A blood sampling device with a proximal dual-port diversion chamber for collecting samples from PIV

Abstract

A blood collection device having an actuator and a blood collection tube operably coupled to the actuator, the actuator being configured to selectively advance the blood collection tube through a catheter of a vascular access device, a blood collection system including the blood collection device and an extension tube extending from the blood collection device, the extension tube being in fluid communication with the blood collection tube of the blood collection device. The system also includes a dual port adapter coupled to the proximal end of the extension tube, the dual port adapter including a first port and a second port, and a vent flashback and diversion chamber coupled to one of the first port and the second port, the vent flashback and diversion chamber being configured to receive and hold an initial volume of blood collected through the extension tube by the blood collection device.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Application Serial No. 63 / 343,772, filed May 19, 2022, entitled "Blood Collection Device with Proximal Dual Port Diversion Chamber for Collection of Blood Culture Samples from a PIV," the entire disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0002] The present disclosure generally relates to systems and methods for collecting blood samples for blood culture testing from vascular access devices such as, for example, a peripheral intravenous catheter (PIVC). More specifically, the systems described herein include a blood collection device having a proximal blood diversion chamber.

[0003] When collecting a blood specimen from an indwelling vascular access device such as a peripheral IV catheter (PIVC), a central venous catheter (CVC), or a peripherally inserted central catheter (PICC), the first 1 - 10 ml of blood is often wasted (i.e., discarded) to avoid contamination from fluid in the dead space of the vascular access path of such a device. This additional step, while reducing the contamination of the blood specimen, can be forgotten or performed inappropriately, i.e., it can compromise the blood specimen.

[0004] Blood culture is often used as a tool to detect the presence of bacteria or fungi in a patient's blood sample, identify the types of bacteria or fungi present, and direct the treatment of the patient. However, accidental contamination of blood samples is a common problem, causing false positives, and often patients will be prescribed unnecessary treatments, such as broad-spectrum antibiotics. To address this concern, some healthcare workers clean the patient's skin before the blood collection procedure. This reduces the false positive rate, but this rate is still significant (e.g., 3-5%) due to, for example, bacteria and / or fungi present in hair follicles. Thus, in some systems, some also divert the first small amount of blood drawn and discard the first (potentially contaminated) volume of blood. However, these systems can be costly and time-consuming and can only be used in conjunction with an intravenous catheter immediately after initial placement. Furthermore, these systems often rely on puncturing the patient's skin to collect the sample, which is uncomfortable for the patient.

[0005] Furthermore, needleless blood sampling systems, such as Becton, Dickinson and Company's PIVO™, are intended to be used in combination with an intravenous catheter placed within a patient's vasculature to collect one or more blood samples directly from the vascular access device, avoiding the need for additional (and painful) venipunctures. However, insertion of an intravenous catheter into a patient's vasculature can introduce bacteria and / or fungi by contacting the patient's skin and dermal layer during the insertion process. Thus, the first volume of blood drawn into the needleless blood sampling system can contain bacteria and / or fungi present due solely to catheter insertion, thereby increasing the risk of false positive blood culture tests. Additionally, in the case of an indwelling catheter, microorganisms can be present within the vascular access device and may not necessarily indicate microorganisms within the bloodstream. As the needleless blood sampling device advances through the indwelling catheter, microorganisms within the catheter device can enter the blood sampling device, and it is preferable to separate the first blood entering the blood sampling device into a diversion volume. SUMMARY OF THE INVENTION

[0006] According to aspects of the present disclosure, a blood collection system is disclosed. The blood collection system can include a blood collection device having a distal end portion and a proximal end portion, the blood collection device including an actuator and a blood collection tube operably coupled to the actuator, the actuator being configured to selectively advance the blood collection tube through a catheter of a vascular access device when the blood collection device is coupled to the vascular access device. The blood collection system also includes an extension tube extending from the proximal end portion of the blood collection device, the extension tube being in fluid communication with the blood collection tube of the blood collection device, a dual port adapter coupled to the proximal end of the extension tube, the dual port adapter including a first port and a second port, and a vented flashback and diversion chamber coupled to one of the first port and the second port, the vented flashback and diversion chamber being configured to receive and hold an initial volume of blood aspirated through the extension tube by the blood collection device.

[0007] In some embodiments, the vented flashback and diversion chamber further includes a venting portion.

[0008] In some embodiments, the venting portion is configured to vent air when the blood collection device is coupled to the vascular access device and the blood collection tube of the blood collection device advances into the patient's vasculature and draws an initial volume of blood into the vented flashback and diversion chamber.

[0009] In some embodiments, the venting portion is configured to automatically vent air when the blood collection device is coupled to the vascular access device and the blood collection tube of the blood collection device advances into the patient's vasculature.

[0010] In some embodiments, the blood sampling device is coupled to a vascular access device, and when the blood sampling tube of the blood sampling device advances into the patient's vasculature, the venting portion is manually vented.

[0011] In some embodiments, the venting portion is formed from at least one of a membrane, paper, porous material, film, or mechanical mechanism that allows air to pass therethrough but prevents fluid from passing therethrough when wet.

[0012] In some embodiments, the system further includes a removable end cap that can be disposed on the other of the first port and the second port.

[0013] In some embodiments, the system further includes a luer lock access device coupled to the other of the first port and the second port.

[0014] In some embodiments, the system further includes a secondary extension tube, the distal end of the secondary extension tube is coupled to one of the first port and the second port, and the proximal end of the secondary extension tube is coupled to a connector.

[0015] In some embodiments, the vented flashback and diversion chamber is coupled to the connector.

[0016] In some embodiments, the system further includes a fluid occlusion device disposed in series with the secondary extension tube, and the fluid occlusion device is configured to selectively occlude blood flow from the vented flashback and diversion chamber.

[0017] In some embodiments, the blood sampling device further includes an introducer body, and the actuator is configured to move linearly along the introducer body to advance and retract the blood sampling tube from the distal end portion of the blood sampling device.

[0018] In some embodiments, the vented flashback and diversion chamber and the second port have a combined internal volume of at least 0.15 mL.

[0019] According to another aspect of the present disclosure, a method of using a blood sample collection system is disclosed. The method can include providing a blood sample collection system that includes a blood collection device having a distal end portion and a proximal end portion, the blood collection device including an actuator and a blood collection tube operably coupled to the actuator, an extension tube extending from the proximal end portion of the blood collection device, the proximal extension tube being in fluid communication with the blood collection tube of the blood collection device and including a dual port adapter coupled to the proximal end of the extension tube, the dual port adapter including a first port and a second port, and a vented flashback and diversion chamber coupled to one of the first port and the second port. The method can also include coupling the blood collection device to a vascular access device having an indwelling catheter, advancing the blood collection tube of the blood collection device through the vascular access device and beyond the distal tip of the indwelling catheter, and allowing an initial volume of blood to flow through the blood collection tube and the extension tube into the vented flashback and diversion chamber of the blood sample collection system.

[0020] In some embodiments, the method can include venting the vented flashback and diversion chamber before allowing the first volume of blood to flow therein.

[0021] In some embodiments, venting the vented flashback and diversion chamber can include manual venting.

[0022] In some embodiments, venting the vented flashback and diversion chamber can include automatic venting.

[0023] In some embodiments, the method may further include coupling a blood collection interface to the other of the first port and the second port of the dual port adapter.

[0024] In some embodiments, the method may further include coupling a first blood collection container to the blood collection interface and collecting a first blood sample in the first blood collection container after an initial volume of blood has been collected in the ventilation flushback and diversion chamber.

[0025] In some embodiments, the method may further include removing the first blood collection container from the blood collection interface, coupling a second blood collection container to the blood collection interface, and collecting a second blood sample in the second blood collection container.

[0026] Further details and advantages of the present invention will become apparent upon reading the following detailed description in conjunction with the accompanying drawings. Here, like parts are designated by like reference numerals throughout.

Brief Description of the Drawings

[0027]

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[0028] The following description is provided to enable one of ordinary skill in the art to make and use the described aspects contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will be apparent to one of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0029] For the purposes of the description below, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "uppermost", "lowermost", "transverse", "longitudinal", and derivatives thereof shall be considered as related to the present invention as oriented in the drawings. However, it will be understood that the present invention may contemplate various alternative variations unless explicitly specified to the contrary. It should also be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical characteristics related to the aspects disclosed herein should not be considered as limiting.

[0030] In the present disclosure, the distal end of a component or device means the end that is furthest from the user's hand when the component or device is in the use position, i.e., when the user is holding the blood collection device during preparation for or during use. The proximal end means the end that is closest to the user's hand. Similarly, in the present application, the terms "in the distal direction" and "distally" mean the direction towards the access connector portion of the fluid transfer device, and the terms "in the proximal direction" and "proximally" mean the direction opposite to the direction of the connector.

[0031] It should be understood that the blood sample collection system described below, which is not shown or described herein, can be utilized for blood collection from any suitable vascular access device, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD CATHENA™ Catheter System, the BD VENFLON™ Pro Safety Shield IV Catheter System, the BD NEOFLON™ IV Cannula System, the BD INSYTE™ AUTOGUARD™ BC Shield IV Catheter System, or another suitable vascular access device.

[0032] Embodiments of the present disclosure are mainly described in the context of a blood culture sample collection system for use with a PIVC. However, embodiments of the present disclosure are equally extended to use with other catheter devices.

[0033] Referring to FIG. 1, a blood collection system 10 according to one aspect of the present disclosure is shown. The blood collection system 10 includes a “line draw” blood collection device 12 configured to couple to a PIVC and includes a flexible probe (not shown) that advances through the PIVC beyond the catheter tip and into the blood vessel for collecting a blood sample. After blood collection, the blood collection device 12 can be removed from the PIVC and discarded. An example of such a blood collection device is known as PIVO™ of Becton, Dickinson and Company. However, it should be understood that the blood collection system 10 is not limited to such a device and any “line draw” blood collection device that can collect blood or allow blood to flow therethrough via an indwelling catheter can be utilized.

[0034] The blood collection device 12 includes an introducer body 14 and an actuator 16. The actuator 16 is configured to be linearly displaceable by a clinician along a track or other mechanism of the introducer body 14 between a proximal end portion 18 and a distal end portion 20 of the introducer body 14. The actuator 16 is operably coupled to an elongate flexible probe or tube (not shown) and advances and retracts the tube through a distal core portion 24 disposed near the distal end portion 20 of the introducer body 14. That is, displacement of the actuator 16 in a first (distal) direction advances the tube through the distal core portion 24 so that the tube can enter the patient's vasculature when the blood collection device 12 is coupled to the vascular access device. Conversely, displacement of the actuator 16 in a second (proximal) direction retracts the tube through the distal core portion 24 and ultimately retracts the tube from the patient's vasculature.

[0035] The blood collection device also includes a connector member 22 configured to selectively couple the blood collection device 12 to, for example, a needleless access connector of an adapter coupled to a vascular access device. In some embodiments, the connector member 22 is configured as an alligator clip type connector, and the opposing distal clip portions enable the blood collection device 12 to be secured to the surface of the needleless access connector. A pair of proximal clip portions are sized and configured to be pinched or otherwise manipulated by a clinician to release the distal clip portions from engagement with the needleless access connector.

[0036] Referring further to FIG. 1, the proximal extension tube 26 extends from the proximal end portion 18 of the introducer body 14 with the proximal extension tube 26 being fluidly coupled to a blood collection tube (not shown) of the blood collection device 12. For example, an occlusion device 28, such as a clamp, may be provided in series with the proximal extension tube 26 to enable a user to selectively block the flow of fluid through the proximal extension tube 26.

[0037] Furthermore, the blood collection system 10 includes a proximal dual port adapter 30 coupled to the proximal end of the proximal extension tube 26. The proximal dual port adapter 30 includes a first port 32 and a second port 34. In some embodiments, the proximal dual port adapter 30 is configured as a Y adapter. However, it should be understood that the proximal dual port adapter 30 may be configured in any suitable manner, such as a T adapter, for example. In some embodiments, a removable end cap 36 may be provided at the proximal end portion of the first port 32, and the end cap 36 is selectively removable to expose any suitable fitting, valve, or connector, such as a luer connector, for example, such that the blood collection system 10 may be coupled to a suitable blood collection interface, such as a luer lock access device, for example. However, in other embodiments, the end cap 36 may be omitted.

[0038] The blood collection system 10 may further include a vented flashback and diversion chamber 38 coupled to the second port 34 of the proximal dual port adapter 30. As will be described in more detail below, the vented flashback and diversion chamber 38 is configured to divert and store an initial volume of blood drawn into the system via the blood collection device 12 because the initial volume of blood can be contaminated by, for example, bacteria and / or fungi introduced during catheter insertion into the patient's skin and skin layers or by microorganisms present in an indwelling IV catheter. Although not shown, the vented flashback and diversion chamber 38 may include a vent plug or other device at its proximal end to allow air to selectively pass through the vented flashback and diversion chamber 38.

[0039] The vented flashback and diversion chamber 38 can have any shape or form having a volume sufficient to divert and hold the initial blood volume. In some embodiments, the internal volume of the combined vented flashback and diversion chamber 38 and the internal volume of the second port 34 are at least 0.15 mL. This amount is considered sufficient to capture the first blood sample taken from a potentially contaminated system. In some embodiments, the combined internal volume of the vented flashback and diversion chamber 38 and the internal volume of the second port 34 are between 0.15 mL and 2.0 mL. In other embodiments, the combined internal volume of the vented flashback and diversion chamber 38 and the internal volume of the second port 34 are between 0.15 mL and 5.0 mL. However, it should be understood that the internal volume of the vented flashback and diversion chamber 38 is not limited to these examples.

[0040] Referring now to FIG. 2, there is shown a blood sampling system 10 coupled to a vascular access device in a first configuration. Specifically, the blood sampling device 12 can be coupled, for example, via a needleless connection, near a patient access port 42. The nearby patient access port 42 is in fluid communication with a catheter adapter 44 having a catheter 46 extending distally therefrom. As described above, the blood sampling system 10 can be used with any suitable vascular access device, such as, for example, a BD NEXIVA™ Closed IV Catheter System, a BD CATHENA™ Catheter System, a BD VENFLON™ Pro Safe-Shield IV Catheter System, a BD NEOFLON™ IV Cannula System, a BD INSYTE™ AUTOGUARD™ BC Shield IV Catheter System, or another suitable vascular access device.

[0041] FIG. 3 shows the blood sampling system 10 in a second configuration. Using a blood sampling device 12 coupled to a proximal patient access port 42, a blood sampling interface, such as, for example, a luer lock access device (LLAD) 40, can be coupled to a first port 32 of a proximal dual port adapter 30. With the luer lock access device 40 in place, a clinician can advance a blood sampling tube 48 housed within the blood sampling device 12 through both the catheter adapter 44 and the catheter 46 by distal advancement of an actuator 16 along an introducer body 14. In its fully advanced position, the blood sampling tube 48 extends to or beyond the distal tip of the indwelling catheter 46 into a high blood flow location within the patient's vein, thereby providing a fluid path for venous blood to be sampled through the blood sampling device 12.

[0042] Using the blood collection tube 48 in this forward position shown in FIG. 3, the vented flashback and diversion chamber 38 extending from the second port 34 is vented either automatically or manually. This venting of the vented flashback and diversion chamber 38 allows the initial volume of blood to flow through the tube 48 into the proximal extension tube 26 and into the vented flashback and diversion chamber 38 while the blood flow stops at the vented portion (not shown) of the vented flashback and diversion chamber 38. In this way, the system 10 is primed with an initial volume of blood isolated within the vented flashback and diversion chamber 38, and the system is in a state for connecting, for example, to a blood culture vacuum tube for collecting a sample via the blood sample fluid path and the luer lock access device 40. However, since the collection container is not yet coupled to the luer lock access device 40, the blood flow stops at the vented flashback and diversion chamber 38.

[0043] In some embodiments, ventilation flashback and ventilation and blood flow to the shunt chamber 38 cease when blood contacts the ventilation portion (not shown). The ventilation portion can be formed from, for example, a membrane, paper, porous material, film, or mechanical mechanism that allows air to pass therethrough but stops fluid from passing therethrough when wet. When the ventilation portion is wet, it prevents air from being drawn into the ventilated flashback and shunt chamber 38, which prevents the volume of blood retained in the ventilated flashback and shunt chamber 38 from entering the first port 32, and thus prevents the initial volume of potentially contaminated blood from entering the blood collection container coupled to the luer lock access device 40. However, alternative means for separating the initial blood sample within the ventilated flashback and shunt chamber 38 are also possible according to other embodiments of the present disclosure. For example, in some embodiments, the initial blood sample can be manually separated via mechanical occlusion (i.e., via a clamp on the distal portion of the ventilated flashback and shunt chamber 38). In some embodiments, a one-way ventilation / fluid or check valve may be provided at the inlet of the ventilated flashback and shunt chamber 38, thereby allowing the first blood sample to flow therethrough but preventing the outflow of the blood sample therefrom.

[0044] Next, referring to FIG. 4, a blood collection system 10 coupled to a vascular access device in a third configuration is shown. In the third configuration shown in FIG. 4, the blood collection container 52 is fluidly coupled to the luer lock access device 40, thereby allowing a blood sample from the patient's vasculature to flow through the extension tube 26 via the first port 32 of the proximal dual port adapter 30. The blood collection container 52 can be any suitable container, such as, for example, a BD BACTEC™ blood culture collection container, a vacuum tube, a syringe, etc. As described above, the initial volume of blood is separated within the ventilated flashback and shunt chamber 38, thereby preventing this initial volume of potentially contaminated blood from passing through the first port and into the blood collection container 52, and assisting in preventing false positive blood culture tests.

[0045] When the desired blood sample is collected in the blood collection container 52, the blood collection container 52 can be removed from the luer lock access device 40 and sent for analysis. If additional blood samples are needed, one or more blood collection containers 52 can be coupled to the luer lock access device 40 to draw the desired sample. In each of these sample collections, the first (and potentially contaminated) amount of blood remains in the vented flashback and diversion chamber 38.

[0046] The blood collection system 10 described above with respect to FIGS. 1-4 is configured with a luer lock access device 40 and an extension tube 26 to allow for greater flexibility during blood collection and to allow for the upright positioning of the blood collection container 52 during sample collection. In some embodiments, the blood collection system 10 can include a luer lock access device 40 having an integrated extension tube. In other embodiments, the luer lock access device 40 can have a removably attached extension tube. In some embodiments, all or some of the fluid pathways of the extension tube 26 can be optimized to reduce hemolysis during blood culture sample collection and / or during subsequent vacuum tube or syringe-based blood sample collection after blood culture sample collection.

[0047] Next, referring to FIG. 5, a blood collection system 100 according to another aspect of the present disclosure is shown. The blood collection system 100 includes the same features as the blood collection system 10 described above with respect to FIGS. 1-4. However, in the blood collection system 100, the vent flushback and diversion chamber 38 is coupled to the first port 32 of the proximal dual port adapter 30, while the luer lock access device 40 is coupled to a second port 34 that extends at an angle from the first port 32. Thus, it should be understood that the vent flushback and diversion chamber 38 can collect and hold an initial blood sample prior to connection of the blood collection container 52, whether the vent flushback and diversion chamber 38 is coupled to the first port 32 where the vent flushback and diversion chamber 38 is arranged in series with the extension tube 26 (as shown in FIG. 5), or to the second port 34 (as shown in FIGS. 1-4).

[0048] Referring to FIG. 6, a blood collection system 200 according to another aspect of the present disclosure is shown. Similar to the blood collection systems 10 and 100 described above, the blood collection system 200 is configured to be used with a blood collection device 12 coupled to a proximal patient access port 42 in fluid communication with a catheter adapter 44. However, instead of a proximal dual port adapter, the blood collection system 200 includes a y-site connector 66 configured to be coupled to the proximal end of a proximal extension tube 60. A capline interface 64 is provided on the y-site connector 66, for example, for selective attachment of a luer lock access device 40. Further, the y-site connector 66 includes a side port 67, and a secondary extension tube 65 extends from the side port 67. The proximal end of the secondary extension tube 65 may include a connector 69, and the connector 69 is configured to receive a vented flushback and diversion chamber 70.

[0049] As shown in FIG. 6, the first occlusion device 62 may be provided in series with the proximal extension tube 60 to enable selective occlusion of the fluid flow through the proximal extension tube 60, and the second occlusion device 68 may be provided in series with the secondary extension tube 65 to enable selective occlusion of the fluid flow through the secondary extension tube 65.

[0050] Before the blood collection container 52 is coupled to the luer lock access device 40, as shown in FIG. 6, the blood collection tube 48 extends beyond the catheter 46 to the forward position. Next, the flashback and diversion chamber 70 is vented either automatically or manually. This venting of the flashback and diversion chamber 70 allows an initial volume of blood to flow through the tube 48, through the proximal extension tube 60, through the secondary extension tube 65, and into the vented flashback and diversion chamber 70 while the blood flow stops at the vented portion (not shown) of the flashback and diversion chamber 70. In this way, the initial volume of blood is isolated within the vented flashback and diversion chamber 70 and the secondary extension tube 65. Next, when the blood collection container 52 is coupled to the luer lock access device 40, the blood flows through the proximal extension tube 60 into the blood collection container 52, and the first volume of blood remains isolated within the vented flashback and diversion chamber 70 and the secondary extension tube 65 so that potentially contaminated blood does not enter the blood collection container 52. As described above, the second occlusion device 68 may be closed by a clamp or other means to ensure that the initial volume of blood remains separated from the blood sample collected in the blood collection container 52.

[0051] Next, referring to FIG. 7, a blood collection system 300 according to another aspect of the present disclosure is shown. The blood collection system 300 is configured to be used with the blood collection device 12 described above with respect to FIG. 1, and the blood collection device 12 can be coupled to a proximal patient access port (not shown) that is in fluid communication with a catheter adapter (not shown). The blood collection system 300 includes a proximal dual port adapter 78 configured to be coupled to the proximal end of the proximal extension tube 75. The dual port adapter 78 includes a first port 80 and a second port 79. The first port 80 extends substantially in series with the proximal end portion of the proximal extension tube 75, and the second port 79 extends at an angle with respect to the first port 80, for example, to form a Y-shaped adapter. A luer lock access device 40 can be coupled to the second port 79, and the luer lock access device is configured to receive, for example, a blood collection container 52. Further, a secondary extension tube 77 may extend from the first port 80. The proximal end of the secondary extension tube 77 may include a connector 82, and the connector 82 is configured to receive a vented flashback and diversion chamber 83.

[0052] As shown in FIG. 7, a first occlusion device 76 may be provided in series with the proximal extension tube 75 to allow for selective occlusion of fluid flow through the proximal extension tube 75, and a second occlusion device 81 may be provided in series with the secondary extension tube 77 to allow for selective occlusion of fluid flow through the secondary extension tube 77.

[0053] Before the blood collection container 52 is coupled to the luer lock access device 40, a blood collection tube (not shown) of the blood collection device 12 extends to an advanced position beyond the distal end of an indwelling catheter (not shown). Next, the flashback and diversion chamber 83 is vented either automatically or manually. This venting of the vented flashback and diversion chamber 83 allows an initial volume of blood to flow through the tube extending into the patient's vasculature, through the proximal extension tube 75, through the secondary extension tube 77, and into the vented flashback and diversion chamber 83 while stopping at the vented portion (not shown) of the vented flashback and diversion chamber 83. In this way, the initial volume of blood is isolated within the vented flashback and diversion chamber 83 and the secondary extension tube 77. Next, when the blood collection container 52 is coupled to the luer lock access device 40, blood flows through the proximal extension tube 75 into the blood collection container 52, and the first volume of blood remains isolated within the vented flashback and diversion chamber 83 and the secondary extension tube 77 so that potentially contaminated blood does not enter the blood collection container 52. As described above, the second occlusion device 82 may be closed by a clamp or other means to ensure that the initial volume of blood remains separated from the blood sample collected in the blood collection container 52.

[0054] Referring now to FIG. 8, a blood sampling system 400 according to another aspect of the present disclosure is shown. The blood sampling system 400 is configured to be used with the blood sampling device 12 described above with respect to FIG. 1, and the blood sampling device 12 can be coupled to a proximal patient access port (not shown) that is in fluid communication with a catheter adapter (not shown). The blood sampling system 400 includes a proximal dual port adapter 88 configured to be coupled to the proximal end of the proximal extension tube 85. The dual port adapter 88 includes a first port 90 and a second port 89, the first port 90 extending substantially in series with the proximal end portion of the proximal extension tube 85, and the second port 89 extending at an angle to the first port 90, for example, to form a Y-shaped adapter. A luer lock access device 40 can be coupled to the second port 89, and the luer lock access device 40 is configured to receive, for example, a blood collection container 52.

[0055] The blood sampling system 400 further includes a venting flashback and diversion device 91 coupled to the first port 90 of the proximal dual port adapter 88. In the embodiment shown in FIG. 8, the venting flashback and diversion device 91 includes a body 92, a venting diversion and isolation chamber 93, and a venting portion 94. In one embodiment, the venting portion 94 is configured to automatically vent air when the blood sampling device 12 is coupled to the vascular access device and the blood sampling tube of the blood sampling device 12 is advanced into the patient's vasculature, thereby allowing an initial volume of blood to flow through the proximal extension tube 85 into the venting diversion and isolation chamber 93. Alternatively, in other embodiments, the venting portion 94 may be manually vented when the blood sampling device 12 is coupled to the vascular access device.

[0056] The ventilation shunt and separation chamber 93 can have any shape or form having a volume sufficient to shunt and hold an initial blood volume. In some embodiments, the internal volume of the ventilation shunt and separation chamber 93 is at least 0.15 mL. This amount is believed to be sufficient to capture the first blood sample taken from a potentially contaminated system. In some embodiments, the internal volume of the ventilation shunt and separation chamber 93 is between 0.15 mL and 2.0 mL. In other embodiments, the internal volume of the ventilation shunt and separation chamber 93 is between 0.15 mL and 5.0 mL. However, it should be understood that the internal volume of the ventilation shunt and separation chamber 93 is not limited to these examples.

[0057] As shown in FIG. 8, the occlusion device 86 may be provided in series with the proximal extension tube 85 to enable selective occlusion of the fluid flow through the proximal extension tube 85.

[0058] Before the blood collection container 52 is coupled to the luer lock access device 40, the blood collection tube (not shown) of the blood collection device 12 extends to a forward position beyond the distal end of the indwelling catheter (not shown). Next, the vented shunt and separation chamber 93 is vented either automatically or manually. This venting of the vented shunt and separation chamber 93 allows an initial volume of blood to flow through the patient's vasculature, the proximal extension tube 85, and the tube extending to the vented shunt and separation chamber 93 while the blood flow stops at the vent flashback and the vent portion 94 of the shunt device 91. In this way, the initial volume of blood is separated within the vented shunt and separation chamber 93. Next, when the blood collection container 52 is coupled to the luer lock access device 40, the blood flows through the proximal extension tube 85 into the blood collection container 52, and the initial volume of blood remains separated within the vented shunt and separation chamber 93 so that potentially contaminated blood does not enter the blood collection container 52.

[0059] Using the blood collection systems 10, 100, 200, 300, and 400 described above with respect to FIGS. 1-8, more advantages can be realized than in the conventional methods of blood culture sample collection. First, since existing vascular access devices are used for blood culture sample collection, the number of needle sticks for the patient can be reduced, thereby improving the patient's comfort and experience. Further, by using a blood collection device such as, for example, PIVO (trademark) of Becton, Dickinson and Company, the blood collection tube can extend beyond the distal tip of the catheter, thus reducing the risk of false positives from microorganisms that may be present in the catheter fluid pathway of the indwelling catheter.

[0060] Furthermore, the blood collection system incorporates the automatic and passive diversion and capture of the initial blood flow, which can be contaminated due to the presence of bacteria and / or fungi on the patient's skin, hair follicles, and dermal layer. This first blood flow can be separated passively or manually within the flashback and diversion chamber. Thus, the blood collection system eliminates the need for separate blood discard samples to be collected, thereby reducing the collection step and improving the workflow while reducing the opportunity for contamination during blood collection due to a reduced number of connections to the blood collection system. Also, existing blood culture collection devices with a diversion chamber can be used immediately with the catheter upon insertion, whereas the above-described blood collection system can extend the use of a blood collection device with a diversion chamber for any period throughout the catheter dwell time.

[0061] The blood collection systems 10, 100, 200, 300, and 400 are also compatible with standard luer lock access devices, thereby enabling vacuum blood collection immediately after blood culture sample collection. Further, the blood collection systems 10, 100, 200, 300, and 400 can be provided with an optimized fluid pathway for reducing hemolysis of blood samples in subsequent blood collection samples after the first blood culture sample collection.

[0062] Although some embodiments of the blood sampling system configured for collecting a blood sample from an indwelling catheter are described in the foregoing detailed description, those skilled in the art can make modifications and changes to these embodiments without departing from the scope and spirit of the present invention. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The present invention described above is defined by the appended claims, and all changes to the present invention within the meaning and scope of equivalence of the claims are included within their scope.

Claims

**Claim 1** A blood sampling system A blood sampling device having a distal end portion and a proximal end portion, the blood sampling device including an actuator and a blood sampling tube operably coupled to the actuator, the actuator configured to selectively advance the blood sampling tube through a catheter of the vascular access device when the blood sampling device is coupled to the vascular access device, the blood sampling device; An extension tube extending from the proximal end portion of the blood sampling device, the extension tube being in fluid communication with the blood sampling tube of the blood sampling device, the extension tube; A dual-port adapter coupled to the proximal end of the extension tube, the dual-port adapter comprising a first port and a second port, the dual-port adapter; A vent flashback and shunt chamber coupled to one of the first port and the second port, the vent flashback and shunt chamber configured to receive and hold an initial volume of blood collected through the extension tube by the blood sampling device, the vent flashback and shunt chamber; A system comprising. **Claim 2** The system of claim 1, wherein the vent flashback and shunt chamber further comprises a vent portion. **Claim 3** The system of claim 2, wherein the vent portion is configured to vent air when the blood sampling device is coupled to the vascular access device and the blood sampling tube of the blood sampling device advances into the patient's vascular system and draws the initial volume of blood into the vent flashback and shunt chamber. **Claim 4** The system of claim 3, wherein the vent portion is configured to automatically vent air when the blood sampling device is coupled to the vascular access device and the blood sampling tube of the blood sampling device advances into the patient's vascular system. **Claim 5** The system of claim 3, wherein the vent portion is manually vented when the blood sampling device is coupled to the vascular access device and the blood sampling tube of the blood sampling device advances into the patient's vascular system. **Claim 6** The ventilation portion is formed from at least one of a membrane, paper, porous material, film, or mechanical mechanism that allows air to pass therethrough but prevents fluid from passing therethrough when wet, the system of claim 3.

7. The system of claim 1, further comprising a removable end cap positionable on the other of the first port and the second port.

8. The system of claim 1, further comprising a luer lock access device coupled to the other of the first port and the second port.

9. The system of claim 1, further comprising a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to one of the first port and the second port, and a proximal end of the secondary extension tube is coupled to a connector.

10. The system of claim 9, wherein the ventilation flashback and diversion chamber are coupled to the connector.

11. The system of claim 9, further comprising a fluid occlusion device disposed in series with the secondary extension tube, the fluid occlusion device configured to selectively occlude its blood flow from the ventilation flashback and diversion chamber.

12. The system of claim 1, wherein the blood collection device further comprises an introducer body, and the actuator is configured to move linearly along the introducer body to advance and retract the blood collection tube from the distal end portion of the blood collection device.

13. The system of claim 1, wherein the ventilation flashback and diversion chamber and the second port have a combined internal volume of at least 0.15 mL.

14. A method of using a blood sample collection system, comprising: providing the blood sample collection system, the system comprising: a blood collection device having a distal end portion and a proximal end portion, the blood collection device comprising an actuator and a blood collection tube operably coupled to the actuator; an extension tube extending from the proximal end portion of the blood collection device, the proximal extension tube being in fluid communication with the blood collection tube of the blood collection device; A dual-port adapter coupled to the proximal end of the extension tube, the dual-port adapter comprising a first port and a second port, a dual-port adapter; A ventilation flashback and diversion chamber coupled to one of the first port and the second port; comprising; coupling the blood collection device to a vascular access device having an indwelling catheter; advancing the blood collection tube of the blood collection device through the vascular access device and beyond the distal tip of the indwelling catheter; allowing an initial volume of blood to flow through the blood collection tube and the extension tube into the ventilation flashback and diversion chamber of the blood sample collection system; A method comprising.

15. The method of claim 14, further comprising venting the ventilation flashback and diversion chamber prior to allowing the initial volume of blood to flow therein.

16. The method of claim 15, wherein venting the ventilation flashback and diversion chamber comprises manual ventilation.

17. The method of claim 15, wherein venting the ventilation flashback and diversion chamber comprises automatic ventilation.

18. The method of claim 14, comprising coupling a blood collection interface to the other of the first port and the second port of the dual-port adapter.

19. After the initial volume of blood has been collected in the ventilation flashback and diversion chamber, coupling a first blood collection container to the blood collection interface; collecting a first blood sample in the first blood collection container; The method of claim 18, comprising.

20. removing the first blood collection container from the blood collection interface and coupling a second blood collection container to the blood collection interface; collecting a second blood sample in the second blood collection container; The method of claim 19, comprising.

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