Iv catheter system with pre-attached blood collection set and added near-patient access port

Abstract

A catheter system is provided that includes a catheter and a first catheter adapter having an adapter body and an adapter wing. The catheter body includes distal, proximal and side ports thereon, with the catheter proximal end secured to the distal port and the side port comprising a luer connection. The adapter wing is joined to the adapter body and includes first and second flexible wings configured to be brought into contact with each other when a pinching force is applied thereto. An extension tube is connected to the proximal port and a second catheter adapter is connected to the proximal end of the extension tube. A blood draw device is coupled to the side port and includes a flow tube configured to be advanced distally out from the blood draw device and through the first catheter adapter and into the catheter to perform a blood draw.

Description

IV CATHETER SYSTEM WITH PRE-ATTACHED BLOOD COLLECTION SET AND ADDED NEAR-PATIENT ACCESS PORTCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to Chinese Patent Application No. 202410288208.1 entitled “A Catheter System” filed March 13, 2024, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present disclosure relates generally to peripheral intravenous catheters (PIVCs) and, more particularly, to passively activated, safety integrated PIVCs with pre-attached blood collection sets and that further include access ports for facilitating attachment of additional devices for instrument delivery and / or fluid administration.Background of the Invention

[0003] Vascular access devices (VADs) are used in the medical field to access peripheral vasculature of a patient for purposes of infusion therapy and / or blood withdrawal. A common type of VAD is an over-the-needle peripheral intravenous catheter (PIVC). As its name implies, the “over-the-needle” PIVC may be mounted over an introducer needle having a sharp distal tip. The sharp distal tip may be used to pierce skin and the vasculature of the patient. Insertion of the PIVC into the vasculature may follow the piercing of the vasculature by the needle. The needle and the PIVC are generally inserted at a shallow angle through the skin into the vasculature of the patient with a bevel of the needle facing away from the skin of the patient. Once placement of the needle within the vasculature has been confirmed, a clinician may temporarily occlude flow in the vasculature and withdraw the needle, leaving the PIVC in place for future fluid infusion and / or blood withdrawal.

[0004] A PIVC catheter system 10 as known in the prior art is shown in FIG. 1, with the catheter system 10 being a Ferghana IV catheter system available from Becton Dickinson & Company of Franklin Lakes, N J, according to a non-limiting embodiment. The catheter system 10 includes a catheter hub 12 having a proximal end 14, a distal end 16, and a lumen 18 extending therebetween. In some embodiments, a side port 20 may be disposed betweenthe distal end 16 and the proximal end 14. A catheter 22 extends distally from the distal end 16 of the catheter adapter 12.

[0005] In some embodiments, a needle hub 24 may be removably coupled to the proximal end 14 of the catheter adapter 12. The catheter 22 may include an over-the-needle catheter such that an introducer needle 26 may extend from the needle hub 24 and through the catheter 22 to insert the catheter system 10 into the vasculature of the patient. In some embodiments, the catheter 22 and the introducer needle 26 may be assembled such that the sharp proximal tip of the introducer needle 26 extends beyond the distal tip of the catheter 22.

[0006] As shown in FIG. 1, the catheter system 10 also includes a blood draw assembly 28 integrated therewith. The blood draw assembly 28 may include an extension tube 30 having a distal end and a proximal end, with the distal end integrated with the side port 20. An adapter 32, connector 34, and blood collection set 36 may be coupled to the proximal end of the extension tube 30. The blood collection set 36 may include a body 38 and a needle 40 extending through the body 38, with the needle 40 having a distal end and a sharpened proximal tip. The blood collection set 36 may also include an elastomeric sheath 42 coupled to the body 38 and extending over the proximal tip. In response to coupling a blood collection device to the blood collection set 36, the proximal tip of needle 40 may pierce the sheath 42, the sheath 42 may be compressed towards the body 38, and the needle 40 may be inserted into the blood collection device. In some embodiments, the blood collection device may include a blood collection tube or the BD VACUTAINER® Blood Collection Tube, available from Becton Dickinson & Company of Franklin Lakes, N.J.

[0007] While catheter systems such as the BD Ferghana IV catheter system of FIG. 1 provide for collection of a blood sample from a patient, it is recognized that there are limitations and / or drawbacks associated with the current configuration of such catheter systems.

[0008] As one example, it is well known that PIVCs are often not able to aspirate blood for their intended dwell time. That is, with a prolonged dwell time, there is a potential for impeded flow through the PIVC, with this being due to thrombus or fibrin tails forming at the catheter tip that may partially or fully restrict flow into the catheter during aspiration. While it is known in the art to use an external device or system with some indwelling PIVCs to aid in fluid blood withdrawal directly from the indwelling catheter of the PIVC (e.g., a BD PIVO™ blood draw device, which advances a flexible, internal probe or flow tube through the PIVC to (or beyond) the catheter tip to collect a blood sample), the configuration of the catheter system (e.g., the number of connections or ports thereon) may inhibit or otherwise increase the difficulty of advancing a flow tube of a blood draw device into and through the catheter hub.Attorney Docket No. 09846-2500931 (P-29345.WO01)

[0009] As another example, the configuration of the catheter system can lead to blood residues forming in the catheter adapter (e.g., under a septum in the catheter adapter). The blood residue in this position may be difficult to wash away with a flush product connected to the luer port at the proximal end of the adapter, and the lack of additional connections or ports in the catheter system limit alternative connection points for performing a flushing.

[0010] Accordingly, a need exists for a catheter system that facilitates the connection of a blood draw device thereto and enables advancement of a flow tube into the indwelling catheter. The catheter system would also provide numerous ports or connections, whereby a fluid delivery device (and associated fluid flushings) could be coupled to the catheter system. SUMMARY OF THE INVENTION

[0011] Provided herein is a catheter system that includes a catheter comprising a catheter distal end and a catheter proximal end, and a catheter adapter including a distal end, a proximal end, and a side port assembly, the catheter adapter defining a lumen therein extending between the distal end and the proximal end, wherein the catheter proximal end is secured to the distal end, and wherein the side port assembly is in fluid communication with the lumen. The catheter system also includes a blood draw assembly connected to the catheter adapter and in fluid communication therewith, the blood draw assembly comprising an extension tube comprising a distal end and a proximal end, the distal end of the extension tube integrated with the side port assembly, an adapter-connector arrangement attached to the proximal end of the extension tube, and a blood collection set coupled to the adapter-connector arrangement and comprising a needle assembly and a housing, the blood collection set configured to receive a blood collection device thereon, with the needle assembly being inserted into the blood collection device. The side port assembly of the catheter adapter comprises a first side port having the extension tube integrated therewith and a second side port branched out from the first side port, the second side port comprising a luer connection.

[0012] Also provided herein is a catheter system that includes a catheter comprising a catheter distal end and a catheter proximal end, and a catheter adapter including a distal port, a proximal port, and a side port, the adapter body defining a lumen therein extending between the distal port and the proximal port, wherein the catheter proximal end is secured to the distal port, and wherein the side port is in fluid communication with the lumen. The catheter system also includes a first extension tube comprising a distal end and a proximal 62I6653.DOCX Page 3 of 18Attorney Docket No. 09846-2500931 (P-29345.WO01) end, the distal end of the first extension tube connected to the side port, and a near-port connector coupled to the proximal end of the first extension tube, the near-port connector comprising a distal port, a proximal port, and a side port. The catheter system further includes a blood draw assembly connected to the side port of the near-port connector, the blood draw assembly comprising a second extension tube comprising a distal end and a proximal end, the distal end of the second extension tube coupled to the side port of the near-port connector, an adapter-connector arrangement attached to the proximal end of the second extension tube, and a blood collection set coupled to the adapter-connector arrangement and comprising a needle assembly and a housing, the blood collection set configured to receive a blood collection device thereon, with the needle assembly being inserted into the blood collection device. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 is a perspective view of a catheter system, as known in the prior art;

[0014] FIG. 2 is a perspective view of a catheter system including a catheter adapter and integrated blood draw assembly, in accordance with an aspect of the disclosure;

[0015] FIG. 3 illustrates the catheter system of FIG. 2, with an instrument delivery device (e.g., blood draw device) connected thereto, in accordance with an aspect of the disclosure;

[0016] FIG. 4 illustrates the catheter system of FIG. 2, with fluid delivery device connected thereto, in accordance with an aspect of the disclosure;

[0017] FIG. 5 is a perspective view of a catheter system including a catheter adapter and integrated blood draw assembly, in accordance with another aspect of the disclosure;

[0018] FIG. 6 illustrates the catheter system of FIG. 5, with an instrument delivery device (e.g., blood draw device) connected thereto, in accordance with an aspect of the disclosure; and

[0019] FIG. 7 illustrates the catheter system of FIG. 5, with fluid delivery device connected thereto, in accordance with an aspect of the disclosure. DESCRIPTION OF THE INVENTION

[0020] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, 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 invention. 62I6653.DOCX Page 4 of 18Attorney Docket No. 09846-2500931 (P-29345.WO01)

[0021] As used in this specification, the words "proximal" and "distal" refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device (e.g., the end of the device being manipulated by the user) would be the proximal end of the device.

[0022] Spatial or directional terms, such as “left”, “right”, “inner”, “outer”, “above”, “below”, and the like, are not to be considered as limiting as the invention can assume various alternative orientations.

[0023] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention.

[0024] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0025] Referring to FIG. 2, shown is a non-limiting embodiment of a safety integrated IV catheter system 100 (hereafter “catheter system 100”) for facilitating needle / catheter placement, blood draw, and / or administering of flushing fluids. Catheter system 100 may include a catheter adapter 102, which may include a proximal end 104, a distal end 106, and a lumen 108 extending therebetween. A side port assembly 110 is disposed between the distal end 106 of the catheter adapter 102 and the proximal end 104 of the catheter adapter 102, and includes multiple side ports thereon, as explained in further detail below. In these and other embodiments, a catheter 112 may extend distally from the distal end 106 of the catheter adapter 102.

[0026] In some embodiments, the catheter 112 may include a peripheral intravenous catheter, a peripherally-inserted central catheter, or a midline catheter. In some embodiments, a needle hub 114 may be removably coupled to the proximal end 104 of the catheter adapter 102. In some embodiments, the catheter 112 may include an over-the-needle catheter such that an introducer needle 116 may extend from the needle hub 114 and through the catheter 112 to insert the catheter system 100 into the vasculature of the patient. In some embodiments, the catheter 112 and the introducer needle 116 may be assembled such that the sharp proximal tip 62I6653.DOCX Page 5 of 18Attorney Docket No. 09846-2500931 (P-29345.WO01) of the introducer needle 116 extends beyond the distal tip of the catheter 112, with the bevel of the introducer needle 116 facing up away from skin of the patient.

[0027] In some embodiments, the introducer needle 116 and the catheter 112 may be inserted at a shallow angle through the skin into the vasculature of the patient. In some embodiments, in response to the introducer needle 116 and the catheter 112 being inserted into the vasculature of the patient, blood may flow through the introducer needle 116 and into the needle hub 114, and the blood may be visible within the needle hub 114 to indicate to a user that the introducer needle 116 is within the vasculature of the patient.

[0028] The catheter system 100 also includes a blood draw assembly 120 connected to the catheter adapter 102 and in fluid communication therewith. The blood draw assembly 120 includes an extension tube 122 comprising a distal end 124 and a proximal end 126, an adapter-connector arrangement 128 attached to the proximal end 126 of the extension tube 122, and a blood collection set 130 coupled to the adapter-connector arrangement 128.

[0029] The adapter-connector arrangement 128 may include a (straight) adapter 132 and a connector 134. In some embodiments, in response to the catheter 112 being inserted into the vasculature of the patient, blood may flow through the catheter 112, at least a portion of the catheter adapter 102, the extension tube 122, and into the adapter-connector arrangement 128. The connector 134 may be connected to a distal port 136 of the adapter 132 (such as via a luer connection) or may be monolithically formed as a single unit with the distal port 136.

[0030] As indicated above, the extension tube 122 may include a distal end 124 integrated with the side port assembly 110 and a proximal end 126 integrated with the adapter 132. In some embodiments, a clamp, such as, for example, a pinch clamp 138 or another suitable clamp, may be disposed on the extension tube 122 and configured to selectively clamp the extension tube 122 to close a fluid path through the extension tube 122. In some embodiments, the pinch clamp 138 may be replaced with any suitable clamp.

[0031] In some embodiments, the connector 134 may include a proximal end configured to receive the blood collection set 130. Some embodiments of the blood collection set 130 may include a needle assembly 140 and a housing 142, which may be configured to engage the connector 134. While not shown in detail in FIG. 2, it is recognized that, as known in the art, the needle assembly 140 of the blood collection set 130 may include a body, a sharp needle extending proximally from the body, and an elastomeric sheath covering a sharp proximal tip of the sharp needle.

[0032] In some embodiments, the housing 142 and the blood collection set 130 may be pre- attached to the connector 134 and the catheter system 100. In some embodiments, the catheter 62I6653.DOCX Page 6 of 18Attorney Docket No. 09846-2500931 (P-29345.WO01) system 100 may be assembled and provided with the housing 142 pre-attached to the connector 134. In other embodiments, the user may couple the blood collection set 130 to the connector 134.

[0033] As shown in FIG.2, the blood collection set 130 may be configured to receive a blood collection device 144 such as a blood collection tube, for example. The blood collection device 144 may be connected to the blood collection set 130 via needle assembly 140, such as by the blood collection device 144 pushing a sheath distally towards the body so that the sharp needle pierces the sheath and the sharp proximal tip of the needle assembly 140 may be inserted into the blood collection device 144. In some embodiments, inserting the sharp proximal tip into the blood collection device 144 may couple the blood collection device 144 to the blood collection set 130. In some embodiments, the blood collection device 144 may be coupled to the blood collection set 130 after the catheter 112 is positioned within the vasculature, with blood flowing into the blood collection device 144 due to a pressure differential between the vasculature and the blood collection device 144.

[0034] According to aspects of the disclosure, it is recognized that at various times and stages of use of catheter system 100, it may be desired to connect one or more external devices to the catheter system 100. For example, as shown in FIGS. 3 and 4, according to various embodiments, it may be desirable to connect an instrument delivery device 150 or a fluid delivery device 152 to the catheter system 100. In order to provide for use and attachment of such devices, the catheter adapter 102 of system 100 is configured to include additional connection ports thereon (i.e., on side port assembly 110), with such connection ports located to enable introduction and advancement of an instrument (e.g., a guidewire, probe, or flow tube) into the indwelling catheter 112 and / or injection of a fluid into the catheter adapter 102, such as for performing a fluid flushing thereof.

[0035] According to aspects of the disclosure, and as shown in FIG. 2 and also in FIGS. 3 and 4, the side port assembly 110 of catheter adapter 102 is formed to include a first side port 154 and a second side port 156. In some embodiments, the first side port 154 and the second side port 156 branch off from one another at an angle, which may be an acute angle (a Y- connector type arrangement) or a right angle (a T-connector type arrangement). The first side port 154 includes the extension tube 122 integrated therewith, to connect the blood draw assembly 120 to the catheter adapter 102, while the second side port 156 provides for connection of an external device to the catheter system 100. According to aspects of the disclosure, the second side port 156 of catheter adapter comprises a luer connection 158 thereon that provides for connection of an external device to the catheter adapter 102. The 62I6653.DOCX Page 7 of 18Attorney Docket No. 09846-2500931 (P-29345.WO01) second side port 156 can be, for example, a male or female luer lock and / or any other suitable coupler, with the non-limiting embodiment of FIG. 2 illustrating the second side port 156 as a female luer connector. In some embodiments, a connector 160 may be coupled to the second side port 156. The connector 160 may include a needleless access connector therein (e.g., a split-septum connector or self-healing septum connector) to facilitate connection of an external device thereto.

[0036] As shown in FIG. 3, in some embodiments, the external device connected to the catheter system 100 (via second side port 156) may comprise an instrument delivery device 150 in the form of a blood draw device that may be operated to introduce a flow tube through the catheter adapter 102 and into the vasculature of a patient, with the flow tube enabling a blood draw. As shown in FIG. 3, according to a non-limiting embodiment, the blood draw device 150 includes at least a housing 260, a coupling device or “lock” 262, a flow tube 264, and an actuator 266. As will be described in further detail below, the flow tube 264 is moveable within the housing 260 so as to provide for advancement thereof from a first or retracted position inside the housing 260 to a second or advanced position outside of the housing 260, such that a distal end thereof may be routed into the catheter adapter and into or out past the indwelling catheter 212.

[0037] As shown in FIG.3, the lock 262 of the instrument delivery device 200 is configured to couple the blood draw device 150 to the catheter system 100, such as by lock 262 engaging with needleless access connector 160 provided on second side port 156. In some embodiments, the lock 262 has a blunt cannula 268 and a pair of locking arms 270. In addition, the lock 262 defines a lumen (not shown) extending therethrough The blunt cannula 268 is disposed between the pair of locking arms 270 and may have a length that is sufficient to extend through at least a portion of the connector 160 (i.e., through the needleless access connector therein).

[0038] As described above, at least a portion of the flow tube 264 is movably disposed within the housing 260. A proximal end of the flow tube 264 is coupled to the actuator 266 such that, when the actuator 266 is moved relative to the housing 260, the flow tube 264 may be moved between a first position, in which the flow tube 264 is disposed within the housing 260 (e.g., the entire flow tube 264 is disposed within the housing 260 or within the housing 260 and the lock 262) and a second position, in which the distal end portion of the flow tube 264 is at least partially disposed in a position distal to the lock 262 and distal to the catheter adapter 102 (e.g., within catheter 212 or out past a distal tip of catheter 112, as is shown in FIG. 3).

[0039] As shown in FIG. 4, in some embodiments, the external device connected to the catheter system (via second side port 156) may comprise a fluid delivery device 152 that may 62I6653.DOCX Page 8 of 18Attorney Docket No. 09846-2500931 (P-29345.WO01) be operated to dispense / inject a fluid into the catheter adapter 102. As shown in FIG. 4, according to a non-limiting embodiment, fluid delivery device 152 is provided as pre-filled syringe 152. The syringe 152 may include a luer connection 276 at the distal tip thereof that is configured to mate with a corresponding luer connection of the second side port 156 and / or with connector 160. With a plunger 278 of the syringe 152 in an initial partially retracted position, the syringe 152 may be actuated to force a fluid (e.g., flushing fluid) out from the syringe 152 and into the catheter adapter 102, such as for purposes of performing a fluid flushing thereof (e.g., to flush residual blood out from adapter 102).

[0040] Beneficially, the configuration of the catheter adapter 102 – with a side port assembly 110 having a first side port 154 and a second side port 156 (with a luer connection 158 and optional connector 160) allows for the connection of additional external devices to the catheter adapter 102. That is, the second side port 156 provides a dedicated port for connection of a blood draw device 150 thereto for collection of a blood sample from a patient (separate from collection of a blood sample by blood draw assembly 120) and / or for connection of a fluid delivery device 152 for flushing of the catheter adapter 102.

[0041] Referring now to FIG. 5, shown is an additional embodiment of a safety integrated IV catheter system 200 (hereafter “catheter system 200”) for facilitating needle / catheter placement, blood draw, and / or administering of flushing fluids, in accordance with another embodiment of the disclosure. Catheter system 200 may include a catheter adapter 202, which may include a proximal end 204, a distal end 206, and a lumen 208 extending therebetween. A side port 210 is disposed between the distal end 206 of the catheter adapter 202 and the proximal end 204 of the catheter adapter 202. In these and other embodiments, a catheter 212 may extend distally from the distal end 206 of the catheter adapter 202.

[0042] In some embodiments, the catheter 212 may include a peripheral intravenous catheter, a peripherally-inserted central catheter, or a midline catheter. In some embodiments, a needle hub 214 may be removably coupled to the proximal end 204 of the catheter adapter 202. In some embodiments, the catheter 212 may include an over-the-needle catheter such that an introducer needle 216 may extend from the needle hub 214 and through the catheter 212 to insert the catheter system 200 into the vasculature of the patient. In some embodiments, the catheter 212 and the introducer needle 216 may be assembled such that the sharp proximal tip of the introducer needle 216 extends beyond the distal tip of the catheter 212, with the bevel of the introducer needle 216 facing up away from skin of the patient.

[0043] In some embodiments, the introducer needle 216 and the catheter 212 may be inserted at a shallow angle through the skin into the vasculature of the patient. In some embodiments, 62I6653.DOCX Page 9 of 18Attorney Docket No. 09846-2500931 (P-29345.WO01) in response to the introducer needle 216 and the catheter 212 being inserted into the vasculature of the patient, blood may flow through the introducer needle 216 and into the needle hub 214, and the blood may be visible within the needle hub 214 to indicate to a user that the introducer needle 216 is within the vasculature of the patient.

[0044] The catheter system 200 also includes a blood draw assembly 220 connected to the catheter adapter 202 and in fluid communication therewith. The blood draw assembly 220 includes an extension tube 222 comprising a distal end 224 and a proximal end 226, an adapter-connector arrangement 228 attached to the proximal end 226 of the extension tube 222, and a blood collection set 230 coupled to the adapter-connector arrangement 228.

[0045] The adapter-connector arrangement 228 may include a (straight) adapter 232 and a connector 234. In some embodiments, in response to the catheter 212 being inserted into the vasculature of the patient, blood may flow through the catheter 212, at least a portion of the catheter adapter 202, the extension tube 222, and into the adapter-connector arrangement 228. The connector 234 may be connected to a distal port 236 of the adapter 232 (such as via a luer connection) or may be monolithically formed as a single unit with the distal port 236.

[0046] As indicated above, the extension tube 222 may include a distal end 224 integrated with the side port assembly 210 and a proximal end 226 integrated with the adapter 232. In some embodiments, a clamp, such as, for example, a pinch clamp 238 or another suitable clamp, may be disposed on the extension tube 222 and configured to selectively clamp the extension tube 222 to close a fluid path through the extension tube 222. In some embodiments, the pinch clamp 238 may be replaced with any suitable clamp.

[0047] In some embodiments, the connector 234 may include a proximal end configured to receive the blood collection set 230. Some embodiments of the blood collection set 230 may include a needle assembly 240 and a housing 242, which may be configured to engage the connector 234. While not shown in detail in FIG. 2, it is recognized that, as known in the art, the needle assembly 240 of the blood collection set 230 may include a body, a sharp needle extending proximally from the body, and an elastomeric sheath covering a sharp proximal tip of the sharp needle.

[0048] In some embodiments, the housing 242 and the blood collection set 230 may be pre- attached to the connector 234 and the catheter system 200. In some embodiments, the catheter system 200 may be assembled and provided with the housing 242 pre-attached to the connector 234. In other embodiments, the user may couple the blood collection set 230 to the connector 234. 62I6653.DOCX Page 10 of 18Attorney Docket No. 09846-2500931 (P-29345.WO01)

[0049] As shown in FIG.5, the blood collection set 230 may be configured to receive a blood collection device 244 such as a blood collection tube, for example. The blood collection device 244 may be connected to the blood collection set 230 via needle assembly 240, such as by the blood collection device 244 pushing a sheath distally towards the body so that the sharp needle pierces the sheath and the sharp proximal tip of the needle assembly 240 may be inserted into the blood collection device 244. In some embodiments, inserting the sharp proximal tip into the blood collection device 244 may couple the blood collection device 244 to the blood collection set 230. In some embodiments, the blood collection device 244 may be coupled to the blood collection set 230 after the catheter 212 is positioned within the vasculature, with blood flowing into the blood collection device 244 due to a pressure differential between the vasculature and the blood collection device 244.

[0050] According to aspects of the disclosure, it is recognized that at various times and stages of use of catheter system 200, it may be desired to connect one or more external devices to the catheter system 200. For example, as shown in FIGS. 6 and 7, according to various embodiments, it may be desirable to connect an instrument delivery device 150 or a fluid delivery device 152 to the catheter system 200. In order to provide for use and attachment of such devices, the catheter adapter 202 of system 200 is configured to include a near-port connector 246 that enables introduction and advancement of an instrument (e.g., a guidewire, probe, or flow tube) into the indwelling catheter 212 and / or injection of a fluid into the catheter adapter 202, such as for performing a fluid flushing thereof.

[0051] According to aspects of the disclosure, and as shown in FIG. 5 and also in FIGS. 6 and 7, the near-port connector 246 is provided between the catheter adapter 202 and the blood draw assembly 220. Near-port connector 246 includes a distal end or port 248, a proximal end or port 250, and a side port 252 arranged between the distal and proximal ends / ports. The near- port connector 246 includes a lumen (not shown) formed therethrough, having any number of branches suitable for the type of connector, such as a branch extending between distal and proximal ends of near-port connector 246 and a branch provided to side port 252 of the near- port connector 246. The side port 252 may be arranged on near-port connector 246 such that the connector is configured as a t-connector (e.g., side port 252 arranged at a 90 degree angle relative to a longitudinal axis of near-port connector 246) or a y-connector (e.g., side port 252 arranged at a 15-85 degree angle relative to a longitudinal axis of near-port connector 246), as non-limiting examples. As shown in FIGS.5-7, the extension tube 222 (i.e., “second extension tube”) of blood draw assembly 220 is coupled to the side port 252 of the near-port connector 246. 62I6653.DOCX Page 11 of 18Attorney Docket No. 09846-2500931 (P-29345.WO01)

[0052] To connect the near-port connector 246 to the catheter adapter 202, a first extension tube 254 is provided that extends from the side port 210. The first extension tube 254 may be formed of any suitable material known to those of skill in the art and may have a distal end and a proximal end. The distal end 250 of first extension tube 254 is coupled to side port 210 of catheter adapter 202, while the proximal end of first extension tube 254 may be coupled to the distal end 248 of near-patient connector 246.

[0053] In some non-limiting embodiments or aspects, near-port connector 246 may include a needleless access connector 256 (e.g., a split-septum connector or self-healing septum connector) coupled to the proximal end 250 of near-port connector 246, with the needleless access connector 256 providing a near-patient access port to the catheter adapter 202.

[0054] As shown in FIG. 6, in some embodiments, the external device connected to the catheter system 200 (via near-port connector 246, such as through needleless access connector 256 provided thereon) may comprise an instrument delivery device 150 in the form of a blood draw device that may be operated to introduce a flow tube through the catheter adapter 202 and into the vasculature of a patient, with the flow tube enabling a blood draw. As shown in FIG. 6, according to a non-limiting embodiment, the blood draw device 150 includes at least a housing 260, a coupling device or “lock” 262, a flow tube 264, and an actuator 266. As will be described in further detail below, the flow tube 264 is moveable within the housing 260 so as to provide for advancement thereof from a first or retracted position inside the housing 260 to a second or advanced position outside of the housing 260, such that a distal end thereof may be routed into the catheter adapter 202 and into or out past the indwelling catheter 212.

[0055] As shown in FIG.6, the lock 262 of the instrument delivery device 200 is configured to couple the blood draw device 150 to the catheter system 200, such as by lock 262 engaging with needleless access connector 256 provided on near-port connector 246. In some embodiments, the lock 262 has a blunt cannula 268 and a pair of locking arms 270. In addition, the lock 262 defines a lumen (not shown) extending therethrough The blunt cannula 268 is disposed between the pair of locking arms 270 and may have a length that is sufficient to extend through at least a portion of the connector 246 (i.e., through the needleless access connector 256 therein).

[0056] As described above, at least a portion of the flow tube 264 is movably disposed within the housing 260. A proximal end of the flow tube 264 is coupled to the actuator 266 such that, when the actuator 266 is moved relative to the housing 260, the flow tube 264 may be moved between a first position, in which the flow tube 264 is disposed within the housing 260 (e.g., the entire flow tube 264 is disposed within the housing 260 or within the housing 260 and the 62I6653.DOCX Page 12 of 18Attorney Docket No. 09846-2500931 (P-29345.WO01) lock 262) and a second position, in which the distal end portion of the flow tube 264 is at least partially disposed in a position distal to the lock 262 and distal to the catheter adapter 202 (e.g., within catheter 212 or out past a distal tip of catheter 212, as is shown in FIG. 6).

[0057] As shown in FIG. 7, in some embodiments, the external device connected to the catheter system 200 (via near-port connector 246, such as through needleless access connector 256 provided thereon) may comprise a fluid delivery device 152 that may be operated to dispense / inject a fluid into the catheter adapter 202. As shown in FIG. 7, according to a non- limiting embodiment, fluid delivery device 152 is provided as pre-filled syringe 152. The syringe 152 may include a luer connection 276 at the distal tip thereof that is configured to mate with the proximal end / port of near-port connector 246 and / or with connector 256 thereon. With a plunger 278 of the syringe 152 in an initial partially retracted position, the syringe 152 may be actuated to force a fluid (e.g., flushing fluid) out from the syringe 152 and into the catheter adapter 202, such as for purposes of performing a fluid flushing thereof (e.g., to flush residual blood out from adapter 202).

[0058] Beneficially, the configuration of the catheter system 200 – with a near-port connector 246 (and needleless access connector 256) provided between catheter adapter 202 and blood draw assembly 220 (i.e., between first extension tube 254 and second extension tube 222), allows for the connection of additional external devices to the catheter system 200. That is, the near-port connector 246 provides a dedicated port for connection of a blood draw device 150 thereto for collection of a blood sample from a patient (separate from collection of a blood sample by blood draw assembly 220) and / or for connection of a fluid delivery device 152 for flushing of the catheter adapter 202.

[0059] Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose 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 that are within the spirit and scope of the appended claims. For example, it is to 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. 62I6653.DOCX Page 13 of 18

Claims

CLAIMSTHE INVENTION CLAIMED IS1. A catheter system comprising: a catheter comprising a catheter distal end and a catheter proximal end; a catheter adapter including a distal end, a proximal end, and a side port assembly, the catheter adapter defining a lumen therein extending between the distal end and the proximal end, wherein the catheter proximal end is secured to the distal end, and wherein the side port assembly is in fluid communication with the lumen; and a blood draw assembly connected to the catheter adapter and in fluid communication therewith, the blood draw assembly comprising: an extension tube comprising a distal end and a proximal end, the distal end of the extension tube integrated with the side port assembly; an adapter-connector arrangement attached to the proximal end of the extension tube; and a blood collection set coupled to the adapter-connector arrangement and comprising a needle assembly and a housing, the blood collection set configured to receive a blood collection device thereon, with the needle assembly being inserted into the blood collection device; wherein the side port assembly of the catheter adapter comprises: a first side port having the extension tube integrated therewith; and a second side port branched out from the first side port, the second side port comprising a luer connection.

2. The catheter system of claim 1, further comprising a needleless access connector coupled to the second side port, the needleless access connector configured to engage the luer connection of the second side port.

3. The catheter system of claim 2, further comprising an instrument delivery device configured to couple with and engage the needleless access connector, the instrument delivery device comprising an instrument configured to be advanced distally out from the instrument delivery device and through the first catheter adapter and into the catheter.

4. The catheter system of claim 3, wherein the instrument delivery device comprises:an introducer having a proximal end and a distal end, and defining an inner volume configured to movably receive the instrument; an actuator movably coupled to the introducer, the actuator configured to move relative to the introducer to move a distal end of the instrument from a position within the introducer to a position outside the introducer housing and past a catheter distal end of the catheter; and a coupler positioned at the distal end of the introducer and configured to engage the needleless access connector, the coupler comprising a blunt cannula and a pair of locking arms.

5. The catheter system of claim 3, wherein the instrument delivery device comprises a blood draw device, with the instrument comprising a flow tube.

6. The catheter system of claim 1, further comprising a fluid delivery device connected to the luer connection of the second side port and configured to dispense / inject a fluid.

7. The catheter system of claim 6, wherein the fluid delivery device comprises a pre-filled syringe including another luer connection at the distal tip thereof coupleable with the luer connection on the second side port.

8. The catheter system of claim 1, wherein the blood collection device comprises a blood collection tube.

9. A catheter system comprising: a catheter comprising a catheter distal end and a catheter proximal end; a catheter adapter including a distal port, a proximal port, and a side port, the adapter body defining a lumen therein extending between the distal port and the proximal port, wherein the catheter proximal end is secured to the distal port, and wherein the side port is in fluid communication with the lumen; a first extension tube comprising a distal end and a proximal end, the distal end of the first extension tube connected to the side port; a near-port connector coupled to the proximal end of the first extension tube, the near-port connector comprising a distal port, a proximal port, and a side port; anda blood draw assembly connected to the side port of the near-port connector, the blood draw assembly comprising: a second extension tube comprising a distal end and a proximal end, the distal end of the second extension tube coupled to the side port of the near-port connector; an adapter-connector arrangement attached to the proximal end of the second extension tube; and a blood collection set coupled to the adapter-connector arrangement and comprising a needle assembly and a housing, the blood collection set configured to receive a blood collection device thereon, with the needle assembly being inserted into the blood collection device.

10. The catheter system of claim 9, further comprising a needleless access connector coupled to the proximal port of the near-port connector.

11. The catheter system of claim 10, further comprising an instrument delivery device configured to couple with and engage the needleless access connector, the instrument delivery device comprising an instrument configured to be advanced distally out from the instrument delivery device and through the first catheter adapter and into the catheter.

12. The catheter system of claim 11, wherein the instrument delivery device comprises: an introducer having a proximal end and a distal end, and defining an inner volume configured to movably receive the instrument; an actuator movably coupled to the introducer, the actuator configured to move relative to the introducer to move a distal end of the instrument from a position within the introducer to a position outside the introducer housing and past a catheter distal end of the catheter; and a coupler positioned at the distal end of the introducer and configured to engage the needleless access connector, the coupler comprising a blunt cannula and a pair of locking arms.

13. The catheter system of claim 11, wherein the instrument delivery device comprises a blood draw device, with the instrument comprising a flow tube.

14. The catheter system of claim 9, further comprising a fluid delivery device connected to the luer connection of the second side port and configured to dispense / inject a fluid.

15. The catheter system of claim 14, wherein the fluid delivery device comprises a pre-filled syringe including another luer connection at the distal tip thereof coupleable with the luer connection on the second side port.

16. The catheter system of claim 9, wherein the blood collection device comprises a blood collection tube.

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