flow diverter XX as described herein such that fluid can be caused to flow into the syringe under the Coanda effect for acceleration of syringe filling and reduction of bubbles as described above.

[0077] Referring to FIGS. 34 and 35, in another example of the present disclosure, a fluid path connector assembly 160 and a syringe are shown and described in detail. The fluid path connector assembly 160 can include a cover element 162 configured to provide protection against contamination to the distal tip of the syringe 16. In one example of the present disclosure, the cover element 162 is configured to prevent dust and related microorganisms from contacting the distal tip of the syringe 16 and causing contamination, for example, during packaging, transportation, and setup. The cover element 162 can include a body 164 that defines a channel for receiving the distal tip of the syringe 16. The distal end of the cover element 162 can include a recess 166 configured to extend into the opening of the distal tip of the syringe 16 when the cover element 162 is disposed on the syringe 16. In one example of the present disclosure, the recess 166 can be configured to prevent dust or a contaminating fluid or object from entering the distal tip of the syringe 16. In one example of the present disclosure, the cover element 162 can include a circumferential locking projection 168 provided on the inner surface of the proximal end of the cover element 162. The locking projection 168 can be configured to removably lock to an undercut 170 defined on the distal tip of the syringe 16, for example, as part of a flexible locking arm 186 on a cap. In one example of the present disclosure, the proximal end of the cover element 162 may be separated into a plurality of locking arms, each including a locking projection 168 at an end. In one example of the present disclosure, a circumferential channel 172 may be defined on the distal tip of the syringe 16. The circumferential channel 172 can be configured to receive at least one seal member 174 that can be configured to form a fluid-tight seal with the inner surface of the cover element 162 when the cover element 162 is disposed on the distal tip of the syringe 16. In one example of the present disclosure, the seal member 174 can be an elastomeric O-ring, an overmolded seal surface, a quad ring, or any other dynamic seal.

[0078] Referring to FIGS. 36 and 37, in an example of the present disclosure, a fluid path connector assembly 180 is shown and described in detail. In an example of the present disclosure, the fluid path connector assembly 180 can include a cover element 182 configured to provide fluid communication between a tube set and a distal tip of the syringe 16. The cover element 182 can include a body 184 that defines a channel for receiving the distal tip of the syringe 16 and one or more fluid paths for filling and delivering a medical fluid. In an example of the present disclosure, the body 184 can include at least one locking arm 186 configured to securely engage the distal tip of the syringe 16 to lock the cover element 182 to the syringe 16. In an example of the present disclosure, the body 184 can include two locking arms 186. The locking arms 186 can be flexible such that when the cover element 182 is slid over the distal tip of the syringe 16, the locking arms 186 can move outwardly relative to each other. The locking arms 186 can include locking protrusions 188 provided on their inner surfaces and configured to securely engage an undercut 190 defined on the distal tip of the syringe 16. In an example of the present disclosure, when the cover element 182 is slid proximally along the distal tip of the syringe 16, a flange 192 defined on the distal tip of the syringe 16 moves the locking arms 186 radially outward. After the locking arms 186 pass through the flange 192 of the syringe 16, the locking arms 186 are biased to move back towards each other to securely lock the locking protrusions 188 to the undercut 190 of the syringe 16. According to various embodiments, the cover element 182 can be non-removably locked to the syringe after the locking protrusions 188 engage the undercut 190. According to this embodiment, the cover element 182 can be easily attached to the syringe by the technician with a stronger connection engagement compared to an assembly by threading or a friction-fit assembly of a conventional luer assembly without the need for threading engagement.In certain embodiments, the cover element 182 can emit an audible "click sound" when locked to the syringe tip, and / or the locking arm 186 can be positioned in the same plane as the outer surface of the cover element 182 when locked to the syringe tip. Thus, the user has at least one of an audible or visual cue that the cover element 182 is securely engaged with the syringe 16.

[0079] Continuing to refer to FIGS. 36 and 37, in one example of the present disclosure, the cover element 182 can further include a fluid transfer member 194 configured to direct fluid between the tubing set or fluid container and the syringe 16. The fluid transfer member 194 can include at least one fluid access port 196 that may be fluidly connected to the tubing set, spike assembly, or fluid container. In one example of the present disclosure, the fluid transfer member 194 can include two fluid ports, one for filling the syringe 16 with fluid and the other for delivering fluid from the syringe 16.

[0080] Referring to FIGS. 38-42, in accordance with another example of the present disclosure, a fluid path connector assembly 200 is shown and described in detail. This embodiment is shown with a rolling diaphragm syringe (see, e.g., International Publication No. WO 2016 / 172467, the disclosure of which is incorporated herein by reference in its entirety), but using the fluid path connector assembly 200 with other types of syringes is also within the scope of the present disclosure. The fluid path connector assembly 200 can include a connector element 202 and a spike member 204 fluidly connected to the connector element 202 either directly (FIGS. 43-46) or via an intervening tube set (FIGS. 38-42). The connector element 202 may be operatively connected to a fluid container 206 via spike members 204, 252. In one example of the present disclosure, the connector element 202 may be fluidly connected to the spike member 204 using a transfer set 208. FIG. 38 shows the connector element 202 separated from the fluid container 206. To connect the connector element 202 to the fluid container 206, an inclined surface 210 on the connector element 202 interacts with an inclined surface 212 on the fluid container 206 when the two elements are pushed towards each other and come into contact. This interaction between the connector element 202 and the fluid container 206 allows a plurality of supports 210 on the connector element 202 to flex so that a pair of flexible legs 212, 214 open wide enough to engage the flexible legs 212, 214 with retaining lips 216 on a collar 218 of the fluid container 206. It should be understood that the fluid container 206 can be any number of technically known containers such as a bottle, syringe, or rolling diaphragm syringe as disclosed in, for example, International Publication No. WO 2016 / 172467, International Publication No. WO 2015 / 164783, International Publication No. WO 2016 / 069711, and U.S. Patent Application No. 62 / 730,228, the disclosures of which are incorporated herein by reference in their entirety.

[0081] The connector element 202 is connected to the transfer set 208 to direct fluid between the spike member 204 and the fluid container 206 via the transfer set 208. The connector element 202 includes at least two flexible legs 212, 214, and when pressure is applied near each top, the latches 220, 222 on the flexible legs 212, 214 are moved laterally outward relative to each other to enable removal of the connector element 202 from a mating fluid container 206, syringe, cap, or adapter. The connector element 202 can further include ribs 224, 226 and a seal member 228 for a seal. In one example of the present disclosure, the seal member 228 can be an O-ring, an overmolded seal surface, a quad-ring, or any other dynamic seal.

[0082] Referring to FIGS. 41 and 42, a valve member 230 may be provided in the connector element 202. The valve member 230 can hold the valve spool 234 in an open state as shown in FIG. 41, or can include a spring 232 that can contact the valve seat 236 of the stem 238 of the connector element 202 as shown in FIG. 42. When the valve spool 234 is in the open position, fluid can flow around the valve spool into the fluid path. When the valve spool 234 is in the closed position, the fluid flow stops. As shown in FIGS. 41 and 42, the tip of the flow diverter 240 contacts the valve spool 234 and pushes the valve spool 234 to the open position. While the valve spool 234 is still in contact with the valve seat 236 and the fluid channel is closed, the operator can insert the spike member 204 into the bulk fluid container, and there is no risk of leakage until the fluid path is fully established. Once the connector element 202 is connected to a fluid container 206, syringe, cap, or adapter that includes the flow diverter 240, the valve member 230 opens and fluid can flow through the valve member 230. A fluid diverter or other contact member for the valve spool 234 can be incorporated into any number of devices to separate the valve spool 234 from the valve seat 236 and complete the fluid path. The presence of the flow diverter 240 allows fluid to flow along the inner surface of the fluid container 206 that receives the fluid by the Coanda effect described herein. Other such filling methods and adapters are described, for example, in WO 2017 / 091643 pamphlet, the disclosure of which is incorporated herein by reference in its entirety.

[0083] Referring to FIGS. 43-46, in accordance with an example of the present disclosure, connector element 250 is shown and described in detail. Connector element 250 may be directly connected with respect to fluid to spike member 252 and fluid container 254. In an example of the present disclosure, connector element 250 is substantially similar to connector element 202 described above, but does not include valve spool 234, and thus, regardless of whether connector element 250 is attached to a device having a fluid diverter or other contact member, the flow of fluid is not restricted. However, as will be understood by those skilled in the art, it is possible to incorporate a valve including a valve spool and valve seat into connector element 250 in the same manner as connector element 202 described above.

[0084] Referring to FIGS. 45 and 46, according to an example of the present disclosure, connector element 250 can be connected to spike member 252. The connection between connector element 250 and spike member 252 may be made by a friction fit, solvent bonding, adhesion, or any other connection method known in the art.

[0085] Referring to FIGS. 47-49, in accordance with an example of the present disclosure, connector element 260 associated with tube set 262 is shown and described in detail. Connector element 260 may be connected with respect to fluid to fluid path tube set 262 and fluid container 264. Since this example of connector element 260 does not include a valve spool, the flow of fluid is not restricted regardless of whether connector element 260 is attached to a device having a fluid diverter or other contact member. However, as will be understood by those skilled in the art, it is possible to incorporate a valve including a valve spool and valve seat into connector element 260 in the same manner as connector element 202 described above. Connector element 260 may be connected to fluid path tube set 262 by a friction fit, solvent bonding, adhesion, or other connection method known in the art.

[0086] Referring to FIGS. 50 and 51, in accordance with an example of the present disclosure, connector element 270 is shown and described in detail. Connector element 270 may be directly connected to fluid container 272. Since this example of connector element 270 does not include a valve spool, the flow of fluid is not restricted whether connector element 270 is attached to an apparatus having a fluid diverter or other contact member or not. However, as will be understood by those skilled in the art, it is possible to incorporate a valve including a valve spool and a valve seat into connector element 270 in the same manner as connector element 202 described above.

[0087] Referring to FIGS. 52-55, in accordance with an example of the present disclosure, connector element 280 is shown and described in detail. Connector element 280 may be fluidly connected to connector element 282. In an example of the present disclosure, a first connector element 280 may be connected to a second connector element 284 provided on fluid container 282. To connect connector element 280 to fluid container 282, an inclined surface 286 on connector element 280 interacts with an inclined surface 288 on the second connector element 284 of fluid container 282 when the two elements are pushed towards each other and come into contact. This interaction between connector element 280 and the second connector element 284 allows a plurality of supports 290 on connector element 280 to flex such that a pair of flexible legs 292, 294 open wide enough to engage the flexible legs 292, 294 with retaining lips 296 on a collar 298 of the second connector element 284. It should be understood that fluid container 282 may be any number of technically known containers such as a bottle, syringe, or rolling diaphragm syringe as disclosed in, for example, WO 2016 / 172467, WO 2015 / 164783, WO 2016 / 069711, and U.S. Provisional Application No. 62 / 730,228.

[0088] The connector element 280 can include a male connector element 300 surrounded by a cylindrical skirt 302. The male connector element 300 can include a seal member 304 and can be in a retracted position within the skirt 302. By retracting the tip of the male connector element 300, for example, by preventing inadvertent contact and contamination between the surface of the male connector element 300 and a corresponding female connector element, the sterility of the male connector element 300 can be helped to be maintained. In other embodiments, the connector element 280 can include a skirt surrounding a retracted female connector element. In one example, the male connector element 290 is received at the distal end of the fluid container 282, and a seal that does not leak fluid is formed between the male connector element 290 and the inner surface of the fluid container 282 using the seal member 304.

[0089] Referring to FIG. 56, in accordance with an example of the present disclosure, a fluid path connector assembly 310 is shown and described in detail. The fluid path connector assembly 310 can include a first connector element 312 and a second connector element 314. In this example, the second connector element 314 can be integrally formed at the distal end of a fluid container such as a syringe. The first connector element 312 can fit into the circumferential gap between the syringe tip and the inner surface of the second connector element 314. When the first connector element 312 is attached to the distal end of the syringe, the skirt of the first connector element 312 can fit into the circumferential gap, preventing fluid leakage during fluid injection. Further, the circumferential gap can collect fluid that can drip from the distal tip of the syringe or the fluid path connector assembly 310 when separating the first connector element 312 from the syringe.

[0090] Referring to FIG. 57, in accordance with an example of the present disclosure, the connector element 320 is shown and described in detail. The connector element 320 can include an inner threaded surface 322 that engages a corresponding outer threaded surface at the distal tip of the syringe. The connector element 320 can be threaded onto the syringe tip to lock the connector element 320 to the syringe tip. In a particular example, the connector element 320 can include a first locking member such as a ratchet assembly at the proximal end of the connector element 320 that engages and locks with a second locking member such as a protrusion or claw at the proximal end of the thread of 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 is threaded with the thread of the syringe tip, when the connector element 320 is screwed into the syringe tip, the first ratchet locking member can engage and lock with the second locking member. In some examples, the connection force can vary depending on the torque applied in the threading process and the required watertightness for a particular injection process such as the fluid injection pressure used.

[0091] Referring to FIGS. 58-60, in accordance with an example of the present disclosure, the 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 tube set (not shown) in a fluid-tight connection. The fluid path connector assembly 330 can include a male connector element 332 that may be attached to the end of a first tube set and a female connector element 334 that may be attached to the end of a second tube set. The male connector element 332 can include flexible legs 336, 338 for forming a secure locking engagement with the retaining lip 340 on the collar 342 of the female connector element 334. Each of the male and female connector elements 332, 334 can include tube set connector elements 344, 346 for connection to their respective tube sets.

[0092] The various example fluid connector assemblies described herein can be suitable for use in medical fluid injectors such as, for example, a powered CT fluid injector system, a powered MR fluid injector system, and a powered CV angiography injector system. The fluid connector assembly can be suitable for high-pressure injection procedures and can exhibit an improvement in the connection force between connector elements in high-pressure injection procedures such as CV injection procedures where fluid pressures up to 1200 psi can be involved or CT or MR injection procedures where fluid pressures up to 400 psi can be involved.

[0093] Referring to FIGS. 61 and 62, a fluid path connector assembly 350 is shown and described in detail in accordance with an example of the present disclosure. The fluid path connector assembly 350 can include a first connector element 352 and a second connector element 354 that are operably connected to each other to form a seal that does not leak liquid between a syringe and a tube set or a fluid container. In an example of the present 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 can include additional features for forming a seal that does not leak fluid between the second connector element 354 and the fluid container while preventing fluid flow through the second connector element 354 when disconnected. A movable seal member 356 can be provided on a connecting member 358 of the second connector element 354. In an example of the present disclosure, the seal member 356 can be an elastomeric O-ring or a slidable seal element. The connecting member 358 can define a circumferential fluid channel 360 and a circumferential groove 362 on an outer surface of the connecting member 358. The seal member 356 can be held in either the circumferential fluid channel 360 or the circumferential groove 362. The seal member 356 can be provided to form a seal that does not leak fluid between the connecting element 358 and the distal tip of the syringe. In an example of the present disclosure, the seal member 356 can slide and / or roll between the circumferential fluid channel 360 and the circumferential groove 362 of the connecting member 358 during each removal and insertion of the second connector member 354 relative to the first connector member 352.

[0094] With continued reference to FIGS. 61 and 62, the operation of the fluid path connector assembly 350 according to this example of the present disclosure is shown and described in detail. The fluid path connector assembly 350 in the disconnected position is shown in FIG. 61. In the disconnected position, the seal member 356 may be held in the circumferential fluid channel 360, which seals the circumferential fluid channel 360 so that fluid from a bulk fluid container or tube set, which may be the mating connector for the second connector element 354, cannot pass through the second connector element 354. When the seal member 356 is held in the circumferential fluid channel 360 when the fluid path connector assembly 350 is in the disconnected position, the seal member 356 prevents fluid from leaking from the second connector element 354 to which the bulk fluid container is connected. Thereby, when the user disconnects the second connector element 354 from the first connector element 352 after filling the syringe 366 with fluid, fluid leakage from the bulk fluid container through the second connector member 354 is prevented.

[0095] Referring to FIG. 62, the fluid path connector assembly 350 is shown in a connected position where the first and second connector elements 352, 354 are connected to each other. In the connection procedure, the connection member 358 is inserted into the first connector element 352. When the connection member 358 is inserted into the first connector element 352, the seal member 356 can engage with the inner surface of the distal tip portion 364 of the syringe 366 with friction. When the connection member 358 is further inserted into the first connector element 352, the seal member 356 continues to slide along the inner surface of the distal tip portion 364 of the syringe 366. The sliding movement of the seal member 356 along the inner surface of the distal tip portion 364 of the syringe 366 can generate a frictional force that rolls or slides the seal member 356 from the circumferential fluid channel 360 to the circumferential groove 362. When the seal member 356 is positioned in the circumferential groove 362, the circumferential fluid channel 360 is opened, and thus fluid can flow from the second connector element 354 through the circumferential fluid channel 360 into the syringe 366 to the first connector element 352. After the syringe 366 is filled, the fluid path connector assembly 350 can be disconnected. When the second connector element 354 is pulled away from the first connector element 352, the seal member 356 is pulled along the inner surface of the distal tip portion 364 of the syringe 366. When the seal member 356 is pulled along the inner surface of the distal tip portion 364 of the syringe 366, the frictional force rolls or slides the seal member 356 from the circumferential groove 362 to the circumferential fluid channel 360, so that the circumferential fluid channel 360 can be sealed when the fluid path connector assembly 350 is moved to the disconnected position. In an example of the present disclosure, a spike member or a tube set can be connected to the second connector element 354 to transfer fluid from a bulk fluid source to the syringe 366.

[0096] Although various examples of the present disclosure have been presented in the above description, those skilled in the art can make modifications and changes to these examples without departing from the scope and spirit of the present disclosure. Therefore, the above description is not intended to be limiting, but rather illustrative. The above disclosure is defined by the claims, and any changes to the present disclosure that are included in the equivalent meaning and scope of the claims are included in the technical scope of the claims.

Explanation of Signs

[0097] 10 Fluid path connector assembly, fluid connector system 12 First connector element, connector member 14 Second connector element, connector member 16 Syringe 17 Rib 18 (Of the first connector element) body 19 First lumen 20 First leg 22 Second leg 24 (Of the first connector element) longitudinal axis 26 First operating arm 28 Second operating arm 30 Gripping rib 32 Support portion 34 First flange 36 Second flange 38 (Of the first flange) a part, inclined portion, inclined surface 40 (Of the second flange) a part, inclined portion, inclined surface 42 (Of the first flange) the most distal surface, inclined surface 44 (Of the second flange) the most distal surface, inclined surface 45a Reinforcing member 45b Reinforcing member 46 (Of the second connector element) body 47 Second lumen 48 Opening 50 Opening 51 Outer skirt 52 Mounting member, mounting portion 53 Flow diverter 54 Support member 56 Support member 60 Support base 62 Peripheral groove 64 Seal element, seal member 66 Undercut 70 Lock sleeve 72 Flange 74 Reinforcement mechanism, reinforcement member 76 Support base 78 Reinforcement member 80 Reinforcement member 82 Reinforcement member 100 Fluid path connector assembly 102 First connector element, connector member 104 Second connector element, connector member 106 Body (of the first connector element) 108 First operating arm 110 Second operating arm 112 First leg 114 Second leg 116 Body (of the second connector element) 118 First operating arm 120 Second operating arm 122 First leg 124 Second leg 126 First undercut 128 Second undercut 130 Support base 131 Cap 132 Seal member 140 Fluid path connector assembly 142 First connector element 144 Second connector element 146 Spike adapter member 148 Body (of the spike adapter member) 150 Connection member 151 Connector member 152 Cap 153 Connection member 154 Vent 155 Spike member 156 Connecting member 160 Fluid path connector assembly 162 Cover element 164 Body (of the cover element) 166 Depression 168 Locking protrusion 170 Undercut 172 Circumferential channel 174 Sealing member 180 Fluid path connector assembly 182 Cover element 184 Body (of the cover element) 186 Locking arm 188 Locking protrusion 190 Undercut 192 Flange 194 Fluid transfer member 196 Fluid access port 200 Fluid path connector assembly 202 Connector element 204 Spike member 206 Fluid container 208 Transfer set 210 Support, inclined surface 212 Leg, inclined surface 214 Leg 216 Retaining lip 218 Collar 220 Latch 222 Latch 224 Rib 226 Rib 228 Sealing member 230 Valve member 232 Spring 234 Valve spool 236 Valve seat 238 Stem 240 Flow diverter 250 Connector element 252 Spike member 254 Fluid container 260 Connector element 262 Fluid path tube set 264 Fluid container 270 Connector element 272 Fluid container 280 Connector element 282 Fluid container, connector element 284 Second connector element 286 Inclined surface 288 Inclined surface 290 Support, connector element 292 Leg 294 Leg 296 Retaining lip 298 Collar 300 Connector element 302 Skirt 304 Sealing member 310 Fluid path connector assembly 312 First connector element 314 Second connector element 320 Connector element 322 Inner threaded surface 330 Fluid path connector assembly 332 Connector element 334 Connector element 336 Leg 338 Leg 340 Retaining lip 342 Collar 344 Tube set connector element 346 Tube set connector element 350 Fluid path connector assembly 352 First connector element, connector member 354 Second connector element, connector member 356 Sealing member 358 Connecting member, connecting element 360 Fluid channel 362 Circumferential groove 364 (Syringe) distal tip 366 Syringe

Claims

1. 1. A fluid pathway connector for a medical fluid delivery system, comprising: a first connector element comprising a body, a first lumen, a first flexible leg, and a second flexible leg; a second connector element comprising a body defining an undercut, a second lumen, a channel defined in said body, and at least one sealing element disposed within said channel; Equipped with the first flexible leg includes a first flange and the second flexible leg includes a second flange; upon engagement of the first connector element and the second connector element, the first flange and the second flange engage the undercut in the body of the second connector element to prevent separation of the first connector element and the second connector element; a sealing element 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 pathway when the first connector element and the second connector element are engaged with each other.

2. 2. The fluid pathway connector of claim 1, wherein the first connector element and the second connector element each communicate with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tubing set, and a bulk fluid container.

3. The fluid pathway connector of claim 1 or 2, wherein the first flange and the second flange each slope inwardly toward a longitudinal axis of the first connector element.

4. The fluid pathway connector of any one of claims 1 to 3, wherein the first flange and the second flange are each inclined at 45 to 75 degrees relative to a longitudinal axis of the first connector element.

5. the first connector element further comprises a first actuating arm associated with the first flexible leg and a second actuating arm associated with the second flexible leg; 5. The fluid pathway connector of claim 1, wherein when inward pressure is applied to the first and second operating arms, the first and second flexible legs move outwardly relative to the body of the second connector element to move the first and second flanges away from the undercut and enable separation of the first and second connector elements.

6. The fluid pathway connector of claim 5 , wherein at least one of the first flexible leg and the second flexible leg includes at least one reinforcing rib.

7. 7. The fluid pathway connector of claim 1, wherein the first connector element and the second connector element are configured to withstand a fluid path fluid pressure of at least 800 psi when the first connector element and the second connector element are connected to each other.

8. the first connector element further comprises a support base extending from the body between the first flexible leg and the second flexible leg; The fluid pathway connector of claim 1 , wherein the support base is configured to reduce deflection of the body due to fluid pressure exerted by fluid moving through the fluid pathway.

9. The fluid pathway connector of claim 8 , wherein the support base comprises at least one reinforcing rib for reducing deflection of the body due to fluid pressure exerted by fluid traveling through the fluid pathway.

10. The fluid pathway connector of claim 1 , wherein the sealing element is one of an elastomeric O-ring, an overmolded sealing surface, and a quad ring.

11. 11. A fluid pathway connector according to any one of claims 1 to 10, wherein the channel is dimensioned such that at least one of the sealing elements moves in opposite directions within the channel along a longitudinal axis of the second connector element when the first connector element and the second connector element are engaged and disengaged from each other.

12. 12. A fluid pathway connector according to any one of claims 1 to 11, wherein at least the sealing element moves between a first position in which at least one sealing member seals a fluid channel defined in the second connector element to prevent fluid from flowing through the second connector element, and a second position in which at least one sealing member moves out of the fluid channel to allow fluid to flow through the second connector element.

13. 13. The fluid pathway connector of claim 1, wherein at least one of the first connector element and the second connector element further comprises a skirt surrounding the body of the first connector element and the body of the second connector element.

14. The fluid pathway connector of claim 13 , wherein the skirt extends past a distal end of the body of at least one of the first connector element and the second connector element.

15. The fluid pathway connector of claim 13 or 14, wherein at least one opening is defined in the skirt for the second connector element.

16. 16. The fluid pathway connector of claim 1, wherein at least one of the first connector element and the second connector element further comprises a fluid pathway adapter configured to connect the at least one of the first connector element and the second connector element to a fluid delivery element.

17. 17. The fluid pathway connector of claim 1, wherein the first connector element comprises a slidable sleeve configured to lock a first flexible arm and a second flexible arm when the first connector element engages with the second connector element.

18. a syringe having a proximal end, a distal end, and a sidewall extending from said proximal end to said distal end; A fluid delivery member; and Fluid Path Connectors Equipped with The fluid pathway connector comprises: a first connector element comprising a body, a first lumen, a first flexible leg, and a second flexible leg; a second connector element comprising a body defining an undercut, a second lumen, a channel defined in said body, and at least one sealing element disposed within said channel; Equipped with the first connector element is fluidly connected to the fluid delivery member; the second connector element is fluidly connected to the distal end of the syringe; the first flexible leg includes a first flange and the second flexible leg includes a second flange; upon engagement of the first connector element and the second connector element, the first flange and the second flange engage the undercut in the body of the second connector element to prevent separation of the first connector element and the second connector element; 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 pathway when the first connector element and the second connector element are engaged with each other.

19. 20. The medical fluid delivery system of claim 18, wherein the first connector element and the second connector element each communicate with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tubing set, and a bulk fluid container.

20. 20. The medical fluid delivery system of claim 18 or 19, wherein the first flange and the second flange each slope inwardly toward a longitudinal axis of the first connector element.

21. 21. The medical fluid delivery system of claim 18, wherein the first flange and the second flange are each angled at 45 to 75 degrees relative to a longitudinal axis of the first connector element.

22. the first connector element further comprises a first actuating arm associated with the first flexible leg and a second actuating arm associated with the second flexible leg; 22. The medical fluid delivery system of claim 18, wherein when inward pressure is applied to the first and second operating arms, the first and second flexible legs move outwardly relative to the body of the second connector element to move the first and second flanges away from the undercut and enable separation of the first and second connector elements.

23. 23. The medical fluid delivery system of claim 22, wherein at least one of the first flexible leg and the second flexible leg includes at least one reinforcing rib.

24. 24. The medical fluid delivery system of claim 18, wherein the first connector element and the second connector element are configured to withstand a fluid path fluid pressure of at least 800 psi when the first connector element and the second connector element are connected to one another.

25. the first connector element further comprises a support base extending from the body between the first flexible leg and the second flexible leg; 25. The medical fluid delivery system of claim 18, wherein the support base is configured to reduce deflection of the body due to fluid pressure exerted by fluid traveling through the fluid pathway.

26. 26. The medical fluid delivery system of claim 25, wherein the support base comprises at least one reinforcing rib for reducing deflection of the body due to fluid pressure exerted by fluid traveling through the fluid pathway.

27. 27. The medical fluid delivery system of claim 18, wherein the channel is dimensioned such that the sealing element moves in opposite directions within the channel along a longitudinal axis of the second connector element when the first connector element and the second connector element are engaged and disengaged from each other.

28. 28. The medical fluid delivery system of claim 18, wherein at least one of the first connector element and the second connector element further comprises a skirt surrounding the body of the first connector element and the body of the second connector element.

29. 30. The medical fluid delivery system of claim 28, wherein the skirt extends past a distal end of the body of the at least one of the first connector element and the second connector element.

30. 30. The medical fluid delivery system of claim 28 or 29, wherein at least one opening is defined in the skirt for the second connector element.

31. 31. The medical fluid delivery system of claim 18, wherein at least one of the first connector element and the second connector element further comprises a fluid pathway adapter configured to connect the at least one of the first connector element and the second connector element to a fluid delivery element.

32. 32. The medical fluid delivery system of claim 18, wherein the first connector element comprises 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.

33. 1. A fluid pathway connector for a medical fluid delivery system, comprising: a first connector element including a body defining a first undercut, a first flexible leg, and a second flexible leg; a second connector element comprising a body defining a second undercut, a third flexible leg, and a fourth flexible leg; Equipped with 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; A fluid pathway connector, wherein when the first connector element and the second connector element are engaged, the first flange and the second flange engage with the second undercut of the body of the second connector element, and the third flange and the fourth flange engage with the first undercut of the body of the first connector element, ensuring prevention of separation of the first connector element and the second connector element from each other.

34. the first flange and the second flange are each inclined inwardly toward a longitudinal axis of the first connector element; 34. The fluid pathway connector of claim 33, wherein the third flange and the fourth flange each slope inwardly toward a longitudinal axis of the second connector element.

35. the first flange and the second flange are each inclined at 45 to 75 degrees relative to a longitudinal axis of the first connector element; The fluid pathway connector of claim 33 or 34, wherein the third flange and the fourth flange are each inclined at between 45 and 75 degrees relative to a longitudinal axis of the second connector element.

36. the first connector element further comprises a first actuating arm and a second actuating arm; the second connector element further comprises a third actuation arm and a fourth actuation arm; when inward pressure is applied to the first and second actuating arms, the first and second flexible legs move outwardly relative to the body of the second connector element to permit separation of the first and second connector elements; 36. A fluid pathway connector as described in any one of claims 33 to 35, wherein when inward pressure is applied to the third and fourth operating arms, the third and fourth flexible legs move outwardly relative to the body of the second connector element to enable separation of the first and second connector elements.

37. 37. The fluid pathway connector of claim 36, wherein at least one of the first operating arm, the second operating arm, the third operating arm, and the fourth operating arm includes at least one reinforcing rib.

38. 38. A fluid pathway connector according to any one of claims 33 to 37, wherein the first connector element and the second connector element are configured to withstand a fluid pressure of at least 800 psi when the first connector element and the second connector element are connected to one another.

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