Vascular Access Device with Septum Access Blood Suction System

Abstract

A system for aspirating blood including a catheter adapter having a catheter and a side inlet defining a fluid passageway into and out of the catheter. The system also includes a proximal-patient access port member having a main branch having a distal end connectable to the side inlet and a proximal end having a needle access connector connected thereto. The system further includes a blood aspirating device removably connectable to the proximal-patient access port member, the blood aspirating device including a cannula configured to penetrate the needle access connector, a flow tube configured to be advanced and retracted through the cannula, and a tube advancement tab connected to the flow tube and configured to linearly advance and retract the flow tube through the cannula, such that the flow tube may be selectively directed through the blood aspirating device, the proximal-patient access port member, and the catheter adapter.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application Serial No. 63 / 301,749, entitled "Vascular Access Device with Septum Access Blood Aspiration System," filed on January 21, 2022, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] FIELD OF THEINVENTION The present disclosure relates generally to vascular access devices (VADs), blood aspiration devices, and related assemblies, systems, and methods, for example, for use with peripheral intravenous catheters (PIVCs). The VADs and blood aspiration devices are each configured for needle access, for example, via a septum-type needle access port on the VAD.

[0003] 2. Description of Related Art Catheters are commonly used to infuse fluids into a patient's vascular system. For example, catheters may be used to infuse normal saline, various medications, 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 fitted over an introducer needle with a sharp distal tip. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle pointing away from the patient's skin. The catheter and introducer needle are generally inserted at a shallow angle through the skin into the patient's vasculature. After proper placement of the needle, the practitioner removes the needle by temporarily occluding flow in the vasculature, leaving the catheter in place (i.e., "indwelling") for future blood withdrawals and / or infusions.

[0005] Although PIVCs may be used for blood withdrawal, they are not usually designed and optimized for such purposes. Thus, several blood aspiration devices have been developed to improve blood collection for use with PIVCs. These devices (e.g., PIVO™ from Velano Vascular Inc.) are configured as single-use devices that are temporarily attached to the PIVC to aspirate a blood sample. Using an existing peripheral venous line as a conduit to the vasculature, the blood aspiration device advances a flexible internal flow tube through the PIVC, past the catheter tip, and into the vein to collect the blood sample. This flow tube is designed to extend beyond the suboptimal blood aspiration conditions around the indwelling line to reach a venous location where blood flow is optimal for aspiration. Once blood collection is complete, the flow tube is retracted and the device is detached from the PIVC and discarded.

[0006] To accommodate such blood aspiration devices, PIVCs with integrated extension sets have been developed. Such integrated vascular access devices (VADs) typically include an extension tube integrated into a catheter adapter at one end, an access port (e.g., a Luer connector) connected to the other end, and a side port to facilitate blood aspiration. One such integrated VAD is disclosed in U.S. Patent Application Serial No. 17 / 143,979, which is incorporated herein by reference in its entirety. Coupler mechanisms, such as, for example, male Luer fittings or Luer lock screw collars, are commonly utilized to attach the blood aspiration device to the integrated VAD, and the blood aspiration device has a blunt plastic cannula and / or Luer end connector to provide the connection. However, in certain parts of the world, the use of such coupler mechanisms (e.g., Luer connectors, etc.) is not common in medical settings. Instead, these parts typically utilize needle access connectors, prorenata (PRN) connectors, etc., which may not be compatible with many modern blood aspiration devices. Summary of the Invention

[0007] Accordingly, the present disclosure generally relates to assemblies, systems, and methods including an integrated VAD having a near patient access port with a needle access septum and a tubing forward compatible fluid pathway, as well as a blood drawing device having a distal access port connector that mates with the septum-type needle access port of the VAD.

[0008] According to one embodiment of the present disclosure, a system for blood aspiration is disclosed that includes a catheter configured to be inserted into a patient's vascular system, a catheter adapter having a side inlet defining a fluid pathway into and out of the catheter, and a proximal-patient access port member having a main branch including a distal end connectable to the side inlet of the catheter adapter and a proximal end having a needle access connector connected thereto. The system also includes a blood aspiration apparatus removably connectable to the proximal-patient access port member, the blood aspiration apparatus including a cannula configured to penetrate the needle access connector of the proximal-patient access port member, a flow tube configured to be advanced and retracted through the cannula, and a tube advancement tab connected to the flow tube and configured to linearly advance and retract the flow tube through the cannula, such that the flow tube is selectively directed through the blood aspiration apparatus, the proximal-patient access port member, and the catheter adapter when the cannula of the blood aspiration apparatus penetrates the needle access connector of the proximal-patient access port member.

[0009] In some embodiments, the needle access connector comprises a septum.

[0010] In some embodiments, the septum is external to the main branch of the proximal-patient access port member.

[0011] In some embodiments, the septum is integrated within the main branch of the proximal-patient access port member.

[0012] In some embodiments, the septum includes an angled end face on the interior of the main branch.

[0013] In some embodiments, the cannula is one of a sharp metal needle, a blunt metal needle, or a blunt plastic cannula.

[0014] In some embodiments, the blood suction device further includes a distal connector interface configured to removably couple the blood suction device to the pro-patient access port member.

[0015] In some embodiments, the terminal connector interface includes a pair of connector clips.

[0016] In some embodiments, the distal connector interface is configured to at least partially surround the cannula and form a safety shield around at least a portion of the cannula.

[0017] In some embodiments, the blood drawing apparatus further includes a safety shield configured to surround the cannula and to be selectively removable from the cannula.

[0018] In some embodiments, the proximal patient access port member further includes a side branch and an extension set coupled to the proximal patient access port member via the side branch.

[0019] In some embodiments, the side branch is oriented distally relative to the main branch.

[0020] In some embodiments, the side branch is oriented proximally relative to the main branch.

[0021] According to another aspect of the present disclosure, a system for blood aspiration is disclosed, the system including a catheter configured to be inserted into a patient's vascular system, a catheter adapter having a side inlet defining a fluid pathway into and out of the catheter, and a proximal-patient access port member having a main branch including a distal end portion connectable to the side inlet of the catheter adapter and a proximal end portion having a septum integrated therein. The system also includes a blood aspiration apparatus removably connectable to the proximal-patient access port member, the blood aspiration apparatus including a cannula configured to pierce the integrated septum of the proximal-patient access port member, a flow tube configured to be advanced and retracted through the cannula, and a tube advancement tab coupled to the flow tube and configured to linearly advance and retract the flow tube through the cannula, such that the flow tube is selectively directed through the blood aspiration apparatus, the proximal-patient access port member, and the catheter adapter when the cannula of the blood aspiration apparatus pierces the integrated septum of the proximal-patient access port member.

[0022] In some embodiments, the integral septum includes an angled end face on the interior of the main branch.

[0023] In some embodiments, the cannula is one of a sharp metal needle, a blunt metal needle, or a blunt plastic cannula.

[0024] In some embodiments, the blood suction device further includes a distal connector interface configured to removably couple the blood suction device to the pro-patient access port member, the distal connector interface including a pair of connector clips.

[0025] In another aspect of the present disclosure, a system for blood aspiration is disclosed, the system including a catheter configured to be inserted into a patient's vascular system, a catheter adapter having a proximal access port with an integrated septum positioned therein and a side inlet, both of which define a fluid pathway into and out of the catheter. The system further includes a proximal-patient access port member having a main branch including a distal end portion and a proximal end portion connectable to the side inlet of the catheter adapter, and a blood aspiration device removably connectable to the proximal access port of the catheter adapter, the blood aspiration device including a cannula configured to pierce the integrated septum of the catheter adapter, a flow tube configured to be advanced and retracted through the cannula, and a tube advancement tab coupled to the flow tube and configured to linearly advance and retract the flow tube through the cannula, such that the flow tube is selectively directed through the blood aspiration device and the catheter adapter when the cannula of the blood aspiration device pierces the integrated septum of the catheter adapter.

[0026] In some embodiments, the cannula is a blunt cannula.

[0027] In some embodiments, the blood suction device further includes a distal connector interface configured to removably couple the blood suction device to the proximal access port of the catheter adapter.

[0028] Further details and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawing figures. [Brief description of the drawings]

[0029] [Figure 1] FIG. 1 is a top view of a vascular access device and a blood aspiration device according to one embodiment of the present disclosure. [Figure 2A] 2A is a partial top view of the vascular access device and blood aspiration device of FIG. 1 in a first configuration. [Figure 2B] 2B is a partial top view of the vascular access device and blood aspiration device of FIG. 1 in a second configuration. [Diagram 3] FIG. 3 is a top view of a vascular access device according to another embodiment of the present disclosure. [Figure 4] FIG. 4 is a partial top view of a vascular access device and a blood aspiration device according to another embodiment of the present disclosure. [Figure 5A] FIG. 5A is a top view of a vascular access device according to another embodiment of the present disclosure. [Figure 5B] FIG. 5B is a top view of a blood aspiration device for use with the vascular access device of FIG. 5A in a first configuration. [Figure 5C] FIG. 5C is a top view of a blood aspiration device for use with the vascular access device of FIG. 5A in a second configuration. [Figure 6] FIG. 6 is a top view of a vascular access device according to another embodiment of the present disclosure. [Figure 7] FIG. 7 is a partial top view of a vascular access device and a blood aspiration device according to another embodiment of the present disclosure. [Figure 8A] FIG. 8A is a top view of a vascular access device and a blood aspiration device according to another embodiment of the present disclosure. [Figure 8B] FIG. 8B is a top view of the vascular access device and blood aspiration device of FIG. 8A in a first configuration. [Figure 8C] FIG. 8C is a partial top view of the vascular access device and blood aspiration device of FIG. 8A in a second configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] 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. 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 be within the spirit and scope of the present disclosure.

[0031] For purposes of the following description, the terms "top," "bottom," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and derivatives thereof, shall refer to the present invention as oriented in the drawings. It should be understood, however, that the present invention may contemplate various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0032] The embodiments of the present disclosure are described primarily in the context of an integrated VAD. However, the embodiments of the present disclosure apply to other IV catheters as well. Thus, the techniques of the present disclosure may be applied to any type of integrated IV catheter. In this specification and claims, an integrated IV catheter should be construed as an IV catheter that includes an integrated extension set.

[0033] With reference to FIG. 1, a VAD system 100 according to one aspect of the present disclosure is shown. The VAD system 100 includes a catheter adapter 110 from which a catheter 112 extends distally from an adapter body 111. Although not shown in FIG. 1, in some embodiments, the catheter adapter 110 may include, for example, a flexible stabilization platform. The catheter adapter 110 also includes a side inlet 113 that defines a fluid passageway into (and out of) the catheter 112. It should be understood that the exact configuration and function of the catheter adapter 110 is not essential to the present disclosure, and any suitable configuration and / or interaction of these components may be employed.

[0034] The VAD system 100 also includes a proximal-patient access port member 120. The proximal-patient access port member 120 has two fluid passageways, including a main branch 121 and a side branch 122. The main branch 121 is coupled to the side inlet 113 of the catheter adapter 110 via an intermediate tube 114. However, it should be understood that in some embodiments, the main branch 122 may be directly coupled to the side inlet 113, thereby eliminating the need for the intermediate tube 114.

[0035] The side branch 122 is configured to couple the extension set to the near-patient access port member 120. As depicted, the extension set includes an extension tube 124 extending between the side branch 122 and the access port 126, and may include a pinch clamp 125 for occluding the extension tube 124. In some embodiments, the access port 126 may include a PRN, a needleless access connector (NAC), or an integrated (non-removable) PRN or NAC connector. Additionally, although the access port 126 is illustrated in FIG. 1 as having a single port, it should be understood that the access port 126 may be configured to have dual ports. In this manner, the extension set provides a means for fluid infusion via the VAD system 100.

[0036] 1, the side branch 122 may be configured as a Y-shaped branch relative to the main branch 121, extending at an angle of, for example, 30° to 150°. However, in some embodiments, the side branch 122 may be configured as a T-shaped branch extending substantially perpendicular (i.e., 90°) to the main branch 121.

[0037] The proximal end of the proximal-patient access port member 120 includes a needle access connector 123. The needle access connector 123 may be configured for use with a needle or other cannula, such as a PRN or other septum. However, it should be understood that the needle access connector 123 may be configured as any suitable connector capable of interfacing with a cannula. The needle access connector 123 may be removably coupled to the main branch 121, or in some embodiments, may be coupled or otherwise affixed to the main branch 121 of the proximal-patient access port member 120.

[0038] 1, the VAD system 100 also includes a blood aspirator 130. The blood aspirator 130 includes a body 132, a tube advance tab 133, and a flow tube 134 extending therethrough. The tube advance tab 133 is slidably coupled to the body 132 and also coupled to a proximal end of the flow tube 134. In this manner, manual longitudinal movement of the tube advance tab 133 along the body 132 results in corresponding longitudinal movement of the flow tube 134 within the body 132. Although the blood aspirator 130 is shown and described utilizing the tube advance tab 133 to longitudinally orient the flow tube 134, it should be understood that other user-operated advancement mechanisms, such as, for example, a rotating mechanism, may be utilized to advance and / or retract the flow tube 134 according to other embodiments.

[0039] The blood aspiration device 130 may include an extension tube 136 coupled to its proximal end, which may be fluidly coupled to the flow tube 134. A pinch clamp 137 may be provided to occlude the extension tube 136. Additionally, the proximal end of the extension tube 136 may be coupled to an end coupling device 140 and an adapter member 141. The end coupling device 140 may be, for example, an end cap, a luer lock access device, or any other suitable coupling device for connecting to a blood collection (or fluid administration) device, while the adapter member 141 may be configured, for example, as a luer adapter. In this manner, the blood aspiration device 130 may be fluidly coupled to a blood collection device, including, for example, a vacuum blood collection tube, to allow blood to be aspirated through the blood aspiration device 130 via the catheter adapter 110 and the near-patient access port member 120.

[0040] The blood aspirator 130 further includes a cannula 131 extending from its distal end. The cannula 131 may be any suitable device capable of puncturing a needle access connector (e.g., a septum), such as, for example, a sharp metal needle, a blunt metal needle, a blunt plastic cannula, or the like. The cannula 131 is sized so that the flow tube 134 may selectively pass therethrough. The blood aspirator 130 also includes a distal connector interface 135. In some embodiments, the distal connector interface 135 at least partially surrounds the cannula 131 and includes a pair of connector clips, as described in further detail below, such that the blood aspirator 130 can be releasably secured to the near-patient access port member 120. However, it should be understood that the distal connector interface 135 is not limited to such an arrangement and may be any suitable connector, such as, for example, a slip or threaded luer, or the like.

[0041] 2A and 2B, blood suction device 130 is shown coupled to proximal-patient access port member 120. Specifically, as shown in FIG. 2A, distal connector interface 135 is coupled to main branch 121 of proximal-patient access port member 120, for example, by fastening a pair of connector clips to corresponding surfaces of main branch 121. In making this attachment, cannula 131 may pierce needle access connector 123 such that blood suction device 130 is fluidly coupled to proximal-patient access port member 120, and therefore to catheter adapter 110.

[0042] 2B, when a user manipulates the tube advance tab 133 of the blood aspiration device 130 distally, the flow tube 134 passes through the cannula 131, the main branch 121 of the proximal access port member 120, the intermediate tube 114, the side inlet 113, and finally through the catheter 112. The length of the flow tube 134 is configured such that when the tube advance tab 133 is moved along the body 132 of the blood aspiration device 130 to its distal-most position, a predetermined length of the flow tube 134 is in the advanced position and extends beyond the distal end of the catheter 112, thereby providing a conduit for blood aspiration that extends beyond the indwelling catheter 112 and into the patient's vasculature.

[0043] 2A and 2B, it should be understood that after the blood aspiration procedure is completed, the flow tube 134 may be retracted by proximal movement of the tube advancement tab 133. With the flow tube 134 in the retracted position, the distal connector interface 135 may be decoupled from the proximal-patient access port member 120, thereby allowing the cannula 131 to be withdrawn from the needle access connector 123. In some embodiments, once decoupled from the proximal-patient access port member 120, the blood aspiration device 130 may be discarded in an appropriate medical waste container.

[0044] 3, in some embodiments, the catheter adapter 110 may be provided with a needle hub grip 150. Although not shown in FIG. 3, in some embodiments, the catheter adapter 110 may include a stabilizing platform that allows the catheter adapter 110 to be stabilized on the patient's skin at the insertion location of the catheter 112 and to resist rotation or other movement of the catheter adapter 110. Additionally, a sleeve 151 may be provided over at least a portion of the catheter 112 before use, during storage, during transport, etc. of the catheter adapter 110. During use, the sleeve 151 may be removed to expose the catheter 112.

[0045] 4, according to another aspect of the disclosure, the blood aspiration device 130 may include a safety shield 160 configured to be positioned over the cannula 131 to prevent accidental needle stick injuries and the like. In some embodiments, the safety shield 160 is non-removable and provides protection when the device is used and the blood aspiration device 130 is removed from the catheter 112. In other embodiments, the safety shield 160 may be selectively removable by a user prior to coupling the blood aspiration device 130 to the near-patient access port member 120. For example, the safety shield 160 may be coupled to the blood aspiration device 130 by, for example, a press-fit connection, a threaded connection, or the like, which may allow a user to manually remove the safety shield 160 prior to use. Alternatively, the safety shield 160 may be formed of a flexible or other foldable material, thereby allowing the safety shield 160 to collapse or fold when the blood aspiration device 130 is pressed towards the near-patient access port member 120, allowing the cannula to penetrate the needle access connector 123 without the user being exposed to the cannula 131. In some embodiments, upon removal of the blood aspiration device 130 from the near-patient access port member 120, the safety shield 160 may be configured to automatically return to a position covering over the cannula 131, thereby reducing user exposure to the cannula 131 following blood collection via the blood aspiration device 130.

[0046] 5A-5C, a proximal-patient access port member 220 and a blood suction device 230 are shown according to another aspect of the present disclosure. The proximal-patient access port member 220 is substantially similar to the proximal-patient access port member 120 described above, in that the proximal-patient access port member 220 has two fluid passageways with a main branch 221 and a side branch 222. The main branch 221 may be coupled to the side inlet 113 of the catheter adapter 110, for example, via an intermediate tube 114. In some embodiments, the side branch 222 may be configured as a Y-branch relative to the main branch 221, extending at an angle of, for example, 30°-150°, and either distally or proximally. Specifically, in the embodiment shown in FIGS. 5A-5C, the side branch 222 is proximally oriented and extends at an angle of about 45° from the main branch 221. With this configuration, the junction formed in the near-patient access port member 220 may be effectively cleaned via the access port 126 and the extension tube 124. However, in some embodiments, the side branch 222 may be configured as a T-shaped branch that extends substantially perpendicular (i.e., 90°) to the main branch 221.

[0047] The near-patient access port member 220 further includes an integrated pierceable septum 223. Thus, unlike the needle access connector 123 which was external to the main branch 121 of the near-patient access port member 220, the septum 223 is internal to (and therefore integrated with) the main branch 221 of the near-patient access port member 220.

[0048] 5B and 5C, blood aspiration device 230 includes a body 232, a tube advance tab 233, and a flow tube 234 extending therethrough. Tube advance tab 233 is slidably coupled to body 232 and also to a proximal end of flow tube 234. In this manner, manual longitudinal movement of tube advance tab 233 along body 232 results in corresponding longitudinal movement of flow tube 234 within body 232. Although not shown in FIGS. 5B and 5C, it should be understood that blood aspiration device 230 may be fluidly coupled to a blood collection device including, for example, a vacuum blood collection tube to allow blood to be aspirated through blood aspiration device 230 via catheter adapter 110 and near-patient access port member 220.

[0049] Blood drawing device 230 further includes a cannula 231 extending from its distal end. Cannula 231 may be any suitable device capable of puncturing septum 223, such as, for example, a sharp metal needle, a blunt metal needle, a blunt plastic cannula, etc. Cannula 231 is sized such that flow tube 234 may selectively pass therethrough.

[0050] The blood aspirator 230 also includes a distal connector interface 235. The distal connector interface 235 at least partially surrounds the cannula 231 to act as a needle safety shield to help prevent accidental needle stick injuries. Additionally, the distal connector interface 235 may include one or more clips to allow the blood aspirator 230 to be releasably secured to the near-patient access port member 220, as shown in FIG. 5C. When secured to the near-patient access port member 220, the cannula 231 of the blood aspirator 230 is configured to pierce the septum 223, thereby providing a fluid connection between the near-patient access port member 220 and the blood aspirator 230, as well as providing a conduit through which the flow tube 234 may be advanced and retracted in a manner similar to that described above with respect to FIG. 2B.

[0051] 6, a VAD system 300 according to another aspect of the present disclosure is shown. The VAD system 300 includes a catheter adapter 310 from which a catheter 312 extends distally from an adapter body 311. Although not shown in FIG. 6, in some embodiments, the catheter adapter 310 may include, for example, a flexible stabilization platform. The catheter adapter 310 also includes a side inlet 313, which defines a fluid path into (and out of) the catheter 312.

[0052] The VAD system 300 also includes a proximal-patient access port member 320. The proximal-patient access port member 320 has two fluid passageways, including a main branch 321 and a side branch 322. The main branch 321 is coupled to a side inlet 313 of the catheter adapter 310 via an intermediate tube 314. However, it should be understood that in some embodiments, the main branch 322 may be directly coupled to the side inlet 313, thereby eliminating the need for the intermediate tube 314.

[0053] The side branch 322 is configured to couple the extension set to the near-patient access port member 320. As depicted, the extension set includes an extension tube 324 extending between the side branch 322 and the access port 326, and may include a pinch clamp 325 for occluding the extension tube 324. In some embodiments, the access port 326 may include a PRN, NAC, or integrated connector. Additionally, although the access port 326 is illustrated in FIG. 6 as having a dual port, it should be understood that the access port 326 may be configured to have a single port. In this manner, the extension set provides a means for fluid infusion via the VAD system 300.

[0054] 6, the side branch 322 may be configured as a distally oriented Y-shaped branch relative to the main branch 321, extending at an angle of, for example, 20° to 160°. Thus, unlike the substantially proximally oriented branches shown with respect to FIGS. 1-5C and described above, the side branch 322 is configured to direct fluid or other substances from the extension tube 324 in a distal direction relative to the main branch 321. Additionally, it should be appreciated that the position of the side branch 322 may vary rotationally (360°) about the axis of the main branch 321.

[0055] The proximal end of the near-patient access port member 320 further includes a needle access connector 323. The needle access connector 323 may be configured for use with a PRN or other needle, and may be, for example, a septum. However, it should be understood that the needle access connector 323 may be configured as any suitable connector capable of interfacing with a cannula. The needle access connector 323 may be removably coupled to the main branch 321, or in some embodiments, may be bonded or otherwise affixed to the main branch 321 of the near-patient access port member 320. Although not shown in FIG. 6, it should be understood that the near-patient access port member 320 is configured for coupling to a blood suction device, such as blood suction device 130 and / or blood suction device 230, as described above.

[0056] 7, a VAD system 400 according to another aspect of the present disclosure is shown. As described in further detail below, the VAD system 400 includes a near-patient access adapter port member configured for improved flushing.

[0057] The VAD system 400 includes a catheter adapter 410 from which a catheter (not shown) extends distally from an adapter body 411. The catheter adapter 410 may include a needle hub gripper 450, which may be removed along with the needle after the catheter is placed. Although not shown in FIG. 7, in some embodiments, the catheter adapter 410 may include a stabilizing platform, which may allow the catheter adapter 410 to be stabilized on the patient's skin at the catheter insertion position to resist rotation or other movement of the catheter adapter 410. Additionally, a sleeve 451 may be provided that covers at least a portion of the catheter before use, during storage, transport, etc. of the catheter adapter 410. During use, the sleeve 451 may be removed to expose the catheter.

[0058] The VAD system 400 also includes a proximal-patient access port member 420. The proximal-patient access port member 420 has two fluid passageways, including a main branch 421 and a side branch 422. In the embodiment shown in FIG. 7, the main branch 421 is coupled to the side inlet 413 of the catheter adapter 410 via an intermediate tube 414. The side branch 422 is configured to couple an extension set to the proximal-patient access port member 420. As depicted, the extension set includes an extension tube 424 extending between the side branch 422 and the access port 426, and may include a pinch clamp 425 for occluding the extension tube 424. In some embodiments, the access port 426 may include a PRN, NAC, or integrated connector. Additionally, as shown in FIG. 7, the side branch 422 may be configured as a Y-branch distally directed relative to the main branch 421, extending at an angle of, for example, 20° to 160°. However, it should be understood that the side branch 422 is not limited to such a configuration.

[0059] The near-patient access port member 420 further includes an integrated pierceable septum 423, which is at least partially disposed within (and thus integrated with) the main branch 421 of the near-patient access port member 420. In some embodiments, the septum 423 may include an angled end face 470. The angled end face 470 is configured to allow for improved flushing of the interior of the near-patient access port member 420 via the side branch 422. Alternatively and / or additionally, the septum 423 may include another flow directing or turbulence generating feature to provide improved flushing. Additionally, other features of the VAD system (400), such as tubing, near-patient access port member, etc., may include one or more flow directing or turbulence generating features (e.g., off-axis tubing extensions, etc.) to provide improved flushing.

[0060] 7, a blood aspiration apparatus is also provided that includes a body 432, a tube advance tab 433, and a flow tube 434 extending therethrough. The tube advance tab 433 is slidably coupled to the body 432 and also to the proximal end of the flow tube 434. The blood aspiration apparatus further includes a cannula 431 extending from its distal end. The cannula 431 may be any suitable device that may pierce the integrated septum 423, such as, for example, a sharp metal needle, a blunt metal needle, a blunt plastic cannula, or the like. The cannula 431 is sized such that the flow tube 434 may selectively pass therethrough.

[0061] The blood aspiration device 430 also includes a distal connector interface 435. The distal connector interface 435 at least partially surrounds the cannula 431 to function as a needle safety shield to help prevent accidental needle stick injuries. Additionally, the distal connector interface 435 may include one or more clips to allow the blood aspiration device to be releasably secured to the near-patient access port member 420. When secured to the near-patient access port member 420, the cannula 431 is configured to pierce the septum 423, thereby providing a fluid connection between the near-patient access port member 420 and the blood aspiration device.

[0062] 8A-8C, a VAD system 500 according to another embodiment of the present disclosure is illustrated. Unlike the VAD systems described herein with respect to Figures 1-7, which utilized a connection between a near-patient access port member and a blood aspiration device to perform blood aspiration, VAD system 500 utilizes a direct connection between a catheter adapter and a blood aspiration device.

[0063] Specifically, the VAD system 500 includes a catheter adapter 510, a proximal-patient access port member 520, and a blood suction device 530. The proximal-patient access port member 520 includes two fluid passageways, comprising a main branch 521 and a side branch 522. The main branch 521 may be coupled to a side inlet 513 of the catheter adapter 510, for example, via an intermediate tube 514. In some embodiments, the side branch 522 may be configured as a Y-shaped branch relative to the main branch 521, extending at an angle of, for example, 30°-150°, and either distally or proximally oriented. However, in some embodiments, the side branch 522 may be configured as a T-shaped branch extending substantially perpendicular (i.e., 90°) to the main branch 521. The proximal-patient access port member 520 further includes an integrated pierceable septum 523.

[0064] In some embodiments, the side branch 522 is configured to couple the extension set with the near-patient access port member 520. As depicted, the extension set includes an extension tube 524 extending between the side branch 522 and the access port 526 and may include a pinch clamp 525 for occluding the extension tube 524. In some embodiments, the access port 526 may include a PRN, NAC, or integrated connector.

[0065] 8A and 8B, blood aspiration device 530 includes a body 532, a tube advancement tab 533, and a flow tube 534 extending therethrough. Tube advancement tab 533 is slidably coupled to body 532 and also coupled to a proximal end of flow tube 534. In this manner, manual longitudinal movement of tube advancement tab 533 along body 532 results in corresponding longitudinal movement of flow tube 534 within body 532.

[0066] The blood aspiration device 530 further includes a cannula 531 extending from its distal end. However, unlike the cannula(s) described above with respect to FIGS. 1-7, which generally included sharp cannulas capable of piercing a septum of a near-patient access port member, the cannula 531 may be configured as any cannula capable of penetrating a needle septum (not shown) integrated within the proximal access port 511 of the catheter adapter 510 itself. That is, the cannula 531 may be sharp or blunt and may be formed of any suitable material, such as, for example, metal or plastic. The cannula 531 is sized such that the flow tube 534 may selectively pass therethrough. The integrated needle septum within the proximal access port 511 of the catheter adapter 510 may be any suitable septum, such as, for example, a solid single piece septum, a three piece septum, or other septum configuration that is penetrable by a cannula. In some embodiments, when accessing the needle septum, the near-patient access port member 520 is not required, and therefore in such embodiments, the device may utilize a standard extension set without the near-patient access port.

[0067] The blood aspirating device 530 also includes a distal connector interface 535. The distal connector interface 535 may at least partially surround the cannula 531 to function as a safety shield. Additionally, the distal connector interface 535 may include one or more clips to allow the blood aspirating device 530 to be releasably secured directly to the catheter adapter 510, as shown in Figures 8B and 8C. When secured to the catheter adapter 510, the cannula 531 of the blood aspirating device 530 is configured to pierce a septum (not shown) integrated within the catheter adapter 510, thereby providing a fluid connection between the catheter adapter 510 and the blood aspirating device 530, as well as providing a conduit through which the flow tube 534 may be advanced such that the flow tube 534 may be selectively advanced beyond the distal tip of the catheter 512, as shown in Figure 8C.

[0068] In some embodiments, blood suction device 530 may include a coupler 536 positioned between body 532 and distal connector interface 535. Coupler 536 may be a safety coupler or a pivotable coupler, and may be further configured to allow direct access to an integrated septum (not shown) in catheter adapter 510.

[0069] Although the blood aspiration device described above utilizes a tube advancement tab to linearly advance the flow tube, it should be understood that other advancement mechanisms may be utilized, such as, for example, a roller mechanism. Additionally, while the terminal connector interface described above utilizes a connector clip, it should be understood that any suitable connection interface may be utilized, such as, for example, a slip luer, a threaded luer, etc.

[0070] Further, it should be understood that the flow tubes of the blood drawing devices described in the various embodiments above may be, for example, straight, stepped, tapered, etc., and may be formed of any suitable material, such as, for example, TPU, polyimide, PEEK, and / or any other polymeric material. Additionally and / or alternatively, it should be understood that the systems and devices described above are not limited to use with flow tubes. The flow tubes may be replaced by, for example, guidewires (active or non-active), tube / guidewire hybrids, sensor delivery probes, braided expansion probes, etc.

[0071] Although several embodiments of the VAD system have been described in the foregoing detailed description, those skilled in the art may make modifications and variations 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 limiting. The invention described herein is defined by the appended claims, and all modifications of the invention that come within the meaning and range of equivalence of the claims are embraced within their scope.

Claims

1. The system for blood aspiration is a catheter adapter comprising a catheter configured to be inserted into a patient's vascular system and a side inlet defining a fluid pathway into and out of the catheter; a proximal-patient access port member having a main branch having a distal end connectable to the side inlet of the catheter adapter and a proximal end having a needle access connector connected thereto; a blood suction device removably connectable to the near-patient access port member, the blood suction device comprising: a cannula configured to penetrate the needle access connector of the near-patient access port member; a flow tube configured to be advanced and retracted through said cannula; and a tube advancement tab coupled to the flow tube and configured to linearly advance and retract the flow tube through the cannula, such that the flow tube is selectively directed through the blood aspiration device, the near-patient access port member, and the catheter adapter when the cannula of the blood aspiration device penetrates the needle access connector of the near-patient access port member. A blood suction device comprising: A system comprising:

2. The system of claim 1 , wherein the needle access connector comprises a septum.

3. The system of claim 2 , wherein the septum is external to the main branch of the near-patient access port member.

4. The system of claim 2 , wherein the septum is integrated within the main branch of the near-patient access port member.

5. The system of claim 2 , wherein the septum has an angled distal end surface within the main branch.

6. The system of claim 1 , wherein the cannula is one of a sharp metal needle, a blunt metal needle, or a blunt plastic cannula.

7. The system of claim 1 , wherein the blood drawer further comprises a distal connector interface configured to removably couple the blood drawer to the near-patient access port member.

8. The system of claim 6 , wherein the terminal connector interface comprises a pair of connector clips.

9. The system of claim 6 , wherein the distal connector interface is configured to at least partially surround the cannula to form a safety shield around at least a portion of the cannula.

10. The system of claim 1 , wherein the blood drawing device further comprises a safety shield surrounding the cannula and configured to be selectively removable from the cannula.

11. The system of claim 1 , wherein the proximal patient access port member further comprises a side branch and an extension set coupled to the proximal patient access port member via the side branch.

12. The system of claim 1 , wherein the side branch is oriented distally relative to the main branch.

13. The system of claim 1 , wherein the side branch is oriented proximally relative to the main branch.

14. The system for blood aspiration is a catheter adapter comprising a catheter configured to be inserted into a patient's vascular system and a side inlet defining a fluid pathway into and out of the catheter; a proximal-patient access port member having a main branch with a distal end portion connectable to the side inlet of the catheter adapter and a proximal end portion having a septum integral therewithin; a blood suction device removably connectable to the near-patient access port member, the blood suction device comprising: a cannula configured to penetrate the integral septum of the near-patient access port member; a flow tube configured to be advanced and retracted through said cannula; and a tube advancement tab coupled to the flow tube and configured to linearly advance and retract the flow tube through the cannula, such that the flow tube may be selectively directed through the blood aspiration device, the near-patient access port member, and the catheter adapter when the cannula of the blood aspiration device penetrates the integrated septum of the near-patient access port member; A blood suction device comprising: A system comprising:

15. The system of claim 14 , wherein the integrated septum comprises an angled end face within the main branch.

16. The system of claim 14 , wherein the cannula is one of a sharp metal needle, a blunt metal needle, or a blunt plastic cannula.

17. 15. The system of claim 14, wherein the blood suction device further comprises a distal connector interface configured to removably couple the blood suction device to the near-patient access port member, the distal connector interface comprising a pair of connector clips.

18. The system for blood aspiration is A catheter adapter comprising: a catheter configured to be inserted into the vascular system of a patient; a proximal access port having an integral septum positioned therein; and a side inlet, wherein both the proximal access port and the side inlet define a fluid pathway into and out of the catheter; a catheter adapter comprising: a proximal-patient access port member having a main branch with a distal end portion connectable to the side inlet of the catheter adapter and a proximal end portion; a blood suction device removably connectable to the proximal access port of the catheter adapter, the blood suction device comprising: a cannula configured to penetrate the integral septum of the catheter adapter; a flow tube configured to be advanced and retracted through said cannula; and a tube advancement tab coupled to the flow tube and configured to linearly advance and retract the flow tube through the cannula, such that the flow tube is selectively directed through the blood aspiration device and the catheter adapter when the cannula of the blood aspiration device penetrates the integrated septum of the catheter adapter. A blood suction device comprising: A system comprising:

19. The system of claim 18 , wherein the cannula is a blunt cannula.

20. 20. The system of claim 18, wherein the blood suction device further comprises a distal connector interface configured to removably couple the blood suction device to the proximal access port of the catheter adapter.

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