A blood sampling device with a series shunt volume for collecting a blood culture sample from a PIV during indwelling

Abstract

The blood collection system comprises a blood collection device having an actuator and a blood collection tube operably connected to the actuator. The actuator is configured to selectively advance the blood collection tube through a catheter of the vascular access device when the blood collection device is connected to the vascular access device. The system also includes an extension tube extending from the blood collection device, a proximal extension tube in fluid communication with the blood collection tube, and a proximal connector disposed at the proximal end of the extension tube. Further, the system includes an initial blood volume shunt device disposed in series with the extension tube between the blood collection device and the proximal connector. The initial blood volume shunt device includes a shunt isolation chamber configured to receive and hold an initial blood volume collected by the blood collection device through the extension tube.

Description

Technical Field

[0001] The present disclosure generally relates to systems and methods for collecting blood samples for blood culture testing from vascular access devices such as peripheral intravenous catheters (PIVCs). More specifically, the systems described herein include blood collection devices having a series-vented blood diversion chamber.

Background Art

[0002] This application claims priority to U.S. Provisional Application No. 63 / 343,752, filed May 19, 2022, entitled "Blood Collection Device with Series Diversion Volume for Collecting Blood Culture Samples from a PIV During Indwelling," the entire disclosure of which is incorporated herein by reference in its entirety.

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

[0004] Blood cultures are often used as a tool to detect the presence of bacteria or fungi in a patient's blood sample, identify the type of bacteria or fungi present, and direct the patient's treatment. However, accidental contamination of blood samples is a common problem, resulting in false positives, often resulting in the patient being prescribed unnecessary treatments, such as broad-spectrum antibiotics. To address this issue, some healthcare professionals wash the patient's skin before the blood collection procedure. This reduces the false positive rate, but due to bacteria and / or fungi living in hair follicles, the false positive rate can still be quite high (e.g., 3-5%). Therefore, some systems also divert a small amount of the initially collected blood and discard the initial (potentially contaminated) volume. However, these systems are costly and time-consuming, and can only be used in conjunction with an intravenous catheter immediately after initial placement. In addition, these systems often require puncturing the patient's skin to obtain the sample, which can be uncomfortable for the patient. Summary of the Invention [Problem to be solved by the invention]

[0005] Additionally, needleless blood collection systems, such as PIVO™ from Velano Vascular, Inc., are intended to be used in conjunction with an indwelling venous catheter placed in a patient's vein to collect one or more blood samples directly from the vascular access device, avoiding the need for additional (and uncomfortable) venipuncture. However, when a venous catheter is inserted into a patient's vein, bacteria and / or fungi may be introduced during the insertion process due to contact with the patient's skin and dermal layer. Thus, the initial blood volume collected by a needleless blood collection system may contain bacteria and / or fungi present solely due to catheter insertion, increasing the risk of false positive blood culture results. [Means for solving the problem]

[0006] According to one aspect of the present disclosure, a blood sampling system is disclosed that includes a blood sampling device having a distal end and a proximal end. The blood sampling device includes an actuator and a blood sampling tube operatively coupled to the actuator. The actuator is 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 system also includes an extension tube extending from the proximal end of the blood sampling device. The proximal extension tube is in fluid communication with the blood sampling tube of the blood sampling device, and a proximal connector is disposed at the proximal end of the extension tube. The blood sampling system further includes an initial blood volume shunt device disposed in series with the extension tube between the blood sampling device and the proximal connector. The initial blood volume shunt device includes a shunt isolation chamber configured to receive and hold an initial blood volume sampled through the extension tube by the blood sampling device.

[0007] In some embodiments, the initial blood volume shunt device further includes a vent in fluid communication with the shunt isolation chamber.

[0008] In some embodiments, the vent is configured to discharge air when the blood sampling tube of the blood sampling device is advanced into a patient's blood vessel to collect an initial blood volume in the shunt isolation chamber when the blood sampling device is coupled to the vascular access device.

[0009] In some embodiments, the vent is configured to automatically discharge air when the blood sampling device is coupled to the vascular access device and the blood sampling tube of the blood sampling device is advanced into a patient's blood vessel.

[0010] In some embodiments, the vent 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 is advanced into a patient's blood vessel.

[0011] In some embodiments, the vent is formed of at least one of a membrane, paper, porous material, film, or mechanical feature that allows air to pass through but not fluid when wet.

[0012] In some embodiments, the initial blood volume shunt device further comprises a flashback visualization section and a blood sample fluid path arm, and the flashback visualization section and the blood sample fluid path arm are in fluid communication with the extension tube and the proximal connector.

[0013] In some embodiments, the initial blood volume shunt device further includes a distal fluid path shunt adapter and a proximal vent collar adapter, and the shunt isolation chamber extends between the distal fluid path shunt adapter and the proximal vent collar adapter.

[0014] In some embodiments, the proximal vent collar adapter includes a vent portion, and the proximal end of the shunt isolation chamber ends at the vent portion.

[0015] In some embodiments, the initial blood volume shunt device further includes a main flow path tube that extends between the distal fluid path shunt adapter and the proximal vent collar adapter and is arranged in parallel with the shunt isolation chamber, and the main flow path tube is in fluid communication with the extension tube and the proximal connector.

[0016] In some embodiments, the initial blood volume shunt device further includes a fluid occlusion device disposed at a distal portion of the shunt isolation chamber to selectively occlude the flow of blood from the shunt isolation chamber.

[0017] In some embodiments, the proximal connector is configured to be removably coupled to a luer lock access device.

[0018] In some embodiments, the proximal connector is integrated with a luer lock access device.

[0019] 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 of the blood sampling device.

[0020] In some embodiments, the split isolation chamber has an internal volume of at least 0.15 mL.

[0021] According to another aspect of the present disclosure, a method of using a blood sample collection system is disclosed. The method includes providing a blood sample collection system, the system including a blood collection device having a distal end and a proximal end, the blood collection device including an actuator and a blood collection tube operably coupled to the actuator, the actuator configured to selectively advance the blood collection tube, the blood collection device having an extension tube extending from the proximal end of the blood collection device, the proximal extension tube being in fluid communication with the blood collection tube of the blood collection device, the blood collection interface being disposed at the proximal end of the extension tube, the initial blood volume diverter being disposed in series with the extension tube between the blood collection device and the blood collection interface, the initial blood volume diverter including a split isolation chamber configured to receive and hold an initial blood volume collected through the extension tube by the blood collection device. The method also includes 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 beyond the distal end of the indwelling catheter, and collecting an initial blood volume into the split isolation chamber of the initial blood volume device through the blood collection tube and the extension tube.

[0022] In some embodiments, the method includes venting the split isolation chamber prior to collecting the initial blood volume into the split isolation chamber.

[0023] In some embodiments, the method further includes clamping the distal portion of the split isolation chamber after the initial blood volume has been collected in the split isolation chamber.

[0024] In some embodiments, the method includes coupling a first blood collection container to the blood collection interface and collecting a first blood sample in the first blood collection container after the initial blood volume has been collected in the split isolation chamber.

[0025] In some embodiments, the method includes removing a first blood collection container from the blood collection interface and connecting a second blood collection container to the blood collection interface, and collecting a second blood sample within the second blood collection container.

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

Brief Description of the Drawings

[0027]

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[0028] The following description is provided to enable a person skilled in the art to make and use the described aspects of the present invention. However, it will be apparent to those skilled in the art that various modifications, equivalents, variations, and alternatives are readily available. All such modifications, variations, equivalents, and alternatives are intended to be included within the spirit and scope of this disclosure.

[0029] In the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof are related to the present invention as shown in the drawings. However, it should be understood that the present invention can assume 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. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0030] In the present disclosure, the distal end of a component or device means the end that is farthest 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 or use, and the proximal end means the end that is closest to the user's hand. Similarly, in the present application, the terms "distal direction" and "distal" mean the direction towards the access connector portion of the fluid transfer device, and the terms "proximal direction" and "proximal" mean the direction opposite to the direction of the connector.

[0031] Although not illustrated or described herein, it should be understood that the blood sample collection system described below can be used for blood collection from any suitable vascular access device, such as, for example, the BD NEXIVA (trademark) closed IV catheter system, the BD CATHENA (trademark) catheter system, the BD VENFLON (trademark) Pro safety shield IV catheter system, the BD NEOFLON (trademark) IV cannula system, the BD INSYTE (trademark) AUTOGUARD (trademark) BC shield IV catheter system, or other suitable vascular access devices.

[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, the embodiments of the present disclosure are similarly extensible for use with other catheter devices.

[0033] Referring to FIG. 1, a blood sampling system 10 according to one aspect of the present disclosure is shown. The blood sampling system 10 includes a “line draw” blood sampling device 12 configured to couple to a PIVC and including a flexible probe (not shown) that is advanced through the PIVC and beyond the tip of the catheter into the blood vessel to collect a blood sample. After blood sampling, the blood sampling device 12 may be removed from the PIVC and discarded. An example of such a blood sampling device is known as the PIVO™ of Velano Vascular, Inc. However, it should be understood that the blood sampling system 10 is not limited to such a device, and any “line draw” blood sampling device capable of collecting blood through an indwelling catheter may be utilized.

[0034] The blood sampling device 12 includes an introducer body 14 and an actuator 16. The actuator 16 is configured to be movably arranged in series by a clinician along a track or other feature between the proximal end 18 and the distal end 20 of the introducer body 14. The actuator 16 is operably coupled to an elongate flexible probe or tube (not shown) through a distal introducer portion 24 located near the distal end 20 of the introducer body 14. That is, when the blood sampling device 12 is coupled to a vascular access device, displacing the actuator 16 in a first (distal) direction causes the tube to advance through the distal introducer portion 24 so that the tube can enter the patient's vasculature. Conversely, moving the actuator 16 in a second direction (proximal direction) causes the tube to retract through the distal introducer portion 24 and ultimately the tube to retract from the patient's blood vessel.

[0035] The blood sampling device also includes a connector member 22 configured to selectively couple the blood sampling 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 a lobster claw clip type connector, and the blood sampling device 12 can be fixed to the surface of the needleless access connector by the distal clip portion on the opposite side. To release the distal clip portion from engagement with the needleless access connector, the pair of proximal clip portions are sized and configured to be pinched or otherwise manipulated by a clinician.

[0036] Continuing to refer to FIG. 1, a proximal extension tube 26 extends from a proximal end 18 of the introducer body 14, and the proximal extension tube 26 is fluidly coupled to a blood sampling tube (not shown) of the blood sampling device 12. Further, a proximal connector 38, such as a luer port, for example, is coupled to the proximal end of the proximal extension tube 26, and the proximal connector 38 is configured to connect to, for example, a luer lock access device or other blood sampling interface.

[0037] In series with the proximal extension tube 26, between the blood sampling device 12 and the proximal connector 38, the blood sampling system 10 includes an initial blood volume diversion device 28. As will be described in more detail below, since the initial blood volume can be contaminated by, for example, bacteria and / or fungi introduced during catheter insertion into the patient's skin and dermal layer, the initial blood volume diversion device 28 is configured to divert and store the initial blood volume collected into the system via the blood sampling device 12.

[0038] In the embodiment shown in FIG. 1, the initial blood volume diversion device 28 includes a body 30, a vented diversion isolation chamber 32, and a venting portion 34. In one embodiment, the venting portion 34 is configured to automatically expel air when the blood collection device 12 is coupled to the vascular access device and the blood collection tube of the blood collection device 12 is advanced into the patient's blood vessel, whereby the initial blood volume can flow through the proximal extension tube 26 into the vented diversion isolation chamber 32. Alternatively, in other embodiments, the venting portion 34 may be manually vented when the blood collection device 12 is coupled to the vascular access device.

[0039] The vented diversion isolation chamber 32 may be of any shape or form as long as it has a volume sufficient to divert and hold the initial blood volume. In some embodiments, the internal volume of the vented diversion isolation chamber 32 is at least 0.15 mL. This volume is considered sufficient to capture the initial blood sample that may be contaminated drawn into the system. In some embodiments, the internal volume of the vented diversion isolation chamber 32 is between 0.15 mL and 2.0 mL. In other embodiments, the internal volume of the vented diversion isolation chamber 32 is between 0.15 mL and 5.0 mL. However, it should be understood that the internal volume of the vented diversion isolation chamber 32 is not limited to these examples.

[0040] Referring now to FIGS. 2 and 4, there is shown a blood sampling system 10 connected in a first configuration to a vascular access device. Specifically, the proximal connector 38 is connected to a luer lock access device 40 configured to receive any suitable blood sampling container and / or syringe for collecting a blood sample. Further, the blood sampling device 12 is connected to a patient-proximal access port 42, for example, via a needle-free connection. The patient-proximal 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 other suitable vascular access devices.

[0041] When the blood sampling device 12 is first coupled to the patient-proximal access port 42, the blood sampling tube 48 is not at the distal end of the catheter 46 or its forward position beyond, and no blood enters the blood sampling device 12. However, the clinician can advance the blood sampling tube 48 housed within the blood sampling device 12 through both the catheter adapter 44 and the catheter 46 by advancing the actuator 16 distally along the introducer body 14. In the fully advanced position, the blood sampling tube 48 extends to the distal end of the indwelling catheter 46 or beyond, and to a high blood flow position within the patient's vein. Thereby, a fluid path for collecting venous blood is provided through the blood sampling device 12.

[0042] With the blood collection tube 48 in this forward position, the venting portion 34 of the initial blood volume diverter 28 is vented either automatically or manually. Due to the venting of this venting portion 34 and the venous pressure, as shown in FIGS. 2 and 4, the initial blood volume flows through the tube 48 into the proximal extension tube 26, then into the vented diverter isolation chamber 32 of the initial blood volume diverter 28, and the blood flow stops at the venting portion 34. When the vented diverter isolation chamber 32 is filled with the initial blood volume, a small amount of blood moves into the flashback visualization portion of the initial blood volume diverter 28 and the blood sample fluid path arm 50. In this way, the system 10 is primed with the initial blood volume isolated within the vented diverter isolation chamber 32, and the system is placed in a state for collecting a sample, for example, connecting to a blood culture vacuum tube, via the blood sample fluid path and the luer lock access device 40. However, since the collection container is not yet connected to the luer lock access device 40, the blood flow stops within the flashback visualization portion of the initial blood volume diverter 28 and the blood sample fluid path arm 50.

[0043] In some embodiments, when blood contacts the venting portion 34, the discharge of air and the inflow of blood into the initial blood volume diverter 28 cease. The venting portion 34 may be formed, for example, of a membrane, paper, porous material, film, or mechanical characteristics that allow air to pass through but do not allow fluid to pass through when wet. When the venting portion 34 is wet, air is prevented from being drawn into the initial blood volume diverter 28, thereby preventing the blood volume retained within the vented diverter isolation chamber 32 from entering the blood sample fluid path portion 36 of the extension tube 26, and thus preventing the potentially contaminated initial blood volume from entering the blood collection container coupled to the luer lock access device. However, according to other embodiments of the present disclosure, alternative means for isolating the initial blood sample within the initial blood volume diverter 28 are also possible. For example, in some embodiments, the first blood sample may be manually isolated via mechanical occlusion (i.e., via a clamp located at the distal portion of the vented diverter isolation chamber 32). In some embodiments, a one-way venting / fluid or check valve is provided at the inlet of the vented diverter isolation chamber 32, thereby allowing the first blood sample to flow therein but preventing the outflow of the blood sample therefrom.

[0044] Next, referring to FIGS. 3 and 5, a blood collection system 10 coupled to a vascular access device in a second configuration is shown. In the second configuration shown in FIGS. 3 and 5, a blood collection container 52 is fluidly coupled to the luer lock access device 40, whereby a blood sample is collected from the patient's blood vessel through the extension tube 26 via the flashback visualization portion and the blood sample fluid path arm 50 of the initial blood volume diverter 28. The blood collection container 52 may 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 blood volume is isolated within the vented diverter isolation chamber 32, thereby preventing this potentially contaminated initial blood volume from reaching the blood collection container 52 by passing through the blood sample fluid path 36, which helps prevent false positives in blood culture testing.

[0045] Once the desired blood sample has been 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 required, one or more blood collection containers 52 can be connected to the luer lock access device 40 to collect the desired samples. In each of these sample collections, the initial (potentially contaminated) blood volume remains within the vented diversion isolation chamber 32 of the initial blood volume diversion device 28.

[0046] With reference to FIGS. 1-5, the blood collection system 10 described above is configured with a luer lock access device 40 and an extension tube 26 to provide greater flexibility during blood collection and to allow the blood collection container 52 to be placed upright 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 may have a removably attached extension tube. In some embodiments, all or part of the fluid path of the extension tube 26 may 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. 6, a blood collection system 70 according to another aspect of the present disclosure is shown. Similar to the blood collection system 10 described above with respect to FIGS. 1-5, the blood collection system 70 is configured to couple to a PIVC (not shown) and includes a "line draw" blood collection device 72 that includes a flexible probe or tube 84 that can be advanced through the PIVC and beyond the tip of the catheter into the blood vessel to collect a blood sample. An example of such a blood collection device is known as the PIVO (trademark) of Velano Vascular, Inc. However, it should be understood that the blood collection system 70 is not limited to such a device and any "line draw" blood collection device that can collect blood through an indwelling catheter can be utilized.

[0048] The blood sampling device 72 includes an introducer body 74 and an actuator 78. The actuator 78 is configured to be linearly movable by a clinician along a track between the proximal end 76 and the distal end 80 of the introducer body 74 or along other features of the introducer body 74. As shown in FIG. 6, when the actuator 78 is moved toward the distal end 80, the actuator 78 is operably coupled to the blood sampling tube 84 to advance or retract the tube 84 through a distal introducer portion located near the distal end 80 of the introducer body 74. Conversely, when the actuator 78 is displaced in the proximal direction, the tube 84 retracts through the distal introducer portion and ultimately the tube 84 retracts from the patient's blood vessel. The blood sampling device also includes a connector member 82 configured to selectively couple the blood sampling device 72 to, for example, a needleless access connector of an adapter coupled to a vascular access device. In some embodiments, the connector member 84 is configured as a luer lock type connector, but is not limited thereto and may be any suitable connector.

[0049] Continuing to refer to FIG. 6, a proximal extension tube 86 extends from the proximal end 76 of the introducer body 74, and the proximal extension tube 86 is fluidly coupled to the blood sampling tube 84 of the blood sampling device 72. Further, a luer lock access device 102 is removably or non-removably coupled to the proximal end of the proximal extension tube 86. However, it should be understood that other blood sampling interfaces may be used and the blood sampling system 70 is not limited to the use of only luer lock access devices.

[0050] In series with the proximal extension tube 86, between the blood collection device 72 and the luer lock access device 102, the blood collection system 70 includes an initial blood volume diversion device 88. Since the initial blood volume can be contaminated by bacteria and / or fungi introduced during catheter insertion into the patient's skin and dermal layer, the initial blood volume diversion device 88 is configured to divert and store the initial blood volume collected into the system via the blood collection device 72.

[0051] In the embodiment shown in FIG. 6, the initial blood volume diversion device 88 includes a distal fluid path diversion adapter 90 and a proximal vent collar adapter 91. A vented diversion isolation chamber 94 is provided between the distal fluid path diversion adapter 90 and the proximal vent collar adapter 91, and the vented diversion isolation chamber 94 terminates at a vent portion 96 within the proximal vent collar adapter 91. Parallel to the vented diversion isolation chamber 94, a main flow path tube 92 passes between the distal fluid path diversion adapter 90 and the proximal vent collar adapter 91, and the main flow path tube 92 is in fluid communication with the proximal extension tube 86 and the luer lock access device 102.

[0052] In one embodiment, the vent portion 96 is configured to automatically discharge air when the blood collection device 72 is connected to the vascular access device and the blood collection tube 84 of the blood collection device 72 is advanced into the patient's blood vessel, whereby the initial blood volume flows through the proximal extension tube 86 and into the vented diversion isolation chamber 94. Alternatively, in other embodiments, the vent portion 96 may be manually vented when the blood collection device 72 is connected to the vascular access device.

[0053] The vented split isolation chamber 94 can have any shape or form with a volume sufficient to divert and hold the initial blood volume. In some embodiments, the vented split isolation chamber 94 is a rigid fluid chamber. In other embodiments, the vented split isolation chamber 94 is a flexible chamber. In some embodiments, the internal volume of the vented split isolation chamber 94 is at least 0.15 mL. This volume is considered sufficient to capture the initial blood sample that can be contaminated drawn into the system. In some embodiments, the internal volume of the vented split isolation chamber 94 is between 0.15 mL and 2.0 mL. In other embodiments, the internal volume of the vented split isolation chamber 94 is between 0.15 mL and 5.0 mL. However, it should be understood that the internal volume of the vented split isolation chamber 94 is not limited to these examples.

[0054] When the blood collection tube 84 of the blood collection device 72 advances through the catheter of a vascular access device (not shown), the vent 96 of the initial blood volume diverter 94 is vented automatically or manually. By venting the vent 96 of the initial blood volume 95 flows through the tube 84 to the proximal extension tube 86 and into the vented split isolation chamber 94 of the initial blood volume diverter 88, and the blood flow can be stopped at the vent 96 as shown in FIG. 6. In this way, the system 70 is primed, the initial blood volume 95 is isolated within the vented split isolation chamber 94, and the system is ready to connect to a blood culture vacuum tube for sample collection etc. via the blood sample fluid path 100 and the luer lock access device 102. However, since the collection container is not yet connected to the luer lock access device 102, in this initial configuration, the blood flow stops at the initial blood volume diverter 88.

[0055] In some embodiments, when blood contacts the venting portion 96, the discharge of air and the inflow of blood into the initial blood volume diverter 88 cease. The venting portion 96 may be formed, for example, of a membrane, paper, porous material, film, or mechanical characteristics that allow air to pass through but prevent fluid from passing through when wet. When the venting portion 96 is wet, air is prevented from being drawn into the initial blood volume diverter 88, thereby preventing the volume of blood held within the vented diverter chamber 94 from entering the blood sample fluid path 100 of the main flow path tube 92 and the extension tube 86, and thus preventing the potentially contaminated initial blood volume 95 from entering the blood collection container coupled to the luer lock access device 102. However, according to other embodiments of the present disclosure, alternative means for isolating the initial blood sample within the initial blood volume diverter 88 are also possible. For example, as shown in FIG. 6, a fluid occlusion device 98 may be provided at the distal portion of the vented diverter chamber 94 to manually isolate the initial blood volume 95 by mechanical occlusion. In other embodiments, a one-way vent / fluid or check valve may be provided at the inlet of the vented diverter chamber 94 to allow the initial blood sample to flow in while preventing the blood sample from flowing out therefrom.

[0056] Although not shown in FIG. 6, in a second configuration of the blood collection system 70, a blood collection container such as, for example, a BD BACTEC™ blood culture collection container, a vacuum tube, a syringe, etc., is fluidly coupled to the luer lock access device 102, whereby a blood sample is collected from the patient's blood vessel through the extension tube 86 and through the main flow path tube 92 of the initial blood volume diverter 88. As described above, the initial blood volume 95 remains isolated within the vented diverter chamber 94, thereby preventing the potentially contaminated initial blood volume 95 from passing through the blood sample fluid path 100 and reaching the blood collection container, which helps prevent false positives in blood culture tests.

[0057] With respect to FIGS. 1-6, using the blood collection systems 10, 70 described above provides many advantages compared to conventional blood culture sample collection methods. First, since an existing vascular access device is used to collect the blood culture sample, the number of times the patient is pricked with a needle is reduced, and the patient's comfort and experience can be improved. Further, when using a blood collection device such as the PIVO (trademark) of Velano Vascular, Inc., for example, the blood collection tube can be extended beyond the distal end of the catheter, thus reducing the risk of false positives due to microorganisms that may be present in the catheter fluid path of the indwelling catheter.

[0058] Furthermore, the blood collection system incorporates automatic and passive diversion and capture of the initial blood stream that may be contaminated by bacteria and / or fungi present in the patient's skin, hair follicles, and dermal layer. This initial blood stream can be isolated passively or manually within the diversion chamber. Thus, with the blood collection system, there is no need to collect a separate blood discard sample, thereby reducing the collection steps, improving the workflow, and reducing the number of connections to the blood collection system, thus also reducing the chance of contamination during collection. Also, existing blood culture collection devices with a diversion chamber can only be used immediately after catheter insertion, whereas with the above blood collection system, the use of a blood collection device with a diversion chamber can be extended to any period during the catheter dwell time.

[0059] The blood collection systems 10, 70 are also compatible with standard luer lock access devices, and blood collection using a vacuum tube is possible immediately after collection of the blood culture sample. Further, the blood collection systems 10, 70 may be provided with an optimized fluid path for reducing hemolysis of the blood sample in subsequent blood collection samples after collection of the first blood culture sample.

[0060] Although some embodiments of a blood sampling system configured for taking a blood sample from an indwelling catheter have been 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 foregoing invention is defined by the appended claims, and all changes to the invention within the meaning and scope of equivalence of the claims are included within its scope.

Claims

**Claim 1** A blood collection system, A blood collection device having a distal end and a proximal end, the blood collection device comprising an actuator and a blood collection tube operably connected to the actuator, the actuator being configured to selectively advance the blood collection tube through a catheter of the vascular access device when the blood collection device is connected to the vascular access device, a blood collection device; An extension tube extending from the proximal end of the blood collection device, the proximal extension tube being in fluid communication with the blood collection tube of the blood collection device, an extension tube; A proximal connector disposed at the proximal end of the extension tube; An initial blood volume shunt device disposed in series with the extension tube between the blood collection device and the proximal connector, the initial blood volume shunt device comprising a shunt isolation chamber configured to receive and hold an initial blood volume collected through the extension tube by the blood collection device, an initial blood volume shunt device; A system comprising. **Claim 2** The system according to claim 1, wherein the initial blood volume shunt device further comprises a vent in fluid communication with the shunt isolation chamber. **Claim 3** The system according to claim 2, wherein the vent is configured to discharge air when the blood collection device is coupled to the vascular access device and the blood collection tube of the blood collection device is advanced into a patient's blood vessel to collect an initial volume of blood into the shunt isolation chamber. **Claim 4** The system according to claim 3, wherein the vent is configured to automatically discharge air when the blood collection device is coupled to the vascular access device and the blood collection tube of the blood collection device is advanced into a patient's blood vessel. **Claim 5** The system according to claim 3, wherein the vent is manually vented when the blood collection device is coupled to the vascular access device and the blood collection tube of the blood collection device is advanced into a patient's blood vessel. **Claim 6** The system according to claim 3, wherein the vent is formed of at least one of a membrane, paper, porous material, film, or mechanical feature that allows air to pass through but does not allow fluid to pass through when wet. **Claim 7** The initial blood volume shunt device further comprises a flashback visualization unit and a blood sample fluid path arm, and the flashback visualization unit and the blood sample fluid path arm are in fluid communication with the extension tube and the proximal connector. The system according to claim 1.

8. The initial blood volume shunt device further comprises a distal fluid path shunt adapter and a proximal vent collar adapter, and the shunt isolation chamber extends between the distal fluid path shunt adapter and the proximal vent collar adapter. The system according to claim 1.

9. The proximal vent collar adapter includes a vent portion, and the proximal end of the shunt isolation chamber terminates at the vent portion. The system according to claim 8.

10. The initial blood volume shunt device further comprises a main flow path tube extending between the distal fluid path shunt adapter and the proximal vent collar adapter and arranged in parallel with the shunt isolation chamber, and the main flow path tube is in fluid communication with the extension tube and the proximal connector. The system according to claim 8.

11. The initial blood volume shunt device further comprises a fluid occlusion device disposed at the distal portion of the shunt isolation chamber for selectively occluding the flow of blood from the shunt isolation chamber. The system according to claim 1.

12. The proximal connector is configured to be removably connected to a luer lock access device. The system according to claim 1.

13. The proximal connector is integrated with a luer lock access device. The system according to claim 1.

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

15. The shunt isolation chamber has an internal volume of at least 0.15 mL. The system according to claim 1.

16. A method of using a blood sample collection system, comprising: providing the blood sample collection system, the system comprising: A blood sampling device having a distal end and a proximal end, the blood sampling device comprising an actuator and a blood sampling tube operably connected to the actuator, the actuator being configured to selectively advance the blood sampling tube, the blood sampling device; An extension tube extending from the proximal end of the blood sampling device, the proximal extension tube being in fluid communication with the blood sampling tube of the blood sampling device, the extension tube; A blood sampling interface disposed at the proximal end of the extension tube; An initial blood volume shunt device disposed in series with the extension tube between the blood sampling device and the blood sampling interface, the initial blood volume shunt device comprising a shunt isolation chamber configured to receive and hold an initial blood volume collected by the blood sampling device through the extension tube, the initial blood volume shunt device; Providing the blood sample collection system comprising; Connecting the blood sampling device to a vascular access device having an indwelling catheter; Advancing the blood sampling tube of the blood sampling device through the vascular access device beyond the distal end of the indwelling catheter; Collecting the initial blood volume in the shunt isolation chamber of the initial blood volume shunt device through the blood sampling tube and the extension tube; A method comprising.

17. The method according to claim 16, further comprising the step of venting the shunt isolation chamber before aspirating the initial blood volume.

18. The method according to claim 16, further comprising the step of clamping a distal portion of the shunt isolation chamber after the initial blood volume has been collected in the shunt isolation chamber.

19. After the initial blood volume has been collected in the shunt isolation chamber, connecting a first blood collection container to the blood sampling interface; Collecting a first blood sample in the first blood collection container; The method according to claim 16, further comprising.

20. Removing the first blood collection container from the blood sampling interface and connecting a second blood collection container to the blood sampling interface; Collecting a second blood sample in the second blood collection container; The method according to claim 19, further comprising.

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