Universal Fluid Connector Assembly with Regulator Component

Abstract

1 illustrates a valve component positioned in a fluid connector assembly, including a universal fluid connector assembly. The valve component is designed to open or close based on fluid pressure from a medical fluid applied to the valve component. Typically, when no force is acting on the valve component, the valve component is in an open position, and portions of the valve component are separated by a threshold force, thus forming a valve chamber. However, in an exemplary embodiment, when a force applied by the medical fluid is at least the threshold force, portions of the valve component contact each other and the valve component moves to a closed position, thereby preventing medical fluid from passing through the valve component and, therefore, the medical fluid from passing through the fluid connector assembly.

Description

[Technical Field]

[0001] This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 63 / 416,891, entitled "UNIVERSAL FLUID CONNECTOR ASSEMBLY WITH A REGULATING VALVE COMPONENT," filed October 17, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to connectors for connecting medical containers, such as syringes, to vascular access devices for instilling medical fluids into patients, and particularly to pressure regulating valves for instilling medical fluids at safe instillation pressures. [Background technology]

[0003] Generally, vascular access devices are inserted into veins via peripheral or central vasculature and may be used to infuse fluids (e.g., saline, blood, medications, and / or total parenteral nutrition) into a patient, withdraw fluids (e.g., blood) from a patient, and / or monitor various parameters of a patient's vascular system.

[0004] However, vascular access devices can become occluded. Standards of practice have been established to ensure that vascular access devices are used properly and do not become occluded. These standards include cleaning procedures, commonly referred to as irrigation procedures. These cleaning procedures maintain the patency of the vascular access device.

[0005] The irrigation procedure can be enhanced by the use of syringes specifically designed to generate lower injection pressures, such as 10 milliliter (mL) syringe barrels, or by the use of "push-pause" or pulsatile irrigation techniques to dislodge debris or residue in the catheter that may cause blockage or other undesirable effects.

[0006] However, high-velocity infusion of irrigation fluid into a peripheral intravenous ("IV") line creates a temporary increase in pressure within the vein in which the catheter is placed. This pressure can result in vein damage (e.g., rupture or collapse) and infusion / extravasation of the infusate, resulting in clinical complications and requiring replacement of the peripheral IV catheter.

[0007] Typical infusion or IV sets are constructed by joining polymer tubing segments to polymer components, many of which use needleless connectors. These IV sets can be used with an infusion pump or gravity system to administer fluids to a user, such as a patient, via a catheter. Typical needleless connectors do not indicate the infusion pressure of the fluid administered through the connector. However, pressure regulation is required to provide infusion therapy in certain conditions, such as for chemotherapy, neonatal infusions, geriatric infusions, high-pressure infusions, etc.

[0008] For example, pressure applied to blood components should not exceed 40 kPa (300 mmHg (5 psi)) as this can cause hemolysis or bag rupture. As another example, during high pressure infusion, IV fluids need to be infused in boluses without control. As yet another example, U.S. Department of Health guidelines recommend that infusion pressures be 6.45 cm 2 The guidelines suggest that infusion pressures should not exceed 25 pounds per square inch, or 25 psi (172 kPa), because infusion pressures higher than 25 psi (172 kPa) can damage blood vessels and adversely affect the health and comfort of the patient.

[0009] A description provided in the Background section should not be deemed to be prior art merely because it is mentioned in or related to the Background section. The Background section may include information that describes one or more aspects of the subject technology. Summary of the Invention [Problem to be solved by the invention]

[0010] In accordance with at least some embodiments disclosed herein, it is recognized that medical devices (e.g., catheters) often result in complications due to the infusion of drugs at relatively high fluid pressures, resulting in seepage / extravasation, obstruction / medical error, dislodgement, venous injury, and catheter replacement. [Means for solving the problem]

[0011] Aspects of the present disclosure provide a fluid connector assembly having a valve component that responds to an applied force imparted by a medical fluid by closing and preventing fluid flow through the fluid connector assembly. By way of non-limiting example, the valve component allows medical fluid to pass therethrough as long as the force imparted by the medical fluid is at or below a threshold force, and then closes when the force imparted by the medical fluid is greater than the threshold force. Additionally, the fluid connector assembly may include components designed to connect to a variety of medical fluid delivery devices without modification, thus allowing the fluid connector assembly to function as a universal connector.

[0012] Accordingly, aspects of the present disclosure provide a fluid connector assembly comprising: a housing having an internal chamber forming a fluid path for a medical fluid; and a valve component disposed in the internal chamber, the valve component having an inner portion, an outer portion, and a valve chamber between the outer portion and the inner portion, the inner portion being movable between i) a first position in which the inner portion is separated from the outer portion, and ii) a second position in which the inner portion contacts the outer portion to seal the valve chamber and close the fluid path.

[0013] Some examples of the present disclosure provide a fluid connector assembly comprising: a housing having a housing chamber; and a valve component disposed in the housing chamber, the valve component comprising a first portion, a second portion, and a valve chamber disposed between the first portion and the second portion, wherein in response to receiving a medical fluid, the first portion moves relative to the second portion to close the valve chamber.

[0014] Some examples of the present disclosure provide a method for regulating medical fluid passing through a fluid connector assembly, the method including the steps of: receiving medical fluid in a first portion of a valve component located in the fluid connector assembly; moving the first portion relative to a second portion of the valve component based on the step of receiving the medical fluid; and closing a valve chamber of the valve component when the first portion contacts the second portion, the valve chamber being located between the first portion and the second portion, and preventing medical fluid from passing through the fluid connector assembly when the valve chamber is closed.

[0015] Thus, the present application addresses several operational challenges faced in traditional infusion applications where high fluid pressure reduces the efficiency of medical fluid delivery and can cause damage to medical equipment or injury to the patient.

[0016] Additional features and advantages of the subject technology will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the written description and examples herein, as well as the accompanying drawings.

[0017] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology.

[0018] Various features of exemplary embodiments of the present invention are described below with reference to the drawings. The illustrated embodiments are intended to illustrate, but not limit, the present invention. The drawings include the following figures: [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 illustrates an IV set connected to a patient, according to an embodiment of the present disclosure. [Figure 2] FIG. 1 is a perspective view of a fluid connector assembly for use with a fluid delivery device, according to an embodiment of the present disclosure. [Figure 3] FIG. 10 is a perspective view of a fluid connector assembly for use with an additional needleless device, according to an embodiment of the present disclosure. [Figure 4] FIG. 1 is a perspective view of a fluid connector assembly according to an embodiment of the present disclosure. [Figure 5] FIG. 1 is an exploded view of a fluid connector assembly according to an embodiment of the present disclosure. [Figure 6] FIG. 1 is a partial cross-sectional view of a fluid connector assembly according to an embodiment of the present disclosure. [Figure 7] FIG. 1 is a perspective view of a valve component according to aspects of the present disclosure. [Figure 8] 8 is a partial cross-sectional view of the valve component shown in FIG. 7 taken along line 8-8, according to an embodiment of the present disclosure. [Figure 9] 1 is a partial cross-sectional view of a fluid connector assembly showing a valve component that allows fluid flow through the fluid connector assembly, according to an embodiment of the present disclosure. [Figure 10] 1 is a partial cross-sectional view of a fluid connector assembly showing a valve component that blocks fluid flow through the fluid connector assembly, according to an embodiment of the present disclosure. [Figure 11] 10A-10C illustrate alternative valve components according to aspects of the present disclosure. [Figure 12] 12 is a partial cross-sectional view of the valve component shown in FIG. 11 taken along line 12-12. [Figure 13] 10A-10C illustrate alternative valve components according to aspects of the present disclosure. [Figure 14] 14 is a partial cross-sectional view of the valve component shown in FIG. 13 taken along line 14-14. [Figure 15] 1 is a flow chart illustrating a method for regulating medical fluid through a fluid connector assembly according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0020] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the subject technology. It should be understood that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail in order to avoid obscuring the subject technology.

[0021] Furthermore, while the present description sets forth specific details of various embodiments, it will be appreciated that the description is illustrative only and should not be construed as limiting in any way. In addition, while particular embodiments of the present disclosure may be disclosed or illustrated in the context of an IV set, it is contemplated that such embodiments may be used in other fluid delivery systems. Still further, various applications of and modifications to such embodiments that may occur to those skilled in the art are also encompassed by the general concepts described herein.

[0022] According to some embodiments, the present disclosure includes various features and advantages of a universal connector having a valve component that regulates pressure by closing when pressure applied to the valve component (proportional to the applied force) reaches or exceeds a threshold pressure that is a function of one or more characteristics of the valve component, depending on design specifications. The valve components described herein may include elastic capabilities that allow the valve to open when pressure applied by the medical fluid is at or below the threshold pressure, depending on design specifications. Thus, in some exemplary embodiments, the valve component may include an elastomeric material.

[0023] Referring now to the figures, Figure 1 illustrates an IV set 1 connected to a patient 10 according to an embodiment of the present disclosure. IV set 1 includes a medication bag 12, a drip chamber 14, and tubing 22. Tubing 22 extends between drip chamber 14 of IV set 1 and a fluid connector assembly 100. To resist unintentional removal or disconnection of tubing 16 or catheter 18 from the patient, tape 26 is placed across tubing 16 and catheter 18 such that tape 26 engages tubing 16, catheter 18, and patient 10.

[0024] 2 illustrates a fluid connector assembly 100 for use with a fluid delivery device 50, according to an embodiment of the present disclosure. In some embodiments, the fluid delivery device 50 includes a syringe, such as a needleless syringe. Thus, in some embodiments, the fluid connector assembly 100 may take the form of a needleless fluid connector assembly. For some exemplary IV applications, the fluid delivery device 50 may be used for rapid injection of medication, sometimes referred to as a "push" or "bolus," to rapidly deliver a single dose of medication into a patient's bloodstream.

[0025] FIG. 3 illustrates a perspective view of a fluid connector assembly 100 for use with an additional needleless device, according to an embodiment of the present disclosure. As shown, the fluid connector assembly 100 is used with a fluid delivery device 50 at a fluid inlet of the fluid connector assembly 100. In addition, the fluid connector assembly 100 is used with a connector 70 at a fluid outlet of the fluid connector assembly 100. In some embodiments, the connector 70 includes a needleless connector, such as a luer. The connector 70 can be connected to another medical device (not shown in FIG. 3 ), such as, by way of non-limiting example, a catheter line or an IV. Alternatively, the fluid delivery device 50, the fluid connector assembly 100, and the connector 70 can be used together in a flushing operation to clean a device (e.g., a catheter) connected to the connector 70.

[0026] 1-3 illustrate that the fluid connector assembly 100 is suitable for use with multiple devices. As a result, the fluid connector assembly 100 may be referred to as a universal fluid connector assembly because the fluid connector assembly 100 may be used in multiple medical applications without the modifications required for integration.

[0027] FIG. 4 illustrates a perspective view of a fluid connector assembly 100 according to an embodiment of the present disclosure. The fluid connector assembly 100 may include a connector component 102 and a connector component 104 coupled to the connector component 102. The connector components 102 and 104 form a housing for the fluid connector assembly 100. The connector components 102 and 104 may also be referred to as a first connector component and a second connector component, respectively. However, "first" and "second" may be used interchangeably. The coupling between the connector components 102 and 104 may include a welding operation (ultrasonic welding), adhesive, etc. The connector component 102 is designed to connect with various fluid delivery devices, including, by way of non-limiting example, some needleless devices.

[0028] Connector component 102 includes a fluid inlet 106, and connector component 104 includes a fluid outlet 108. Fluid inlet 106 and fluid outlet 108 form the fluid inlet and fluid outlet, respectively, for fluid connector assembly 100. Fluid inlet 106 and fluid outlet 108 are cylindrical or generally cylindrical bodies having circular cross sections; however, other shapes are possible.

[0029] The fluid connector assembly 100 includes a fluid regulating device carried within the fluid connector assembly 100. FIG. 5 illustrates an exploded view of the fluid connector assembly 100 according to an embodiment of the present disclosure. As shown, the fluid connector assembly 100 includes a valve component 110 designed to regulate fluid flow through the fluid connector assembly 100. For example, fluid passing through the fluid inlet 106 can further pass through the valve component 110 and the fluid outlet 108 when open. Conversely, the valve component 110 can prevent or inhibit fluid passing through the fluid inlet 106 from further passing through the fluid outlet 108 when closed. The opening or closing of the valve component 110 is based on the amount of applied pressure the valve component 110 experiences from a fluid (e.g., a medical fluid). This will be described in more detail below. When the fluid connector assembly 100 is assembled, the valve component 110 is disposed in a compartment 112 of the connector component 104. In some embodiments (not shown), connector component 102 includes a compartment similar to compartment 112 for carrying valve component 110 .

[0030] FIG. 6 illustrates a partial cross-sectional view of a fluid connector assembly 100 according to an embodiment of the present disclosure. As shown, connector component 102 includes a channel 114. Additionally, connector component 104 includes a post 116 that includes a channel 118. Compartment 112 and channels 114 and 118 can collectively form an internal chamber 120 of fluid connector assembly 100, through which fluid passes through fluid connector assembly 100 into fluid inlet 106 and out fluid outlet 108 when valve component 110 is open. Thus, internal chamber 120 forms a fluid path. As shown in FIG. 6 , valve component 110 is sealed with connector 104 at compartment 112. As a result, fluid can flow through valve component 110, rather than around it, when valve component 110 is open.

[0031] 7 illustrates a perspective view of a valve component 110 according to an embodiment of the present disclosure. As shown, the valve component 110 includes an inner portion 122 (or inner region) and an outer portion 124 (or outer region). Based on their respective portions, the inner portion 122 is positioned within the outer portion 124. In other words, the outer portion 124 surrounds the inner portion 122. Additionally, the outer portion 124 includes a cylindrical body, and as a result, the valve component 110 takes the form of a cylindrical valve component. However, other shapes are possible.

[0032] Valve component 110 further includes surface 126, which has several openings formed therein. For example, valve component 110 includes opening 128, opening 130, opening 132, and opening 134, each of which is formed in surface 126. Openings 128, 130, 132, and 134 each represent a void in surface 126 through which fluid can enter valve component 110. Thus, surface 126 may be referred to as a fluid-receiving surface. In addition, valve component 110 includes several ledges connecting inner portion 122 with outer portion 124. For example, valve component 110 includes ledge 136, ledge 138, ledge 140, and ledge 142. Ledges 136, 138, 140, and 142 can collectively suspend inner portion 122 from outer portion 124. Although a discrete number of openings (ie, openings 128, 130, 132, and 134) and ledges (ie, ledges 136, 138, 140, and 142) are shown, the number of openings and ledges may vary in other embodiments.

[0033] In some embodiments, the valve component 110 is formed from a flexible material, such as an elastomer, such that the valve component 110 is flexible in at least some locations.

[0034] FIG. 8 illustrates a partial cross-sectional view of the valve component 110 shown in FIG. 7 taken along line 8-8, according to an embodiment of the present disclosure. In addition to surface 126, valve component 110 further includes surface 144. Surfaces 126 and 144 may be referred to as a first surface and a second surface, respectively. However, "first" and "second" may be used interchangeably. Valve component 110 includes an opening 146 formed in surface 144. Opening 146 represents a void in surface 144 through which fluid can exit valve component 110.

[0035] Additionally, valve component 110 includes a valve chamber 148 that forms a void or space within valve component 110. Additionally, valve chamber 148 represents a separation between inner portion 122 and outer portion 124. Valve chamber 148 is also fluidly connected to openings 128, 130, 132, and 134 (some of which are shown in FIG. 7 ) in surface 126 and opening 146 in surface 144. Thus, fluid passing through openings 128, 130, 132, and 134 can enter valve chamber 148 and then pass through opening 146.

[0036] As shown in FIGS. 7 and 8 , the valve component 110 is in the open position. Thus, fluid entering any one or more of the openings 128, 130, 132, and 134 can pass through the valve chamber 148 and exit through the opening 146. However, in the closed position, the valve component 110 prevents fluid passing through any of the openings 128, 130, 132, and 134 from exiting through the opening 146 because the valve chamber 148 collapses closed in the closed position. In this regard, the inner portion 122 includes a surface 150, and the outer portion 124 includes a surface 152. The inner portion 122 and the outer portion 124 each include a symmetrical body, and the respective surfaces (i.e., surfaces 150 and 152) may be parallel, or at least approximately parallel, to one another. When the surface 150 does not contact the surface 152 (as shown in FIG. 8 ), the valve component 110 is in the open position. Conversely, when inner portion 122 moves relative to outer portion 124 and contacts outer portion 124, surface 150 contacts surface 152 (and surfaces 150 and 152 are no longer parallel), and valve component 110 is in the closed position.

[0037] 7 , ledges 136, 138, 140, and 142 provide separation between inner portion 122 and outer portion 124, which separation generally defines valve chamber 148. Ledges 136, 138, 140, and 142 may define a threshold pressure that maintains at least partial separation between inner portion 122 and outer portion 124 such that inner portion 122 and outer portion 124 do not contact one another, thus maintaining valve component 110 in an open position. The threshold pressure may be a function of one or more of the size and shape of ledges 136, 138, 140, and 142, the material composition (e.g., elastomer) of ledges 136, 138, 140, and 142, the number of ledges (i.e., more or fewer than shown), and the area of ​​surface 126. Accordingly, design considerations of surface 126 and / or ledges 136, 138, 140, and 142 may be taken into account in determining the threshold pressure. In some embodiments of the present disclosure, inner portion 122 has a first area defined by first surface 126, and inner portion 122 has a second area defined by second surface 144, where the first area is greater than the second area.

[0038] In some embodiments, the threshold pressure is 172 kPa (25 psi), or at least approximately 172 kPa (25 psi). However, the desired threshold pressure can be less than 172 kPa (25 psi) or greater, depending on the specifications of the valve component 110. In some embodiments, the valve component 110 transitions from an open position to a closed position when a fluid exerts an external pressure that is at least the threshold pressure, and the valve component 110 returns to the open position when the external pressure is less than the threshold pressure. Alternatively, in some embodiments, the valve component 110 transitions from an open position to a closed position when a fluid exerts an external pressure greater than the threshold pressure, and the valve component 110 returns to the open position when the external pressure is at least the threshold pressure. Also, pressure is directly proportional to force; as a result, a comparison of an external pressure to a threshold pressure is analogous to a comparison of an external force to a threshold force, respectively.

[0039] 9 illustrates a partial cross-sectional view of the fluid connector assembly 100 showing the valve component 110 that allows fluid flow through the fluid connector assembly 100, according to an embodiment of the present disclosure. The arrows represent fluid flow in a downstream or generally downstream direction through the fluid connector assembly 100. When fluid enters the fluid inlet 106 of the fluid connector assembly 100, the fluid passes through the channel 114 of the connector component 102 and the valve component 110 via the openings in the valve component 110 (i.e., openings 128, 130, 132, and 134 shown in FIG. 7 ), and then through the channel 118 of the post 116, where the fluid exits the fluid outlet 108 of the fluid connector assembly 100.

[0040] As shown in the enlarged view, the valve component 110 changes at least some of its characteristics in response to fluid flow. For example, if a fluid applies sufficient pressure (i.e., external pressure) to the surface 126 of the valve component 110, the inner portion 122 may deform. Additionally, the inner portion 122 moves relative to the outer portion 124. The degree to which the inner portion 122 moves varies in response to the applied pressure provided by the fluid. The inner portion 122 and the outer portion 124 may be referred to as the movable portion and the stationary portion, respectively. The ledges (i.e., ledges 136, 138, 140, and 142) provide flexibility and bend or flex to allow relative movement of the inner portion 122 in response to the pressure provided by the fluid. However, as shown in FIG. 9, the valve component 110 remains in the open position. Thus, a force (proportional to the pressure) exerted by a fluid flowing through the fluid connector assembly 100 can change the valve component 110. However, as long as the force is below the threshold force, the valve component 110 remains in the open position.

[0041] FIG. 10 illustrates a partial cross-sectional view of the fluid connector assembly 100, showing the valve component 110 blocking fluid flow through the fluid connector assembly 100, according to an embodiment of the present disclosure. The arrows represent fluid flow in a downstream or generally downstream direction through the fluid connector assembly 100. When fluid enters the fluid inlet 106 of the fluid connector assembly 100, the fluid passes through the channel 114 of the connector component 102. However, as shown in FIG. 10, the valve component 110 is in a closed position because the inner portion 122 moves relative to the outer portion 124 based on pressure exerted by the fluid, such that the inner portion 122 contacts the outer portion 124. As a result, the valve chamber 148 collapses closed, closing the opening 146. Therefore, fluid does not pass through the channel 118 of the post 116 of the connector component 104 and does not flow out the fluid outlet 108.

[0042] 11-14 show and describe valve components using different embodiments. The valve components shown and described in Figures 11-14 may include some of the features shown and described for valve component 110 (e.g., shown in Figure 7), and the valve components shown and described in Figures 11-14 may be substituted for valve component 110.

[0043] 11 and 12 illustrate an alternative valve component 210 according to an embodiment of the present disclosure. As shown, the valve component 210 includes an upper portion 222 and a lower portion 224. Based on their respective portions, the upper portion 222 is positioned above the lower portion 224. The upper portion 222 and the lower portion 224 may be referred to as a first portion and a second portion, respectively. However, "first" and "second" may be used interchangeably. The upper portion 222 and the lower portion 224 are separated by several ledges. For example, the valve component 210 includes ledge 236, ledge 238, ledge 240, and ledge 242. The ledges 236, 238, 240, and 242 may represent one or more additional ledges. Additionally, an opening is partially defined by adjacent ledges. For example, opening 228 (representing an additional opening) is partially defined by ledges 236 and 238 (ie, adjacent ledges).

[0044] 11 and 12 show valve component 210 in the open position. As shown in FIG. 12, upper portion 222 includes protrusion 254, and lower portion 224 includes compartment 256 and channel 258 fluidly connected to compartment 256. In the open position, fluid flows between upper portion 222 and lower portion 224, through compartment 256, to the opening between adjacent ledges (i.e., opening 228 in FIG. 11), and then through channel 258 to exit valve component 210. However, valve component 210 can move from the open position to the closed position when fluid applies sufficient pressure to surface 226 of upper portion 222. When the pressure applied by the fluid is greater than a threshold pressure provided by ledges 236, 238, 240, and 242 (as well as the remaining ledges of valve component 210), upper portion 222 moves relative to lower portion 224. In this manner, protrusion 254 of upper portion 222 enters compartment 256. When protrusion 254 contacts one or more surfaces defining compartment 256, valve component 210 is in the closed position and fluid is prevented from entering channel 258. The ledges, including their number, size, shape, and material composition, as well as the area of ​​surface 226, can define a threshold pressure at which protrusion 254 and the surface of compartment 256 remain separated (i.e., do not contact). Transition of valve component 210 from the open position to the closed position can occur when the external pressure applied by the fluid exceeds the threshold pressure, and transition back to the open position can occur when the external pressure applied by the fluid is reduced to the threshold pressure. Alternatively, transition of valve component 210 from the open position to the closed position can occur when the external pressure applied by the fluid is at least the threshold pressure, and transition back to the open position can occur when the external pressure applied by the fluid is reduced to a value below the threshold pressure.

[0045] 13 and 14 illustrate an alternative valve component 310 according to an embodiment of the present disclosure. As shown, the valve component 310 includes an upper portion 322 and a lower portion 324. The upper portion 322 and the lower portion 324 may be referred to as a first portion and a second portion, respectively. However, "first" and "second" may be used interchangeably. Based on their respective portions, the upper portion 322 is positioned above the lower portion 324. The upper portion 322 and the lower portion 324 are separated by several ledges. For example, the valve component 310 includes ledge 336, ledge 338, ledge 340, and ledge 342. The ledges 336, 338, 340, and 342 may represent one or more additional ledges. Also, an opening is partially defined by adjacent ledges. For example, opening 328 (representing an additional opening) is partially defined by ledges 336 and 338 (ie, adjacent ledges).

[0046] 13 and 14 show valve component 310 in the open position. As shown in FIG. 14 , upper portion 322 includes protrusion 354, and lower portion 324 includes compartment 356 and channel 358 fluidly connected to compartment 356. In the open position, fluid flows between upper portion 322 and lower portion 324, through compartment 356, to the opening between adjacent ledges (i.e., opening 328 in FIG. 13 ), and then through channel 358 to exit valve component 310. However, valve component 310 can move from the open position to the closed position when fluid applies sufficient pressure to surface 326 of upper portion 322. When the pressure applied by the fluid is greater than the threshold pressure provided by ledges 336 and 342 (and the remaining ledges of valve component 310), upper portion 322 moves relative to lower portion 324. In this manner, protrusion 354 of upper portion 322 enters compartment 356. When the protrusion 354 contacts one or more surfaces defining the compartment 356, the valve component 310 is in the closed position and fluid is prevented from entering the channel 358. The ledges, including the number, size, shape, and material composition thereof, and the area of ​​the surface 326 can define a threshold pressure at which the protrusion 354 and the surface of the compartment 356 remain separated (i.e., do not contact). The transition of the valve component 310 from the open position to the closed position can occur when the external pressure applied by the fluid exceeds the threshold pressure, and the transition back to the open position can occur when the external pressure applied by the fluid is reduced to the threshold pressure. Alternatively, the transition of the valve component 310 from the open position to the closed position can occur when the external pressure applied by the fluid is at least the threshold pressure, and the transition back to the open position can occur when the external pressure applied by the fluid is reduced to a value below the threshold pressure.

[0047] 15 illustrates a flow chart 400 showing a method for regulating medical fluid through a fluid connector assembly according to an embodiment of the present disclosure. The valve components shown or described herein are capable of performing the method steps shown in flow chart 400.

[0048] In step 402, a medical fluid is received in a first portion of the valve component. The medical fluid may be received through a fluid inlet of the fluid connector assembly. The medical fluid may include, by way of non-limiting example, saline, blood, medication, and / or total parenteral nutrition. The first portion of the valve component may include an inner portion of the valve component. Alternatively, the first portion may include an upper portion.

[0049] In step 404, the first portion of the valve component is moved relative to the second portion of the valve component based on the step of receiving the medical fluid. The second portion may include an outer portion surrounding the inner portion. Alternatively, the second portion may include a lower portion.

[0050] In step 406, a valve chamber of the valve component is closed when the first portion contacts the second portion. The valve chamber is located between the first portion and the second portion. When closed, the valve chamber prevents medical fluid from passing through the fluid connector assembly. The valve chamber represents a space or void between the first portion and the second portion. Initially, the first portion and the second portion are separated from each other, thus defining an open position of the valve component. In some embodiments, the valve component transitions from an open position to a closed position when a fluid exerts an external pressure that is at least a threshold pressure, and the valve component returns to the open position when the external pressure is less than the threshold pressure. Alternatively, in some embodiments, the valve component transitions from an open position to a closed position when a fluid exerts an external pressure greater than the threshold pressure, and the valve component returns to the open position when the external pressure is at least the threshold pressure. Also, pressure is directly proportional to force; as a result, a comparison of an external pressure to a threshold pressure is akin to a comparison of an external force to a threshold force, respectively.

[0051] Examples of subject matter art as clauses The subject technology is exemplified by various aspects described below, for example. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. Any of the dependent clauses may be combined in any combination and incorporated into a respective independent clause, e.g., clause 1, clause 8, or clause 15. Other clauses may be presented similarly.

[0052] Clause 1. A fluid connector assembly for medical fluids, comprising: a housing having an internal chamber forming a fluid path for the medical fluid; and a valve component disposed in the internal chamber, the valve component having an inner portion, an outer portion, and a valve chamber between the outer portion and the inner portion, the inner portion being movable between i) a first position in which the inner portion is separated from the outer portion, and ii) a second position in which the inner portion contacts the outer portion to seal the valve chamber and close the fluid path.

[0053] Clause 2. A fluid connector assembly as described in Clause 1, wherein the valve component has a first surface having a plurality of first surface openings, and a second surface opposite the first surface having second surface openings that are fluidly connected to the plurality of first surface openings when the inner portion is in the first position.

[0054] Clause 3. The fluid connector assembly of clause 2, wherein an external force applied by the medical fluid to the first surface causes the inner portion to move relative to the outer portion.

[0055] Clause 4. A fluid connector assembly as described in clause 3, wherein the inner portion is separated from the outer portion by a valve chamber, and in response to an external force exceeding a threshold force, the inner portion is in a second position.

[0056] Clause 5. A fluid connector assembly according to any of clauses 2 and 3, wherein the second surface opening is fluidly connected to a plurality of the first surface openings.

[0057] Clause 6. The fluid connector assembly of any of clauses 1 to 5, wherein the valve component comprises a cylindrical valve component.

[0058] Clause 7. The fluid connector assembly of any of clauses 1 to 6, further comprising a ledge connecting the inner portion with the outer portion.

[0059] Clause 8. A fluid connector assembly for medical fluids, comprising: a housing having a housing chamber; and a valve component disposed in the housing chamber, the valve component having a first portion, a second portion, and a valve chamber disposed between the first portion and the second portion, wherein in response to receiving medical fluid, the first portion moves relative to the second portion to close the valve chamber.

[0060] Clause 9. The fluid connector assembly of clause 8, wherein the second part surrounds the first part.

[0061] Clause 10. A fluid connector assembly as described in clause 8, wherein the first part is separated from the second part by a threshold force before an external force is applied by the medical fluid, and the first part contacts the second part when the external force is at least the threshold force.

[0062] Clause 11. A fluid connector assembly as described in Clause 10, wherein the valve component comprises a first surface having a plurality of first surface openings, and a second surface opposite the first surface having second surface openings that are fluidly connected to the plurality of first surface openings by a valve chamber before an external force reaches at least a threshold force.

[0063] Clause 12. A fluid connector assembly as described in clause 11, wherein the first portion moves relative to the second portion based on the first surface receiving the medical fluid.

[0064] Clause 13. The fluid connector assembly of any of clauses 8 to 12, further comprising a plurality of ledges, wherein the first portion is suspended from the second portion by the plurality of ledges.

[0065] Clause 14. A fluid connector assembly according to any of clauses 8 to 13, wherein the second part remains stationary when the first part moves.

[0066] Clause 15. A method for regulating a medical fluid passing through a fluid connector assembly, comprising: a valve component located in the fluid connector assembly; receiving the medical fluid in a first portion of the valve component; moving the first portion relative to a second portion of the valve component based on the step of receiving the medical fluid; and closing a valve chamber of the valve component when the first portion contacts the second portion, the valve chamber being located between the first portion and the second portion, and the valve chamber preventing the medical fluid from passing through the fluid connector assembly when closed.

[0067] Clause 16. The method of clause 15, wherein the first portion is separated from the second portion by a threshold force before the external force is applied by the medical fluid, and wherein closing the valve chamber includes receiving an external force by the medical fluid that is at least the threshold force.

[0068] Clause 17. The method of clause 16, further comprising the step of opening the valve chamber when the external force is less than a threshold force.

[0069] Clause 18. The method of clause 17, wherein opening the valve chamber includes separating the first portion from the second portion.

[0070] Clause 19. The method of any of clauses 15 to 18, wherein the step of receiving the medical fluid in the first portion includes the step of receiving the medical fluid in a first surface of the valve component, the first surface comprising a plurality of first surface openings fluidly connected to the valve chamber.

[0071] Clause 20. The method of clause 19, wherein closing the valve chamber includes moving the first portion toward a second surface of the valve component, the second surface comprising second surface openings fluidly connected to the plurality of first surface openings.

[0072] Further Considerations In some embodiments, any of the clauses herein may depend on any one of the independent clauses or any one of the dependent clauses. In one aspect, any of the clauses (e.g., dependent or independent clauses) may be combined with any other one or more clauses (e.g., dependent or independent clauses). In one aspect, a claim may include some or all of the words (e.g., steps, actions, means, or components) recited in a clause, sentence, phrase, or paragraph. In one aspect, a claim may include some or all of the words recited in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some of the words in each clause, sentence, phrase, or paragraph may be removed. In one aspect, additional words or elements may be added to a clause, sentence, phrase, or paragraph. In one aspect, the subject technology may be implemented without utilizing some of the components, elements, functions, or operations described herein. In one aspect, the subject technology may be implemented using additional components, elements, functions, or operations.

[0073] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. While this disclosure provides various examples of the subject technology, the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0074] Reference to a singular element is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Headings and subheadings, if present, are used for convenience only and do not limit the invention.

[0075] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0076] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure of an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of an embodiment may apply to all embodiments, or one or more examples. An embodiment may provide one or more examples. A phrase such as an embodiment may refer to one or more embodiments, and vice versa. A phrase such as "configuration" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. A phrase such as a configuration may refer to one or more configurations, and vice versa.

[0077] In one aspect, unless otherwise stated, all measurements, values, estimates, locations, sizes, dimensions, and other specifications set forth in this specification, including the following claims, are approximate and not precise, and are intended to have a reasonable range consistent with the function to which they relate and with that which is customary in the art to which they pertain.

[0078] In one aspect, the term "coupled" or the like can refer to being directly coupled. In another aspect, the term "coupled" or the like can refer to being indirectly coupled.

[0079] As used in this disclosure, terms such as "upper," "lower," "front," "rear," etc., should be understood to refer to any frame of reference other than the typical gravity-based frame of reference. Thus, upper, lower, front, and rear surfaces may extend upward, downward, diagonally, or horizontally in a gravity-based frame of reference.

[0080] Various items may be arranged differently (e.g., placed in a different order or divided in a different manner) without departing from the scope of the subject technology. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112, paragraph 6, unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for." Still further, with respect to the use of the terms "comprising," "having," and the like, such terms are intended to be as inclusive as "comprising," as the term "comprising" would be interpreted when used as a transitional phrase in a claim.

[0081] The Title, Background, Summary, Brief Description of the Drawings, and Abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. This disclosure is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the Detailed Description, it may be recognized that the description provides exemplary illustrations, and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0082] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the claims as written and to encompass all legal equivalents. Nevertheless, no claim is intended to, and should not be construed to, encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. 1. A fluid connector assembly for medical fluids, comprising: a housing including an interior chamber forming a fluid path for the medical fluid; a valve component disposed in the internal chamber, inner part, an outer portion, and a valve chamber between the outer portion and the inner portion, the inner portion being movable between i) a first position in which the inner portion is separated from the outer portion, and ii) a second position in which the inner portion contacts the outer portion to seal the valve chamber and close the fluid path; Valve components and A fluid connector assembly comprising:

2. the valve component comprising: a first surface comprising a plurality of first surface openings; and a second surface opposite the first surface, the second surface comprising second surface openings fluidly connected to the plurality of first surface openings when the inner portion is in the first position; The fluid connector assembly of claim 1 , comprising:

3. 3. The fluid connector assembly of claim 2, wherein an external force imparted by the medical fluid to the first surface causes the inner portion to move relative to the outer portion.

4. the inner portion is separated from the outer portion by the valve chamber; and in response to the external force exceeding a threshold force, the inner portion is in the second position.

4. The fluid connector assembly of claim 3.

5. 3. The fluid connector assembly of claim 2, wherein the inner portion has a first area defined by the first surface, and the inner portion has a second area defined by the second surface, the first area being greater than the second area.

6. The fluid connector assembly of claim 1 , wherein the valve component comprises a cylindrical valve component.

7. The fluid connector assembly of claim 1 , further comprising a ledge connecting said inner portion with said outer portion.

8. 1. A fluid connector assembly for medical fluids, comprising: a housing having a housing chamber; a valve component disposed in the housing chamber, A first part, a second part, and a valve chamber disposed between the first portion and the second portion, wherein in response to receiving the medical fluid, the first portion moves relative to the second portion to close the valve chamber. Valve components and A fluid connector assembly comprising:

9. The fluid connector assembly of claim 8 , wherein the second portion surrounds the first portion.

10. the first portion is separated from the second portion by a threshold force before the external force is applied by the medical fluid; the first portion contacts the second portion when the external force is at least the threshold force; 9. The fluid connector assembly of claim 8.

11. the valve component comprising: a first surface comprising a plurality of first surface openings; and a second surface opposite the first surface, the second surface comprising second surface openings fluidly connected to the plurality of first surface openings by the valve chambers before the external force reaches at least the threshold force; The fluid connector assembly of claim 10, comprising:

12. 12. The fluid connector assembly of claim 11, wherein the first portion moves relative to the second portion based on the first surface receiving a medical fluid.

13. 9. The fluid connector assembly of claim 8, further comprising a plurality of ledges, said first portion being suspended from said second portion by said plurality of ledges.

14. 9. The fluid connector assembly of claim 8, wherein the second portion remains stationary when the first portion moves.

15. 1. A method of regulating a medical fluid through a fluid connector assembly, comprising: receiving the medical fluid in a first portion of the valve component; moving the first portion relative to the second portion of the valve component based on the receiving of the medical fluid; closing a valve chamber of the valve component when the first portion contacts the second portion, the valve chamber being located between the first portion and the second portion, the valve chamber preventing the medical fluid from passing through the fluid connector assembly when closed; A method comprising:

16. the first portion is separated from the second portion by a threshold force before the external force is applied by the medical fluid; and closing the valve chamber includes subjecting the medical fluid to an external force of at least the threshold force.

16. The method of claim 15.

17. 17. The method of claim 16, further comprising opening the valve chamber if the external force is less than the threshold force.

18. 18. The method of claim 17, wherein opening the valve chamber comprises separating the first portion from the second portion.

19. 16. The method of claim 15, wherein receiving the medical fluid in the first portion comprises receiving the medical fluid in a first surface of the valve component, the first surface comprising a plurality of first surface openings fluidly connected to the valve chamber.

20. 20. The method of claim 19, wherein closing the valve chamber comprises moving the first portion toward a second surface of the valve component, the second surface comprising second surface openings fluidly connected to the plurality of first surface openings.

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