Blood collection connector for open peripheral intravenous catheters

Abstract

Provided herein is a catheter system including a catheter and a catheter hub, the catheter hub further including a hub body having a cavity extending between the hub distal end and the hub proximal end, a hub port disposed at the hub proximal end, and a wedge disposed in the cavity adjacent the hub distal end, the wedge being coupled to the proximal end of the catheter. A connector is coupled to the catheter hub and includes a proximal coupler, a distal coupler configured to mate with the hub port, and a primary lumen extending between the distal coupler and the proximal coupler and in fluid communication with the lumen of the catheter. The distal coupler includes a collar portion configured to mate with the hub port and an extension tip extending distally beyond the collar portion into the cavity and to the wedge of the catheter hub.

Description

[Technical Field]

[0001] This application claims priority to U.S. Application No. 18 / 110,098, filed February 15, 2023, entitled "Blood Draw Connector for Open Peripheral Intravenous Catheters," the entire disclosure of which is incorporated herein by reference.

[0002] Provided herein are devices and systems for use in vascular access, and in particular catheter connectors for advancing instruments through open peripheral intravenous catheters. [Background technology]

[0003] Vascular access devices (VADs) are used in the medical field to access a patient's peripheral vasculature for the purposes of infusion therapy and / or blood sampling. Common types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. VADs can be placed for short-term (days), medium-term (weeks), or long-term (months to years) placement.

[0004] Instrument delivery devices are often used with VADs to deliver instruments to indwelling intravenous (IV) catheters, where the instrument delivery device advances the instrument beyond the tip of the indwelling catheter. When the instrument delivery device is used to collect blood, by way of example, the instrument may be in the form of a flexible tube or catheter, but in other embodiments, the instrument may also be a guidewire, occluder, wire, electrical wiring, probe, or sensor(s). In some configurations, the instrument delivery device may be coupled directly to an open catheter hub (to which the indwelling catheter is secured), and the instrument delivery device operates to advance the instrument from the instrument delivery device, through the interior of the catheter hub (i.e., through the internal cavity and the wedge that holds the catheter), and then out beyond the tip of the indwelling catheter. In other configurations, a catheter adapter or connector may serve as an interface between the catheter hub and the instrument delivery device, with the distal end of the instrument delivery device secured to the catheter adapter. Once coupled to the catheter adapter, the instrument delivery device may be operated to advance the instrument from the instrument delivery device, through the lumen of the catheter adapter, through the interior of the catheter hub, and then beyond the tip of the indwelling catheter.

[0005] It is recognized that in any of the above configurations, difficulties may arise when attempting to advance an instrument through the catheter hub. In a configuration in which the instrument delivery device is directly coupled to the catheter hub 1, as shown in FIG. 1A, a large portion of the cavity 2 within the catheter hub 1 may remain open, and when attempting to advance the instrument 3 through this cavity 2 and into the lumen of the wedge 4 and catheter 5, the instrument 3 may not be properly aligned with the cavity 2. Thus, the instrument 3 may become trapped within the cavity 2 of the catheter hub 1, and as the instrument 3 advances further, the instrument 3 may twist and double back on itself. Even in a configuration in which a catheter connector 6 is used to connect the instrument delivery device to the catheter hub 1, as shown in FIG. 1B, the male connecting portion 7 of the catheter connector 6 that mates with the catheter hub 1 may not fill a large portion of the cavity 2 therein. If at least a portion of cavity 2 remains open, the distal end of male connecting portion 7 remains spaced apart from wedge 4 within catheter hub 1, so that when an attempt is made to advance instrument 3 through this cavity 2 (i.e., through the portion of the open cavity remaining between male connecting portion 7 and wedge 4), instrument 3 may again remain out of proper alignment with the lumen within wedge 4. Thus, instrument 3 may become trapped within cavity 2 of catheter hub 1, and as instrument 3 is advanced further, instrument 3 may twist and double back upon itself.

[0006] Therefore, there is a need in the art for an improved adapter or connector that provides for the advancement of an instrument through a catheter connector and a catheter hub connected thereto to prevent twisting of the instrument as it is advanced through the instrument delivery device. Summary of the Invention

[0007] Provided herein is a catheter system including a catheter having a catheter distal end and a catheter proximal end, and a catheter hub configured to receive a portion of the catheter therein, the catheter hub further including a hub body having a cavity formed therein extending between the hub distal end and the hub proximal end, a hub port disposed at the hub proximal end, and a wedge disposed in the cavity adjacent the hub distal end, the wedge being coupled to the catheter proximal end to hold the catheter to the catheter hub. The catheter system also includes a connector coupled to the catheter hub, the connector having a connector distal end and a connector proximal end, the connector further including a distal coupler disposed at the connector distal end and configured to mate with the hub port, a proximal coupler disposed at the connector proximal end, and a primary lumen extending between the distal coupler and the proximal coupler, the primary lumen being in fluid communication with the catheter lumen defined by the catheter when the distal coupler is coupled to the hub port. The distal coupler further includes a collar portion configured to mate with the hub port and an extension tip extending distally beyond the collar portion and into the cavity to the wedge of the catheter hub.

[0008] In some embodiments, the distal end of the extension tip is adjacent the wedge such that the distal end of the primary lumen is directly adjacent the proximal end of the catheter lumen.

[0009] In some embodiments, the wedge includes a wedge lumen formed therein, and abutment of the distal end of the extension tip with the wedge directly aligns the primary lumen with the wedge lumen.

[0010] In some embodiments, the hub port is a female luer port, the distal coupler is a male luer connection, the collar portion threadably engages the female luer port, and the extension tip extends through the female luer port.

[0011] In some embodiments, the connector further includes a side port disposed in the connector between the proximal coupler and the distal coupler, the side port configured to be in fluid communication with the primary lumen.

[0012] In some embodiments, the connector is a Y-connector and the side port extends from the connector at an angle of 15 to 165 degrees relative to the primary lumen.

[0013] In some embodiments, the catheter system further includes a needleless access connector coupled to the side port.

[0014] In some embodiments, the catheter system further includes IV tubing coupled to the side port and fluidly connected to the primary lumen for delivering fluid to the primary lumen and onto the catheter.

[0015] In some embodiments, the proximal coupler includes a proximal access port and a split bulkhead connector coupled to the proximal access port, the split bulkhead connector including a first ring and a second ring laterally spaced from the first ring.

[0016] In some embodiments, the catheter system further includes a blood collection device coupled to the proximal coupler of the connector.

[0017] In some embodiments, the blood collection device includes a secondary catheter; an introducer having proximal and distal ends defining an interior volume configured to movably receive the secondary catheter, and a top and bottom surface; an actuator movably coupled to the introducer and configured to move relative to the introducer to move the distal end of the secondary catheter from a position within the introducer to a position outside the introducer housing to pass through the distal end of the catheter; and a lock disposed at the distal end of the introducer and coupled to the proximal coupler of the connector.

[0018] In some embodiments, the lock includes a pair of locking arms that engage the split bulkhead connector by snapping in between the first ring and the second ring.

[0019] In some embodiments, the primary lumen has a linear shape such that when the blood sampling device is coupled to the proximal coupler of the connector, the secondary catheter may be advanced in a straight line through the primary lumen.

[0020] In some embodiments, the extension of the extension tip distal to the wedge of the catheter hub provides concentricity between the secondary catheter and the catheter.

[0021] In some embodiments, the catheter hub is an open peripheral intravenous catheter (PIVC) catheter hub.

[0022] Also provided herein is a catheter system including a catheter having a catheter distal end and a catheter proximal end, and a catheter hub configured to receive a portion of the catheter therein, the catheter hub further including a hub body having a cavity formed therein extending between the hub distal end and the hub proximal end, a hub port disposed at the hub proximal end provided as a female Luer connection, and a wedge disposed in the cavity adjacent the hub distal end, the wedge being coupled to the catheter proximal end to hold the catheter to the catheter hub. The catheter system also includes a connector coupled to the catheter hub, the connector having a connector distal end and a connector proximal end, the connector further including a male Luer connection at the connector distal end configured to mate with the female Luer connection. The male Luer connection includes an extended tip extending into and substantially through the cavity and abutting the wedge.

[0023] In some embodiments, the male luer connection includes a collar disposed around a portion of the extended tip, the collar having a threaded inner surface configured to engage the threaded outer surface of the female luer connection.

[0024] In some embodiments, the connector further includes a proximal coupler disposed at the connector proximal end, the proximal coupler having a proximal access port and a split bulkhead connector coupled to the proximal access port, the split bulkhead connector including a first ring and a second ring spaced laterally from the first ring.

[0025] In some embodiments, the catheter system further includes a blood collection device coupled to the proximal coupler of the connector, the blood collection device including: a secondary catheter; an introducer having proximal and distal ends and a top and bottom surface defining an interior volume configured to movably receive the secondary catheter; an actuator movably coupled to the introducer and configured to move relative to the introducer to move the distal end of the secondary catheter from a position within the introducer to a position outside the introducer housing to pass through the distal end of the catheter; and a lock disposed at the distal end of the introducer and coupled to the proximal coupler of the connector.

[0026] In some embodiments, the lock includes a pair of locking arms that engage the split bulkhead connector by snapping in between the first ring and the second ring. [Brief explanation of the drawings]

[0027] [Figure 1A] FIG. 1A is a cross-sectional view of a catheter hub with an instrument advanced therethrough, as known in the art. [Figure 1B] FIG. 1B is a cross-sectional view of a catheter hub and associated catheter connector with an instrument advanced therethrough, as known in the art. [Figure 2] FIG. 2 is a perspective view of a catheter system according to one aspect or embodiment of the present application. [Figure 3] FIG. 3 is a top view of a portion of the catheter system of FIG. [Figure 4] FIG. 4 is a cross-sectional view of the catheter system of FIG. [Figure 5]FIG. 5 is a cross-sectional view of the catheter system of FIG. 2 showing the device in a first position. [Figure 6] FIG. 6 is a cross-sectional view of the catheter system of FIG. 2 showing the device in a second position. DETAILED DESCRIPTION OF THE INVENTION

[0028] The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0029] For purposes of explanation hereinafter, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and derivatives thereof, shall refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. As such, specific dimensions and other physical characteristics relating to aspects disclosed herein are not to be considered limiting.

[0030] In this disclosure, the distal end of a component or device means the end farthest from the user's hand when the component or device is in the use position, i.e., when the user is holding the catheter insertion device in preparation for or during use, and the proximal end means the end closest to the user's hand. Similarly, in this application, the terms "distally" and "distally" mean the direction toward the distal tip of the needle or catheter of the system, and the terms "proximally" and "proximally" mean the direction opposite to the direction of the distal tip of the needle or catheter.

[0031] Referring to Figure 2, a catheter system 10 is shown according to one aspect or embodiment of the present disclosure. The catheter system 10 includes a catheter 12 and an associated catheter hub 14 that may collectively provide an open PIVC catheter 16. The catheter system 10 further includes a catheter adapter or connector 18 (hereinafter "connector 18") to which an instrument delivery device 20 and / or additional extension sets or fluid delivery systems may be connected to provide for delivery of instruments and / or fluids into the catheter 12.

[0032] As shown in Figures 2, 3, and 4, an open PIVC catheter 16 includes a catheter 12 and a catheter hub 14 that provide intravenous access to a patient's vascular system. In some embodiments, the catheter 12 may include a peripheral intravenous catheter, although it will be recognized that the catheter 12 may also be provided as a midline catheter or a peripherally inserted central catheter. The catheter 12 may be formed of any suitable material and may be of any useful length, as known to those skilled in the art. A proximal end 22 of the catheter 12 is coupled to the catheter hub 14 and extends distally therefrom to a distal end 24 of the catheter 12. The catheter 12 defines a lumen 26 therein through which fluids can be administered to the patient, instruments can be introduced into the patient's vascular system, or blood can be withdrawn from the patient.

[0033] The catheter hub 14 is comprised of a main hub body 28 having a distal end 30 and a proximal end 32, with stabilizing wings 34 extending from the main hub body 28 providing for securing the hub to the patient's skin. The main hub body 28 defines a cavity 36 therein that extends between the distal end 30 and the proximal end 32 of the catheter hub 14. According to some aspects or embodiments, the cavity 36 is configured as a tapered cavity 36 and forms a portion of a hub port 38 included at the proximal end of the catheter hub 14, with the hub port 38 configured as a female Luer connection 40. In addition to including the tapered cavity 36, the hub port 38 also includes threads 41 formed on the exterior surface of the main hub body 28 provided adjacent the proximal end 32 of the catheter hub 14. The tapered cavity 36 and threads 41 of the hub port 38 provide a male luer connection that mates with a female luer connection 40 of the hub port 38 for coupling to the catheter hub 14, as will be described in more detail below.

[0034] As shown in FIG. 4 , the catheter hub 14 further includes a wedge 42 disposed within the cavity 36 of the main hub body 28. The wedge 42 is disposed within the cavity 36 adjacent the distal end 30 of the catheter hub 14 and includes an outer surface contoured to match the contours of the cavity 36 so that the wedge 42 can fit within the cavity 36. The wedge 42 includes openings 44, 46 formed therein at opposite distal and proximal ends thereof, with a wedge lumen 48 extending between the distal openings 44, 46. The wedge 42 is disposed within the cavity 36 such that the distal opening 44 in the wedge 42 aligns with the distal opening 50 in the main hub body 28. With the openings in the wedge 42 and the main hub body 28 aligned, the catheter 12 extends through the distal opening 50 of the main hub body 28 and into the distal opening 44 of the wedge 42, which is sized so that the catheter 12 is secured within the opening 44 and to the wedge 42, thereby securing the catheter 12 to the catheter hub 14.

[0035] The connector 18 of the catheter system 10 connects to the proximal end 32 of the catheter hub 14 and functions as an adapter or connection between the catheter hub 14 and the instrument delivery device 20. The connector 18 is formed from a main connector body 52 that includes a proximal port 54 with a proximal coupler 56, a distal port 58 with a distal coupler 60, and defines a primary lumen 62 that extends through or otherwise in fluid communication with the couplers 56 and 58. According to aspects of the present disclosure, the primary lumen 62 has a linear shape and extends straight through the main connector body 52 to facilitate advancement of an instrument through the connector 18, as described in more detail below. According to some aspects and embodiments, the proximal port 54 is configured as a receptacle that receives the proximal coupler 56 therein. The proximal coupler 56 may be configured as a split septum, needleless connector (NFC), or the like, including a split septum 64 partially mounted within the proximal port 54 and functioning as an access control feature, whereby a peripheral device (e.g., a blood collection device or vascular access probe for intravenous digital measurement of patient data such as temperature, pH, lactate, and / or other blood-based measurements) may be physically and fluidly coupled to the connector 18, the split septum connector allowing the connector 18 to be accessed multiple times by the peripheral device. In some embodiments, when the peripheral device is a blood collection device that introduces a secondary catheter into the catheter 12, the split septum connector 56 functions as a blood control feature that may be accessed multiple times by the blood collection device to draw blood from the patient's vein. The split septum connector 56 also includes a pair of connecting rings 66, 68 formed therearound, the first ring 66 and the second ring 68 being laterally spaced apart. The connecting rings 66, 68 provide for engagement of the instrument delivery device 20 to the connector 18, as will be explained in further detail below.

[0036] According to some aspects and embodiments, the distal port 58 of the connector 18 provides a distal coupler 60 that may be at least partially integrally formed with the main connector body 52, with the distal coupler 60 provided as a male luer connection 70. The male luer connection 70 generally includes an extended tip 72 and an annular shield or collar portion 74 that is disposed around a portion of the extended tip 72 (i.e., the extended tip 72 extends beyond the collar portion 74). The collar portion 74 may be configured to engage with the female luer connection 40 of the catheter hub 14 via twist-turn or threaded engagement, with one or more threads 76 formed on the inner surface of the collar portion 74 mating with the threads 41 on the female luer connection 40 of the catheter hub 14. As shown in the illustrated embodiment, the collar portion 74 may be integrally formed with the main connector body 52 and configured as a “locking” collar relative to the extended tip 72. However, it will be appreciated that in other embodiments, the collar portion 74 may be configured as a "rotating" collar in which the collar portion 74 is formed separately from the connector body 52 and the extension tip 72 to allow rotation of the collar portion 74 when the collar portion 74 is threadably engaged with the catheter hub 14.

[0037] As shown in FIG. 4 , the extended tip 72 is formed as an elongated member that extends past the collar portion 74 and into the cavity 36 of the catheter hub 14. The extended tip 72 may be configured with a tapered outer surface that is received by a corresponding tapered cavity 36 of the female Luer connection 40 of the catheter hub 14. The length of the extended tip 72 is such that the distal end 78 of the extended tip 72 extends completely through the cavity 36 and contacts the wedge 42 of the catheter hub 14, i.e., the extended tip 72 abuts the wedge 42. When the extended tip 72 abuts the wedge 42 in this manner, the distal opening 80 of the primary lumen 62 through the extended tip 72 is directly adjacent the wedge lumen 48 and proximate the proximal end 22 of the catheter 12. With the extension tip 72 inter-fitted with the cavity 36 of the catheter hub 14 in this manner, the primary lumen 62 within the extension tip 72 (and more generally within the connector 18) is directly aligned with the wedge lumen 48. Thus, the distal coupler 60 can be physically and fluidly coupled to the catheter hub 14 such that the primary lumen 62 of the connector 18 is in at least selective fluid communication with the catheter 12 via the catheter hub 14.

[0038] The connector 18 also includes and / or defines one or more additional ports, such as a side port 82. The side port 82 may be formed at a desired location along the length of the main connector body 52 between the distal port 58 and the proximal port 54 to allow for shortening the length of the connector 18 and / or to facilitate flushing and / or fluid transfer through the side port 82. The side port 82 defines a lumen 83 in fluid communication with the primary lumen 62 between the distal coupler 60 and the proximal coupler 56. Thus, the side port 82 can provide access to the primary lumen 62 between the distal coupler 60 and the proximal coupler 56, which in turn can provide access to a device (e.g., the catheter hub 14) coupled to the distal coupler 60.

[0039] In some embodiments, the arrangement of the side port 82 can be such that the connector 18 forms, for example, a Y-connector or a T-connector. More specifically, the side port 82 can be positioned substantially perpendicular (e.g., at about 90 degrees) to the lumen of the connector 18 and positioned near or adjacent to the proximal coupler 56. In non-limiting embodiments, the side port 82 extends from the connector 18 at an angle other than 90 degrees relative to the primary lumen 62 between the distal coupler 60 and the proximal coupler 56 (e.g., the side port 82 extends at an angle between, for example, but not limited to, 15 and 165 degrees, including all values ​​and subranges therebetween). In non-limiting embodiments, multiple side ports 82 are included in the connector 18.

[0040] 2, in some embodiments, an extension tube 84 may be connected to the side port 82 such that the extension tube 84 is in fluid communication with the lumen of the side port 82. The side port 82 and / or extension tube 84 may be and / or form at least a portion of a fluid line that may be used to deliver fluid, remove fluid, flush fluid, etc., such as receiving fluid from an attached IV bag (not shown), by way of example. In such embodiments, a configuration in which the side port 82 is positioned adjacent to the proximal coupler 56 may enable flushing of the proximal coupler 56, any valve(s) contained therein, and / or the space between the any valve(s) and the interior surface of the connector 18 (e.g., defining at least a portion of the primary lumen 62).

[0041] 2-4, NFC 86 may be coupled to side port 82 to provide controlled access to connector 18, with extension tube 84 connected to side port 82 via NFC 86. NFC 86 may be configured as a split bulkhead NFC, such as, for example, a Q-Syte™ or SmartSite™ NFC from Becton, Dickinson and Co., or any other suitable split bulkhead NFC.

[0042] As shown in FIG. 2 and FIGS. 5 and 6 , the instrument delivery device 20 of the catheter system 10 is coupled to the proximal coupler 56 of the connector 18. The instrument delivery device 20 includes an introducer 88, a lock 90, an instrument 92 ( FIGS. 5 and 6 ), and an actuator 94. The instrument 92 may be any of several devices suitable for insertion into a patient's vasculature, including, by way of example, a secondary catheter, a guidewire, or a probe. A portion of the actuator 94 is configured to advance along the top surface of the introducer 88, which in turn facilitates advancement of the instrument 92 through the introducer 88, the lock 90, the connector 18, and distal exit through the catheter 12. In some embodiments, a Luer adapter, Luer lock access device (LLAD), or other connection device 96 may be provided at the proximal end of the introducer 88 to enable connection of another component 98, such as a syringe or vacutainer, to the instrument delivery device 20 to facilitate blood withdrawal. According to one embodiment, the instrument delivery device 20 functions as a blood collection device to facilitate the withdrawal of blood from the patient by inserting a secondary catheter through the catheter 12, with the blood being collected in a syringe or vacuum tube attached to the device, and therefore, hereinafter, reference is made to the blood collection device 20 and the secondary catheter 92.

[0043] As shown in more detail in FIGS. 3 and 4 , the lock 90 of the blood collection device 20 is configured to be physically and fluidly coupled to the introducer 88 and to couple the introducer 88 to the connector 18. The lock 90 has a blunt cannula 100, a first arm 102, and a second arm 104, and the lock 90 also defines a lumen 106 extending through the blunt cannula 100. The blunt cannula 100 is disposed between the first arm 102 and the second arm 104 and has a length sufficient to extend at least partially through the proximal connector 56 (i.e., the split septum connector) of the proximal port 54 and into the primary lumen 62 of the connector 18. Furthermore, the blunt cannula 100 can have an inner diameter (the diameter of the surface at least partially defining the lumen 106) that is similar to or slightly larger than the outer diameter of a portion of the secondary catheter 92. Thus, lumen 106 of lock 90 can receive a portion of secondary catheter 92 as the secondary catheter is advanced therethrough.

[0044] As described above, at least a portion of the secondary catheter 92 is movably disposed within the introducer 88. A proximal end portion of the secondary catheter 92 is coupled to the actuator 94, such that the actuator 94 can be moved relative to the introducer 88 to move the secondary catheter 92 between a first position in which the secondary catheter 92 is disposed within the introducer 88 (e.g., the secondary catheter 92 is disposed entirely within the introducer 88 or within the introducer 88 and the lock 90) and a second position in which the distal end portion 108 of the secondary catheter 92 is at least partially disposed at a location distal to the lock 90 and the connector 18 when the lock 90 is coupled to the connector 18.

[0045] 5 and 6, there is shown a change between a first and a second configuration of blood collection device 20. Blood collection device 20 can be placed in the first configuration prior to use and can be transitioned from the first configuration (FIG. 5) to the second configuration (FIG. 6) by a user (e.g., a doctor, nurse, technician, phlebotomist, etc.) to position at least the distal end portion 108 of secondary catheter 92 in a distal position relative to introducer 88 (e.g., within or distal to indwelling catheter 12).

[0046] 5 when the secondary catheter 92 is disposed in a first position within the introducer 88. In some embodiments, substantially the entire secondary catheter 92 is disposed within the introducer 88 when the secondary catheter 92 is in the first position. In other embodiments, the secondary catheter 92 is disposed within the introducer 88 and the lock 90 when the secondary catheter 92 is in the first position.

[0047] Actuator 94 (FIG. 2) is disposed in a proximal position when blood collection device 20 is in the first configuration, and a user may engage actuator 94 with introducer 88, which in turn moves secondary catheter 92 from a first position (e.g., disposed within introducer 88) toward a second position. In this manner, secondary catheter 92 is moved through the interior volume of introducer 88 and lumen 106 of lock 90.

[0048] When the secondary catheter 92 is disposed in the second position, the blood collection device 20 is in the second configuration of FIG. 6 . The second position of the secondary catheter 92 is reached when the distal end portion 108 of the secondary catheter 92 is positioned in a desired location relative to the distal end of the connector 18 and is disposed through the catheter 12. In some examples, for example, the distal end 108 of the secondary catheter 92 can be substantially flush with the distal end 24 of the catheter 12 when the secondary catheter 92 is in the second position. In other examples, the distal end 108 of the secondary catheter 92 can extend a predetermined distance beyond the distal end 24 of the catheter 12 (e.g., toward the side of the distal end 24 of the catheter 12) such that the distal end 108 of the secondary catheter 92 is disposed within the vein a predetermined distance beyond the distal end 24 of the catheter 12 (e.g., at a position within the vein substantially free of debris (e.g., fibrin / thrombus) surrounding the distal end 24 of the catheter 12).

[0049] When the secondary catheter 92 is in the second position (e.g., when the blood collection device 20 is in the second configuration shown in FIG. 6 , for example), a user can establish fluid communication between a component 98 (e.g., a fluid reservoir, a fluid source, a syringe, etc.) and the secondary catheter 92. With the secondary catheter 92 in fluid communication with the component 98, the blood collection device 20 can aspirate a volume of blood from a vein based, at least in part, on positioning the distal end 108 of the secondary catheter 92 a predetermined and / or desired distance beyond the distal end 24 of the indwelling catheter 12.

[0050] Advantageously, the structure of the connector 18 and its mating with the catheter hub 14 facilitates advancement of the secondary catheter 92 from the first position to the second position. That is, the extension tip 72 has a length such that it extends completely through the cavity 36 of the catheter hub 14 and contacts the wedge 42; i.e., the extension tip 72 abuts the wedge 42; and the distal opening 80 of the primary lumen 62 (extending through the extension tip 72) is brought into direct proximity with and aligned with the wedge lumen 48. Thus, the secondary catheter 92 can be advanced in a straight line through the primary lumen 62 of the connector 18 and the wedge lumen 48 of the wedge 42 without the opportunity for the secondary catheter 92 to deflect or otherwise become trapped / caught within the cavity 36 of the catheter hub 14. The structure of the connector 18 and its mating with the catheter hub 14 thereby maintains concentricity between the secondary catheter 92 and the catheter 12 , thus aiding in the advancement of the secondary catheter 92 .

[0051] While the present disclosure has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is for that purpose only, and that the present disclosure 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 should be understood that the present disclosure 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. a catheter having a distal catheter end and a proximal catheter end; a catheter hub configured to receive a portion of the catheter therein, the catheter hub comprising: a hub body having a hub distal end and a hub proximal end, the hub body having a cavity formed therein extending between the hub distal end and the hub proximal end; a hub port disposed at the hub proximal end; a wedge disposed within the cavity adjacent the hub distal end, the wedge coupled to the catheter proximal end to retain the catheter to the catheter hub; a catheter hub comprising: a connector coupled to the catheter hub, the connector having a connector distal end and a connector proximal end, the connector comprising: a distal coupler disposed at a distal end of the connector and configured to mate with the hub port; a proximal coupler disposed at a proximal end of the connector; a primary lumen extending between the distal coupler and the proximal coupler, the primary lumen being in fluid communication with a catheter lumen defined by the catheter when the distal coupler is coupled to the hub port; a connector comprising: Including, The distal coupler a collar portion configured to mate with the hub port; an extension tip extending distally beyond the collar portion and into the cavity to the wedge of the catheter hub; A catheter system comprising:

2. The catheter system of claim 1 , wherein the distal end of the extension tip abuts the wedge such that the distal end of the primary lumen is directly adjacent the proximal end of the catheter lumen.

3. 3. The catheter system of claim 2, wherein the wedge includes a wedge lumen formed therein, and the distal end of the extension tip abuts the wedge to directly align the primary lumen with the wedge lumen.

4. 2. The catheter system of claim 1, wherein the hub port includes a female luer port, the distal coupler includes a male luer connection, the collar portion threadably engages the female luer port, and the extension tip extends through the female luer port.

5. 10. The catheter system of claim 1, wherein the connector further comprises a side port disposed in the connector between the proximal coupler and the distal coupler, the side port configured to be in fluid communication with the primary lumen.

6. The catheter system of claim 5, wherein the connector comprises a Y-connector, and the side port extends from the connector at an angle of 15 to 165 degrees relative to the primary lumen.

7. The catheter system of claim 5 , further comprising a needleless access connector coupled to the side port.

8. 6. The catheter system of claim 5, further comprising an IV tubing coupled to the side port and fluidly connected to the primary lumen for delivering fluid to the primary lumen and the catheter.

9. The proximal coupler a proximal access port; a split septum connector coupled to the proximal access port, the split septum connector comprising a first ring and a second ring spaced laterally from the first ring; The catheter system of claim 1 , comprising:

10. The catheter system of claim 9 , further comprising a blood collection device, the blood collection device coupled to the proximal coupler of the connector.

11. The blood collection device comprises: a secondary catheter; an introducer having proximal and distal ends and a top and bottom surface, the introducer defining an interior volume configured to movably receive the secondary catheter; an actuator movably coupled to the introducer, the actuator configured to move relative to the introducer to move a distal end of the secondary catheter from a position within the introducer to a position outside a housing of the introducer past the catheter distal end; a lock disposed at the distal end of the introducer coupled to the proximal coupler of the connector; The catheter system of claim 10, comprising:

12. 12. The catheter system of claim 11, wherein the lock includes a pair of locking arms that engage the split bulkhead connector by snapping in between the first ring and the second ring.

13. 13. The catheter system of claim 12, wherein the primary lumen has a linear shape and the secondary catheter can be advanced linearly through the primary lumen when the blood collection device is coupled to the proximal coupler of the connector.

14. 12. The catheter system of claim 11, wherein the extension of the extension tip distal to the wedge of the catheter hub provides concentricity between the secondary catheter and the catheter.

15. The catheter system of claim 1 , wherein the catheter hub comprises an open peripheral intravenous catheter (PIVC) catheter hub.

16. a catheter having a distal catheter end and a proximal catheter end; a catheter hub configured to receive a portion of the catheter therein, the catheter hub comprising: a hub body having a hub distal end and a hub proximal end, the hub body having a cavity formed therein extending between the hub distal end and the hub proximal end; a hub port disposed at the hub proximal end, the hub port comprising a female Luer connection; a wedge disposed within the cavity adjacent the hub distal end, the wedge coupled to the catheter proximal end to retain the catheter to the catheter hub; a catheter hub comprising: a connector coupled to the catheter hub, the connector having a connector distal end and a connector proximal end, the connector including a male luer connection at the connector distal end configured to mate with the female luer connection; Including, The male luer connection includes an extended tip that extends into the cavity and substantially through the cavity and abuts the wedge.

17. 17. The catheter system of claim 16, wherein the male luer connection includes a collar disposed around a portion of the extended tip, the collar having a threaded inner surface configured to engage a threaded outer surface of the female luer connection.

18. The connector further comprises a proximal coupler disposed at the connector proximal end, the proximal coupler comprising: a proximal access port; a split septum connector coupled to the proximal access port, the split septum connector comprising a first ring and a second ring spaced laterally from the first ring; The catheter system of claim 16, comprising:

19. The catheter system further comprises a blood collection device coupleable to the proximal coupler of the connector, the blood collection device comprising: a secondary catheter; an introducer having proximal and distal ends and a top and bottom surface, the introducer defining an interior volume configured to movably receive the secondary catheter; an actuator movably coupled to the introducer, the actuator configured to move relative to the introducer to move a distal end of the secondary catheter from a position within the introducer to a position outside a housing of the introducer past the catheter distal end; a lock disposed at the distal end of the introducer coupled to the proximal coupler of the connector; 20. The catheter system of claim 18, comprising:

20. 20. The catheter system of claim 19, wherein the lock includes a pair of locking arms that engage the split bulkhead connector by snapping in between the first ring and the second ring.

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