A blood collection device that isolates the first collected part

Abstract

Various embodiments of the present disclosure describe a flow diverter device that captures an initial flow of blood within a flow diverter chamber of the flow diverter device. The flow diverter device includes a housing having an inlet conduit and an outlet conduit, a flow path defined by a single channel or a series of channels terminating in a flow diverter chamber valve, a take sample valve, and a bypass flow chamber positioned within the housing, where the take sample valve is configured to allow a subsequent flow of fluid into the bypass flow chamber and the bypass flow chamber is configured to allow the subsequent flow of fluid out of the flow diverter device. The flow diverter chamber valve allows air to pass through but not blood to pass through.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 883,941, filed August 7, 2019, the contents of which are incorporated herein by reference.

[0002] The present technology relates to devices that capture initial blood loss during the blood collection process. [Background technology]

[0003] Blood cultures are currently the preferred method for identifying bacteremia and sepsis. Sepsis is a systemic response to a bacterial infection of the bloodstream that can lead to organ failure and death. Sepsis kills one in six infected patients and is associated with half of all hospital deaths. In fact, sepsis kills more people than AIDS, breast cancer, and prostate cancer combined. Sepsis affects more hospital patients than any other diagnosis.

[0004] Unfortunately, the U.S. healthcare system spends over $4 billion annually on unnecessary procedures associated with false-positive blood culture results. See Non-Patent Document 1. Also, "It is currently accepted that most organisms identified as contaminants in blood cultures originate from the skin of the patient." (Non-Patent Document 2).

[0005] Therefore, there is a need for a device capable of diverting and capturing a patient's initial blood flow, which may contain contaminants from the patient's skin, in order to reduce the number of false positives during the blood collection process. One such device is described in U.S. Patent Application Publication No. PCT / US2018 / 042367 to Milan Ivosevic, filed July 17, 2018, and incorporated herein by reference. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Publication No. 2019018324 [Non-patent literature]

[0007] [Non-Patent Document 1] Oren Zwang & Richard K. Albert, Analysis of Strategies to Improve Cost Effectiveness of Blood Cultures, 1 J. Hosp. Med. 272 ​​(Sep.2006) [Non-patent document 2] Robert A. Garcia et al., Multidisciplinary Team Review of Best Practices for Collection and Handling of Blood Cultures to Determine Effective Interventions for Increasing the Yield of True-Positive Bacteremia, Reducing Contamination, and Eliminating False-Positive Central Line- Associated Bloodstream Infections, 43 Am. J. Infect. Control 1222 (Nov. 2015) Summary of the Invention

[0008] Various embodiments of the present disclosure describe a flow diversion device that captures initial blood flow within a diversion chamber of the device. The diversion chamber can be defined in part by a flow path defined by a channel or series of channels that terminate in a diversion chamber valve. The diversion chamber valve is a passage configured to allow the passage of air but not liquid, such as collected blood. After the diversion chamber fills, the collected blood begins to flow through the collection sample valve, through a bypass flow chamber of the flow diversion device, and into a collection reservoir that is in fluid communication with and downstream of the diversion device.

[0009] One aspect of the present disclosure includes a flow diverter device comprising: (1) a housing having an inlet conduit and an outlet conduit, the housing configured to receive an initial blood flow and a subsequent blood flow through the inlet conduit and to allow the subsequent blood flow to exit the flow diverter device through the outlet conduit; (2) a flow diverter chamber defined by a flow path defined by a single channel or series of channels terminating in a flow diverter chamber valve; (3) a sample collection valve; and (4) a bypass flow chamber, the sample collection valve configured to allow the subsequent flow of fluid to enter the bypass flow chamber and the bypass flow chamber configured to allow the subsequent flow of fluid to exit the flow diverter device through the outlet conduit.

[0010] Both the flow diversion chamber valve and the collection sample valve utilize hydrophobic materials and small diameter passages or channels to increase flow resistance to blood flow through the channels. Non-limiting examples of hydrophobic materials include, for example, polytetrafluoroethylene (PTFE), polypropylene, or other conventional non-polar polymers. Suitable polymers will have sufficient heat stability so that the device can be sterilized.

[0011] The diversion chamber valve is configured to completely prevent the flow of liquid through the valve. When the diversion chamber is filled with an initial flow portion of blood, the draw sample valve is configured to provide a flow resistance that prevents the initial flow portion of blood being collected into the collection reservoir from passing through. Once the diversion chamber is filled, the diversion chamber valve provides a flow resistance such that a subsequent portion of blood entering the diversion device "breaks through" the flow resistance of the draw sample valve and flows into the bypass flow chamber and through the outlet conduit.

[0012] In some embodiments, a portion of the housing comprises a hydrophilic material. The hydrophilic material is optionally used to enhance fluid transport, for example, by wicking liquid through the device. In some embodiments, the hydrophilic material is carboxymethylcellulose ("CMC").

[0013] In some embodiments, the cross-sectional area of ​​the diversion chamber is larger than the cross-sectional area of ​​the bypass flow chamber. In some embodiments, the diversion flow chamber comprises a tube. In some embodiments, the housing comprises a housing shell, the housing shell containing an inlet conduit at one end and an outlet conduit at an opposite end. In some embodiments, the initial blood flow is drawn into the diversion chamber by vacuum pressure generated by a collection reservoir coupled to the diversion device. In some embodiments, the diversion flow chamber is configured to allow a subsequent flow of fluid to exit the diversion device using only vacuum pressure generated by a collection reservoir coupled to the diversion device.

[0014] Another aspect of the present disclosure relates to a blood collection kit comprising instructions for assembling a blood collection pathway from a patient to a collection reservoir, the blood collection pathway comprising a first needle that pierces the patient's skin and a flow diverter, the collection reservoir having an internal pressure below atmospheric pressure that (a) draws an initial blood flow from the patient through the first needle and into the flow diverter, and (b) draws subsequent blood flows through the first needle and the flow diverter into the collection reservoir, respectively, and the blood collection pathway is a closed system that prevents the initial flow of air through the flow diverter from being vented to the atmosphere.

[0015] In some embodiments, the blood collection pathway further comprises a holder having a second needle that pierces the cap of the collection vessel. In some embodiments, the flow diversion device is integrated into the holder. In some embodiments, the flow diversion device and the holder are separate units. In some embodiments, the flow diversion device is integrated into a first needle used to puncture a patient's vein or artery. In some embodiments, the flow diversion device and the first needle are separate units that are adjacent to each other, or in some embodiments, adjacent to each other. In some embodiments, the collection vessel contains one or more bacterial growth media, antibiotic scavenger, or pH sensor.

[0016] Yet another aspect of the present disclosure includes assembling a blood collection pathway from a patient to a collection reservoir, the blood collection pathway including a first needle for piercing the patient's skin and a flow diverter device, the collection reservoir having an internal pressure below atmospheric pressure that (a) draws an initial blood flow from the patient through the first needle and into the flow diverter device, and (b) draws subsequent blood flows through the first needle and the flow diverter device, respectively, into the collection reservoir, the flow diverter device including: (1) a housing having an inlet conduit and an outlet conduit, the housing configured to receive the initial blood flow and the subsequent blood flow through the inlet conduit; The present invention relates to a method of collecting blood, the method comprising: (1) a housing configured to allow a subsequent flow of fluid to exit the flow diverter device through an outlet conduit; (2) a diversion chamber defined by a flow path defined by a single channel or a series of channels terminating in a diversion chamber valve; (3) a take sample valve; and (4) a bypass flow chamber, the take sample valve configured to allow a subsequent flow of fluid to enter the bypass flow chamber, and the bypass flow chamber configured to allow the subsequent flow of fluid to exit the flow diverter device through the outlet conduit.

[0017] In some embodiments, the blood collection pathway is a closed system that prevents the initial flow of air through the flow diversion device from being vented to the atmosphere. In some embodiments, the blood collection pathway further comprises a holder having a second needle that pierces the cap of the collection vessel. In some embodiments, the flow diversion device is integrated into the holder. In some embodiments, the flow diversion device and the holder are separate units. In some embodiments, the flow diversion device is integrated into a first needle that is used to puncture a patient's vein or artery. In some embodiments, the flow diversion device and the first needle are separate units that are proximate to each other, or in some embodiments, adjacent to each other.

[0018] A flow diverter device for collecting biological samples is described herein. The flow diverter device has an inlet for receiving a biological sample collected from a patient. The flow diverter device has an outlet for delivering the collected biological sample to a collection reservoir, the collection reservoir being under subatmospheric pressure. The flow diverter device also has a first channel through which a first portion of the collected biological sample flows at the start of sample collection. The first channel has a first valve, such that air in the first channel flows through the valve and exits the first channel as the collected sample fills the first channel. The device also has a second channel through which a second portion of the collected sample flows after the first channel is substantially filled with the collected sample. The second channel is in fluid communication with the first channel through a second valve. The flow diverter device outlet is configured for attachment to a needle having an internal lumen. The needle is configured to pierce a seal on the collection reservoir, such that the subatmospheric pressure of the collection reservoir draws the biological sample from the device into the collection reservoir.

[0019] Optionally, the inlet of the flow diverter is configured for connection to a line set for withdrawing a biological sample from a patient. Typically, the line set includes a sample collection needle and a collection tubing. Optionally, the sample collection needle is a butterfly needle selected from the group consisting of a single-winged butterfly needle or a dual-winged butterfly needle. Optionally, the flow diverter is integrated into a wing of the butterfly wing needle.

[0020] Optionally, the flow distribution device is configured to be coupled to an adapter that is in fluid communication with a collection reservoir that is sealed and has an internal pressure below atmospheric pressure. The adapter is coupled to the flow distribution device by any conventional connection (e.g., a threaded connection, a snap connection, a luer connector, etc.).

[0021] The valves of the flow splitter operate as follows: A first valve operates to allow air to escape from the first channel but retain sample collected in the first channel. Air passing from the first channel is received from the second channel and drawn through the flow splitter by the reduced pressure in the collection reservoir. The second valve operates to prevent sample from flowing from the first channel to the second channel until the first channel fills with sample and exceeds the liquid flow resistance of the second valve. Optionally, both valves are hydrophobic flow restrictors. Optionally, both valves have barriers with one or more openings that provide liquid flow resistance. Optionally, the flow restrictor is a barrier having an orifice therein of about 2 mm or less. Optionally, the flow restrictor has multiple barriers, each with one or more orifices. Optionally, the flow splitter has orifices with a diameter of about 0.5 μm or less.

[0022] The first channel in the flow distributor can be a serpentine channel or a straight channel. Optionally, the first channel has a diameter of about 3 mm to about 4 mm.

[0023] Optionally, the first valve and the second valve are hydrophobic membranes. Such membranes are porous, with pore sizes of about 0.45 μm or less. Examples of hydrophobic materials from which the hydrophobic flow restrictions or membranes are made include polytetrafluoroethylene (PTFE) or polypropylene.

[0024] Described herein is a flow diverter assembly for collecting biological samples. The assembly includes a butterfly needle and a flow diverter integrated with the butterfly needle. The flow diverter has an inlet for receiving a biological sample collected from a patient. The flow diverter has an outlet for delivering the collected biological sample to a collection vessel. The collection vessel is typically under subatmospheric pressure (i.e., the pressure inside the vessel is lower than atmospheric pressure). The flow diverter has a first channel into which a first portion of the collected biological sample enters at the start of sample collection. The first channel has a first valve, which allows air within the first channel to exit the first channel through the valve as the collected sample fills the first channel. The valve is in fluid communication with the outlet of the flow diverter, which allows air exiting the first channel to be drawn from the device into the collection vessel. That is, the flow diverter is not vented to the atmosphere. The flow diverter device has a second channel into which a second portion of the collected sample flows after the first channel is substantially filled with the collected sample, the second channel being in fluid communication with the first channel through a second valve. The second channel is also in fluid communication with an adapter, the adapter receiving the collected biological sample from the second channel, the adapter outlet being configured for attachment to a needle having a lumen, the needle being configured to pierce a seal on the collection reservoir, such that subatmospheric pressure in the collection reservoir draws the biological sample from the flow diverter device into the collection reservoir. The first and second valves are as described above. [Brief explanation of the drawings]

[0025] [Figure 1] 1 illustrates a blood collection system including a flow diverter according to the present technology; [Figure 2] 14A-14D show an embodiment of a flow diverter integrated into a holder in accordance with the present technology. [Figure 3] 1 illustrates an embodiment of a flow diverter in accordance with the present technology; [Figure 4A] 10A-10C illustrate alternative embodiments of flow diverters in accordance with the present technology. [Figure 4B] 10A-10C illustrate alternative embodiments of flow diverters in accordance with the present technology. [Figure 4C] 10A-10C illustrate alternative embodiments of flow diverters in accordance with the present technology. [Figure 5] 1 is a schematic diagram illustrating the path of blood flow through a flow diverter device according to the present technology and into a blood collection bottle; [Figure 6A] FIG. 10 illustrates the sequence of blood flow through one embodiment of a flow diverter device in accordance with the present technology, from first filling the diversion chamber to flowing through the bypass chamber. [Figure 6B] FIG. 10 illustrates the sequence of blood flow through one embodiment of a flow diverter device in accordance with the present technology, from first filling the diversion chamber to flowing through the bypass chamber. [Figure 6C] FIG. 10 illustrates the sequence of blood flow through one embodiment of a flow diverter device in accordance with the present technology, from first filling the diversion chamber to flowing through the bypass chamber. [Figure 7] FIG. 13 is a close-up view of a flow diverter chamber valve of one embodiment of a flow diverter device in accordance with the present technology. [Figure 8] FIG. 10 is a plot showing the percentage of contaminants remaining in the needle and / or needle with tubing versus the amount of blood expelled. DETAILED DESCRIPTION OF THE INVENTION

[0026] Embodiments of the present disclosure will be described in detail with reference to the drawings. In the drawings, like reference numerals indicate similar or identical components. It is understood that the disclosed embodiments are merely examples of the present disclosure, which may be embodied in various forms. Known functions or structures are not described in detail to avoid obscuring the present disclosure with unnecessary detail. Therefore, details of specific structures and functions disclosed herein should not be construed as limitations, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art to variously employ the present disclosure in substantially any reasonably detailed structure.

[0027] FIG. 1 shows a blood collection system equipped with a flow diverter according to the present technology. As shown in FIG. 1, the blood collection system includes a first needle 110, a tube 120, a flow diverter 130, a holder 140, and a collection bottle 150. During the process of collecting a blood sample from a patient, the first needle 110 is used to puncture the patient's vein or artery. Driven by the vacuum pressure generated by the collection bottle 150 and the patient's blood pressure, the patient's blood flows through the tube 120 and toward the collection bottle 150. The initial blood flow passes through the tube 120 and is captured in a flow diverter chamber within the flow diverter 130. The subsequent blood flow is collected in the collection bottle 150. Meanwhile, the subsequent blood flow passes through the flow diverter chamber of the flow diverter 130 and toward the second needle in the holder 140.

[0028] In some embodiments, the blood collection system of FIG. 1 can be implemented using one of the Becton, Dickinson and Company ("BD") Vacutainer™ blood collection sets, such as a BD Vacutainer™ push-button blood collection set, a BD Vacutainer™ Safety-Lok™ blood collection set, or a BD Vacutainer™ UltraTouch™ push-button blood collection set. Thus, in some embodiments, the adapter can be implemented using a BD Vacutainer™ multi-sample luer adapter. Also, in some embodiments, holder 140 can be implemented using a BD Vacutainer™ single-use holder.

[0029] As shown in FIG. 1 , the flow diverter 130 is a separate unit located near the holder 140. However, in other embodiments, the flow diverter 130 can be integrated into the holder 140. In some embodiments, the flow diverter 130 is integrated into the first needle 110 used to puncture a patient's vein or artery. In some embodiments, the flow diverter 130 and the first needle 110 are separate units that are adjacent to each other, or in some embodiments, adjacent to each other. Additionally, the size of the flow diverter 130 can be varied to adjust the amount of blood initially directed into a diversion chamber within the flow diverter 130. The amount of blood diverted into the flow diverter can also be varied depending on the proximity of the flow diverter to the first needle. For example, in some embodiments, when the flow diverter is located immediately behind the first needle (e.g., as part of a winged first butterfly needle), the flow diverter can be configured to direct less than about 150 μL of blood into its diversion chamber. In some embodiments, the flow diverter device can be configured to direct between about 30 μL and about 50 μL of blood into its flow diverter chamber.

[0030] In some embodiments, the flow diversion device 130 can have a display that provides feedback regarding the amount of blood collected. For example, the flow diversion device 130 can have a flow meter that indicates how much blood has been collected into the collection bottle 150. The flow meter can help the healthcare professional ensure that the appropriate amount of blood is collected, thereby minimizing the possibility of false-positive blood cultures. Furthermore, in some embodiments, the transmitter can be communicatively coupled to the display for wirelessly transmitting information regarding the amount of blood collected to the receiver. In such embodiments, the receiver can be communicatively coupled to a display device configured to display information regarding the amount of blood collected.

[0031] The collection bottle 150 can be constructed from glass, plastic, or other suitable materials. In some embodiments, the collection bottle 150 can be implemented using one of BD's BACTEC™ culture vials or one of BD's Vacutainer™ blood collection tubes. In some embodiments, the collection bottle 150 can contain liquid and / or solid additives, such as bacterial growth media, antibiotic scavengers, or a pH sensor. In some embodiments, the collection bottle 150 can contain one of BD's blood culture media, such as BD's BACTEC™ Peds Plus media, BD's BACTEC™ Plus aerobic media, BD's BACTEC™ Plus anaerobic media, BD's BACTEC™ Lytic anaerobic media, BD's BACTEC™ standard aerobic media, or BD's BACTEC™ standard anaerobic media.

[0032] As discussed above, most organisms identified as contaminants in blood cultures originate from the patient's skin. These contaminants are typically introduced into a patient's blood sample through venipuncture and the patient's initial blood flow, which enters the collection bottle. In the blood collection system of FIG. 1 , the initial blood flow is diverted and captured in the diverting chamber of the diverting device 130. As a result, the blood collection system of FIG. 1 provides a means for potentially reducing the number of false-positive blood cultures. Additionally, incorporating the diverting device 130 into the blood collection system of FIG. 1 does not require additional steps for the medical professional compared to current conventional techniques for collecting blood samples. For example, the medical professional does not need to wait for a conduit or chamber to be partially or completely filled before inserting the collection bottle 150 into the holder 140.

[0033] 2 illustrates an embodiment of a holder-integrated flow diverter device in accordance with the present technology. As shown in FIG. 2, a flow diverter device 230 is integrated into a holder 240 having a second needle 242. The holder 240 is configured to be received on a bottle or collection device (not shown). The second needle 242 provides a fluid channel from the flow diverter device 230 to the collection device. In embodiments in which the holder 240 is sealed prior to assembly to the flow diverter device 230, the second needle 242 punctures the holder 240 when the holder 240 and the flow diverter device are assembled.

[0034] 3 shows an embodiment of a flow diverter device in accordance with the present technology. As shown in FIG. 3, flow diverter device 300 is connected to holder 380. Holder 380 has a second needle 382 that pierces a septum or cap having a septum opening on a collection bottle.

[0035] As shown in FIG. 3, the flow diversion device 300 comprises a housing having an inlet conduit 310 and an outlet conduit 320, a flow diversion chamber 330 having a single channel or series of channels 340, a flow diversion chamber valve 350, a collection sample valve 360, and a bypass flow chamber 370.

[0036] As described with respect to FIG. 1, during the process of withdrawing a blood sample from a patient, a first needle is used to puncture the patient's vein or artery. Driven by vacuum pressure generated by the collection bottle, the patient's blood is directed through tubing and the flow diverter device described herein toward the collection bottle. Referring to FIG. 3, initial blood flow passes through inlet conduit 310 and is captured in flow diverter chamber 330 within flow diverter device 300. Subsequent blood flow passes through bypass chamber 370 and is collected in the collection bottle. Meanwhile, subsequent blood flow passes from flow diverter device 300 to second needle 382 in holder 380.

[0037] 4A-4C show alternative embodiments of flow diverter devices in accordance with the present technology. As shown, the size and shape of the flow diverter device, as well as its location within the blood collection system, can vary.

[0038] FIG. 4A illustrates an embodiment in which a flow diversion device 400 is proximate, and in some embodiments adjacent, to a first needle 401 used to draw blood from a patient. In contrast to the embodiment shown in FIG. 2, the flow diversion device 400 in the embodiment of FIG. 4A is not proximate or adjacent to a holder 402 connected to a collection bottle. In this embodiment, the flow diversion device is within the line set and is proximate to the sample collection point. As discussed elsewhere herein, having the flow diversion device closer to the collection point reduces the amount of blood that needs to be sequestered in the diversion chamber.

[0039] Figure 4B shows an embodiment in which the flow diverter device 410 is part of a wing of a double-winged first butterfly needle 412 used to withdraw blood from a patient. As shown, the other wing 411 of the double-winged first butterfly needle 412 does not house a flow diverter device. In contrast to the embodiment shown in Figure 2, the flow diverter device 410 in the embodiment of Figure 4B is not proximate or adjacent to a holder 413 connected to a collection bottle, but is proximate to the point where blood is withdrawn from the patient.

[0040] Figure 4C shows a preferred embodiment in which the flow diverter 420 is part of a wing of a single-winged first butterfly needle 421 used to withdraw blood from a patient. In contrast to the embodiment shown in Figure 2, the flow diverter 420 in the embodiment of Figure 4C is not proximate or adjacent to the holder connected to the collection bottle, but is proximate to the point where blood is withdrawn from the patient. The withdrawn blood flows into the flow diverter 420 (first filling the flow chamber) and then into tubing 422 connected to the holder attached to the collection bottle.

[0041] As shown in FIGS. 4A-4C, first needles 401, 412, and 421 can have one or more wings. For example, in FIG. 4A, first needle 401 is a double-winged butterfly needle having wing 403. The wings allow a medical professional to easily grasp the first needle. However, in other embodiments of the present invention, the wings can be omitted. In some embodiments, the wings can be constructed from a flexible plastic material. In some embodiments, the first needle can also have a body. For example, in FIG. 4A, first needle 401 is a double-winged butterfly needle having body 404. Body 404 can provide a medical professional with an indication of whether the patient's vein or artery has been successfully punctured. For example, body 404 can be constructed from a translucent plastic material that allows the medical professional to see the initial flash of the patient's blood. In other embodiments, the body can be constructed from a transparent material or can have a window. In some embodiments, the blood collection system of Figures 4A-4C can be implemented in part by using a BD Vacutainer™ push-button blood collection set in combination with one of BD's BACTEC™ culture vials.

[0042] In some embodiments, the housing of the flow diverter and / or holder can be constructed from a plastic material, such as acrylonitrile butadiene styrene ("ABS"). In some embodiments, the tubing can be constructed from a hydrophobic material. For example, in some embodiments, the tubing can be constructed from a plastic material, such as polyethylene. In some embodiments, the housing shell can be attached to the housing base by an ultrasonic welding process.

[0043] 5 is a schematic diagram illustrating how a patient's initial blood flow and subsequent flows can flow through a flow diverter device according to the present technology. When flow diverter device 500 is used as part of a blood collection system 501, the patient's blood immediately flows under venous pressure through a first needle 580 located at the proximal end of system 501. Driven by vacuum generated by a collection bottle 590 at the distal end of system 501, the patient's blood enters flow diverter device 500 through inlet conduit 510, and after the initial collected portion is diverted, the collected blood flows into collection bottle 590. A sample collection valve 560 is shown perpendicular to the incoming blood flow and the path of the flow diverter chamber 530. Preferably, the draw sample valve 560 of the flow diverter device 500 is located as close to the first needle 580 as possible without stagnant flow areas (see, e.g., FIG. 4C ), thereby minimizing the amount of blood that must be sequestered before it is allowed to flow out of the flow diverter chamber 530 and into a collection bottle 590 mounted in a holder 585. The path from the first needle 580 to the flow diverter chamber 530 should be as direct as possible, so that the momentum of the blood is not impeded. The draw sample valve 560 is positioned (i.e., perpendicular to the incoming blood) and configured (i.e., a small orifice or hole in the hydrophobic material) so that the initial flow portion of the blood entering the flow diverter device 500 preferentially enters and fills the flow diverter chamber 530. Only after the flow diverter chamber 530 is filled does the oncoming blood flow provide enough force to overcome the flow resistance of the draw sample valve 560, and blood then flows through the draw sample valve 560. Non-limiting examples of hydrophobic materials used to construct the collection sample valve 560 include, for example, polytetrafluoroethylene (PTFE) or polypropylene. In some embodiments, the small orifices or holes in the hydrophobic material of the collection sample valve 560 have a diameter of about 0.2 mm. In an alternative embodiment, the collection sample valve 560 is a membrane having a plurality of holes or apertures. In some embodiments, each hole or aperture in the membrane of the collection sample valve 560 has a diameter of about 5 μm. In an alternative embodiment, each hole or aperture in the membrane of the collection sample valve 560 has a diameter of about 0.45 μm.In some embodiments, the membrane of the collect sample valve 560 is made from a hydrophobic material. Non-limiting examples of hydrophobic materials used to construct the membrane of the collect sample valve 560 include, for example, polytetrafluoroethylene (PTFE) or polypropylene.

[0044] The initial blood flow bypasses the collect sample valve 560 and enters the flow division chamber 530. This path reflects the path of least resistance to blood flow because, as noted above, blood must overcome the flow resistance of the collect sample valve 560 to flow through it. Therefore, the initial flow portion of blood entering the flow division chamber 530 is the preferred flow path for the initial portion of the collected blood sample entering the flow division device 500.

[0045] The flow split chamber 530 has a single channel or a series of channels terminating in the flow split chamber 550. In some embodiments, the single channel or series of channels in the flow split chamber 530 has a diameter of about 3 mm to about 4 mm. In some embodiments, the path length through the flow split chamber 530 is minimized to prevent unnecessary airflow restriction. In some embodiments, the diameter of the flow split chamber valve 550 is such that it can dampen the force of the column of liquid, thereby preventing it from passing through the flow split chamber valve 550 and entering the bypass flow chamber 570. In some embodiments, the flow split chamber valve 550 has a diameter significantly smaller than about 0.2 mm. In an alternative embodiment, the flow split chamber valve 550 is a membrane having a plurality of holes or apertures. In some embodiments, each hole or aperture in the membrane of the flow split chamber valve 550 has a diameter of about 5 μm. In an alternative embodiment, each hole or aperture in the membrane of the flow split chamber valve 550 has a diameter of about 0.45 μm. In some embodiments, the membrane of the diversion chamber valve 550 is made from a hydrophobic material. Non-limiting examples of hydrophobic materials used to construct the membrane of the diversion chamber valve 550 include, for example, polytetrafluoroethylene (PTFE) or polypropylene. In some embodiments, the diversion chamber valve 550 resists static pressure to a significantly greater extent than the collection sample valve 560.

[0046] FIG. 5 illustrates how a patient's initial blood flow 531 may enter the diversion chamber 530. The initial blood flow 531 may contain contaminating bacteria (i.e., bacteria from the surface of the skin and not from the collected sample). As the diversion chamber 530 begins to fill with the initial blood flow 531, the diversion chamber valve 550 prevents the blood from entering the outlet conduit 520. However, if a vacuum is applied, for example, through a vacutainer adapter, the diversion chamber valve 550 allows gas or air to pass through, but the collected blood cannot flow past the diversion chamber valve 550. In some embodiments, the diversion chamber valve 550 can be constructed from a hydrophobic material that allows air to pass through but not blood. Non-limiting examples of materials used to construct the draw test valve 560 include, for example, polytetrafluoroethylene (PTFE) or polypropylene. Air entering the diversion device ahead of the initial blood flow portion proceeds through both valves and the outlet conduit 520. As such, the flow diverter device 500 is a closed system. The initial flow of air through the flow diverter device 500 is not vented to the atmosphere. Therefore, a medical professional does not need to wait for the air to be removed from the flow diverter device 500 before connecting the flow diverter device 500 to a collection bottle 590. As a result, the initial blood flow 531 pushes air from the flow diverter chamber 530 into the collection bottle 590 through the flow diverter chamber valve 550. The portion of the initial blood flow 531 that fills the flow diverter chamber 530 remains in place. Advantageously, this portion of the initial blood flow 531 is most likely to contain contaminants (e.g., bacteria). Once the flow diverter chamber is filled with the initial blood flow 531, the flow of blood therethrough is blocked.

[0047] 5 also shows how the patient's trailing blood flow 571 can flow through inlet conduit 510 toward collection bottle 590. Once diversion chamber 530 is filled, pressure begins to build at collect sample valve 560, allowing the trailing blood flow 571 to enter bypass flow chamber 570. The trailing blood flow 571 passes through bypass flow chamber 570 and exits flow diversion device 500 through outlet conduit 520 into collection bottle 590.

[0048] 6A-6C illustrate the sequence of blood flow through one embodiment of a flow diverter device according to the present technology, from initially filling the diversion chamber to flowing through the bypass chamber. In this embodiment, the flow diverter device 600 is attached to a holder 680, which is a vacutainer adapter as shown. The labels shown in FIG. 6A apply equally to FIGS. 6B and 6C. As shown in FIGS. 6A-6C, the flow diverter device 600 includes a housing having an inlet conduit 610 and an outlet conduit 620, a diversion chamber 630 having a single channel or a series of channels 640, a diversion chamber valve 650, a collection sample valve 660, and a bypass chamber 670. Additionally, the blood collection system may include a first needle, tubing, an adapter, a holder 680, a second needle 682, and a collection bottle. As shown in FIG. 6A, before the blood collection procedure begins, both the diversion chamber 630 and the bypass chamber 670 of the flow diverter device 600 are empty.

[0049] The arrows in Figure 6A indicate the direction of initial blood flow into the flow diverter 600. This is the path of least flow resistance without user intervention and is driven by vacuum pressure generated by a collection bottle connected to holder 680.

[0050] As shown in Figure 6B, the initial flow fills a single channel or series of channels 640 of the diversion chamber 630. Once the initial flow reaches the diversion chamber valve 650, blood flow therethrough is prevented.

[0051] 6C, the subsequent blood flow passes through the collection sample valve 660 and into the bypass flow chamber 670. The bypass flow chamber 670 allows the subsequent blood flow through the outlet conduit 620 and out the holder 680 and ultimately into the collection bottle.

[0052] FIG. 7 shows an enlarged view of one embodiment of the diversion chamber valve 650 of the flow diversion device 600 of FIGS. 6A-6C. As shown in FIG. 7, a gap 800 between the two flow restriction sections 700 ensures that contaminated initial blood does not come into contact with the subsequent blood flow. As described above, the flow restriction section 700 is made of a hydrophobic material. The flow restriction section 700 also has a small orifice 810 or hole (e.g., about 2 mm or less) therein to create flow resistance. The embodiment of the diversion chamber valve 650 of FIGS. 6A-6C shown in FIG. 7 has multiple redundant gaps and multiple flow restriction sections to ensure that blood does not pass through the diversion chamber valve 650 into the bypass flow chamber 670.

[0053] Gaps between flow restrictions may also be provided in other embodiments of the divided chamber valve. In some embodiments, the divided chamber valve may have two or more sets of gaps.

[0054] In some embodiments, the flow diverter is a distance away from the first needle and close to a holder or adapter connected to the collection bottle. In some embodiments, the flow diverter is close to the first needle and far away from a holder or adapter connected to the collection bottle. In a preferred example, the flow diverter is part of a winged first butterfly needle.

[0055] Figure 8 illustrates the effect of placing the flow diverter closer to the first needle. The plot in Figure 8 shows the percentage of contaminants remaining after a given amount of clean blood has flowed through a needle and a needle with a 50 mm tubing attached. The conclusion drawn from this plot is that diversion of contaminated blood can be more effective after a small amount of blood has been drawn if the flow diverter is located closer to the needle.

[0056] The amount of blood diverted into the flow diverter device can vary depending on the proximity of the flow diverter device to the first needle. For example, in some embodiments, when the flow diverter device is located immediately behind the first needle (e.g., as part of a winged first butterfly needle), the flow diverter device can be configured to direct less than about 150 μL of blood into its flow diverter chamber. In some embodiments, the flow diverter device can be configured to direct between about 30 μL and about 50 μL of blood into its flow diverter chamber.

[0057] As indicated above, some embodiments of the present invention provide significant advantages. Most organisms identified as contaminants in blood cultures originate from the patient's skin. These contaminants are typically introduced into a patient's blood sample through venipuncture and the patient's initial blood flow into the collection bottle. Therefore, by diverting and capturing the initial blood flow, a flow diversion device according to the present technology can reduce the number of false-positive blood cultures.

[0058] Furthermore, the flow diverter of the present technology provides a versatile solution, for example, the distance of the flow diverter relative to the first needle can be varied to divert and capture any volume of blood, for example, less than about 150 μL.

[0059] Additionally, incorporating a flow diverter according to the present technology into a blood collection system does not require additional steps for medical personnel compared to current conventional techniques for collecting blood samples. For example, medical personnel do not need to wait for a conduit or chamber to partially or completely fill before inserting a collection bottle into a holder. This advantage is realized primarily because some embodiments of a flow diverter according to the present technology operate using vacuum pressure generated by the collection bottle. As a result, some embodiments of a flow diverter according to the present technology do not rely on a separate power source or the patient's venous pressure to capture the initial blood flow or to collect subsequent blood flows into the collection bottle.

[0060] As described above, some embodiments of blood collection systems with a flow diverter according to the present technology represent a closed system solution. In these embodiments, air preceding the liquid blood flow is not vented from the system to the atmosphere. Instead, these embodiments use vacuum pressure generated by the collection bottle to immediately draw blood from the patient. The flow diverter in these embodiments can be used within a closed system to balance pressure and air flow along the flow path. For example, a flow diverter chamber valve can be used to allow air preceding the blood sample to exit the flow diverter chamber into an outlet conduit. In such embodiments, the flow diverter chamber valve can prevent the passage of liquid, such as blood.

[0061] From the foregoing and with reference to the various drawing figures, those skilled in the art will appreciate that certain modifications can be made to the present disclosure without departing from the scope of the present disclosure. For example, a flow diverter according to the present technology can be positioned anywhere along a flow path. For example, a flow diverter according to the present disclosure can be attached to the body of a first needle. As another example, a flow diverter according to the present disclosure can be positioned along a tube between a holder and a second needle.

[0062] Furthermore, the blood collection system according to the present technology does not need to include all of the components illustrated in the above embodiments. For example, the needle, flow diverter, and holder can be integrated into one device without the need for tubing. For example, the flow diverter according to the present technology can be integrated into a BD Vacutainer™ Eclipse™ blood collection needle.

[0063] Additionally, in many of the embodiments discussed above, collection bottles having subatmospheric internal pressures were used to collect blood from patients. However, a wide variety of collection vessels having subatmospheric internal pressures can be used with the present technology. For example, collection tubes can be used with the present technology. As another example, collection vials can be used with the present technology.

[0064] While several embodiments of the present disclosure are shown in the drawings, the disclosure is not intended to be limited thereto, but rather to be as broad as the art will permit, and the specification is intended to be read in a similar manner. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the appended claims.

Claims

1. 1. A flow diverter for collecting a biological sample, comprising: an entrance for receiving a biological sample taken from a patient; an outlet for delivering the collected biological sample to a collection vessel, the collection vessel being under subatmospheric pressure; and a first channel into which a first portion of the collected biological sample flows at the start of sample collection, the first channel having a first valve such that air within the first channel passes through the first valve and exits the first channel as the collected sample fills the first channel; a second channel into which a second portion of the collected biological sample flows after the first channel is substantially filled with the collected biological sample, the second channel being in fluid communication with the first channel through a second valve; Equipped with the outlet is configured for attachment to a needle having a lumen, the needle configured to pierce a seal on the collection reservoir such that the subatmospheric pressure in the collection reservoir draws the biological sample from the flow diversion device into the collection reservoir; A flow dividing device, wherein the second valve is a hydrophobic flow restricting portion and includes a barrier having a hole, and the first valve is a hydrophobic flow restricting portion and consists of two second barriers, each having an orifice, and a gap between them, which obstructs the flow of liquid.

2. 10. The flow diversion device of claim 1, wherein the inlet is configured for connection to a line set for withdrawing a biological sample from a patient.

3. The flow diversion device of claim 2 , wherein the line set includes a sample collection needle and a collection tube.

4. 4. The flow diversion device of claim 3, wherein the sampling needle is a butterfly needle selected from the group consisting of a single-wing butterfly needle or a double-wing butterfly needle.

5. 5. The flow diverter device of claim 4, wherein the butterfly needle is a double-winged butterfly and the flow diverter device is integrated into one wing of the butterfly.

6. The flow diversion device of claim 1 , wherein the flow diversion device is configured to be coupled to an adapter that couples to a collection reservoir.

7. The flow diverter device of claim 6 , wherein the adapter is coupled to the flow diverter device by a threaded connection.

8. 8. The flow diversion device of claim 7, wherein the adapter is connected to the flow diversion device by a luer connector.

9. A flow diversion device as described in claim 1, wherein the orifice has a diameter of 2 mm or less.

10. The flow diverter of claim 1 , wherein the first channel is a serpentine channel.

11. The flow diverter device of any one of claims 1 to 10, wherein the first channel has a diameter of between 3 mm and 4 mm.

12. 10. The flow diverter of claim 1, wherein the holes have a diameter of 0.5 μm or less.

13. 10. The flow diverter of claim 1, wherein both of the barriers are made from one of polytetrafluoroethylene (PTFE) or polypropylene.

14. 1. A flow diverter assembly for collecting a biological sample, comprising: Butterfly needles and a flow diverter integrated into the butterfly needle; Equipped with The flow dividing device is an entrance for receiving a biological sample taken from a patient; an outlet for delivering the collected biological sample to a collection vessel, the collection vessel being under subatmospheric pressure; and a first channel into which a first portion of the collected biological sample flows at the start of sample collection, the first channel having a first valve such that air within the first channel passes through the first valve and exits the first channel as the collected sample fills the first channel; a second channel into which a second portion of the collected sample flows after the first channel is substantially filled with the collected sample, the second channel being in fluid communication with the first channel through a second valve; Equipped with the second channel is in fluid communication with an adapter, the adapter receiving the collected biological sample from the second channel; the outlet is configured for attachment to a needle having a lumen, the needle configured to pierce a seal on the collection reservoir such that the subatmospheric pressure in the collection reservoir draws the biological sample from the device into the collection reservoir; A flow diverter assembly, wherein the second valve is a hydrophobic flow restrictor and includes a barrier having a hole, and the first valve is a hydrophobic flow restrictor consisting of two barriers, each having an orifice, and a gap between them.

15. A flow diverter assembly as described in claim 14, wherein the orifice has a diameter of 2 mm or less.

16. 15. The flow diverter assembly of claim 14, wherein the first channel is a serpentine channel.

17. The flow diverter assembly of any one of claims 14 to 16, wherein the first channel has a diameter of between 3 mm and 4 mm.

18. 15. The flow diverter assembly of claim 14, wherein the holes have a diameter of 0.5 μm or less.

19. 15. The flow diverter assembly of claim 14, wherein any of the barriers are made from polytetrafluoroethylene (PTFE) or polypropylene.

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