Device

Abstract

To provide fluid diversion, sequestration and / or isolation devices and methods for procuring bodily fluid samples with reduced contaminants such as dermally residing microbes and / or other contaminants exterior to a bodily fluid source.SOLUTION: A fluid control device includes an inlet configured to be placed directly or indirectly in fluid communication with a bodily fluid source, and an outlet. The fluid control device has a first state in which a negative pressure differential produced from an external source such as a fluid collection device is applied to the fluid control device to draw an initial volume of bodily fluid from the bodily fluid source through the inlet into a sequestration portion of the fluid control device. The fluid control device has a second state in which (1) the sequestration portion sequesters the initial volume, and (2) the negative pressure differential draws a subsequent volume of bodily fluid, being substantially free of contaminants, from the bodily fluid source through the fluid control device into the fluid collection device.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a joint venture of the "Fluid Control Device" filed on September 12, 2017. and Methods of Using the Same (Fluid Control Device) and methods of using the fluid control device,” U.S. Provisional Patent Application No. 62 / 557,533 No. 60 / 099,299, filed on Oct. 1, 2007, the disclosure of which is incorporated by reference in its entirety.

[0002] This application also relates to "Fluid Control Device" filed on February 23, 2018. ces and Methods of Using the Same" Priority and benefit of Provisional Patent Application No. 62 / 634,569 is claimed, the disclosure of which is incorporated herein by reference. It is incorporated herein in its entirety.

[0003] This application also relates to "Fluid Control Device" filed on May 31, 2018. ces and Methods of Using the Same" Priority and benefit of Provisional Patent Application No. 62 / 678,632 is claimed, the disclosure of which is incorporated herein by reference. It is incorporated herein in its entirety. [Background technology]

[0004] The present invention relates generally to the parenteral acquisition of body fluid samples, and more particularly to samples of body fluids present on the skin. A bodily fluid sample having reduced contaminants, such as microorganisms and / or other contaminants external to the source of the bodily fluid. The present invention relates to a device and method for diversion, isolation, and / or separation of fluids for harvesting.

[0005] Medical practitioners use parenterally obtained body fluids to perform various types of microbiological tests on patients. and a wide range of other diagnostic tests are routinely performed. As advanced diagnostic techniques evolve and improve, As a result, the speed, accuracy (both sensitivity and specificity), and value of the information that can be provided to the clinician Also, maintaining the integrity of body fluid samples during and / or after collection This also ensures that analytical diagnostic results represent the internal state of the patient. Examples of diagnostic techniques that are not based on and / or rely on pure body fluid samples include microbiology. Detection, molecular diagnostics, gene sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (R These include genomic DNA sequencing (GA), next-generation sequencing (NGS), and biomarker identification. may include, but are not limited to, cells outside the source from which the sample is obtained. Biological material and / or other extraneous contaminants may be accidentally included in the body fluid sample to be analyzed. In other words, when samples are taken from a particular body fluid source, inaccurate test results may be obtained. The purity of the sample intended to be taken or collected is not compromised during the specimen acquisition process. When used in a clinical setting, the resulting analytical test results may be inaccurate, abnormal, poor, false positive, or may be false negative and / or otherwise not representative of the patient's actual situation, thereby , incomplete, inaccurate, messy, uncertain, unreliable, and / or otherwise undesirable This may lead to better clinical decision-making.

[0006] In some instances, the patient sample (e.g., bodily fluid) may be free of bacteria, fungi, or yeast (e.g., Tested for the presence of one or more potentially undesirable microorganisms, such as Candida In some instances, microbiological testing involves the testing of culture media, general additives, and / or microbial One or more sterile and / or non-sterile containers that can contain other types of solutions that support growth. In another example, the method may involve culturing a patient sample in a bath of bacteria. The sample may be analyzed directly (i.e., not cultured) or the culture medium or In yet another example, various technologies are employed to The presence of microorganisms and other types of biological material, specific types of cells, biomarkers, and proteins It can aid in the detection of proteins, antigens, enzymes, blood components and / or the like. These include molecular polymerase chain reaction (PCR), magnetic resonance, and other magnetic analytical platforms. room, automated microscope, spatial clonal separation, flow cytometry, whole blood ("non-culture") specimen separation analysis (e.g., NGS) and related techniques, morphokinetic cell analysis, and / or analysis of patient samples Characterizing and / or detecting specific organisms, antibiotic susceptibility, and / or the like; Used in clinical testing settings to identify, type, classify, and / or characterize This includes, but is not limited to, other common or advanced techniques used.

[0007] In some instances, detecting the presence of a microorganism may involve determining whether the microorganism and / or organism has been present for a period of time (e.g., , which can vary from less than an hour to several hours or days, depending on the diagnostic technique employed. and then allowing the cells to grow (which may be longer or shorter, depending on the circumstances). Automated and continuous monitoring and / or detection and identification of microbial and / or biological growth. and / or in other ways specific to the analytical platform and technology used in the same. Therefore, it can be detected.

[0008] In a culture test, for example, if a microorganism is present in a patient sample, the microorganism will be absorbed into the culture medium. In some cases, automated monitoring techniques can detect the growth of organisms over time. The presence of microorganisms in the culture medium (observation of carbon dioxide) can be detected. (as shown by ELISA and / or other detection methods) indicates that the same microorganism is present in the patient sample. This suggests the presence of the same microorganisms in the patient's body fluids from which the samples were obtained. Therefore, the presence of the organism in the culture medium (or more generally in the test A patient is diagnosed when the presence of the microorganism is confirmed in the sample used for one specifically designed to treat or otherwise remove unwanted microorganisms from a patient The above antibiotics or other treatments may be prescribed.

[0009] However, patient samples may be contaminated during acquisition and / or may result in false positives or may be more susceptible to false negative results. For example, the specimen acquisition process (i.e., Needle insertion, peripheral intravenous catheter (PIV), peripherally inserted central catheter (PICC), and and / or other indwelling catheter(s) or other lumen-containing device, such as specimen acquisition, syringe collection, or any other suitable means employed to collect patient specimens. Microorganisms on the body surface (e.g., microorganisms present on the skin) that are expelled into the then directly or indirectly through tissue fragments, hair follicles, sweat glands, and other skin appendage structures. , culture media, test vials, or other suitable specimen collection vessels or vessels containing patient samples. It may be included in samples to be transferred to a transfer vessel and / or analyzed in non-culture based tests. Another possible source of contamination is the person taking the patient sample (doctor, phlebotomist, nurse, technician, etc.). Specifically, the equipment, materials, and procedures used during the patient sample acquisition process Products and / or devices often contain multiple components, each of which can introduce potential points of contamination. Fluid interfaces (e.g., patient to needle, needle to transfer adapter, transfer adapter to to sample reservoir, catheter hub to syringe, syringe to transfer adapter, needle / tubing to the sample vessel, and / or any other fluid interface or any combination thereof. In some instances, such contamination may occur. The substance may grow in culture media and / or be recognized by other non-culture based diagnostic techniques. may be differentiated, ultimately resulting in false-positive and / or false-negative microbiological test results. The test results may indicate the presence or absence of such microorganisms in the patient (i.e., in the body). may inaccurately reflect the lack of

[0010] Such inaccuracies due to contamination and / or other sources of adulteration that compromise sample purity The results may include a broad range of suspected illnesses, diseases, infections, patient conditions, or other conditions of concern. This is a concern when diagnosing or treating the disease. For example, false-negative microbiological test results This can lead to misdiagnosis and / or delayed treatment of patients' illnesses, and in some cases, Conversely, a false-positive microbiological test result can cause the patient to die. Patients may need to undergo one or more antimicrobial therapies, which can result in serious complications, including death. This can cause serious side effects, prolong the patient's hospital stay and / or other complications related to the incorrect treatment. Complications can place unnecessary strain and costs on the healthcare system. The use of diagnostic imaging equipment due to these false positive results is a concern for various imaging procedures (e.g., CT scans). Unnecessary exposure to radiation associated with MRI has many negative effects on long-term patient health. It has known adverse effects and is a concern from both a cost and patient safety perspective.

[0011] In some instances, the devices and / or systems are used to extract a sample of bodily fluid for testing. This can reduce the likelihood of contamination, tampering, and / or the like. For example, some Some known devices may harbor contaminants, such as microorganisms present on the skin. Collect, divert, separate, and / or separate the initial volume of fluid, which may be higher. However, some such devices can be configured to The system is perceived as cumbersome, difficult to understand, and difficult to use, especially when considering the target patient population. In addition, some such Devices that require training, user supervision, and multiple user intervention may be and / or environmental, educational, clinician skills, patient situation, and / or similar factors. These may present issues where validity may be otherwise limited based on differences including: In some instances, such issues include uncontaminated, sterile, and unadulterated products. This can complicate the collection of reliable, high-quality samples, thereby limiting the accuracy of test results. This may affect the validity of the argument.

[0012] On the other hand, some known passive shunting devices and / or systems (e.g., direct use Specifically does not utilize or rely on user intervention, interaction, manipulation, and / or the like systems) require, for example, the time required to fill a segregation reservoir with a significant volume of fluid. Clinical realities, such as time, may require appropriate division of clinically desirable and effective pre-test volumes of body fluids. In some instances, it may not be possible to flush, isolate, and / or separate the The operation of some known passive devices relies on positive pressure applied by a body fluid source (e.g., the patient's However, positive pressure exerted by a fluid source is not sufficient to The chair is practical for use in a variety of clinical settings, including emergency rooms and other intensive care settings. For example, the flow velocity is usually insufficient to generate sufficient flow force and / or velocity. The symptomatic patient population requiring the above diagnostic tests includes those with hypotensive states (i.e., low blood pressure), circulatory problems, Hypovolemic state (i.e., low blood volume), and / or other physical problems (e.g., severe Vascular access problems due to dehydration, obesity, difficult and / or inaccessible vasculature, etc. physical conditions that make collection of blood and / or body fluid samples difficult to achieve; Such conditions or physical circumstances may provide sufficient blood flow and / or pressure to allow the isolation chamber, Clinically validated evidence of passive filling of channels, reservoirs, containers (or other divided volumes) This can make it difficult to reliably achieve a volume sufficient to meet efficacy based on abnormal, inaccurate, false positive, false negative, and / or otherwise adulterated diagnostic test results Divert, isolate, and / or separate contaminants that may otherwise lead to adverse effects. Problems associated with the method (e.g., without specific external energy sources and / or negative pressure, Relying on a positive pressure differential applied by a fluid source to achieve an adequate and clinically effective initial volume of fluid collection. The frail patient population from which these samples are collected (facilitating collection) is a significant factor in preventing failure. This approach may not be practical as the rates may be unacceptably high.

[0013] Therefore, it is important to consider the presence of microorganisms and / or fluid sources on the skin that result in consistent fluid collection. A method for obtaining a body fluid sample with reduced contaminants, such as other contaminants present in the body fluid, There is a need for body flow diversion devices and methods (e.g., for general patient populations and / or Some such devices and methods involve, for example, various external It may include fluid collection with the assistance of an energy source and / or negative pressure. Difficulties impacting the ability to demonstrate consistent efficacy and collect further bodily fluid samples Issues associated with collecting samples from patients with different health conditions and / or physical characteristics There needs to be a device that can deal with this. Summary of the Invention

[0014] Reduced contaminants such as microorganisms present on the skin and / or other contaminants external to the source of bodily fluids Described herein are devices and methods for obtaining bodily fluid samples. In some embodiments, the system includes a housing, a flow controller, and a fluid collection device. The housing has an inlet and an outlet and forms an isolation portion. The inlet The isolation portion is configured to allow fluid to flow between the source and the isolation portion. The flow controller is configured to receive the fluid from a body fluid source. and configured to transition from a first state to a second state. The fluid collection device is fluidly coupled to the outlet and is disposed in at least one of the housings. The negative pressure difference is generated by the flow controller in the first When in the flow control state, the flow control is operable to draw an initial volume of body fluid into the isolation portion, When the controller is in the second state, a test volume of body fluid is passed through the outlet and into the fluid collection device. The device is operable to retract into a vice. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a schematic diagram of a fluid control device, according to one embodiment. [Figure 2] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 3] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 4] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 5] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 6] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 7] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 8] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 9] FIG. 1 is a front view of a fluid control device in a first mode of operation, according to one embodiment. [Figure 10] FIG. 1 is a front view of a fluid control device in a second mode of operation, according to one embodiment. [Figure 11] FIG. 1 is a front view of a fluid control device in a first mode of operation, according to one embodiment. [Figure 12] FIG. 1 is a front view of a fluid control device in a second mode of operation, according to one embodiment. [Figure 13] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 14]1A-1D are various views of a fluid control device, according to one embodiment. [Figure 15A] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 15B] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 16] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 17A] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 17B] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 18] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 19] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 20] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 21] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 22] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 23] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 24] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 25] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 26] 1A-1C are perspective views of fluid control devices according to different embodiments. [Figure 27] 1A-1C are perspective views of fluid control devices according to different embodiments. [Figure 28] 1A-1C are perspective views of fluid control devices according to different embodiments. [Figure 29] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 30] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 31]1A-1D are various views of a fluid control device, according to one embodiment. [Figure 32] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 33] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 34] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 35] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 36] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 37] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 38] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 39] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 40] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 41] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 42] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 43] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 44] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 45] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 46] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 47] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 48] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 49] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 50]1A-1D are various views of a fluid control device, according to one embodiment. [Figure 51] 1 is a cross-sectional view of a fluid control device according to one embodiment. [Figure 52] 1 is a cross-sectional view of a fluid control device according to one embodiment. [Figure 53] 1 is a flowchart illustrating a method of using a fluid control device, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0016] Collecting, diverting, isolating, separating, etc., an initial volume of fluid and subsequently obtaining Described herein are devices and methods for reducing contamination in bodily fluid samples. Any of the fluid control devices described herein may be used to control the flow, bolus, volume, etc. of bodily fluids. The first reservoir may be configured to receive, acquire, and / or transfer the fluid. The channel, flow path, or portion of the device is capable of accepting an initial volume of bodily fluid flow. and then directing this flow of bodily fluid into or from a first reservoir or first portion of the device. By means of such means, substantial or complete isolation (e.g., containment or retention, avoidance, (separate, separate, isolate, vapor-tight, separate, and / or the like) In some instances, contaminants, such as microorganisms present on the skin, may be present in the initial volume of fluid. may be mixed in and / or contaminated with the first reservoir or first portion of the device. Once the initial volume is isolated, the subsequent volume of any fluid flow is , into a second reservoir, a second portion of the device, and / or any additional flow channel(s). Can be flowed, guided, directed, flow-controlled (manual, automatic, and / or (semi-automatically). Therefore, by isolating the initial volume, any additional and / or subsequent amount(s) may be inaccurate, occurring in some diagnostic and / or testing Contaminants that may produce different results, such as abnormal, poor, false positive, or false negative results In some instances, an initial volume of bodily fluid may be used, e.g., For example, other tests may be used that are less affected by the presence of contaminants, or the waste volume may be reduced. can be disposed of as a steroid, can be reinfused into the patient, and / or can be in any other suitable form. It can be used for appropriate clinical purposes.

[0017] In some embodiments, the fluid control devices and / or methods described herein are characterized by , an external negative pressure source (e.g., provided by a fluid collection device or any other suitable means) ) to (1) fully engage the isolation chamber and / or restrict fluid flow to the fluid collection chamber; Limit the pressure difference (e.g., the difference in blood pressure relative to ambient air pressure) sufficient to transfer the pressure to the collection device. (2) overcoming physical patient problems that may prevent and / or prevent the patient from receiving treatment; Properly filling the isolation chamber with a clinically verified and / or desired amount of body fluid; (3) The fluid collection process is efficient, timely, and / or user-acceptable. and / or (4) manipulate and / or automatically transfer fluid flow. means for performing the desired action (e.g., movement of a physical component of the system or the flow of a desired fluid) change, switch, engage, and / or otherwise adopt or achieve) to provide an initial sample The objective is to enable isolation and / or separation of the infected person and subsequent collection of samples.

[0018] In some embodiments, the fluid control device includes an inlet and an outlet. The fluid source or intermediate body fluid transfer device is configured to be placed in fluid communication with the fluid source or intermediate body fluid transfer device, and the outlet The port may be, for example, a sample reservoir, a syringe, a lumen containing device, and / or any other suitable and a fluid collection device, such as a suitable bodily fluid collection and / or transfer device. The fluid control device is configured to be placed in a A fluid collection device, such as a reservoir, syringe, tank, and / or any suitable intermediate fluid reservoir. A negative pressure differential generated from the fluid source is applied to the fluid control device to induce an initial volume of fluid into the fluid source. from the isolation and / or diversion portion of the fluid control device through the inlet (formed by or in, or capable of joining to, The fluid control device has a first state. (1) The isolation chamber isolates the initial volume, and (2) 2) a negative pressure differential directs a subsequent volume of substantially contaminant-free fluid from the fluid source to the fluid control It has a second state that draws fluid through the device and into the fluid collection device.

[0019] In some embodiments, the system comprises a housing, a flow controller, and a fluid collection system. The housing has an inlet and an outlet and forms an isolation portion. The inlet The isolation portion is configured to be disposed in fluid communication with a source of bodily fluid. The flow controller is configured to receive a volume of fluid from a body fluid source. a first state transitioning to a second state, the first state transitioning to a third state transitioning to a fourth ... The fluid collection device is fluidly coupled to the outlet and includes at least one fluid collection device. The negative pressure difference is generated within the flow controller. When in the first state, the flow is operable to draw an initial volume of bodily fluid into the isolation portion, When the controller is in a second state, the test volume of bodily fluid is passed through the outlet and into the fluid collection system. The device is operable to retract into the device.

[0020] In some embodiments, the device comprises a housing and an actuator coupled to the housing. The housing includes an inlet configured to be in fluid communication with a source of bodily fluid. and an outlet configured to be placed in fluid communication with the fluid collection device. The housing forms an isolation portion configured to receive an initial volume of bodily fluid from a bodily fluid source. The actuator positions the first fluid flow path at the inlet and the isolation portion so that the fluid can flow through the isolation portion. The first and second fluid flow paths have a second configuration that fluidly aligns the inlet and the outlet. The fluid collection device is disposed in fluid communication with the outlet, and includes: (1) an actuator; When the valve is in the first configuration, it is operable to draw an initial volume of bodily fluid into the isolation portion. (2) creating a negative pressure differential within the first fluid flow path when the actuator is in the second configuration; and a second fluid sample volume operable to draw the fluid sample volume into the fluid collection device; It is configured to create a negative pressure differential within the fluid flow path.

[0021] In some embodiments, the fluid control device is used to control body fluids with reduced contamination. The method for obtaining the sample allows fluid communication between a source of bodily fluid and an inlet of a fluid control device. The fluid collection device is coupled to the outlet of the fluid control device, The initial volume of bodily fluid is configured to generate a negative pressure differential within at least a portion of the space. In response to a negative pressure differential, body fluid is received from the inlet and into the isolated portion of the fluid control device. In response to contact with a portion of the initial volume of the The flow controller allows the gas to flow through the flow controller. The first state prevents the flow of fluid through the flow controller. The flow controller is transitioned to a second state that prevents the flow of gases and body fluids. and a subsequent volume of bodily fluid is transferred from the inlet to the outlet in fluid communication with the fluid collection device. The initial volume of bodily fluid is then isolated within the isolation portion.

[0022] As used in this specification and claims, the singular forms "a," "an," and "th" are used interchangeably. "e" includes plural referents unless the context clearly dictates otherwise. For example, the term "element" is intended to mean a single element or a combination of elements. and "a material" is intended to mean one or more materials or combinations thereof.

[0023] As used herein, the terms "about," "approximately," and / or "substantially" When used in connection with stated values ​​and / or other geometric relationships, The defined structure is nominally the stated values ​​and / or stated geometric relationships. In some instances, the terms "about," "approximately," and / or "substantially" are used. The term "substantially" generally means plus or minus 10% of the stated value or relationship. For example, approximately 0.01 can be considered to be 0.009 and 0. 0.5 includes 0.45 and 0.55; about 10 includes 9 to 11; Approximately 1000 includes 900 to 1100. The stated values ​​may be desirable, e.g. Manufacturing tolerances or other practical considerations (e.g., through portions of devices, conduits, lumens, etc.) Some variance may occur as a result of factors such as the pressure or force applied to the Therefore, the terms "about," "approximately," and / or "substantially" are used herein. and may account for such tolerances and / or considerations.

[0024] As used herein, a "body fluid" refers to any fluid obtained directly or indirectly from a patient's body. For example, "body fluid" includes blood, cerebrospinal fluid, urine, bile, Lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous humor, air, etc., or Any combination of these may be used, but is not limited to these.

[0025] As used herein, the terms "proximal" and "distal" refer to the location of the device connected to the patient. These refer to the direction closer to the user who touches the object and the direction farther away from the user. For example, the end of the device that first touches the patient's body is the distal end, while the The contralateral end (e.g., the end of the device that the user is manipulating) is the proximal end of the device. do.

[0026] As described in more detail herein, any of the devices and methods may be used to For example, divert a "pre-sample" volume of fluid before collecting a "sample" volume of fluid. This allows for the acquisition of a body fluid sample with reduced contamination. The terms "first," "initial," and / or "initial" refer to a transfer prior to obtaining a "sample" volume. Describe the amount, portion, or volume of body fluid to be diverted, diverted, and / or sequestered. In some embodiments, The terms "pre-sample," "first," and / or "initial" refer to a predetermined, defined sample of a bodily fluid. It can refer to a desired, desired, or given volume, portion, or amount. In some embodiments, the predetermined and / or desired pre-test volume of bodily fluid is about 0.1 milliliters. liter (mL), approx. 0.2mL, approx. 0.3mL, approx. 0.4mL, approx. 0.5mL, approx. 1.0 mL, approx. 2.0mL, approx. 3.0mL, approx. 4.0mL, approx. 5.0mL, approx. 10.0mL, approx. 20 mL, about 50 mL, and / or any volume or fraction of a volume therebetween In other embodiments, the pre-test volume may be greater than 50 mL or less than 0.1 mL. In some specific embodiments, the predetermined and / or desired pre-test volume is about 0.1 m In other embodiments, the pre-test volume may be, for example, one drop of bodily fluid. , a few drops of bodily fluid, e.g., from a bodily fluid source to an initial collection chamber, portion, reservoir, etc. (e.g., isolation The total volume of any number of lumens forming a flow path (or a portion thereof) to the chamber. do.

[0027] On the other hand, when used in the context of a volume of bodily fluid, "sample," "second," and / or The term "subsequent" refers to the transfer, diversion, isolation, and / or disposal of a pre-test volume of bodily fluid. is the random volume after separation or the predetermined or desired volume of collected body fluid. Refers to a volume, portion, or amount of fluid. For example, in some embodiments, the desired test of a bodily fluid The volume can be from about 10 mL to about 60 mL. In other embodiments, the desired bodily fluid sample volume is The volume can be less than 10 mL or more than 60 mL. The volume may include one or more tests, chemical analyses, analyses, and / or processes performed on the test volume. The method may be based at least in part on the process.

[0028] The embodiments described herein may be used to selectively transfer bodily fluid to one or more fluid collection device(s). In some embodiments, the fluid collection device may be configured to transfer The container may be any suitable vessel, container, reservoir, bottle, adapter, dish, vial, syringe, device, or the like. may include, but are not limited to, instruments, diagnostic and / or testing machines, and / or the like. As a specific example, some examples may include, but are not limited to, "S systems and methods for Parenterally Proc uring Bodily-Fluid Samples with Reduced U.S. Patent No. 8,197,420 ("'420"), entitled "Contamination" Any of those detailed in "Permitted" (the disclosure of which is incorporated by reference in its entirety) The control volume can be sampled using any of the embodiments and / or methods described herein, such as The liquid can be transferred to a pull reservoir.

[0029] In some embodiments, the sample reservoir may be, for example, an aerobic or anaerobic culture bottle. The culture bottle may be a sample bottle or a culture bottle, such as a The body fluid sample can then be analyzed for, for example, gram-positive bacteria, gram-negative bacteria, and , yeast, fungi, and / or any other organisms (e.g., in vitro). via an IVD test, and / or any other suitable test). The culture bottle can receive a body fluid sample and the culture medium (provided therein) can be any A positive result from such a test of the culture medium may be If so, the culture medium is then tested using a PCR-based system to identify specific organisms. Furthermore, as will be described in more detail herein, some In some cases, diverting a pre-test or initial volume of fluid can lead to inaccurate test results. To reduce and / or substantially eliminate contaminants in body fluid samples that may lead to It is possible.

[0030] Any of the sample containers, reservoirs, bottles, dishes, vials, etc. described herein may be used to measure bodily fluids. The contents may be empty prior to receiving the test volume, or any suitable additive may be added, for example. It may include additives, culture media, substances, enzymes, oils, fluids, and / or the like. For example, in some embodiments, the sample reservoir contains at least one aerobic or anaerobic culture medium. Nutrient media (e.g., nutrient-rich and / or environmentally controlled media to promote growth, and and / or other suitable medium(s), which culture medium may be used for sample storage. In some embodiments, the suction cup occupies at least a portion of the interior volume defined by the suction cup. The sample reservoir may contain, for example, heparin, citrate, ethylenediaminetetraacetic acid (EDT A), including any suitable additives such as oxalates, SPS, and / or the like. Similarly, the additive can be added to the internal volume defined by the sample reservoir. In other embodiments, the sample reservoir comprises at least a portion of a The container may be any suitable container used for this purpose.

[0031] The term "culture medium" refers to a material that is configured to react with organisms (microorganisms such as bacteria) in body fluids. The term "additive" can be used to describe substances that are added to the body. are designed to react with a portion of a fluid (e.g., the constituent cells of blood, serum, synovial fluid, etc.) Although the sample reservoir may be used to describe a substance, any suitable It is understood that the substance may include a liquid, a solid, a powder, a lyophilized compound, a gas, etc. Furthermore, when referring to the "additive" in the sample reservoir, the additive is contained in the culture bottle. culture media, such as aerobic and / or anaerobic culture media, culture bottles such as those described above, and and / or any other suitable additive and / or any suitable substance contained in a suitable reservoir. It is understood that the present invention may be a combination of materials, i.e., Embodiments may be used with any suitable fluid reservoir containing any suitable substance, etc. Additionally, any of the embodiments and / or methods described herein may be used to Before accepting the fluid flow, the volume of the fluid may be adjusted to contain culture medium, additives, and / or any other The substance can be transferred to an uncontaining reservoir (or the like).

[0032] Some embodiments are used to obtain bodily fluids for one or more culture sample tests. Although described herein as being suitable for such use, embodiments are not limited to such use. It should be understood that any of the embodiments and / or methods described herein may be used to measure bodily fluids. The flow can be transferred to any suitable device in fluid communication therewith. Therefore, although specific examples are described herein, the devices, methods, and / or concepts is not intended to be limited to such specific examples.

[0033] The embodiments and / or portions thereof described herein may be formed from one or more biocompatible materials. In some embodiments, the biocompatible material may be, for example, rigid, Selection based on one or more properties of the constituent materials, such as toughness, durometer, or bioreactivity Examples of suitable metals include pharmaceutical grade stainless steel, gold, titanium, and nickel. , iron, platinum, tin, chromium, copper, and / or alloys thereof. They may be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactide, Polyglycolide, polylactide-co-glycolide (PLGA), polyanhydrides, polyols Polyester, polyetherester, polycaprolactone, polyesteramide, poly( poly(butyric acid), poly(valeric acid), polyurethane, and / or blends and copolymers thereof Examples of non-biodegradable polymers include nylon, polyester, and polycarbonate. , polyacrylates, ethylene-vinyl acetate and other acyl-substituted cellulose acetates polymers, non-degradable polyurethane, polystyrene, polyvinyl chloride, polyvinyl fluoride Nyl, poly(vinylimidazole), chlorosulfonic acid polyolefin, polyethylene oxide oxides, and / or mixtures and copolymers thereof.

[0034] The embodiments and / or portions thereof described herein may include one or more components, features, structures, When referring to such a component, the term "component" refers to a component formed by a An element is formed by a singular part having any number of regions, areas, parts, and / or properties. It should be understood that the wall may be formed of a single piece or may be formed by multiple pieces or features. When referring to a structure such as a chamber or a structure, the structure may refer to a number of parts or components that are bonded together to form the structure. It can be considered a singular structure with multiple individual substructures combined together. A structure constructed in a body may, for example, include a set of substructures. A substructure may include multiple portions that are contiguous or discontinuous with one another. The sets of substructures are fabricated separately and later joined together (e.g., by welding, adhesive, or may also be made from multiple items or components (via any suitable method).

[0035] Referring now to the drawings, FIG. 1 is a schematic diagram of a fluid control device 100, according to one embodiment. Generally, a fluid control device 100 (referred to herein as a "control device" or "device") The device (also called a "device") is configured to collect bodily fluids from a patient. The first portion or amount of bodily fluid (e.g., initial amount) is greater than the second portion or amount of bodily fluid (e.g., The fluid is then either used for additional testing or discarded. and / or reinjected into the patient. In this way, contaminants and the like are substantially The substance may be isolated within a first portion or amount, separate from a second portion or amount that does not contain the substance. The second portion or amount of bodily fluid may be used for medical diagnosis and treatment, as described in more detail herein. and / or biological samples for one or more tests (e.g., blood cultures) for therapeutic purposes. The first portion or amount of the body fluid can be discarded as waste. or as a result of potential contaminants contained therein, Use with any suitable test that is unlikely to produce inconsistent and unreliable results In another example, the first portion or amount of bodily fluid can be reinfused into the patient.

[0036] The control device 100 includes an inlet 131, at least one outlet 136, and an isolation chamber. The inlet 131 includes a housing 130 having and / or forming a bore containing device 134. The lumen-containing device is configured to be fluidly coupled to the device. The housing 130 can be in fluid communication with a source of bodily fluid. For example, the housing 130 can be a lumen-contained device in fluid communication with the inlet 131 and configured to be percutaneously placed in the patient; catheters (e.g., butterfly needles, intravenous (IV) catheters, peripherally inserted central catheters (PICCs) , syringes, sterile tubing, intermediate lumen containment devices, and / or bodily fluid transfer devices, etc. Therefore, as described in more detail herein, As shown, bodily fluids enter housing 13 from a patient and / or other bodily fluid source through inlet 131. The outlet(s) 136 may be connected to a fluid collection device 180 (e.g., a fluid reservoir). The fluid can be in fluid communication with a reservoir or sample reservoir, syringe, vacuum vessel, etc. Therefore, as described in more detail herein, the control device 100 may be used and / or Operated to direct a volume of bodily fluid from a bodily fluid source through the inlet 131, the housing 130, and the outlet(s). 136 to a fluid collection device 180.

[0037] The housing 130 defines one or more fluid flow paths 131 between the inlet 131 and the isolation chamber 134. 33 and / or define one or more fluid flow paths 154 between the inlet 131 and the outlet 136 . The housing 130 of the device 100 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 130 may be, for example, an isolation chamber. 134. A size based at least in part on the volume of fluid to be at least temporarily stored within the As described in more detail herein, the control device 100 and and / or housing 130, wherein bodily fluids pass through at least one of fluid flow paths 133 and / or 154. The system may be configured to transition between operational modes in a flow-through fashion. , the control device 100 and / or the housing 130 may be automatically (e.g., based on pressure differential, time , electronically, based on membrane saturation, absorbents and / or barrier materials, etc.) or by intervention The transition can be configured to occur (e.g., user intervention, mechanical intervention, etc.).

[0038] The isolation chamber 134 is at least in communication with the inlet 131 via the fluid flow path(s) 133. As described in more detail herein, the isolation chamber The bath 134 (1) receives a flow and / or volume of fluid from the inlet 131 and (2) Isolate (e.g., separate, separate, contain, hold) a flow and / or volume of bodily fluid The isolation chamber 134 is configured to, for example, separate a particular It can have any suitable arrangement, such as those described herein with respect to the embodiments. However, the control device 100 and / or housing 130 may be isolated in any suitable arrangement. The chamber 134 may have any suitable configuration, but is not limited to those shown and described herein. It should be understood that this is not intended to be a barrier to isolation chambers. For example, in some embodiments, 134 may be formed at least in part by the housing 130. The isolation chamber 134 may be positioned and / or provided in a portion of the housing 130. In other embodiments, the isolation chamber 134 may be a reservoir that is connected to the fluid flow path 133. That is, the housing 130 may be formed and / or defined by a portion of The body fluid passageway 130 may define one or more lumens and / or receive a flow of bodily fluid from the inlet 131. one or more lumen-defining devices configured to define a fluid flow path 133 therethrough. In such an embodiment, at least a portion of the lumen may include a chair(s). and / or a portion of the lumen-defining device(s) forming the isolation chamber 134. can be and / or can be prescribed.

[0039] The isolation chamber 134 can have any suitable volume and / or fluid capacity. For example, in some embodiments, the isolation chamber 134 may have a volume ranging from about 0.25 mL to about 5.0 mL. In some embodiments, the isolation chamber may have a volume and / or fluid capacity of 1 L. The isolation chamber 134 may be configured to transfer a volume of bodily fluid (e.g., The volume can be measured by the initial or first volume of fluid. In some embodiments, the isolation chamber 134 is as small as a microliter or less of bodily fluid. Initial volume of fluid (e.g., 20 drops of fluid, 10 drops of fluid, 5 drops of fluid, 1 drop of fluid, or anything in between) The volume may be large enough to accommodate any suitable volume (as small as In other embodiments, the isolation chamber 134 may have a maximum volume of, for example, about 5.0 mL, 10.0 mL, or more. L, 15mL, 20mL, 30mL, 40mL, 50mL, or more of fluid In some embodiments, the isolation chamber may have a volume sufficient to accommodate the volume. The chamber 134 has one or more lumens (or lumen) that fluidly connect the isolation chamber 134 with a source of bodily fluid. having a volume equal to a fraction and / or multiple of at least some of the volume of can be done.

[0040] Although not shown in FIG. 1, in some embodiments, the isolation chamber 134 may include any and / or isolation chamber 134, which may include any suitable arrangement, configuration, and / or feature. formed of one or more materials configured to interact with a portion of the body fluid transported therein For example, in some embodiments, the housing 130 may include a separation chamber 134. The present invention can include absorbent and / or hydrophilic materials provided on the surface of the substrate. As will be described in more detail below, when bodily fluid is transferred to the isolation chamber 134, it absorbs and / or Alternatively, the hydrophilic material may absorb, attract, retain, or spread at least a portion of the body fluid. and / or otherwise interact with it, thereby displacing at least an initial portion of the bodily fluid. The components can be isolated and / or held in isolation chamber 134. The isolation chamber 134 is in a first state (e.g., an initial portion of the bodily fluid is in the isolation chamber 134 ). while the initial portion of the body fluid is being transferred into the isolation chamber 13 4) after being transferred into the In some embodiments, the The forces associated with and / or resulting from such expanding or contracting materials may be 130 and / or converting the device 100 from a first state, position, configuration, etc. to a second state, position, , configuration, etc. In some embodiments, the isolation channel The member 134 and / or any other suitable portion of the housing 130 may be one or more chemicals configured to chemically interact with the body fluid transported through the portion A portion of this housing 130 may contain substances, compounds, and / or the like. may be configured to move the control device 100 and / or the housing 130 between a first state and a second state. It may be operable to transition (eg, via force or other suitable means).

[0041] In some embodiments, the control device 100 and / or the housing 130 may include a 100. The device 100 may be configured to selectively control the flow of a fluid (e.g., gas or liquid) through a portion of the device 100. The flow controller 120 may include and / or define a flow controller 120 configured as follows: For example, in some embodiments, the flow controller 120 may be a control device 100 (or and / or otherwise control the flow of bodily fluid through the housing 130) and the fluid flow paths 133 and and / or 154. The flow controller 120 may be, for example, a valve, membrane, diaphragm, restrictor, drain, selectively permeable A member (e.g., a fluid-transmitting member) that at least selectively allows the passage of air or gas therethrough. impermeable barriers or seals), ports, joints, actuators, and / or similar or any suitable combination thereof. The controller 120 may be configured to direct the fluid flow to the isolation chamber 134 and / or the housing 1 30 (at least part of the In this context, for example, a fluid flow may be water, oil, or The liquid may be a liquid, such as a puking fluid, a bodily fluid, and / or other suitable liquid; and / or is air, oxygen, carbon dioxide, helium, nitrogen, ethylene oxide, and / or any For example, in some embodiments, the housing 1 The walls or structure of 30 may have openings, apertures, or pores that allow fluid communication with the isolation chamber 134. In such an embodiment, the apertures, orifices, and / or the like may be defined. The flow controller 120 may be, for example, a semi-permeable element disposed in or around an opening. a flexible member or membrane that selectively allows air or gas flow through the opening while The device may be configured to restrict or substantially prevent the flow of fluid (e.g., bodily fluids such as blood) through the device. Cut.

[0042] In some embodiments, one or more flow controllers 120 or the like are control devices. 100. The device may be configured to promote the displacement of air (or other fluid) through one or more portions of the device. In some examples, the control device 100 may include one or more A pressure differential can be created across one or more portions of the housing 130. and / or allow pressure equalization over a period of time. In some embodiments, the control device 100 can be configured to control the volume of bodily fluid in the isolation chamber 13. 4 or an output based at least in part on a pressure differential between two or more portions of the control device 100. In some embodiments, the pressure The force differential is created by fluidly coupling the outlet 136 to a fluid collection device 180 The fluid collection device 180 may define and / or generate a negative pressure. can be configured to create a vacuum or pressure differential (e.g., a vacuum reservoir that creates a vacuum or pressure differential, syringes, pressure-filled canisters, and / or other sources of potential energy). In some embodiments, the pressure difference may result from a change in volume and / or temperature. The pressure difference is generated by at least a portion of the control device 100, the housing 130, and / or or other portions of the vacuum and / or filled flow path (e.g., isolation chamber 134 and In some embodiments, the pressure differential may be generated automatically from: Or it may be established through direct or indirect intervention (eg, by the user).

[0043] Furthermore, the flow of fluids (e.g., gases and / or liquids) resulting from pressure differences can be, e.g., One or more flow controllers capable of transitioning between one or more operating conditions to control fluid flow. In some embodiments, the For example, the flow controller 120 may transition between one or more operating conditions or states to control the configured to establish fluid communication between one or more portions of the device 100; and / or To isolate one or more portions of the control device 100 (e.g., isolation chamber 134) In some embodiments, the flow controller may be a configured actuator. The filter 120 is an absorbent material configured to selectively allow fluid flow therethrough. For example, such absorbent materials may be formed articles or devices. allows the flow of gas (e.g., air) through it, but not the flow of liquid (e.g., body fluids) through it The material transitions from a first state where it prevents gas and liquid flow therethrough to a second state where it substantially prevents gas and liquid flow therethrough. In other embodiments, the flow controller 120 may be configured to In some embodiments, the flow path may include a flow path, a membrane, a diaphragm, and / or the like. The controller 120 may control any suitable combination of devices, components, and / or features. The flow controllers included in the embodiments described herein include, but are not limited to: It should be understood that the present invention is presented as an example and not as a specific flow control. Although a controller is described herein, the flow of fluid may be controlled by any suitable means. It should be understood that the control may be performed through the device 100.

[0044] The outlet(s) 136 are in fluid communication with the fluid flow paths 133 and / or 154; and / or configured to be in fluid communication with the outlet. 136 may include any suitable outlet, opening, port, stopcock, latch, seal, coupler, valve (e.g., For example, one-way, check valves, duckbill valves, and / or the like), and the fluid A collection device 180 (e.g., a fluid reservoir, a culture sample bottle, a syringe, a container, a vial, a filter, dish, receptacle, pump, adapter, and / or any other suitable collection device or In some embodiments, the fluidic device is configured to be fluidly coupled to a transfer device. In other embodiments, the outlet 136 may be integrally formed with the fluid collection device 180. , the outlet 136 may be provided by adhesive, resistance fitting, mechanical fastening, threaded coupling, drilling or puncture arrangement, via any number of mating recesses, and / or any other suitable coupling or combination thereof. and may be at least temporarily coupled to the fluid collection device 180. The port 136 is configured to allow the interior volume defined by the fluid collection device 180 to be in fluid communication with the outlet 136. The fluid collection device 180 may be physically (e.g., mechanically) and / or fluidly In yet other embodiments, the outlet 136 may be coupled to an intervening structure such as a flexible sterile tube. The fluid collection device 180 may be operably coupled to the fluid collection device 180 via a structure (not shown in FIG. 1). In some embodiments, the outlet 136 is connected to the fluid collection device 180 via the outlet 1 36 can be arranged to be physically and / or fluidically sealed. In an embodiment, the outlet 136 is responsive to coupling to a fluid collection device 180 and / or The environment within the outlet 136 and / or housing 130 and the environment within the fluid collection device 180 The sealing configuration can be transitioned to a non-sealing configuration in response to a negative pressure differential between the sealing configuration and the interface.

[0045] The fluid collection device 180 may be a device for collecting a small amount of bodily fluid, such as any of those described in detail above. The device may be any suitable device for temporarily housing the device. For example, in some implementations In form, the fluid collection device 180 may be a single-use disposable collection tube(s), a syringe , collection tube(s) of a vacuum system, intermediate fluid transfer device, and / or the like. In some embodiments, the fluid collection device 180 may be, for example, a Vacutainer ( Registered trademark) (manufactured by BD), BacT / ALERT® SN or B acT / ALERT® FA (manufactured by Biomerieux, Inc. (as described above), and / or any suitable reservoir, vial, microvial, microliquid, torr vials, nanoliter vials, containers, microcontainers, nanocontainers, and / or the like The sample container may be substantially similar to or identical to known sample containers, such as those described in US Pat. In this embodiment, as described in more detail herein, the fluid collection device 180 may include a sample reservoir. The sample reservoir contained a vacuum seal that maintained a negative pressure condition (vacuum condition) inside the reservoir. The sample reservoir may be connected to a control device via vacuum or suction from the patient. 100 and into the sample reservoir. In embodiments where the fluid collection device 180 is a vacuum vessel or the like, the fluid collection device 180 may be a vacuum vessel or the like, as described in more detail herein. As will be described, a first or initial portion of the bodily fluid is transferred into the isolation chamber 134; and a subsequent portion or volume of bodily fluid is bypassed by the isolation chamber 134. and / or otherwise diverting flow from the isolation chamber 134 into the fluid collection device 180. To allow fluid to flow in, the user couples the fluid collection device 180 to the outlet 136 to allow fluid to flow out of the patient. Fluid flow can be initiated.

[0046] The outlet 136 of the control device 100 and / or housing 130 may be connected to the fluid collection device 1 80 and / or otherwise fluidly connected thereto. Although described above, in other embodiments, the control device 100 may be configured to control any suitable bodily fluid collection device. For example, in some embodiments, The control device 100 described herein is a part of the "Sterile Bodily-Fluid Collection Device and Meth No. 2015 / 0342510 (referred to herein as "'51 0 publication), the disclosure of which is incorporated herein by reference in its entirety. The present invention can be used in any suitable fluid transfer device, such as a control device. The control device 100 may be an "all-in-one" or pre-assembled device (e.g., '510 and to reduce contaminants in subsequent volumes of body fluids. The device can receive and isolate an initial volume of bodily fluid for removal and / or storage.

[0047] As described above, the device 100 can be used to detect, for example, microorganisms present on the skin and / or A bodily fluid sample can be obtained that has reduced contamination from microorganisms such as For example, in some instances, users such as doctors, physicians, nurses, phlebotomists, and technicians may The device 100 is manipulated to connect the inlet 131 to a fluid source (e.g., a patient's blood vessel, cerebrospinal fluid from the spinal cavity, etc.). establishing fluid communication between the patient and the cerebrospinal fluid (CSF), urine collection, and / or the like; For example, in some instances, the inlet 131 may be configured to pierce the patient's skin and allow the needle to penetrate. At least a portion of the inlet 131 is manipulated to be inserted into a patient's blood vessel, thereby providing access to the body fluids. A fluid source (e.g., blood vessel, IV catheter, PICC, etc.) can be connected to the device. The needle may be coupled to and / or include a needle or the like.

[0048] In some embodiments, the inlet 131 is in fluid communication with a source of bodily fluid (e.g., a portion of a patient). When enabled, the outlet 136 can be fluidly coupled to a fluid collection device 180. As such, in some embodiments, the fluid collection device 180 is configured to accept a volume of bodily fluid. The reservoir, container, and / or device may be any suitable reservoir, container, and / or device configured to For example, the fluid collection device 180 can be a vacuum reservoir or container that establishes a negative pressure. and / or a syringe that can be operated to generate negative pressure. In the example, the outlet 136 is coupled to a fluid collection device 180 to allow the fluid flow path 133 and and / or at least a portion of 154 are selectively exposed to negative pressure, thereby reducing the bodily fluid source (e.g., Operable to draw bodily fluid from a patient (e.g., a patient) through inlet 131 and into housing 130. A negative pressure difference of

[0049] In some embodiments, the housing 130 may be configured to accommodate a volume of bodily fluid at the inlet 131 and / or When transported therethrough, the initial portion of the volume of the body fluid (referred to herein as the "initial volume" or " The fluid (also referred to as the "first volume") flows from the inlet 131 through at least a portion of the fluid flow path 133. and arranged to flow into the isolation chamber 134. In this embodiment, the control device 100 and / or the housing 130 may be configured to detect an initial portion or volume of bodily fluid. within or through at least a portion of the fluid flow path 133 and into the isolation chamber 134 For example, in some embodiments, The initial state of the control device 100 and / or housing 130 may include one or more flow controllers. Controller 120 (e.g., valve, membrane, diaphragm, restrictor, vent, air permeable and fluid impermeable) barriers, ports, actuators, and / or the like, or combinations thereof) is in a first state in which the fluid flow path 133 is exposed to a negative pressure difference via the isolation chamber 134. In other words, in or by the fluid collection device 180 The negative pressure created causes one or more flow controllers 120 to enter a first or initial state. At some point, a separator operable to draw an initial flow of bodily fluid into the isolation chamber 134 A negative pressure (or negative pressure differential) can be created within at least a portion of the isolation chamber 134. .

[0050] For example, in some embodiments, the flow controller 120 may be configured to 80 and the isolation chamber 134 (e.g., at least a portion of the fluid flow path 154) a valve (e.g., a one-way valve, a check valve, a duckbill valve) at least temporarily fluidly coupled to the , umbrella valves, and / or the like), selectively permeable members (e.g., at least one of which is permeable to gas or air) a fluid-impermeable barrier or seal that allows selective passage through a membrane, a selectively permeable membrane, a diaphragm, and / or the like. The above example flow controller 120 may be, for example, a These may be known commercially available components used in medical devices, but in other embodiments, - Controller 120 may be custom made, proprietary, and / or integrated with device 100 The flow controller 120 may be in a first or initial state. When the negative pressure in the fluid collection device 180 is reached, the flow controller 120 In some embodiments, a flow control may be used. The controller 120 or any part or component thereof is configured such that only the flow of air or gas is controlled. The flow controller 120 is configured to be able to pass through the roller 120. configured to restrict and / or substantially prevent the flow of a liquid (e.g., a bodily fluid) therethrough. Therefore, the flow controller 120 prevents the initial portion of the body fluid from entering the fluid flow path 154. and / or otherwise not allowing flow out of the isolation chamber 134. When in the initial state, the fluid collection device 180 sequesteres an initial portion and / or amount of bodily fluid. creating a negative pressure differential within isolation chamber 134 that is operable to draw pressure into chamber 134; It can be achieved.

[0051] Although not shown in FIG. 1, in some embodiments, the control device 100 and / or the hardware The housing 130 is configured to adjust the amount of negative pressure to which the isolation chamber 134 is exposed. For example, some embodiments may include components, devices, mechanisms, features, etc. In this embodiment, the housing may contain valves, membranes, porous materials, restrictors, orifices, and / or pressure adjusting devices. and / or any other suitable components, devices, and / or features configured to In some embodiments, the amount of pressure to which the isolation chamber 134 is exposed can be adjusted. and / or control the amount of pressure exerted on the patient's body fluids and / or blood vessels. In some instances, such pressure adjustments can be used to adjust, for example, The likelihood of hemolysis and / or vascular collapse of the blood sample can be reduced (e.g. , requiring microbiological and / or other diagnostic testing associated with the use of the control device 100. (This is especially important for frail patients.) Additionally, the regulation of negative pressure can be achieved by, for example, controlling device 100. at least in part to determine the rate at which the device transitions between the first configuration or state and the second configuration or state. In some embodiments, the timer can be controlled by adjusting the negative pressure. For example, the introduction of a negative pressure difference may cause the control device 100 to change from the first state to the second state. The time to transition to the second state may be known, predetermined, calculated, and / or controlled. Therefore, in some instances, the isolation chamber can be opened by adjusting the negative pressure. The amount or volume of bodily fluid transferred into the chamber 134 can be at least partially controlled. (i.e., the volume of the initial amount of body fluid can be controlled).

[0052] As noted above, the initial portion and / or amount of bodily fluid can be any suitable amount of bodily fluid. For example, in some instances, the control device 100 and / or the housing 130 may be configured to and / or a desired volume (e.g., initial volume) of bodily fluid is transferred to the isolation chamber 134. In some embodiments, the initial volume may remain in the first state until the isolation chamber The volume of the member 134 may be related to and / or based at least in part on the volume of the member 134. In an embodiment, the initial volume is determined by the amount of absorbent material, expandable material, parent material, etc., provided within the isolation chamber 134. The amount of bodily fluid that can be absorbed by the water-based material, the wicking material, and / or other suitable material or may be related to and / or based at least in part on volume. The initial volume of bodily fluid is the amount of bodily fluid that can be transferred into the isolation chamber 134 in a given time. or volume-related and / or based at least in part on. In this configuration, the initial volume is the volume of the isolation chamber 134 that is filled with the fluid collection device 180 (i.e., air A flow controller (120), such as a permeable and liquid-impermeable member or membrane, selectively applies negative pressure. The amount of water sufficient to completely wet or saturate the semipermeable member or membrane that is configured to be exposed to the The amount or volume of bodily fluids present may be related to and / or based at least in part on. In other words, in some embodiments, the initial volume of bodily fluid is controlled by one or more flow controllers. 120 to a second state (e.g., saturated or fully wet). In yet other embodiments, the control device 100 and / or the housing 130 may be The pressure difference between the isolation chamber 134 and the fluid flow path 133 and / or the body fluid source is substantially balanced. and / or until the volume of bodily fluid (e.g., The initial volume can be configured to be transferred into the isolation chamber 134.

[0053] After the initial volume of bodily fluid has been transferred and / or diverted into the isolation chamber 134, the initial The volume is isolated, spaced apart, held, contained, or separated within the isolation chamber 134. For example, in some embodiments, one or more flow controllers 120 By transitioning from the first state to the second state, the initial flow of the body fluid in the isolation chamber 134 The portions may be operable to be isolated and / or retained. As will be described in detail, in some instances, the presence of sebaceous glands in the skin, e.g., during venipuncture, Contaminants such as microorganisms present in the sample, other external sources of contamination, and the Catheterization and PICC line colonization may result in the inclusion and / or inclusion of fluid in the initial volume. 134 when the initial volume is isolated therein. Be isolated.

[0054] Once the initial volume has been transferred and / or diverted into the isolation chamber 134, the device 1 00 indicates that the subsequent volume(s) of bodily fluid are / are present in at least one of the fluid flow paths 133 and / or 154. transition to a second state in which the fluid can flow through the portion from the inlet 131 to the outlet 136 In some embodiments, the control device 100 and / or the housing 13 0 indicates that the first state changes to the second state once an initial volume of bodily fluid is isolated within the isolation chamber 134. can transition to a state passively and / or automatically (e.g., without user intervention) For example, in some embodiments, the isolation chamber 134 is filled to capacity, and and / or an absorbent or similar material disposed between the isolation chamber 134 and the fluid collection device 180. By completely saturating, wetting, and / or impregnating such materials, the isolation channel of body fluids is Further transport into chamber 134 is limited due to negative pressure relief or diversion and / or In other embodiments, the control device 100 and / or The housing 130 may be manually moved or at least moved indirectly by a user. For example, in some embodiments, a user may operate an actuator, etc. activating (e.g., activating flow controller 120 or a portion thereof) ) to move the control device 100 and / or the housing 130 from the first state to the second state. In yet another embodiment, at least a portion of the initial volume of bodily fluid can transition to transitions the control device 100 and / or the housing 130 from a first state to a second state. For example, the control device 100 may include fluid-activated switches, valves, ports, and and / or the like and / or a flow controller 120 including In other embodiments, the volume of bodily fluid can be measured, for example, by measuring the volume of a port, a channel, and / or a One or more flow controllers 120 (e.g., actuators) that can open the outlets. In yet another embodiment, the use of The user may use such a flow controller 120 (e.g., a switch, valve, port, actuator, etc.) and operating a power supply (e.g., a computer) to place the control device 100 and / or the housing 130 in a first state. The first state can be transitioned to the second state.

[0055] When the fluid collection device 180 is fluidly coupled to the outlet 136, as well as the control device 100 and / or housing 130 in a second state (e.g., when the initial volume of bodily fluid is If any body fluid is in or isolated by this chamber, the subsequent The product(s) extend from the inlet 131 through at least one of the fluid flow paths 133 and / or 154. The fluid can then flow through the outlet 136 and into the fluid collection device 180. Therefore, as described above, prior to collecting or obtaining a test volume of one or more bodily fluids, isolation By isolating the initial volume of body fluid within chamber 134, contamination in one or more test volumes is prevented. The amount of contaminants is reduced and / or substantially eliminated. , the control device 100 and / or the housing 130 Before the housing 130 collects and isolates the initial volume in the isolation chamber 134, a second state are arranged so that transition to

[0056] 2 to 5 show a fluid control device 200 according to one embodiment. 0 is similar in form and / or function to the fluid control device described above with reference to FIG. Therefore, the fluid control device 100 may be similar to the fluid control device 100. The portions of the fluid control device 200 that are not described in further detail herein.

[0057] As shown in FIGS. 2 to 5, a fluid control device 200 (referred to herein as a "control device" or The device (also referred to as "device") has an inlet 231, an outlet 236, and an actuator 250. As described above with reference to the control device 100, the control device 100 includes a housing 230 having an inlet 2 31 is arranged to be in fluid communication with a body fluid source, and the body fluid is supplied therefrom (e.g., by a needle, IV To accept through lumen containing devices such as catheters, PICC lines, etc. The outlet 236 may be configured to connect, for example, a sample reservoir, a syringe, and / or other An intermediate fluid transfer device or container (e.g., a transfer device similar to that described in the '510 disclosure) configured to be fluidly coupled to a fluid collection device, such as a fluid collection device (e.g., a fluid collection device), and / or the like. It is being done.

[0058] As described above with reference to housing 130, housing 230 is isolated from inlet 231. One or more fluid flow paths 233 and / or inlets 231 and outlets 236 between chambers 234 The housing 230 of the device 200 defines one or more fluid flow paths 254 therebetween. It may be of any suitable shape, size, and / or configuration. For example, in some embodiments, The housing 230 may be at least as configured and / or functionally similar to that described above with reference to FIG. The isolation chamber 234 of the housing 230 may be substantially similar to the housing 130. is positioned in at least temporary fluid communication with the inlet 231 via the fluid flow path(s) 233. Additionally, as described in more detail herein, the isolation chamber 234 may be The fluid flow paths 254 are selected so that at least air or gas can be transferred therebetween. Alternatively, it can be arranged so that the fluid can flow through it.

[0059] As described in more detail herein, the isolation chamber 234 is configured to: (1) control the flow of bodily fluids; (2) receiving a body fluid flow and / or volume from an inlet 231; To separate (e.g., to keep apart, spaced apart, contained, held, separated, etc.) The isolation chamber 234 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the isolation chamber 234 can be, for example, an isolation any suitable size, volume, and / or volume, such as those described above with reference to separation chamber 134 In the embodiment shown in Figures 2-5, the isolation chamber 234 can have a fluid capacity of It may be formed at least in part by a housing 230 that defines a lumen or flow path. In some embodiments, at least a portion of the fluid flow path 233 is formed within a portion of the housing 230. Extending through the cavity to form and / or define at least a portion of the isolation chamber 234. As shown in FIGS. 2 to 5, the isolation chamber 234 and / or the isolation chamber The portion of fluid flow path 233 that forms 234 can have a serpentine configuration or the like. In other embodiments, the isolation chamber 234 can have any suitable configuration. For example, in some embodiments, the housing may be arranged in any suitable shape and / or configuration. The isolation chamber may include a separation chamber formed by a flexible tube or the like that can be inserted through the isolation chamber.

[0060] In some embodiments, the housing 230 and / or the isolation chamber 234 may include a flow The flow controller 242 may include, form, and / or define a The rollers 242 may be positioned within the isolation chamber 234 and / or any other suitable portion of the housing 230. to selectively control (at least in part) the flow of fluid into and / or out of the For example, a valve, membrane, diaphragm, restrictor, drain hole, selectively permeable member (e.g., blood A flow barrier that allows at least selective passage of gas or air, such as a liquid barrier, and / or the like. The fluid passage may be a body-impermeable barrier or seal), a port, or the like (collectively referred to herein as a "flow passage"). More specifically, in the embodiment shown in FIGS. 2 to 5, The roller 242 selectively allows gas flow but prevents liquid flow therethrough. a selectively permeable fluid barrier including and / or formed of a porous material configured to (e.g. blood barrier).

[0061] A flow controller 242 is positioned within the housing 230 to connect the isolation chamber 2 34 and the fluid flow path 254. As will be described in more detail below, the flow controller 242 is configured as a semi-permeable member. This separates the flow controller 242 from the gas or air flow path 254. The device is configured to be able to be at least temporarily transported between the device and the isolation chamber 234. and substantially impeding the flow of liquid between the fluid flow path 254 and the isolation chamber 234. It can be configured as follows.

[0062] Outlet 236 of housing 230 is in fluid communication with fluid flow paths 233 and / or 254. and / or are configured to be arranged so that fluid can flow between them. As such, outlet 236 may be connected to a sample reservoir, syringe, container, and / or other sample Any suitable outlet configured to be fluidly coupled to a fluid collection device, such as a reservoir. , openings, ports, stops, seals, couplers, etc. In some embodiments, The outlet 236 is connected to a fluid collection device as described above with reference to the outlet 136 of the housing 130. The device may be integrally formed with the chair or may be at least temporarily coupled to the fluid collection device. The fluid collection device may be, for example, as described in detail above with reference to fluid collection device 180. Any suitable reservoir, container, and / or device for containing a bodily fluid, such as any of the More specifically, in some embodiments, the outlet 236 may be a vacuum sump. The fluid reservoir may be configured to couple to a first portion or initial portion of the fluid. The initial portion is transferred into the isolation chamber 234 and isolated by the isolation chamber 234. and any subsequent portion or volume of bodily fluid bypassing and / or otherwise isolating chambers. The user may direct the sample to be diverted away from the sample reservoir 234 and into the sample reservoir. A reservoir can be coupled to the outlet 236 to initiate the flow of bodily fluid from the patient.

[0063] As shown in FIGS. 3-5, the housing 230 is configured to selectively control the flow of bodily fluids through the housing 230. and / or coupled to an actuator 250 configured to selectively control More specifically, the actuator 250 is, for example, a part of the fluid flow path 233 and a fluid The actuator 250 is provided between the fluid passage 254 and a part of the fluid passage 254. at a distance from the junction between the flow path 233 and the isolation chamber 234, and / or Although shown as being positioned downstream, in other embodiments, actuator 250 , may be provided in any suitable location within housing 230. For example, in some embodiments In this example, the actuator 250 includes a fluid flow path 233, an isolation chamber 234, and a fluid flow path 2 54. Cut.

[0064] The actuator 250 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the actuator 250 may be configured to have a first state and a second state. The components or devices shown in FIGS. In this embodiment, when the actuator 250 is in the first state, it is in fluid communication with the fluid flow path 233. Separate, isolate, separate, and / or otherwise separate fluid communication between the body flow path 254 and the When in the second state, the fluid passage 233 is configured to block the fluid passage 254. In some embodiments, for example, The actuator 250 may be a valve, plunger, seal, membrane, flap, plate, and / or For example, as shown in FIG. 5, the actuator 250 may be in a first state. When transitioning from the first state to the second state (e.g., pressing, rotating, moving, starting, Actuator 250 (switching, sliding, etc.) is connected to flow channels 233 and 25 one or more seals 265 configured to selectively allow fluid communication between the It can include.

[0065] Actuator 250 is specifically shown in FIGS. 2-5 and described above, but in other embodiments The control device 200 selectively allows fluid communication between the fluid flow paths 233 and 254. The actuator may include any suitable actuator or device configured to: Therefore, although specifically shown in FIGS. 2 to 5, the control device 200 is not limited to a single device. It should be understood that this is presented as an example. For example, actuator 250 may be Although shown in Figures 1-5 as being provided at a given location, in other embodiments, the actuator The rotor 250 may be positioned at any suitable location along the housing 230. For example, In some embodiments, the actuator 250 includes a fluid flow path 233 and an isolation chamber. 234 and the inlet 231. In such an embodiment, the actuator When the actuator 250 is in the first state, the flow of body fluid is directed from the inlet 231 to the isolation chamber 2. 34 when the actuator 250 is in the second state. 231 directly to the fluid flow path 254. In other words, the actuator 2 When actuator 250 is in the first state, it directs body fluid from the inlet to isolation chamber 2. A portion of the isolation chamber 234 can be formed to flow directly into the access When activating, positioning, and / or transitioning actuator 250 to a second state, e.g. For example, actuator 250 may be configured to allow bodily fluid to flow directly from inlet 231 to fluid flow path 233. In such an embodiment, the actuator 250 may 31, the isolation chamber 234, and the fluid flow path 233. Furthermore, when in the second state, the actuator 250 can Operable to at least partially isolate the inlet 231 and / or fluid flow path 233. could be.

[0066] Additionally, the actuator 250 may be actuated and / or transitioned in any suitable manner. For example, in some embodiments, the actuator 250 may be manually actuated by a user ( For example, applying manual force to a button, slider, switch, rotating member, etc. In another embodiment, the actuator 2 can transition between the first and second states. 50 as a function of pressure difference (or lack thereof), change in potential or kinetic energy, composition or The actuator may undergo a change in configuration (e.g., a portion of the actuator at least partially decomposes or changes shape). automatically transitioning between the first and second states in response to In yet another embodiment, the actuator 250 may be configured to mechanically and / or electrically actuated or transitioned based on time, volumetric flow rate, flow velocity, etc. Examples of actuators and / or ways in which actuators can transition are given in the present specification. Although provided in the specification, they are presented by way of example only and not by way of limitation. It should be understood that the control device 200 may therefore be configured to transition in any suitable manner. Any suitable actuator may be included.

[0067] As described above, the device 200 can be used to detect, for example, microorganisms present on the skin and / or similar microorganisms. It is possible to obtain a body fluid sample with reduced contamination from microorganisms such as those For example, in some instances, users such as doctors, physicians, nurses, phlebotomists, and technicians may Operate the chair 200 to establish fluid communication between the inlet 231 and a source of bodily fluid (e.g., a patient's blood vessel). The inlet 231 is in fluid communication with a source of bodily fluid (e.g., a portion of a patient). When positioned in the fluid collection device, the outlet 236 may be fluidly coupled to a fluid collection device. As such, in the embodiment shown in Figures 2-5, the fluid collection device may be, for example, a vacuum that defines a negative pressure. It may be a reservoir or container and / or any other suitable source of negative pressure.

[0068] By coupling the outlet 236 to a fluid collection device, at least one of the fluid flow paths 254 A portion is selectively exposed to negative pressure within the fluid collection device. The controller 242 is in fluid communication with the fluid flow path 254 and the isolation chamber 234. Thus, by coupling the outlet 236 to a fluid collection device, the isolation chamber becomes a fluid collection The device is subjected to negative pressure, which allows fluid to be drawn from a fluid source (e.g., a patient) through inlet 2. 31 and into the housing 230. As described above with reference to the control device 100, the housing 230 accommodates a volume of bodily fluid. When transferred to and / or through port 231, an initial portion of the volume of bodily fluid (referred to herein as (also called "initial volume" or "first volume") flows from the inlet 231 to the fluid flow path 233. and into isolation chamber 234. That is, in some embodiments, the control device 200 and / or the housing 230 , an initial portion or volume of bodily fluid into or through at least a portion of the fluid flow path 233; and may be in a first or initial state in which it can flow into the isolation chamber 234.

[0069] As described above, the flow controller 242 and the actuator 250 are in a first state, position When in position, configuration, etc., the housing 230 and / or control device 200 are in an initial state. Therefore, the actuator 250 is directly connected between the fluid flow paths 233 and 254. To separate, separate, separate, isolate, and / or otherwise prevent the flow of fluids through a space. Additionally, the inlet 231 is exposed to a negative pressure differential via the isolation chamber 234. The negative pressure in the fluid collection device may be such that the housing 230 and / or the control device 200 are first When in the initial state, the initial flow of body fluid is directed from the inlet 233 to the isolation chamber 234. A negative pressure (or negative It is possible to create a pressure difference.

[0070] When the flow controller 242 is in the first or initial state, the housing 130 As described above with reference to a fluid collection device (e.g., a sample reservoir, syringe, or Depending on the negative pressure of the flow control (other potential energy sources used to generate negative pressure), The roller 242 may allow the flow of fluid (e.g., gas or air) therethrough. In some instances, it may be desirable to adjust and / or control the magnitude of the negative pressure differential. In the embodiment shown in FIGS. 2 to 5, for example, the housing 230 may include a flow control The flow path 254 is connected to the flow control unit 242, which defines a restricted flow path 232 through which the fluid can flow. More specifically, the restricted flow path 232 has a diameter that is at least smaller than the fluid flow path 254. A fluid flow path having:

[0071] For example, in some embodiments, the restricted flow path 232 may be approximately 0.0005 inches, approximately 0. 001 inch, approx. 0.003 inch, approx. 0.005 inch, approx. 0.01 inch, approx. 0.1 In other embodiments, the restricted flow path may have a diameter of about 0.5 inches or greater. 232 can have a diameter less than 0.0005 inches or greater than 0.5 inches. In some embodiments, the restricted flow path 232 is about 0.01 inches, about 0.05 inches, about 0.01 inches, or about 0.05 inches. 0.1 inch, about 0.15 inch, about 0.2 inch, about 0.5 inch or more, and / or can have any desired length. In other embodiments, the restricted flow path 232 is 0.01 may have a predetermined and / or desired length of less than an inch or greater than about 0.5 inches Additionally, in some embodiments, the restricted flow path 232 may be at least diameter and length to allow and / or provide desirable flow characteristics through the portion The thickness may be any suitable combination of thicknesses.

[0072] In this embodiment, when the restrictive flow path has a larger diameter, the The restricted flow path 232 is configured to reduce the magnitude of the negative pressure applied through the isolation chamber by more than the magnitude of the negative pressure. In some cases, the amount of negative pressure can be adjusted to reduce fluid sequestration. The rate at which the material is transferred into chamber 234 can be controlled. For example, in some implementations In one embodiment, the fluid collection device and / or other suitable negative pressure source provides approximately 0.5 pounds per square inch. PSI, approx. 1.0 PSI, approx. 2.0 PSI, approx. 3.0 PSI, approx. 4.0 PSI, approx. 5.0 PSI, about 10 PSI, about 12.5 PSI, or about 14.7 PSI (e.g., approximately having a magnitude (e.g., a negative magnitude) of at or substantially near atmospheric pressure at sea level In some embodiments, a fluid collection device, such as a vacuum vessel, may be used to create a negative pressure differential. The gas may have a predetermined negative pressure of about 12.0 PSI. By controlling the diameter and / or length of the separator 232, the amount of negative pressure to which the separator chamber 234 is exposed can be controlled. The amount and / or rate at which negative pressure is applied may be controlled, reduced, and / or otherwise adjusted. In some examples, the use of a restricted flow path 232 can There may be a delay or build-up of negative pressure applied to or within the isolation chamber.

[0073] Furthermore, in this embodiment, the restricted flow path 232 may be configured to restrict the flow of, for example, a liquid (e.g., a bodily fluid). Rather than a gas flow path, the gas flow path is configured to receive a flow of gas or air. In this embodiment, the diameter of the restriction channel 232 limits the flow of liquid therethrough and / or In addition, the fluid flow path 254 and the flow controller 242 may be small enough to obstruct the The restricted flow path 232 between the body fluid and / or any other fluid is a flow control. substantially blocked by a controller 242 (e.g., a selectively permeable barrier or seal) They are arranged as follows.

[0074] The pressure regulation is based on the diameter of the restricted flow passage 232 (i.e., the single restricted flow passage). Although the above has been mentioned, it should be understood that this is presented by way of example only and not limitation. Other means for adjusting the amount of negative pressure to which the isolation chamber is exposed include, for example, a porous a porous material, valve, membrane, diaphragm, specific restriction, vent, deformable member or flow path and / or In other embodiments, the control device may include any suitable number of each restriction flow channel may have substantially the same diameter; For example, in some embodiments, the control device may include up to 100 or more restriction channels. In such embodiments, each restriction The flow path may be from about 0.0005 inches to about 0.1 inches, from about 0.0005 inches to about 0.05 inches. The diameter may be from about 0.0005 inches to about 0.01 inches. In some embodiments, the multiple restricted flow paths may be configured to include: (1) an outlet that exposes the isolation chamber 234 to a negative pressure differential; (2) selectively providing a flow path between the port 236 and the isolation chamber 234; and The membrane is configured to selectively allow the passage of air while substantially preventing the passage of liquids (e.g., bodily fluids). The flow controller may be configured to act as a flow controller configured to:

[0075] In some embodiments, the isolation chamber 234 adjusts the amount of pressure to which it is exposed. and / or control the amount of pressure exerted on the patient's bodily fluids and / or blood vessels. In some instances, such pressure regulation can be achieved, for example, by adjusting the pressure of a blood sample. This can reduce the likelihood of hemolysis and / or vascular collapse. The ability to regulate and / or control the amount or magnitude of pressure allows the patient to cope with physiological difficulties. so that sudden forces can be applied to facilitate the collection of body fluids, e.g., blood. Not flattened, collapsed, invaginated, and / or otherwise impaired in its patency and blood collection capacity Negative pressure is required (the pressure difference between atmospheric pressure and the patient's vascular pressure) to promote uniform and sufficiently strong flow. The device 200 can be used on a wide range of patients, often with insufficient It is Noh.

[0076] As detailed above with reference to the control device 100, the initial portion of the body fluid and / or The initial volume can be any suitable volume of bodily fluid. For example, in some instances, the initial volume is: The amount or volume of body fluid sufficient to fully wet or saturate the flow controller 242 In other words, several In some embodiments, the initial volume of bodily fluid may be adjusted to place the flow controller 242 in a second state (e.g., The volume may be sufficient to transition the solution to a state of saturated or fully wetted state. In this configuration, the flow controller 242 is placed in a sealing configuration when transitioned to the second state. That is, the flow controller 242 (e.g., a semi-permeable material) is saturated and / or or completely wetted, the flow controller 242 2 are disposed in a sealing configuration that substantially prevents the flow of liquids and gases therethrough. By transitioning the flow controller 242 to the second state, the flow is isolated from the restricted flow path 232. The flow through the flow controller 242 to or from the chamber 234 is isolated or blocked. Separated, separated, set apart, spaced apart, and / or otherwise obstructed.

[0077] After the initial volume of bodily fluid has been transferred and / or diverted into the isolation chamber 234, the control device The chair 200 and / or housing 230 are transitioned to their second state or mode of operation. , to isolate, separate, hold, contain, or separate the initial volume within the isolation chamber 234. For example, as described above, the flow controller 242 may be placed in a sealed configuration. In addition, the actuator 250 transitions from its first state to its second state. 254. Therefore, negative pressure otherwise applied on or through the isolation chamber 234 Here, the fluid flow paths 233 and 254 are connected to or through the fluid flow paths 233 and 254. In response, bodily fluid flows from inlet 231 through fluid flow paths 233 and 254 to outlet 256. 36 and into the fluid collection device. The flow controller 242 and the actuator 250 are respectively moved from the first state to the second state. By transitioning to the second state, the initial portion of the bodily fluid in the isolation chamber 234 is isolated. As described in more detail herein, In some cases, for example, microorganisms present on the skin that are expelled during venipuncture Contaminants may be entrained and / or contained in the initial volume of body fluid, and therefore When the initial volume is isolated therein, it is isolated within the isolation chamber 234 .

[0078] A fluid collection device is fluidly coupled to the outlet 236 and is connected to the control device 200 and / or the hand When housing 230 is in a second state (e.g., an initial volume of bodily fluid is in or on isolation chamber 234), Once the fluid is in the chamber (isolated by the chamber), any subsequent volume(s) of fluid may be introduced into the inlet 2 31, through fluid flow paths 233 and 254, through outlet 236, and into the fluid collection device. Thus, as described above, one or more test volumes of body fluids can be By isolating an initial volume of bodily fluid in the isolation chamber 234 prior to collection or acquisition. This reduces and / or substantially eliminates the amount of contaminants in one or more test volumes. Additionally, in some embodiments, the control device 200 and / or the housing 230 may be: The control device 200 and / or the housing 230 may contain an initial volume within the isolation chamber 234. Before consolidating and isolating, the devices can be arranged so that they cannot transition to the second state. .

[0079] The control device 200 may be configured to transition between a first state and a second state (e.g., as a function of the user's actions). and including an actuator 250 configured to move the actuator 250 (via a force applied thereto). 2-5, in other embodiments, the control device may include two or more Any suitable member or device configured to selectively establish fluid communication between fluid flow paths. 6-8 show a fluid control device according to one embodiment. The fluid control device 300 is similar to the fluid control device described above with reference to FIG. device 100 and / or fluid control device 200 described above with reference to FIGS. 2-5. The fluid control device 100 and the and / or a portion of fluid control device 300, which may be similar to a portion of 200. The specification does not go into further detail.

[0080] As shown in FIGS. 6 to 8, a fluid control device 300 (referred to herein as a "control device") or "device") has an inlet 331 and an outlet 336, and an actuator The control device includes a housing 330 that includes an actuator 350 or is coupled to an actuator 350. As described above with reference to chairs 100 and / or 200, inlet 331 is a fluid source and and a lumen-containing device, such as a needle, through which a body fluid can flow (e.g., via a lumen-containing device, such as a needle). The outlet 336 is configured to receive a fluid collection device (e.g., The fluid path is configured to be fluidly coupled to a fluid path (not shown).

[0081] As described above with reference to housings 130 and / or 230, housing 330 may include: The inlet 331 is selectively arranged to be in fluid communication with the isolation chamber 334 and / or the outlet 336. The fluid passages 333, 354A, and 354B define one or more fluid flow paths 333, 354A, and 354B configured to The housing 330 of the device 300 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 330 may have at least the form and / or or may be substantially similar in function to the housings 130 and / or 230 described above. In some embodiments, the housing 330 may include at least one ion exchange membrane, for example, in the isolation chamber 334. and having a size based at least in part on the volume of bodily fluid to be stored, at least temporarily. The isolation chamber 334 of the housing 330 is connected to the fluid passage(s) 333. The inlet 331 is disposed in at least temporary fluid communication with the inlet 331. As will be described in detail below, the isolation chamber 334 may be configured to allow at least air or gas to pass between them. The fluid passage 354A is selectively arranged to be in fluid communication with the fluid passage 354A so that the fluid can be transferred. It is possible.

[0082] As described in more detail herein, the isolation chamber 334 is configured to: (1) allow for the flow of bodily fluids; (2) receiving a body fluid flow and / or volume from inlet 331; To separate (e.g., to keep apart, spaced apart, contained, held, separated, etc.) The isolation chamber 334 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the isolation chamber 334 can be 1. The isolation chamber 234 may be substantially similar to the isolation chamber 234 described above with reference to Similarly, the housing 330 and / or isolation chamber 334 may be , a flow controller 342, which may be substantially similar to the flow controller 242 described above. As such, as further detailed herein, Additionally, a flow controller 342 is positioned within the housing 330 to control the isolation chamber. 334 and fluid flow path 354A.

[0083] Outlet 336 of housing 330 is connected to fluid flow paths 333, 354A and / or 354B. The fluid communication device is configured to be in fluid communication with and / or be fluidly disposed therewith. Additionally, the outlet 336 may be connected to, for example, a sample reservoir, a container, a vial, a negative pressure source, a syringe, , and / or intermediate control devices and / or transport devices (not shown in FIGS. 6-8 ) and the outlet 336. and the fluid collection device each have the outlet 236 and The fluid collection device may be substantially similar to each of the outlets 336 and the flow Body collection devices will not be discussed in further detail herein.

[0084] As shown in FIGS. 6-8, the housing 330 is configured to selectively control the flow of bodily fluids through the housing 330. and / or coupled to an actuator 350 configured to selectively control In some embodiments, the actuator 350 has at least one function and / or form. 2-5, which may be substantially similar to the actuator 250 described above with reference to FIGS. However, in this embodiment, the actuator 350 is arranged as a plunger. The plunger includes a set of seals 365 along the outer surface of the plunger. As shown, the actuator 350 has a substantially circular shape and is At least temporarily accept a portion of and / or otherwise control the flow controller 342 As described above with reference to actuator 250, As described above, when the actuator 350 is in the first state, the fluid flow path 333 and the fluid flow Separating, isolating, separating, and / or otherwise preventing fluid communication between the channel 354B and the When in the second state, the fluid flow path 333 is configured to be connected to the fluid flow path 354B. and configured to be arranged to allow fluid to flow therethrough.

[0085] As described above, device 300 can be used to detect, for example, microorganisms present on the skin and / or similar microorganisms. It is possible to obtain a body fluid sample with reduced contamination from microorganisms such as those of In some instances, users such as doctors, physicians, nurses, phlebotomists, and technicians may The sensor 300 is operated to allow fluid communication between the inlet 331 and a source of bodily fluid (e.g., a patient's blood vessel). The inlet 331 can be connected to a source of bodily fluid (e.g., a portion of a patient) and allows fluid to flow therethrough. Once enabled, the outlet 336 may be fluidly coupled to a fluid collection device. In the embodiment shown in Figures 6-8, the fluid collection device may be, for example, a vacuum reservoir, a syringe, and / or any vessel that defines a negative pressure.

[0086] By coupling outlet 336 to a fluid collection device, fluid flow paths 354A and 354B At least a portion of B is negative pressure within and / or generated by the fluid collection device. The actuator 350 is selectively exposed to the first state, configuration, and / or position. When in the position, actuator 350 separates fluid flow path 354B from fluid flow path 333, Therefore, the fluid flow path 333 is not subjected to a negative pressure differential created by the fluid collection device. As described above, the flow controller 342 is arranged to A and is in fluid communication with isolation chamber 334. More specifically, actuator 350 The annular arrangement of the flow controller 342 allows the flow controller 342 to be in fluid communication with the fluid flow path 354A. (See, for example, FIG. 8). Thus, coupling outlet 336 to a fluid collection device This exposes the isolation chamber 334 to the negative pressure of the fluid collection device, thereby Fluid is introduced from a bodily fluid source (e.g., a patient) through inlet 331 and into housing 330. When retracting, a negative pressure difference is generated that is operable. As mentioned above, the housing 330 allows a volume of bodily fluid to enter and / or pass through the inlet 331. When transferred, an initial portion of the volume of bodily fluid (referred to herein as the "initial volume" or "first volume") ") is arranged to flow from the inlet 331 and into the isolation chamber 334. That is, in some embodiments, the housing 330 may contain an initial portion or volume of bodily fluid. A first or initial state in which the liquid is able to flow from the inlet 331 and into the isolation chamber 334. It can be in a state.

[0087] As described above, the flow controller 342 and the actuator 350 are in a first state, position When in position, configuration, etc., the housing 330 and / or control device 300 are in an initial state. Therefore, the actuator 350 is directly connected between the fluid flow paths 333 and 354B. To separate, separate, space away, isolate, and / or otherwise prevent substantial fluid communication therebetween. Additionally, the inlet 331 is exposed to a negative pressure differential via the isolation chamber 334. The negative pressure within or generated by the fluid collection device may be applied to the housing 3 30 and / or the control device 300 in a first or initial state, An isolation chamber operable to draw flow from inlet 331 and into isolation chamber 334. A negative pressure (or negative pressure differential) can be created within at least a portion of the chamber 334. As detailed above, in some instances, any suitable means, such as those described herein, may be used. It may be desirable to regulate and / or control the magnitude of the negative pressure differential by

[0088] As described in detail above with reference to the control device 100 and / or 200, the initial The initial portion and / or initial volume can be any suitable volume of bodily fluid. For example, in some instances In this case, the initial volume is sufficient to completely wet or saturate the flow controller 342. The amount or volume of bodily fluids present may be related to and / or based at least in part on. In other words, in some embodiments, the initial volume of bodily fluid is The volume may be sufficient to transition to two states (e.g., saturated or fully wet). As described above with reference to flow controller 242, flow controller 342 When transitioning to the second state, it is positioned in a sealed configuration. By transitioning the flow controller 342 to the second state, the flow through the flow controller 342 is , isolated, blocked, separated, set apart, spaced apart, and / or otherwise Be prevented.

[0089] After the initial volume of bodily fluid has been transferred and / or diverted into the isolation chamber 334, the control device The device 300 and / or housing 330 are transitioned to their second state or mode of operation. , to isolate, separate, hold, contain, or separate the initial volume within the isolation chamber 334. As described above, the flow controller 342 is positioned in a sealed configuration. Thus, substantially preventing the flow of fluid therethrough. The flow controller 342 is positioned in the sealed configuration. At least a portion of the negative pressure otherwise applied through controller 342 is applied to actuator 350. instead, thereby causing the actuator 350 to transition from its first state to its second state. For example, in some embodiments, , the negative pressure moves the actuator 350 from a first position (e.g., a first state) to a second position (e.g., (e.g., a second state), thereby eliminating fluid communication between fluid flow paths 333 and 354B. The device is operable to establish communication.

[0090] More specifically, moving (or otherwise displacing) actuator 350 to its second position , transitioning the actuator 350 to its second state) to allow fluid to pass between them. The seal 365 is moved relative to the fluid flow paths 333 and 354B to allow flow of Therefore, the separation chamber 334 may be placed on or through the separation chamber 334. The negative pressure otherwise applied by the fluid flow paths 333 and 354B or by the fluid flow paths 333 and 354B. In response, the body fluid flows from inlet 331 through fluid flow path 333 and 354B, through outlet 336 and into the fluid collection device. In some embodiments, the flow controller 342 and the actuator 350 By transitioning from each first state to each second state, the isolation chamber 334 is operable to isolate and / or retain an initial portion of the bodily fluid within 334. As described in more detail herein, in some instances, the fluid may be expelled during, for example, venipuncture. Contaminants, such as microorganisms present on the exposed skin, may be introduced and / or contained in the initial volume of body fluid. and thus, when the initial volume is isolated therein, be isolated in

[0091] A fluid collection device is fluidly coupled to the outlet 336 and is connected to the control device 300 and / or the hand When housing 330 is in a second state (e.g., an initial volume of bodily fluid is in or on isolation chamber 334), Once the fluid is in the chamber (isolated by the chamber), any subsequent volume(s) of fluid may be introduced into the inlet 3 31, through fluid flow paths 333 and 354B, through outlet 336, and into the fluid collection device. Thus, as described above, a test volume of one or more body fluids can be By isolating an initial volume of bodily fluid in the isolation chamber 334 before collecting or acquiring the fluid. Thus, the amount of contaminants in one or more test volumes is reduced and / or substantially eliminated. Additionally, in some embodiments, the housing 330 may be configured such that the housing 330 is an isolation chamber. It is not possible to transition to the second state before collecting and isolating the initial volume in member 334. It can be arranged as follows.

[0092] 9-10 show a fluid control device 400 according to one embodiment. 400 is similar in form and / or function to the fluid control device described above with reference to FIG. 2-5, and / or the fluid control device 200 shown in FIGS. 8. Therefore, the fluid control device 300 may be similar to the fluid control device 300 described above with reference to Fluid control devices that may be similar to portions of devices 100, 200, and / or 300 Portions of 400 will not be described in further detail herein.

[0093] As shown in FIGS. 9 and 10, a fluid control device 400 (referred to herein as a "control device") or "device") has an inlet 431 and an outlet 436, and an actuator 450 and / or includes a housing 430 coupled thereto. As described above with reference to the 0, 200, and / or 300, the inlet 431 may be connected to a source of bodily fluid and a fluid is fluidly disposed therein, and allows the flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle). The outlet 436 is configured to receive a fluid collection device (see FIGS. 9 and 1). 0 (not shown).

[0094] As mentioned above, the housing 430 of the control device 400 is configured to (1) control the flow of bodily fluids and / or (2) receives a volume from the inlet 431 and (3) controls the flow of body fluids and / or To isolate a volume (e.g., separate, set apart, contain, hold, separate, etc.) The housing 430 may be of any suitable shape, size, and / or configuration. In some embodiments, the housing 430 may be, for example, a separation chamber 4 34, and a size based at least in part on the volume of bodily fluid to be at least temporarily stored within the For example, in the embodiment shown in Figures 9 and 10, As described above, the housing 430 may be configured as a syringe-like device or the like (at least (partially) arranged.

[0095] The housing 430 is in selective fluid communication with the outlet 436, allowing the flow of fluid therethrough. Fluid flow paths 433 and 454 that selectively accept a flow of (e.g., liquid and / or gas) The outlet 436 of the housing 430 defines a fluid passage 433 and / or 454 and a fluid configured to be in fluid communication with and / or arranged in fluid communication therewith. Additionally, outlet 436 is fluidly coupled to a fluid collection device (not shown in FIGS. 9 and 10). Each of the outlet 436 and the fluid collection device is configured to 200. Therefore, the outlet 436 and the fluid collection device are further described herein as is not described in detail.

[0096] The housing 430 is configured to selectively control the flow of bodily fluid through the housing 430. In this embodiment, the actuator 450 includes and / or is coupled to the actuator 450. The actuator 450 is movably mounted within the housing 430 and is connected to the isolation chamber 43 a first plunger 460 and a second plunger 470 configured to at least partially define a More specifically, the actuator 450 includes a plunger 461. In a first state (FIG. 9) in which the chamber 434 is arranged to allow fluid flow, and in a second state (FIG. 9) in which the inlet 431 is arranged to allow fluid flow. between the outlet 436 and the second state (FIG. 10) in which the fluid is allowed to flow through the passage 454; In this embodiment, the actuator 450 and / or When the housing 430 is in the first state, the inlet 431 is in communication with the first plunger 460 and the second plunger 462. The fluid can flow between the portion of the housing 430 defined between the plunger 461 and the second plunger 461. be.

[0097] When in the first state, the first plunger 460 causes the damping chamber 437 to become an isolation chamber. The first plunger 460 is defined by the housing 430 on the side of the first plunger 460 opposite the spring 434. As shown, the damping chamber 437 is positioned so that the The port 435 is configured to be disposed so that the fluid can flow through the fluid flow path 433. at least selectively allowing fluid communication between the fluid flow path 433 and the damping chamber 437. orifices, valves, membranes, diaphragms, and / or any other suitable flow control Further, the actuator 450 and / or the housing 430 may When in the first state, the damping chamber 437 contains a gas (compressed or uncompressed) and / or a liquid. Damping fluid 456 (e.g., water, oil, a damping fluid, and / or any other suitable liquid) Contains and / or contains.

[0098] When the actuator 450 and / or the housing 430 are in the first state, the second The plunger 461 is formed by the second plunger 461 or the second plunger 4 One or more seals 465 coupled to 61 fluidly separate the inlet 431 from the fluid flow path 454. Separate, separate, and / or isolated locations within the housing 430 In addition, the second plunger 461 and / or the seal formed thereon or coupled thereto 465 fluidly separates the fluid flow path 454 from the isolation chamber 434. When the actuator 450 and / or the control device 400 are in the first state, the inlet 431 is in fluid communication with isolation chamber 434 and includes fluid flow paths 433 and 454 and It is fluidly isolated from the outlet 436 (see FIG. 9). Thus, the actuator 450 and / or the control device 400 may be configured to The inlet 431 is arranged in isolation within the housing 430 so as to be in fluid communication with the fluid flow path 454. The state can be configured to transition to the second state (see FIG. 10).

[0099] As described above, the device 400 can be used to detect, for example, microorganisms present on the skin and / or similar microorganisms. It is possible to obtain a body fluid sample with reduced contamination from microorganisms such as those of In some instances, users such as doctors, physicians, nurses, phlebotomists, and technicians may The sensor 400 is operated to allow fluid communication between the inlet 431 and a source of bodily fluid (e.g., a patient's blood vessel). The inlet 431 can be connected to a source of bodily fluid (e.g., a portion of a patient) and allows fluid to flow therethrough. When positioned in the fluid collection device, the outlet 436 may be fluidly coupled to a fluid collection device. 9 and 10, the fluid collection device may be a true It may be an empty reservoir or container.

[0100] As shown in FIG. 9, the actuator 450 and / or control device 400 may be 6 may be in a first or initial state prior to coupling to the fluid collection device. , fluid flow passage 433 is in fluid communication with damping chamber 437, and fluid flow passage 454 is , fluidly isolated from the inlet 431 and the isolation chamber 434 (e.g., a second plug As described above, the outlet 436 can be coupled to a fluid collection device. At least a portion of the fluid flow paths 433 and 454 are thereby subjected to negative pressure within the fluid collection device. The actuator 450 and / or the control device 400 are in a first state. When the second plunger 461 is pressed against the housing 430 and / or the isolation chamber 434, the second plunger 461 causes the housing 430 and / or the isolation chamber 434 to flow. The negative pressure applied through the fluid flow path 433 is isolated from the negative pressure applied through the fluid flow path 454. The pressure is at least a portion of the negative pressure on the damping chamber 437 (e.g., via port 435). In some embodiments, for example, port 435 may be operable in , can be transitioned from a closed configuration to an open configuration in response to negative pressure.

[0101] Negative pressure applied through fluid flow path 433 causes actuator 450 to transition from a first state to a second state. For example, in some embodiments, the negative pressure differential is operable to transition to a damping state. Fluid 456 is drawn from the damping chamber 437 and into the fluid flow path 433 or an auxiliary chamber, etc. Additionally, the negative pressure causes the first plunger 460 to move in the first configuration relative to the housing 430. prompting the user to transition and / or move from one configuration or position to a second configuration or position. In this embodiment, the first plunger 460 is a first plunger 460 and a second plunger The volume of the housing 430 defined between the separator 461 and the separator 462 increases (i.e., the isolation chamber). Some can transition and / or move (increasing the volume of 434). In this embodiment, the increase in the volume of the isolation chamber 434 creates a negative pressure therein, which thereby drawing an initial volume of bodily fluid through inlet 431 and into isolation chamber 434. In other words, the negative pressure in the fluid collection device can isolate the initial volume of bodily fluid. An inlet 431 operable to draw into the chamber 434 and an isolation chamber 434 This indirectly creates a negative pressure difference between them.

[0102] As shown in FIG. 10, the movement of the first plunger 460 causes the second plunger 46 For example, in some embodiments, the actuator 450 moves the first After the plunger 460 has moved a predetermined amount (and / or the volume of the isolation chamber 434 has increased), After the initial volume of fluid has been drawn into the isolation chamber 434, The plunger 461 is moved from a first position and / or configuration to a second position and / or configuration. Therefore, the actuator 450 is arranged to The second state is defined by the inlet 431. Plunger 461 and / or a seal 465 coupled thereto may connect inlet 431 to fluid flow passage 4 54 so as to be in fluid communication with the fluid flow path 433. Similarly, negative pressure is now exerted on or through the fluid flow path 454. , the body fluid passes from the inlet 431 through the fluid flow path 454, through the outlet 436, and into the fluid collection It can flow into the device.

[0103] In some embodiments, the actuator 450 is configured to transition from a first state to a second state. This isolates and / or retains an initial portion of the bodily fluid within the isolation chamber 434. As described in more detail herein, in some instances For example, contaminants such as microorganisms present on the skin that are expelled during venipuncture may be present in the initial sample of body fluids. may be mixed and / or contained in the initial volume, thus isolating the initial volume therein. When the liquid is introduced into the isolation chamber 434, it is isolated within the isolation chamber 434. Thus, as described above, one or more Prior to collecting or obtaining a test volume of bodily fluid, the initial volume of bodily fluid in the isolation chamber 434 is Isolation reduces and / or substantially reduces the amount of contaminants in one or more test volumes. Furthermore, in some embodiments, the housing 430 is 30 transitions to a second state before collecting and isolating the initial volume in the isolation chamber 434. It can be positioned so that it cannot be

[0104] As described above with reference to control devices 100, 200, and / or 300, the actuator When the actuator 450 is in the first state, the control device 400 controls the first plunger 460 to Specifically, in this embodiment, the damping The damping fluid 456 in the chamber 437 acts to damp the negative pressure applied to the first plunger 460. Therefore, the actuator 450 and / or the control device 400 can be You can control the rate at which the transition from state 1 to state 2 occurs. By subjecting the housing 430 to maximum negative pressure, the amount of body fluid in the isolation chamber 434 is reduced. Before accepting the initial volume, the actuator 450 and / or the control device 400 may be It is possible to transition from the first state to the second state. Therefore, the magnitude of the pressure can be adjusted This ensures that the desired volume of bodily fluid is transferred into the isolation chamber 434. 9 and 10 are shown as adjusting the negative pressure via damping fluid 456. However, it should be understood that this is provided by way of example only and not by way of limitation. Any other suitable means of damping and / or regulating the magnitude of the negative pressure may be used to actuate the actuator. The movement of the ethanol 450 and / or the housing 430 can be controlled.

[0105] Housing 430 includes plungers 460 and 461 and is configured like a syringe. 9 and 10 and described above as having a housing, in other embodiments, the housing may be Any other suitable means for controlling fluid flow therethrough may be included, for example 11 and 12 show a fluid control device 500 according to one embodiment. The device 500 is similar in form and / or function to any of the fluid control devices 100. , 200, 300, and / or 400. Thus, the fluid control device Fluid control devices that may be similar to portions of 100, 200, 300, and / or 400. Portions of 500 will not be described in further detail herein. As shown, a fluid control device 500 (referred to herein as a "control device" or "device") ) has an inlet 531 and an outlet 536 and is coupled to an actuator 550 The control device 100, 200, 300, and / or 400 includes a housing 530. As mentioned above with reference to the inlet 531, the inlet 531 is in fluid communication with a source of bodily fluid, configured to receive bodily fluid (e.g., via a lumen-containing device such as a needle) from the The outlet 536 fluidly connects to a fluid collection device (not shown in FIGS. 11 and 12). The inlet 531, the outlet 536, and the fluid collection device are configured to be coupled together. can be substantially similar to those described above and are not described in further detail herein. stomach.

[0106] As mentioned above, the housing 530 of the control device 500 is configured to (1) control the flow of bodily fluids and / or (2) receives a volume from the inlet 531 and (3) controls the flow of body fluids and / or To isolate a volume (e.g., to separate, set apart, contain, hold, separate, etc.) ), the housing 530 may be of any suitable shape, size, and / or In some embodiments, the housing 530 may be configured as, for example, an isolation chamber. The size is based at least in part on the volume of bodily fluid that is at least temporarily stored within the reservoir 534. For example, in the embodiment shown in FIGS. 9 and 10. As described in more detail herein, the housing 530 can accommodate the actuator. 550, for example, by placing a diaphragm in place of one or more plungers. Housing 430 may be different.

[0107] The housing 530 is in selective fluid communication with the outlet 536 to allow the flow of fluid ( a set of fluids configured to selectively receive a flow of fluids (e.g., liquids and / or gases) The housing 530 defines flow paths 533 and 554. The housing 530 allows for the flow of bodily fluid through the housing 530. and / or including an actuator 550 configured to selectively control the flow. In this embodiment, the actuator 550 is movable within the housing 530. a diaphragm disposed in the cavity and configured to at least partially define an isolation chamber 534; 576. More specifically, the actuator 550 is configured to actuate the inlet 531 to the isolation chamber 5 11, in which the inlet 531 is disposed in a fluid flow path 55. 4 to the second state (FIG. 12) in which the outlet 536 is arranged to be fluidly connected to the It is configured to:

[0108] As shown in FIG. 11, when the actuator 550 and / or 500 is in a first state, The inlet 531 is defined between the diaphragm 576 and one or more seals 565 in the housing 5. 30. Furthermore, as described above with reference to housing 430, As shown, the diaphragm 576 is located on the opposite side of the diaphragm 576 from the isolation chamber 534 so that the attenuation chamber 537 is The damping circuit is provided in a first state as defined by the housing 530 on the side of the damping circuit. The chamber 537 is arranged so that the fluid can flow through the fluid flow path 533 via the port 535. The port 535 is configured to allow flow between the fluid flow path 533 and the damping chamber 537. An opening, valve, membrane, diaphragm, and / or The actuator 550 and the flow controller 560 may be any other suitable flow controller. When the control device 500 is in a first state, the damping chamber 537 is filled with gas (pressure compressible or incompressible) and / or liquid (e.g., water, oil, damping fluid, and / or any other suitable The control device 400 includes and / or contains a damping fluid such as a damping fluid (e.g., a liquid). As described above, the damping chamber 537, damping fluid, and port 535 arrangement are The amount of negative pressure applied to the diaphragm 576 is adjusted when the actuator 550 is in the first state. 11 and 12 are shown as adjusting the negative pressure via a damping fluid. However, it should be understood that this is presented by way of example only and not by way of limitation. Any other suitable means of damping and / or adjusting the magnitude of the pressure may be used to actuate the actuator. The transition of data 550 and / or 500 can be controlled.

[0109] As described above with reference to actuator 450, actuator 550 and / or control When the control device 500 is in the first state, the one or more seals 565 The inlet 531 is fluidly separated, distinct, and / or separated from the fluid flow path 554. In addition, one or more seals 5 65 fluidly separates the fluid flow path 554 from the isolation chamber 534. When the actuator 550 and / or the control device 500 are in a first state, the inlet 531 The isolation chamber 534 is in fluid communication with the fluid flow paths 533 and 554 and the outlet 536 (see FIG. 11). Thus, the actuator 550 and / or the housing 530 of the control device 500 may be isolated. A chamber 534 is isolated within the housing 530, and an inlet 531 is connected to the fluid flow passage 554. The second state can be configured to transition to a second state in which the ).

[0110] As described in detail above, device 500 can be used to detect microorganisms present on the skin, for example. and / or the like can be used to obtain bodily fluid samples with reduced contamination from microorganisms such as For example, in some instances, a user may connect the inlet 531 to a source of bodily fluid (e.g., a portion of a patient). ) and the outlet 536 can be fluidly connected to a fluid collection device. As shown in FIG. 11, the actuator 550 and / or the device 5 00 is in a first or initial state prior to coupling the outlet 536 to a fluid collection device. Therefore, as detailed above with reference to the control device 400 of FIGS. As such, fluid flow path 533 is in fluid communication with damping chamber 537, and fluid flow path 554 is in fluid communication with Fluidically isolated from the inlet 531 and the isolation chamber 534 (e.g., by one or more seals) via 565).

[0111] By coupling outlet 536 to a fluid collection device, the fluid flow paths 533 and 554 At least a portion of the fluid collection device is selectively subjected to negative pressure within and / or generated by the fluid collection device. When the actuator 550 and / or the device 500 are in a first state, One or more seals 565 may be provided to seal the housing 530 and / or isolation chamber 534 against the fluid flow path. 554. Conversely, negative pressure applied through fluid flow path 533 Apply at least a portion of the negative pressure onto the damping chamber 537 (e.g., via port 535). In some embodiments, for example, port 535 may be operable to apply negative pressure. The fluid passage 533 may be transitioned from the closed configuration to the open configuration in response to a negative pressure applied through the fluid passage 533. is operable in transitioning the actuator 550 from a first state to a second state. For example, in some embodiments, a negative pressure differential may cause damping fluid to flow from the damping chamber 537 The negative pressure also draws the diaphragm 576 from the first configuration or state (FIG. 11) to the passage 533. to a second configuration or state (Fig. 12), flip, move, switch, transform, As described above with reference to the actuator 450, the diaphragm 576 is first The transition from the first state to the second state allows the diaphragm 576 and one or more seals 565 to The volume of the housing 530 defined therebetween increases (i.e., the volume of the isolation chamber 534 increases), thereby allowing an initial flow of body fluid through inlet 531 and into isolation chamber 534 A negative pressure may be created therein that is operable to draw in the volume.

[0112] As shown in FIG. 12, the movement of the diaphragm 576 causes one or more seals 565 to contact the diaphragm 57. One or more seals 565 are similarly moved to be provided on the same side of the inlet 531 as 6. Thus, the isolated chamber 534 is isolated within the housing 530. In addition, one The seal 565 is configured to establish fluid communication between the inlet 531 and the fluid flow path 554. Therefore, the fluid flow path 533 is not necessarily coupled to the fluid flow path 533. Negative pressure is now applied on or through fluid flow path 554. As described in detail above, bodily fluid flows from inlet 531 through fluid flow path 554 to outlet 536. and into the fluid collection device. By transitioning the actuator 550 from the first state to the second state, the isolation channel and operable to isolate and / or retain an initial portion of the bodily fluid within the chamber 534. The initial portion of the fluid contains contaminants, such as microorganisms present on the skin that are expelled during venipuncture. Thus, as described above, a test volume of one or more body fluids may be collected. By isolating an initial volume of bodily fluid in the isolation chamber 534 before collecting or acquiring the fluid. This reduces and / or substantially eliminates the amount of contaminants in one or more test volumes. Additionally, in some embodiments, the control device 500 and / or the housing 530 may include a control The control device 500 and / or housing 530 collects the initial volume in the isolation chamber 534. and isolating it so that it cannot transition to the second state before

[0113] 13-15 show a fluid control device 600 according to one embodiment. The device 600 may be similar in form and / or function to any of the fluid control devices 100, 200, 300, 400, and / or 500. The flow may be similar to a portion of devices 100, 200, 300, 400, and / or 500. Portions of the body control device 600 will not be described in further detail herein. 13-15, a fluid control device 600 (referred to herein as a "control device" or The actuator 65 has an inlet 631 and an outlet 636. 0. The control device 100, 200, 300, 500 and / or as described above with reference to 500, the inlet 631 may be in fluid communication with a source of bodily fluid. and receiving fluid from the body (e.g., via a lumen-containing device such as a needle). The outlet 636 is configured to be connected to a fluid collection device (not shown in FIGS. 13-15). The inlet 631, the outlet 636, and the flow The collection device may be substantially similar to those described above and will be described in further detail herein. does not state.

[0114] As mentioned above, the housing 630 of the control device 600 is configured to: (1) control the flow of bodily fluids and / or (2) receives a volume from inlet 631; and (3) is contained within and / or attached to housing 630. The flow and / or volume of bodily fluids within the isolated chamber 634 thus formed at least in part to isolate (e.g., separate, set apart, contain, hold, separate, etc.) The housing 630 may be of any suitable shape, size, and / or configuration. In some embodiments, the housing 630 may be, for example, a separation chamber 6 34, and a size based at least in part on the volume of bodily fluid to be at least temporarily stored within the For example, in the embodiment shown in FIGS. 13-15, the housing 630 may include: 11 and 12. That is, the housing 630 contains an actuator 650 arranged as a diaphragm. nothing.

[0115] The housing 630 is in selective fluid communication with an outlet 636 for allowing fluid (e.g., a set of fluid flow paths configured to selectively accept a flow of fluid (e.g., liquid and / or gas) The housing 630 defines a flow path for the body fluid through the housing 630. and / or an actuator 650 configured to selectively control In this embodiment, the actuator 650 is coupled to the housing 63. 0 and configured to at least partially define an isolation chamber 634. More specifically, the control device 500 includes a diaphragm 676 formed thereon. As described above, the actuator 650 allows the inlet 631 to be in fluid communication with the isolation chamber 634. In the first state, the inlet 631 is connected to the outlet 636 via the fluid flow path 654. The fluidly disposed second state is configured to move between the fluidly disposed second state and the fluidly disposed second state.

[0116] As shown in FIGS. 14 and 15, when the actuators 650 and / or 600 are in a first state, At some point, the inlet 631 is a housing defined between the diaphragm 676 and one or more seals 665. 5. The housing 530 is in fluid communication with a portion of the housing 630. As mentioned above, the diaphragm 676 is located on the opposite side of the attenuation chamber 637 from the isolation chamber 634. The diaphragm 676 is provided on a side thereof in a first state as defined by the housing 630. As shown, the attenuation chamber 637 is connected to the The fluid passage 654 is configured to be arranged so that the fluid can flow therethrough. as described in detail above with reference to device 500, actuator 650 and / or When the control device 600 is in a first state, the damping chamber 637 is filled with a gas (compressed or non-compressed). compression) and / or liquid (e.g., water, oil, damping fluid, and / or any other suitable liquid) and / or contain a damping fluid, such as a Although it is described as adjusting the negative pressure via a damping fluid, this is not a limitation. It should be understood that this is presented as an example only and is not a definitive statement. and / or any other suitable means for adjusting the actuator 650 and / or The transition of the device 600 can be controlled.

[0117] As described above with reference to actuator 550, actuator 650 and / or control When the control device 600 is in the first state, the seal 665 is in contact with the inlet 631. the housing to fluidly separate, separate, and / or isolate the fluid from the fluid flow path 654. In addition, a seal 665 isolates the fluid flow path 654. The actuator 650 and / or the device 634 are fluidly isolated from each other. When the vise 600 is in the first state, the inlet 631 is in fluid communication with the isolation chamber 634. and is fluidly isolated from the fluid flow path 654 and the outlet 636. The isolation chamber 634 isolates the heater 650 and / or device 600 within the housing 630. and the inlet 631 transitions to a second state in which the inlet 631 is arranged to be able to communicate with the fluid flow channel 654. Thus, the device 600 can be used to perform the functions shown in FIGS. microbial (e.g., present on the skin) in a manner substantially similar to device 500 described above with reference to A body fluid sample can be obtained that has reduced contamination from microorganisms and / or the like. Therefore, the functionality of device 600 will not be described in further detail herein. .

[0118] 16-18 show a fluid control device 700 according to one embodiment. The device 700 may be similar in form and / or function to any of the fluid control devices 100, 200, 300, 400, 500, and / or 600. a portion of the body control device 100, 200, 300, 400, 500, and / or 600; Portions of the fluid control device 700, which may be similar, are described in more detail herein. As shown in FIGS. 16 to 18, a fluid control device 700 (hereinafter referred to as a "control device") The control device (also referred to as "control device" or "device") has an inlet 731 and an outlet 736. A housing 730 having or coupled to an actuator 750. See control devices 100, 200, 300, 400, 500, and / or 600 As described above, the inlet 731 is disposed in fluid communication with a body fluid source, and the body fluid configured to receive a fluid (e.g., via a lumen-containing device such as a needle) The outlet 736 is fluidly coupled to a fluid collection device (not shown in FIGS. 16-18). The inlet 731, outlet 736, and fluid collection device are configured as described above. and therefore will not be described in further detail herein.

[0119] As mentioned above, the housing 730 of the control device 700 is configured to: (1) control the flow of bodily fluids and / or (2) receives a volume from the inlet 731 and (3) allows the flow of body fluids into the isolation chamber 734 and / or To isolate a volume (e.g., to separate, set apart, contain, hold, separate, etc.) ), the housing 730 may be of any suitable shape, size, and / or In some embodiments, the housing 730 may be configured as, for example, an isolation chamber. The size is based at least in part on the volume of bodily fluid that is at least temporarily stored within the reservoir 734. For example, in the embodiment shown in FIGS. 16 to 18, the housing 730 can be arranged substantially similarly to housings 530 and / or 630. the housing 530 includes an actuator 750 arranged as a diaphragm; and / or is connected to it.

[0120] The housing 730 is in selective fluid communication with an outlet 736 (see, e.g., FIGS. 17A and 17B). 17B), selectively receiving the flow of fluid (e.g., liquid and / or gas) therethrough. The housing 730 defines a pair of fluid flow paths 733 and 754 configured to receive the fluid. The actuator is configured to selectively control the flow of bodily fluid through the housing 730. In this embodiment, the actuator 750 includes and / or is coupled to the actuator. 750 is movably provided in the housing 730 and has the isolation chamber 734 More specifically, the control device 5 includes a diaphragm 776 configured to partially define As described in detail above with reference to 00, the actuator 750 is configured to actuate the inlet 731 to the isolation chamber. In a first state, the inlet 731 is arranged to allow fluid to flow through the inlet 731 and the fluid flow path 754. configured to move between a first state in which the outlet 736 is disposed and a second state in which the outlet 736 is disposed and a fluid is allowed to flow therethrough. It has been done.

[0121] In the embodiment shown in FIGS. 16-18, the actuator 750 and / or the device 700 When in the first state, the inlet 731 is connected to the diaphragm 776 and the flow controller 742 (e.g., , optionally a selectively permeable fluid barrier or seal, and / or any of the above. A portion of the housing 730 defined between the The diaphragm 77 is in fluid communication with an isolation chamber 734 formed by the diaphragm 77. 6 is provided in a first state so that the fluid flow path 733 is in fluid communication with the isolation chamber 734. As described above with reference to actuator 550, actuators 750 and and / or when the control device 700 is in the first state, the diaphragm 776 and / or the seal 765 The diaphragm 776 and / or seal 765 fluidly separates the inlet 731 from the fluid flow path 754. The housing 730 may be provided with a location within the housing 730 to separate, distinguish, and / or isolate the In addition, the diaphragm 776 and / or seal 765 separate the fluid flow path 754 from the isolation chamber 73. 4. Therefore, the actuator 750 and / or the device 700 When in the first state, the inlet 731 is in fluid communication with the isolation chamber 734, allowing fluid flow. It is fluidly isolated from the passage 754 .

[0122] For example, as described above with reference to the control device 200, the actuator 750 and / or Alternatively, when device 700 is in the first state, a negative pressure difference in isolation chamber 734 reduces fluid collection. This can occur by coupling a collection device to outlet 736. More specifically, fluid flow path 7 33 is in fluid communication with outlet 736 and flow controller 742. When the flow controller 742 is in a first state, the flow controller 742 Thus, the negative pressure in the isolation chamber 734 can be The pressure differential can be created by coupling a fluid collection device to the outlet 736 .

[0123] As shown in FIG. 18, the actuator, as described in detail above with reference to device 600, The isolation chamber 734 encloses the heater 750 and / or the control device 700 in the housing 730. and the inlet 731 is arranged to be able to communicate fluidly with the fluid flow path 754. More specifically, the initial volume of bodily fluid can be configured to transition into the isolation chamber. 734, thereby transitioning the flow controller 742 to the first state or can be saturated, wetted, or converted from an open state to a second state or closed state In some embodiments, the flow control The transition of the roller 742 from the first state to the second state separates the fluid flow path 733 from the outlet 736. Therefore, negative pressure applied through the fluid flow path 754 acts on the actuator. Transitioning, switching, or flipping membrane 776 so that eta 750 is in its second state It may be operable in changing, moving, transforming, and / or otherwise reconfiguring. Therefore, as described in detail above, the negative pressure in the fluid collection device draws bodily fluid from the inlet 731 into the housing. through the casing 730 (bypassing the isolation chamber 734) and through the fluid flow path 754 and the outlet 736. The fluid can then be drawn through the device 70 and into the fluid collection device. 0 to one or more of the control devices 100, 200, 300, 400 described in detail above. , 500, and / or 600, and / or the like) can be obtained. Therefore, the functionality of device 700 will not be described in further detail herein.

[0124] In some embodiments, any of the control devices 100, 200, 300, 400, 50 0, 600, and / or 700 are manufactured as an assembly or integrated device. It may be formed from any suitable components that can be assembled, sterilized, and packaged. In such an embodiment, for example, a user may The package containing the device can be opened and the control device 100, 200, 3 00, 400, 500, 600, and / or 700. In some embodiments, any control device may be used either entirely or It may be at least partially integrally formed.

[0125] In some embodiments, the optional control device may be configured to control the fluid collection device during the manufacturing process. (e.g., sample reservoirs, syringes, blood culture bottles, collection vials, fluid transfer containers, and and / or other suitable reservoirs, collection devices, and / or transfer devices) This may be done, attached, formed, and / or otherwise connected. collection path(s) and connection interface(s) (e.g. , where the control device couples to the fluid collection device) are designed to prevent touchpoint contamination from external sources. Maintaining the closed system mechanical flow diversion device in a sterile, contamination-free environment. In order for the user to transfer the test volume to the fluid collection device, the user must determine the initial volume of bodily fluid. or first forcing at least a portion of the flow to be isolated, spaced apart, and / or separated. In some embodiments, the fluid control device is coupled to the fluid collection device. The connection and / or installation must be such that the control device is removed (physically disconnected, especially after use). and / or to separate the control device from the fluid collection device. other techniques used to obtain fluid collection devices), which may provide access to the fluid collection device. The fluid collection device may then be positioned in an incubator and / or any other type of analytical machine. The data may be stored, accessed for analysis, and / or otherwise further processed. So, it is important to block, limit, and / or substantially prevent such unbound state before use. In other embodiments, the fluid control The device and fluid collection device are permanently bonded to prevent such debonding. and / or may be integrally formed (at least in part).

[0126] For example, although described above as being joined and / or assembled during manufacturing, However, in other embodiments, the control device may be configured to operate based on desired use, preferences, patient, etc. It may contain one or more modular components that can be selected by the user. In such an embodiment, the user may install one or more modular components (packaged together) or individually packaged) to form the desired fluid control device. For example, Figures 19-25 show a modular fluid control device according to one embodiment. The fluid control device 800 is at least as good as the fluid control device 800 in form and / or function. The fluid control device may be similar to the fluid control device described herein. A portion of the chair 800 corresponds to the fluid control device 200 as described above with reference to FIGS. The fluid control device 8 may be similar and / or substantially the same as the corresponding parts. Such portions of 00 are not discussed in further detail herein.

[0127] Fluid control device 800 (also referred to herein as a "control device" or "device") The control device (which may be a control device) includes a housing 830 and an actuator 850. The sensor 800 may be at least partially integrally formed or may be pre-assembled during manufacture. In other embodiments, the control device 800 can be mounted in a housing 8 30 and actuator 850 are physically and fluidly coupled to form control device 800. It can be at least partially modular so that it can be configured. The housing 830 of the chair 800 may be of any suitable shape, size, and / or configuration. For example, in the embodiment shown in FIGS. 19-25, the housing 830 may be relatively thin. In some embodiments, a portion of the housing 830 may be substantially rectangular. 2-5。 At least in form and / or function similar to the housing 230 described above with reference to Figures 2-5. Therefore, although such parts are specified, similar configurations may be used. The elements, features and / or functions are not described in further detail herein.

[0128] As shown in FIGS. 19 and 20, the housing 830 includes a first port 845 and a second port 846. The isolation chamber 834 selectively forms and / or defines a fluid communication port 846 . The first port 845 and the second port 846 are at least partially connected to a portion of the actuator 850. and a selective fluid between the housing 830 and the actuator 850. As described in more detail herein, the isolation Chamber 834 (1) allows for the selective flow of bodily fluids and / or fluids through first port 845; (2) to receive the product from a portion of the actuator 850; and (3) to separate the isolation chamber 83. 4. The flow and / or volume of fluid (e.g., the initial or second flow of fluid or any part thereof) within the to separate (e.g., separate, separate, contain, hold) one flow and / or volume The isolation chamber 834 may be configured to separate, isolate, or otherwise separate the components. For example, in some embodiments, the shape, size, and / or configuration may be: Isolation chamber 834 may be any suitable chamber, such as those described above with reference to isolation chamber 134. It can have any suitable size, volume, and / or fluid capacity. In an embodiment, the isolation chamber 834 may be, for example, a gas supply through at least a portion of the housing 830. a fluid flow extending through and / or defined by at least a portion of the housing 830; For example, in some embodiments, the isolation chamber 834 may have at least one 2-5. They may be similar and therefore will not be described in further detail here.

[0129] As shown in FIG. 20, the housing 830 includes a flow controller 842 and a restricted flow path 844. 32. The flow controller 842 directs the flow of fluid to the isolation chamber. and / or in any other suitable portion of the housing 830. configured to selectively control (at least partially) the outside, e.g., a valve, membrane, diaphragm, It may be a restrictor, a vent, a selectively permeable member, a port, etc. The roller 842 is configured to selectively allow gas flow but prevent liquid flow therethrough. A selectively permeable fluid barrier including and / or formed of a porous material configured In some embodiments, the flow controller 84 2 is substantially similar to the flow controller 242 described in detail above with reference to FIGS. may be, and therefore will not be described in further detail herein.

[0130] As shown, the housing 830 defines a restricted flow path 832 that is connected to a second port 846. The second port 846 is in fluid communication with the flow controller 842 (or a portion of the housing 830 that receives or houses the roller 842. As described above with reference to the flow path restriction 232 shown in FIGS. For example, one or more other flow paths defined by the housing 830 and / or the actuator 850 may be For example, in some embodiments, the restricted flow path 8 32 is between about 0.0005 inches and about 0.5 inches, as described above with reference to the restricted flow path 232. The diameter of the tube may be about 0.01 inches to about 0.5 inches, and the length may be about 0.01 inches to about 0.5 inches. As mentioned above, the smaller diameter of the restriction channel 832 allows the restriction channel 832 to flow more efficiently. When the diameter of the isolation chamber 834 is larger than the magnitude of the negative pressure being applied through the isolation chamber 834, In other words, the magnitude of the negative pressure is lower. The amount of negative pressure to which the device is exposed can be adjusted. By adjusting the volume, the rate at which bodily fluid is transferred into the isolation chamber 834 can be controlled. Furthermore, in this embodiment, the restricted flow path 832 can be configured to allow, for example, a liquid (e.g., a gas flow path configured to receive a gas or air flow rather than a liquid flow; , sufficient to adequately collect an initial amount of bodily fluid, and / or at least A negative pressure difference sufficient to transition a portion of the body to the second state can be achieved, while A portion of the initial or first volume of liquid passes through the isolation chamber 834 and the second port 846. Limit and / or substantially prevent the intrusion of

[0131] As shown in FIGS. 19 to 24, the actuator 850 includes a main body 851 and an actuator The body 851 of the actuator 850 includes an inlet 852 and an outlet 853. The inlet 852 and the outlet 853 are at least in form and / or function similar to those shown in FIGS. 5. The inlet 852 is fluidly disposed with a source of bodily fluid and allows the flow of bodily fluid therefrom (e.g., Accepts needles, IV catheters, PICC lines, and other lumen-containing devices The outlet 853 may be configured, for example, to accommodate a transfer device similar to that described in the '510 disclosure. For example, sample reservoirs, syringes, and / or other intermediate fluid transfer devices, such as chairs , adapter, or reservoir (see, e.g., FIG. 25 ). It is configured to be coupled.

[0132] As shown in FIG. 21, the body 851 of the actuator 850 includes a first port 858 and a second port 859. The first port 858 includes and / or defines a second port 859. The first port 858 is connected to the inlet 852 and the flow The second port 859 is in fluid communication with the outlet 853. The first port 858 and the second port 859 are connected to the first port 845 of the housing 830. and second port 846. As described in more detail herein, the actuator 850 is a first operating model. and a second operating mode or state to control the actuator 850 Flow through ports 858 and 859 and ports 845 and 846 of housing 830 The flow of the body can be selectively controlled, thereby allowing the isolation chamber of the housing 830 The flow of bodily fluid into and / or out of 834 can be selectively controlled.

[0133] In some embodiments, ports 858 and 859 of actuator 850, and The placement of ports 845 and 846 in housing 830 allows housing 830 to be actuated. and physically couples the housing 830 to the actuator 850. Means for coupling may be enabled and / or otherwise provided. For example, in some embodiments, ports 858 and 859 of actuator 850 Ports 845 and 846 of housing 830 may be friction, press, or interference fit. , and / or the like. In other embodiments, the actuator 8 Ports 858 and 859 of 50 may be fitted with adhesives, mechanical fasteners, elastic joints, gaskets, of the housing 830 via the ring(s), and / or any other suitable coupling means. In yet another embodiment, the actuator may be coupled to ports 845 and 846, respectively. Ports 858 and 859 of the eta 850 may be, for example, one or more sterile, flexible and ports 845 and 846 of housing 830 via intervening structure such as tube(s). Thus, device 800 can be, for example, A modular structure in which the housing 830 can be at least fluidly coupled to the actuator 850. It may consist of and / or have.

[0134] In some embodiments, such a modular configuration allows for, for example, have one or more desirable properties based on the objective and / or use of the assembled device. The housing (or actuator) can be selected by the user. The modular arrangement allows for the combination of one or more components with desired properties during manufacturing. It may be possible and / or easy to do and / or assemble. For example, In some instances, a hardware device may be provided that includes and / or defines a segregation chamber having a particular or desired volume. For example, in pediatric patients and / or those with severe When using the device to obtain fluids from patients (for example, apparently healthy adult patients) When using a device to obtain fluid from a smaller volume than is selected If desired, select a housing that defines and / or includes an isolation chamber having Therefore, such a modular configuration allows users (e.g., physicians, (doctors, nurses, technicians, phlebotomists, etc.) may, for example, Allows you to select a housing or actuator with one or more desired characteristics In other examples, the modular arrangement can be used for one or more manufacturing processes. Without significant modification during manufacturing, a housing or It may enable or facilitate assembly of the actuator.

[0135] The actuator rod 862 of the actuator 850 moves within a portion of the body 851. The actuator rod 862 has a first end 863 and a second end 864. 64, and the body 850 of the actuator 850 having the actuator rod 862. At least one of the ribs 51 and 52 is provided within the main body 851 (see, for example, FIG. 23 and 24). A portion of the actuator rod 862 includes a set of seals 865. and / or coupled thereto. The seal 865 may be, for example, an O-ring, an elastomeric overmolding, or the like. It may be a groove, a protruding or raised feature or fitting, and / or the like. The inner portion of the seal 865 is , forming a fluid-tight seal with the surface of actuator rod 862, and the outer portion of seal 865 The component can be positioned to form a fluid-tight seal with the inner surface of the body 851. In other words, the seal 865 is between the actuator rod 862 and the inner surface of the body 851. As shown in Figures 23 and 24, the actuator forms one or more fluid-tight seals. The rod 862 is connected to a first fluid passage 833 in the body 851 of the actuator 850 and to the actuator. forming and / or defining a second fluid flow path 854 within the body 851 of the actuator 850; The seal 865 includes and / or is coupled to three seals 865.

[0136] The actuator rod 862 is movable between a first position or configuration and a second position or configuration. 851. For example, some In the example, as shown in FIG. 23, a force is applied to a first end 863 of an actuator rod 862. and positioning the actuator rod 862 in its first position and / or configuration. The force applied to the first end 863 of the actuator rod 862 can be applied by any suitable means. For example, the user may use their own hand or finger, a syringe, a positive or negative pressure source, and / or any other external energy source may generate the force. When in the or configuration, the inlet 852 of the actuator 850 is in communication with the first fluid flow path 833 and the fluid and an outlet 853 of the actuator 850 is in fluid communication with a second fluid flow path 854. In some examples, as shown in FIG. 24, the second A force is applied to end 864 to move actuator rod 862 to its second position and / or configuration. When in the second position and / or configuration, the actuator 85 Each of the inlet 852 and outlet 853 of the nozzle 80 is in fluid communication with a second fluid flow path 854. , while the first fluid flow path is isolated from the inlet 852 and the outlet 853; and / or otherwise not fluid-permitting. The first port 858 is in fluid communication with the first fluid flow path 833 and is connected to the actuator 8. The second port 859 of 50 is in fluid communication with the second fluid flow path 854. As described in more detail herein, the actuator rod 862 (or generally, the actuator Moving and / or transitioning the actuator 850 between a first position and a second position , between the inlet 852 of the actuator 850 and the housing 830, or between the inlet 852 of the actuator 850 and the housing 830 The flow of fluid (e.g., body fluid) between the inlet 852 of the actuator 850 and the outlet 853 of the actuator 850 may be operable in selectively controlling

[0137] As described above, device 800 can be used to detect microorganisms present on the skin, outside of bodily fluid sources, for example. Obtaining body fluid samples with reduced contamination from microorganisms such as certain microorganisms and / or the like For example, in some instances, doctors, physicians, nurses, phlebotomists, technicians, A user, such as a user, operates device 800 to connect inlet 852 to a bodily fluid source (e.g., a patient's blood vessels). ) can establish fluid communication between the inlet 852 and a source of bodily fluid (e.g., a patient's When the fluid is placed in fluid communication with the fluid collection device 880, the outlet 853 In the embodiment shown in Figures 19-25, the fluid collection device 880 may be, for example, For example, a syringe (as shown in FIG. 25) and / or a negative pressure or energy source may be provided. The container or device may be any other suitable container or device configured to generate or produce a

[0138] For example, outlet 853 may be configured as a fluid collection device, as described in detail above with reference to device 200. By coupling to the device 880, at least a portion of the control device 800 selectively exposed to negative pressure within and / or generated by the body collection device 880 More specifically, in the embodiment shown in Figures 19 to 25, the outlet 853 is connected to the fluid collection device 8 80, the outlet 853 of the actuator 850 and the second fluid flow path 85 4 is exposed to negative pressure within and / or generated by the fluid collection device 880 Additionally, the second port 859 of the actuator 850 is connected to the second fluid flow path 854 and the This allows fluid communication with the second port 846 of the housing 830. A second port 846 of 830 is connected to the flow controller 842 and the restricted flow path 832. The device 800 and / or the isolation chamber 834 may be selectively in fluid communication with each other. The flow controller 842 is While allowing the flow of gas (e.g., air) through the flow controller 842 a first operating state that restricts and / or prevents the flow of a fluid (e.g., a bodily fluid such as blood); or In the first mode, the fluid collection device 880 is coupled to the outlet 853. This allows the fluid collection device 880 (and / or any suitable negative pressure source) and the isolation chamber A negative pressure difference occurs between the heater 834 and the heater 834.

[0139] As described above, the flow controller 842 and / or the actuator 850 are in a first state. When the control device 800 is in a state, position, configuration, etc., the control device 800 is in a first or initial state. Therefore, the actuator rod 862 is connected to the first fluid passage 833 through the inlet 852. It may be in its first position and / or configuration that allows fluid to flow therethrough. The first port 858 of the actuator 850 and the first port 845 of the housing 830 are separated. This allows fluid communication between the separation chamber 834 and the first fluid flow path 833. , when the actuator 850 and / or the control device 800 are in a first or initial state. (e.g., actuator rod 862 is in its first state, position, and / or configuration) When the fluid collection device 880 is in a circumferential position, the negative pressure in the fluid collection device 880 causes the initial flow, portion, amount, or volume of the bodily fluid to From the inlet 852, fluid is drawn through the first fluid flow path 833 and into the isolation chamber 834. creating a negative pressure (or negative pressure differential) within at least a portion of the isolation chamber 834 that is operable to In some examples, the device 200 may be configured as described in detail above. The flow controller 842 and / or the restriction flow path 832 may be arranged in the isolation chamber 83. Limiting or restricting the amount or magnitude of negative pressure applied on or through isolation chamber 834 , control, and / or otherwise regulate.

[0140] As described above in detail with reference to the control device 100, the initial portion and / or the initial portion of the bodily fluid The amount can be any suitable amount of bodily fluid. For example, in some instances, the initial volume is - an amount or volume of bodily fluid that is sufficient to completely wet or saturate the controller 842 may be related to and / or based at least in part on. In an embodiment, the initial volume of bodily fluid is determined by switching the flow controller 842 from the first state to the second state. The volume may be sufficient to transition to a saturated or fully wetted state. In some embodiments, the flow controller 842, when transitioning to the second state, That is, the flow controller 842 (e.g., a semi-permeable material) is positioned By becoming saturated and / or fully wetted, the flow controller 842 The controller 842 is positioned in a sealing configuration that substantially prevents the flow of liquids and gases therethrough. Therefore, by transitioning the flow controller 842 to the second state, The flow through the flow controller 842 between the restriction flow path 832 and the isolation chamber 834 is Isolated, blocked, separated, set apart, set apart, and / or otherwise obstructed It will be stopped.

[0141] After transferring and / or diverting the initial volume of bodily fluid to the isolation chamber 834, the control device 800 and / or actuator 850 are transitioned to their second state or mode of operation. , to isolate, separate, hold, contain, or separate the initial volume within isolation chamber 834. For example, the actuator 850 may be, for example, an actuator rod. 862 from its first state to its second state by applying a force to the second end 864 of the Therefore, the actuator rod 862 can be actuated to transition to the first flow. a second state, position, and / or location of the body flow passage 833 that isolates and / or separates the body flow passage 833 from the inlet 852; and / or moved and / or transferred to the isolation chamber 834. The flow controller 842 is in a sealing configuration depending on the initial volume of the body fluid, and the inlet The initial volume of fluid may be increased by an initial fluid flow path 833 isolated and / or separated from 852. are isolated within isolation chamber 834. As discussed in detail above, in some instances, e.g. For example, contaminants such as microorganisms present on the skin that are expelled during venipuncture may contribute to the initial volume of fluid. may be mixed and / or contained within the initial volume and thus isolated there and isolated within isolation chamber 834.

[0142] As shown in FIG. 24, the control device 800 and / or the actuator 850 may be the second fluid flow path 854 by moving and / or transitioning to a state or configuration This establishes fluid communication between the inlet 852 and the outlet 853. Negative pressure applied on 34 or otherwise through isolation chamber 834 now acts on fluid flow path 854 In response, bodily fluid flows from inlet 852 to fluid flow path 854 , through outlet 853 and into fluid collection device 880. Therefore, as described above, prior to collecting or obtaining a test volume of one or more bodily fluids, a separation By isolating an initial volume of fluid in isolation chamber 834, the amount of fluid in one or more test volumes can be reduced. The amount of contaminants is reduced and / or substantially eliminated. The control device 800 is configured to control the initial volume in the isolation chamber 834. Before collecting and isolating, it can be arranged so that it cannot transition to the second state. thereby reducing the likelihood of contaminants being transferred to the fluid collection device 880.

[0143] In some instances, for example, multiple fluid collection devices 880 (e.g., syringes) may be used. When it is desirable to collect multiple samples of a body fluid using a negative pressure source (e.g., It may be desirable to separate the collection device 880 from the inlet 853. For example, some In some examples, after filling the fluid collection device 880, the user may press the actuator 850 862 to apply a force to the first end 863 of the actuator rod 862, Rod 862 is moved from its second position and / or configuration to its first position and / or configuration. Therefore, the second fluid flow path 854 can move and / or transition along the inlet The port 852 is not arranged to be in fluid communication with the outlet 853. The rollers 842 are positioned such that the outlet 853 is substantially isolated or separated from the rest of the control device 800. A sealed state or configuration (e.g., completely saturated) so as to be separated or isolated. , wetted, and / or otherwise obstruct flow therethrough). In this example, the user then inserts the filled fluid collection device 880 (e.g., a syringe) and connect a new fluid collection device 880 (e.g., a syringe) to the outlet 853. As mentioned above, a novel fluid collection device 880 coupled to the outlet 853 This allows a user to, for example, apply force to the second end 864 of the actuator rod 862. , moving the actuator rod 862 back to the second position, state, and / or configuration. can be and / or transitioned.

[0144] The fluid collection device 880 coupled to the device 800 is a syringe, as shown in FIG. Although shown as such, in other embodiments, the control device may be physically attached to any suitable collection device. For example, FIG. 26 shows a fluid control device 900. As described above with reference to the control device 800, the fluid control device 900 may be 930 and actuator 950, which may be arranged, for example, in a modular configuration. The actuator 950 is arranged to be in fluid communication with a body fluid source. and a fluid collection device 980. In the embodiment shown in FIG. 26, the fluid collection device 980 includes, for example, configured to be coupled to one or more reservoirs, such as a vacuum vessel, a sample bottle, or a culture bottle. In such an embodiment, the reservoir is connected to the transfer adapter (i.e., That is, it may be sealed before being coupled to the fluid collection device 980, and once coupled, the seal The valve is punctured or displaced to expose the outlet 953 to the negative pressure in the reservoir. , deformed, and / or otherwise opened. Thus, the fluid control device 900 19-25. can.

[0145] The fluid control device 800 applies a force to change its first configuration, state, and / or position and a second configuration, state, and / or position. a first end 863 that can transition between two configurations, states, and / or positions; and Although shown to include an actuator rod 862 including two portions 864, other implementations may be used. In some embodiments, the control device may include an actuator having any suitable configuration. For example, as shown in FIG. 26, the fluid control device 900 includes an actuator 950. It includes an actuator rod 962 having only a single end that extends beyond the body 951 . In such an embodiment, device 900 can be used to, for example, sample reservoirs, containers, A fluid collection device, such as a bottle, can be filled and two or more samples can be collected. If desired, the user may, for example, connect the inlet 952 to a lumen containing device and / or otherwise The port 952 can be disconnected from any suitable device that is in fluid communication with a source of bodily fluid. Once disconnected, the user can insert the inlet of the new control device 900 into the lumen containing device and / or or the like, as described above with reference to control device 800. One or more additional samples can be collected by

[0146] As mentioned above, some of the fluid control devices described herein have a desirable set of properties. Combining one or more components to collectively form a fluid control device having It may be and / or have a modular configuration that allows for, for example: The fluid control device 800 shown in Figures 19-25 is a housing in a modular arrangement. The control device may include a module 830 and an actuator 850. However, the control device may include any suitable module. It should be understood that the present invention may have a modular arrangement. For example, FIG. 27 shows one embodiment. 1 shows a modular fluid control device 1000 according to the present invention. (also referred to as a "device") forms and / or defines an isolation chamber 1034. forming and / or having a housing 1030 and an inlet 1052 and an outlet 1053; The device 1000 includes an actuator 1050. The device 1000 is similar to the control device 80 described in detail above. 10B, but the housing 1030 may be substantially similar to the actuator 1050. In some embodiments, the ion exchanger 100 may be arranged to be mounted in different positions and / or orientations. Changing the layout to, for example, enhance usability, visibility, and / or the like and / or may otherwise allow for a more compact design. .

[0147] As another example, FIG. 28 illustrates a modular fluid control device 1100, according to one embodiment. The fluid control device (also referred to herein as "device") includes a separation chamber. The housing 1130 and the inlet 1152 and outlet 1134 define and / or define and an actuator 1150 forming and / or having a 53. 10 may be substantially similar to the control device 800 described in detail above, but may include a housing 11 30 are arranged to be provided at different positions and / or orientations relative to the actuator 1150. Further, as shown in FIG. 28, the actuator 1150 may be positioned between the inlet 1152 and and outlet 1153 may be arranged in a substantially perpendicular position relative to each other. As mentioned above, in some embodiments, the configuration can be changed to, for example, may enhance the visibility, relevance, and / or the like, and / or otherwise This allows for a compact design. While examples of such embodiments are shown, it is to be understood that such embodiments are presented by way of example and not by way of limitation. Therefore, when a particular location and / or orientation is mentioned herein, While there may be other uses for the devices and / or concepts described herein, the present disclosure is not intended to be limiting. It is not intended to be.

[0148] The housings 230, 330, 830, 930, 1030, and 1130 have a serpentine configuration. The invention is shown and described herein as including and / or defining a separation chamber disposed in a structure. However, in other embodiments, the housing and / or any other suitable part of the control device may be The component may include and / or define a segregation chamber having any suitable configuration. For example, Figures 29-34 show a fluid control device 1200 according to one embodiment. The fluid control device 1200 may be any of the fluid control devices described herein, at least in form and / or function. More specifically, the fluid control device 120 may be similar to the fluid control device described in A portion of the fluid control device 200, 300, 800, 900, 1000, and and / or may be similar and / or substantially the same as the corresponding parts of 1100. , such portions of the fluid control device 1200 are described in more detail herein. Not yet.

[0149] Fluid control device 1200 (also referred to herein as a "control device" or "device") The control device 800 includes a housing 1230 and an actuator 1250. As described above with reference to the embodiment, the control device 1200 is configured with a housing 1230 and an actuator. The controller 1250 may be physically and fluidly coupled to form the control device 1200. In other embodiments, the control device may be arranged in a modular configuration so that Chair 1200 need not be modular. That is, in some embodiments, The control device 1200 is assembled during manufacturing and sold to the supplier as an assembled device. and / or delivered to an end user. In other embodiments, the control device may be As described, may be integrally formed with and / or coupled to a fluid collection device in any suitable manner. It can be done.

[0150] The housing 1230 of the control device 1200 may be of any suitable shape, size, and / or For example, in some embodiments, the housing 1230 comprises at least 1. The housing 830 is substantially similar in form and / or function to the housing 830 described in detail above. Accordingly, such similar portions of the housing 1230 may be identified as follows: , which may not be described in further detail herein.

[0151] As shown in FIGS. 29-31, the housing 1230 includes a first port 1245 and a second port 1246. forming and / or defining an isolation chamber 1234 in selective fluid communication with the port 1246; The second port 1246 is connected to a flow controller 1242 (see, for example, FIG. 30). and receiving, containing, and / or defining a restrictive flow path 1232 (see, e.g., FIG. 31). Although shown to include a restricted flow path 1232, other embodiments may In this case, the housing need not contain or accommodate a restricted flow path (e.g., a fluid collection device). If excessive negative pressure is applied to the isolation chamber 1234, such as when the source is a syringe, (unlikely intended or otherwise unintended). First port 1245 and second port 1246 is at least fluidly coupled to a portion of actuator 1250. 1230 and the actuator 1250. As described in further detail herein, the isolation chamber 1 234 (1) controls the selective flow and / or volume of bodily fluid through a first port 1245; (1) a portion of the actuator 1250; and (2) an isolation chamber 12 34, the flow and / or volume of the body fluid (e.g., the initial or to isolate (e.g., separate, separate, contain, preserve) a first flow and / or volume It is configured to (hold, separate, etc.)

[0152] The isolation chamber 1234 may have any suitable shape, size, and / or configuration. For example, in some embodiments, the isolation chamber 1234 can be, for example, an isolation chamber Any suitable size, volume, and / or fluid capacity, such as those described above with reference to bath 134. In the embodiment shown in FIGS. 29-34, the isolation chamber 1234 may have, for example, For example, extending through at least a portion of housing 1230 and / or 230. In some embodiments, the fluid flow path may be defined by at least a portion of 230. 19-25, the isolation chamber 1234 may be at least in form and / or function similar to that of FIGS. 30. The isolation chamber 834 may be substantially similar to the isolation chamber 834 described above with reference to , the isolation chamber 1234 and / or the housing 1230 may be, for example, a spiral isolation chamber. A first port 1245 in fluid communication with the inner portion of 1234 and a spiral isolation The second port 1246 is in fluid communication with the outer portion of the chamber. The isolation chamber 834 and / or the housing 830 may be different by virtue of the In some embodiments, the isolation chamber 1234 is part of the housing 1230, for example. The channel may be formed in a portion.

[0153] In some embodiments, the channel forming at least a portion of the isolation chamber 1234 The volume of the segregation chamber 1234 (channel) is the initial volume of fluid drawn into the segregation chamber 1234 (channel). The volume of air within chamber 1234 (e.g., as described in more detail herein) is reducing and / or substantially preventing mixing with the unpurged or unpurged air volume The cross-sectional shape and / or size may be relatively small. For example, in some instances, the relatively small cross-sectional shape and and / or size, surface tension associated with the bodily fluid flowing into the isolation chamber 1234, and the separation The surface of the housing 1230 that forms the isolation chamber 1234 and the interior of the isolation chamber 1234 The contact angle between the incoming body fluid and the volume of air in the isolation chamber 1234 is Collectively, they can limit and / or substantially prevent.

[0154] As shown in FIG. 30, the housing 1230 is a cover configured to enclose a channel. 1238 and / or coupled to the cover 1238, thereby isolating chamber 1234 The cover 1238 can be formed in any suitable manner (e.g., friction fit, slip fit, etc.). Nap fit, interference fit, adhesive, one or more mechanical fasteners, laser welding, ultrasonic welding, Plasma techniques, annealing, heat boarding, and / or any other suitable bonding means or a combination thereof) to the housing 1230. In this embodiment, the cover 1238 is integrally formed with the housing 1230 and / or Additionally, in some embodiments, the cover 1238 may be configured to allow the user to isolate At least partially transparent to allow viewing of the flow of bodily fluid through the chamber 1234 In some embodiments, the arrangement of the housing 1230 and cover 1238 may be , for example, a device that can facilitate one or more manufacturing processes and / or control devices 1200 can be made easier to use.

[0155] As shown in FIG. 30, the housing 1230 includes a flow controller 1242 and a restrictor. The flow controller 1242 includes and / or defines a channel 1232. in the isolation chamber 1234 and / or any other suitable portion of the housing 1230. or configured to selectively control (at least in part) the flow of a fluid, e.g., a valve, membrane, diaphragm, It may be a membrane, a restrictor, a drain, a selectively permeable member, a port, etc. The flow controller 1242 selectively allows gas flow but does not prevent liquid flow therethrough. a selectively permeable fluid containing and / or formed of a porous material configured to Therefore, the flow controller 1242 may be configured to control In response to a negative pressure differential within a portion of the control device 1200, the pump 1200 is pumped through a flow controller 1242. configured to evacuate and / or purge the volume of air within the separation chamber 1234. Such evacuation and / or purging of the volume of air within the isolation chamber 1234 can a separation chamber 1234 operable to draw an initial volume of bodily fluid therein by suction force and / or negative pressure differential exerted and / or applied within or on the isolation chamber 1234 Furthermore, the use of a selectively permeable fluid barrier can reduce the volume of bodily fluids flowing through the body. -Air is vented without allowing it to pass through the controller 1242 and / or Therefore, in some embodiments, the flow controller 124 2 is substantially similar to flow controller 242 described in detail above with reference to FIGS. This is not described in further detail herein.

[0156] The actuator 1250 of the control device 1200 may be of any suitable shape, size, and For example, in some embodiments, the actuator 1250 may be configured to: 8. Actuator 850, substantially similar in form and / or function to actuator 850 described in detail above. Therefore, such similar portions of the actuator 1250 may be Identified below, but may not be further detailed herein.

[0157] As shown in FIGS. 32 to 34, the actuator 1250 includes a main body 1251 and an actuator The body 1251 of the actuator 1250 includes an inlet 1252 and a The inlet 1252 and the outlet 1253 may be at least as shaped and / or functional. In this case, the inlet 852 and the outlet 853 described above with reference to FIGS. Therefore, the inlet 1252 is disposed in fluid communication with the source of bodily fluid. and directs fluid flow from it (e.g., the lumen of a needle, IV catheter, PICC line, etc.). The outlet 1253 is configured to receive, for example, a 5 10. A transfer device similar to that described in the publication, e.g., a sample reservoir, a syringe, etc. , and / or other intermediate fluid transfer devices, adapters, or fluid collection devices such as reservoirs (Figure 1 29-34) are configured to be fluidly coupled to the In embodiments, such a transfer device may provide negative pressure and / or contain External energy sources that enable the desired function and fluid flow path dynamics / characteristics of the control device 1200. It can act as a source of

[0158] The body 1251 of the actuator 1250 has a first port 1258 and a second port 1259. The first port 1258 is in fluid communication with the inlet 1252. and the second port 1259 is in fluid communication with the outlet 1252. The first port 1258 and the second port 1259 are connected to the first port of the housing 1230. 1245 and a second port 1246, respectively. In some embodiments, the port 1258 of the actuator 1250 and 1259, and the arrangement of ports 1245 and 1246 in housing 1230. Physically couples the housing 1230 to the actuator 1250 and 12. The actuator 1250 may include a means for fluidly coupling the actuator 1250 to the actuator 1250; That is, in some embodiments, the actuator may be Ports 1258 and 1259 of the connector 1250 and port 124 of the housing 1230 5 and 1246, the modules as described above with reference to the control device 800 In other embodiments, the housing 1230 and / Or the actuator 1250 need not be modular.

[0159] In some embodiments, the body 1251 and the actuator rod 1262 are collectively including locking portions configured to at least temporarily lock the actuator 1250. For example, in some embodiments, the body 1251 and the actuator The actuator rod 1262 is also fitted into an opening 1257 in which a locking member can be placed. can each be defined through opening 1257. In such an embodiment, the locking When a member (not shown in FIG. 32) is placed in the opening 1257, the locking member Limiting and / or substantially limiting movement of the eta rod 1262 relative to the body 1251 On the other hand, by removing the locking member from the opening 1257, the actuator The actuator rod 1262 may be movable relative to the body 1251 . Although described as forming a stop, in some embodiments, the body 1251 and The actuator rod 1262 is detachable from the main body 1251. A collection of features and / or configurations that can limit and / or substantially prevent the creation of In such embodiments, the features may include, but are not limited to, snap, lock, and / or engage. It may be a stop, a clasp, and / or any other suitable feature and / or arrangement.

[0160] As shown in Figures 33 and 34, a portion of the actuator rod 1262 is The seal 1265 may include and / or be coupled to a set of seals 1265. The seals 1265 may be, for example, For example, O-rings, overmolded elastomeric materials, raised protrusions, and / or similar As described above with reference to actuator 850, actuator 12 62 and the body 1251 of the actuator 1250. A seal 1265 The rod 1262 may be configured to form one or more fluid-tight seals between the rod 1262 and the inner surface of the body 1251. In the embodiment shown in Figures 33 and 34, the actuator rod 1262 is a first fluid flow path 1233 in the body 1251 of the actuator 1250 and the actuator forming a second fluid flow path 1254 within the body 1251 of the actuator 1250 and / or or defining three seals 1265 and / or coupled to the three seals 1265. In other embodiments, any number of seals may be used to achieve the desired performance. can.

[0161] As described above with reference to device 800, device 1200 can be used to treat, for example, skin contamination from microorganisms such as those present in the body fluid source, microorganisms external to the body fluid source, and / or the like. A reduced bodily fluid sample can be obtained. For example, actuator rod 1262 is moved relative to body 1251 between a first position or configuration and a second position or configuration. In some embodiments, the actuator rod is configured to The transition of 1262 occurs automatically in response to the negative pressure and associated flow forces within the device 1200. and / or other functions achieved by user interaction and manipulation of actuator rod 1262. and / or generate a force that causes the actuator rod 1262 to move. It may be performed by or in response to an external energy source. Thus, when in the first position and / or configuration, the inlet 1252 of the actuator 1250 is in fluid communication with the first fluid flow path 1233, thereby 58. The outlet 1253 of the actuator 1250 is in fluid communication with the second fluid The second fluid flow path 1254 is in fluid communication with the second port 12 59. Therefore, the actuator 1250 and / or the actuator locomotive When head 1262 is in a first position and / or configuration (e.g., when control device 1200 a fluid collection device (not shown in FIGS. 29-34 ) when in a first state or mode of operation; The negative pressure within the inlet 1252 directs at least a portion of the initial flow, amount, or volume of bodily fluid through the inlet 1252. Operable in drawing fluid through one fluid flow path 1233 and into isolation chamber 1234 A negative pressure (or negative pressure differential) is created within at least a portion of isolation chamber 1234 where Additionally, in some instances, bodily fluids disposed within, for example, isolation chamber 1234 may be present in the flow -controller 1242 in an open or non-sealed configuration or state (e.g., gas or air) The configuration or state of the seal (e.g., gas and liquid) from a state in which flow can be drawn into it. The initial volume and / or volume of fluid until the body transitions to a state where it cannot draw in the body's flow. Alternatively, the initial flow can be transferred into the isolation chamber 1234 .

[0162] In some instances, as shown in FIG. 34, the end 126 of the actuator rod 1262 3, a force is applied to the actuator rod 1262 and / or the actuator 1250. As noted above, some examples include Now, before a force is applied to the end 1263 of the actuator rod 1262, 1250 from a locked configuration or state to an unlocked configuration or state. The actuator rod 1262 and / or the actuator 1250 can When the control device 1200 is positioned in a second position and / or configuration (e.g., when the control device 1200 is in a second state When the actuator 1250 is in a non-operating state or operational mode, the inlet 1252 and outlet Each of the first fluid flow channels 1253 is in fluid communication with the second fluid flow channel 1254, while the second The fluid flow path 1233 is isolated and separated from the inlet 1252 and the outlet 1253, and and / or otherwise not in fluid communication with the inlet 1252 and outlet 1253. As mentioned above, in some instances, for example, during venipuncture or throughout the fluid collection process, Contaminants such as microorganisms present on the skin that are expelled by the body fluid may be mixed into the initial volume of fluid. and / or may be contained therein, and thus when the initial volume is isolated therein, the isolation chamber Therefore, the temperature is isolated within the isolation chamber 1234. The negative pressure otherwise applied through 34 now acts on the second fluid flow path 1254 or on the second fluid In response, the body fluid flows from the inlet 1252 through the flow path 1254. Through passage 1254, through outlet 1253 and into a fluid collection device coupled to outlet 1253. Therefore, device 1200 has the same functions as device 800. The functionality of device 1200 may be further described herein as being substantially similar to that of the device 1200. It does not go into further detail.

[0163] 35-40 show a fluid control device 1300 according to one embodiment. Device 1300 may be any fluid control device described herein, at least in form and / or function. More specifically, a portion of the fluid control device 1300 may be similar to the The fluid control devices 200, 300, 800, 900, 1000, 1100, and / or 1200. Such portions of the control device 1300 are not described in further detail herein. stomach.

[0164] Fluid control device 1300 (also referred to herein as a "control device" or "device") The control device 800 includes a housing 1330 and an actuator 1350. As described above with reference to the embodiment, the control device 1300 is configured with a housing 1330 and an actuator. 13. The control device 1300 may be physically and fluidly coupled to the controller 1350. In other embodiments, the control device may be arranged in a modular configuration so that Chair 1300 need not be modular. That is, in some embodiments, The control device 1300 is assembled during manufacturing and sold to the supplier as an assembled device. and / or delivered to an end user. For example, the fluid collection device may be integrally formed and / or collectively formed with the fluid collection device. can.

[0165] The housing 1330 of the control device 1300 may be of any suitable shape, size, and / or As shown in FIGS. 35 to 37, the housing 1330 has a first port 1 345 and a second port 1346. The second port 1346 forms and / or defines the flow controller 1342. (see, e.g., FIG. 36) and restrictor flow path 1332 (see, e.g., FIG. 37). The first port 1345 and the second port 1346 are configured to include, and / or define Port 1346 is at least fluidly coupled to a portion of actuator 1350 and 1330 and the actuator 1350. As described in further detail herein, the isolation chamber 1334 is configured as follows: 1) Actuating a selective flow and / or volume of bodily fluid through a first port 1345 1350, and (2) to allow the flow of bodily fluid into the isolation chamber 1334. flow and / or volume (e.g., at least the initial or first flow and / or volume of bodily fluid) to separate (e.g., to keep apart, set apart, contain, hold, separate) The isolation chamber 1334 may be configured to have any suitable shape, size, and For example, in some embodiments, the isolation chamber 1 may have a 334 may be, for example, a channel formed in a portion of the housing 1330, The housing 1330 can include a cover 1338 configured to enclose the channel. and / or can be coupled to a cover 1338, thereby enclosing the isolation chamber 1334 In some embodiments, the housing 1330 forms at least the shape and / or 29-34. Accordingly, the housing 1330 will be described in more detail herein. does not state.

[0166] The actuator 1350 of the control device 1300 may be of any suitable shape, size, and For example, in some embodiments, the actuator 1350 may be configured to: At least in form and / or function, the actuator 850 and / or can be substantially similar to 1250. Therefore, such a Similar parts are identified below but may not be described in further detail herein.

[0167] As shown in FIGS. 38 to 40, the actuator 1350 includes a main body 1351 and an actuator The body 1351 of the actuator 1350 includes an inlet 1352 and a The inlet 1352 and the outlet 1353 may be at least as shaped and / or functional. In this case, the inlet 852 and the outlet 853 described above with reference to FIGS. Therefore, the inlet 1352 is positioned to be in fluid communication with the source of bodily fluid. and directs the flow of fluid from it (e.g., needles, IV catheters, surgical tubing, other standard fluid transfer devices, PICC lines, and other lumen-containing devices The exit 1353 may be configured, for example, as a transfer device similar to that described in the '510 disclosure. sample reservoirs, syringes, and / or other intermediate fluid transfer devices, etc. fluidly into a fluid collection device (not shown in FIGS. 35-40), such as a pump, adapter, or reservoir. It is configured to be coupled.

[0168] The body 1351 of the actuator 1350 has a first port 1358 and a second port 1359. The first port 1358 is in fluid communication with the inlet 1352. The second port 1359 is in fluid communication with the outlet 1353. The port 1358 and the second port 1359 are connected to the first port 1345 of the housing 1330. and second port 1346. In some embodiments, the ports 1358 and 1359 of the actuator 1350 59, and the placement of ports 1345 and 1346 in housing 1330. 1330 to the actuator 1350 and the housing 1330 to the actuator. The actuator 1350 may be fluidly coupled to the actuator 1350 and / or may otherwise be That is, in some embodiments, the actuator 1350 Ports 1358 and 1359, and ports 1345 and 1346 of housing 1330 6 arrangement allows for a modular configuration or arrangement such as that described above with reference to control device 800. In other embodiments, the housing 1330 and / or the actuator may be The computer 1350 does not need to be modular.

[0169] As shown in Figures 39 and 40, a portion of the actuator rod 1362 is The seal 1365 may include and / or be coupled to a set of seals 1365. As described above with reference to ball 1265, for example, an O-ring, an elastomeric material, silicone, or may be any other suitable material or construction. In this way, the actuator 1362 and the body 1351 of the actuator 1350 are sealed. 1365 is provided between the actuator rod 1362 and the inner surface of the body 1351. The embodiment shown in Figures 33 and 34 can be arranged to form a fluid-tight seal. In this example, the actuator rod 1362 is inserted into the body 1351 of the actuator 1350. a first fluid flow path 1333 and a second fluid flow path 1351 in the body 1351 of the actuator 1350; 354 and / or includes three seals 1365 forming and / or defining the The seal 1365 is bonded to the inner surface of the inner wall of the housing 1300.

[0170] As described above with reference to device 800, device 1300 can be used to treat, for example, skin contamination from microorganisms such as those present in the body fluid source, microorganisms external to the body fluid source, and / or the like. A reduced bodily fluid sample can be obtained. For example, actuator rod 1362 is moved relative to body 1351 between a first position or configuration and a second position or configuration. As shown in FIG. 39, the first position and / or configuration When in this position, the inlet 1352 of the actuator 1350 is in fluid communication with the first fluid flow path 1333. 1358. The first fluid flow path 1333 is in fluid communication with the first port 1358. The outlet 1353 of the actuator 1350 is connected to a second fluid flow path 1354 and a fluid flow path. The second fluid flow path 1354 is in fluid communication with the second port 1359. Therefore, the actuator 1350 and / or the actuator rod 13 62 is in a first position and / or configuration (e.g., when the control device 1300 is in a first state When in a fluid collection mode (not shown in Figures 35-40), negative pressure within the fluid collection device directs at least a portion of the initial flow, amount, or volume of bodily fluid from the inlet 1352 to the first flow Operable in drawing fluid through the body flow path 1333 and into the isolation chamber 1334 A negative pressure (or negative pressure differential) is created within at least a portion of the isolation chamber 1334. In some instances, for example, bodily fluid disposed within the isolation chamber 1334 may be The controller 1342 may be in an open or non-sealed configuration or state (e.g., gas or air flow). the configuration or state of the seal (e.g., gas and liquid flow) The initial volume and / or initial volume of fluid is then calculated until the body transitions to a state where it is unable to draw fluid into it. The flow can be transferred into the isolation chamber 1334.

[0171] In some examples, as shown in FIG. 35, the first end of the actuator rod 1362 1363, and the actuator rod 1362 and / or the actuator 135 0 can be positioned in its second position, state, operating mode, and / or configuration. As mentioned above, in some examples, the first end 1363 of the actuator rod 1362 Before the force is applied, the actuator 1350 is moved from the locked configuration or state to the unlocked position. In some embodiments, the actuator robot may transition to a different configuration or state. The transition of head 1362 is automatically driven by the negative pressure and associated flow forces within device 1300. and correspondingly, achieved by user interaction and manipulation of actuator rod 1362. and / or otherwise generate and / or cause the force that causes the actuator rod 1362 to move. It may be performed by or in response to an external energy source that produces it.

[0172] The actuator rod 1362 and / or the actuator 1350 are in their second position and and / or configuration (e.g., when the control device 1300 is in a second state or operation). When the actuator 1350 is in the operating mode, the inlet 1352 and the outlet 1353 of the actuator 1350 Each of the fluid channels is in fluid communication with the second fluid channel 1354, while the first fluid channel 1333 is isolated, separated, and / or separate from the inlet 1352 and the outlet 1353. Similarly, inlet 1352 and outlet 1353 are not in fluid communication with each other. As described in detail above, In some instances, for example, during venipuncture or throughout the fluid collection process, Contaminants, such as microorganisms present on the exposed skin, may be introduced and / or entrained in the initial volume of body fluid. Thus, when the initial volume is isolated therein, Therefore, the air is isolated from the air on or through the isolation chamber 1334. The negative pressure applied otherwise may now be on or through the second fluid flow path 1354. In response, the bodily fluid flows from the inlet 1352 through the second fluid flow path 1354. through the outlet 1353 and into the fluid collection device 1353. Thus, device 1300 may function substantially similarly to the function of device 800. Therefore, the functionality of device 1300 will not be described in further detail herein.

[0173] In some instances, for example, multiple fluid collection devices (e.g., syringes, etc.) may be used. If it is desirable to collect multiple samples of body fluids using a negative pressure source (e.g., fluid collection It may be desirable to separate the collection device from the inlet 1353. For example, some In an example, after filling the fluid collection device, the user may use the actuator 1350 to Applying a force to the second end 1364 of the actuator rod 1362 causes the actuator rod 1362 from its second position and / or configuration to its first position and / or configuration. Therefore, the second fluid flow path 13 54 does not fluidly align the inlet 1352 with the outlet 1353. The flow controller 1342 is configured such that the outlet 1353 is substantially separated from the rest of the control device 1300. A sealed state or configuration (e.g., , fully saturated, wetted, and / or otherwise obstructing flow therethrough) In some instances, the user then removes the filled fluid collection device. A new fluid collection device can be coupled to the outlet 1353. Actuator 8 As described above with reference to 50, a novel fluid collection device coupled to outlet 1353 For example, a user may apply force to the first end 1363 of the actuator rod 1362. to return the actuator rod 1362 to the second position, state, and / or configuration. can be moved and / or transitioned to.

[0174] 41-44 show a fluid control device 1400, according to one embodiment. Device 1400 may be at least in form and / or function similar to the fluid control devices described herein. More specifically, a portion of the fluid control device 1400 may be similar to the Fluid control devices 200, 300, 800, 900, 1000, 1100, 1200, and / or may be similar and / or substantially the same as the corresponding parts of 1300. Such portions of the fluid control device 1400 are described in more detail herein. It does not state this.

[0175] Fluid control device 1400 (also referred to herein as a "control device" or "device") The control device 800 includes a housing 1430 and an actuator 1450. As described above with reference to the control device 1400, the control device 1400 is configured with a housing 1430 and an actuator. The controller 1400 may be physically and fluidly coupled to the controller 1450. In other embodiments, the control device may be arranged in a modular configuration so that Chair 1400 need not be modular. That is, in some embodiments, The control device 1400 is assembled during manufacturing and sold to the supplier as an assembled device. and / or delivered to an end user. For example, the fluid collection device may be integrally formed and / or collectively formed with the fluid collection device. can.

[0176] The housing 1430 of the control device 1400 may be of any suitable shape, size, and / or The housing 1430 has a first port 1458 and a second port 1459. 59 and configured to be in selective fluid communication with a portion of the actuator 1450. As shown in FIGS. 43 and 44, the housing 1430 is in a first configuration and / or state. to a second configuration and / or state to form and / or define an isolation chamber 1434. As described in more detail herein, the bladder 1478 may be The ladder 1478 moves from a first configuration and / or state (FIG. 43) to a second configuration and / or state. (FIG. 44) configured to form and / or define an isolation chamber 1434 1458. The isolation chamber 1434 is then actuated via the first port 1458. configured to receive a selective flow and / or volume of bodily fluid from a portion of the sensor 1450. After the bladder 1478 is positioned in the second configuration and / or state, the isolation chamber The isolation chamber 1434 may be configured to control the flow and / or volume of bodily fluid within the isolation chamber 1434 (e.g., the amount of bodily fluid). at least a portion of the initial or first flow and / or volume) is isolated (e.g., separated) Separate, separate, contain, hold, separate, etc.

[0177] Although bladder 1478 is specifically shown in FIGS. 43 and 44, in other embodiments, the bladder 1478 may be of any suitable shape, size, and / or configuration. 1478 may be made of any suitable material (e.g., any suitable biocompatible material such as those described herein). The material may be made of a suitable material (e.g., a compliant material and / or any other suitable material). In form, the bladder 1478 may be, for example, a bellows, an expandable bag, a flexible pouch, and / or any other suitable reconfigurable container, etc. In addition, the isolation chamber 1434 formed by the bladder 1478 can be The slits may have any suitable shape, size, and / or configuration. The housing 1430 may be at least as similar in form and / or function to the housing 1430 shown in FIGS. Substantially similar to housings 1230 and 1330 described in detail above with reference to FIGS. Therefore, the housing 1430 will not be described in further detail herein. Not yet.

[0178] The actuator 1450 of the control device 1400 may be of any suitable shape, size, and For example, in some embodiments, the actuator 1450 may be configured to: Actuators 850, 125 similar in form and / or function to those described in detail above. 0, and / or may be substantially similar to 1350. Thus, the actuator 145 Such similar portions of 0 are identified below but will not be described in further detail herein. There are cases where this happens.

[0179] As shown in FIGS. 41 to 44, the actuator 1450 includes a main body 1451 and an actuator The body 1451 of the actuator 1450 includes an inlet 1452 and a The inlet 1452 and the outlet 1453 may be at least as shaped and / or functional. In this case, each of the inlet 1252 and the outlet 1253 described above with reference to FIGS. Thus, the inlet 1452 may be in fluid communication with a source of bodily fluid. It is placed in a location that allows fluid flow to pass through it (e.g., a needle, IV catheter, surgical tubing, or other target). Accepts fluids from a standard fluid transfer device (through an intraluminal device such as a PICC line) The exit 1453 may be configured, for example, as a transition valve similar to that described in the '510 disclosure. For example, sample reservoirs, syringes, and / or other intermediate fluid transfer devices. a fluid collection device (not shown in FIGS. 41-44), such as a vice, adapter, or reservoir. The components are configured to be effectively coupled together.

[0180] The body 1451 of the actuator 1450 has a first port 1458 and a second port 1459. 459. Although not shown, the first port 1458 may be connected to the inlet 1 452, and the second port 1459 is in fluid communication with the outlet 1453. Additionally, the first port 1458 is configured to allow fluid to pass through the housing 14. 30, more particularly, the interior volume of the bladder 1478 that forms the isolation chamber 1434 or The second port 1459 is configured to be in fluid communication with the inlet side of the housing 1. A portion of the housing 1430 is defined between the inner surface of the housing 1430 and the outer surface of the bladder 1478. In other words, the second port 1459 is configured to be in fluid communication with the The isolation chamber 1434 is separated and / or isolated from the interior volume of the bladder 1478. In some embodiments, the separated portions of the housing 1430 are in fluid communication with each other. , the arrangement of ports 1458 and 1459 of actuator 1450 is similar to that of housing 1430 a means for physically coupling the housing 1430 to the actuator 1450; A means for fluidly coupling to the eta 1450 may be enabled and / or otherwise provided. That is, in some embodiments, the poles of the actuator 1450 The arrangement of ports 1458 and 1459 is similar to that of modules described above with reference to control device 800. In other embodiments, the housing 1430 may allow for a modular configuration or arrangement. And / or the actuator 1450 need not be modular.

[0181] As shown in FIGS. 41-44, a portion of the actuator rod 1462 is secured to a pair of seals. The seal 1365 includes and / or is coupled to the seal 1265 and / or 13 As described above with reference to 65, for example, an O-ring, an elastic material, silicone, or any Other suitable materials or configurations may be used. As described above with reference to 50, the actuator rod 1462 and the actuator 14 The body 1451 of the 50 is sealed by a seal between the actuator rod 1462 and the inner surface of the body 1451. The device may be arranged to form one or more fluid-tight seals between the device and the As described above with reference to actuators 1250 and / or 1350, The head 1462 may include and / or be coupled to a set seal. , these set seals connect the inlet 1452 of the actuator 1450 to the first port 14 58 (e.g., in a first position, state, in an operational mode, configuration), and to place the inlet 1452 in fluid communication with the outlet 1453 a second fluid flow path configured (e.g., in a second position, state, mode of operation, or configuration) (i) selectively forming and / or defining

[0182] As described above with reference to devices 800, 1200, and / or 1300, 1400 can be used to detect, for example, microorganisms present on the skin, microorganisms external to a body fluid source, and / or the like. It is possible to obtain a body fluid sample with reduced contamination from microorganisms such as those of As described above with reference to devices 1200 and / or 1300, the actuator lock The rod 1462 is moved relative to the body 1451 between a first position or configuration and a second position or configuration. The first position and / or configuration may be configured to be moved or translated. When the actuator 1450 is inlet 1452, the actuator 1450 is in fluid communication with the first fluid flow path, for example. The first fluid flow path is thereby in fluid communication with the first port 1458 (FIG. 41). (Not shown in Figure 44). The outlet 1453 of the actuator 1450 is connected to the second fluid flow path 14 54, thereby forming a second fluid flow path 1454 at a second port 1459. Therefore, the actuator 1450 and / or the actuator rotor When the head 1462 is in a first position and / or configuration (e.g., when the control device 1400 a fluid collection device (not shown in FIGS. 41-44 ) when in a first state or mode of operation; A negative pressure within the housing 1430 is established between the inner surface of the housing 1430 and the outer surface of the bladder 1478. A negative pressure (or negative pressure differential) can be created within a portion of the housing 1430 .

[0183] As shown in FIG. 43, the bladder 1478 is connected to the outlet 1453 of the fluid collection device. In some embodiments, for example, the block may be in a first state and / or configuration. The ladder 1478 is inverted, inside out, before coupling the fluid collection device to the outlet 1453. As shown in FIG. 44, the bladder may have a deflated and / or empty configuration. 1478 to a negative pressure differential created by coupling a fluid collection device to the outlet 1453. configured to transition from a first state and / or configuration to a second state and / or configuration in response to In other words, the negative pressure differential can cause the bladder 1478 to be in a contracted or unexpanded configuration. and / or a state from an extended configuration and / or an extended state. For example, in some embodiments, the transition of the bladder 1478 may be as shown in Figures 11 and 12. This may be similar to the transition and / or "inversion" of diaphragm 576 described above.

[0184] As described above, the bladder 1478 can be moved from a first configuration and / or state to a second configuration and / or state. or transition to a state to form and / or define an isolation chamber 1434. In some embodiments, by transitioning the bladder 1478, The internal volume of the bladder 1478 (i.e., the isolation chamber 1434) increases. The increase in internal volume allows the isolation chamber 1434 defined by the bladder 1478 to A negative pressure differential is created between the port 1452 and the body fluid, which negative pressure differential causes an initial flow, amount, or volume of the body fluid. At least a portion of the fluid is directed from the inlet 1452 through the first port 1458 and into the isolation chamber. The body may be operable to retract into the chamber 1434. Additionally, in some examples, The initial volume and / or flow of fluid may be, for example, until the bladder 1478 is fully expanded. and / or until the negative pressure differential is reduced and / or equalized. It can be transferred into

[0185] As described in detail above with reference to device 1200 and / or 1300, the initial flow of bodily fluid After transferring the volume to the isolation chamber 1434, the first end 1462 of the actuator rod 1462 463, the actuator rod 1462 and / or the actuator 1450 can be placed in its second position, state, mode of operation, and / or configuration. As such, in some examples, a force is applied to the first end 1463 of the actuator rod 1462. Before activation, the actuator 1450 must be unlocked from a locked configuration or state. In some embodiments, the actuator rod 146 can be moved to a different configuration or state. The transition between the two is automatic and responsive to the negative pressure and associated flow forces within the device 1400. and / or otherwise achieved by user interaction and manipulation of actuator rod 1462. and / or external forces that cause the actuator rod 1462 to move. It may be performed by an internal energy source or in response to an external energy source.

[0186] The actuator rod 1462 and / or the actuator 1450 are in their second position and and / or configuration (e.g., when the control device 1400 is in a second state or operation). When the actuator 1450 is in the operating mode, the inlet 1452 and the outlet 1453 of the actuator 1450 are , (e.g., via a second fluid flow path (not shown)), while the first fluid A flow path (not shown) and / or first port 1458 may be connected to the inlet 1452 and / or outlet 1458. 53, isolated, separated, and / or otherwise not fluid-permeable. As noted above, in some instances, for example, during venipuncture or throughout the fluid collection process, Contaminants such as microorganisms present on the skin that are expelled by the body fluid may be mixed into the initial volume of fluid. and / or may be contained therein, and thus when the initial volume is isolated therein, the isolation chamber Therefore, the housing 1430 is isolated in the housing 1434. The negative pressure otherwise applied through the outlet port may now be applied, for example, via a second fluid flow path (not shown). 1453 and inlet 1452 or through outlet 1453 and inlet 1452. In response, the body fluid flows from the inlet 1452 through the body 1451 of the actuator 1450 and out. flowing through port 1453 and into a fluid collection device coupled to outlet 1453 Thus, device 1400 can be used with devices 800, 1200, and / or 1 300, the functions of device 1400 may be substantially the same as those of device 300. The document does not go into further detail.

[0187] The device 1400 includes a housing 1430 and an actuator 1450. Although described above as a fluid control device, in other embodiments, the fluid control device may be, for example, at least partially For example, Figures 45-50 show a fluid A control device 1500 is shown. The fluid control device 1500 has at least the form and / or It may be similar in function to the fluid control devices described herein. More specifically, A portion of the fluid control device 1500 includes at least one of the fluid It may be similar and / or substantially the same as the corresponding parts of the control device 1400. Accordingly, such portions of the fluid control device 1500 are described in further detail herein. does not state.

[0188] Fluid control device 1500 (also referred to herein as a "control device" or "device") The actuator (1551) has an actuator body 1552 and an actuator rod 1562. The actuator 1550 may be of any suitable shape, size, and For example, in some embodiments, the actuator 1550 may be , at least in form and / or function, the actuators 850, 12 50, 1350, and / or 1450. Such similar portions of Eta 1550 are identified below and are further detailed herein. It may not be stated in detail.

[0189] As shown in FIGS. 45-50, the actuators 1550 are each in fluid communication with a body 1551. The inlet 1552 and the outlet 1553 are , at least in form and / or function, the inlet 125 described above with reference to FIGS. 29-34 2 and outlet 1253, respectively. Thus, inlet 1552 is The fluid source is in fluid communication with the body fluid source, and the body fluid is directed therefrom (e.g., via a needle, IV catheter, etc.). Lumen accommodation for catheters, surgical tubing, other standard fluid transfer devices, PICC lines, etc. The outlet 1553 is configured to receive, for example, a '51 0 publication, such as a sample reservoir, syringe, or transfer device similar to those described in and / or other intermediate fluid transfer devices, adapters, or fluid collection devices such as reservoirs (Figure 4 5 to 50 are configured to be fluidly coupled to the

[0190] As shown in FIGS. 48-50, the actuator 1550 is in a first configuration and / or state ( 48) to a second configuration and / or state (FIG. 49) to allow the isolation chamber 1534 to The bladder 1578 may be formed and / or defined. As will be described in detail, the bladder 1578 may be adapted to transition from a first configuration and / or state (FIG. 48) to a second configuration and / or state (FIG. 49). configuration and / or state (FIGS. 49 and 50) to form the isolation chamber 1534. and / or configured to define, whereby the isolation chamber 1534 is configured to receive a selective flow and / or volume of bodily fluid from the bladder. After 1578 is positioned in the second configuration and / or state, the isolation chamber 1534 The flow and / or volume of bodily fluid within the separation chamber 1534 (e.g., the initial or first flow of bodily fluid) and / or at least a portion of the volume) Therefore, the bladder 1578 can 41-44. They may be substantially similar and therefore will not be described in further detail herein.

[0191] As shown in FIGS. 46 and 48 to 50, the main body 1551 of the actuator 1550 is 1553 includes and / or defines a port 1559 configured for fluid communication with the port 1559. Additionally, a port 1559 is provided between the inner surface of the body 1551 and the outer surface of the bladder 1578. a fluid flow path configured to be in fluid communication with a portion of the actuator 1550 defined therein; In other words, the port 1559 defines the isolation chamber 1534 and / or or configured to form an internal volume of the bladder 1578. It is in fluid communication with a portion of the separated actuator 1550 .

[0192] As described above with reference to devices 1200, 1300, and / or 1400, A portion of the feeder rod 1562 includes and / or is coupled to a set of seals 1565. Seal 1565 may be any of the seals described above with reference to seals 1265 and / or 1365. For example, an O-ring, an elastic material, silicone, or any other suitable material or configuration. As described above with reference to actuators 850, 1250, and / or 1350, The actuator rod 1562 and the body 1551 of the actuator 1550 are connected to each other by a seal. One or more screws 1565 are provided between the actuator rod 1562 and the inner surface of the body 1551. The actuator 12 can be arranged to form a fluid-tight seal. As described above with reference to 50 and / or 1350, the set seal 1565 disposed along the eta rod 1562 to selectively form the fluid flow path 1554 and / or The fluid flow path can be defined such that the actuator rod 1562 is in the first position and and / or configured to be isolated and / or fluidly separated from the inlet 1552 and When the actuator rod 1562 is in the second position and / or configuration, It is configured to be in fluid communication with the port 1553 .

[0193] As described above with reference to devices 800, 1200, 1300, and / or 1400 , using device 1500 to detect microorganisms present on the skin, microorganisms outside a body fluid source, and / or the like can be used to obtain bodily fluid samples with reduced contamination from microorganisms such as For example, as described above with reference to devices 1200, 1300, and / or 1400, and moving the actuator rod 1562 between a first position or configuration and a second position or configuration. The first electrode 1551 may be configured to be moved or translated relative to the body 1551. When in the position and / or configuration, the inlet 1552 of the actuator 1550 forms a fluid flow path. The fluid is allowed to flow through the bladder 1578, thereby providing a fluid flow path on the inlet side of the bladder 1578. In other words, the fluid flow path is such that bladder 1578 is in fluid communication with main body 1551. When the inlet 1553 and bladder 1578 are moved to the second configuration and / or state, The flow between the at least partially defined bladder 1578 and / or isolation chamber 1534 The outlet 1553 of the actuator 1550 is in fluid communication with the port 1559. Therefore, the actuator 1550 and / or the actuator rod 15 62 is in a first position and / or configuration (e.g., when the control device 1500 is in a first state and (when in a fluid collection or operational mode), as described above with reference to device 1400. The negative pressure within the device (not shown in FIGS. 45-50) creates a pressure between the inner surface of the body 1551 and the bladder 15 Negative pressure (or negative pressure) is created within a portion of actuator body 1551 defined between the outer surface of 78. It is possible to create a pressure difference.

[0194] As shown in FIG. 48, the bladder 1578 is connected to the outlet 1553 of the fluid collection device. In some embodiments, for example, the block may be in a first state and / or configuration. The ladder 1578 is inverted, inside out, before coupling the fluid collection device to the outlet 1553. The actuator lock may have a retracted and / or empty configuration. When the inlet 1562 is in a first position and / or configuration, the fluid flow path 1554 is Therefore, as shown in FIG. 49, the bladder 1578 is fluidly isolated from the fluid In response to a negative pressure differential created by coupling a collection device to the outlet 1553, and / or configuration to a second state and / or configuration. In other words, the negative pressure differential causes the bladder 1578 to be in a contracted or unexpanded configuration and / or state. The system may be operable to transition from one configuration to another to an extended configuration and / or state. In some embodiments, the transition of the bladder 1578 is similar to the separation described above with reference to FIGS. This may be similar to the transition and / or "inversion" of membrane 576. In other embodiments, bladder 15 78 may be configured to change the first state and / or configuration in any suitable manner, such as any of those described herein. The device may be configured to transition from a first state and / or configuration to a second state and / or configuration.

[0195] As described above, the bladder 1578 can be moved from a first configuration and / or state to a second configuration and / or state. or transition to a state to form and / or define an isolation chamber 1534. In some embodiments, the bladder 1578 may be transitioned. The internal volume of the isolation chamber 1578 (i.e., isolation chamber 1534) increases. The increase in pressure causes the isolation chamber 1534 defined by the bladder 1578 to become inlet 15 52, which creates a negative pressure difference that reduces the initial flow, amount, or volume of the body fluid. at least a portion of the inlet 1552 and a portion of the actuator body 1551, and It may be operable to draw into chamber 1534. Additionally, in some examples, The initial volume and / or flow of fluid may be, for example, until the bladder 1578 is fully expanded. and / or until the negative pressure differential is reduced and / or equalized, the isolation chamber 153 It can be transferred into 4.

[0196] As described in detail above with reference to device 1200 and / or 1300, the initial flow of bodily fluid After transferring the volume to the isolation chamber 1534, the first end 1 563, and the actuator rod 1562 and / or the actuator 15 50 can be positioned in its second position, state, mode of operation and / or configuration. As mentioned above, in some examples, the first end 156 of the actuator rod 1562 Before a force is applied to the actuator 1550, the actuator 1550 is locked from the locked configuration or state. In some embodiments, the actuator rod may be moved to a configuration or state other than the one shown. The transition of 1562 occurs automatically in response to the negative pressure and associated flow forces within the device 1500. and / or otherwise achieved by user interaction and manipulation of actuator rod 1562. and / or external forces that cause the actuator rod 1562 to move. It may be performed by an internal energy source or in response to an external energy source.

[0197] The actuator rod 1562 and / or the actuator 1550 are in their second position and and / or configuration (e.g., when the control device 1500 is in a second state or operation). When the actuator 1550 is in the operating mode, the inlet 1552 and the outlet 1553 of the actuator 1550 is in fluid communication with the fluid flow channel 1554, while the isolation chamber 1534 is in fluid communication with the inlet 1552 and outlet 1553. and outlet 1553. As detailed above, in some instances For example, the presence of skin that is ejected during venipuncture or throughout the fluid collection process Contaminants, such as microorganisms, may be entrained and / or contained in the initial volume of body fluid. and thus, when the initial volume is isolated therein, the volume is isolated within the isolation chamber 1534. .

[0198] As described above with reference to devices 1200 and / or 1300, the actuator lock Transitioning the rod 1562 to a second position and / or configuration opens the fluid flow path 1554. The port 1552 is arranged to be in fluid communication with the outlet 1553. Transitioning the motor rod 1562 to a second position and / or configuration allows the fluid flow path 15 54 is arranged so that fluid can flow through both the inlet 1552 and the outlet 1553. The valve 1565 can be moved relative to the inlet 1552. Negative pressure otherwise applied to the outer surface of the fluid passage 1554 is now directed through the fluid passage 1554 to the outlet 1553 and and inlet 1552 or through outlet 1553 and inlet 1552. Fluid flows from inlet 1552, through fluid flow path 1554, through outlet 1553, and into the outlet. The fluid can flow into the fluid collection device 1553 to which it is connected. Device 1500 may perform the functions and implementation of devices 800, 1200, 1300, and / or 1400. Because they may function qualitatively similarly, the functionality of device 1500 is not described in further detail herein. It doesn't go into detail.

[0199] Actuators 850, 1250, 1350, 1450, and 1550 may be used, for example. Although the transition is described in detail above as occurring in response to external forces such as force applied by the user, other implementations may be possible. In one embodiment, the fluid control device may be configured to: For example, the actuators shown in Figures 51 and 52 may include one or more actuators that can be moved by the actuators. 1 shows a portion of a fluid control device 1600, according to one embodiment. 600 is a fluid control device as described herein, at least in form and / or function. More specifically, a portion of the fluid control device 1600 may be similar to at least one of the above. at least similar to corresponding portions of fluid control devices 500, 600, and / or 700 or may be substantially the same. Therefore, such portions of the fluid control device 1600 are not discussed in further detail herein.

[0200] As shown in FIGS. 51 and 52, a fluid control device 1600 (referred to herein as a "control device") The active element (also called a "device") has an inlet 1631 and an outlet 1636. The housing 1630 is coupled to a computer 1650. Thus, the housing 1630 may be configured to provide fluid communication between one or more portions of the housing 1630. to selectively accept the flow of fluid (e.g., liquid and / or gas) therethrough. The inlet 1631 defines a pair of fluid flow paths 1633 and 1654 configured to A source of bodily fluid is in fluid communication with the source of bodily fluid, and the flow of bodily fluid is directed therefrom (e.g., as described in detail above). The outlet 16 is configured to receive a needle or other lumen-containing device. 36 is fluidly coupled to a fluid collection device (not shown in FIGS. 51 and 52). The inlet 1631, outlet 1636, and fluid collection device are configured as described above. and therefore will not be described in further detail herein.

[0201] The housing 1630 may be of any suitable shape, size, and / or configuration. In some embodiments, the housing 1630 may include, for example, one or more of the housing 1630. a volume of bodily fluid configured to be at least temporarily stored within the volume; As mentioned above, the housing of the control device 1600 may have a size based on the The gland 1630 (1) receives a flow and / or volume of bodily fluid from the inlet 1631; Isolation included in and / or formed at least in part by housing 1630 Isolating (e.g., separating, separating) the flow and / or volume of bodily fluid within chamber 1634 Some implementations In some embodiments, the housing 1630 may be configured similarly to, for example, the housings 630, 730, and / or 1630. Portions and / or aspects of are not described in further detail herein.

[0202] The housing 1630 may be configured to selectively control the flow of bodily fluid through the housing 1630. and / or coupled to the actuator 1650. In this embodiment, the actuator 1650 is connected to a diaphragm 1676 and a set of seals ( For example, it includes an actuator rod 1662 having seals 1665 and 1666. As described in more detail herein, the diaphragm 1676 and the actuator rod 1662 transitions within the housing 1630 in response to a negative pressure differential within at least a portion of the device. , move, and / or otherwise reconfigure. As described in detail above with reference to device 500, actuator 1650 a first state in which the inlet 1631 is arranged to be in fluid communication with the isolation chamber 1634; 31 is arranged to be in fluid communication with the outlet 1636 via the fluid flow path 1654. The device is configured to move between the

[0203] In some embodiments, the diaphragm 1676 may be, for example, a diaphragm 576, 67, or the like, as described in detail above. 6 and / or 776. Thus, the diaphragm 1676 is located within the housing 16 30 is at least partially disposed in the isolation portion of the isolation chamber 1634 As described in detail above, the diaphragm 1676 may define and / or form a portion. transitions, moves, or reverses from a first state to a second state in response to a negative pressure differential; and and / or otherwise configured to reconfigure, and this negative pressure differential reduces the initial volume of bodily fluid The isolation chamber 1634 may be configured to retract into the isolation chamber 1634 and / or, once there, The chamber 1634 may be operable to isolate an initial volume of bodily fluid within the chamber 1634. Further, as shown in FIG. As shown at 1 and 52, the diaphragm 1676 may include a flow controller 1642. The flow controller 1642 may be configured to include and / or be coupled to a The flow controller may be any suitable flow controller, such as any of those described in In some embodiments, the flow controller 1642 may be configured to act as an air permeable / liquid impermeable barrier ( For example, it may be a semi-permeable member or membrane, such as a blood barrier.

[0204] As described in detail above, the flow controller 1642 allows the flow of gas (e.g., air) through the flow controller 1642, A first condition that prevents the flow of fluid (e.g., body fluid) through it, followed by a flow control The flow controller 1642 restricts the flow of gas and liquid through the flow controller 1642 and and / or may be configured to substantially prevent the transition to a second state. In an embodiment, the flow controller 1642 may, for example, , can be configured to transition from a first state to a second state (e.g., At least a portion of the initial volume wets or saturates the flow controller 1642, The row controller 1642 can be placed in a second state).

[0205] Diaphragms 576, 676, and 776 may be formed with one or more seals (e.g., seals 5 and 776, respectively). 65, 665, and 765, etc.) and / or pins, rods, etc. connected thereto Although shown and described above as including posts, etc., in the embodiment shown in Figs. The diaphragm 1676 does not include a seal and / or a pin 1677 coupled thereto. (e.g., rods, extensions, protrusions, hooks, latches, and / or any other suitable For example, in this embodiment, the invention further includes the features, components, and / or features described herein. As will be described in detail below, the pin 1677 extends through a portion of the housing 1630. selectively engage a portion of the actuator rod 1662, thereby A portion of rod 1662 may include one or more seals (e.g., seals 1665 and 1666). Includes:

[0206] As shown in FIGS. 51 and 52, the actuator rod 1662 may be, for example, a housing The actuator rod 1630 is movably mounted on the actuator portion 1639 of the actuator rod 1630. 1662 includes a first seal 1665 and a second seal 1666 and is connected to the housing 163 an energy storage member 1667, such as a spring, disposed within the actuator portion 1639 of the actuator; In the embodiment shown in Figures 51 and 52, the actuator 1650 is in contact with A first end of the actuator rod 1662 selectively contacts a pin 1677 of the diaphragm 1676. The second end of the actuator rod 1662 (opposite the first end) is an energy storage 1667. The energy storage member 1667 may be in contact with and / or otherwise engaged with the energy storage member 1667. The arrangement can be as follows:

[0207] As shown in FIG. 51, when the actuator 1650 is in a first state, the diaphragm 1676 The pin 1677 engages with the actuator rod 1662 to 662, the energy storage member 1667 has a relatively high potential energy (e.g., When the energy storage member 1667 is in the first state, it is maintained in compression and / or The first or initial state and / or position may be maintained by a spring. Furthermore, a first actuator coupled to and / or provided on the actuator 1662 may The seal 1665 closes the fluid flow path 1633 when the actuator 1650 is in the first state. a first or initial valve that allows fluid communication between the inlet 1631 and the isolation chamber 1634; As shown, similarly, and / or coupled to actuator rod 1662 Alternatively, the second seal 1666 may be provided so that the second seal 1666 is a sealing surface 1640 formed by at least a portion of the actuator portion 1639; The first or initial position is spaced apart from the first or initial position.

[0208] In some embodiments, the second seal 1666 is separate from the sealing surface 1640. This allows the fluid flow path 1654 to connect the outlet 1636 to the isolation chamber via the restriction flow path 1632. In some embodiments, the casing 1634 may be in fluid communication with the casing 1634 (see FIG. 52). The restricted flow path 1632 may be at least as configured and / or functionally as any of the flow paths described herein. (e.g., restriction channels 232, 832, 1232, and / or 1332) Therefore, the restricted flow path 1632 may be located above or within the isolation chamber 1634. The magnitude of the negative pressure differential applied within the isolation chamber 1634 and / or the amount of negative pressure differential within the isolation chamber 1634 In other embodiments, the outlet 1636 may be configured to adjust the increasing speed. is in fluid communication with the isolation chamber 1634 via any suitable channels, ports, openings, valves, etc. In other words, in some embodiments, the control device 1600 , it is not necessary to include a restricted flow path 1632.

[0209] As shown in FIG. 51, when the actuator 1650 is in a first state, the actuator The tarod 1662 has a fluid flow passage 1633 that connects the inlet 1631 to the isolation chamber 1634 and the fluid The fluid flow path 1654 may be maintained in a first state or position that allows fluid to flow through the fluid. An outlet 1636 is in fluid communication with isolation chamber 1634 via passage 1632 . Thus, a fluid collection device (such as those described herein) is coupled to the outlet 1636 When the negative pressure defined within and / or otherwise generated by the fluid collection device is may be operable to draw an initial volume of bodily fluid into the isolation chamber 1634.

[0210] As described in detail above, the actuator 1650 is transferred to the isolation chamber 1634. Depending on the initial volume, the second state and / or configuration may be transitioned. In this embodiment, the initial volume of bodily fluid is controlled by a flow controller 1642 (e.g., a selective permeation In response to negative pressure applied through the porous membrane, the porous membrane can be drawn into the isolation chamber 1634. In some instances, at least a portion of the bodily fluid drawn into the isolation chamber 1634 may be flow controller 1642, thereby 42 can transition from a first state to a second state (e.g., a flow controller 1642 restricts and / or substantially prevents the flow of gases and liquids therethrough. Thus, a negative pressure can be generated on the surface of the diaphragm 1676, causing the diaphragm to be in a first state. and / or configuration to a second state and / or configuration, In some embodiments, the transition of the diaphragm 1676 may be sufficient to For the flow controller 1642 that is transitioning from the first state to the second state by and / or may be responsive to a flow controller 1642 (see details below). (e.g., complete wetting, as described in detail above). transition before or after the flow controller 1642 transitions from the first state to the second state. In yet another embodiment, the control device 1600 may include a flow control The fluid collection device need not include a filter 1642, but may be configured to apply a negative pressure differential to the diaphragm 1676. Some such implementations can be configured to transition in response to exposure to In an embodiment, the diaphragm 1676 (and / or at least a portion thereof) is closed by a predetermined negative pressure difference or and a predictable and / or predetermined manner from a first state to a second state after being subjected to a constant rate of negative pressure change. By transitioning to state 2, it acts in the same way as the flow controller 1642. Additionally, the transition of the diaphragm 1676 can be automatic (e.g., (not due to user intervention).

[0211] As shown in FIG. 52, when the diaphragm 1676 is translated, moved, inverted, etc. Move pin 1677 within housing 1630 and relative to actuator rod 1662 More specifically, the transition of the diaphragm 1676 can cause the pin 167 7 is disengaged from the actuator rod 1662. Therefore, the energy storage member 1667 (e.g., a spring) can be The device may be configured to release and / or convert at least a portion of the energy Specifically, in this embodiment, moving pin 1677 causes spring 1667 can be expanded from a first or compressed state to a second or substantially uncompressed state. The energy storage member 1667 (e.g., a spring) transitions from the first state to the second state. By this, the actuator rod 1662 in the actuator portion 1639 Move from one state and / or position to a second state and / or position.

[0212] As shown in FIG. 52, the actuator rod 1662 is in a second state and / or position. When the first seal 1665 is inserted, the first seal 1665 closes the isolation chamber 1634 to the inlet. 1631. Similarly, the second seal may be positioned at a second or subsequent location that is spaced apart from 1631. 1666 is pressed against the sealing surface 1640 (e.g., energy storage member 166 7) at a second or subsequent location, thereby The roller 1642 is isolated from the fluid flow path 1654. Furthermore, the actuator rod 166 When the first seal 1665 and the second seal 1666 are in the second state and / or position, 66 is positioned so that the fluid flow path 1633 can communicate with the fluid flow path 1654. Therefore, the negative pressure differential generated by the fluid collection device coupled to the outlet 1636 flows from the inlet 1631, through the fluid flow paths 1633 and 1654, through the outlet 1636, and may be operable to draw a subsequent volume of bodily fluid into the fluid collection device. By collecting and isolating an initial volume of body fluid, as described in detail above, the contaminants are removed. A subsequent volume of fluid substantially free of the substance can be obtained.

[0213] 53, which illustrates a method for reducing contamination using a fluid control device, according to one embodiment. 1 shows a flow chart illustrating a method 10 for obtaining a body fluid sample while the fluid control device is in a closed state. The device may be similar and / or substantially the same as any of the fluid control devices described in detail above. The method 10 may include, in step 11, providing a fluid between a source of bodily fluid and an inlet of a fluid collection device. For example, in some embodiments, a user may Operate the body control device to insert a lumen-containing device (e.g., needle, IV, The inlet can be physically and / or fluidly coupled to a catheter (e.g., a PICC line).

[0214] In step 12, a fluid collection device is coupled to the outlet of the fluid control device. As mentioned above, by coupling a fluid collection device to the outlet, In some embodiments, a negative pressure differential is generated within at least a portion of the chamber. For example, the fluid collection device may be a sample bottle or container that defines a negative pressure. In embodiments, the fluid collection device comprises a syringe that can be operated to generate a negative pressure. Therefore, the control devices 100, 200, 300, 400, 500 , 600, 700, 800, 900, 1000, 1100, 1200, 1300, 140 0, 1500, and / or 1600, one of the fluid control devices A negative pressure difference can be created within these sections.

[0215] In step 13, an initial volume of fluid is delivered from the inlet to the fluid control device in response to a negative pressure differential. For example, in some embodiments, the isolation portion may be a portion of the insulating portion shown in FIG. may be similar to and / or substantially the same as the isolation chamber 1234 described above with reference to In other embodiments, the isolation portion is similar and / or substantially similar to isolation chamber 1634. In yet other embodiments, the isolation portion may be the same as the isolation chamber described herein. Further, in some instances, the amount of bodily fluid The initial volume may contain contaminants entrained within it, and these contaminants may be present in the body fluid sample. This can otherwise cause erroneous results during pull testing.

[0216] In step 14, in response to contacting at least a portion of the initial volume of bodily fluid, the isolation portion The flow controller installed in the part is A first state that allows gas to flow and prevents the flow of fluid through the flow controller. The flow controller is transitioned from the first state to a second state that prevents the flow of gases and fluids through the flow controller. For example, in some embodiments, as described above with reference to flow controller 242, In particular, the flow controller may comprise a selectively permeable member or membrane (e.g., a fluid or blood barrier and In other embodiments, the flow controller may be a It may be similar and / or substantially the same as any of the flow controllers described. In some embodiments, contacting at least a portion of the initial volume of bodily fluid comprises contacting a fluid with a flow medium. - the controller limits the flow of gases and liquids (e.g., body fluids) therethrough; and / or For example, the flow controller can be wetted or saturated so as to substantially prevent In other embodiments, the flow controller is configured to transition in response to a negative pressure differential. For example, in such an embodiment, the flow control The roller is configured to: a substantially impermeable bladder or barrier capable of transitioning from a first state to a second state; It may be a membrane.

[0217] In step 15, after the flow controller transitions to the second state, the initial volume of the body fluid is For example, in some embodiments, the fluid control device may be - Transition after the controller is positioned in its second configuration and isolates an initial volume of fluid. and / or any other suitable feature or mechanism configured to In some embodiments, the actuator may be, for example, actuator 1650. As described above with reference to the first state, the transition from the first state to the second state is In other embodiments, the actuator 8 may automatically isolate the volume. As described above with reference to 50, the actuator is configured to move into a first state in response to a force applied by a user. In yet another embodiment, the fluid control device isolates the initial volume of bodily fluid within the isolation portion in any suitable manner, such as those described herein. It is possible.

[0218] In step 16, after isolating the initial volume of fluid, subsequent volumes of fluid are pumped from the inlet to the outlet. As detailed above, in some instances, By isolating the initial volume of bodily fluid within the isolated portion of the fluid control device, the initial volume is reduced. Contaminants in subsequent volumes of body fluid can be similarly isolated. The substance can be reduced or substantially eliminated.

[0219] While various embodiments have been described above, they have been presented by way of example only, and not limitation. It should be understood that the schematic illustrations and / or embodiments described above may not be arranged in a particular orientation or position. When specific components are shown, the placement of the components may be modified. Although the present invention has been specifically illustrated and described, it will be understood that various changes in form and details can be made. For example, the control devices 100, 200, 300, 400, 500, 600, 7 00, 800, 900, 1000, 1100, 1200, 1300, 1400, and / or The device 1500 transfers bodily fluid into the device as a result of negative pressure within the fluid collection device. Although described as such, in other embodiments, the devices described herein may be configured to utilize a pressure differential (e.g., The device may be used with any suitable device configured to establish a negative pressure differential (e.g., a negative pressure differential). For example, in some embodiments, the outlet of the control device can be connected to a syringe or pump. In other embodiments, the control device may be coupled to a pre-charged isolation chamber, an exhaust an isolation chamber; a manual activation device configured to generate a negative pressure; an energy source (e.g., (e.g., chemical energy sources, kinetic energy sources, and / or the like), and / or or any other suitable means for defining and / or creating a pressure differential within a portion of the control device. Furthermore, as mentioned above, the control device may include a user (e.g., a person (such as a doctor, nurse, technician, physician, etc.) who may be coupled to such a collection device; Alternatively, the control may be coupled or assembled during manufacturing. Pre-assembling the device and collection device (e.g., sample container or syringe) For example, a sample volume of body fluid may be collected prior to the collection of the sample volume. It can enforce compliance with the sample acquisition protocol.

[0220] Some of the above-described embodiments involve flow controllers having particular configurations and / or arrangements. and / or actuators, but in other embodiments the fluid control device may include a fluid control Any device configured to selectively control the flow of bodily fluid through one or more portions of the device. Suitable flow controllers and / or actuators may be included. For example, some Some embodiments may include a step of reversing or flipping the diaphragm from the first state to the second state. and a portion of the device (e.g., an inlet, an outlet, or any other suitable portion) One or more seals arranged as movable O-rings or elastomeric overmolding In other embodiments, the fluid control device may include any suitable actuator, such as a diaphragm. The seal may include one or more seals having any suitable configuration. For example, in some embodiments In one embodiment, the fluid control device comprises a resilient sheet fixedly coupled to a portion of the control device. In such an embodiment, the seal may include one or more seals arranged as A portion of the actuator, such as a pin or rod, extending from the diaphragm (e.g., FIGS. 11 and 1 2) extend through openings defined in one or more elastic sheets, thereby The elastomeric sheet forms a substantially fluid-tight seal with the outer surface of the pin or rod. Thus, when the actuator (e.g., a diaphragm) transitions from a first state to a second state, A portion of the actuator (e.g., a pin or rod) moves through one or more elastic sheets. In other words, a portion of the actuator can be moved by one or more elastic sheets. The resilient sheet moves relative to the control device, thereby being substantially fixed relative to a portion of the control device. In some embodiments, a removable portion or portion of the actuator is defined by one or more elastic sheets occluded by a portion of the actuator. The openings may allow fluid flow through the one or more elastic seals. The seals may function similarly to any of the seals described herein. In some embodiments, such an arrangement may, for example, form a desirable fluid-tight seal. This reduces the amount of friction associated with the control device, thereby allowing the fluid-tight seal to Eliminates the need for lubricants that are otherwise used to facilitate movement of the seal within the vise It is possible.

[0221] The diaphragms (e.g., diaphragms 576, 676, and 776) are configured such that the surface of the diaphragm exceeds a threshold negative pressure. transitions, moves, inverts, and / or otherwise reconfigures depending on the amount of negative pressure applied thereon Although described herein as being configured to The control device may transition in response to exposure to a desired and / or predetermined amount of negative pressure. Any suitable actuator configured to rotate, move, flip, and / or otherwise reconfigure. For example, in some embodiments, a fluid control device may be included. The device is adapted to selectively control the flow of fluid through at least a portion of the fluid control device. Movable members, plugs, plungers, closures, seals, and / or the like configured on More specifically, the actuator may include a movable part. The first member is provided with a movable member and / or otherwise blocking the opening. From this state and / or position, a second state and / or position is taken where the movable member etc. is removed from the opening. In such an embodiment, negative pressure can be applied through a portion of the device. For example, an initial volume of bodily fluid can be transferred into the isolation portion and / or chamber. .

[0222] As detailed above, in some embodiments, the device is configured to accommodate an initial volume of bodily fluid. transitioning from a first state to a second state in response to being wetted (or otherwise transitioned) by The present invention also includes a flow controller, such as a selectively permeable member or membrane, which can be configured to After transferring the initial volume of fluid, and the flow controller is in its second state, After the transition to the negative pressure, the amount of negative pressure exerted on the surface of the moving part is determined by the magnitude of the negative pressure. The force may increase sufficiently to withdraw or move the movable member from the mouth, thereby This allows fluid to flow through an opening that would otherwise be blocked by the The member is configured to transition or reverse from a first state to a second state. 576, 676, and / or 776. In such an embodiment, the movable member may be positioned such that the opening or can be moved or "pulled out" from the part, e.g., elastic plugs, cork stoppers, It may be a plunger, and / or any other suitable member.

[0223] Some of the above-described embodiments involve the isolation chamber and a fluid collection device (e.g., a sample reservoir). a reservoir, a syringe, and / or any other suitable negative pressure source) to selectively establish fluid communication between the In other embodiments, the control may include a flow controller and / or actuator. The device may be configured to pump fluids in response to a negative pressure differential generated from any suitable portion(s) of the device. For example, the control device 200 may be configured to transfer a flow. until the controller 242 is transitioned to a sealed or closed state (e.g., the flow controller 242 is sufficiently wetted), the isolation chamber 234 is selectively connected to the sample reservoir. The flow controller 242 and the restricted flow path 232 are arranged so that the fluid can flow through them. Although described above, in other embodiments, the control device may include a flow control device for controlling the flow between the inlet and the isolation chamber. By establishing bodily communication, a negative pressure sufficient to draw an initial volume of bodily fluid into the isolation chamber To make the difference, an isolation chamber, which is a pre-sealed vacuum chamber and / or charging chamber, is used. In such an embodiment, the control device may be configured to and / or until the pressure is otherwise substantially equalized. Additionally, in some such embodiments, the isolation channel The chambers and / or inlets may establish fluid communication therebetween (e.g., isolation a coupler, an actuator, which can transition the chamber from a sealed configuration to an unsealed configuration; It may include a needle, a septum, a port, and / or any other suitable member.

[0224] Some of the above-described embodiments involve physically and / or mechanically modifying one or more portions of the fluid control device. Other embodiments include mechanically isolating flow controllers and / or actuators. In the fluid control device, one or more parts of the fluid control device may be physically and / or functionally Mechanical isolation is not required. For example, in some embodiments, actuator 1250 Such actuators allow an initial volume of body fluid to flow from the inlet to a segregation chamber or section. From the first state, (1) the isolation chamber or portion is physically and / or mechanically isolated; (2) transition to a second state in which the inlet is in fluid communication with the outlet of the fluid control device. However, in other embodiments, the actuator and / or any of the fluid control devices may Other suitable portions may include portions that allow an initial volume of bodily fluid to flow from the inlet to the isolation chamber or portion. a first state in which the isolation chamber or portion is physically and / or mechanically isolated (or separated) from the first state in which the isolation chamber or portion is ) can transition to a second state in which the inlet and the outlet are arranged to be able to communicate with each other. When such a control device is in the second state, one or more characteristics of the control device and and / or the shape can cause preferential flow of fluid from the inlet to the outlet, The initial volume may be separated or not separated physically and / or mechanically into the isolation chamber. The bar or part can be retained.

[0225] The restricted flow path 232 may be located in at least a portion of the device 200 or at least a portion of the device 200. Also described above as adjusting and / or controlling the amount of negative pressure applied through a portion of the However, in other embodiments, the control device may be configured to control the configured to regulate, create, and / or otherwise control one or more pressure differentials Any suitable features, mechanisms, and / or devices may be included. For example, some In an embodiment, a user may shift and / or move an actuator to activate a control device. The size of one or more portions of a fluid flow path or fluid flow interface within a portion of the device. Vary (e.g., decrease or increase) the amount or magnitude of negative pressure within one or more portions of the control device. can be manually sized and / or otherwise controlled.

[0226] Various embodiments may include combinations of particular features, concepts, and / or components. Although described as such, other embodiments may incorporate any of the embodiments described herein. Having any combination or subcombination of features, concepts, and / or components For example, as described above, device 700 can be As another example, any of the embodiments described herein may include concepts, features, and / or elements. or placing one or more components in a desired position, condition, arrangement, and / or configuration. The device may include a lock or other suitable feature configured to temporarily maintain contact. As such, any of the embodiments described herein may be implemented using, for example, the spacing described above with reference to FIG. and / or includes an isolation chamber and / or isolation portion configured similarly to isolation chamber 1234. In other words, any of the fluid control devices described herein may include isolation chambers arranged and / or formed as channels. In some embodiments, the isolation chamber may be a 1234, as described above with reference to the isolation chamber 1234. The channel forming at least a portion of the reservoir is configured to allow an initial volume of body fluid to be drawn into the channel. When the air is mixed with the body fluid, the mixing of the air and the body fluid can be reduced and / or substantially prevented. Further, such channels may have a small cross-sectional shape and / or size. 1234. The isolation chamber 1234 may have a spiral shape and / or configuration similar to that of the isolation chamber 1234 described above. and / or may have any other suitable shape and / or configuration.

[0227] As another example, as described above with reference to, for example, flow controller 242, Any of the control devices described in may be configured as a selectively permeable member or membrane. More specifically, the control device 600 may include a flow controller. Although not described as including a roller, in other embodiments, a portion of the diaphragm 676 may include at least one comprising and / or forming a flow controller formed at least in part from a selectively permeable material. In such an embodiment, the flow controller may be configured to (as described above) Evacuating the volume of the isolation chamber and / or portion 634 in response to being subjected to a negative pressure differential. In other words, one of the fluid control devices 600 Depending on the negative pressure difference in the part, a volume of air is transferred through the flow controller to the isolation chamber 63. 4 can be drawn from (e.g., drained or purged from) some In the example, the volume of air that otherwise occupies a portion of the isolation chamber 634 may flow in response to a negative pressure differential. Such an arrangement is not an isolation chamber since it is vented or purged through the controller. This may allow for a reduction in the size and / or volume of the bar 634.

[0228] As another example, any of the embodiments described herein may comprise at least a portion of a device any suitable actuator configured to selectively control the flow of fluid through and / or a flow controller. Specifically, the flow controller etc. , selectively permeable materials or membranes, valves, diaphragms, and / or any other suitable flow control devices. Some embodiments may include a first configuration or position to a second configuration or position. An actuator rod (e.g., an actuator rod) configured to be moved to a configuration or position Although the description includes the actuator rod 1262 of the eta 1250, other In embodiments, any actuator described herein may have a first position and a second position. Transition between the device and the exit from one or more other parts of the device at least temporarily The actuator rod may be configured to separate (e.g., (as described above with reference to eta 850 and / or 1350). In some embodiments Such an actuator may be coupled to a given and / or predetermined collection device, such as a syringe. In other embodiments, such actuators may be configured for use with a The computer can be used with any suitable acquisition device.

[0229] In some embodiments, the specific configuration of the various components may also be changed. For example, the size and specific shape of various components may vary from the illustrated embodiment, but may be incorporated herein by reference. For example, in Figures 45-50, Part of the actuator body 1551, the isolation chamber 1534, and / or the bladder 1578 The components are shown as being substantially tubular with circular or substantially semicircular ends. However, in other embodiments, a portion of the actuator body 1551, the isolation chamber 1534, and / or bladder 1578 can have any suitable shape and / or size. In some embodiments, the size and / or shape of such components may be varied. This allows the overall size of the device 1500 to be reduced without changing the functionality of the device 1500. This may reduce the size and / or improve the ergonomics of the device 1500. Illustratively, the housing, isolation chamber, and / or bladder may be relatively flat. The tubular member may have a substantially cylindrical shape with curved ends, etc. In this state, the control device "inverts" in response to exposure to a negative pressure differential, similar to the diaphragm described above. In other embodiments, the bladder may include a bladder configured to: Gradually transition from a first state to a second state (e.g., stretch, open, unfold, and / or In some instances, the bladder may be configured to transition By controlling the rate at which the pressure is increased, the negative pressure differential created within the isolation chamber can be adjusted and / or controlled. It may be possible to control it.

[0230] In other embodiments, the device may be a similar size to the housing 1230 and / or 1330. a bladder (bladder 147) disposed within a housing having a size, shape, and / or configuration; 8 and / or 1578) may be used. In such embodiments, the bladder may be configured in various shapes and / or sizes, overall size, and and / or the shape of the housing (e.g., cylindrical with a relatively low profile or height). In some instances, such an arrangement may define an initial volume of bodily fluid. At least a portion of the volume is in contact with the surface of the bladder (or diaphragm or other actuator). The bladder can remain in place and be used for bodily fluids transferred into the isolation chamber. In other embodiments, the same as the housing 1230 may be used to provide a visual indication to the user. Such a housing may define a helical channel or any other suitable channel. The fluid channel may include a bladder disposed within at least a portion of the channel. In such an embodiment, the bladder expands in response to exposure to a negative pressure differential. It may function similarly to a bladder 1578 that opens and / or otherwise increases in volume. In some embodiments, the bladder is configured to receive an initial volume of bodily fluid. In other embodiments, one of the bladder and the housing may define a sealed volume. The portion (e.g., the surface defining the isolation chamber and / or channel) may be configured to accommodate an initial volume of bodily fluid. The flow can collectively define a volume that is configured to receive the The body control device may have any suitable shape, features, channels, or the like in a housing in which the bladder is provided. The device may include a bladder configured to conform to the configuration. In embodiments of the present invention, the size and shape of the various components may be adjusted to accommodate the flow of bodily fluid into the fluid reservoir. The desired rate and / or volume of the injection can be specifically selected.

[0231] In some embodiments, the size and / or shape of the various components may be adjusted to suit desired or intended purposes. It may be specifically selected for the intended use. For example, in some embodiments , devices such as those described herein, with or on apparently healthy adult patients. In such an embodiment, the device may be configured for use in a first The device may include a separation chamber having a volume (e.g., about 0.5 ml to about 5.0 ml). In other embodiments, devices such as those described herein may be used in, for example, critically ill and / or It may be adapted for use with or on pediatric patients. In such embodiments, the device may include a second volume less than the first volume (e.g., less than about 0.5 ml). The embodiment and / or its The size, shape, and / or arrangement of the components of It should be understood that the present invention may be adapted to a given application, so long as the present invention is not limited to the above.

[0232] Although not shown, any of the devices described herein may include an isolation chamber and a fluid flow passage. Permeable openings, ports, couplers, septa, Luer-Lok, gas sockets, valves, threaded connectors, standard fluid interfaces, etc. (for brevity, we will refer to them as "ports"). In some such embodiments, the port may include any suitable The device may be configured to couple to a suitable device, reservoir, pressure source, etc. In some embodiments, the port can be configured to couple to a reservoir; The reservoir thereby diverts a greater amount of bodily fluid into the isolation chamber and / or In other embodiments, the port may be connected to a vacuum vessel, a pump, a syringe, or the like. and / or the like to provide a negative pressure source to the isolation chamber, channel, reservoir, and collecting a portion or the entire volume of body fluid, such as for the purpose of additional clinical and / or in vitro diagnostic testing, That volume of bodily fluid (e.g., a pre-test volume) can be used. The port is used to perform one or more tests (e.g., tests that are not sensitive to potential contamination) at the initial volume. probes, sampling instruments, testing devices, and / or or the like, while the initial volume can be configured to accommodate an isolation chamber. In yet another embodiment, the port is located within the isolation chamber. configured to reinfuse the initial volume of fluid isolated therein into the patient and / or the source of fluid. It can be coupled to any suitable pressure source or infusion device (e.g., for pediatric patients, critically ill patients, In other embodiments, the isolation channel may be The chamber, chamber, and / or reservoir may be configured to accommodate the initial body fluid to be used in the test. It may be possible to add other diagnostic test components (e.g., paper tests) integrated into the server. This can be done.

[0233] In yet other embodiments, the isolation chamber, channel, and / or reservoir may be removed. available, compatible with testing equipment, and / or specifically for patients with suspected conditions Designed and sized to provide access to other types of body fluid testing commonly performed For example, patients suspected of having sepsis usually undergo lactate testing, Blood samples will be taken for procalcitonin testing and blood culture testing. Remove all fluid control devices, including isolation chambers, channels, reservoirs, etc. (e.g., after receiving an initial volume of bodily fluid), where Body fluids contained in these containers may be collected before or after subsequent samples are collected for microbiological testing. It can be used for additional testing purposes.

[0234] Although not shown, in some embodiments, the fluid control device may provide a "bypass" flow of bodily fluids. The device may include one or more lumens, channels, flow paths, etc. configured to selectively allow wherein the initial amount or volume of fluid is introduced into a lumen, channel, flow path, etc. from an inlet. can flow through the separation chamber, bypassing the separation chamber and into the collection device. In some embodiments, the fluid control device may be an actuator having, for example, at least three states. In a first state, the bodily fluid can flow from the inlet to the isolation chamber. In the second state, the body fluid is allowed to flow from the inlet after isolating the initial volume in the isolation chamber. In a third state, the fluid can flow from the inlet through a bypass flow path to the outlet. In other embodiments, the flow may be as described in detail above with reference to specific embodiments. The control device is configured to transition the device between a first state and a second state. a first actuator configured to transition the device to a bypass configuration, etc. In yet another embodiment, the control device may include a second actuator. The device may be any device configured to selectively position the fluid control device in a bypass configuration or state. includes any suitable device, feature, component, mechanism, actuator, controller, etc. It is possible.

[0235] Any of the embodiments described herein may be used with, for example, the fluids described in the '420 patent. Any suitable fluid transfer device, fluid collection device, and / or fluid storage, such as a reservoir In some examples, the embodiments described herein may be used in conjunction with the device. Any of the devices described in the '510 publication and / or the 2015 Apparatus and Methods for Disinfecting Published U.S. patent entitled "Action of a Specimen Container" No. 2015 / 0246352, filed on October 12, 2012, "Fluid Dive rsion Mechanism for Bodily-Fluid Samplin U.S. Patent No. 8,535,241, entitled "Flui g," filed May 29, 2013; d Diversion Mechanism for Bodily-Fluid S U.S. Patent No. 9,060,724, entitled "Sampling," filed December 2, 2013 Syringe-Based Fluid Diversion Mechanism U.S. Patent No. 9,111,139, entitled "Using U.S. Patent No. 9,111,139, entitled ' ... No. 55,495, filed June 13, 2016, entitled "Devices and Methods" s for Syringe Based Fluid Transfer for B U.S. Patent Publication No. 2016 / 036 entitled "Synthetic Fluid Sampling" No. 1006, filed November 20, 2017, entitled "Systems and Methods for Sample Collection with Reduced Hemo U.S. Patent Publication No. 2018 / 0140240 entitled "Ultra-High-Performance Imaging and Imaging Technology," and / or 2016 Apparatus and Methods for Maintenance filed on September 6, aining Sterility of a Specimen Container No. 2017 / 0065733, entitled "U.S. Patent Publication No. 2017 / 0065733," the disclosure of each of which is incorporated herein by reference in its entirety. (which are incorporated herein by reference), Suitable transfer adapters, fluid transfer devices, fluid collection devices, and / or fluid storage devices It can be used in conjunction with

[0236] In some embodiments, methods using fluid control devices such as those described herein The method includes providing fluid communication between a body fluid source (e.g., a patient's blood vessel) and an inlet of a fluid control device. The method may include sequential steps that enable the flow of the fluid control device. The outlet is in fluid communication with and / or otherwise engaged with a negative pressure source. Negative pressure sources such as sample reservoirs, syringes, vacuum vessels, intermediate transfer devices, and / or or the like. The fluid control device, when the outlet is coupled to a negative pressure source, The fluid control device may be in a first state or mode of operation, such that an initial volume of bodily fluid is A negative pressure differential is applied through the fluid control device drawing into the isolation chamber of The negative pressure in the sample reservoir draws an initial volume of bodily fluid from the patient and into the isolation chamber. Once an initial volume of bodily fluid is placed in the isolation chamber, the flow regime may be The control device has (1) an initial volume isolated in an isolation chamber, and (2) fluid communication between an inlet and an outlet. a first state or operating mode, automatically or through user intervention, to be established between the The initial volume is transitioned from the initial state to a second state or mode of operation. The initial volume of fluid can be isolated so that the contaminant is similarly isolated in the isolation chamber. With the chamber isolated and fluid communication established between the inlet and the outlet, A subsequent volume of substantially uncontaminated bodily fluid may be collected in one or more sample reservoirs. do.

[0237] A method of using a fluid control device is intended to include the recited ordered steps. Although expressly stated herein, in other embodiments, any of the methods or processes described herein may be used. The order of certain events and / or steps in any of the foregoing may be modified, and such modifications may include, but are not limited to, the following: In addition, certain events and / or steps may be implemented in parallel processes. The processes may be performed simultaneously in the same system, or, where possible, sequentially as described above. Certain steps may be partially completed or omitted before proceeding to subsequent steps. For example, a device may transition from a first state to a second state by a separate action. Although the devices described herein are described as being in a first state, the devices described herein may be The second state may be configured to transition automatically and / or passively, such that It should be understood that such a transition may occur over a period of time. In other words, the first state The transition from the initial state to the second state occurs in some instances when the last part of the initial volume of fluid enters the sequestration chamber. When the housing is being transported into the chamber, it begins to transition from the first state to the second state. In some instances, the transition from the first state to the second state may be relatively gradual. Selectively control the rate of change during the transition to achieve one or more desirable properties associated with the transition. Furthermore, in some such instances, the flow of the final portion of the initial volume and / or Thus, the transition from the first state to the second state can be prevented or substantially prevented. This may occur over a given time period, but the isolation chamber may still A volume of fluid can be sequestered.

Claims

1. a housing having an inlet fluidly connectable to a patient and an outlet configured to be fluidly connectable to a fluid collection device, the housing defining a containment flow path and a collection flow path; a flow controller disposed within the housing and configured to, in a first state, prevent blood from entering at least a portion of the collection channel and, in a second state, allow blood to enter at least a portion of the collection channel; a selectively permeable blood barrier disposed within the housing and fluidly coupling between the containment channel and the outlet; the selectively permeable blood barrier is configured such that suction applied to the outlet causes air to flow from the containment flow path through the selectively permeable blood barrier and causes blood to flow into the containment flow path; The selectively permeable blood barrier facilitates a partial increase in the suction force in the collection channel in response to the amount of blood in the containment channel, and the partial increase in suction force causes the flow controller to transition from the first state to the second state.

2. The apparatus of claim 1 , wherein the suction force is applied to the outlet by fluidly coupling the outlet to a fluid collection device.

3. the housing defines a flow path between an end of the containment flow path and the outlet; The apparatus of claim 2 , wherein at least a portion of the flow path is configured to adjust the suction force applied to the end of the containment flow path.

4. The device of claim 1 , wherein the containment channel and the collection channel are fluidly coupled to the inlet and the outlet, respectively.

5. The device of claim 1 , wherein the selectively permeable blood barrier comprises an air-permeable and blood-impermeable material.

6. The device of claim 1 , wherein the flow controller comprises at least one of a plunger, a seal, a moveable plug, or a resilient material.

7. 10. The device of claim 1, wherein the local increase in suction force within the collection flow path occurs in a portion of the collection flow path between the flow controller and the outlet.

8. the selectively permeable blood barrier is disposed at an end of the containment channel; The device of claim 1 , wherein the flow controller is disposed at an end of the collection flow path.

9. a housing having an inlet fluidly connectable to a patient and an outlet fluidly connectable to a fluid collection device, the housing defining a containment flow path and a collection flow path; a flow controller disposed within the housing and configured to prevent blood from entering at least a portion of the collection channel in a first state and to allow blood to enter at least a portion of the collection channel in a second state; a selectively permeable blood barrier disposed within the housing and fluidly coupled between the containment channel and the outlet; the selectively permeable blood barrier is configured such that suction applied to the outlet causes air to flow from the containment flow path through the selectively permeable blood barrier and causes blood to flow into the containment flow path; The flow controller transitions from the first state to the second state until the suction force in the collection channel increases in response to the amount of blood in the containment channel.

10. The apparatus of claim 9 , wherein fluidly coupling the outlet with the fluid collection device applies a suction force to the outlet.

11. The device of claim 9 , wherein at least a portion of the collection flow path is disposed between the flow controller and the outlet, such that the blood or the air can move between the flow controller and the outlet.

12. The device of claim 9 , wherein the selectively permeable blood barrier is disposed at an end of the contained flow path.

13. The device of claim 9 , wherein the flow controller comprises at least one of a plunger, a seal, a moveable plug, or a resilient material.

14. 10. The device of claim 9, wherein the flow controller is configured to at least partially define at least a portion of the collection flow path in the first state.

15. 10. The device of claim 9, wherein the flow controller is in a first position in the first state and in a second position in the second state, the flow controller being configured to be at least temporarily maintained in the second position that allows the blood to flow into at least a portion of the collection channel.

16. 10. The device of claim 9, wherein the flow controller is configured to transition from the first state to the second state depending on the amount of blood in the containment channel.

17. 10. The device of claim 9, wherein the housing and the selectively permeable blood barrier are configured such that the blood in the containment channel restricts the flow of the air through the selectively permeable blood barrier.

18. The device according to claim 9 , wherein each of the containment channel and the collection channel is arranged to allow the blood or the air to flow between the inlet and the outlet.

19. 10. The device of claim 9, wherein the flow controller transitions from the first state to the second state by a portion of the suction force within the collection channel moving at least a portion of the flow controller from a first position that prevents the blood from entering at least a portion of the collection channel to a second position that allows the blood to flow into at least a portion of the collection channel.

20. 10. The device of claim 9, wherein the flow controller is configured such that in the second state, the collection channel forms part of a flow path between the inlet and the outlet through which subsequent blood enters.

21. a housing having an inlet and an outlet, forming a containment flow path and a collection flow path, respectively; a selectively permeable blood barrier disposed within the housing and in fluid communication with the containment channel and the outlet, the selectively permeable blood barrier and containment flow path are configured to form at least a portion of a flow path; the selectively permeable blood barrier configured such that, upon application of suction to the outlet, air flows from the containment flow path through the selectively permeable blood barrier to the outlet and blood flows from the inlet into the containment flow path; a flow controller disposed within the housing, configured to, in a first state, prevent the flow of the blood and the air through at least a portion of the collection channel and, in a second state, allow the flow of the blood through at least a portion of the collection channel, and configured to transition from the first state to the second state in response to a partial increase in suction force within the collection channel; The device, wherein the partial increase in suction force occurs due to the amount of blood in the containment channel.

22. 22. The device of claim 21, wherein the inlet is configured for fluid connection with a patient.

23. 22. The apparatus of claim 21, wherein the outlet is configured to be fluidly connectable to a fluid collection device.

24. 22. The apparatus of claim 21, wherein the suction force is applied to the outlet by fluidly coupling the outlet to a fluid collection device.

25. 22. The device of claim 21, wherein at least a portion of the collection flow path is disposed between the flow controller and the outlet, such that the blood or the air can move between the flow controller and the outlet.

26. 22. The device of claim 21, wherein the selectively permeable blood barrier forms part of the containment flow path.

27. 22. The device of claim 21, wherein the flow controller comprises at least one of a plunger, a seal, a moveable plug, or a resilient material.

28. 22. The device of claim 21, wherein the flow controller transitions from the first state to the second state by a portion of the suction force in the collection channel moving at least a portion of the flow controller from a first position that prevents the blood from entering at least a portion of the collection channel to a second position that allows the blood to enter at least a portion of the collection channel.

29. The device described in claim 21, wherein the flow path is a first flow path, and the flow controller is configured such that in a second state, the collection flow path forms part of a second flow path between the inlet and the outlet that receives subsequent blood.

30. a housing having an inlet fluidly connectable to a patient and an outlet fluidly connectable to a fluid collection device, the housing defining a containment flow path and a collection flow path; a flow controller disposed within the housing and configured to, in a first state, prevent blood from flowing into at least a portion of the collection channel and, in a second state, allow blood to flow into at least a portion of the collection channel; a selectively permeable blood barrier disposed within the housing and fluidly coupling between the containment channel and the outlet; the selectively permeable blood barrier is configured such that suction applied to the outlet causes air to flow from the containment flow path through the selectively permeable blood barrier and directs blood flow from the inlet into the containment flow path and toward the selectively permeable blood barrier; the selectively permeable blood barrier is configured to promote the accumulation of a portion of suction force in the collection channel in response to the amount of blood in the containment channel, thereby transitioning the flow controller from the first state to the second state.

31. 31. The device of claim 30, wherein fluidly connecting the outlet and the fluid collection device applies a suction force to the outlet.

32. the selectively permeable blood barrier is disposed at an end of the containment flow path; 31. The device of claim 30, wherein the collection channel has a portion through which the blood or the air can flow between the collection channel's connection with the selectively permeable blood barrier and the outlet.

33. 31. The device of claim 30, wherein the selectively permeable blood barrier comprises an air-permeable, blood-impermeable material.

34. 31. The device of claim 30, wherein the flow controller comprises at least one of a plunger, a seal, a moveable plug, or a resilient material.

35. 31. The device of claim 30, wherein an increase in the amount of blood in the containment channel stops the flow of air from the containment channel through the selectively permeable blood barrier.

36. 31. The device of claim 30, wherein the flow controller is configured to block an end of the collection channel in a first state.

37. the containment channel is configured to contain the blood and separate subsequent blood within the containment channel; 31. The device of claim 30, wherein the collection channel forms part of a flow path that directs the trailing blood from the inlet, through the collection channel, to the outlet by the suction force when the flow controller is in the second state, bypassing at least a portion of the blood separated in the containment channel.

38. a housing having an inlet and an outlet, forming a containment flow path and a collection flow path; a selectively permeable blood barrier disposed within the housing and in fluid communication with the containment channel and the outlet, the selectively permeable blood barrier and the containment flow path form at least a portion of a flow path between the inlet and the outlet; a selectively permeable blood barrier, the flow path configured to receive a flow of air in response to a first suction force applied to the outlet; a flow controller disposed within the housing, the flow controller configured to, in a first state, prevent blood from flowing through at least a portion of the collection channel, and, in a second state, allow blood to flow into at least a portion of the collection channel, and to transition from the first state to the second state in response to an increase in a second suction force within the collection channel; The device wherein the second increase in suction force is caused by blood within the containment channel.

39. 39. The device of claim 38, wherein the flow controller comprises a plunger.

40. 39. The apparatus of claim 38, wherein the flow controller comprises a seal.

41. 39. The apparatus of claim 38, wherein the flow controller is configured to automatically transition from the first state to the second state.

42. 39. The device of claim 38, wherein the flow controller is configured to facilitate flow of the blood from the inlet to the outlet in the second state.

43. 43. The device of claim 42, wherein the housing is configured to retain the blood within the contained flow path to limit contamination of subsequent blood and reduce false results in culture testing of blood collected through the collection flow path.

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