Closed IV Access Device with Y-Port Needle-Free Connector

Abstract

To provide an improved multiport connector.SOLUTION: There is provided, a needle free connector, including: a needle-free valve formed from an upper housing, a compressible sealing member, and a lower housing, the upper housing including a first input port; a second input port extending from a sidewall of the lower housing at a predetermined angle and including an engagement feature configured to engage with one of the upper housing and the compressible sealing member; and an output port in the lower housing, fluidly connected to the first and second input ports, wherein the compressible sealing member includes at least one feature configured to facilitate and guide compression of the compressible sealing member in the upper housing.SELECTED DRAWING: Figure 10

Description

[Technical field]

[0001] The present disclosure relates generally to needle-free connectors, and more particularly to needle-free connectors with multiple ports. [Background technology]

[0002] Needle-free ports are commonly used in intravenous (IV) fluid delivery systems. In some situations, it is desirable to be able to provide multiple different fluids to a patient. Needle-free ports with multiple input ports have been developed. However, if care is not taken when connecting to and disconnecting from such conventional multiple input devices, there may be an increased risk of microbial entry, colonization, and blood reflux upon disconnection. It would therefore be desirable to be able to provide an improved multi-port connector. Summary of the Invention [Means for solving the problem]

[0003] A multi-port connector may be provided with a secondary fluid path that enters distal to the valve component of the primary fluid path. However, this configuration may create complex internal fluid geometries that prevent adequate flushing, thus presenting a risk of microbial colonization within the multi-port connector. According to various aspects of the present disclosure, a multi-port connector may be provided that includes a primary fluid path and a secondary fluid path, the secondary fluid path being, for example, a y-port, that accesses the connector in a manner that improves flushability of the connector and thus reduces the risk of microbial colonization.

[0004] According to some embodiments, a needle-free connector is provided that includes a housing, a first input port in the housing, a second input port in the housing, a chamber in the housing fluidly connected to the first input port and the second input port, and an output port fluidly connected to the chamber.

[0005] According to another aspect, a housing for a needle-free connector is provided, the housing including an elongated central portion having a longitudinal axis, a needle-free valve formed along the longitudinal axis, an output port formed along the longitudinal axis, an open Luer port including an extension from a sidewall of the elongated central portion, and a chamber within the elongated central portion, the chamber fluidly connected to the needle-free valve, the open Luer port, and the output port.

[0006] According to another aspect, there is provided a patient fluid delivery system including at least one fluid source configured to contain a fluid, tubing configured to provide the fluid to a patient, and a needle-free connector configured to couple between the at least one fluid source and the tubing, the needle-free connector including a housing, a first input port in the housing, a second input port in the housing, a chamber in the housing fluidly coupled to the first input port and the second input port, an output port fluidly coupled to the chamber, and a compressible sealing member in the housing, the compressible sealing member having an uncompressed state and a compressed state, wherein in the uncompressed state the compressible sealing member seals the first input port and the compressed state allows for a continuous fluid passage between the first input port and the output port.

[0007] According to another aspect, a method is provided that includes providing a first fluid from a first input port of a needle-free connector, through a chamber of the connector, to an output port of the connector, and providing a second fluid from a second input port of the connector, through the chamber, to the output port.

[0008] According to another aspect, a needle free connector is provided that includes a lower housing having a sidewall, a needle free valve having an upper housing and a compressible sealing member disposed between the upper and lower housings, a y-port formed from a portion of the lower housing, the y-port extending at a non-parallel angle from the sidewall of the lower housing, and an output port in the lower housing, the output port fluidly connected to the needle free valve and the y-port.

[0009] It is understood that various configurations of the subject technology will be readily apparent to those skilled in the art from this disclosure, and that the various configurations of the subject technology have been shown and described by way of illustration. As will be appreciated, the subject technology is capable of other and different configurations, and its several details are capable of modification in various other respects without departing from the scope of the subject technology. Accordingly, the summary, drawings, and detailed description are to be regarded as illustrative in nature, and not as restrictive. [Brief description of the drawings]

[0010] The accompanying drawings, which are included to provide a further understanding, are incorporated in and constitute a part of this specification, illustrate disclosed embodiments, and together with the description, serve to explain the principles of the disclosed embodiments.

[0011] [Figure 1]FIG. 1 illustrates an example of an IV system having a needle-free connector, according to an embodiment of the present disclosure. [Diagram 2] FIG. 1 illustrates an example of a needle-free connector according to an embodiment of the present disclosure. [Diagram 3] FIG. 1 is a diagram illustrating a conventional connector. [Figure 4] 1A-1C illustrate examples of fluid paths of a needle-free connector according to an embodiment of the present disclosure. [Diagram 5] FIG. 1 illustrates a perspective view of an example of a needle-free connector having a first input port implemented as a positive displacement needle-free valve and a negative-displacement needle-free valve, according to an embodiment of the present disclosure. [Figure 6] FIG. 6 illustrates a side view of the needle-free connector of FIG. 5 according to an embodiment of the present disclosure. [Figure 7] FIG. 6 illustrates an enlarged perspective view of the negative displacement needle-free valve of FIG. 5 according to an embodiment of the present disclosure. [Figure 8] FIG. 1 illustrates a perspective view of an example system having multiple needle-free connectors, according to an embodiment of the present disclosure. [Figure 9] FIG. 9 illustrates a side view of one of the needle-free connectors of FIG. 8 according to an embodiment of the present disclosure. [Figure 10] FIG. 10 illustrates an exploded side view of the connector of FIG. 9 according to an embodiment of the present disclosure. [Figure 11] 13A-13C illustrate two additional embodiments of a needle-free connector having first and second input ports and an output port according to an aspect of the present disclosure. [Figure 12] FIG. 1 illustrates a cross-sectional view of a needle-free connector according to an embodiment of the present disclosure. [Figure 13]FIG. 13 illustrates a cross-sectional view of the connector of FIG. 12 with an end cap over the y-port of the connector, according to an embodiment of the present disclosure. [Figure 14] FIG. 13 illustrates a perspective view of the connector of FIG. 12 according to an embodiment of the present disclosure. [Figure 15] FIG. 14 illustrates a perspective view of the connector of FIG. 13 according to an embodiment of the present disclosure. [Figure 16] FIG. 1 illustrates an exploded perspective view of a needle-free connector having an upper housing, a middle housing, and a lower housing with a y-port, according to an embodiment of the present disclosure. [Figure 17] FIG. 1 illustrates an exploded perspective view of a needle-free connector having an upper housing and a lower housing with a y-port according to an embodiment of the present disclosure. [Figure 18] FIG. 1 illustrates an exploded perspective view of a needle-free connector having an upper housing with a y-port and a lower housing according to an embodiment of the present disclosure. [Figure 19] FIG. 19 illustrates a side view of the connector of FIGS. 16, 17, and 18 according to an embodiment of the present disclosure. [Figure 20] FIG. 19 illustrates a perspective top view of the connector of FIGS. 16, 17, and 18 according to an embodiment of the present disclosure. [Figure 21] FIG. 1 illustrates a perspective bottom view of an example of a needle-free connector according to an embodiment of the present disclosure. [Figure 22] FIG. 13 illustrates a perspective bottom view of an example needle-free connector with an end cap over the y-port, according to an embodiment of the present disclosure. [Diagram 23] FIG. 1 illustrates a perspective view of an example needle-free connector with an end cap over the y-port and a needleless syringe attached to the needle-free valve, according to an embodiment of the present disclosure. [Figure 24]FIG. 1 illustrates a perspective view of an example needle-free connector with a first needle-free syringe attached to a needle-free valve and a second needle-free syringe attached to a y-port, according to an embodiment of the present disclosure. [Diagram 25] 1 illustrates an exploded side perspective view of an example needle-free connector having an upper housing, a middle housing, and a lower housing with a y-port, according to an embodiment of the present disclosure. [Figure 26] FIG. 26 illustrates a side view of the needle-free connector of FIG. 25 in an assembled configuration, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Thus, dimensions may be provided for certain embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring concepts of the subject technology.

[0013] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to specific, but non-limiting examples. The various embodiments described in the present disclosure can be implemented in different ways and variations and according to a desired application or implementation.

[0014] Systems and methods are provided for infusing medical fluids (e.g., saline or liquid medications) into a patient using an intravenous (IV) catheter connected through an arrangement of flexible tubing and fittings (commonly referred to as an "IV set") to a fluid source (e.g., an IV bag or syringe). The fittings can include interconnectable male and female needleless connectors having a "Luer taper" conforming to International Organization for Standardization (ISO) standards or other needleless connectors. The connectors can have self-sealing features to prevent leakage of fluids from the attached tubing when the connector is disconnected from the mating connector.

[0015] FIG. 1 illustrates an example of a patient fluid delivery system 100. As shown, the system 100 may be implemented as a closed system vascular access device, such as a closed intravenous catheter system, having a patient interface, such as a catheter assembly 113, and a needle-free connector 102 with a first input port 104, a second input port 106, and an output port 108. In the example of FIG. 1, the needle-free connector (NFC) 102 is attached to the catheter assembly 113 via tubing 110. The catheter assembly 113 may include a needle hub 115 and a catheter adapter 112. The catheter assembly 113 may include a catheter 114 with an associated introducer needle that passes from the needle hub through the catheter adapter. Catheter 114 and associated introducer needle are shown in FIG. 1 within a protective sheath 119 (eg, a removable covering for the needle).

[0016] The catheter adapter 112 may be integrally or removably connected to the tubing 110. The needle hub 115 may be removably coupled to the catheter adapter 112. The needle hub 115 may include a grip portion (implemented as a paddle grip 118 in FIG. 1). The needle hub 115 may be configured to attach to the proximal side of a needle, and both may be removed following insertion and placement of the catheter.

[0017] The needle hub 115 may be provided with a paddle grip 118 or may be provided with other types of grips, such as a straight grip or a ported grip, and / or an extension set, as would be understood by one of ordinary skill in the art. The catheter assembly of FIG. 1 is for illustrative purposes only. In other embodiments, the needle-free connector 102 may be coupled (e.g., via tubing 110) to other types of catheter systems. Some examples of catheter systems that may be fluidly coupled (e.g., via tubing) to the needle-free connector 102 are described in U.S. Pat. Nos. 5,935,110, 6,638,252, and 8,337,461, all of which are incorporated herein by reference in their entirety.

[0018] The needle-free connector 102 may be provided as an integral component of a peripheral IV catheter system or may be provided separately and connected to the tubing 110 of the peripheral IV catheter system. The needle-free connector 102 may include a first input port 104 implemented by a needle-free valve and a second input port 106 implemented as a Luer access y-port. As described in more detail below, the input port 104 may be provided with a flat swabable surface. In some embodiments, the needle-free connector 102 may be provided with one or more antimicrobial features, such as, for example, a chlorhexidine eluting antimicrobial feature implemented as an insert ring, coating, or lubricant at one or more locations within the valve chamber.

[0019] Needle-free connector 102 provides multiple access ports for continuous and intermittent injections in a compact size with a positive displacement, negative displacement, or neutral displacement needle-free connector with a flat swabable surface for ease of cleaning. In various embodiments, any or all of ports 104, 106, and / or 108 can be attached directly to a syringe or tubing or can have a threaded connection at the outer end for connecting to, for example, a threaded female Luer adapter.

[0020] 2 illustrates a perspective view of a needle-free connector with multiple input ports according to an embodiment. As shown in FIG. 2, the needle-free connector 102 can include a positive displacement needle-free connector input port 104 and an open y-port 106 in a housing 200. The housing 200 can be a monolithic housing structure or can include an upper housing 201 and a lower housing 203 that enclose an internal chamber in which a valve member 204 (e.g., a compressible silicone sealing member) is disposed.

[0021] 2, the upper housing 201 can include an elongated main structure 207 (sometimes referred to herein as an elongated central portion) that extends along a longitudinal axis 205. The second input port 106 can be formed from an extension 210 of the housing 200 that extends from a sidewall of the elongated main structure 207 at a non-parallel angle to the longitudinal axis. The second input port 106 allows a secondary access port into the fluid pathway between the upper housing 201 and the valve member 204 for fluid administration or aspiration (i.e., withdrawing blood or fluid) while the needle-free valve 104 is closed (e.g., not connected to a fluid source such as an IV bag or syringe) or open (e.g., connected to a fluid source such as an IV bag or syringe).

[0022] In various embodiments, the needle-free valve 104 can be a positive displacement valve, a neutral displacement valve, or a negative displacement valve. The valve member 204 can be a collapsible inner valve member made of a flexible material. When a force is applied to the top of the valve member 204 (e.g., by the tip of a male Luer connector (not shown)), the valve can collapse or otherwise compress or open, thereby opening a flow path through the connector 102. In the closed position (i.e., uncompressed with respect to the valve member 204) shown in FIG. 2, a seal can be formed, for example, between a shoulder of the valve and a sealing ridge of the housing 200 and / or between a rim around the exterior surface of the valve member 204 and the edge of an opening in the top surface 202 of the housing 200.

[0023] Although the embodiment depicted in FIG. 2 shows the first input port 104 implemented as a needle-free valve and the second input port 106 implemented as an open Luer access port, this is for illustrative purposes only, and either or both of the input ports 104 and 106 may be implemented as a needle-free valve, an open Luer port, or other needle-free connector.

[0024] The output port 108 may be formed, for example, from a hollow cylindrical bottom extension 208 that extends along a longitudinal axis defined by the main structure 207 of the upper housing 201. The extension 208 can be an extended portion of the lower housing structure 203 that is configured to form a tubing attachment for the connector 102. Features such as ribs 206 on the housing 200 can have corresponding internal features that help form chambers that guide the movement of the valve member 204 when the valve is compressed to form a continuous fluid passageway from the input 106 to the output 108.

[0025] Additional internal features, such as standoff structures, may be formed in or near the extension 210 to prevent compression of the valve member 204 from sealing off or blocking the fluid path from the input 106 to the output 108, as discussed in further detail below (see, e.g., FIG. 13). Such standoff features can help ensure that the y-port fluid path remains open when the needle-free connector port is accessed and the valve is collapsed. Threads 212 and 214 may be formed on the outer surface (or inner surface) of the upper housing 201 at the inputs 106 and 104, respectively, to form threaded ports for connection to a fluid source or recipient (e.g., an IV bag or syringe).

[0026] As shown in FIG. 4, the open port 106 accessing the connector 102 in the side wall portion of the upper housing 201 allows for a compact length and maximum flushability compared to conventional mechanical valves (see FIG. 3, which shows a conventional valve 300 having an additional port 304 with a fluid path 306 entering the valve component 302 distally, thereby generating a relatively more complex internal fluid geometry that may prevent sufficient flushing of the non-flushable area 303 from the fluid path 306 and thus significantly increase the risk of microbial colonization). As shown in FIG. 4, the y-port 106 can access the connector 102 through the upper housing 201, which can provide a fluid path 400 including internal chamber paths 400A and 400B, which improves the flushability of the connector and therefore reduces the risk of microbial colonization.

[0027] FIG. 5 illustrates a perspective view of a connector 102 (left) with a positive displacement valve 104 and a perspective view of another embodiment of a connector 102' with a negative displacement needle-free valve 104'. As shown in FIG. 5, the connector 102 on the left has a y-port access in an upper housing as in FIGS. 1, 2, and 4, and the connector 102' on the right includes a y-port access 106' in a lower housing structure 502. The lower housing structure 502 may engage or otherwise be attached to an upper housing 500 that encloses a compressible negative displacement valve 104'. The lower housing 502 may include an output port 108' along a longitudinal axis of the lower housing.

[0028] FIG. 6 shows a side view of the connectors 102 and 102' of FIG. 5. As shown in FIG. 6, the Luer access y-port 106 can include an antimicrobial eluting insert or coating 600 at the distal end 602 of the Luer opening to provide further reduction in microbial colonization risk. Antimicrobial eluting coatings, rings, and / or lubricants can be included in other internal locations, such as on the lower portion of the housing (e.g., surrounding the output port 108) and / or on and / or around a compressible internal sealing member (e.g., antimicrobial eluting lubricant on the valve 104 or on a portion of the housing along which the valve travels when compressed and / or released). In some embodiments, one or more of the valve 104 and ports 106 can include mechanical valve features (e.g., one or more O-rings, a piston, a piston chamber, one or more gaskets, one or more springs, etc.). In these embodiments, the antimicrobial elution features may be disposed near one or more O-rings (e.g., near the upper and lower O-rings of the valve), near the piston, near the piston chamber, near one or more gaskets, and / or near one or more springs.

[0029] The antimicrobial eluting features can elute a substance when a fluid contacts the feature (e.g., chlorhexidine, octenidine, silver, and / or other antimicrobial agents can be eluted). The antimicrobial eluting features can be implemented as either an antimicrobial eluting ring, coating, or lubricant. Also, the connector 102' or other connector implementations described herein can be provided with one or more antimicrobial eluting coatings, ring inserts, or lubricants. Examples of antimicrobial features that can be provided in the needle-free connectors described herein are described in U.S. Patent Application Publication No. 2015 / 0231307, U.S. Patent Nos. 8,426,348 and 8,754,020, and U.S. Patent Application No. 12 / 397,760, all of which are incorporated herein by reference in their entirety.

[0030] 7 shows an enlarged perspective view of the needle-free connector 102' and illustrates how a negative displacement needle-free valve 700 can be provided in a chamber 702 between the upper housing 500 and the lower housing 502. As shown, the upper housing 500 can include a threaded feature 704 for connecting to a source such as IV tubing or a syringe. As shown, a second input port 106' extends from a sidewall of the elongated central portion of the lower housing 502 to provide access to the chamber 702.

[0031] 8 illustrates an example of a system 800 having multiple connectors 801 and 808. As shown, connector 801 can include a positive displacement needle-free valve 805 with a housing 802 that engages a lower housing 803 having a y-port 804 such that the output of the needle-free valve 805 flows into the lower housing 803 and merges with the fluid path from the y-port 804 and connects to tubing 810. A removable end cap 806 is shown that seals the y-port 804 when seated over the open end of the y-port.

[0032] FIG. 9 shows a side view of connector 801 of FIG. 8 with end cap 806 removed from y-port 804 (eg, to allow connection of a syringe to the y-port).

[0033] Figure 10 shows an exploded side view of the connector 801 of Figure 8 and illustrates how a compressible sealing member 1002 can be disposed between the upper housing 802 and the lower housing 803 to form a needle-free valve 805. An engagement feature 1008 can be seen on the lower housing 803 that engages with a corresponding internal feature of the upper housing 802 to seal the valve member 1002 within a chamber formed in the housing structure and / or that provides a fluid path around a portion of the member 1002 to an output port in the lower housing 803. Also shown on the outer surface of the upper housing 802 is a threaded feature 1006.

[0034] Thus, a needle free connector 801 is provided that includes a lower housing 803 having a sidewall 820, an upper housing 802, a needle free valve 805 including a compressible sealing member 1002 disposed between the upper housing 802 and the lower housing 803, a y-port 804 formed from a portion of the lower housing that extends at a non-parallel angle from the sidewall 820 of the lower housing 803, and an output port 822 in the lower housing 803, the output port being fluidly coupled to the needle free valve 805 and the y-port 804. The lower housing 803 can include one or more openings (not visible in FIG. 10 ) that allow fluid flowing past the compressible sealing member 1002 in the upper housing 802 to pass into the lower housing 803 and to the output port 822.

[0035] The compressible sealing member 1002 can include a circumferential flange 1009. The engagement feature 1008 of the lower housing 803 can include an engagement feature 1011 (e.g., a lip) that secures the circumferential flange 1009 between the engagement feature 1011 and a portion of an interior surface 1013 of the upper housing 802. For example, the circumferential flange 1009 can have a shoulder 1022. The shoulder 1022 has a shape that corresponds to a shape of the portion of the interior surface 1013, as described in more detail below.

[0036] 10, the compressible sealing member 1002 can include one or more features, such as a notch 1020 in a neck portion 1021, that facilitate and guide compression of the member 1002. The neck portion 1021 can extend from a relatively wider cylindrical central portion 1023 that is disposed between the neck portion 1021 and the flange 1009. An upper shoulder 1024 can be formed between the cylindrical central portion 1023 and the neck portion 1021. The shoulder 1022 can be a lower shoulder formed between the cylindrical central portion 1023 and the flange 1009.

[0037] FIG. 11 shows two additional embodiments of needle-free connectors having first and second input ports and an output port. In the example on the left of FIG. 11, a needle-free connector 1100 includes a first input port 1102, a perpendicular second input port 1104, and an output port 1106. The connector 1100 includes an upper housing 1108, a lower housing 1110, and a valve (e.g., a compressible sealing member) 1114 that forms a needle-free valve that is perpendicular to the second input port (e.g., an open Luer port) 1104. A coupling member 1112 is formed on the lower housing 1110 to engage the output port 1106, for example, with tubing or another output container. The connector 1100' on the right of FIG. 11 shows how a relatively narrower second input port 1120 can be provided.

[0038] FIG. 12 shows a cross-sectional view of the connector 102 according to an embodiment. In the example of FIG. 12, the valve member 204 is disposed in a chamber 1208 in the upper housing 201 and is surrounded by the upper housing 201 and the lower housing 203. An internal bore 1210 in the y-port 106 is shown fluidly connected to the chamber 1208. The lower housing 203 also includes an internal bore 1214 for receiving the tubing 110. The valve member 204 can include features such as a shoulder 1024 that engages with a recess 1206 in the chamber 1208 when the compressible sealing member 204 is in a non-compressed state shown in FIG. 12 to help seal the needle-free valve 104. When pressed against the top surface 1200, the compressible sealing member 204 can be deformed to a compressed state that allows fluid to flow between the valve 104 and the output port 108. The valve member 204 may include one or more features, such as a cutout 1020 in the compressible sealing member 204 that forms a cavity 1230 in the valve 104 that ensures that a desired fluid pathway is formed when the valve is in a compressed state.

[0039] As shown in Fig. 12, the compressible sealing member 204 can include a central cavity 1220, which helps provide flexibility for compression. Fig. 12 shows how, in an uncompressed state, an upper surface 1200 of the compressible sealing member 204 can form a planar surface in a common plane with an upper surface 1202 of the upper housing 201. In this manner, a flat (planar) swabbable surface can be provided that is easily cleaned before and / or after use.

[0040] 12 also shows how the shoulder 1022 can conform to a recess 1222 in a portion of the inner surface of the housing 201. An inner portion of the flange 1009 can also interface with a protrusion 1224 of the lower housing 203 to help secure the compressible sealing member 204 between the upper housing 201 and the lower housing 203. A recess 1240 can be provided in the lower housing 203, and in some implementations, an inner shoulder 1232 of the compressible sealing member 204 can move into the lower housing 203 during compression.

[0041] As shown in FIG. 12, cutouts 1242 may be provided in the inner surface of the upper housing 201 that expand the size of the chamber 1208 in the housing 201 in some locations such that when the compressible sealing member 204 is compressed, a fluid path may be established from the input port of the needle-free valve 104, through the chamber 1208, through the opening 1234 in the lower housing 203, to the output port 108. As shown, the y-port 106 may provide a fluid path 1246 into the chamber 1208 whether the sealing member 204 is compressed or not. Thus, the chamber 1208 is provided in the housing 201, which may be flushed through the port 106 or the port 104, if desired. Also, a fluid flow path 1244 may be provided from the port 106 through the opening 1234 to the output port 108. The fluid flow path 1246 can be a portion of the fluid flow path 1244 , which flows into and through the chamber 1208 before flowing out the output port 108 .

[0042] The configuration of valve 104 shown in Figure 12 is for illustrative purposes only, and other implementations of needle-free valves may be used in combination with a y-port feeding a common chamber with a needle-free valve. Various examples of needle-free valve configurations are described in U.S. Patent Application Nos. 13 / 801,399, 13 / 801,412, and 13 / 801,422, all of which are incorporated herein by reference in their entireties.

[0043] FIG 13 shows a cross-sectional view of the connector 102 of FIG 12 with an end cap 1300 engaged onto the y-port connector 106 via engagement between a threaded feature 1302 on the end cap 1300 and a corresponding threaded feature 212 on the y-port 106. FIG 13 also shows optional features such as standoff features 1304 and 1306 that may be provided to prevent the compressible sealing member 204 from blocking the port 106 in a compressed configuration. For example, the standoff feature 1304 can be a protrusion from an inner wall of the upper housing 201 that extends into the chamber 1208 to block and / or guide movement of the compressible sealing member 204 during compression. As another example, the standoff feature 1306 can be a porous screen having openings 1308 that allow fluid to flow through the openings 1308. The screen 1306 can extend from the port 106 into the chamber 1208 to block and / or guide movement of the compressible sealing member 204 during compression.

[0044] Figure 14 is a perspective view of connector 102 showing the planar flat swabable surface formed from upper surface 1200 of valve member 204 and upper surface 1202 of housing 200. Figure 15 shows a perspective view of connector 102 of Figure 14 with end cap 1300 engaged over y-port connector 106 (e.g., over extension 210).

[0045] 16, 17, and 18 show exploded perspective views of several respective embodiments of a needle free connector having a needle free valve and a y-port according to various embodiments. In the example of FIG. 16, the needle free connector 1601 includes (a) a needle free valve 104 formed from an upper housing 1602, a compressible sealing member 1600, and a mid-housing 1604, (b) a y-port 106 formed in a lower housing 1608 configured to engage with the mid-housing 1604, and (c) an output port 108 in the lower housing 1608.

[0046] In the example of FIG. 17, the needle-free connector 1701 includes (a) a needle-free valve 104 formed from an upper housing 1602, a compressible sealing member 1600, and a lower housing member 1700, (b) a y-port 106 formed in the lower housing 1700, the lower housing 1700 having an engagement feature 1702 configured to engage with the upper housing 1602 and / or the compressible sealing member 1600, and (c) an output port 108 in the lower housing 1700.

[0047] 17, the compressible sealing member 1600 can include a circumferential flange 1709 having a shoulder 1722. The shoulder 1722 can have a shape that corresponds to the shape of a portion of the interior surface of the upper housing 1602.

[0048] The compressible sealing member 1600 can include one or more features to facilitate and guide compression of the member 1600, such as a notch 1720 in the neck portion 1721 and / or a notch 1739 in the cylindrical central portion 1723. The neck portion 1721 can extend from the cylindrical central portion 1723. The cylindrical central portion 1723 can be disposed between the neck portion 1721 and the flange 1709. An upper shoulder 1704 can be formed between the cylindrical central portion 1723 and the neck portion 1721. The shoulder 1722 can be a lower shoulder formed between the cylindrical central portion 1723 and the flange 1709.

[0049] 17 implementation, the lower housing 1700 includes a circular protrusion 1731 that forms a circular recess 1740 therein. The inner surface of the flange 1709 can interface with the upper surface 1730, the protrusion 1731, and the recess 1740 in a manner similar to that described above in connection with the protrusion 1224 and the recess 1240 of FIG. 12 in some implementations. Fluid can flow from the upper housing 1602 into the lower housing 1700 and through an opening 1734 in the lower housing 1730 to the output port 108.

[0050] In the example of FIG. 18 , the needle-free connector 1801 includes (a) a needle-free valve 104 formed from an upper housing 1800, a compressible sealing member 1600, and a lower housing member 1802, (b) a y-port 106 formed in the upper housing 1800, the lower housing 1802 having an engagement feature 1804 configured to engage with the upper housing 1800, and (c) an output port 108 in the lower housing 1802.

[0051] In the implementation of FIG. 18, the lower housing 1802 includes a circular protrusion 1831 that forms a circular recess 1840 therein. The inner surface of the flange 1709 can interface with the upper surface 1830, the protrusion 1831, and the recess 1840 in a manner similar to that described above in connection with the protrusion 1224 and the recess 1240 of FIG. 12 in some implementations. For example, the lower housing 1802 can be an implementation of the lower housing 203, where the protrusion 1224 is implemented as a circular protrusion 1831 and the recess 1240 is implemented as a circular recess 1840. Fluid can flow from the upper housing 1800 (e.g., from the port 104 and / or the port 106) into the lower housing 1802 and through an opening 1834 in the lower housing 1802 to the output port 108.

[0052] Figure 19 shows an assembled side view of connectors 1601, 1701, and 1801 of Figures 16, 17, and 18. Figure 20 shows an assembled perspective top view of connectors 1601, 1701, and 1801 of Figures 16, 17, and 18, showing how each has a flat swabbable surface formed by the top surface of the valve and the top surface of the upper housing.

[0053] FIG. 21 illustrates a perspective bottom view of the needle free connector 102 of FIG. 2. FIG. 22 illustrates the needle free connector 102 of FIG. 21 with an end cap 2200 sealingly engaged over the second input port 106. FIG. 23 illustrates the needle free connector 102 of FIG. 21 with an end cap 2200 sealingly engaged over the second input port 106 and a needleless syringe 2300 attached to the needle free valve 104. As shown in FIG. 23, when a connector, such as a syringe 2300, is connected to the needle free valve 104, the compressible sealing member 204 can be deformed to a compressed configuration 204C where a fluid pathway 2302 is formed from the needle free valve 104 to the output port 108.

[0054] 24 illustrates the needle-free connector 102 of FIG. 21 with a first needleless syringe 2300 attached to the needle-free valve 104 and a second needleless syringe 2400 attached to the y-port 106. In a configuration such as that shown in FIG. 24, a first fluid may be provided from the first syringe 2300, through the needle-free valve 104, into a chamber in the connector (see, e.g., chamber 1208 in FIG. 12) along a first fluid path 2302, and a second fluid may be provided from the second syringe 2400 along a fluid path 2306 into at least a portion of the same chamber while both the first and second syringes are coupled to the needle-free connector 102. The second fluid from the second syringe 2400 can also flow along the third fluid flow path 2304 from the port 106 through the output port 108. Some or all of the second fluid flowing along the fluid path 2306 into the chamber can be flushed into the chamber and can also exit the chamber and out the output port 108. The first fluid from the port 104 can also be flushed into any remaining second fluid from the chamber after delivery of the fluid from the port 106. The first and second fluids can be provided to the patient via the output port 108 intermittently or in combination.

[0055] FIG. 25 shows an exploded side perspective view of connector 801 implemented with an upper housing, a lower housing with a y-port, and a mid-housing. As shown in FIG. 25, a mid-housing 2500 can be interposed between upper housing 802 and lower housing 803, such that flange 1009 interfaces with mid-housing 2500 in an assembled configuration (see, for example, FIG. 26). Mid-housing 2500 can be provided with a cylindrically shaped central extension 2504. Extension 2504 can have a common central axis with that of connector 801 and can extend into a corresponding opening 2506 in lower housing 803 in an assembled configuration. The mid housing 2500 can include one or more openings, such as opening 2502, such that fluid flowing through the compressible sealing member 1002 in the upper housing 802 can pass through the opening 2502, into the mid housing 2500, through the extension 2504, into the lower housing 803, and through the output port 822. The mid housing 2500 can engage an internal feature of the upper housing 802 to seal the valve member 1002 in a chamber formed by the upper housing 802 and the mid housing 2500.

[0056] Thus, a needle-free connector 801 is provided, the needle-free connector 801 including a lower housing 803 having a sidewall 2508, an upper housing 802, a middle housing 2500, a needle-free valve 805 including a compressible sealing member 1002 disposed between the upper housing 802 and the middle housing 2500, a y-port 804 formed from a portion of the lower housing extending at a non-parallel angle from the sidewall 2508 of the lower housing 803, and an output port 822 in the lower housing 803, the output port being fluidly connected to the needle-free valve 805 and the y-port 804.

[0057] Figure 26 illustrates an assembled side view of the needle free connector 801 of Figure 25. As shown in Figure 26, in the assembled configuration, an outer sidewall of the connector 801 may be formed from portions of the upper housing 802, the middle housing 2500, and the lower housing 803. For example, a portion of the middle housing 2500 forming a portion of the sidewall 2600 may be interposed between a portion of the lower housing 803 and a portion of the upper housing 802 (e.g., to form a continuous cylindrically shaped portion of the sidewall 2600).

[0058] Needle-free connectors of the type described herein with needle-free valves and Luer access y-ports can provide significant improvements in usability, compact form, ease of connection, ease of cleaning of connector valve surfaces, positive fluid displacement upon disconnection, and the added benefit of antimicrobial efficacy. Needle-free connectors of the type described herein with needle-free valves and Luer access y-ports can provide all of the functionality of needle-free access with a secondary open access port in a form and configuration that reduces the risk of microbial entry, colonization, and blood backflow upon disconnection. The concepts described herein can also provide a flat swabable surface for ease of cleaning prior to access to reduce the risk of introducing microorganisms into the system.

[0059] The subject technology is illustrated according to various aspects, for example, as described above. Various examples of these aspects are described as numbered concepts or clauses (1, 2, 3, etc.) for convenience. These concepts or clauses are provided as examples and do not limit the subject technology. It is noted that any of the dependent concepts can be combined in any combination with each other or with one or more other independent concepts to form an independent concept. The following is a non-limiting summary of some concepts presented herein. Concept 1. Housing and a first input port in the housing; a second input port in the housing; a chamber in the housing fluidly connected to the first input port and the second input port; an output port fluidly connected to the chamber; Includes needle-free connectors. Concept 2. The needle free connector of Concept 1 or any other concept, further comprising a compressible sealing member within the housing, the compressible sealing member having an uncompressed state and a compressed state, wherein in the uncompressed state, the compressible sealing member seals the first input port and the compressed state allows a continuous fluid passage between the first input port and the output port. Concept 3. The needle free connector of Concept 2 or any other concept, wherein the continuous fluid passage includes a first continuous fluid passage, and the needle free connector further includes a second continuous fluid passage between the second input port and the output port. Concept 4. The needle-free connector of concept 3 or any other concept, wherein the needle-free connector further comprises a third continuous fluid passageway from the second input port into the chamber to facilitate flushing of the chamber. Concept 5. The needle free connector of concept 2 or any other concept, wherein the compressible sealing member forms a compressible sealing member of a positive displacement valve or a negative displacement valve. Concept 6. The needle free connector of Concept 5 or any other concept, further comprising at least one extension on the housing, the at least one extension configured to prevent the compressible sealing member from blocking the second input port in a compressed state. Concept 7. The needle-free connector of concept 2 or any other concept, wherein in an uncompressed state, the compressible sealing member forms a planar swabable surface in a common plane with an upper surface of the housing. Concept 8. The needle-free connector of concept 1 or any other concept, wherein the second input port comprises an open Luer access port. Concept 9. The open Luer access port, comprising a threaded Luer port, a needle-free connector as described in concept 8 or any other concept. Concept 10. The needle free connector of Concept 1 or any other concept, wherein the housing includes an elongated central portion having a longitudinal axis, the first input port includes a needle free valve formed along the longitudinal axis, and the second input port includes a tubular extension from a sidewall of the elongated central portion. Concept 11. A housing for a needle-free connector, the housing comprising: an elongated central portion having a longitudinal axis; a needle free valve formed along the longitudinal axis; an output port defined along the longitudinal axis; an open Luer port including an extension from a sidewall of the elongated central section; a chamber within the elongated central portion, the chamber being fluidly connected to a needle-free valve, an open Luer port, and an output port; Including, a housing. Concept 12. The housing of concept 11 or any other concept, wherein the housing further comprises a first threaded feature on the needle free valve and further comprises a second threaded feature on the open Luer port. Concept 13. The housing of concept 11 or any other concept, further comprising at least one antimicrobial eluting feature. Concept 14. The housing of concept 13 or any other concept, wherein the at least one antimicrobial elution feature comprises an antimicrobial elution coating on an interior surface of the extension from the sidewall. Concept 15. A patient fluid delivery system, comprising: tubing configured to provide fluid to a patient; a needle-free connector configured to couple between at least one fluid source and the tubing; Needle-free connectors include Housing and a first input port in the housing; a second input port in the housing; a chamber in the housing fluidly connected to the first input port and the second input port; an output port fluidly connected to the chamber; a compressible sealing member within the housing, the compressible sealing member having an uncompressed state and a compressed state, in which the compressible sealing member seals the first input port and the compressed state allows a continuous fluid passage between the first input port and the output port; 1. A patient fluid delivery system comprising: Concept 16. The patient fluid delivery system of Concept 15 or any other concept, further comprising a catheter assembly integrally attached to the tubing. Concept 17. The patient fluid delivery system of concept 16 or any other concept, wherein the catheter assembly includes a needle hub having a paddle grip, a straight grip, or a ported grip. Concept 18. The patient fluid delivery system of Concept 17 or any other concept, further comprising an end cap configured to seal the second input port. Concept 19. An antimicrobial coating or antimicrobial insert ring in a second input port; an antibacterial lubricant on the compressible sealing member; The patient fluid delivery system of Concept 15 or any other concept, further comprising: Concept 20. Providing a first fluid from a first input port of a needle-free connector, through a chamber of the connector, and to an output port of the connector; providing a second fluid from a second input port of the connector through the chamber to the output port; A method comprising: Concept 21. The method of Concept 20 or any other concept, wherein the step of providing a first fluid includes attaching a first fluid source having the first fluid to a needle-free valve formed by a first input port. Concept 22. The method of Concept 21 or any other concept, wherein the step of providing the second fluid includes attaching a second fluid source having the second fluid to the open Luer port formed by the second input port while the first fluid source is coupled to the first fluid source. Concept 23. The method of concept 22 or any other concept, wherein the first fluid source and the second fluid source each comprise a needleless syringe. Concept 24. The method of Concept 23 or any other concept, further comprising providing the first fluid and the second fluid from the output port to the patient. Concept 25. A lower housing having a side wall; A needle-free valve, comprising: An upper housing; and A compressible sealing member disposed between the upper and lower housings. Needle-free valves, including a y-port formed from a portion of the lower housing, the y-port extending at a non-parallel angle from a sidewall of the lower housing; an output port in the lower housing, the output port being fluidly connected to the needle free valve and the y-port; Includes needle-free connectors. Concept 26. The needle free connector of Concept 25 or any other concept, wherein the compressible sealing member includes a circumferential flange and the lower housing includes an engagement feature, the engagement feature securing the circumferential flange between the engagement feature and an inner surface of the upper housing. Concept 27. The needle free connector of concept 25 or any other concept, further comprising an intermediate housing interposed between the upper housing and the lower housing.

[0060] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and 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 general principles defined herein may be applied to other aspects.

[0061] Reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." The term "several" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and are not intended to be limiting of the invention.

[0062] 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.

[0063] As used herein, the phrase "at least one of" preceding a list of items, together with the term "or" separating any of the items, modifies the list as a whole rather than each item in the list. The phrase "at least one of" does not require the selection of at least one of the items. Rather, the phrase allows for a meaning including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrase "at least one of A, B, or C" can refer to only A, only B, or only C; or any combination of A, B, and C.

[0064] 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. A disclosure regarding an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may represent one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. A disclosure regarding an embodiment may apply to all embodiments, or to one or more embodiments. An embodiment may provide one or more examples. A phrase such as an embodiment may represent one or more embodiments, and vice versa. A phrase such as "configuration" does not imply that such a configuration is essential to the subject technology or that such a configuration applies to all configurations of the subject technology. A disclosure regarding a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A term such as "configuration" can refer to one or more configurations, and vice versa.

[0065] In one aspect, unless otherwise stated, all measurements, values, orders, positions, magnitudes, sizes, and other specifications set forth herein, including the claims that follow, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and what is customary in the art to which they pertain.

[0066] It is understood that the specific order or hierarchy of steps or operations in the disclosed processes or methods is an illustration of example approaches. It is understood that based on implementation preferences or scenarios, the specific order or hierarchy of steps, operations, or processes may be rearranged. Some of the steps, operations, or processes may be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations, or processes may be performed automatically, without user intervention. The accompanying method claims present elements of the various steps, operations, or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0067] All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or that 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. Moreover, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. 112(f) unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step for". Moreover, to the extent that terms such as "comprise" or "having" are used, such terms are intended to be inclusive in the same manner as the term "comprise" is to be construed when "comprise" is used as a transitional phrase in a claim.

[0068] The title, background, summary, brief description of the drawings, and abstract of the present disclosure are hereby incorporated into the present disclosure and are provided as examples for illustrative purposes of the present disclosure, and not as limiting descriptions of the present disclosure. The present disclosure is submitted with the understanding that they shall not be used to limit the scope or spirit of the claims. In addition, in the detailed description, the description provides examples for illustrative purposes, and it can be understood that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. The method of the present disclosure should not be interpreted as indicating 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.

[0069] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the language of the claims and are intended to encompass all legal equivalents. Nonetheless, none of the claims are intended to encompass subject matter that fails to meet the requirements of 35 U.S.C. §§ 101, 102, or 103, and they should not be so interpreted.

Claims

1. A needle-free connector, comprising: a needle free valve formed from an upper housing, a compressible sealing member, and a lower housing, the needle free valve including a first input port in the upper housing; a second input port extending at an angle from a sidewall of the lower housing, the lower housing including an engagement feature configured to engage one of the upper housing and the compressible sealing member; an output port in the lower housing, the output port fluidly connected to the first and second input ports; Including, the compressible sealing member includes at least one feature configured to facilitate and guide compression of the compressible sealing member within the upper housing; the compressible sealing member includes a circumferential flange having a lower shoulder having a shape corresponding to a shape of a portion of an interior surface of the upper housing; the lower housing includes a circular protrusion disposed on an upper surface thereof and a circular recess formed adjacent an inner side of the circular protrusion; an inner shoulder of the compressible sealing member configured to move into the circular recess when the compressible sealing member is compressed;

2. 2. The needle free connector of claim 1, wherein the compressible sealing member includes a neck portion and a cylindrical central portion, the cylindrical central portion being disposed between the neck portion and the circumferential flange.

3. The compressible sealing member comprises: an upper shoulder formed between the neck portion and the cylindrical central portion; and the lower shoulder formed between the cylindrical central portion and the circumferential flange; 3. The needle free connector of claim 2, comprising one of:

4. The at least one feature of the compressible sealing member comprises: a notch in the neck portion of the compressible sealing member; and a notch in the cylindrical central portion of the compressible sealing member 3. The needle free connector of claim 2, comprising one of:

5. 2. The needle free connector of claim 1, wherein an inner surface of the circumferential flange is configured to interface with the circular protrusion, the circular recess, and the upper surface of the lower housing to secure the compressible sealing member between the upper housing and the lower housing.

6. 2. The needle free connector of claim 1, wherein the lower housing includes an opening disposed below the upper surface and outside a periphery of the upper surface, and the compressible sealing member is configured to provide fluid flow from the upper housing into the lower housing and through the opening into the output port.

7. The needle free connector of claim 1 , wherein in an uncompressed state, the compressible sealing member forms a planar swabbable surface common to a top surface of the upper housing.

8. A needle-free connector, comprising: a needle free valve formed from an upper housing, a compressible sealing member, and a lower housing, the needle free valve including a first input port in the upper housing; a second input port extending at an angle from a sidewall of the upper housing, the lower housing including an engagement feature configured to engage one of the upper housing and the compressible sealing member; an output port in the lower housing, the output port fluidly connected to the first and second input ports; Including, the compressible sealing member includes at least one feature configured to facilitate and guide compression of the compressible sealing member within the upper housing; the compressible sealing member includes a circumferential flange having a lower shoulder having a shape corresponding to a shape of a portion of an interior surface of the upper housing; the lower housing includes a circular protrusion disposed on an upper surface thereof and a circular recess formed adjacent an inner side of the circular protrusion; an inner shoulder of the compressible sealing member configured to move into the circular recess when the compressible sealing member is compressed;

9. 9. The needle free connector of claim 8, wherein the compressible sealing member includes a neck portion and a cylindrical central portion, the cylindrical central portion being disposed between the neck portion and the circumferential flange.

10. The compressible sealing member comprises: an upper shoulder formed between the neck portion and the cylindrical central portion; and the lower shoulder formed between the cylindrical central portion and the circumferential flange; 10. The needle free connector of claim 9, comprising one of:

11. The at least one feature of the compressible sealing member comprises: a notch in the neck portion of the compressible sealing member; and a notch in the cylindrical central portion of the compressible sealing member 10. The needle free connector of claim 9, comprising one of:

12. 9. The needle free connector of claim 8, wherein an inner surface of the circumferential flange is configured to interface with the circular protrusion, the circular recess, and the upper surface of the lower housing to secure the compressible sealing member between the upper housing and the lower housing.

13. 9. The needle free connector of claim 8, wherein the lower housing includes an opening disposed below the upper surface and outside a periphery of the upper surface, and the compressible sealing member is configured to provide fluid flow from the upper housing into the lower housing and through the opening into the output port.

14. The needle free connector of claim 8 , wherein in an uncompressed state, the compressible sealing member forms a planar swabbable surface common to a top surface of the upper housing.

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