Patent Grant
11938093
The present disclosure relates connectors, syringes, and syringe and connector systems for use in fluid delivery systems, and, especially, to connectors, syringes, and syringe and connector systems for use in medical fluid delivery systems in which one or more fluids are delivered to a patient under time constraints.
In many medical procedures, such as drug delivery, it is desirable to inject a liquid into a patient. Numerous types of liquids, such as contrast media (often referred to simply as “contrast”) and/or saline, may be injected into a patient during diagnostic and therapeutic procedures. In some medical procedures, for example, 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 contrast, in a timed fashion under high pressure. Injectors suitable for these applications typically use a relatively large volume syringe and are capable of producing relatively large flow rates.
Medical personnel work under increasingly difficult time and physical constraints. Thus, it is desirable to fill syringes or other liquid containers and to connect and disconnect fluid delivery system components as quickly as possible. However, filling a large syringe with liquid, such as a contrast medium or saline, is typically a time consuming process. Conventional syringes have a distal opening that is typically used for filling the interior of the syringe with liquid. The size of this distal opening places significant constraints on the filling rate. Further, since conventional syringes are typically shipped with the plunger in the fully retracted position, filling a syringe first requires moving the plunger to a distal end of the syringe to eject air from the syringe and start the liquid filling process. Since the cost of many medical processes, such as diagnostic imaging, increases in relation to duration, any delays can significantly increase cost.
Furthermore, in many such fluid delivery systems, it is necessary to form a fluid connection between separate fluid path components. For example, it may be necessary to connect an injector-powered syringe to flexible plastic tubing that, in turn, is connected to a spike connected to a bulk fluid source or catheter inserted into a patient. A common connector used in the medical arts is the luer connector or luer lock. The luer connector includes a male connector or member and a female connector or member. The male member and female member are typically connected via a friction fit or a radially inwardly projecting threading attached to the female member, which cooperates with one or more radially outwardly extending flanges on the male luer member to create a leak-free connection.
Many fluid connectors for use in medical procedures, including luer connectors, exhibit drawbacks, not the least of which include fragility, breakability (for example, from over tightening), and difficulty in forming a connection, for example by taking the time to rotate one or both connectors. Because medical personnel are under increasingly difficult time and physical constraints during various medical procedures, quite often, many fluid path elements must be connected and/or disconnected in a relatively short time under stressed and/or emergency conditions. This may lead to over-tightening of the luer connector which can compromise the structural integrity of the connector and even crack the connector components, leading to leakage and potential ingress of air. With many conventional connector configurations, there is no indication (audible or visual) that indicates to the user that the connectors are suitably assembled and further tightening is unnecessary. Additionally, the seal between the male member and the female member of the luer connector may be compromised due to tolerance stacking between the male member and the female member due to variances in the manufacturing process. Further, in certain procedures such as angiography, very high fluid pressures (up to 1200 psi) are used to inject fluid. The high pressure may lead to disconnection of conventional luer connectors, for example, unscrewing of the luer, such as when the male and/or female connector is wet resulting in reduced friction between the connector components.
Medical personnel must connect and/or disconnect fluid delivery systems in a relatively short time and under stressed and/or emergency conditions. It is thus desirable to develop syringe adapters that are configured for filling a syringe and/or deliver a medical fluid to a patient that have durable syringe and connector interfaces capable of connecting or disconnecting simply and quickly without leaking, breaking, or inadvertently disconnecting.
In one example of the present disclosure, a fluid path connector for a medical fluid delivery system may include a first connector element including a body, a first lumen, a first flexible leg, and a second flexible leg; and a second connector element including a body defining an undercut, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel, wherein the first flexible leg includes a first flange and the second flexible leg includes a second flange, wherein, 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, and wherein the sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and second connector element are engaged with one another.
In another example of the present disclosure, the first connector element and the second connector element are each in fluid communication with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tube set, and a bulk fluid container. The first flange and the second flange are each angled inwardly towards a longitudinal axis of the first connector element. The first flange and the second flange are each angled at 45-75 degrees relative to a longitudinal axis of the first connector element. The first connector element includes a first actuating arm associated with the first flexible leg and a second actuating arm associated with the second flexible leg, and wherein, upon applying an inwardly-directed pressure to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move in an outward direction relative to the body of the second connector element to disengage the first flange and the second flange from the undercut to allow the first connector element and the second connector element to be disengaged. 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 one another, 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 that extends from the body between the first flexible leg and the second flexible leg, and wherein the support base is configured to reduce deflection of the body due to a fluid pressure exerted by a fluid moving through the fluid path. The support base includes at least one reinforcing rib to reduce deflection of the body due to the fluid pressure exerted by the fluid moving through the fluid path. The sealing element is one of the following: an elastomeric O-ring, an overmolded sealing surface, and a quad ring. The channel is dimensioned such that the at least one sealing element moves along a longitudinal axis of the second connector element in opposite directions within the channel when the first connector element and the second connector element are engaged and disengaged from one another. The at least sealing element moves between a first position in which the at least one sealing member seals a fluid channel defined in the second connector element to prevent the fluid from flowing through the second connector element and a second position in which the at least one sealing member is moved out of the fluid channel to permit the 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 that surrounds the body of the first connector element and the body of the second connector element. The skirt extends beyond a distal end of the body of at least one of the first connector element and the second connector element. At least one aperture is defined in the skirt for the second connector element. At least one of the first connector element and the second connector element further includes a fluid path adaptor configured for connecting the 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 is engaged with the second connector element.
In another example of the present disclosure, a medical fluid delivery system includes a syringe including a proximal end, a distal end, and a sidewall extending from the proximal end to the distal end, a fluid delivery member, and a fluid path connector, including a first connector element including a body, a first lumen, a first flexible leg, and a second flexible leg; and a second connector element including a body defining an undercut, a second lumen, a channel defined in the body, and at least one sealing element positioned within the channel, wherein the first connector element is fluidly connected to the fluid delivery member, wherein the second connector element is fluidly connected to the distal end of the syringe, wherein the first flexible leg includes a first flange and the second flexible leg includes a second flange, wherein, 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, and wherein the sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element are engaged with one another.
In another example of the present disclosure, the first connector element and the second connector element are each in fluid communication with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tube set, and a bulk fluid container. The first flange and the second flange are each angled inwardly towards a longitudinal axis of the first connector element. The first flange and the second flange are each angled at 45-75 degrees relative to a longitudinal axis of the first connector element. The first connector element including a first actuating arm associated with the first flexible leg and a second actuating arm associated with the second flexible leg, and wherein, upon applying an inwardly-directed pressure to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move in an outward direction relative to the body of the second connector element to disengage the first flange and the second flange from the undercut to allow the first connector element and the second connector element to be disengaged. At least one of the first flexible leg and the second flexible leg include at least one reinforcing rib. When the first connector element and the second connector element are connected to one another, the first connector element and the second connector element are configured to withstand up a fluid pressure in the fluid path of at least 800 psi. The first connector element further includes a support base that extends from the body between the first flexible leg and the second flexible leg, and wherein the support base is configured to reduce deflection of the body due to a fluid pressure exerted by a fluid moving through the fluid path. The support base includes at least one reinforcing rib to reduce deflection of the body due to the fluid pressure exerted by the fluid moving through the fluid path. The channel is dimensioned such that the sealing element moves along a longitudinal axis of the second connector element in opposite directions within the channel when the first connector element and the second connector element are engaged and disengaged from one another. At least one of the first connector element and the second connector element further includes a skirt that surrounds the body of the first connector element and the body of the second connector element. The skirt extends beyond a distal end of the body of at least one of the first connector element and the second connector element. At least one aperture is defined in the skirt for the second connector element. At least one of the first connector element and the second connector element further includes a fluid path adaptor configured for connecting the 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 is engaged with the second connector element.
In another example of the present disclosure, a fluid path connector for a medical fluid delivery system, the fluid path connector including a first connector element including a body defining a first undercut, a first flexible leg, and a second flexible leg; and a second connector element including a body defining a second undercut, a third flexible leg, and a fourth flexible leg, wherein the first flexible leg includes a first flange, the second flexible leg defines a second flange, the third flexible leg includes a third flange, and the fourth flexible leg defines a fourth flange, and wherein, upon engagement of the first connector element with the second connector element, the first flange and the second flange link into the second undercut of the body of the second connector element and the third flange and the fourth flange link into the first undercut of the body of the first connector element to ensure the first connector element and the second connector element are prevented from disengaging with one another.
In another example of the present disclosure, the first flange and the second flange are each angled inwardly towards a longitudinal axis of the first connector element, and wherein the third flange and the fourth flange are each angled inwardly towards a longitudinal axis of the second connector element. The first flange and the second flange are each angled at 45-75 degrees relative to a longitudinal axis of the first connector element, and wherein the third flange and the fourth flange are each angled at 45-75 degrees relative to a longitudinal axis of the second connector element. The first connector element further includes a first actuating arm and a second actuating arm, wherein the second connector element further includes a third actuating arm and a fourth actuating arm, wherein, upon applying an inwardly-directed pressure to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move in an outward direction relative to the body of the second connector element to allow the first connector element and the second connector element to be disengaged, and wherein, upon applying an inwardly-directed pressure to the third actuating arm and the fourth actuating arm, the third flexible leg and the fourth flexible leg move in an outward direction relative to the body of the second connector element to allow the first connector element and the second connector element to be disengaged. At least one of the first actuating arm, the second actuating arm, the third actuating arm, and the fourth actuating arm include at least one reinforcing rib. When the first connector element and the second connector element are connected to one another, the first connector element and the second connector element are configured to withstand up a fluid pressure of at least 800 psi.
The following clauses also recite further features of the present disclosure:
Clause 1: A fluid path connector for a medical fluid delivery system, the fluid path connector comprising 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, wherein the first flexible leg includes a first flange and the second flexible leg includes a second flange, wherein, upon engagement of the first connector element with the second connector element, the first flange and the second flange engage with the undercut of the body of the second connector element to prevent disengagement of the first connector element and the second connector element, and wherein the sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element are engaged with one another.
Clause 2: The fluid path connector of Clause 1, wherein the first connector element and the second connector element are each in fluid communication with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tube set, and a bulk fluid container.
Clause 3: The fluid path connector of Clause 1 or 2, wherein the first flange and the second flange are each angled inwardly towards a longitudinal axis of the first connector element.
Clause 4: The fluid path connector of any of Clauses 1-3, wherein the first flange and the second flange are each angled at 45-75 degrees relative to a longitudinal axis of the first connector element.
Clause 5: The fluid path connector of any of Clauses 1-4, the first connector element comprising a first actuating arm associated with the first flexible leg and a second actuating arm associated with the second flexible leg, and wherein, upon applying an inwardly-directed pressure to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move in an outward direction relative to the body of the second connector element to disengage the first flange and the second flange from the undercut to allow the first connector element and the second connector element to be disengaged.
Clause 6: The fluid path connector of Clause 5, wherein at least one of the first flexible leg and the second flexible leg include at least one reinforcing rib.
Clause 7: The fluid path connector of any of Clauses 1-6, wherein, when the first connector element and the second connector element are connected to one another, 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.
Clause 8: The fluid path connector of any of Clauses 1-7, wherein the first connector element further comprises a support base that extends from the body between the first flexible leg and the second flexible leg, and wherein the support base is configured to reduce deflection of the body due to a fluid pressure exerted by a fluid moving through the fluid path.
Clause 9: The fluid path connector of Clause 8, wherein the support base comprises at least one reinforcing rib to reduce deflection of the body due to the fluid pressure exerted by the fluid moving through the fluid path.
Clause 10: The fluid path connector of any of Clauses 1-9, wherein the sealing element is one of the following: an elastomeric O-ring, an overmolded sealing surface, and a quad ring.
Clause 11: The fluid path connector of any of Clauses 1-10, wherein the channel is dimensioned such that the at least one sealing element moves along a longitudinal axis of the second connector element in opposite directions within the channel when the first connector element and the second connector element are engaged and disengaged from one another.
Clause 12: The fluid path connector of any of Clauses 1-11, wherein the at least sealing element moves between a first position in which the at least one sealing member seals a fluid channel defined in the second connector element to prevent the fluid from flowing through the second connector element and a second position in which the at least one sealing member is moved out of the fluid channel to permit the fluid to flow through the second connector element.
Clause 13: The fluid path connector of any of Clauses 1-12, wherein at least one of the first connector element and the second connector element further comprises a skirt that surrounds the body of the first connector element and the body of the second connector element.
Clause 14: The fluid path connector of Clause 13, wherein the skirt extends beyond a distal end of the body of at least one of the first connector element and the second connector element.
Clause 15: The fluid path connector of Clause 13 or 14, wherein at least one aperture is defined in the skirt for the second connector element.
Clause 16: The fluid path connector of any of Clauses 1-15, wherein at least one of the first connector element and the second connector element further comprises a fluid path adaptor configured for connecting the at least one of the first connector element and the second connector element to a fluid delivery element.
Clause 17: The fluid path connector of any of Clauses 1-16, wherein the first connector element comprises a slidable sleeve configured to lock the first and second flexible arms when the first connector element is engaged with the second connector element.
Clause 18: A medical fluid delivery system, comprising a syringe comprising a proximal end, a distal end, and a sidewall extending from the proximal end to the distal end; a fluid delivery member; and a fluid path connector, comprising a first connector element 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, wherein the first connector element is fluidly connected to the fluid delivery member, wherein the second connector element is fluidly connected to the distal end of the syringe, wherein the first flexible leg comprises a first flange and the second flexible leg comprises a second flange, wherein, upon engagement of the first connector element with the second connector element, the first flange and the second flange engage with the undercut of the body of the second connector element to prevent disengagement of the first connector element and the second connector element, and wherein the sealing element is configured to define a fluid tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path when the first connector element and the second connector element are engaged with one another.
Clause 19: The medical fluid delivery system of Clause 18, wherein the first connector element and the second connector element are each in fluid communication with a fluid element selected from the group consisting of a syringe, a spike member, a fluid tube set, and a bulk fluid container.
Clause 20: The medical fluid delivery system of Clause 18 or 19, wherein the first flange and the second flange are each angled inwardly towards a longitudinal axis of the first connector element.
Clause 21: The medical fluid delivery system of any of Clauses 18-20, wherein the first flange and the second flange are each angled at 45-75 degrees relative to a longitudinal axis of the first connector element.
Clause 22: The medical fluid delivery system of any of Clauses 18-21, the first connector element comprising a first actuating arm associated with the first flexible leg and a second actuating arm associated with the second flexible leg, and wherein, upon applying an inwardly-directed pressure to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move in an outward direction relative to the body of the second connector element to disengage the first flange and the second flange from the undercut to allow the first connector element and the second connector element to be disengaged.
Clause 23: The medical fluid delivery system of Clause 22, wherein at least one of the first flexible leg and the second flexible leg include at least one reinforcing rib.
Clause 24: The medical fluid delivery system of any of Clauses 18-23, wherein, when the first connector element and the second connector element are connected to one another, the first connector element and the second connector element are configured to withstand up a fluid pressure in the fluid path of at least 800 psi.
Clause 25: The medical fluid delivery system of any of Clauses 18-24, wherein the first connector element further comprises a support base that extends from the body between the first flexible leg and the second flexible leg, and wherein the support base is configured to reduce deflection of the body due to a fluid pressure exerted by a fluid moving through the fluid path.
Clause 26: The medical fluid delivery system of Clause 25, wherein the support base comprises at least one reinforcing rib to reduce deflection of the body due to the fluid pressure exerted by the fluid moving through the fluid path.
Clause 27: The medical fluid delivery system of any of Clauses 18-26, wherein the channel is dimensioned such that the sealing element moves along a longitudinal axis of the second connector element in opposite directions within the channel when the first connector element and the second connector element are engaged and disengaged from one another.
Clause 28: The medical fluid delivery system of any of Clauses 18-27, wherein at least one of the first connector element and the second connector element further comprises a skirt that surrounds the body of the first connector element and the body of the second connector element.
Clause 29: The medical fluid delivery system of Clause 28, wherein the skirt extends beyond a distal end of the body of at least one of the first connector element and the second connector element.
Clause 30: The medical fluid delivery system of Clause 28 or 29, wherein at least one aperture is defined in the skirt for the second connector element.
Clause 31: The medical fluid delivery system of any of Clauses 18-30, wherein at least one of the first connector element and the second connector element further comprises a fluid path adaptor configured for connecting the at least one of the first connector element and the second connector element to a fluid delivery element.
Clause 32: The medical fluid delivery system of any of Clauses 18-31, wherein the first connector element comprises a slidable sleeve configured to lock the first and second flexible arms when the first connector element is engaged with the second connector element.
Clause 33: A fluid path connector for a medical fluid delivery system, the fluid path connector comprising a first connector element comprising a body defining a first undercut, a first flexible leg, and a second flexible leg; and a second connector element comprising 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, and the fourth flexible leg defines a fourth flange, and wherein, upon engagement of the first connector element with the second connector element, the first flange and the second flange link into the second undercut of the body of the second connector element and the third flange and the fourth flange link into the first undercut of the body of the first connector element to ensure the first connector element and the second connector element are prevented from disengaging with one another.
Clause 34: The fluid path connector of Clause 33, wherein the first flange and the second flange are each angled inwardly towards a longitudinal axis of the first connector element, and wherein the third flange and the fourth flange are each angled inwardly towards a longitudinal axis of the second connector element.
Clause 35: The fluid path connector of Clause 33 or 34, wherein the first flange and the second flange are each angled at 45-75 degrees relative to a longitudinal axis of the first connector element, and wherein the third flange and the fourth flange are each angled at 45-75 degrees relative to a longitudinal axis of the second connector element.
Clause 36: The fluid path connector of any of Clauses 33-35, wherein the first connector element further comprises a first actuating arm and a second actuating arm, wherein the second connector element further comprises a third actuating arm and a fourth actuating arm, wherein, upon applying an inwardly-directed pressure to the first actuating arm and the second actuating arm, the first flexible leg and the second flexible leg move in an outward direction relative to the body of the second connector element to allow the first connector element and the second connector element to be disengaged, and wherein, upon applying an inwardly-directed pressure to the third actuating arm and the fourth actuating arm, the third flexible leg and the fourth flexible leg move in an outward direction relative to the body of the second connector element to allow the first connector element and the second connector element to be disengaged.
Clause 37: The fluid path connector of Clause 36, wherein at least one of the first actuating arm, the second actuating arm, the third actuating arm, and the fourth actuating arm include at least one reinforcing rib.
Clause 38: The fluid path connector of any of Clauses 33-37, wherein, when the first connector element and the second connector element are connected to one another, the first connector element and the second connector element are configured to withstand up a fluid pressure of at least 800 psi.
The illustrations generally show preferred and non-limiting aspects of the systems and methods of the present disclosure. While the description presents various aspects of the devices, it should not be interpreted in any way as limiting the disclosure. Furthermore, modifications, concepts, and applications of the disclosure's aspects are to be interpreted by those skilled in the art as being encompassed, but not limited to, the illustrations and description provided herein.
The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the disclosure. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure. Further, for purposes of the description hereinafter, the terms “end”, “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the disclosure as it is oriented in the figures. The term “proximal” in relation to a syringe refers generally to an axial or a longitudinal direction toward the end of a syringe nearest the injector and opposite the tubing towards the patient. The term “distal” in relation to a syringe refers generally to an axial or a longitudinal direction away from the injector and towards the patient. The term “proximal” in relation to a tubing set refers generally to an axial or a longitudinal direction toward the end of a tubing set nearest the syringe and opposite the injection member towards the patient. The term “distal” in relation to a tubing set refers generally to an axial or a longitudinal direction away from the syringe and towards the injection member of the patient. The term “radial” and related terms refers generally to a direction normal to a longitudinal axis of a syringe. However, it is to be understood that the disclosure may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the disclosure. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.
In some examples of the present disclosure, the first connector element 12 may include a body 18, a first lumen 19 extending through the body 18, a first leg 20, and a second leg 22 with a support base 76 connected to the first leg 20 and the second leg 22. The first and second legs 20, 22 may be formed integral with the body 18. The first and second legs 20, 22 may extend from the body 18 in a distal direction relative to the distal end of the syringe 16 as shown in
In some examples of the present disclosure, the first connector element 12 may also include a first actuating arm 26 and a second actuating arm 28 that extend from the body 18 in a direction opposite to the first and second legs 20, 22. The first and second actuating arms 26, 28 may be formed integral 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 actuating arms 26, 28 are configured to be pushed radially inwards towards one another by an operator to move the first and second legs 20, 22 radially outwardly away from one another. Pressure on the first and second actuating arms 26, 28 forces the first and second legs 20, 22 to move away from one another. In one embodiment of the present disclosure, at least one of the first and second actuating arms 26, 28 may include a plurality of gripping ribs 30 to assist in gripping the first and second actuating arms 26, 28 when handling the first connector element 12. In some examples of the present disclosure, the first connector element 12 may also include a support portion 32 that extends from the body 18 in the same direction as the first and second actuating arms 26, 28, that is, toward the body of the syringe 16 as shown in
According to various examples of the present disclosure, each of the first and second legs 20, 22 may include a first flange 34 and a second flange 36, respectively, that are configured to engage with a portion of the second connector element 14, as described herein, to readily connect the first connector element 12 with the second connector element 14 in a manner to withstand pressures associated with a pressurized fluid injection procedure without disconnecting and to create the fluid-tight seal between the first lumen 19 of the first connector element 12 and a second lumen 47 of the second connector elements 14. In some examples of the present disclosure, at least a portion 38, 40 of each flange 34, 36, respectively, may be angled inwardly relative to the longitudinal axis 24 of the first connector element 12. In one example of the present disclosure, the portions 38, 40 of the flanges 34, 36 may be angled 60 degrees from the longitudinal axis 24 of the first connector element 12, where the angled portion is angled toward the proximal end of the syringe 16 as shown in
According to various examples of the present disclosure, each of the legs 20, 22 may also 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 an outer surface of the legs 20, 22. In certain examples, the reinforcing members 45a, 45b may extend the entire length of the legs 20, 22. The reinforcing members 45a, 45b may be formed integral with the legs 20, 22, for example on an outer surface of the leg 20 or 22. The reinforcing members 45a, 45b may be made of a similar material as the legs 20, 22 and the first connector element 12, for example, by co-molding the leg 20, 22 with the respective reinforcing member 45a, 45b. In other examples, the reinforcing members 45a, 45b may be made of a different material than the legs 20, 22 and the first connector element 12 to increase the strength of the legs 20, 22. The reinforcing members 45a, 45b may be provided on the legs 20, 22 to add rigidity to the legs 20, 22 while still allowing the legs 20, 22 to retain sufficient flexibility to move inwardly and outwardly during connection and disconnection of the first connector element 12 and the second connector element 14. In one example of the present disclosure, the reinforcing members 45a, 45b may be strips of material that extend along at least a portion of the length of the legs 20, 22 and extend outwardly from an 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 have been 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 outward flexing or stretching of the legs 20, 22 during a pressurized injection procedure. Due to high fluid pressures between the first and second connector elements 12, 14, in certain embodiments, the first and second connector elements 12, 14 may have a tendency to flex radially outward from one another. Therefore, the reinforcing members 45a, 45b assist in ensuring that the legs 20, 22 do not move outwardly under these high fluid pressures, thereby preventing the first connector element 12 from disconnecting from the second connector element 14.
With continued reference to
In various examples of the present disclosure, the second connector element 14 may also include a support base 60 that extends from the body 46 in a direction opposite to the attachment member 52. The skirt 51 may extend around the support base 60 as described herein. In one example of the present disclosure, the support base 60 may be configured for insertion into an opening of a distal tip of the syringe 16 to connect the syringe 16 attached to the first connector element 12 to the tubing set, spike assembly, or fluid container attached to the second connector element 14. It is also contemplated that the support base 60 may also be configured to receive the distal tip of the syringe 16. In one example of the present disclosure, the support base 60 may define at least one circumferential channel 62 that may be configured to receive at least one sealing element 64. In one example of the present disclosure, the at least one sealing element 64 may be at least one O-ring, an overmolded sealing surface molded onto an outer surface of the support base 60, a quad ring, or any other dynamic seal. In one example of the present disclosure, upon connection of the first and second connector elements 12, 14, the at least one sealing element 64 is configured to establish a fluid-tight seal between the support base 60 and the distal tip of the syringe 16. By using this sealing element 64, as fluid passes between the syringe 16 connected to the first connector element 12 and the tubing set or fluid container connected to the second connector element 14, no fluid is permitted to leak from the fluid path connector assembly 10. As the second connector element 14 is pulled away from the first connector element 12, the support base 60 is pulled out of the distal tip of the syringe 16. As the support base 60 is pulled out of the distal tip of the syringe 16, the sealing member 64 continues to hold the fluid-tight seal between the support base 60 and the distal tip of the syringe 16 until the support base 60 is removed completely from the distal tip of the syringe 16. In one example of the present disclosure, the fluid path connector assembly 10 may include two sealing members provided on the support base 60 of the second connector element 14. By providing a plurality of sealing members, the sterility of the fluid path connector assembly 10 is improved.
In one example of the present disclosure, the body 46 of the second connector element 14 may also define an undercut 66 on a proximal surface thereof, such as in the form of a groove or channel having an outer angled wall with an angle that is complementary to the angled surface of flanges 34, 36. The undercut 66 may be configured to receive the portions 38, 40 of the first and second flanges 34, 36 of the first connector element 12 to ensure the first and second connector elements 12, 14 remain connected during use of the fluid path connector assembly 10. In one 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 a sloped surface that extends towards the second lumen 47 of the second connector element 14 from an outer surface of the body 46 to an inner surface of the body 46. In one example of the present disclosure, the undercut 66 may extend around the entire circumference of the body 46. It is also contemplated that the undercut 66 may also only be provided on a portion of the circumference of the body 46. In one example of the present disclosure, the sloped surface of the undercut 66 may substantially correspond to the sloped surface of the corresponding portions 38, 40 of the first and second flanges 34, 36 of the first connector element 12. The sloped surface of the undercut 66 may extend at an angle relative to a longitudinal axis of the second connector element 14 that corresponds to the longitudinal axis 24 of the first connector element 12. In one example of the present disclosure, the sloped surface of the undercut 66 extends at an angle of 60 degrees relative to the longitudinal axis of the second connector element 14. In other examples of the present disclosure, the sloped surface of the undercut 66 may be angled ranging from 45 degrees and 75 degrees from the longitudinal axis of the second connector element 14. In another example of the present disclosure, the sloped surface of the undercut 66 may be angled ranging from 55 degrees and 65 degrees from the longitudinal axis of the second connector element 14. In one example of the present disclosure, the sloped surface of the undercut 66 slopes inwardly from an end of the body 46 proximate the attachment member 52 towards an end of the body 46 proximate the support base 60.
With continued reference to
In one example of the present disclosure, after the syringe 16 has been connected to the first connector element 12 and the tubing set/spike assembly/fluid container has been connected to the second connector element 14, the first and second connector elements 12, 14 may be moved towards one another for connection. As the second connector element 14 is moved towards the first connector element 12, the body 46 of the second connector element 14 may come into engagement with the sloped surfaces 42, 44 of the first and second flexible legs 20, 22 of the first connector element 12. Since a diameter of the body 46 of the second connector element 14 may be greater than an opening defined by the legs 20, 22 of the first connector element 12, the body 46 of the second connector element 14 may force the legs 20, 22 to move outwardly as the body 46 pushes against the sloped surfaces 42, 44. At a certain point the legs 20, 22 will be forced outwardly enough to permit the body 46 of the second connector element 14 to move past the legs 20, 22 to be received within the first connector element 12. It is also contemplated that the actuating arms 26, 28 may be simultaneously pressed inwardly in order to move the legs 20, 22 outwardly to receive the second connector element 14 within the first connector element 12 while exerting less engagement force on the second connector element 14 or without having to press the body 46 of the second connector element 14 against the sloped surfaces 42, 44 of the legs 20, 22. The actuating arms 26, 28 may then be released after the body 46 of the second connector element 14 has been received within the first connector element 12.
In one example of the present disclosure, after the body 46 of the second connector element 14 moves past the legs 20, 22, the legs 20, 22 may be configured to move inwardly towards one another to an original resting position. As the legs 20, 22 move inwardly, the flanges 34, 36 of the legs 20, 22 are moved into position to engage with the undercut 66 of the body 46 of the second connector element 14. An audible click or other noise may be heard at this time, indicating that the connector assembly 10 is engaged. In one example of the present disclosure, before fluid is transferred through the fluid path connector assembly 10, the first connector element 12 may be movable relative to the second connector element 14 (see FIG. 5). As the body 46 of the second connector element 14 is moved into the first connector element 12, the support base 60 of the second connector element 14 is inserted into the distal tip of the syringe 16 to create a fluid tight seal using the sealing member 64. As fluid is transferred 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 be moved away from the syringe 16. In order to prevent disconnection of the second connector element 14 from the first connector element 12, as the second connector element 14 moves away from the syringe 16, the flanges 34, 36 of the first connector element 12 positively engage with the undercut 66 of the second connector element 14 to prevent disconnection of the first and second connector elements 12, 14 (see
In one example of the present disclosure, after the fluid has been transferred through the fluid path connector assembly 10, for example after completion of the imaging procedure, the first and second connector elements 12, 14 are ready for disconnection from one another. In one example of the present disclosure, the actuating arms 26, 28 of the first connector element 12 may be pressed inwardly towards one another by an operator. As the actuating arms 26, 28 are moved inwardly, the legs 20, 22 of the first connector element 12 are moved outwardly away from one another. As the legs 20, 22 move away from one another, the opening defined by the legs 20, 22 is increased in diameter to allow the body 46 of the second connector element 14 to be pulled from the first connector element 12. Once the body 46 of the second connector element 14 has been removed from the first connector element 12, the actuating arms 26, 28 may be released by the operator to permit legs 20, 22 to move back towards one another.
With reference to
As shown in
With reference to
With reference to
Stiffness=(b*h3)/12 Eq. 1
where b is the width of the beam and h is the height. In this example of the present disclosure, the first connector element 12 may be configured to withstand a fluid pressure of greater than 933 psi. With reference to
With reference to
In one example of the present disclosure, the body 106 of the first connector element 102 may define an undercut 126, and the body 116 of the second connector element 104 may define an undercut 128. The undercuts 126, 128 are provided on the first and second connector elements 102, 104 to assist in locking and operatively connecting the first and second connector elements 102, 104 with one another to create a fluid tight seal for the fluid path connector assembly 100. As shown in
Referring back to
With reference to
In one example of the present disclosure, the second connector element 144 may include a spike adaptor member 146 configured to permit a bulk fluid container to be connected to the second connector element 144, for example, for filling the syringe with a contrast agent or saline. The spike adaptor member 146 may include a body 148, a support base 150, a cap 152 that covers a spike member 155 (see
With reference to
With reference to
With continued reference to
With reference to
The connector element 202 is connected to the transfer set 208 to channel fluid between the spike member 204 through the transfer set 208 and into the fluid container 206. The connector element 202 includes at least two flexible legs 212, 214 that, when pressure is applied near a top portion of each, will cause latches 220, 222 on the flexible legs 212, 214 to move laterally and outwardly relative to one another to allow for the connector element 202 to be removed from the fluid container 206, syringe, cap, or adaptor to which the connector element 202 is connected. The connector element 202 may also include ribs 224, 226 and a sealing member 228 for sealing. In one example of the present disclosure, the sealing member 228 may be an O-ring, an overmolded sealing surface, a quad ring, or any other dynamic seal.
With reference to
With reference to
With reference to
With reference to
With reference to
With reference to
The connector element 280 may include a male connector element 300 surround by a cylindrical skirt 302. The male connector element 300 may include a sealing member 304 and may be recessed within the skirt 302. The recess of the tip of the male connector element 300 may assist in retaining sterility of the male connector element 300, for example by preventing inadvertent touching and contamination of a surface of the male connector element 300 with a corresponding female connector element. In other embodiment, the connector element 280 may include a skirt surrounding a recessed female connector element. In one example, the male connector element 290 is received in a distal end of the fluid container 282 and a fluid-tight seal is created between the male connector element 290 and the inner surface of the fluid container 282 using the sealing member 304.
With reference to
With reference to
With reference to
The fluid connector assemblies of the various examples described herein may be suited for use with a medical fluid injector, for example a powered CT fluid injector system, a powered MR fluid injector system, and a powered CV angiography injector system. The fluid connector assemblies may be suited for high pressure injection procedures and may demonstrate an increased connective force between the connector elements during a high-pressure injection procedure, such as a CV injection procedure which may involve fluid pressures of up to 1200 psi or CT or MR injection procedures which may involve fluid pressures of up to 400 psi.
With reference to
With continued reference to
With reference to
While various examples of the present disclosure were provided in the foregoing description, those skilled in the art may make modifications and alterations to these examples without departing from the scope and spirit of the disclosure. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The disclosure described hereinabove is defined by the appended claims, and all changes to the disclosure that fall within the meaning and the range of equivalency of the claims are to be embraced within their scope.
This application is a U.S. national phase application under 35 U.S.C. § 371 of PCT International Application No. PCT/US2021/018523, filed Feb. 18, 2021, and 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 incorporated by reference in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/018523 | 2/18/2021 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2021/168076 | 8/26/2021 | WO | A |
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