Blood suction connector for a vascular access system

Abstract

A vascular access system configured for delivering a tube or probe to a patient's vasculature, the vascular access system including a catheter adapter having a distal portion and a proximal portion, a catheter extending from the distal portion, and a septum assembly housed within the proximal portion, and a connector assembly. The connector assembly includes a connection interface configured to couple the connector assembly to the proximal portion of the catheter adapter, and a cannula. The cannula may be configured to extend through the septum assembly of the catheter adapter when the connector assembly is coupled to the proximal portion of the catheter adapter. The connector assembly also includes a proximal interface configured to couple to a blood aspiration device having an elongate core extending from its distal end.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the priority of Indian Provisional Application No. 202211040724, filed on July 15, 2022, entitled "Blood Aspiration Connector for a Vascular Access System", the entire disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Background of the Invention Field of the Invention The present disclosure generally relates to vascular access systems, such as, for example, a peripheral intravenous catheter (PIVC). More particularly, the present disclosure relates to a vascular access system having an add - on connector for improved compatibility with a blood aspiration and / or probe delivery device.

[0003] Description of the Related Art Catheters are commonly used to inject fluids into a patient's vascular system. For example, catheters may be used to inject normal saline, various pharmaceuticals, or total parenteral nutrition. Additionally, catheters may also be used to withdraw blood from a patient.

[0004] The catheter may be an over - the - needle peripheral intravenous catheter (PIVC). In this case, the catheter may be placed over an introducer needle having a sharp distal tip. The catheter and the introducer needle may 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 upward away from the patient's skin. The catheter and the introducer needle are generally inserted at a shallow angle from the skin into the patient's vascular system. After proper placement of the needle, the operator may temporarily occlude the flow of the vascular system, remove the needle, and leave the catheter in place (i.e., "indwell") for future blood withdrawal and / or infusion.

[0005] To complete blood aspiration from a PIVC having an indwelling catheter, for example, a blood aspiration device has been developed that is configured to overcome previous problems associated with blood aspiration via a PIVC, such as the possibility of catheter collapse and the reduction of blood flow due to debris accumulated on or within the catheter. One such device, the PIVO™ manufactured by Velano Vascular, is configured as a single-use device that is temporarily attached to the PIVC to aspirate a blood sample. Using an existing peripheral venous line as a conduit to the vascular system, the PIVO™ device advances a probe in the form of a flow tube through the PIVC beyond the catheter tip into the patient's vein to collect a blood sample. This flow tube extends beyond the suboptimal blood aspiration conditions around the indwelling line and is designed to reach a venous location where the blood flow is optimal for aspiration. When blood collection is complete, the flow tube is retracted and the device is removed from the PIVC and discarded.

[0006] In addition to blood aspiration devices such as the PIVO™ device described above, similar devices for advancing a probe (e.g., a nitinol wire, a guide wire, an instrument, an obturator, a rod, a wire with a fluid path, and / or a sensor) through an indwelling catheter into a patient's vascular system have also been developed. However, existing vascular access devices are generally not optimized for compatibility with these blood aspiration and / or probe delivery devices. For example, the tubes or probes of such devices are typically configured to access the indwelling catheter through a side port of the catheter adapter of the PIVC, which, due to the curved path of the side port, may increase the risk of unwanted hemolysis and / or bending of the tube or probe. Additionally, a separate needle-free connector (NFC) is generally required to enable compatibility between existing vascular access devices and, for example, the PIVO™ device. SUMMARY OF THE INVENTION

[0007] Accordingly, the present disclosure generally relates to a vascular access system configured to deliver a tube or probe to a patient's vasculature, the vascular access system including a catheter adapter having a distal portion and a proximal portion, a catheter extending from the distal portion, and a septum assembly housed within the proximal portion. The system also includes a connector assembly, the connector assembly including a coupling interface configured to couple the connector assembly to the proximal portion of the catheter adapter, a cannula configured such that the cannula extends through the septum assembly of the catheter adapter when the connector assembly is coupled to the proximal portion of the catheter adapter, and a proximal interface configured to couple the proximal interface to a blood aspiration device having an elongate core extending from its distal end.

[0008] In certain configurations, the vascular access system includes at least a portion of a cannula that is slidable within the connector assembly. The connector assembly may also include a biasing member configured to bias the cannula proximally within the connector assembly. The biasing member may be a steel spring. Optionally, the biasing member is a rubber bellows.

[0009] In certain configurations, the cannula may be configured to extend at least partially through an opening formed in the distal end portion of the connector assembly. In some embodiments, the vascular access system further includes an O-ring seal surrounding the opening formed in the distal end portion of the connector assembly. Optionally, the vascular access system further includes a split septum positioned at the proximal end portion of the connector assembly. The cannula may include a proximal interface surface configured to receive at least a portion of the distal end of the elongate core of the blood aspiration device when the blood aspiration device is coupled to the connector assembly.

[0010] In other configurations, the connection interface of the connector assembly includes a plurality of extensions that project from there to the end. The connector assembly includes a groove formed in its side wall, and the groove may be configured to receive the end ends of one or more clips of the connector member of the blood suction device. The cannula may be fixed and extend from the connection interface of the connector assembly to the end. In a particular configuration, the connector assembly also includes a slidable actuator disposed therein, and the actuator may be configured to selectively penetrate a split septum positioned within the body of the connector assembly.

[0011] In a particular embodiment, the proximal interface of the connector assembly may include a needleless connector. The proximal interface of the connector assembly may include a T-extension set.

[0012] According to a particular embodiment of the present invention, a connector assembly configured to be used with a vascular access system for delivering a tube or probe to a patient's vasculature includes a connection interface configured to connect the connector assembly to the proximal portion of a catheter adapter of the vascular access system, and a cannula, and the cannula is configured to selectively extend through the septum assembly of the catheter adapter. The system also includes a proximal interface, and the proximal interface may have an elongated core extending from its end end and be configured to connect to a blood suction device.

[0013] In a particular configuration, at least a portion of the cannula is slidable within the connector assembly. Optionally, the system includes a biasing member configured to bias the cannula proximally within the connector assembly. The cannula may be fixed and extend from the connection interface of the connector assembly to the end. The connector assembly includes a slidable actuator disposed therein, and the actuator may be configured to selectively penetrate a split septum positioned within the body of the connector assembly.

[0014] Further details and advantages of the present invention will become apparent upon reading the following detailed description in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0015]

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[0016] Description of Preferred Embodiments The following description is provided to enable those skilled 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 remain readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0017] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the invention as oriented in the drawings. However, it is to be understood that the invention may assume various alternative variations, unless explicitly specified to the contrary. Also, it is to be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0018] 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 aspiration or probe delivery device during preparation for use or during use, and the proximal end means the end closest to the user's hand. Similarly, in the present application, the terms "distally" and "distal to" mean the direction towards the connector portion of the fluid transfer device, and the terms "proximally" and "proximal to" mean the direction opposite to the direction of the connector.

[0019] Embodiments of the present disclosure will primarily be described in the context of a vascular access system including an integrated peripheral IV catheter (PIVC). Although not illustrated or described herein, it is to be understood that the connector assemblies described below may be utilized for blood aspiration and / or advancement of a probe via any suitable vascular access device, such as, for example, the BD NEXIVA (trademark) closed IV catheter system. However, the embodiments of the present disclosure extend equally to use with other catheter devices.

[0020] Referring to FIG. 1, a vascular access system 10 according to one aspect of the present disclosure is illustrated. The vascular access system 10 includes an integrated catheter adapter 12 having a catheter 20 extending distally from a distal end portion 21, and the catheter 20 is configured to be inserted into a patient's vasculature. As will be described in detail below, the vascular access system 10 further includes a connector assembly 16, a distal end portion of the connector assembly 16 being configured to be connectable to a proximal end portion 18 of the catheter adapter 12, and a proximal end portion of the connector assembly 16 being configured to be connectable to a blood aspiration device 14. The blood aspiration device 14 may be any suitable device capable of advancing a tube or probe therethrough for collection of a blood sample through the indwelling catheter 20. For example, in one embodiment, the blood aspiration device 14 may be a PIVO™ device manufactured by Velano Vascular. However, the blood aspiration device 14 according to the present disclosure is not so limited.

[0021] Still referring to FIG. 1, the catheter adapter 12 may include a pair of wing members 29, which may serve, for example, to assist in the deployment of the catheter 20, provide stabilization of the catheter adapter 12, and provide a larger surface area for dressing and securing the catheter adapter 12. A side port 23 may be provided, and the side port 23 may be in fluid communication with the catheter 20. Although not shown, in some embodiments, an extension set may be connected to the side port 23 to provide a fluid conduit for fluid injection, flushing, etc.

[0022] As described above, the blood suction device 14 is configured to selectively advance a tube or probe for the purpose of collecting a blood sample via the indwelling catheter 20. In the embodiment shown in FIG. 1, the blood suction device includes an elongated introduction unit main body 30 having an actuator 32 slidably disposed thereon. The actuator 32 is operably connected to a tube or probe (not shown), and the distal end movement of the actuator 32 causes the tube or probe to pass through the blood suction device 14, through the connector assembly 16, and through the catheter adapter 12 until the distal tip of the tube or probe reaches or exceeds the distal tip of the catheter 20 and the tube or probe functions as a conduit for collecting blood into a blood suction container (not shown) to which it is fluidly connected. The blood suction device 14 may further include a connector member 28 for connecting the blood suction device 14 to the proximal end portion 38 of the connector assembly 16. In some embodiments, the connector member 28 may be configured as an alligator clip member. However, it should be understood that the connector member 28 may be configured as any interface or device capable of connecting the blood suction device 14 to the connector assembly 16.

[0023] Referring now to FIGS. 2A - 2C, connector assembly 16 according to one aspect of the present disclosure is shown in more detail. Connector assembly 16 may include a primary housing 22 and a secondary housing 38, which may be connected by any suitable method such as, for example, welding, adhesives, screws, etc. However, in alternative embodiments, it should be understood that the primary housing 22 and the secondary housing 38 may be formed as a single member. Connector assembly 16 further includes a terminal connection interface 34 extending from the primary housing 22. In some embodiments, the terminal connection interface 34 includes a plurality of extensions 41 configured to snap fit into grooves or recesses 19 formed on the outer surface of the proximal portion 18 of the catheter adapter 12, thereby fixing the connector assembly 16 to the catheter adapter 12 and preventing rotation of the connector assembly 16 relative to the catheter adapter 12. However, it should be understood that the terminal connection interface 34 may utilize any suitable connection method for fixing the connector assembly 16 to the catheter adapter 12 and is not limited to the features shown and described herein.

[0024] The primary housing 22 and the secondary housing 38 are configured to slidably hold a cannula 36 therein, and the cannula 36 is selectively movable along the interior of the connector assembly 16. The cannula 36 extends from a beveled portion 39 to a distal end and includes a distal tip 37 that is capable of piercing, for example, a septum of a catheter adapter. The cannula 36 may be formed of a suitable material such as, for example, plastic, metal, etc.

[0025] Biasing members such as spring 34 are also provided inside the connector assembly 16. In the first configuration, spring 24 is configured to bias cannula 36 and bevel portion 39 in the proximal direction, such that only a small portion of cannula 36 and distal tip 37 extends from opening 44 formed near distal connection interface 34, and cannula 36 is substantially retained within connector assembly 16. However, as will be described in further detail below, in the second configuration, spring 24 is compressed such that a substantial portion of cannula 36 extends distally from connector assembly 16, allowing cannula 36 to extend through the septum of the catheter adapter.

[0026] In some embodiments, bevel portion 39 includes one or more vent openings (not shown) formed therein, and the one or more vent openings may be configured to reduce the resistance force of cannula 36 and bevel portion 39 due to air resistance during slidable movement within connector assembly 16. Further, an O-ring seal 45 may be positioned around (and distal to) opening 44 to provide a fluid-tight seal when connector assembly 16 is coupled to the catheter adapter. O-ring seal 45 may be formed of any suitable material such as, for example, rubber.

[0027] Referring further to FIGS. 2A - 2C, the connector assembly 16 further includes a split septum 40 positioned near its proximal end, which is configured to selectively seal the interior of the connector assembly 16 while being configured to provide selective access to the proximal interface surface 42 of the cannula 36 when a blood aspiration device is coupled to the connector assembly 16, as further described below. In some embodiments, the split septum 40 may be retained within the secondary housing 38 by an annular projection 27 formed at the proximal end of the secondary housing 38. However, it should be understood that the split septum 40 may be retained via any suitable method and is not limited to use with an annular projection 27 as shown in FIG. 2B.

[0028] In some embodiments, the connector assembly 16 may also include at least one groove 43 formed in its sidewall. The groove 43 may be sized and configured, for example, as shown in FIG. 1, to receive the distal ends of one or more clips of a connector member 28 for coupling the blood aspiration device 14 to the proximal portion 26 of the connector assembly 16. In some embodiments, the size and / or position of the groove 43 may be determined, for example, based on compatibility with a particular blood aspiration device such as the PIVO™ device described above.

[0029] Next, referring to FIGS. 3 and 4A - 4C, vascular access systems 10 of various configurations according to aspects of the present disclosure are illustrated. First, referring to FIG. 4A, the connector assembly 16 is initially coupled to the proximal portion 18 of the catheter adapter 12. Within the proximal portion 18, the catheter adapter 12 includes an internal cannister 49 that is configured to hold both a primary septum 46 and a secondary septum 47. The combined primary septum 46 and secondary septum 47 act to form a fluid seal for the proximal portion 18 of the catheter adapter 12 when not being punctured by a needle or cannula, thereby preventing the passage of fluid to or from the internal conduit 25 of the catheter adapter 12 through the primary septum 46 and / or the secondary septum 47. FIGS. 3 and 4A - 4C show the use of a two - piece primary septum 46 and secondary septum 47, but it should be understood that according to another aspect of the present disclosure, a single - piece (or more than two - piece) septum may be used.

[0030] As shown in FIG. 4A, when the connector assembly 16 is initially coupled to the proximal portion 18 of the catheter adapter 12, the O - ring seal 45 contacts the proximal end of the cannister 49, forming a substantially fluid - tight seal between the connector assembly 16 and the interior of the proximal portion 18. However, in this initial configuration, the cannula 36 is in an "idle" position, and the spring 24 acts to bias the cannula 36 proximally within the connector assembly 16 such that the distal tip 37 of the cannula 36 does not puncture or otherwise penetrate the primary septum 46, thereby maintaining fluid isolation between the internal conduit 25 of the catheter adapter 12 and the cannula 36.

[0031] However, referring to FIGS. 3 and 4B, when the blood aspiration device 14 is connected to the connector assembly 16, the elongated core 33 extending from the distal end of the blood aspiration device 14 is configured to penetrate the split septum 40 of the connector assembly 16, and the blunt distal tip of the elongated core 33 is configured to contact the proximal interface surface 42 of the cannula 36 to form a fluid passage from the cannula 36 to the blood aspiration device 14. When the elongated core 33 moves distally while connecting the blood aspiration device 14 to the connector assembly 16, the bevel portion 39 and the cannula 36 are correspondingly pushed distally, thereby compressing the spring 24 and enabling the cannula 36 to pierce the primary septum 46 and the secondary septum 47, thereby providing a fluid passage between the internal conduit 25 of the catheter adapter 12 and the cannula 36. In some embodiments, the proximal interface 42 may be configured to allow mating with blood aspiration devices and / or probe advancement devices having elongated cores of various diameters.

[0032] With a fluid path established between the blood aspiration device 14 and the catheter adapter 12 via the cannula 36, the operator may use the blood aspiration device 14 to advance the blood aspiration tube 35 through the elongated core 33, the cannula 36, the internal conduit 25, and into and / or beyond an indwelling catheter (not shown) extending from the catheter adapter 12, as shown in FIG. 4C. With the blood aspiration tube 35 in a forward position within the patient's vasculature, the operator may collect one or more blood samples via the blood aspiration device 14. When the blood aspiration procedure is complete, the operator may disconnect the blood aspiration device 14 from the connector assembly 16, thereby allowing the elongated core 33 to be withdrawn from the connector assembly 16 and enabling the spring 24 to bias the cannula 36 to the idle state shown in FIG. 4A. The connector assembly 16 may remain in this idle state until another blood aspiration device and / or other probe advancement device is connected thereto. Thus, the same connector assembly 16 can be actuated multiple times to provide multiple blood aspiration procedures from an indwelling catheter.

[0033] Using the connector assembly 16 shown and described above with respect to FIGS. 1-4C, a blood aspiration device may be fluidly coupled to the proximal portion 18 of the catheter adapter 12, which is substantially in-line with the indwelling catheter 20. This in-line configuration allows the blood aspiration tube of the blood aspiration device to enter the patient's vasculature along a substantially straight path, thereby avoiding the curved entry path of prior art devices configured to enter, for example, via the side port 23. The extension of the blood aspiration tube along this substantially straight path reduces the risk of tube kinking and / or hemolysis of the blood sample. Further, the use of the connector assembly 16 does not require modification of existing catheter adapters 12, blood aspiration devices 14, and / or any extension sets coupled thereto.

[0034] Next, referring to FIG. 5, a connector assembly 50 according to another aspect of the present disclosure is shown. The connector assembly 16 described above with respect to FIGS. 1-4C utilized a spring 24 to bias the cannula 36 proximally when in the idle state, whereas the connector assembly 50 utilizes a rubber bellows 52 to apply a similar biasing force to the bevel portion 39 of the cannula 36. It should be understood that the present disclosure is not limited to the use of a spring or rubber bellows, and any suitable biasing means may be utilized within the connector assembly.

[0035] Referring now to FIGS. 6A - 6C, a connector assembly 64 according to another aspect of the present disclosure is shown. Unlike the connector assembly 16 described above that includes a slidable cannula 36 configured to selectively pierce the septum portion of the catheter adapter 12 to provide a fluid connection between the connector assembly 16 and the catheter adapter 12, the connector assembly 64 includes a fixed cannula 69 extending from the distal end portion of the body 68, and the fixed cannula 69 is configured to penetrate the septum portion of a catheter adapter (not shown) when the connector assembly 64 is coupled to the proximal end portion of the catheter adapter. The connector assembly 64 includes a connection interface 70 configured to secure the connector assembly to the proximal end portion of the catheter adapter, similar to the connection interface 34 described above with respect to FIGS. 1 - 4C.

[0036] The connector assembly 64 further includes a proximal interface 56 configured to receive a connector member of a blood aspiration device such that an elongate core (not shown) of the blood aspiration device can enter the conduit 57 of the connector assembly 64. In some embodiments, the proximal interface 56 is a luer connection.

[0037] Further, an actuator member 72 is provided within a conduit 57, and the actuator member 72 is biased in the proximal direction via a spring 74. A split septum 55 is positioned at the distal end portion of the conduit 57, and the split septum 55 can be selectively opened and closed by the distal end portion of the actuator member 72. More specifically, when a blood suction device is connected to the connector assembly 64, the elongated core of the blood suction device is configured to contact the actuator member 72 and presses the actuator member 72 against the force of the spring 74 until the distal end portion of the actuator member 72 pierces the split septum 55. When the actuator member 72 completely pierces the split septum 55, the actuator member 72 has a channel formed therethrough and provides fluid communication between the fixed cannula 69 and a blood suction device (not shown) connected to the connector assembly 64. A tube or probe of the blood suction device may then be advanced through the connector assembly 64 and a catheter adapter (not shown) to which it is attached to perform a blood suction procedure. When the blood suction procedure is completed, the blood suction device is disconnected from the proximal interface 56 of the connector assembly 64, thereby retracting the elongated core of the blood suction device and causing the spring 74 to bias the actuator member 72 in the proximal direction to close the split septum 55 again, and thus, close the fluid communication between the catheter adapter and the actuator member 72.

[0038] In some embodiments, the connector assembly 64 may include an end cap 58, which may be positioned over the proximal interface 56 when the blood suction device is not in use. Additionally and / or alternatively, a cannula cover 59 may also be provided to cover and protect the fixed cannula 69 prior to insertion into the catheter adapter. Further, in some embodiments, the body 68 of the connector assembly 64 includes one or more grooves formed thereon, and the one or more grooves may be configured to receive the distal end portions of clips of the connecting members of the blood suction device, for example.

[0039] Shown with respect to FIGS. 6A - 6C, using the connector assembly 64 described above, the blood aspiration device is fluidly connected to the proximal portion of the catheter adapter, which may be substantially in - line with the indwelling catheter. This in - line configuration allows the blood aspiration tube of the blood aspiration device to enter the patient's vasculature along a substantially straight - line path, thereby avoiding the curved entry path of prior - art devices.

[0040] Next, referring to FIGS. 7A and 7B, a needle - free connector assembly 60 according to another aspect of the present disclosure is shown. The needle - free connector assembly 60 includes the connector assembly 64 described above with respect to FIGS. 6A and 6B, but further includes a needle - free connector 62. In some embodiments, the needle - free connector 62 may be configured, for example, as a BD Q - Syte™ needle - free connector of Becton, Dickinson and Co. The needle - free connector 62 may include a distal interface portion 65 extending distally from a body 66 and a proximal interface portion 67 extending proximally from the body 66. In some embodiments, the distal interface portion 65 may be configured as a male Luer connector, while the proximal interface portion 67 may be configured as a female Luer connector having a split septum seal formed therein.

[0041] Referring to FIGS. 7B and 7C, the needleless connector assembly 60 is configured to be used with a blood aspiration device 80. Unlike the blood aspiration devices described above with respect to FIGS. 1-6C, which were configured to be used with a blood aspiration device having an alligator clip type connecting member, the blood aspiration device 80 includes a male luer lock connecting member 82, which is configured to connect to the proximal interface portion 67. The blood aspiration device 80 further includes an introduction portion body 81 and an elongated core 84 extending distally from the male luer lock connecting member 82. As shown in FIG. 7B, when the blood aspiration device 80 is connected to the needleless connector assembly 60, the elongated core 84 opens the split septum seal, passes through the male luer lip 75 of the distal interface portion 65, contacts the actuator 72 and moves distally, such that the blood aspiration device 80 is configured to be in fluid communication with the fixed cannula 69 and thus a catheter adapter (not shown).

[0042] Due to the presence of the needleless connector 62, the needleless connector assembly 60 may advantageously be cleaned by conventional cleaning methods and also provides an effective seal against backflow of blood. Further, the needleless connector 62 is sterilizable prior to first use and between each use, helping to prevent contamination of the sample and / or introduction of contaminants.

[0043] Figure 8 shows a needleless connector assembly 90 according to another aspect of the present disclosure. Similar to the needleless connector assembly 60 described above with respect to FIGS. 7A and 7B, the needleless connector assembly 90 includes the connector assembly 64 described above with respect to FIGS. 6A and 6B, and further includes a needleless connector 92. In some embodiments, the needleless connector 92 may be configured as, for example, a BD SmartSite™ needleless connector from Becton, Dickinson and Co. The needleless connector 92 may include a distal interface portion 94 and a proximal interface portion 95. Similar to the needleless connector assembly 60 described above, the needleless connector assembly 90 may also be cleaned by conventional cleaning methods and provides an effective seal against blood backflow. Further, the needleless connector 92 is sterilizable before first use and between each use, helping to prevent sample contamination and / or ingress of contaminants.

[0044] Referring now to FIG. 9, a needleless connector assembly 100 according to another aspect of the present disclosure is shown. The needleless connector assembly 100 includes the connector assembly 64 described above with respect to FIGS. 6A and 6B, and further includes a T-extension set 102 coupled to the proximal end portion of the connector assembly 64. The T-extension set 102 includes a proximal connector portion 105 that can receive the elongate core of a blood aspiration device, such as a PIVO™ device. Similar to the needleless connector assemblies described above with respect to FIGS. 7A - 8, the T-extension set 102 is configured such that the elongate core of the blood aspiration device passes therethrough and engages the actuator 72 to provide fluid communication with the cannula 69. The T-extension set 102 also includes an extension tube 104 extending from its lateral surface, and the proximal end portion of the extension tube 104 is coupled to a connector 106. In some embodiments, a clamp 108 may be provided on the extension tube 104 to allow selective occlusion of the fluid flow through the extension tube 104. The extension tube 104 and the connector 106 allow for peripheral fluid injection (e.g., cleaning fluid injection) into the T-extension set 102 and the connector assembly 64.

[0045] Next, referring to FIGS. 10A - 10C, a needleless connector assembly 110 according to another aspect of the present disclosure is shown. Different from the connector assemblies described herein with respect to FIGS. 1 - 9, the needleless connector assembly 110 does not utilize a slide actuator or a slide cannula, but instead selectively forms a fluid path between a catheter adapter and a blood aspiration device. The needleless connector assembly 110 includes a connector body 115, which has a connection interface 118 and a fixed cannula 117 extending distally therefrom. Although not shown, the connection interface 118 is configured to secure the needleless connector assembly 110 to the proximal portion of a catheter adapter, and the fixed cannula 117 is sized and configured to pass through a septum configuration in the proximal portion of the catheter adapter so as to form a passage between an indwelling catheter and the needleless connector assembly 110. The proximal portion 116 of the connector body 115 is connected to a connection portion 114. In some embodiments, the connection portion 114 may be configured, for example, as a BD Q - Syte (trademark) needleless connector of Becton, Dickinson and Co. The connection portion 114 includes a proximal interface portion 112, which may be configured as a female Luer connector having a split septum seal 113 formed therein.

[0046] As shown in FIG. 10C, when the blood suction device 80 is connected to the needleless connector assembly 110, the elongated core 84 of the blood suction device is configured to open the split septum seal 113 and pass through the internal channel 111 of the connector body 115. Further, the distal tip portion of the elongated core 84 is also configured to pass through the pre-perforated septum 119 positioned within the internal channel 111, thereby providing a conduit between the fixed cannula 117 and the blood suction device 80. In this way, a tube or probe (not shown) of the blood suction device 80 can be advanced through the needleless connector assembly 110, a catheter adapter (not shown), and an indwelling catheter (not shown) to enable blood suction. After the blood collection procedure, the blood suction device 80 can be disconnected from the proximal interface portion 112 and the elongated core 84 retracted so that both the pre-perforated septum 119 and the split septum seal 113 may be closed until another blood suction device is connected thereto.

[0047] The needleless connector assembly 110 is configured to provide an effective seal against blood backflow when the blood suction device is not connected thereto. Further, the needleless connector assembly 110 is disinfectable prior to first use and between each use to help prevent sample contamination and / or ingress of contaminants and may be primed after connection to the catheter adapter.

[0048] Next, referring to FIGS. 11A - 11C, a connector assembly 120 according to another aspect of the present disclosure is shown. Similar to the needleless connector assembly 110 described above with respect to FIGS. 10A - 10C, the connector assembly 120 does not utilize a slide actuator or a slide cannula and selectively forms a channel between the catheter adapter and the blood aspiration device. The connector assembly 120 includes a connector body 122, and the connector body 122 has a connection interface 125 for connecting the connector assembly 120 to the proximal portion of a catheter adapter (not shown). In some embodiments, the connection interface 125 may include a plurality of extensions 126, and the extensions 126 are configured to snap fit into grooves or recesses formed on the outer surface of the proximal portion of a catheter adapter (not shown), thereby fixing the connector assembly 120 to the catheter adapter and preventing rotation of the connector assembly 120 relative to the catheter adapter.

[0049] The connector assembly 120 further includes a fixed cannula 124 extending distally therefrom. Although not shown, the connection interface 125 is configured to fix the connector assembly 120 to the proximal portion of the catheter adapter, and the fixed cannula 124 is sized and configured to pass through a septum configuration of the proximal portion of the catheter adapter to form a passage between the indwelling catheter and the connector assembly 120. Rather than a split septum seal or other seal features, the connector assembly 120 may alternatively utilize a removable end cap 128, and an inner portion 130 of the end cap 128 is configured to selectively seal an inner channel 131 of the connector body 122.

[0050] When a blood suction device (not shown) is connected to the connector assembly 120, the end cap 128 may be removed, thereby exposing the internal channel 131 of the connector body. The blood suction device may then be connected to the connector assembly, for example, via a clip engagement with a groove 123 formed on the connector body 122. The elongated core of the blood suction device is configured to pass through the internal channel 131 of the connector body 122, and the distal tip portion of the elongated core can also pass through a pre-perforated septum 127 positioned within the internal channel 131, thereby providing a conduit between the fixed cannula 124 and the blood suction device. In this way, a tube or probe (not shown) of the blood suction device can be advanced through the connector assembly 120, a catheter adapter (not shown), and an indwelling catheter (not shown) to enable blood suction. After the blood suction procedure, the blood suction device can be disconnected from the connector body 122, thereby allowing the elongated core to be retracted, and the pre-perforated septum 127 may be closed until another blood suction device is connected thereto. The end cap 128 may be repositioned on the connector body 122 during the blood suction procedure. Additionally and / or alternatively, a cannula cover 129 may be provided to cover and protect the fixed cannula 124 prior to insertion into the catheter adapter.

[0051] Next, referring to FIGS. 12A and 12B, a connector assembly 140 according to another aspect of the present disclosure is illustrated. Similar to the needleless connector assembly 110 described above with respect to FIGS. 10A - 10C, the connector assembly 140 does not utilize a slide actuator or a slide cannula and selectively forms a channel between the catheter adapter and the blood suction device. The connector assembly 140 includes a connector body 146, and the connector body 146 has a connection interface 145 for connecting the connector assembly 140 to the proximal portion of a catheter adapter (not shown). In some embodiments, the connection interface 145 may include a plurality of extensions 147 configured to snap fit into grooves or recesses formed on the outer surface of the proximal portion of a catheter adapter (not shown), thereby fixing the connector assembly 140 to the catheter adapter and preventing rotation of the connector assembly 140 relative to the catheter adapter.

[0052] The connector assembly 140 further includes a fixed cannula 148 extending distally therefrom. Although not shown, it should be understood that the connection interface 145 is configured to fix the connector assembly 140 to the proximal portion of the catheter adapter, and the fixed cannula 148 is sized and configured to pass through the septum configuration of the proximal portion of the catheter adapter to form a passage between the indwelling catheter and the connector assembly 140.

[0053] Furthermore, the connector assembly 140 includes a needleless connector 142, which can be removably coupled to the connector body 146. In some embodiments, the needleless connector 142 may be configured as, for example, the BD Q-Syte (trademark) needleless connector of Becton, Dickinson and Co. However, it should be understood that any suitable needleless connector may be used, such as, for example, the BD SmartSite (trademark) needleless connector of Becton, Dickinson and Co. The needleless connector 142 has a proximal interface portion 143, and the proximal interface portion 143 may be configured as a female Luer connector having a split septum seal 144 formed therein.

[0054] Referring to FIG. 12B, the needleless connector 142 is configured to be used with a blood aspiration device 80, which includes a male Luer lock connecting member 82 and an elongated core 84 extending distally from the male Luer lock connecting member 82. As shown in FIG. 12B, when the blood aspiration device 80 is coupled to the needleless connector 142, the elongated core 84 is configured to open the split septum seal 144 and pass through the male Luer lip 149 of the distal interface portion. Further, the distal tip portion of the elongated core 84 is also configured to pass through a pre-perforated septum 150 positioned within the internal channel of the connector body, thereby providing a conduit between the fixed cannula 148 and the blood aspiration device 80. In this way, a tube or probe (not shown) of the blood aspiration device 80 can be advanced through the connector assembly 140, a catheter adapter (not shown), and an indwelling catheter (not shown) to enable blood aspiration. After the blood aspiration procedure, the blood aspiration device 80 can be detached from the proximal interface portion 143, whereby the elongated core 84 is retracted and both the pre-perforated septum 150 and the split septum seal 144 may be closed until another blood aspiration device is coupled thereto.

[0055] The connector assembly 140 is configured to provide an effective seal against blood backflow when the blood suction device is not connected thereto. Further, the connector assembly 140 is sterilizable before the first use and between each use, helping to prevent contamination of the sample and / or ingress of contaminants.

[0056] Next, referring to FIG. 13, a needleless connector assembly 160 according to another aspect of the present disclosure is shown. The needleless connector assembly 160 includes a connector body 162, and the connector body 162 has a connection interface 165 for connecting the connector assembly 162 to the proximal end portion of a catheter adapter (not shown). The connector assembly 162 further includes a fixed cannula 164 extending therefrom to the end. Although not shown, the connection interface 165 is configured to fix the needleless connector assembly 160 to the proximal end portion of the catheter adapter, and the fixed cannula 164 is sized and configured to pass through the septum configuration of the proximal end portion of the catheter adapter so as to form a passage between the indwelling catheter and the needleless connector assembly 160.

[0057] The needleless connector assembly 160 further includes a T-extension set 168 connected to the proximal end portion of the connector body 162. The T-extension set 168 includes a proximal connector portion 169 that can receive the elongated core of a blood suction device such as, for example, a PIVO™ device. The T-extension set 168 is configured such that the elongated core of the blood suction device passes therethrough and enters an internal channel 167 formed within the connector body, and at least the distal end portion of the elongated core also passes through a pre-perforated septum 166 positioned within the internal channel, thereby providing fluid communication with the fixed cannula 164. When the blood suction device is disconnected from the T-extension set 168, the elongated core is withdrawn and the septum 166 seals again, thereby acting as a backflow prevention valve to shield the distal end portion of the catheter (not shown) from experiencing potential backflow originating from the needleless configuration of the proximal connector portion 169.

[0058] The T-extension set 168 also includes an extension tube 170 extending from its side surface, and the proximal end portion of the extension tube 170 is connected to a connector 172. In some embodiments, a clamp 174 may be provided on the extension tube 170 to enable selective occlusion of the fluid flow through the extension tube 170. The extension tube 170 and the connector 172 allow for peripheral fluid injection (e.g., wash fluid injection) into the T-extension set 168 and the connector body 162.

[0059] Although some embodiments of the connectors for use with a catheter adapter and a blood suction device for blood suction procedures during catheterization have been described in the foregoing detailed description, those skilled in the art can make modifications and changes to these embodiments without departing from the scope and spirit of the present invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The present invention described herein is defined by the appended claims, and all changes to the present invention that fall within the meaning and scope of equivalence of the claims are included within its scope.

Claims

1. A vascular access system configured for delivering a tube or probe into a patient's vasculature, the vascular access system comprising: A catheter adapter having a distal portion and a proximal portion, a catheter extending from the distal portion, and a septum assembly housed within the proximal portion; and A connector assembly, the connector assembly comprising: A connection interface configured to couple the connector assembly to the proximal portion of the catheter adapter; A cannula configured to extend through the septum assembly of the catheter adapter when the connector assembly is coupled to the proximal portion of the catheter adapter; and A proximal interface configured to couple to a blood suction device having an elongate core extending from its distal end, The connector assembly comprising The vascular access system comprising

2. The vascular access system according to claim 1, wherein at least a portion of the cannula is slidable within the connector assembly.

3. The vascular access system according to claim 2, wherein the connector assembly further comprises a biasing member configured to bias the cannula proximally within the connector assembly.

4. The vascular access system according to claim 3, wherein the biasing member is a steel spring.

5. The vascular access system according to claim 3, wherein the biasing member is a rubber bellows.

6. The vascular access system according to claim 2, wherein the cannula is configured to extend at least partially through an opening formed in a distal end portion of the connector assembly.

7. The vascular access system according to claim 6, further comprising an O-ring seal surrounding the opening formed in the distal end portion of the connector assembly.

8. The vascular access system according to claim 2, further comprising a split septum positioned at a proximal end portion of the connector assembly.

9. The cannula comprises a proximal interface surface, and the proximal interface surface is configured to receive at least a portion of the distal end portion of the elongated core of the blood suction device when the blood suction device is connected to the connector assembly. The vascular access system according to claim 2.

10. The connection interface of the connector assembly comprises a plurality of extensions protruding from there to the distal end. The vascular access system according to claim 1.

11. The connector assembly further comprises a groove formed in its side wall, and the groove is configured to receive the distal end portions of one or more clips of the connector member of the blood suction device. The vascular access system according to claim 1.

12. The cannula is fixed and extends distally from the connection interface of the connector assembly. The vascular access system according to claim 1.

13. The connector assembly further comprises a slidable actuator disposed therein, and the actuator is configured to selectively pierce a split septum positioned within the body of the connector assembly. The vascular access system according to claim 12.

14. The proximal interface of the connector assembly comprises a needleless connector. The vascular access system according to claim 1.

15. The proximal interface of the connector assembly comprises a T-extension set. The vascular access system according to claim 1.

16. A connector assembly configured to be used with a vascular access system for delivering a tube or probe to a patient's vascular system, the connector assembly comprising a connection interface configured to connect the connector assembly to the proximal portion of the catheter adapter of the vascular access system, a cannula, the cannula being configured to selectively extend through the septum assembly of the catheter adapter, and a proximal interface, the proximal interface being configured to connect to a blood suction device having an elongated core extending from its distal end portion, The connector assembly comprising.

17. The connector assembly according to claim 16, wherein at least a part of the cannula is slidable within the connector assembly. **Claim 18** The connector assembly according to claim 17, further comprising a biasing member configured to bias the cannula towards its proximal end within the connector assembly. **Claim 19** The connector assembly according to claim 16, wherein the cannula is fixed and extends distally from the connection interface of the connector assembly. **Claim 20** The connector assembly according to claim 19, further comprising a slidable actuator disposed therein, the actuator being configured to selectively pierce a split septum positioned within the body of the connector assembly.

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