Integrated catheter system having features for blood aspiration at the time of placement and allowing blood aspiration during placement - Patents.com

Abstract

An integrated peripheral intravenous (IV) catheter configured for blood aspiration both at the time of catheter placement and during catheter placement. The peripheral IV catheter includes a catheter adapter having a catheter configured for insertion into a patient's vascular system and a side inlet defining a fluid pathway into and out of the catheter. The peripheral IV catheter also includes a side port member having a main branch, the main branch including a distal end configured to couple the side port member to the side inlet of the catheter adapter and a connector portion accessible through a proximal end of the main branch. Additionally, the peripheral IV catheter includes a blood collection adapter removably connected directly to the connector portion of the side port member at the proximal end of the main branch. Additionally, the side port member of the peripheral IV catheter may include a side branch.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 297,083, filed January 6, 2022, entitled "Integrated Catheter System with Features for Blood Aspiration at Placement and Allowing for Blood Aspiration During Placement," the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] The present disclosure relates generally to blood collection adapters for use with peripheral intravenous catheters (PIVCs) and associated assemblies, systems, and methods. The adapters are configured to enable blood collection via a PIVC both at the time of catheter placement and during catheterization.

[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 placed 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 and the bevel of the needle points 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 may temporarily block flow in the vasculature and remove the needle, leaving the catheter in place (i.e., "indwelling") for future blood withdrawals and / or infusions.

[0005] Although PIVCs are sometimes used for blood withdrawal, they are not usually designed and optimized for such purposes. For example, aspiration failure rates can reach 20-50% when a PIVC remains inserted for more than a day. Furthermore, blood extracted from a PIVC often undergoes hemolysis, which is the rupture of red blood cells and the release of their contents into the surrounding fluid, resulting in the need to discard the sample and repeat the blood collection procedure.

[0006] Several factors may contribute to the challenges associated with blood extraction via a PIVC. First, most catheters are formed from soft bioreactive polymers, which can lead to potential stenosis or collapse of the catheter when negative pressure is applied for aspiration. Additionally, longer indwelling times can lead to increased debris (e.g., fibrin / platelet clumps) accumulating at the tip of the catheter and within the lumen of the catheter and / or PIVC. In turn, such debris can at least partially occlude the lumen of the vein in which the PIVC is placed. In certain embodiments, this debris (e.g., fibrin / platelet clumps) around the PIVC can lead to reduced blood flow within the portion of the vein surrounding the inserted PIVC (e.g., both upstream and downstream), resulting in inadequate and / or inefficient aspiration. Another barrier results from the "suction cup" effect, where the tip of the catheter adheres to the wall of the vein due to the negative pressure created by aspiration through the catheter and the potential for a tortuous path of the vein.

[0007] Given the challenges associated with withdrawing blood from a PIVC over long periods of indwelling, fluid transfer devices have been developed to mitigate potential catheter collapse, reduced blood flow due to debris accumulation on or within the catheter, etc. One such device, the PIVO™ from Velano Vascular, Inc., is configured as a single-use device that is temporarily attached to the PIVC to aspirate a blood sample. Using an existing peripheral venous line as a conduit to the vasculature, the PIVO™ device advances a flexible internal flow tube through the PIVC, past the catheter tip, and into the vein to collect the blood sample. The flow tube is designed to overcome suboptimal aspiration conditions around the indwelling line to reach a location in the venous system where blood flow is optimal for aspiration. Once blood collection is complete, the flow tube is retracted and the device is removed from the PIVC and discarded.

[0008] To accommodate the PIVO™ device, PIVCs with integrated extension sets have been developed. Such "integral PIVCs" typically include an extension tube integrated into the 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 PIVC is disclosed in U.S. Patent Application Serial No. 17 / 143,979, the entirety of which is incorporated herein by reference.

[0009] However, while such integrated PIVCs can accommodate a blood aspiration device (such as PIVO™) for use with an indwelling catheter (i.e., blood aspiration at some time after catheter placement), such integrated PIVCs are not configured for use with a pre-attached blood collection system having a fluid path optimized for blood collection at the time of catheter placement. To accommodate such blood collection at the time of catheter placement, another type of integrated PIVC with a pre-attached blood collection device has been developed. One such integrated PIVC is disclosed in U.S. Provisional Patent Application No. 63 / 138,174, which is also incorporated herein by reference in its entirety. However, the pre-attached blood collection device shown and described with respect to U.S. Provisional Patent Application No. 63 / 138,174 utilizes an elongated extension tubing set. Thus, while the integrated PIVC of U.S. Provisional Patent Application No. 63 / 138,174 is configured to allow blood collection at the time of catheter placement, the elongated extension tubing set is not readily adaptable for use with, for example, a PIVO™ device for subsequent blood collection during catheter placement. Summary of the Invention

[0010] Accordingly, the present disclosure relates generally to a blood collection / aspiration adapter and related assemblies, systems, and methods. The adapter is configured to enable blood collection via a PIVC both at the time of catheter placement and during catheter indwelling.

[0011] According to one aspect of the present disclosure, an integrated peripheral intravenous catheter (PIVC) is disclosed. The integrated PIVC includes a catheter adapter having 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. The PIVC also includes a side port member having a main branch including a distal end configured to couple the side port member to the side inlet of the catheter adapter and a connector portion accessible via a proximal end of the main branch. The PIVC also includes a blood collection adapter removably coupled directly to the connector portion of the side port member at the proximal end of the main branch.

[0012] In some embodiments, the PIVC also includes a Luer lock access device coupled to the blood collection adapter.

[0013] In some embodiments, the luer lock access device includes a needle assembly and a blood collection container holder.

[0014] In some embodiments, the connector portion is configured as a needleless connector.

[0015] In some embodiments, the connector portion is configured as a PRN connector.

[0016] In some embodiments, the main branch of the side port member provides a fluid pathway for aspirating blood from the patient's vascular system.

[0017] In some embodiments, the side port member further comprises a side branch.

[0018] In some embodiments, the PIVC further includes an extension set coupled to the side port member via the side branch.

[0019] In some embodiments, the main branch of the side port member provides a first fluid pathway for aspirating blood from the patient's vascular system, and the side branch of the side port member provides a second fluid pathway for injecting fluid into the patient's vascular system.

[0020] In some embodiments, the blood collection adapter includes a fluid path having a non-linear portion.

[0021] In some embodiments, the non-linear portion is one of a coil shape or an S shape.

[0022] In some embodiments, the blood collection adapter is coupled to the extension tube and the access port.

[0023] In some embodiments, the blood collection adapter is directly connected to the blood collection device.

[0024] In some embodiments, the blood collection device includes a needle assembly having a needle configured to receive a blood collection container.

[0025] According to another aspect of the present disclosure, an integrated peripheral intravenous catheter (PIVC) is disclosed. The PIVC includes a catheter adapter having 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. The PIVC also includes a main branch having a distal end configured to couple the side port member to the side inlet of the catheter adapter and a side port member having a connector portion accessible through a proximal end of the main branch, and a side branch. The PIVC also includes a blood collection adapter directly coupled to the connector portion of the side port member at the proximal end of the main branch.

[0026] In some embodiments, the main branch of the side port member provides a first fluid pathway for aspirating blood from the patient's vascular system, and the side branch of the side port member provides a second fluid pathway for injecting fluid into the patient's vascular system.

[0027] In some embodiments, the blood collection adapter is configured to allow for the aspiration of blood from the patient's vascular system upon catheter placement.

[0028] In some embodiments, the blood collection adapter is selectively detachable from the connector portion of the main branch of the side port member.

[0029] In some embodiments, the PIVC further comprises a Luer lock access device coupled to the blood collection adapter.

[0030] In some embodiments, the blood collection adapter includes a fluid path having a non-straight portion.

[0031] Further details and advantages of the present invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawing figures, in which like parts are referred to throughout with like reference characters. [Brief description of the drawings]

[0032] [Figure 1] FIG. 1 illustrates an integrated PIVC having a multi-branch side port member and a blood collection adapter according to one embodiment of the present disclosure. [Diagram 2] FIG. 2 illustrates an integrated PIVC having a multi-branch side port member and a blood collection adapter according to another embodiment of the present disclosure. [Diagram 3] FIG. 3 illustrates an integrated PIVC having a single branch side port member and a blood collection adapter according to another embodiment of the present disclosure. [Figure 4] FIG. 4 illustrates an integrated PIVC having a multi-branch side port member with a non-linear fluid passageway and a blood collection adapter according to another embodiment of the present disclosure. [Diagram 5] FIG. 5 illustrates an integrated PIVC having a multi-branch side port member with a non-linear fluid passageway and a blood collection adapter according to another embodiment of the present disclosure. [Figure 6] FIG. 6 shows an integrated PIVC with a catheter and an in-line blood suction adapter according to another embodiment of the present disclosure. [Figure 7] FIG. 7 shows an integrated PIVC with a catheter and an in-line blood suction adapter according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Description of the Preferred Embodiments The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the 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.

[0034] 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 invention as oriented in the drawings. It should be understood, however, that the 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 invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0035] The embodiments of the present disclosure are primarily described in the context of an integrated PIVC. However, the embodiments of the present disclosure apply to other integrated IV catheters as well. Thus, the techniques of the present disclosure can be applied to any type of integrated IV catheter. In this specification and claims, an integrated IV catheter should be interpreted as an IV catheter that includes an integrated extension set.

[0036] 1, a PIVC 100 is shown according to one embodiment of the present disclosure. The PIVC 100 includes a catheter adapter 110 having a catheter 111 extending distally therefrom, and a needle assembly 120 having a needle 121 extending distally therefrom. Prior to insertion, the needle assembly 120 is coupled to the catheter adapter 110, causing the needle to extend distally from the catheter 111. The catheter adapter 110 also includes a side inlet 112 that defines a fluid passageway into (and out of) the catheter 111. The exact configuration and function of the catheter adapter 110 and / or needle assembly 120 are not essential to the present disclosure, and any suitable configuration and / or interaction of these components may be employed.

[0037] The PIVC 100 also includes a side port member 130. The side port member 130 has two fluid passageways, including a main branch 133 and a side branch 131. The main branch 133 is coupled to the side inlet 112 of the catheter adapter 110 via an intermediate tube 113. However, it should be understood that in some embodiments, the main branch 133 may be directly coupled to the side inlet 112, thereby eliminating the need for the intermediate tube 113.

[0038] The side branch 131 is configured to couple an extension set 140 to the side port member 130. As depicted, the extension set 140 includes an extension tube 141 extending between the side branch 131 and the access port 143, and may include a pinch clamp 142 for occluding the extension tube 141. It should be noted, however, that many different types and configurations of extension sets may be used. In this manner, the extension set 140 provides a means for fluid infusion via the PIVC 100.

[0039] Unlike the side branch 131, the main branch 133 of the side port member 130 is not connected to an elongated extension tube. Rather, the main branch 133 incorporates a connector portion 134 configured as a needleless connector, such as, for example, a SMARTSITE™ needleless connector from Becton Dickinson & Company. However, it should be understood that the connector portion 134 may be any suitable needleless connector.

[0040] 1, connector portion 134 is configured for direct connection to a variety of devices utilized for blood aspiration via PIVC 100. For example, as shown in FIG. 1, a blood collection adapter 135 may be removably coupled to connector portion 134, which in turn is coupled to a luer lock access device 137, such as, for example, a VACUTAINER® LUER-LOK™ access device from Becton Dickinson & Company. Luer lock access device 137 may include a needle assembly and blood collection container holder (not shown) that allows for rapid blood aspiration into a blood collection tube (e.g., a VACUTAINER® blood collection tube) upon catheter placement.

[0041] However, as discussed above, the effectiveness of blood collection via an indwelling catheter may decrease over time due to several factors, such as, for example, the potential for catheter collapse, reduced blood flow due to debris accumulation on or within the catheter, etc. Thus, when it is desirable to aspirate blood via an indwelling catheter at any time other than immediately (or relatively soon) after catheter insertion, the use of a device such as, for example, a PIVO™ Needleless Blood Aspirator can be highly beneficial, as it is configured to circumvent potential debris accumulation or other problems associated with indwelling catheters.

[0042] Thus, according to one aspect of the disclosure, the side port member 130 of the PIVC 100 is not only configured to allow for blood aspiration during catheter insertion as described above, but the connector portion 134 also allows for connection to a device, such as a PIVO™ needleless blood aspiration device, for blood aspiration via an indwelling catheter at any time after catheter insertion. That is, the connector portion 134 of the side port member 130 allows for selective connection and disconnection of a variety of blood aspiration devices, including a blood collection adapter 135 and a luer lock access device 137 as shown in FIG. 1, as well as other devices, such as the PIVO™ needleless blood aspiration device. In the case of the PIVO™ needleless blood aspiration device, which utilizes a flexible internal flow tube configured to advance through the PIVC 100 and beyond the tip of the catheter 111, the connection of the main branch 133 of the side port member 130 to the side inlet 112 of the catheter adapter 110 via a short length of intermediate tubing 113 allows for the flexible internal flow tube to effectively pass through the catheter 111. Conversely, if a conventional long extension tube were used to connect the main branch 133 to the side inlet 112, passage of the flexible inner flow tube of the PIVO™ Needleless Blood Aspiration Device through the catheter 111 would not be possible.

[0043] 2, a PIVC 300 according to another embodiment of the present disclosure is shown. The PIVC 150 is substantially similar to the PIVC 100 described above with respect to FIG. 1. As such, the purpose of components having common reference numbers between the PIVC 100 and the PIVC 150 will not be repeated here. However, whereas the PIVC 100 included a side branch 131 oriented substantially perpendicular to the main branch 133 of the side port member 130, the PIVC 150 includes a side branch 132 having a distally oriented orientation relative to the side port member 130. The side branch 132 is coupled to an extension tube 141 that extends between the side branch 131 and the access port 143, and may include a pinch clamp 142 for occluding the extension tube 141. Thus, while the overall purpose and effect are the same as the PIVC 100 described above, the PIVC 150 shown in FIG. 2 illustrates that the side port member 130 may be configured in various ways to allow for blood aspiration both at the time of catheterization and during catheterization.

[0044] 3, a PIVC 200 according to another embodiment of the present disclosure is illustrated. Similar to the PIVC 100 described above, the PIVC 200 includes a catheter adapter 110 having a catheter 111 extending distally therefrom, and a needle assembly 120 having a needle 121 extending distally therefrom. Prior to insertion, the needle assembly 120 is coupled to the catheter adapter 110 causing the needle to extend distally from the catheter 111. The catheter adapter 110 also includes a side inlet 112 that defines a fluid passageway into (and out of) the catheter 111. The exact configuration and function of the catheter adapter 110 and / or needle assembly 120 are not essential to the present disclosure, and any suitable configuration and / or interaction of these components may be employed.

[0045] The PIVC 200 also includes a side port member 230. However, unlike the side port member 130 of the PIVC 100, the side port member 230 has only a single fluid passageway with a branch 233. The branch 233 is coupled to the side inlet 112 of the catheter adapter 110 via an intermediate tube 113. However, it should be understood that in some embodiments, the branch 233 may be directly coupled to the side inlet 112, thereby eliminating the need for the intermediate tube 113.

[0046] In one embodiment, the branch 233 of the side port member 230 incorporates a connector portion 234 configured as a needleless connector, such as, for example, a SMARTSITE™ needleless connector from Becton Dickinson & Company. However, it should be understood that the connector portion 234 may be any suitable needleless connector. The connector portion 234 is configured for direct connection to a variety of devices utilized for blood aspiration via the PIVC 200. For example, as shown in FIG. 2, a blood collection adapter 235 may be removably coupled to the connector portion 234, which is coupled to a luer lock access device 237, such as, for example, a VACUTAINER® LUER-LOK™ access device from Becton Dickinson & Company. The luer lock access device 237 may include a needle assembly and blood collection container holder (not shown) to allow for rapid blood aspiration into a blood collection tube (e.g., a VACUTAINER® blood collection tube) upon catheter placement.

[0047] Furthermore, in addition to accommodating blood aspiration at the time of catheter insertion, the connector portion 234 also allows for connection to devices such as, for example, a PIVO™ needleless blood aspiration device for blood aspiration through the indwelling catheter at any time after catheter insertion. That is, the connector portion 234 of the side port member 230 allows for selective connection and disconnection of a variety of blood aspiration devices, including a blood collection adapter 235 and a luer lock access device 237 as shown in FIG. 2, as well as other devices such as the PIVO™ needleless blood aspiration device (not shown). In the case of the PIVO™ needleless blood aspiration device, which utilizes a flexible internal flow tube configured to advance through the PIVC 200 and beyond the tip of the catheter 111, the connection of the branch 233 of the side port member 230 to the side inlet 112 of the catheter adapter 110 via a short length of intermediate tubing 113 allows for effective passage of the flexible internal flow tube through the catheter 111.

[0048] With further reference to FIG. 3, it will be appreciated that the connector portion 234 is not limited to a needleless connector, such as the SMARTSITE™ needleless connector from Becton Dickinson & Company. Instead, according to another aspect of the present disclosure, the connector portion 234 is configured as a PRN connector, which is commonly utilized in some markets. If the connector portion 234 is configured as a PRN connector, the blood collection adapter 235 may be configured to include a sharp cannula suitable for penetrating the PRN connector during blood aspiration during catheter placement. Additionally, for blood aspiration after catheter placement (i.e., during catheter placement), for example, using a PIVO™ needleless blood aspiration device, the blunt cannula / internal flow tube typically provided with the device may be replaced with a sharp cannula to allow penetration of the PRN connector by the cannula / internal flow tube as it is delivered through the side port member 230 and ultimately through the catheter 111.

[0049] Referring now to FIG. 4, a PIVC 300 according to another embodiment of the present disclosure is illustrated. Similar to the PIVC 100, 150, 200 described above with respect to FIGS. 1-3, the PIVC 300 includes a catheter adapter 110 having a catheter 111 extending distally therefrom, and a needle assembly 120 having a needle 121 extending distally therefrom. Prior to insertion, the needle assembly 120 is coupled to the catheter adapter 110, causing the needle to extend distally from the catheter 111. The catheter adapter 110 also includes a side inlet 112 that defines a fluid passageway into (and out of) the catheter 111. The exact configuration and function of the catheter adapter 110 and / or needle assembly 120 are not essential to the present disclosure, and any suitable configuration and / or interaction of these components may be employed.

[0050] The PIVC 300 also includes a side port member 330. The side port member 330 has two fluid passageways, including a main branch 333 and a side branch 331. The main branch 333 is coupled to the side inlet 112 of the catheter adapter 110 via an intermediate tube 113. However, it should be understood that in some embodiments, the main branch 333 may be directly coupled to the side inlet 112, thereby eliminating the need for the intermediate tube 113.

[0051] The side branch 331 is configured to couple the extension set 140 to the side port member 330. As depicted, the extension set 140 includes an extension tube 141 extending between the side branch 131 and the access port 143 and may include a pinch clamp 142 for occluding the extension tube 141. However, it should be noted that many different types and configurations of extension sets may be used. In this manner, the extension set 140 provides a means for fluid infusion via the PIVC 300.

[0052] Unlike the side branch 331, the main branch 333 of the side port member 330 is not connected to an elongated extension tube. Rather, the main branch 333 incorporates a connector portion 334 configured as a needleless connector, such as, for example, a SMARTSITE™ needleless connector from Becton Dickinson & Company. However, it should be understood that the connector portion 334 may be any suitable needleless connector, PRN connector, or the like.

[0053] 4, connector portion 334 is configured for direct connection to a variety of devices utilized for blood aspiration via PIVC 300. However, unlike FIGS. 1-3 discussed above, in which a blood collection adapter and a Luer lock access device were utilized for blood aspiration during catheter insertion, PIVC 300 utilizes a blood aspiration extension set 338 that is specifically configured to reduce the possibility of hemolysis during blood collection using PIVC 300. Extension set 338 includes an adapter 335 that is configured to couple to connector portion 334. Examples of adapters 335 and associated components are shown and described in more detail in U.S. Patent Application Serial No. 17 / 146,388, which is incorporated herein by reference in its entirety.

[0054] In some embodiments, the adapter 335 includes a distal end coupled to the connector portion 334 and a proximal end configured to couple to a blood collection device (not shown) via an extension tube 336 and an access port 337. The adapter 335 includes a fluid path disposed between its distal end and its proximal end, the fluid path having a non-linear portion. Blood cells may experience shear stress as they flow through the fluid passage of the adapter 335. The maximum shear stress is the stress along the wall of the blood cell, i.e., wall shear stress. Wall shear stress on blood cells is believed to be the primary cause of mechanical damage to blood cells. In some embodiments, the non-linear portion of the adapter 335 may facilitate an increase in flow resistance within the PIVC 300 to distribute pressure differentials and reduce shear stress experienced by red blood cells.

[0055] In some embodiments, the non-linear portion of the adapter 335 may form a coil (or helix) shape, an S-shape, or other suitable non-linear shape. Additionally, in some embodiments, the non-linear portion may increase the length of the fluid path through the adapter 335, thereby increasing flow resistance and decreasing blood flow within the adapter 335. In these embodiments, the risk of hemolysis during blood collection may be reduced.

[0056] In some embodiments, fluid resistance may be provided by carefully selecting the length and diameter of the extension tube 336. Increased fluid resistance will reduce blood flow rate within the entire fluid path through the PIVC 300. In these embodiments, the risk of hemolysis during blood collection may be reduced.

[0057] The adapter 335, along with the extension tube 336 and the access port 337, may be removably coupled to the connector portion 334, such that any suitable blood collection device can be coupled to the access port 337, allowing for rapid blood aspiration at the time of catheter placement. Furthermore, the connector portion 334, in addition to accommodating blood aspiration during catheter insertion via the removable adapter 335, also allows for connection to a device, such as a PIVO™ Needleless Blood Aspiration Device, for blood aspiration through the indwelling catheter at any time after catheter insertion. In the case of the PIVO™ Needleless Blood Aspiration Device, which utilizes a flexible internal flow tube configured to advance through the PIVC 300 and beyond the tip of the catheter 111, the connection of the branch 333 of the side port member 230 to the side inlet 112 of the catheter adapter 110 via a short length of intermediate tube 113 effectively allows for the flexible internal flow tube to pass through the catheter 111.

[0058] Referring now to Figure 5, a PIVC 400 according to another embodiment of the present disclosure is illustrated. Similar to the PIVCs 100, 150, 200, 300 described above with respect to Figures 1-4, the PIVC 400 includes a catheter adapter 110 having a catheter 111 extending distally therefrom, and a needle assembly 120 having a needle 121 extending distally therefrom. Prior to insertion, the needle assembly 120 is coupled to the catheter adapter 110, causing the needle to extend distally from the catheter 111. The catheter adapter 110 also includes a side inlet 112 that defines a fluid passageway into (and out of) the catheter 111. The exact configuration and function of the catheter adapter 110 and / or needle assembly 120 are not essential to the present disclosure, and any suitable configuration and / or interaction of these components may be employed.

[0059] The PIVC 400 also includes a side port member 430. The side port member 430 has two fluid passageways, comprising a main branch 433 and a side branch 431. The main branch 433 is coupled to the side inlet 112 of the catheter adapter 110 via an intermediate tube 113. However, it should be understood that in some embodiments, the main branch 433 may be directly coupled to the side inlet 112, thereby eliminating the need for the intermediate tube 113.

[0060] The side branch 431 is configured to couple the extension set 140 to the side port member 430. As depicted, the extension set 140 includes an extension tube 141 extending between the side branch 131 and the access port 143, and may include a pinch clamp 142 for occluding the extension tube 141. However, it should be noted that many different types and configurations of extension sets may be used. In this manner, the extension set 140 provides a means for fluid infusion via the PIVC 400.

[0061] Unlike the side branch 431, the main branch 433 of the side port member 430 is not connected to an elongated extension tube. Instead, the main branch 433 incorporates a connector portion 434 configured as a needleless connector, such as, for example, a SMARTSITE™ needleless connector from Becton Dickinson & Company. However, it should be understood that the connector portion 434 may be any suitable needleless connector, PRN connector, or the like.

[0062] The connector portion 434 is configured for direct connection to a variety of devices utilized for blood aspiration via the PIVC 400. Similar to the PIVC 300 described above with respect to FIG. 4, the PIVC 400 is configured to reduce the possibility of hemolysis during blood collection. However, rather than using an adapter coupled to an extension set and an access port to accommodate blood aspiration as described above with respect to the PIVC 300, the PIVC 400 utilizes an adapter 435 having a proximal end that is directly coupled to a blood collection device 438. For example, the proximal end of the adapter 435 may be integral with the blood collection device 438 or may be monolithically formed as a single unit with the blood collection device 438. In another embodiment, the proximal end of the adapter 435 may include a female luer connector that may be coupled to a male luer connector of the blood collection device 438. Examples of the adapter 435 and blood collection device 438 are shown and described in further detail in U.S. Patent Application Serial No. 17 / 146,388, which is incorporated herein by reference in its entirety.

[0063] In some embodiments, the blood collection device 438 may include a needle assembly 437, which may include a needle configured to receive the blood collection container. In these and other embodiments, the blood collection container may include an evacuated blood collection tube. In some embodiments, the blood collection container may have all or part of the air removed such that the pressure within the blood collection container is less than the ambient pressure.

[0064] In some embodiments, the blood collection device 438 may include or correspond to a Luer lock access device, such as, for example, the VACUTAINER® LUER-LOK™ access device from Becton, Dickinson and Company. Additionally, in some embodiments, the proximal end of the needle assembly 437 may be encased within an elastomeric sheath. The elastomeric sheath may include an open distal end and a closed proximal end. In response to the blood collection container pushing the elastomeric sheath distally, the needle of the needle assembly 437 may penetrate the elastomeric sheath and the needle may be inserted into a cavity of the blood collection container to aspirate blood therein.

[0065] Similar to the adapter 335 described above with respect to FIG. 4, the adapter 435 of the PIVC 400 is specifically configured to reduce the possibility of hemolysis during blood collection. In some embodiments, the adapter 435 includes a distal end coupled to the connector portion 434 and a proximal end configured to couple to a blood collection device 438. The adapter 435 includes a fluid path disposed between its distal end and its proximal end, the fluid path having a non-linear portion. The non-linear portion of the adapter 435 may facilitate increasing flow resistance within the PIVC 400 and distribute pressure differentials to reduce shear stress experienced by red blood cells. In some embodiments, the non-linear portion of the adapter 435 may form a coil (or helix) shape, an S-shape, or other suitable non-linear shape. Additionally, in some embodiments, the non-linear portion may increase the length of the fluid path through the adapter 435, thereby increasing flow resistance to reduce blood flow within the adapter 435. In these embodiments, the risk of hemolysis during blood collection may be reduced.

[0066] 6, a PIVC 500 according to another embodiment of the present disclosure is illustrated. Similar to the various PIVCs described above with respect to Figures 1-5, the PIVC 500 includes a catheter adapter 110 having a catheter 111 extending therefrom, and a needle assembly (not shown) having a needle extending therefrom. The exact configuration and function of the catheter adapter 110 and / or needle assembly are not essential to the present disclosure, and any suitable configuration and / or interaction of these components may be employed.

[0067] The PIVC 500 includes a blood aspiration adapter 501 and a luer lock access device 502, such as a VACUTAINER® LUER-LOK™ access device from Becton, Dickinson and Company. The blood aspiration adapter 501 is configured to be coupled to the catheter adapter 110 in-line with the catheter 111 via tubing 504.

[0068] Additionally, in some embodiments, the PIVC 500 may include an access port 506 having a vent cap 508 located on the first branch and a connector 510 (e.g., PRN, NAC, integrated connector, etc.), which is coupled to a side port of the catheter adapter 110 via tubing 508. Although the access port 506 is shown in FIG. 6 as having a dual port, it should be understood that the access port 506 may be configured to have a single port. In this manner, the extension set provides a means for fluid infusion via the PIVC 500.

[0069] The PIVC 500 allows for blood aspiration upon placement of the catheter 111, such blood aspiration being possible via the blood aspiration adapter 501 and luer lock access device 502, which are fluidly coupled to the catheter 111 upon placement. Conversely, during catheter placement (i.e., after placement), the blood aspiration adapter 501 and luer lock access device 502 may be removed, thereby accommodating, for example, a PIVO™ needleless blood aspiration device for blood aspiration through an indwelling catheter any time after catheter insertion. Although not shown, a needle may be partially retracted within the catheter adapter 110 during catheter placement.

[0070] 7, a PIVC 600 according to another embodiment of the present disclosure is illustrated. Similar to the various PIVCs described above with respect to Figures 1-6, the PIVC 500 includes a catheter adapter 110 having a catheter 111 extending distally therefrom, and a needle assembly (not shown) having a needle extending distally therefrom.

[0071] 6, the PIVC 600 includes a blood aspiration adapter 601 and a luer lock access device 602, such as, for example, a VACUTAINER® LUER-LOK™ access device from Becton, Dickinson and Company. Unlike the PIVC 500, however, the blood aspiration adapter 601 of the PIVC 600 is configured to be directly coupled to the catheter adapter 110 in-line with the catheter 111 (i.e., without any intervening tubing). In such a configuration, the needle (not shown) utilized during insertion of the catheter 111 may be long such that it extends through the blood aspiration adapter 601 during placement of the catheter 111.

[0072] Further, in some embodiments, the PIVC 600 may include an access port 606 having, for example, a vent cap disposed on the first branch and a connector (e.g., a PRN, NAC, integrated connector, etc.) disposed on the second branch, the access port 606 being connected to a side port of the catheter adapter 110 via a tube 604.

[0073] The PIVC 600 also allows for blood aspiration during placement of the catheter 111. After insertion of the catheter 111, an elongated needle (not shown) may be removed through the blood aspiration adapter 601 and a luer lock access device 602 may be coupled to the blood aspiration adapter 601 to allow for blood aspiration during placement of the catheter.

[0074] It should be understood that according to some embodiments of the present disclosure, the adapter(s) coupled to the side port member may be pre-attached and / or pre-packaged to the side port member, however, in other embodiments, the side port member, adapter(s), and any other associated components may be provided and / or packaged separately and attached by the end user.

[0075] Although the above detailed description describes several embodiments of a PIVC capable of aspirating blood both at the time of catheterization and during catheterization, those skilled in the art can make modifications and variations to these embodiments without departing from the scope and spirit of the present invention. Accordingly, the above 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. An integrated peripheral intravenous catheter A catheter adapter comprising: a catheter configured to be inserted into a patient's vascular system; and a side inlet defining a fluid path into and out of the catheter; a side port member having a main branch, the main branch comprising a distal end configured to couple the side port member to the side inlet of the catheter adapter and a connector portion accessible through a proximal end of the main branch; a blood collection adapter removably connected directly to the connector portion of the side port member at the proximal end of the main branch; 1. An integrated peripheral intravenous catheter comprising:

2. 10. The integrated peripheral intravenous catheter of claim 1, further comprising a luer lock access device coupled to the blood collection adapter.

3. The integrated peripheral IV catheter of claim 2 , wherein the luer lock access device comprises a needle assembly and a blood collection container holder.

4. The integrated peripheral IV catheter of claim 1 , wherein the connector portion is configured as a needleless connector.

5. The integrated peripheral IV catheter of claim 1 , wherein the connector portion is configured as a PRN connector.

6. The integrated peripheral IV catheter of claim 1 , wherein the main branch of the side port member provides a fluid path for aspirating blood from a patient's vascular system.

7. The integrated peripheral IV catheter of claim 1 , wherein the side port member further comprises a side branch.

8. The integrated peripheral IV catheter of claim 7, further comprising an extension set coupled to the side port member via the side branch.

9. 9. The integrated peripheral IV catheter of claim 8, wherein the main branch of the side port member provides a first fluid pathway for aspirating blood from a patient's vascular system and the side branch of the side port member provides a second fluid pathway for infusing fluid into a patient's vascular system.

10. The integrated peripheral IV catheter of claim 1 , wherein the blood collection adapter comprises a fluid path having a non-straight portion.

11. The integrated peripheral IV catheter of claim 10 , wherein the non-straight portion is one of a coil shape or an S shape.

12. The integrated peripheral IV catheter of claim 10 , wherein the blood collection adapter is connected to an extension tube and an access port.

13. The integrated peripheral IV catheter of claim 10 , wherein the blood collection adapter is directly connected to a blood collection device.

14. The integrated peripheral IV catheter of claim 13 , wherein the blood collection device comprises a needle assembly having a needle configured to receive a blood collection container.

15. An integrated peripheral intravenous (IV) catheter, A catheter adapter comprising: a catheter configured to be inserted into a patient's vascular system; and a side inlet defining a fluid path into and out of the catheter; A side port member comprising: a main branch having a distal end configured to connect the side port member to the side inlet of the catheter adapter and a connector portion accessible through a proximal end of the main branch; and a side port member comprising a side branch; and a blood collection adapter directly connected to the connector portion of the side port member at the proximal end of the main branch; 1. An integrated peripheral intravenous (IV) catheter comprising:

16. 16. The integrated peripheral IV catheter of claim 15, wherein the main branch of the side port member provides a first fluid pathway for aspirating blood from a patient's vascular system and the side branch of the side port member provides a second fluid pathway for infusing fluid into a patient's vascular system.

17. 16. The integrated peripheral IV catheter of claim 15, wherein the blood collection adapter is configured to allow for the aspiration of blood from a patient's vascular system upon catheter placement.

18. 20. The integrated peripheral IV catheter of claim 17, wherein the blood collection adapter is selectively detachable from the connector portion of the main branch of the side port member.

19. 16. The integrated peripheral IV catheter of claim 15, further comprising a luer lock access device coupled to the blood collection adapter.

20. The integrated peripheral IV catheter of claim 15, wherein the blood collection adapter comprises a fluid passageway having a non-straight portion.

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