Catheter system

Abstract

A catheter system is provided that includes a catheter and a first catheter adapter having an adapter body and adapter wings. The catheter body includes a distal port thereon, a proximal port, and a side port, where the catheter proximal end is secured to the distal port, and the side port includes a luer connection. The adapter wings are joined to the adapter body and include first and second flexible wings configured to contact each other when a clamping force is applied thereto. An extension tube is connected to the proximal port, and a second catheter adapter is connected to a proximal end of the extension tube. A blood extraction device is coupled to the side port and includes a flow tube configured to advance distally from the blood extraction device and through the first catheter adapter and into the catheter to perform blood extraction.

Description

Technical Field

[0001] The present invention generally relates to peripheral intravenous catheters (PIVCs) and, more particularly, to a passively actuated, safety-integrated PIVC having a pre-attached blood collection set and further including an access port that facilitates the attachment of additional devices for instrument delivery and / or administration of fluids. Background Art

[0002] Vascular access devices (VADs) are used in the medical field to access a patient's peripheral vasculature for the purpose of infusion therapy and / or blood withdrawal. One common type of vascular access device is a needle-on peripheral intravenous catheter. As its name implies, a "needle-on" peripheral intravenous catheter can be mounted on an introducer needle having a sharp distal tip. The sharp distal tip can be used to pierce the patient's skin and vasculature. Insertion of the peripheral intravenous catheter into the vasculature can be performed after the needle has pierced the vasculature. The needle and peripheral intravenous catheter are typically inserted into the patient's vasculature through the skin at a shallow angle, with the bevel of the needle facing away from the patient's skin. Once placement of the needle within the vasculature is confirmed, the clinician can temporarily occlude flow in the vasculature and withdraw the needle, leaving the peripheral intravenous catheter in place for future fluid infusions and / or blood withdrawals.

[0003] Figure 1 A peripheral intravenous catheter catheter system 10 known in the art is shown. According to a non-limiting embodiment, the catheter system 10 is a Ferghana intravenous (IV) catheter system available from Becton Dickinson & Company of Franklin Lakes, NJ. The catheter system 10 includes a catheter adapter (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 provided between the distal end 16 and the proximal end 14. A catheter 22 extends distally from the distal end 16 of the catheter adapter 12.

[0004] In some embodiments, the needle hub 24 can be removably coupled to the proximal end 14 of the catheter adapter 12. The catheter 22 can include an over-the-needle type catheter such that an introducer needle 26 can extend from the needle hub 24 and through the catheter 22 to insert the catheter system 10 into the patient's vasculature. In some embodiments, the catheter 22 and introducer needle 26 can be assembled such that the sharp proximal tip of the introducer needle 26 extends beyond the distal tip of the catheter 22.

[0005] like Figure 1As shown, the catheter system 10 also includes a blood extraction assembly 28 integrated therewith. The blood extraction assembly 28 may include an extension tube 30 having a distal end and a proximal end, the distal end being integral with the side port 20. An adapter 32, a connector 34, and a blood collection kit 36 ​​may be connected to the proximal end of the extension tube 30. The blood collection kit 36 ​​may include a body 38 and a needle 40 extending through the body 38, the needle 40 having a distal end and a sharp proximal end. The blood collection kit 36 ​​may also include an elastomeric sheath 42 connected to the body 38 and extending over the proximal end. In response to coupling a blood collection device to the blood collection kit 36, the proximal end of the needle 40 may pierce the sheath 42, the sheath 42 may be compressed toward 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 a BD available from Beckton Dickinson, Inc. of Franklin Lakes, New Jersey. Blood collection tubes.

[0006] Although catheter systems (e.g. Figure 1 The BD Ferghana intravenous (IV) catheter system) provides a way to collect blood samples from patients, but it will be recognized that there are limitations and / or disadvantages associated with current configurations of these catheter systems.

[0007] As an example, it is well known that peripheral intravenous catheters are often unable to aspirate blood within their intended indwelling time. That is, as the indwelling time increases, there is a possibility that flow through the peripheral intravenous catheter will be obstructed due to the formation of a thrombus or fibrin tail at the end of the catheter, which may partially or completely restrict flow into the catheter during aspiration. Although it is known in the art to use external devices or systems with some indwelling peripheral intravenous catheters to assist in withdrawing fluid blood directly from the indwelling catheter of the peripheral intravenous catheter (e.g., BD PIVO TM A blood drawing device that advances a flexible internal probe or flow tube through a peripheral intravenous catheter to (or beyond) the end of the catheter to collect a blood sample), but the configuration of the catheter system (e.g., the number of connectors or ports thereon) may inhibit or otherwise increase the difficulty of advancing the flow tube of the blood drawing device into and through the catheter adapter.

[0008] As another example, the configuration of the catheter system may result in blood residue forming in the catheter adapter (e.g., beneath a septum in the catheter adapter). Blood residue at this location may be difficult to flush out using a flushing 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 limits alternative connection points for performing flushing.

[0009] Therefore, a need exists for a catheter system that facilitates connection of a blood extraction device thereto and enables advancement of a fluid tube into an indwelling catheter. The catheter system also provides a plurality of ports or connections through which a fluid delivery device (and associated fluid flushing device) may be coupled to the catheter system. Summary of the Invention

[0010] The present invention provides a catheter system, comprising: a catheter including a distal end and a proximal end; and a catheter adapter including a distal end, a proximal end, and a side port assembly, the catheter adapter defining a lumen extending between the distal and proximal ends of the catheter adapter, wherein the proximal end of the catheter is secured to the distal end of the catheter adapter, and wherein the side port assembly is in fluid communication with the lumen. The catheter system also comprises: a blood extraction assembly connected to the catheter adapter and in fluid communication therewith, the blood extraction assembly including an extension tube having a distal end and a proximal end, the distal end of the extension tube being integrally formed with the side port assembly; an adapter-connector device connected to the proximal end of the extension tube; and a blood collection kit connected to the adapter-connector device and including a needle assembly and a housing, the blood collection kit being configured to receive a blood collection device thereon, wherein the needle assembly is inserted into the blood collection device. The side port assembly of the catheter adapter includes a first side port and a second side port, the first side port having an integral extension tube, the second side port branching from the first side port, the second side port including a Luer connection.

[0011] The present invention also provides a catheter system comprising a catheter and a catheter adapter, the catheter comprising a distal catheter end and a proximal catheter end, the catheter adapter comprising a distal port, a proximal port, and a side port, the body of the catheter adapter defining a lumen therein extending between the distal port and the proximal port, wherein the proximal catheter end is secured to the distal port of the catheter adapter, 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 end, the distal end of the first extension tube being connected to the side port; and a proximal port connector connected to the proximal end of the first extension tube, the proximal port connector comprising the distal port, the proximal port, and the side port. The catheter system also includes: a blood extraction assembly connected to the side port of the proximal connector, the blood extraction assembly including a second extension tube having a distal end and a proximal end, the distal end of the second extension tube being coupled to the side port of the proximal port connector; an adapter-connector device attached to the proximal end of the second extension tube; and a blood collection kit coupled to the adapter-connector device and including a needle assembly and a housing, the blood collection kit being configured to receive a blood collection device thereon, wherein the needle assembly is inserted into the blood collection device. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a perspective view of a catheter system known in the prior art;

[0013] Figure 2 is a perspective view of a catheter system including a catheter adapter and an integrated blood withdrawal assembly according to one aspect of the present disclosure;

[0014] Figure 3 According to one aspect of the present disclosure Figure 2 a catheter system wherein an instrument delivery device (e.g., a blood withdrawal device) is connected to the catheter system;

[0015] Figure 4 According to one aspect of the present disclosure Figure 2 a catheter system to which a fluid delivery device is connected;

[0016] Figure 5 is a perspective view of a catheter system including a catheter adapter and an integrated blood withdrawal assembly according to another aspect of the present disclosure;

[0017] Figure 6 According to one aspect of the present disclosure Figure 5 a catheter system wherein an instrument delivery device (e.g., a blood withdrawal device) is connected to the catheter system; and

[0018] Figure 7 According to one aspect of the present disclosure Figure 5 A catheter system to which the fluid delivery device is connected. DETAILED DESCRIPTION

[0019] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for practicing the present invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the present invention.

[0020] As used herein, the terms "proximal" and "distal" refer to directions closer to and farther from, respectively, a user who will bring the device into contact with a patient. Thus, for example, the end of the device that first contacts the patient's body would be the distal end, while the opposite end of the device (e.g., the end of the device that is manipulated by the user) would be the proximal end of the device.

[0021] Spatial or directional terms such as "left", "right", "inner", "outer", "above", "below", etc. should not be considered limiting as the invention can assume various alternative orientations.

[0022] For the purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall relate to the orientation of the present invention in the accompanying drawings. However, it will be understood that the present invention may assume various alternative variations unless expressly specified to the contrary. It will also be understood that the specific arrangements shown in the drawings and described in the following specification are merely exemplary aspects of the present invention.

[0023] The terms "first", "second", etc. do not refer to any particular order or temporal sequence, but rather to different states, properties or elements.

[0024] Reference Figure 2 , a non-limiting embodiment of a safe, integrated intravenous catheter system 100 (hereinafter referred to as "catheter system 100") for facilitating needle / catheter placement, blood withdrawal, and / or administration of flushing fluids is shown. The 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 a plurality of 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.

[0025] In some embodiments, the catheter 112 can include a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the needle hub 114 can be removably coupled to the proximal end 104 of the catheter adapter 102. In some embodiments, the catheter 112 can include an over-the-needle catheter such that an introducer needle 116 can extend from the needle hub 114 and through the catheter 112 to insert the catheter system 100 into the patient's vasculature. In some embodiments, the catheter 112 and introducer needle 116 can be assembled such that the sharp proximal tip of the introducer needle 116 extends beyond the distal tip of the catheter 112, with the bevel of the introducer needle 116 facing upward, away from the patient's skin.

[0026] In some embodiments, introducer needle 116 and catheter 112 can be inserted through the skin at a shallow angle into the patient's vasculature. In some embodiments, in response to introducer needle 116 and catheter 112 being inserted into the patient's vasculature, blood can flow through introducer needle 116 and into needle hub 114, and the blood can be visible within needle hub 114 to indicate to the user that introducer needle 116 is within the patient's vasculature.

[0027] The catheter system 100 also includes a blood withdrawal assembly 120 connected to and in fluid communication with the catheter adapter 102. The blood withdrawal assembly 120 includes an extension tube 122 having a distal end 124 and a proximal end 126, an adapter-connector device 128 coupled to the proximal end 126 of the extension tube 122, and a blood collection set 130 connected to the adapter-connector device 128.

[0028] Adapter-connector assembly 128 may include a (straight) adapter 132 and a connector 134. In some embodiments, in response to insertion of catheter 112 into the patient's vasculature, blood may flow through catheter 112, at least a portion of catheter adapter 102, extension tube 122, and into adapter-connector assembly 128. Connector 134 may be connected to a distal port 136 of adapter 132 (e.g., via a Luer connection) or may be integrally formed with distal port 136 as a single unit.

[0029] As described above, extension tube 122 may include distal end 124 integral with side port assembly 110 and proximal end 126 integral with adapter 132. In some embodiments, a clamping member, such as, for example, a clamp-on clip 138 or other suitable clamp, may be provided on extension tube 122 and configured to selectively clamp extension tube 122 to close the fluid path through extension tube 122. In some embodiments, clamp-on clip 138 may be replaced with any suitable clamp.

[0030] 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. Figure 2 Although not shown in detail, it should be appreciated that, as is known in the art, the needle assembly 140 of the blood collection kit 130 may include a body, a sharp needle extending proximally from the body, and an elastomeric sheath covering the sharp proximal end of the sharp needle.

[0031] In some embodiments, the housing 142 and blood collection set 130 can be pre-attached to the connector 134 and the catheter system 100. In some embodiments, the catheter system 100 can be assembled and provided with the housing 142 pre-attached to the connector 134. In other embodiments, the user can couple the blood collection set 130 to the connector 134.

[0032] like Figure 2As shown, the blood collection set 130 can be configured to receive a blood collection device 144, such as a blood collection tube. The blood collection device 144 can be connected to the blood collection set 130 via the needle assembly 140, for example, by the blood collection set 144 pushing the sheath distally toward the body, such that the sharp needle pierces the sheath, and the sharp proximal tip of the needle assembly 140 can be inserted into the blood collection set 144. In some embodiments, inserting the sharp proximal tip into the blood collection set 144 can couple the blood collection set 144 to the blood collection set 130. In some embodiments, after the catheter 112 is positioned within the vasculature, the blood collection set 144 can be coupled to the blood collection set 130, wherein blood flows into the blood collection set 144 due to the pressure differential between the vasculature and the blood collection set 144.

[0033] According to some aspects of the present disclosure, it will be appreciated that at various times and stages in the use of the catheter system 100, it may be desirable to connect one or more external devices to the catheter system 100. For example, Figure 3 and 4 As shown, 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. To accommodate the use and attachment of these devices, the catheter adapter 102 of the catheter system 100 is configured to include additional connection ports thereon (i.e., on the side port assembly 110), wherein such additional connection ports are positioned to enable the introduction and advancement of instruments (e.g., a guidewire, stylet, or fluid tube) into the indwelling catheter 112 and / or the injection of fluids into the catheter adapter 102 (e.g., for performing a fluid flush therewith).

[0034] According to some aspects of the present disclosure, and as Figure 2 as well as Figure 3 and 4 As shown, the side port assembly 110 of the 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 diverge from each other at a certain angle, which can be an acute angle (Y-connector type arrangement) or a right angle (T-connector type arrangement). The first side port 154 includes an extension tube 122 integral therewith to connect the blood withdrawal assembly 120 to the catheter adapter 102, while the second side port 156 provides connection of an external device to the catheter system 100. According to some aspects of the present disclosure, the second side port 156 of the catheter adapter includes a Luer connection 158 thereon, which provides connection of an external device to the catheter adapter 102. The second side port 156 can be, for example, a male Luer lock or a female Luer lock and / or any other suitable coupler, Figure 2The non-limiting embodiment of the present invention shows the second side port 156 as a female Luer connector. In some embodiments, a connector 160 can be coupled to the second side port 156. The connector 160 can include a needleless access connector (e.g., a split septum connector or a self-healing septum connector) to facilitate connection of external devices thereto.

[0035] like Figure 3 As shown, in some embodiments, the external device connected to the catheter system 100 (via the second side port 156) can include an instrument delivery device 150 in the form of a blood withdrawal device, which can be operated to introduce a flow tube through the catheter adapter 102 and into the patient's vasculature, wherein the flow tube can perform blood withdrawal. Figure 3 As shown, according to a non-limiting embodiment, an instrument delivery device 150 in the form of a blood withdrawal device includes at least a housing 260, a coupling or "lock" 262, a flow tube 264, and an actuator 266. As will be described in further detail below, the flow tube 264 is movable within the housing 260 to provide for its travel from a first position, or retracted position, within the housing 260 to a second position, or advanced position, outside the housing 260 so that its distal end can be guided into the catheter adapter and into or out through the indwelling catheter 212.

[0036] like Figure 3 As shown, the lock 262 of the instrument delivery device is configured to couple the instrument delivery device 150 in the form of a blood extraction device to the catheter system 100, for example, by engaging the lock 262 with the needleless access connector 160 disposed on the 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 an inner cavity (not shown) extending therethrough. The blunt cannula 268 is disposed between the pair of locking arms 270 and can have a length sufficient to extend through at least a portion of the needleless access connector 160 (i.e., the needleless access connector therethrough).

[0037] As described above, at least a portion of the flow tube 264 is movably disposed within the housing 260. The proximal end of the flow tube 264 is coupled to the actuator 266 such that when the actuator 266 moves relative to the housing 260, the flow tube 264 can move 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 portion of the flow tube 264 is at least partially positioned distal to the lock 262 and distal to the catheter adapter 102 (e.g., within the catheter 212 or exiting through the distal end of the catheter 112, as shown). Figure 3 shown).

[0038] like Figure 4 As shown, in some embodiments, the external device connected to the catheter system (via the second side port 156) may include a fluid delivery device 152 that is operable to dispense / inject fluid into the catheter adapter 102. Figure 4 As shown, according to a non-limiting embodiment, the fluid delivery device 152 is provided as a pre-filled syringe 152. The syringe 152 may include a luer connection 276 at its distal end that is configured to mate with a corresponding luer connection of the second side port 156 and / or the connector 160. With the plunger 278 of the syringe 152 in an initial partially retracted position, the syringe 152 may be actuated to force fluid (e.g., flushing fluid) out of the syringe 152 and into the catheter adapter 102, for example, for the purpose of performing a fluid flush thereof (e.g., to flush residual blood out of the adapter 102).

[0039] Advantageously, the configuration of catheter adapter 102, in which side port assembly 110 has a first side port 154 and a second side port 156 (with a Luer connection 158 and an optional connector 160), allows for connection of additional external devices to catheter adapter 102. That is, second side port 156 provides a dedicated port for connecting blood withdrawal device 150 thereto to collect a blood sample from a patient (separate from collecting a blood sample via blood withdrawal assembly 120) and / or for connecting fluid delivery device 152 to flush catheter adapter 102.

[0040] Now refer to Figure 5 , an additional embodiment of a safe, integrated intravenous (IV) catheter system 200 (hereinafter referred to as "catheter system 200") for facilitating needle / catheter placement, blood withdrawal, and / or administration of flushing fluids according to another embodiment of the present disclosure is shown. The 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.

[0041] In some embodiments, the catheter 212 can include a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, the needle hub 214 can be removably coupled to the proximal end 204 of the catheter adapter 202. In some embodiments, the catheter 212 can include an over-the-needle catheter such that an introducer needle 216 can extend from the needle hub 214 and through the catheter 212 to insert the catheter system 200 into the patient's vasculature. In some embodiments, the catheter 212 and the introducer needle 216 can 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 upward, away from the patient's skin.

[0042] In some embodiments, introducer needle 216 and catheter 212 can be inserted through the skin at a shallow angle into the patient's vasculature. In some embodiments, in response to introducer needle 216 and catheter 212 being inserted into the patient's vasculature, blood can flow through introducer needle 216 and into needle hub 214, and the blood can be visible within needle hub 214 to indicate to the user that introducer needle 216 is within the patient's vasculature.

[0043] Catheter system 200 also includes a blood withdrawal assembly 220 coupled to and in fluid communication with catheter adapter 202. Blood withdrawal assembly 220 includes an extension tube 222 having a distal end 224 and a proximal end 226, an adapter-connector assembly 228 coupled to proximal end 226 of extension tube 222, and a blood collection set 230 coupled to adapter-connector assembly 228.

[0044] Adapter-connector arrangement 228 can include a (straight) adapter 232 and a connector 234. In some embodiments, in response to insertion of catheter 212 into the patient's vasculature, blood can flow through catheter 212, at least a portion of catheter adapter 202, extension tube 222, and into adapter-connector arrangement 228. Connector 234 can be connected to a distal port 236 of adapter 232 (e.g., via a Luer connection) or can be integrally formed with distal port 236 as a single unit.

[0045] As described above, extension tube 222 can include a distal end 224 integral with side port assembly 210 and a proximal end 226 integral with adapter 232. In some embodiments, a clamp such as, for example, a clamp-type clamp 238 or another suitable clamp can be provided on extension tube 222 and configured to selectively clamp extension tube 222 to close the fluid path through extension tube 222. In some embodiments, clamp-type clamp 238 can be replaced with any suitable clamp.

[0046] 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 that may be configured to engage the connector 234. Figure 5 Although not shown in detail, it should be appreciated that, as is known in the art, the needle assembly 240 of the blood collection kit 230 may include a body, a sharp needle extending proximally from the body, and an elastomeric sheath covering the sharp proximal end of the sharp needle.

[0047] In some embodiments, the housing 242 and the blood collection set 230 can be pre-attached to the connector 234 and the catheter system 200. In some embodiments, the catheter system 200 can be assembled and provided with the housing 242 pre-attached to the connector 234. In other embodiments, the user can couple the blood collection set 230 to the connector 234.

[0048] like Figure 5 As shown, the blood collection set 230 can be configured to receive a blood collection device 244, such as a blood collection tube. The blood collection device 244 can be connected to the blood collection set 230 via a needle assembly 240, for example, by the blood collection set 244 pushing the sheath distally toward the body, causing the sharp needle to pierce the sheath, and the sharp proximal tip of the needle assembly 240 to be inserted into the blood collection set 244. In some embodiments, inserting the sharp proximal tip into the blood collection set 244 can couple the blood collection set 244 to the blood collection set 230. In some embodiments, the blood collection set 244 can be coupled to the blood collection set 230 after the catheter 212 is positioned within the vasculature, wherein blood flows into the blood collection set 244 due to a pressure differential between the vasculature and the blood collection set 244.

[0049] According to some aspects of the present disclosure, it can be recognized that at various times and stages in the use of the catheter system 200, it may be desirable to connect one or more external devices to the catheter system 200. For example, Figure 6 and 7 As shown, 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. To accommodate the use and attachment of these devices, the catheter adapter 202 of the catheter system 200 is configured to include a proximal port connector 246 that enables the introduction and advancement of instruments (e.g., a guidewire, stylet, or flow tube) into the indwelling catheter 212 and / or the injection of fluids into the catheter adapter 202, for example, to perform a fluid flush therewith.

[0050] According to some aspects of the present disclosure, and as Figure 5 as well as Figure 6 and Figure 7As shown, the proximal port connector 246 is disposed between the catheter adapter 202 and the blood extraction assembly 220. The proximal port connector 246 includes a distal end or distal port 248, a proximal end or proximal port 250, and a side port 252 disposed between the distal end and the proximal end / distal port and proximal port. The proximal port connector 246 includes a cavity (not shown) formed therethrough having any number of branches suitable for the type of connector, such as branches extending between the distal end and the proximal end of the proximal port connector 246 and branches disposed to the side port 252 of the proximal port connector 246. As a non-limiting example, the side port 252 can be disposed on the proximal port connector 246 such that the proximal port connector is configured as a T-connector (e.g., the side port 252 is disposed at a 90 degree angle relative to the longitudinal axis of the proximal port connector 246) or a Y-connector (e.g., the side port 252 is disposed at an angle of 15-85 degrees relative to the longitudinal axis of the proximal port connector 246). As shown Figure 5-7 As shown, extension tube 222 (ie, “second extension tube”) of blood withdrawal assembly 220 is connected to side port 252 of proximal port connector 246 .

[0051] In order to connect the proximal 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 can be formed of any suitable material known to those skilled in the art and can have a distal end and a proximal end. The distal end 250 of the first extension tube 254 is connected to the side port 210 of the catheter adapter 202, while the proximal end of the first extension tube 254 can be connected to the distal end 248 of the proximal port (near-patient) connector 246.

[0052] In some non-limiting embodiments or aspects, the proximal port connector 246 can include a needleless access connector 256 (e.g., a split septum connector or a self-healing septum connector) coupled to the proximal end 250 of the proximal port connector 246 , wherein the needleless access connector 256 provides a proximal patient access port to the catheter adapter 202 .

[0053] like Figure 6 As shown, in some embodiments, the external device connected to the catheter system 200 (via the proximal port connector 246, such as by a needleless access connector 256 disposed thereon) may include an instrument delivery device 150 in the form of a blood withdrawal device operable to introduce a flow tube through the catheter adapter 202 and into the patient's vasculature, wherein the flow tube is capable of withdrawing blood. Figure 6As shown, according to a non-limiting embodiment, an instrument delivery device 150 in the form of a blood withdrawal device includes at least a housing 260, a coupling or "lock" 262, a flow tube 264, and an actuator 266. As will be described in further detail below, the flow tube 264 is movable within the housing 260 to provide for its travel from a first or retracted position within the housing 260 to a second or advanced position outside the housing 260 so that its distal end can be guided into the catheter adapter 202 and into or out through the indwelling catheter 212.

[0054] like Figure 6 As shown, the lock 262 of the instrument delivery device 150 is configured to couple the instrument delivery device 150, which is in the form of a blood extraction device, to the catheter system 200, for example, by engaging the lock 262 with the needleless access connector 256 disposed on the proximal 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 an inner lumen (not shown) extending therethrough. The blunt cannula 268 is disposed between the pair of locking arms 270 and can have a length sufficient to extend through at least a portion of the connector 246 (i.e., through the needleless access connector 256 therethrough).

[0055] As described above, at least a portion of the flow tube 264 is movably disposed within the housing 260. The proximal end of the flow tube 264 is coupled to the actuator 266 such that the flow tube 264 can be moved between a first position and a second position when the actuator 266 is moved relative to the housing 260. In the first position, 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 in the second position, the distal 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 the catheter 212 or exiting through the distal end of the catheter 212, as shown). Figure 6 shown).

[0056] like Figure 7 As shown, in some embodiments, an external device connected to the catheter system 200 (via the proximal port connector 246, such as through a needleless access connector 256 disposed thereon) may include a fluid delivery device 152 operable to dispense / inject fluid into the catheter adapter 202. Figure 7As shown, according to a non-limiting embodiment, the fluid delivery device 152 is provided as a pre-filled syringe 152. The syringe 152 can include a luer connection 276 at its distal end that is configured to mate with the proximal end / proximal port of the proximal port connector 246 and / or the connector 256 thereon. With the plunger 278 of the syringe 152 in an initial partially retracted position, the syringe 152 can be actuated to force fluid (e.g., flushing fluid) out of the syringe 152 and into the catheter adapter 202, such as for the purpose of performing a fluid flush thereon (e.g., to flush residual blood out of the adapter 202).

[0057] Advantageously, this configuration of catheter system 200 having proximal port connector 246 (and needleless access connector 256) disposed between catheter adapter 202 and blood drawing assembly 220 (i.e., between first extension tube 254 and second extension tube 222) allows for connection of additional external devices to catheter system 200. That is, proximal port connector 246 provides a dedicated port for connecting blood drawing device 150 thereto for collecting a blood sample from a patient (separate from collecting a blood sample through blood drawing assembly 220) and / or for connecting fluid delivery device 152 for flushing catheter adapter 202.

[0058] Although the present disclosure has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments or aspects, it should be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. A catheter system comprising: a catheter, the catheter comprising a distal catheter end and a proximal catheter end; a catheter adapter comprising 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 of the catheter adapter, and wherein the side port assembly is in fluid communication with the lumen; and a blood withdrawal assembly connected to and in fluid communication with the catheter adapter, the blood withdrawal assembly comprising: an extension tube, the extension tube comprising a distal end and a proximal end, the distal end of the extension tube being integral with the side port assembly; an adapter-connector assembly attached to the proximal end of the extension tube; and a blood collection kit coupled to the adapter-connector device and comprising a needle assembly and a housing, the blood collection kit configured to receive a blood collection set thereon, wherein the needle assembly is inserted into the blood collection set; Wherein, the side port assembly of the catheter adapter comprises: a first side port, the extension tube being integrated with the first side port; and A second side port is branched from the first side port, wherein the second side port includes 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 to and engage the needleless access connector, the instrument delivery device comprising an instrument configured to travel distally from the instrument delivery device and out of the instrument delivery device and through the first catheter adapter into the catheter.

4. The catheter system of claim 3, wherein: The device delivery apparatus comprises: an introducer having a proximal end and a distal end and defining an interior volume configured to movably receive the instrument; an actuator movably coupled to the introducer, the actuator being configured to move relative to the introducer to move the distal end of the instrument from a position within the introducer to a position outside of the introducer housing and past the catheter distal end of the catheter; and A coupler is positioned at the distal end of the introducer and is 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 withdrawal device, wherein the instrument comprises 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 fluid.

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

8. The catheter system of claim 1, wherein: The blood collection device includes a blood collection tube.

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

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

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

12. The catheter system of claim 11, wherein: The device delivery apparatus comprises: an introducer having a proximal end and a distal end and defining an interior volume configured to movably receive the instrument; an actuator movably coupled to the introducer, the actuator being configured to move relative to the introducer to move the distal end of the instrument from a position within the introducer to a position outside of the introducer housing and past the catheter distal end of the catheter; and A coupler is positioned at the distal end of the introducer and is 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 withdrawal device, wherein the instrument comprises 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 fluid.

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

16. The catheter system of claim 9, wherein: The blood collection device includes a blood collection tube.

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