Split septum needleless connector with improved flushing function for macro bore side port

Abstract

An integrated intravenous catheter system including a catheter adapter having a catheter and an inlet, together with a needleless connector. The needleless connector includes a proximal port, a distal port disposed opposite the proximal port, and a side port disposed between the proximal port and the distal port. The system also includes an extension tube extending from the side port. The side port includes a tube receiving portion having a first inner diameter sized and configured to receive a distal portion of the extension tube, an inlet portion having a second inner diameter smaller than the first inner diameter, and a tapered portion extending between the tube receiving portion and the inlet portion.

Description

Technical Field

[0001] The present disclosure relates to an integrated intravenous catheter having a needle-free connector (NFC) configured to be used with a blood collection device.

Background Art

[0002] This application claims priority to U.S. Provisional Application No. 63 / 339,776, filed May 9, 2022, entitled "Split Septum Needle Free Connector with Improved Flushing Features for Macrobore Side Port", the entire disclosure of which is hereby incorporated by reference in its entirety.

[0003] Catheters are commonly used in various infusion therapies. For example, a catheter can be used to infuse fluids such as saline, various drugs, and total parenteral nutrition to a patient. Also, a catheter can be used to collect blood from a patient.

[0004] A common type of catheter is an over-the-needle peripheral intravenous (IV) catheter (PIVC), such as the BD NEXIVA™ Closed System IV Catheter System from Becton, Dickinson and Co. An over-the-needle catheter is a catheter that can be mounted on an introducer needle having a sharp distal end. The catheter and the introducer needle can be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the bevel of the needle faces away from the patient's skin surface. The catheter and the introducer needle are generally inserted at a shallow angle through the skin into the patient's vasculature. To verify proper placement of the introducer needle and / or catheter within the blood vessel, a clinician generally checks for a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily occlude the flow of the vasculature, remove the introducer needle, and leave the catheter in place for future blood sampling and infusions.

[0005] Blood sampling using a peripheral IV catheter can be difficult for several reasons, specifically when the catheter has been in place for longer than one day. For example, when a catheter is left inserted in a patient for an extended period of time, the catheter or the blood vessel may be more susceptible to the effects of stenosis, breakage, kinking, occlusion by debris (e.g., fibrin or platelet clots), and tip attachment of the catheter to the vasculature. For this reason, catheters are often used to obtain blood samples at the time of catheter placement, but are much less frequently used to obtain blood samples during the catheter dwell period.

[0006] Accordingly, blood sampling devices have been developed for collecting blood samples through existing PIVCs. The blood sampling device is attached to the PIVC and includes a flexible flow tube that advances through the PIVC, beyond the catheter tip, and into the blood vessel to collect a blood sample. After blood sampling, the blood sampling device is removed from the PIVC and discarded. An example of such a blood sampling device known as PIVO (trademark) from Becton, Dickinson and Company is shown and described, for example, in Patent Document 1, the entire content of which is incorporated herein by reference. As described in Patent Document 1, the blood sampling device includes an introducer having an actuator slidably coupled thereto, and the actuator is configured to selectively advance the flexible flow tube through the PIVC. The introducer is, for example, connectable to the proximal port of a needleless connector (NFC), and the NFC is configured to receive a connector or lock disposed at the distal end portion of the introducer.

[0007] In addition to the proximal port, the NFC may also include a side port, which is, for example, connectable to an extension tube used to introduce a flushing fluid into the NFC. The dimensions of the extension tube and / or the side port may be selected with respect to the gauge and / or other dimensions of the indwelling catheter to which the NFC is coupled. For example, referring to FIG. 1, an NFC 100 according to an embodiment of the prior art is shown, and the NFC 100 is configured to be used, for example, with 22G and 24G PIVCs. The NFC 100 includes a proximal port 102 having a split septum valve 103 at its proximal end, a side port 104, and a distal end portion configured to receive a short extension tube 105, and the short extension tube 105 is configured to be connectable to a catheter adapter (not shown). The side port 104 is configured to receive a long extension tube 106, and the long extension tube 106 has a "microbore" internal channel 108. The inner diameter of the internal channel 108 is relatively small, resulting in a relatively high fluid velocity of the flushing fluid delivered through the long extension tube 106.

[0008] When fluid enters the NFC100 through the side port 104, the NFC100 may further include an internal structure 111 configured to create a vortex or otherwise redirect the fluid. In some embodiments, the vortex generating features of the internal structure 111 are the same as or similar to the flushing features shown and described in Patent Document 2, which is hereby incorporated by reference in its entirety. The relatively high velocity of the fluid flow through the "microbore" internal channel 108, in combination with the features that create the vortices of the internal structure 111, can result in a flush of the main channel 110 of the NFC100 that removes a substantial portion of the volume fraction of the blood 112 remaining in the NFC100, for example, after a 5 mL flush volume.

[0009] Referring to FIG. 2, another prior art embodiment of an NFC150 is shown, which is configured for use with larger gauge PIVCs such as 18G and 20G PIVCs, for example. The NFC150 includes a proximal port 152 having a split septum valve 153 at its proximal end, a side port 154, and a distal end portion configured to receive a short extension tube 155 that can be coupled to a catheter adapter (not shown). The side port 154 is configured to receive a long extension tube 156. However, unlike the long extension tube 106 described above with respect to FIG. 1, the long extension tube 156 has a "macro bore" internal channel 158 with a relatively large inner diameter. This "macro bore" configuration results in an increase in the gravity flow rate and power injection flow rate performance of the flushing procedure, but also reduces the fluid velocity of the flushing fluid delivered to the main channel 160 of the NFC150 through the long extension tube 156. Even if there are features that create vortices, such as an internal structure 161, within the main channel 160, this reduction in fluid velocity due to the "macro bore" configuration can result in a relatively large volume fraction of the blood 162 remaining within the NFC150, for example, after a 5 mL flush volume.

Prior Art Documents

Patent Documents

[0010] [Patent Document 1] U.S. Patent No. 11,090,461 [Patent Document 2] U.S. Patent Application Publication No. 2021 / 0220548 [Summary of the Invention] [Problems to be Solved by the Invention]

[0011] Therefore, there is a need to provide a needleless connector (NFC) configured to be used with a "macro bore" extension tube and having improved flushing characteristics. [Means for Solving the Problems]

[0012] According to one aspect of the present disclosure, an integrated intravenous catheter system is disclosed. The system may include a catheter and a catheter adapter having an inlet, the catheter adapter configured such that the catheter is inserted into a patient's vasculature, and a needleless connector including a proximal port, a distal port disposed opposite the proximal port, and a side port disposed between the proximal port and the distal port. The system may also include an extension tube extending from the side port of the needleless connector, the side port of the needleless connector having a tube receiving portion sized and configured to receive a distal portion of the extension tube, an inlet portion having a second inner diameter smaller than the first inner diameter, and a tapered portion extending between the tube receiving portion and the inlet portion.

[0013] In some embodiments, the needleless connector includes a first body portion and a second body portion, the first body portion and the second body portion defining a flow path extending between the proximal port and the distal port.

[0014] In some embodiments, the inlet portion of the side port fluidly couples the extension tube to the flow path of the needleless connector.

[0015] In some embodiments, the side port is offset from the center of the flow path.

[0016] In some embodiments, the second body portion of the needleless connector includes an internal structure configured to redirect fluid as the fluid enters the needleless connector through the side port.

[0017] In some embodiments, the first body portion and the second body portion of the needleless connector define a longitudinal axis extending between the proximal port and the distal port, and the side port extends from the second body portion at an angle of 30 to 150 degrees with respect to the longitudinal axis.

[0018] In some embodiments, the inner diameter of the extension tube is larger than the second inner diameter of the inlet portion of the side port.

[0019] In some embodiments, the proximal port of the needleless connector includes a valve member.

[0020] In some embodiments, the valve member includes a split septum valve.

[0021] In some embodiments, the system further includes a medical connector disposed at the proximal end of the extension tube.

[0022] According to another aspect of the present disclosure, a needleless connector is disclosed, the needleless connector including a first body portion, a second body portion coupled to the first body portion, a proximal port disposed at a proximal end portion of the first body portion, a distal port disposed at a distal end portion of the second body portion, and a side port disposed between the proximal port and the distal port. The side port may include a tube receiving portion having a first inner diameter, an inlet portion having a second inner diameter smaller than the first inner diameter, and a tapered portion extending between the tube receiving portion and the inlet portion.

[0023] In some embodiments, the first body portion and the second body portion define a flow path extending between the proximal port and the distal port.

[0024] In some embodiments, the side port is offset from the center of the flow path.

[0025] In some embodiments, the second body portion includes an internal structure configured to redirect fluid when the fluid enters the needleless connector through the side port.

[0026] In some embodiments, the first and second body portions of the needleless connector define a longitudinal axis extending between the proximal port and the distal port, and the side port extends from the second body portion at an angle of 30 to 150 degrees with respect to the longitudinal axis.

[0027] In some embodiments, the proximal port includes a valve member.

[0028] In some embodiments, the valve member includes a split septum valve.

[0029] According to another aspect of the present disclosure, a needleless connector is disclosed, the needleless connector including a first body portion, a second body portion coupled to the first body portion, a proximal port disposed at a proximal end portion of the first body portion, and a distal port disposed at a distal end portion of the second body portion, wherein the first and second body portions define a flow path extending between the proximal port and the distal port, and include a side port disposed between the proximal port and the distal port. The side port includes a primary channel portion and a tapered portion extending between the primary channel portion and the flow path.

[0030] In some embodiments, the side port includes a luer connector at its proximal end.

[0031] In some embodiments, the side port includes a secondary needleless connector disposed at its proximal end.

[0032] Further details and advantages of the present invention will become apparent upon reading the following detailed description in conjunction with the accompanying drawings, in which like parts are designated by like reference numerals throughout.

Brief Description of the Drawings

[0033] The above and other features and advantages of the present disclosure, and the manner of achieving them, will become more apparent and the present disclosure itself will be better understood by reference to the following description of embodiments of the present disclosure taken in conjunction with the accompanying drawings.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

[0034] Corresponding reference numerals indicate corresponding parts throughout the several views. The examples presented herein illustrate exemplary embodiments of the present disclosure and such examples should not be construed as limiting the scope of the present disclosure in any way.

Best Mode for Carrying Out the Invention

[0035] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to one of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0036] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "uppermost," "lowermost," "lateral," "longitudinal," and derivatives thereof are related to the present invention as oriented in the drawings. However, it will be understood that the present invention may assume various alternative variations unless explicitly specified to the contrary. Also, it should be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0037] In the present disclosure, the distal end of a component or device means the end that is farthest from the user's hand when the component or device is in the use position, i.e., when the user is holding the blood collection device during preparation for or during use, and the proximal end means the end that is closest to the user's hand. Similarly, in the present application, the terms "in the distal direction" and "distally" mean the direction toward the indwelling catheter, and the terms "in the proximal direction" and "proximally" mean the direction opposite to the direction of the indwelling catheter.

[0038] Spatial or directional terms such as "left," "right," "inner," "outer," "above," "below," etc. should not be considered limiting since the present invention may assume various alternative orientations.

[0039] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the starting and ending values, and any and all sub-ranges or sub-ratios included therein. For example, a specified range or ratio of "1 to 10" is to be considered to include any and all sub-ranges or sub-ratios between (and including) the minimum value of 1 and the maximum value of 10, i.e., all sub-ranges or sub-ratios begin with a minimum value of 1 or more and end with a maximum value of 10 or less.

[0040] The terms "first", "second", and the like are not intended to refer to any particular order or chronology, but rather to refer to different conditions, characteristics, or elements.

[0041] As used herein, "at least one" is synonymous with "one or more". For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of A alone, or one or more of B alone, or one or more of C alone, or one or more of A and one or more of B, or one or more of A and one or more of C, or one or more of B and one or more of C, or one or more of A, B, and C all.

[0042] Embodiments of the present disclosure are mainly described in the context of a vascular access system including an integrated peripheral IV catheter (PIVC). It should be understood that the connector assemblies described below, which are not shown or described herein, can be utilized for blood sampling and / or probe advancement via any suitable vascular access device, such as, for example, the BD NEXIVA™ closed system IV catheter system. However, embodiments of the present disclosure are equally extended to use with other catheter devices.

[0043] Referring to FIG. 3, an integrated intravenous catheter 10 according to an aspect of the present disclosure is shown. The integrated intravenous catheter 10 includes a catheter adapter 12 having a catheter 14 configured to be inserted into a patient's vasculature, a needleless connector (NFC) 16, an intermediate fluid path 18, and an extension tube 20. The catheter adapter 12 includes an inlet 22. In the embodiment shown in FIG. 3, the needleless connector 16 includes a distal port 24, a proximal port 26 disposed opposite the distal port 24, and a side port 28 disposed between the distal port 24 and the proximal port 26. In some embodiments, the proximal port 26 includes a valve member 30. In some embodiments, the valve member 30 is configured as a split septum valve.

[0044] In some embodiments, the intermediate fluid path 18 extends between the inlet 22 of the catheter adapter 12 and the distal port 24 of the needleless connector 16. In some embodiments, the intermediate fluid path 18 is formed by the length of a tube. However, the intermediate fluid path 18 is not limited to a tube and can be any suitable fluid path, such as a luer connector, for example. Alternatively, in other embodiments, the intermediate fluid path 18 can be omitted and the needleless connector 16 is directly coupled to the catheter adapter 12. The extension tube 20 extends from the side port 28 of the needleless connector 16. The intermediate tube 18 is configured to provide flexibility when inserting and attaching the catheter 14 and when manipulating the needleless connector 16 for other procedures without obstructing flushing, blood sampling, and / or the catheter insertion site.

[0045] Referring further to FIG. 3, in some embodiments, the integrated catheter 10 includes a needle hub assembly 34 and a medical component 36, such as a vent plug, and the medical component 36 is coupled to the side port 28 of the needleless connector 16 via the extension tube 20. The needle hub assembly 34 is assembled with the catheter adapter 12 by inserting a needle (not shown) into the lumen of the catheter 14. In one aspect or embodiment, the needle hub assembly 34 includes a needle shield 38 configured to secure the tip of the needle within the needle shield 38 after use. The needle shield 38 can be actuated passively. The needle hub assembly 34 can include a push tab 40 to facilitate advancement of the catheter during insertion. The push tab 40 also allows for advancement with one or both hands. In one aspect or embodiment, the catheter adapter 12 includes one or more vanes configured to engage the patient's skin surface as shown. In another aspect or embodiment, the catheter adapter 12 does not include vanes.

[0046] In some embodiments, at least a portion of the needleless connector 16 is transparent. The connector components of the integrated catheter 10 may be transparent, opaque, and / or colored. In one aspect or embodiment, the needleless connector 16 can include a backflow prevention valve.

[0047] In some embodiments, the medical component 36 at the end of the extension tube 20 is a single port or dual port connector and can include various connectors, including a needleless connector such as a PRN or a needle access connector. The extension tube 20 can be oriented left or right. In some embodiments, in addition to the vent plug, the medical component 36 can be a removable or non-removable needleless connector or a needle access connector such as a PRN attached to a female Luer connection provided on the extension tube 20. In some embodiments, a dual male Luer port can be joined or attached to the extension tube 20 instead of a single Luer connector.

[0048] Next, referring to FIG. 4, a blood sampling device 200 according to one aspect of the present disclosure is shown. The blood sampling device 200 may be, for example, a PIVO (trademark) blood sampling device from Becton, Dickinson and Company. In one embodiment, the blood sampling device 200 is the same as or similar to the blood sampling device shown in Patent Document 1, which is incorporated herein by reference in its entirety. In one aspect or embodiment, the blood sampling device 200 can be any device that is integrated into the fluid path of the intravenous catheter 10 with a tube, probe, guide wire, instrument, and / or sensor, or advanced beyond the tip of the catheter 14.

[0049] The blood sampling device 200 may include an introduction portion 210, a lock 240, a secondary catheter 265, and an actuator 270. The introduction portion includes a proximal end portion 211 and a distal end portion 212, and the lock 240 is disposed adjacent to the distal end portion 212. The secondary catheter 265 includes a proximal end portion 266 that is coupled to and / or otherwise includes a coupler 269. The coupler 269 is configured to physically and fluidly couple the secondary catheter 265 to any suitable device such as, for example, a fluid reservoir, a fluid source, a syringe, a vacuum container holder (e.g., configured to have a sheathed needle or be coupled to a sheathed needle), a pump, etc.

[0050] According to some embodiments, a user can operate the blood collection device 200 to couple the lock 240 to, for example, the needleless connector 16. For example, in some embodiments, the user can apply sufficient force to pivot the first and second clip arms of the lock 240 so that a portion of the needleless connector 16 can be inserted into a space defined between the arm of the lock 240 and, for example, a distal core 242 extending distally from the lock 240. In some embodiments, the distal core 242 can be inserted into, for example, the proximal port 26 of the needleless connector 16 when the lock 240 is coupled thereto, while the first and second clip arms of the lock 240 can latch onto the outer surface (or surfaces) of the needleless connector 16 to hold the blood collection device 200 in a predetermined position relative to the catheter adapter 12. The distal core 242 is of sufficient length to dispose at least a portion of the distal core 242 through the valve member 30 of the needleless connector 16, thereby providing a path for a flow tube or probe to pass through the catheter adapter 12 of the integrated catheter 10 from the blood collection device 200.

[0051] Next, referring to FIGS. 5 and 6, various details of the needleless connector 16 according to aspects of the present disclosure are shown. The needleless connector 16 includes a proximal body 52 and a distal body 64, and the proximal body 52 and the distal body 64 are joined together by any suitable method. In some embodiments, the proximal body 52 and the distal body 64 may be integrally formed. The proximal body 52 and the distal body 64 define a flow path 62 that extends between the distal port 24 and the proximal port 26. In some embodiments, the side port 28 may be offset from the center of the flow path 62. Such an offset of the side port 28 causes the fluid entering the flow path 62 through the side port 28 to enter along the inner surface of the distal body 64, swirling or otherwise redirecting the fluid within the distal body 64 and the proximal body 52 to assist in flushing the needleless connector 16. In some embodiments, the distal body 64 of the needleless connector 16 further includes an internal structure 59 configured to create a vortex or otherwise redirect the fluid when the fluid enters the needleless connector 16 through the side port 28. In some embodiments, the offset and vortex generation features are the same as or similar to the flushing features shown and described in Patent Document 2, which is hereby incorporated by reference in its entirety.

[0052] The proximal body 52 and the distal body 64 of the needleless connector 16 define a longitudinal axis that extends between the distal port 24 and the proximal port 26, and the side port 28 extends from the distal body 64 at an angle of, for example, 30° to 150° with respect to the longitudinal axis of the distal body 64. In one embodiment, the side port 28 extends from the distal body 64 at an angle of 60° with respect to the longitudinal axis of the distal body 64.

[0053] Referring further to FIGS. 5 and 6, the side port 28 of the needleless connector 16 includes a tube receiving portion 56, a tapered portion 57, and an inlet portion 58, and the inlet portion 58 provides fluid communication to the flow path 62. As shown in FIG. 6, the tube receiving portion 56 has an inner diameter of the tube receiving portion 56 that is substantially larger than the inner diameter of the inlet portion 58 and includes an inner diameter sized and configured to securely receive the distal end of the extension tube 20 such that it acts to gradually decrease the inner diameter of the side port 28 between the tube receiving portion 56 and the inlet portion 58.

[0054] In the embodiment shown in FIG. 6, the extension tube 20 is composed of a “macro-bore” internal channel 68 having a relatively large inner diameter, thereby enabling increased gravity flow and power injection flow rate performance during the injection procedure. However, unlike the prior art “macro-bore” extension tubes and side ports described above with respect to FIG. 2, which result in a decrease in fluid velocity and thus a decrease in flushing performance, the combination of the tapered portion 57 and the inlet portion 58 forms a progressive restriction between the side port 28 and the flow path 62 and functions as a nozzle for increasing the fluid velocity as the fluid delivered through the extension tube 20 enters the flow path 62. This increased fluid velocity can result in a relatively low volume fraction of blood 70 remaining in the NFC 16, for example, after a 5 mL flush volume has been delivered through the extension tube 20, equivalent to a decrease in the volume fraction of blood remaining when a “micro-bore” extension tube is used as shown and described with respect to FIG. 1. In some embodiments, the effect of the increased fluid velocity, along with the internal structure 59 that creates vortices and / or an offset of the side port 28, may further assist in flushing the blood remaining in the NFC 16.

[0055] Although not shown in FIG. 6, it should be understood that the small inner diameter of the inlet portion 58 also enables the NFC16 to be used with a "microbore" extension tube without the need to change the body mold of the NFC16 between the "macro bore" and "micro bore" configurations. Thus, the NFC16 can be used with any suitable catheter gauge, such as 18G, 20G, 22G, 24G, etc.

[0056] Next, referring to FIG. 7, a needleless connector 75 according to another aspect of the present disclosure is shown. The needleless connector 75 includes a proximal body 76 and a distal body 77, and the proximal body 76 and the distal body 77 are joined together by any suitable method. The proximal body 76 and the distal body 77 define a flow path 83 that extends between a distal port 78 and a proximal port 84.

[0057] The needleless connector 75 further includes a side port 79. In some embodiments, the side port 79 can be offset from the center of the flow path 83. Such an offset of the side port 79 is configured such that fluid entering the flow path 83 through the side port 79 enters along the inner surface of the distal body 77, swirling or otherwise redirecting the fluid within the distal body 77 and the proximal body 76 to assist in flushing the needleless connector 75.

[0058] In some embodiments, the distal body 77 of the needleless connector 75 further includes an internal structure 82 configured to create a vortex or otherwise redirect the fluid when the fluid enters the needleless connector 75 through the side port 79. In some embodiments, the offset and vortex generation features are the same as or similar to the flushing features shown and described in Patent Document 2, which is hereby incorporated by reference in its entirety.

[0059] The proximal body 76 and the distal body 77 of the needleless connector 75 define a longitudinal axis that extends between the distal port 78 and the proximal port 84, and the side port 79 extends from the distal body 77 at an angle, for example, between 15° and 165° with respect to the longitudinal axis of the distal body 77. The needleless connector 16 described above with respect to FIGS. 5 and 6 includes a side port configured to receive the length of the extension tube therein, and the side port 79 of the needleless connector 75 is configured as, for example, a luer port for accommodating the coupling to a removable connector. However, the side port 79 includes a primary channel portion 80 and a tapered portion 81, and the tapered portion 81 provides fluid communication to the flow path 83. The tapered portion 81 acts to gradually decrease the inner diameter of the side port 79 between the primary channel portion 80 and the flow path 83 and acts as a nozzle to increase the fluid velocity of the fluid delivered through the side port 79 when entering the flow path 83. As detailed above, such an increased fluid velocity can assist in the flushing performance to remove a substantial portion of the blood remaining within the needleless connector 75 after a blood sampling procedure.

[0060] Referring now to FIG. 8, a needleless connector 85 according to another aspect of the present disclosure is shown. The needleless connector 85 includes a proximal body 86 and a distal body 87, and the proximal body 86 and the distal body 87 are coupled together by any suitable method. The proximal body 86 and the distal body 87 define a flow path 93 that extends between a distal port 88 and a proximal port 90.

[0061] The needleless connector 85 further includes a side port 95. In some embodiments, the side port 95 can be offset from the center of the flow path 93. Such an offset of the side port 95 causes the fluid entering the flow path 93 through the side port 95 to enter along the inner surface of the distal body 87 and can be configured to swirl or otherwise redirect the fluid within the distal body 87 and the proximal body 86 to assist in flushing the needleless connector 85.

[0062] In some embodiments, the distal body 87 of the needleless connector 85 further includes an internal structure 92 configured to create a vortex or otherwise redirect fluid as it enters the needleless connector 785 through the side port 95. In some embodiments, the offset and vortex generating features are the same as or similar to the flushing features shown and described in Patent Document 2, which is incorporated herein by reference in its entirety.

[0063] The proximal body 86 and distal body 87 of the needleless connector 85 define a longitudinal axis extending between the distal port 88 and the proximal port 90, and the side port 95 extends from the distal body 87 at an angle, for example, between 15° and 165° with respect to the longitudinal axis of the distal body 87.

[0064] The needleless connector 16 described above with respect to FIGS. 5 and 6 includes a side port configured to receive the length of the extension tube therein, and the side port 95 of the needleless connector 85 is configured to include, for example, a secondary needleless connector 89 for accommodating a fluid injection device usable with a needleless interface. However, the side port 95 includes a tapered portion 91 that provides fluid communication to the flow path 93. The tapered portion 91 acts to gradually reduce the inner diameter of the side port 95 and acts as a nozzle to increase the fluid velocity of the fluid delivered through the side port 95 as it enters the flow path 93. As detailed above, such increased fluid velocity can assist in the flushing performance to remove a significant portion of the blood remaining in the needleless connector 85 after a blood sampling procedure.

[0065] Although described with respect to a needleless connector used with an integrated intravenous catheter, it should be understood that the concepts described herein may be applicable to any medical device fluid junction having a fluid inlet or outlet with different central axes. The fluid junction can be an optimization of one or more of the optimized positions of the lateral fluid path inlet angle, central or planar offset, lateral port flow rate indicator lamp(s), and / or proximal flow bypass feature(s).

[0066] Furthermore, it should be understood that the needleless connector described herein may (and may be attached to) integrally comprise an integrated catheter system, or alternatively, the needleless connector described herein may be utilized as a stand-alone extension set provided separately from other components of the integrated catheter system.

[0067] The present invention has been described in detail for purposes of illustration based on what is presently considered to be the most practical and preferred embodiments or aspects thereof, but such details are for that purpose only, and it is to be understood that the invention is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. An integrated intravenous catheter system comprising: a catheter and a catheter adapter having an inlet, wherein the catheter is a catheter adapter configured to be inserted into a patient's vasculature; a needleless connector including a proximal port, a distal port disposed opposite the proximal port, and a side port disposed between the proximal port and the distal port; an extension tube extending from the side port of the needleless connector; and the side port of the needleless connector includes a tube receiving portion having a first inner diameter sized and configured to receive a distal portion of the extension tube, an inlet portion having a second inner diameter smaller than the first inner diameter, and a tapered portion extending between the tube receiving portion and the inlet portion. The integrated intravenous catheter system is characterized by this.

2. The needleless connector includes a first body portion and a second body portion, and the first body portion and the second body portion define a flow path extending between the proximal port and the distal port. The integrated intravenous catheter system according to claim 1.

3. The inlet portion of the side port fluidly couples the extension tube to the flow path of the needleless connector. The integrated intravenous catheter system according to claim 2.

4. The side port is offset from the center of the flow path. The integrated intravenous catheter system according to claim 2.

5. The second body portion of the needleless connector includes an internal structure configured to redirect fluid when the fluid enters the needleless connector through the side port. The integrated intravenous catheter system according to claim 2.

6. The first body portion and the second body portion of the needleless connector define a longitudinal axis extending between the proximal port and the distal port, and the side port extends from the second body portion at an angle of 30 to 150 degrees with respect to the longitudinal axis. The integrated intravenous catheter system according to claim 2.

7. The inner diameter of the extension tube is larger than the second inner diameter of the inlet portion of the side port. The integrated intravenous catheter system according to claim 1.

8. The proximal port of the needleless connector includes a valve member. The integrated intravenous catheter system according to claim 1.

9. The integrated intravenous catheter system according to claim 8, wherein the valve member includes a partition wall valve.

10. The integrated intravenous catheter system according to claim 1, further comprising a medical connector disposed at a proximal end of the extension tube.

11. A needleless connector, a first body portion, a second body portion coupled to the first body portion, a proximal port disposed at a proximal end portion of the first body portion, a distal port disposed at a distal end portion of the second body portion, and a side port disposed between the proximal port and the distal port, wherein the side port includes a tube receiving portion having a first inner diameter, an inlet portion having a second inner diameter smaller than the first inner diameter, and a tapered portion extending between the tube receiving portion and the inlet portion. The needleless connector is characterized by this.

12. The needleless connector according to claim 11, wherein the first body portion and the second body portion define a flow path extending between the proximal port and the distal port.

13. The needleless connector according to claim 12, wherein the side port is offset from the center of the flow path.

14. The needleless connector according to claim 11, wherein the second body portion includes an internal structure configured to redirect fluid when the fluid enters the needleless connector through the side port.

15. The first body portion and the second body portion of the needleless connector define a longitudinal axis extending between the proximal port and the distal port, and the side port extends from the second body portion at an angle of 30 to 150 degrees with respect to the longitudinal axis. The needleless connector according to claim 11.

16. The needleless connector according to claim 11, wherein the proximal port includes a valve member.

17. The needleless connector according to claim 16, wherein the valve member includes a partition wall valve.

18. A needleless connector, a first body portion, a second body portion coupled to the first body portion, a proximal port disposed at a proximal end portion of the first body portion, a distal port disposed at a distal end portion of the second body portion, and a side port disposed between the proximal port and the distal port, comprising wherein the first body portion and the second body portion define a flow path extending between the proximal port and the distal port, The needleless connector is characterized in that the side port includes a primary channel portion and a tapered portion extending between the primary channel portion and the flow path. **Claim 19** The needleless connector according to claim 18, wherein the side port includes a luer connector at its proximal end. **Claim 20** The needleless connector according to claim 18, wherein the side port includes a secondary needleless connector disposed at its proximal end.

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