Blood collection device with isolated initial collection portion

Abstract

Various embodiments of the present disclosure describe a transfer device that traps an initial blood flow in a transfer chamber of the transfer device. The transfer device includes a housing having an inlet conduit and an outlet conduit; a transfer chamber including a flow path defined by a channel or series of channels that terminate in a transfer chamber valve; a sample collection valve; and a side flow chamber positioned in the housing, wherein the sample collection valve is configured to allow a subsequent liquid flow to enter the side flow chamber, and the side flow chamber is configured to allow the subsequent flow to exit the transfer device. The transfer chamber valve allows air but not blood to flow through it.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 883,941, filed August 7, 2019, the contents of which are incorporated herein by reference. Technical Field

[0003] This technology relates to a device for capturing the initial blood flow during a blood collection process. Background Technology

[0004] Blood culture tests are currently the preferred method for identifying bacteremia and sepsis. Sepsis is a systemic response to a bloodstream bacterial infection that can lead to organ failure and death. One in six patients with sepsis will die. Furthermore, sepsis is involved in half of all in-hospital deaths. In fact, sepsis causes more deaths than AIDS, breast cancer, and prostate cancer combined. Sepsis affects more hospitalized patients than any other diagnosis.

[0005] Unfortunately, the U.S. healthcare system spends over $4 billion annually on unnecessary treatments associated with false-positive blood culture results. See 1 J. Hosp. Med. 272 ​​(September 2006), Oren Zwang & Richard K. Albert, “Analysis of Strategies to Improve Cost Effectiveness of Blood Cultures.” Furthermore, “the currently accepted view is that most organisms identified as contaminants in blood cultures originate from the patient’s skin.” See 43 Am.J. Infect. Control 1222 (November 2015) 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”.

[0006] Therefore, during the blood collection process, there is a need for a device capable of transferring and capturing the initial blood flow from a patient, which may contain contaminants from the patient's skin, in order to reduce the number of false positives. Such a device is described in Milan Ivosevic WO2019018324, which was filed on July 17, 2018 as PCT / US2018 / 042367 and is incorporated herein by reference. Summary of the Invention

[0007] Various embodiments of this disclosure describe a transfer device that captures an initial blood flow in a transfer chamber. The transfer chamber may be partially defined by a flow path defined by a channel or a series of channels terminating in a transfer chamber valve. The transfer chamber valve is configured to allow airflow through it but not allow liquid (such as the collected blood) to flow through it. After the transfer chamber is filled, the collected blood begins to flow through a sample collection valve and is drawn through a bypass chamber of the transfer device and into a collection vessel in fluid communication with and downstream of the transfer device.

[0008] One aspect of this disclosure relates to a transfer device comprising: (1) a housing having an inlet conduit and an outlet conduit, wherein the housing is configured to receive an initial blood flow and a subsequent blood flow through the inlet conduit, and wherein the housing is configured to allow the subsequent blood flow to exit the transfer device through the outlet conduit; (2) a transfer chamber defined by a flow path of a passage or a series of passages terminating in a transfer chamber valve; (3) a sample collection valve; and (4) a bypass chamber, wherein the sample collection valve is configured to allow a subsequent fluid flow to enter the bypass chamber, and the bypass chamber is configured to allow the subsequent fluid flow to exit the transfer device through the outlet conduit.

[0009] Both the transfer chamber valve and the sample collection valve are equipped with hydrophobic materials and smaller diameter passages or channels to increase flow resistance to blood flow through these channels. Non-limiting examples of hydrophobic materials include, for example, polytetrafluoroethylene (PTFE), polypropylene, or other conventional nonpolar polymers. Suitable polymers will have sufficient thermal stability to allow the device to be sterilized.

[0010] The transfer chamber valve is configured to completely block liquid flow through the valve. While the transfer chamber is filling with the initial portion of blood, the sample collection valve is configured to provide flow resistance that prevents the initial portion of blood from entering the collection vessel. When the transfer chamber is full, the flow resistance of the transfer chamber valve is such that subsequent portions of blood flowing into the transfer device will "break through" the flow resistance of the sample collection valve and flow into the bypass chamber and through the outlet pipe.

[0011] In some embodiments, a portion of the housing comprises a hydrophilic material. The hydrophilic material may optionally be used to enhance the propulsion for fluids, for example, by wicking liquid to drive it through the device. In some embodiments, the hydrophilic material is carboxymethyl cellulose (“CMC”).

[0012] In some embodiments, the cross-sectional area of ​​the transfer chamber is larger than that of the bypass chamber. In some embodiments, the bypass chamber includes a tube. In some embodiments, the housing includes a housing shell, wherein the housing shell includes an inlet pipe at one end and an outlet pipe at the opposite end. In some embodiments, vacuum pressure generated by a collection vessel coupled to the transfer device draws an initial blood flow into the transfer chamber. In some embodiments, the bypass chamber is configured to allow subsequent fluid flow to exit the transfer device using only the vacuum pressure generated by a collection vessel coupled to the transfer device.

[0013] Another aspect of this disclosure relates to blood collection equipment comprising: instructions for assembling a blood collection path from a patient to a collection vessel, wherein the blood collection path includes a first needle piercing the patient's skin and a transfer device, and wherein the collection vessel has an internal pressure below atmospheric pressure, the internal pressure (a) drawing an initial blood flow from the patient through the first needle and into the transfer device, and (b) drawing subsequent blood flows through the first needle and the transfer device respectively, and then into the collection vessel, and wherein the blood collection path is a closed system that prevents the initial air flow through the transfer device from being released into the atmosphere.

[0014] In some embodiments, the blood collection path further includes a retainer having a second needle that pierces the cap of the collection dish. In some embodiments, the transfer device is integrated with the retainer. In some embodiments, the transfer device and the retainer are separate units. In some embodiments, the transfer device is integrated with a first needle for piercing a patient's vein or artery. In some embodiments, the transfer device and the first needle are separate units adjacent to each other or, in some embodiments, adjacent to each other. In some embodiments, the collection dish includes one or more bacterial growth media, antibiotic scavengers, or pH sensors.

[0015] Another aspect of this disclosure relates to a blood collection method comprising: assembling a blood collection path from a patient to a collection vessel, wherein the blood collection path includes a first needle piercing the patient's skin and a transfer device, and wherein the collection vessel has an internal pressure below atmospheric pressure, the internal pressure (a) drawing an initial blood flow from the patient through the first needle and into the transfer device, and (b) drawing a subsequent blood flow through the first needle and the transfer device respectively, and then into the collection vessel, and wherein the transfer device includes: (1) a housing having an inlet conduit and an outlet conduit, wherein the housing is configured to receive the initial blood flow and the subsequent blood flow through the inlet conduit, and wherein the housing is configured to allow the subsequent blood flow to exit the transfer device through the outlet conduit; (2) a transfer chamber defined by a flow path of a channel or a series of channels terminating in a transfer chamber valve; (3) a sample collection valve; and (4) a bypass chamber, wherein the sample collection valve is configured to allow a subsequent fluid flow into the bypass chamber, and the bypass chamber is configured to allow the subsequent fluid flow to exit the transfer device through the outlet conduit.

[0016] In some embodiments, the blood collection path is a closed system that prevents the initial airflow from being released into the atmosphere through the transfer device. In some embodiments, the blood collection path further includes a retainer with a second needle that pierces the cap of the collection dish. In some embodiments, the transfer device is integrated with the retainer. In some embodiments, the transfer device and the retainer are separate units. In some embodiments, the transfer device is integrated with a first needle used to pierce a patient's vein or artery. In some embodiments, the transfer device and the first needle are separate units adjacent to each other or, in some embodiments, adjacent to each other.

[0017] This document describes a transfer device for collecting biological samples. The transfer device has an inlet for receiving biological samples collected from a patient. The transfer device has an outlet for delivering the collected biological sample to a collection dish under sub-atmospheric pressure. The transfer device also has a first channel into which a first portion of the collected biological sample flows after the start of sample collection. The first channel has a first valve such that air in the first channel exits the first channel through the valve when the collected sample fills the first channel. The device also has a second channel into which a second portion of the collected sample flows after the first channel has been substantially filled with the collected sample. The second channel is in fluid communication with the first channel via a second valve. The outlet of the transfer device is adapted to be attached to a needle having a lumen. The needle is adapted to pierce a seal on the collection dish such that the sub-atmospheric pressure of the collection dish draws the biological sample from the device into the collection dish.

[0018] Optionally, the inlet of the transfer device is adapted to connect to a tubing device for collecting biological samples from a patient. Typically, the tubing device has a sample collection needle and a collection tube. Optionally, the sample collection needle is a butterfly needle selected from the group consisting of a single-winged butterfly needle or a double-winged butterfly needle. Optionally, the transfer device is integrated into the wing of a winged butterfly needle.

[0019] Optionally, the transfer device is adapted to be coupled to an adapter, which is fluidly coupled to a collection vessel. The collection vessel is sealed and has an internal pressure less than atmospheric pressure. The adapter is coupled to the transfer device via any conventional coupling (e.g., threaded connection, snap-fit ​​connection, Luer connector, etc.).

[0020] The valves of the transfer device operate as follows. The first valve operates to allow air to escape from the first channel, but retains the collected sample in the first channel. Air received from the second channel and passing through the first channel is drawn from the transfer device by a reduced pressure in the collection dish. The second valve operates to prevent the sample from flowing from the first channel to the second channel until the first channel is full of sample, thus overcoming the fluid flow resistance of the second valve. Optionally, both valves are hydrophobic flow resistors. Optionally, both valves have barriers with one or more openings providing fluid flow resistance. Optionally, the flow resistor is a barrier having orifices of approximately 2 mm or less. Optionally, the flow resistor has multiple barriers, each having one or more orifices. Optionally, the transfer device has orifices with a diameter of approximately 0.5 μm or less.

[0021] The first channel in the transfer device can be a meandering channel or a straight channel. Optionally, the first channel has a diameter of approximately 3 to approximately 4 mm.

[0022] Optionally, the first and second valves are hydrophobic membranes. Such membranes are porous, and the pore size is approximately 0.45 μm or smaller. Examples of hydrophobic materials used to fabricate hydrophobic flow resistors or membranes include polytetrafluoroethylene (PTFE) or polypropylene.

[0023] This document describes a transfer device assembly for collecting biological samples. The assembly includes a butterfly needle and a transfer device integrated onto the butterfly needle. The transfer device has an inlet for receiving biological samples collected from a patient. The transfer device has an outlet for delivering the collected biological sample to a collection vessel. The collection vessel is typically under sub-atmospheric pressure (i.e., the internal pressure of the container is less than atmospheric pressure). The transfer device has a first channel into which a first portion of the collected biological sample flows after the start of sample collection. The first channel has a first valve such that when the collected sample fills the first channel, air in the first channel exits the first channel through the valve. The valve is in fluid communication with the outlet of the transfer device, such that any air exiting the first channel is drawn from the device into the collection vessel. That is, the transfer device is not vented to the atmosphere. The transfer device has a second channel into which a second portion of the collected sample flows after the first channel has been substantially filled with the collected sample; the second channel is in fluid communication with the first channel through a second valve. The second channel is also in fluid communication with an adapter, wherein the adapter receives the collected biological sample from the second channel, and wherein the adapter outlet is adapted to attach to a needle having a lumen, the needle being adapted to pierce a seal on a collection dish, such that the subatmospheric pressure of the collection dish draws the biological sample from the transfer device into the collection dish. The first and second valves are as previously described. Attached Figure Description

[0024] Figure 1 The illustration shows a blood collection system including a transfer device according to the present technology.

[0025] Figure 2 An embodiment of a transfer device integrated with a retainer according to the present technology is illustrated.

[0026] Figure 3 An embodiment of a transfer device according to the present technology is illustrated.

[0027] Figures 4A-4C An alternative embodiment of the transfer device according to the present technology is illustrated.

[0028] Figure 5 This is a schematic diagram illustrating the path of blood flow through the transfer device according to this technology into the blood collection bottle.

[0029] Figures 6A-6C The illustration shows the sequence in which blood flows into a transfer device according to the present technology, first filling the transfer chamber before flowing through the bypass chamber.

[0030] Figure 7 This is an enlarged view of the transfer chamber valve of one embodiment of the transfer device according to the present technology.

[0031] Figure 8 It is a plot of the percentage of contamination remaining in the needle and / or the needle and tube based on the volume of blood dispensed. Detailed Implementation

[0032] Embodiments of this disclosure are described in detail with reference to the accompanying drawings, wherein similar reference numerals identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of this disclosure, which may be embodied in various forms. Well-known functions or structures have not been described in detail to avoid obscuring this disclosure with unnecessary detail. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as the basis of the claims and as a representative basis for teaching those skilled in the art to use this disclosure differently in virtually any suitably detailed structure.

[0033] Figure 1 The illustration shows a blood collection system including a transfer device according to the present technology. Figure 1 As shown, the blood collection system includes a first needle 110, a tube 120, a transfer device 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 a vein or artery in the patient. Driven by the vacuum pressure generated by the collection bottle 150 and the pressure of the patient's blood, blood from the patient is guided through the tube 120 toward the collection bottle 150. The initial blood flow passes through the tube 120 and is captured in the transfer chamber within the transfer device 130. Subsequent blood flows are collected in the collection bottle 150. The subsequent blood flow follows this route through the transfer chamber of the transfer device 130 to the second needle in the holder 140.

[0034] In some embodiments, Figure 1 The blood collection system can use Beckton Dickinson (“BD”) One of the blood collection devices used to perform this, such as BD. Button-operated blood collection device, BD Safety-Lok TM Blood collection device, or BD UltraTouch TM A button-type blood collection device. Therefore, in some embodiments, the adapter can use BD's... A multi-sampling Luer connector adapter is used for implementation. Additionally, in some embodiments, the retainer 140 can use a BD... A disposable retainer is used for implementation.

[0035] like Figure 1As shown, the transfer device 130 is a separate unit adjacent to the retainer 140. However, in other embodiments, the transfer device 130 may be integrated with the retainer 140. In some embodiments, the transfer device 130 is integrated with a first needle 110 used to puncture a patient's vein or artery. In some embodiments, the transfer device 130 and the first needle 110 are separate units adjacent to each other or, in some embodiments, adjacent to each other. Furthermore, the dimensions of the transfer device 130 can be varied to adjust the amount of blood initially guided into the transfer chamber within the transfer device 130. Depending on the proximity of the transfer device to the first needle, the volume of blood transferred into the transfer device can also be varied. For example, in some embodiments, if the transfer device is directly behind the first needle (e.g., as part of a winged butterfly first needle), the transfer device can be configured to guide less than approximately 150 μL of blood into its transfer chamber. In some embodiments, the transfer device can be configured to guide less than approximately 30-50 μL of blood into its transfer chamber.

[0036] In some embodiments, the transfer device 130 may include an indicator for providing feedback related to the amount of blood collected. For example, the transfer device 130 may include a flow meter indicating how much blood has been collected in the collection bottle 150. The flow meter can minimize potential false-negative blood cultures by helping to ensure that healthcare workers collect sufficient blood. Furthermore, in some embodiments, a transmitter may be communicatively coupled to the indicator for wirelessly transmitting information related to the amount of blood collected to a receiver. In such embodiments, the receiver may be communicatively coupled to a display device configured to display information related to the amount of blood collected.

[0037] The collection bottle 150 may be made of glass, plastic, or other suitable materials. In some embodiments, the collection bottle 150 may use BD's BACTEC. TM One of the culture vials or BD One of the blood collection tubes is used for implementation. In some embodiments, the collection bottle 150 may contain liquid and / or solid additives, such as bacterial growth media, antibiotic scavengers, or pH sensors. In some embodiments, the collection bottle 150 may contain one of BD's blood culture media, such as BD's BACTEC. TM Peds Plus TM Culture medium, BD's BACTEC TM Plus aerobic culture medium, BD BACTEC TM Plus anaerobic culture medium, BD's BACTEC TM Cell lysis-promoting anaerobic culture medium, BD's BACTEC TM Standard aerobic culture medium, or BD's BACTEC TM Standard anaerobic culture medium.

[0038] As mentioned above, most organisms identified as contaminants in blood cultures originate from the patient's skin. These contaminants are typically introduced into the patient's blood sample via venipuncture and the initial blood flow from the patient into the collection bottle. Figure 1 In the blood collection system, the initial blood flow is transferred and collected in the transfer chamber of the transfer device 130. Therefore, Figure 1 The blood collection system offers a device for potentially reducing the number of false-positive blood cultures. Furthermore, compared to conventional techniques currently used for collecting blood samples, in... Figure 1 The blood collection system, including transfer device 130, does not introduce additional workflow steps for healthcare workers. For example, healthcare workers do not need to wait for the tubing or chamber to be partially or completely filled before inserting collection bottle 150 into retainer 140.

[0039] Figure 2 An embodiment of a transfer device integrated with a retainer according to the present technology is illustrated. For example... Figure 2 As shown, the transfer device 230 is integrated with a retainer 240, which includes a second needle 242. The retainer 240 is adapted to be received onto a bottle or collection device (not shown). The second needle 242 provides a fluid passage from the transfer device 230 into the collection device. In those embodiments where the retainer 240 is sealed before assembly with the transfer device 230, the second needle 242 pierces through the retainer 240 when the retainer 240 and the transfer device are assembled together.

[0040] Figure 3 An embodiment of a transfer device according to the present technology is illustrated. For example... Figure 3 As shown, the transfer device 300 is connected to the retainer 380, which includes a second needle 382 that pierces through the septum of the collection bottle or a cap having a septum port.

[0041] like Figure 3 As shown, the transfer device 300 includes a housing, a transfer chamber 330, a transfer chamber valve 350, a sample collection valve 360, and a bypass chamber 370. The housing has an inlet pipe 310 and an outlet pipe 320. The transfer chamber 330 includes a channel or a series of channels 340.

[0042] Such as about Figure 1 As mentioned, during the process of collecting a blood sample from a patient, a first needle is used to puncture the patient's vein or artery. Driven by the vacuum pressure generated by the collection bottle, blood from the patient is guided towards the collection bottle through tubing and transfer equipment, as described herein. Reference Figure 3The initial blood flow passes through the inlet conduit 310 and is captured in the transfer chamber 330 within the transfer device 300. Subsequent blood flow passes through the bypass chamber 370 and is collected in a collection bottle. The subsequent blood flow follows this route from the transfer device 300 to the second needle 382 of the retainer 380.

[0043] Figures 4A-4C Alternative embodiments of the transfer device according to the present technology are illustrated. As shown, the size and shape of the transfer device, as well as its position in the blood collection system, can be varied.

[0044] Figure 4A The illustration shows a transfer device 400 adjacent to, and in some embodiments, a first needle 401 for collecting blood from a patient. Compared to Figure 2 The embodiment shown, Figure 4A In this embodiment, the transfer device 400 is not located adjacent to or next to the holder 402 connected to the collection bottle. In this embodiment, the transfer device is in the form of a tubing device and is located adjacent to the sample collection site. As explained elsewhere herein, moving the transfer device closer to the collection site reduces the volume of blood that needs to be isolated in the transfer chamber.

[0045] Figure 4B The illustration shows an embodiment where the transfer device 410 is part of a wing of a double-winged butterfly-shaped first needle 412 used to collect blood from a patient. As shown, the other wing 411 of the double-winged butterfly-shaped first needle 412 does not include the transfer device. Compared to... Figure 2 The embodiment shown, Figure 4B In the embodiments, the transfer device 410 is not adjacent to or next to the holder 413 connected to the collection bottle, but is adjacent to the site where blood is collected from the patient.

[0046] Figure 4C The illustration shows a preferred embodiment of the transfer device 420 as a portion of the wing of a single-winged butterfly-shaped first needle 421 used to collect blood from a patient. Compared to Figure 2 The embodiment shown, Figure 4C In this embodiment, the transfer device 420 is not adjacent to or next to the holder connected to the collection bottle, but is adjacent to the site from which blood is collected from the patient. The collected blood flows into the transfer device 420 (first filling the transfer chamber) and then into the tube 422 connected to the holder attached to the collection bottle.

[0047] like Figures 4A-4C As shown, the first needles 401, 412, and 421 may include one or more wings. For example, in Figure 4AIn this design, the first needle 401 is a double-winged butterfly needle with wings 403. The wings make it easier for healthcare workers to grip the first needle. However, in other embodiments of the invention, the wings may be omitted. In some embodiments, the wings may be made of a flexible plastic material. In some embodiments, the first needle may also include a body. For example, in Figure 4A In this embodiment, the first needle 401 is a double-winged butterfly needle with a body 404. The body 404 can provide medical staff with an indication that a patient's vein or artery has been successfully punctured. For example, the body 404 can be made of a translucent plastic material that allows medical staff to see the initial flash of blood from the patient. In other embodiments, the body can be made of a transparent material or include a window. In some embodiments, Figures 4A-4C The blood collection system can be partially achieved through the use of BD. Button-operated blood collection device and BD's BACTEC TM This is carried out using a combination of culture vials.

[0048] In some embodiments, the housing and / or retainer of the transfer device may be made of a plastic material such as acrylonitrile butadiene styrene (“ABS”). In some embodiments, the tubing may be made of a hydrophobic material. For example, in some embodiments, the tubing may be made of a plastic material such as polyethylene. In some embodiments, the housing outer shell may be attached to the housing base by an ultrasonic welding process.

[0049] Figure 5 This is a schematic diagram illustrating how initial and subsequent blood flow from a patient can pass through a transfer device according to the present technology. When the transfer device 500 is used as part of a blood collection system 501, blood from the patient flows instantaneously under venous pressure through a first needle 580 located proximally at the system 501. Driven by the vacuum pressure generated by a collection bottle 590 at the distal end of the system 501, blood from the patient flows into the transfer device 500 through an inlet conduit 510, and after the initial collection portion is transferred, the collected blood flows into the collection bottle 590. A sample collection valve 560 is illustrated perpendicular to the path of the incoming blood flow and the transfer chamber 530. Preferably, the sample collection valve 560 of the transfer device 500 is located as close as possible to the first needle 580 without any stagnant areas (e.g., see...). Figure 4CThis minimizes the volume of blood to be isolated before allowing blood to flow from the transfer chamber 530 and into the collection bottle 590 assembled to the holder 585. The path from the first needle 580 into the transfer chamber 530 should be as straight as possible so that blood momentum is unimpeded. The sample collection valve 560 has a location (i.e., perpendicular to the incoming blood) and structure (i.e., orifices or pores in the hydrophobic material) that causes an initial portion of blood flowing into the transfer device 500 to preferentially flow into and fill the transfer chamber 530. Only after the transfer chamber 530 is filled does sufficient force from the backup blood flow exist to overcome the flow resistance of the sample collection valve 560, after which blood flows through the sample collection valve 560. Non-limiting examples of the hydrophobic material used to constitute the sample collection valve 560 include, for example, polytetrafluoroethylene (PTFE) or polypropylene. In some embodiments, the orifices or pores in the hydrophobic material of the sample collection valve 560 have a diameter of approximately 0.2 mm. In alternative embodiments, the sample collection valve 560 is a thin film having a plurality of pores or pores. In some embodiments, each pore or aperture of the membrane of the sample collection valve 560 has a diameter of approximately 5 μm. In alternative embodiments, each pore or aperture of the membrane of the sample collection valve 560 has a diameter of approximately 0.45 μm. In some embodiments, the membrane of the sample collection valve 560 is made of a hydrophobic material. Non-limiting examples of hydrophobic materials used to constitute the membrane of the sample collection valve 560 include, for example, polytetrafluoroethylene (PTFE) or polypropylene.

[0050] The initial blood flow bypasses the sample collection valve 560 and flows into the transfer chamber 530. This path reflects the path of least flow resistance for blood, because, as mentioned above, the flow through the sample collection valve 560 needs to overcome the flow resistance of the sample collection valve 560. Therefore, the flow of the initial portion of blood into the transfer chamber 530 is the preferred flow path for the initial portion of the collected blood sample flowing into the transfer device 500.

[0051] The transfer chamber 530 has a channel or series of channels terminating in the transfer chamber valve 550. In some embodiments, the channel or series of channels of the transfer chamber 530 has a diameter of approximately 3 to approximately 4 mm. In some embodiments, the length of the path through the transfer chamber 530 is minimized to prevent unnecessary airflow restriction. In some embodiments, the transfer chamber valve 550 has such a diameter that it can maintain the momentum of the liquid column, thereby preventing any blood from passing through the transfer chamber valve 550 and entering the bypass chamber 570. In some embodiments, the transfer chamber valve 550 has a diameter much smaller than approximately 0.2 mm. In an alternative embodiment, the transfer chamber valve 550 is a membrane having a plurality of pores or holes. In some embodiments, each pore or hole of the membrane of the transfer chamber valve 550 has a diameter of approximately 5 μm. In an alternative embodiment, each pore or hole of the membrane of the transfer chamber valve 550 has a diameter of approximately 0.45 μm. In some embodiments, the membrane of the transfer chamber valve 550 is made of a hydrophobic material. Non-limiting examples of hydrophobic materials used to constitute the membrane of the transfer chamber valve 550 include, for example, polytetrafluoroethylene (PTFE) or polypropylene. In some embodiments, the transfer chamber valve 550 maintains a much higher static pressure than the sample acquisition valve 560.

[0052] Figure 5 The illustration shows how the initial blood flow 531 from the patient can flow into the transfer chamber 530. The initial blood flow 531 may contain contaminating bacteria (i.e., bacteria from the skin surface rather than from the collected sample). When the transfer chamber 530 begins to fill with the initial blood flow 531, the transfer chamber valve 550 prevents blood from flowing into the outlet conduit 520. However, if a vacuum is applied, for example via a vacuum blood collection tube adapter, the transfer chamber valve 550 allows gas or air to flow through, but the collected blood cannot flow through the transfer chamber valve 550. In some embodiments, the transfer chamber valve 550 may be constructed of a hydrophobic material that allows air to pass through but not blood. Non-limiting examples of materials used to construct the sample collection valve 560 include, for example, polytetrafluoroethylene (PTFE) or polypropylene. Air preceding the initial portion of blood entering the transfer device travels through either valve into the outlet conduit 520. Therefore, the transfer device 500 is a closed system. The initial airflow through the transfer device 500 is not vented to the atmosphere. Therefore, healthcare workers do not need to wait for air to be purged from the transfer device 500 before connecting the transfer device 500 to the collection bottle 590. Therefore, the initial blood flow 531 pushes air from the transfer chamber 530 through the transfer chamber valve 550 into the collection bottle 590. The portion of the initial blood flow 531 that fills the transfer chamber 530 is locked in place. Advantageously, this portion of the initial blood flow 531 may contain most contaminants (e.g., bacteria). When the transfer chamber is filled with the initial blood flow 531, it seals off the blood flow passing through it.

[0053] Figure 5The illustration also shows how the subsequent blood flow 571 from the patient can flow toward the collection bottle 590 through the inlet conduit 510. Once the transfer chamber 530 is filled, the pressure at the sample collection valve 560 begins to increase, allowing the subsequent blood flow 571 to pass through the bypass chamber 570. The subsequent blood flow 571 passes through the bypass chamber 570 and exits the transfer device 500 through the outlet conduit 520 into the collection bottle 590.

[0054] Figures 6A-6C The illustration shows the sequence of blood flow into one embodiment of a transfer device according to the present technology, first filling the transfer chamber before flowing through the bypass chamber. In this embodiment, the transfer device 600 is attached to a retainer 680, which is a vacuum blood collection tube adapter as illustrated. Figure 6A The markings shown are also suitable for Figure 6B and Figure 6C .like Figures 6A-6C As shown, the transfer device 600 includes a housing, a transfer chamber 630, a transfer chamber valve 650, a sample collection valve 660, and a bypass chamber 670. The housing has an inlet pipe 610 and an outlet pipe 620. The transfer chamber 630 includes a channel or a series of channels 640. Furthermore, the blood collection system may include a first needle, a tube, an adapter, a retainer 680, a second needle 682, and a collection bottle. Figure 6A As shown, before the blood collection procedure begins, both the transfer chamber 630 and the bypass chamber 670 of the transfer device 600 are empty.

[0055] Figure 6A The arrows indicate the direction of the initial blood flow into the transfer device 600. This is the path of least flow resistance without user intervention, driven by the vacuum pressure generated by the collection bottle connected to the retainer 680.

[0056] like Figure 6B As shown, the initial blood flow fills the channels or a series of channels 640 of the transfer chamber 630. Once the initial blood flow reaches the transfer chamber valve 650, it stops the blood flow through it.

[0057] like Figure 6C As shown, the subsequent blood flow enters the bypass chamber 670 through the sample collection valve 660. The bypass chamber 670 allows the subsequent blood flow to leave the transfer device 600 through the outlet pipe 620, enter the holder 680, and eventually reach the collection bottle.

[0058] Figure 7 The diagram shows Figures 6A-6C An enlarged view of an embodiment of the transfer chamber valve 650 of the transfer device 600. (See diagram below.) Figure 7As shown, the air gap 800 between the two flow resistors 700 ensures that contaminated initial blood does not come into contact with subsequent blood flow. As mentioned above, the flow resistors 700 are made of a hydrophobic material. The flow resistors 700 also have a small orifice 810 or hole (e.g., approximately 2 mm or smaller) therein to create flow resistance. To ensure redundancy and prevent blood from flowing through the transfer chamber valve 650 and entering the bypass chamber 670, in... Figure 7 The diagram in the middle Figures 6A-6C An embodiment of the transfer chamber valve 650 has multiple air gaps and multiple flow resistors.

[0059] Air gaps between flow resistors may also exist in other embodiments of the transfer chamber valve. In some embodiments, the transfer chamber valve may contain more than one set of air gaps.

[0060] In some embodiments, the transfer device is located at a distance from the first needle and close to the holder or adapter connected to the collection bottle. In some embodiments, the transfer device is close to the first needle and away from the holder or adapter connected to the collection bottle. In a preferred example, the transfer device is part of the winged butterfly-shaped first needle.

[0061] Figure 8 The effect of proximity of the transfer device to the first needle is shown. Figure 8 The plot shows the percentage of contaminants remaining in the needle and the 50mm tube after a certain volume of clean blood has flowed through each of the needle and the 50mm tube. The conclusion drawn from the plot is that the transfer of contaminated blood is more likely to be effective after collecting a smaller volume of blood if the transfer device is positioned closer to the needle.

[0062] Depending on the proximity of the transfer device to the first needle, the volume of blood transferred into the transfer device can be varied. For example, in some embodiments, if the transfer device is directly behind the first needle (e.g., as part of a winged butterfly first needle), the transfer device can be configured to guide less than approximately 150 μL of blood into its transfer chamber. In some embodiments, the transfer device can be configured to guide less than approximately 30-50 μL of blood into its transfer chamber.

[0063] As demonstrated above, some embodiments of the present invention offer significant advantages. Most organisms identified as contaminants in blood cultures originate from a patient's skin. These contaminants are typically introduced into the patient's blood sample via venipuncture and the initial blood flow from the patient into the collection bottle. Therefore, by transferring and capturing the initial blood flow, the transfer device according to the present technology can potentially reduce the number of false-positive blood cultures.

[0064] Furthermore, the transfer device according to this technology provides a universal solution. For example, the distance from the transfer device to the first needle can be easily changed, allowing any predetermined amount of blood (such as less than approximately 150 μL) to be transferred and collected.

[0065] Furthermore, compared to conventional techniques currently used for blood sample collection, incorporating the transfer device according to this technology into a blood collection system does not introduce additional workflow steps for healthcare workers. For example, healthcare workers do not need to wait for partial or complete filling of the tubing or chamber before inserting the collection bottle into the retainer. This advantage is largely achieved because some embodiments of the transfer device according to this technology operate using vacuum pressure generated by the collection bottle. Therefore, some embodiments of the transfer device according to this technology do not rely on a separate power source or the patient's venous pressure to capture the initial blood flow or collect subsequent blood flows in the collection bottle.

[0066] As described above, some embodiments of blood collection systems having a transfer device according to the present technology are closed-system solutions. In these embodiments, air is not expelled from the system and enters the atmosphere before the liquid blood flows. Instead, these embodiments use vacuum pressure generated by the collection bottle to draw blood immediately from the patient. In these embodiments, the transfer device can be used within a closed system to balance the pressure and airflow along the flow path. For example, a transfer chamber valve can be used to allow air to flow out of the transfer chamber and into an outlet pipe before the blood sample. In such embodiments, the transfer chamber valve can prevent the flow of liquids such as blood through it.

[0067] Based on the foregoing and with reference to the accompanying drawings, those skilled in the art will understand that certain modifications may be made to this disclosure without departing from its scope. For example, the transfer device according to the present technology can be positioned anywhere along the flow path. For example, the transfer device according to the present technology can be attached to the body of the first needle. As another example, the transfer device according to the present technology can be positioned along the tube between the retainer and the second needle.

[0068] Furthermore, the blood collection system according to this technology may not include all the components illustrated in the above embodiments. For example, the needle, transfer device, and retainer can be integrated into a single device without any tubing. For example, the transfer device according to this technology can be used with BD. Eclipse TM Blood collection needle integration.

[0069] Furthermore, in some of the above embodiments, collection bottles with an internal pressure below atmospheric pressure are used to collect blood from patients. Moreover, various collection vessels with an internal pressure below atmospheric pressure can be used with this technology. For example, collection tubes can be used with this technology. As another example, collection vials can be used with this technology.

[0070] Although several embodiments of the present disclosure have been shown in the accompanying drawings, it is not intended to limit the disclosure thereto, as the intention is to make the scope of the disclosure as permissible in the art and to ensure that this specification is read in the same manner. Therefore, the above description should not be construed as limiting, but merely as illustrative of particular embodiments. Other modifications within the scope and spirit of the appended claims will be contemplated by those skilled in the art.

Claims

1. A transfer device for collecting biological samples, the transfer device comprising: An importer used to receive biological samples collected from patients; Used to deliver collected biological samples to the outlet of a collection vessel, which is operated under sub-atmospheric pressure; A first channel is provided in which a first portion of the collected biological sample flows into the first channel after the start of sample collection. The first channel includes a first valve that allows air in the first channel to exit the first channel through the first valve when the collected biological sample fills the first channel. The second channel is where a second portion of the collected biological sample flows into the first channel after the first channel has been filled with the collected biological sample. The second channel is in fluid communication with the first channel through a second valve. The outlet is attachable to a needle with a lumen that can pierce a seal on the collection dish, allowing the sub-atmospheric pressure of the collection dish to draw the biological sample from the transfer device into the collection dish. When connected to the collection vessel, the transfer device is a closed system, allowing air exiting the first channel through the first valve to flow into the second channel and not be released into the atmosphere; and The first valve is a first hydrophobic flow resistor, and the second valve is a second hydrophobic flow resistor, wherein each hydrophobic flow resistor includes a barrier having an orifice, and the barrier prevents liquid from flowing through the hydrophobic flow resistor, wherein the first valve is configured to prevent liquid from passing through it, and the second valve is configured to allow liquid to flow into the second channel when the first channel is filled with fluid.

2. The transfer device according to claim 1, wherein, The inlet can be connected to a tubing device for collecting biological samples from patients.

3. The transfer device according to claim 2, wherein, The tubing device includes a sample collection needle and a collection tube.

4. The transfer device according to claim 3, wherein, The sample collection needle is a butterfly needle selected from the group consisting of a single-winged butterfly needle or a double-winged butterfly needle.

5. The transfer device according to claim 4, wherein, The butterfly needle is biwing butterfly-shaped, and the transfer device is integrated into one wing of the butterfly.

6. The transfer device according to claim 1, wherein, The transfer device can be coupled to an adapter, which is coupled to a collection vessel.

7. The transfer device according to claim 6, wherein, The adapter is coupled to the transfer device via a threaded connection.

8. The transfer device according to claim 7, wherein, The adapter is coupled to the transfer device via a Luer connector.

9. The transfer device according to claim 1, wherein, The barrier in the hydrophobic flow resistor has an orifice of less than or equal to 2 mm.

10. The transfer device according to claim 9, wherein, The hydrophobic flow resistor includes multiple barriers, each of which has the orifice.

11. The transfer device according to claim 1, wherein, The first passage is a winding passage.

12. The transfer device according to claim 11, wherein, The first channel has a diameter of 3 to 4 mm.

13. The transfer device according to claim 9, wherein, The orifice has a diameter of less than or equal to 0.5µm.

14. The transfer device according to claim 1, wherein, The hydrophobic flow resistor is a thin film.

15. The transfer device according to claim 14, wherein, The film is a porous film.

16. The transfer device according to claim 15, wherein, The porous film comprises pores having a diameter of less than or equal to 0.45 µm.

17. The transfer device according to claim 1, wherein, The hydrophobic flow resistor is made of either polytetrafluoroethylene (PTFE) or polypropylene.

18. A transfer device assembly for collecting biological samples, the transfer device assembly comprising: butterfly needle; A transfer device, integrated on the butterfly needle, comprising: An importer used to receive biological samples collected from patients; Used to deliver collected biological samples to the outlet of a collection vessel, which is operated under sub-atmospheric pressure; A first channel is provided in which a first portion of the collected biological sample flows into the first channel after the start of sample collection. The first channel includes a first valve that allows air in the first channel to exit the first channel through the first valve when the collected biological sample fills the first channel. The second channel is where a second portion of the collected biological sample flows into the first channel after the first channel has been filled with the collected biological sample. The second channel is in fluid communication with the first channel through a second valve. The second channel is in fluid communication with an adapter including an outlet, wherein the adapter receives the collected biological sample from the second channel, and wherein the outlet of the adapter can be attached to a needle having a lumen, the needle being capable of piercing a seal on a collection vessel, such that the sub-atmospheric pressure of the collection vessel draws the biological sample from the transfer device into the collection vessel. The transfer device is a closed system that prevents the initial airflow through the transfer device from being released into the atmosphere; and The first valve is a hydrophobic flow resistor, the second valve is a hydrophobic flow resistor, wherein each of the hydrophobic flow resistors includes a barrier having an orifice and the barrier prevents liquid from flowing through the hydrophobic flow resistor, wherein the first valve is configured to prevent liquid from passing through it, and the second valve is configured to allow liquid to flow into the second channel when the first channel is filled with fluid.

19. The transfer device assembly according to claim 18, wherein, The barrier in the hydrophobic flow resistor has an orifice of less than or equal to 2 mm.

20. The transfer device assembly according to any one of claims 18 and 19, wherein, The hydrophobic flow resistor includes multiple barriers, each of which has the orifice.

21. The transfer device assembly according to claim 18, wherein, The first passage is a winding passage.

22. The transfer device assembly according to claim 21, wherein, The first channel has a diameter of 3 to 4 mm.

23. The transfer device assembly according to claim 19, wherein, The orifice has a diameter of less than or equal to 0.5 µm.

24. The transfer device assembly of claim 18, wherein, The hydrophobic flow resistor is a thin film.

25. The transfer device assembly according to claim 24, wherein, The film is a porous film.

26. The transfer device assembly according to claim 25, wherein, The porous film comprises pores having a diameter of less than or equal to 0.45 µm.

27. The transfer device assembly according to claim 18, wherein, The hydrophobic flow resistor is made of either polytetrafluoroethylene (PTFE) or polypropylene.

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