Fluid control devices and methods of using fluid control devices

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 and Methods of Using the Same (Fluid Control Device and methods of using the fluid control devices,” U.S. Provisional Patent Application No. 62 / 557,533. No. 6,313,635, filed on Oct. 13, 2006, and claims priority to and the benefit of US Pat. No. 6,313,635, 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 This application claims priority to and the benefit of Provisional Patent Application No. 62 / 634,569, 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 This application claims priority to and the benefit of Provisional Patent Application No. 62 / 678,632, 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 parenteral acquisition of body fluid samples, and more particularly to the acquisition of body fluid samples 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 devices and methods for diversion, isolation, and / or separation of fluids for harvesting.

[0005] Medical practitioners use parenterally obtained body fluids to perform various types of microbial 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 bodily 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 available 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 (GA), next-generation sequencing (NGS), and biomarker identification. may include, but is not limited to, cells that are external to the source from which the sample is obtained. Biological material and / or other extraneous contaminants may be inadvertently 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 derived. The purity of the sample intended to be taken or collected is not compromised during the specimen acquisition process. When such tests are performed, the resulting analytical test results may be inaccurate, abnormal, or defective, false positive, or may be false negatives and / or otherwise not representative of the patient's actual situation, , incomplete, inaccurate, messy, uncertain, unreliable, and / or otherwise undesirable. This could result in better clinical decision-making.

[0006] In some instances, the patient sample (e.g., bodily fluid) may be contaminated with bacteria, fungi, or yeast (e.g., The sample is tested for the presence of one or more potentially undesirable microorganisms, such as Candida albicans. In some instances, microbiological testing may involve the determination of the culture medium, general additives, and / or the presence of microorganisms. One or more sterile and / or non-sterile containers that can accommodate other types of solutions that support growth. In another example, the method may include culturing the patient sample in a bath of bacteria. Samples may be analyzed directly (i.e., not cultured) or the culture medium or In yet another example, various techniques are employed to In 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-cultured") 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 environments to identify, type, classify, and / or characterize These include, but are not limited to, other commonly used or advanced techniques.

[0007] In some instances, detecting the presence of a microorganism may involve determining whether the microorganism and / or organism is 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 (for longer or shorter periods, depending on the circumstances). Automated, 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. Thus, it can be detected.

[0008] In a culture test, for example, if a microorganism is present in a patient sample, the microorganism is cultured in a culture medium. They grow over time in the soil, and in some cases, automated monitoring techniques can detect the growth of the organisms. The presence of microorganisms in the culture medium (observation of carbon dioxide) can be detected. microbial expression (as demonstrated by ELISA and / or other detection methods) in patient samples. This suggests that the same microorganisms are present in the body fluids of the patients from whom the samples were obtained. This suggests the presence of organisms 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 catheters (PIVs), peripherally inserted central catheters (PICCs), and and / or other indwelling catheter(s) or other lumen-containing device, collection by syringe, or any other suitable means employed to collect patient specimens. Microorganisms on the body surface (e.g., microorganisms present on the skin) that are released into the It then transports the cells directly or indirectly through tissue fragments, hair follicles, sweat glands, and other skin appendage structures. , culture medium, test vial, or other suitable specimen collection vessel or vessel containing a patient sample. It may be included in the sample to be transferred to the transfer chamber and / or analyzed in a non-culture based test. Another possible source of contamination is the people taking the patient samples (doctors, phlebotomists, nurses, technicians, 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 contamination points. Fluid interfaces (e.g., patient to needle, needle to transfer adapter, transfer adapter to from sample tank, 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 include, but is not limited to, The substance may grow in culture medium and / or be identified by other non-culture based diagnostic techniques. ultimately resulting in false positive and / or false negative microbiological test results. The results of this test may indicate the presence or absence of such microorganisms in the patient (i.e., in the body). may inaccurately reflect the deficiency.

[0010] Such inaccuracies due to contamination and / or other sources of contamination that compromise sample purity. The results may include a broad range of suspected illnesses, diseases, infections, patient conditions, or other conditions of concern. For example, false negative results from microbiological tests are a concern when diagnosing or treating This may result in misdiagnosis and / or delayed treatment of patients' illnesses, and in some cases, Conversely, false positive results in microbiological tests can cause patient death. Patients may need to undergo one or more antimicrobial therapies, which can have serious side effects, including death. This can cause serious side effects, increase the patient's hospital stay and / or other complications related to the incorrect treatment. Complications may result in unnecessary burdens and costs to the health care system. The use of diagnostic imaging equipment due to these false positive results is a problem for various imaging procedures (e.g., CT scanning). The unnecessary exposure to radiation associated with cancer treatment 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 standpoint.

[0011] In some instances, the devices and / or systems may be used to detect and / or diagnose a sample of bodily fluid for testing. The likelihood of contamination, tampering, and / or the like can be reduced. 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 bodily fluid, which may be higher. However, some such devices can be configured to The system is often considered cumbersome, difficult to understand, and difficult to use, especially when considering the patient population it targets. In addition, some of these may be unrecognized, inappropriate or unavailable. Devices that are suitable for use with the Internet may require training, user supervision, and / or multiple user intervention. and / or may be influenced by environmental, educational, clinician skills, patient situation, and / or similar factors. These cases present problems where the validity may be otherwise limited based on differences including: In some instances, such issues include uncontaminated, sterile, uncontaminated, etc. This can complicate the collection of reliable, high-quality samples, thereby limiting the quality 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 that do not require, for example, the time required to fill an isolation reservoir with a significant volume of fluid. Depending on clinical realities such as time, appropriate division of the clinically desirable and valid pre-test volume of body fluids may be required. In some cases, it may be impossible 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 designed to be practical for use in a variety of clinical settings, including emergency rooms and other intensive care settings. For example, the flow velocity and / or force required for the flow to occur is usually insufficient. The symptomatic patient population requiring the above diagnostic tests includes those with hypotensive states (i.e., low blood pressure), 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. The physical condition of the subject makes collection of blood and / or body fluid samples difficult to accomplish. 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) and Abnormal, inaccurate, false positive, false negative, and / or otherwise contaminated diagnostic test results Divert, segregate, and / or separate contaminants that may otherwise lead to adverse effects. Problems associated with the technique (e.g., without the use of 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 useful initial volume of fluid collection. The aim of this study is to facilitate the collection of samples from the frail patient population from which these samples are collected. This approach may not be practical since 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 blood, There is a need for a systemic flow diversion device and method (e.g., for treating the general patient population and / or the problem) Some such devices and methods include, for example, 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 bodily fluid samples Issues associated with collecting samples from patients with specific health conditions and / or physical characteristics There needs to be a device that can deal with this. Summary of the Invention

[0014] Reduces 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 accordance with the present invention. 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 communication with the source. The flow controller is configured to receive the body fluid from a source of body fluid. 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 portion. a flow control operable to draw an initial volume of bodily fluid into the isolation portion when in the flow control state; When the controller is in the second state, a test volume of bodily fluid is passed through the outlet and into the fluid collection device. The device is operable to retract into a vice. [Brief description of the drawings]

[0015] [Figure 1] 1 is a schematic diagram of a fluid control device, according to one embodiment. [Diagram 2] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 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. [Diagram 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. 2 is a front view of a fluid control device in a first mode of operation, according to one embodiment. [Figure 10] FIG. 2 is a front view of a fluid control device in a second mode of operation, according to one embodiment. [Figure 11] FIG. 2 is a front view of a fluid control device in a first mode of operation, according to one embodiment. [Figure 12] FIG. 2 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. [Diagram 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. [Diagram 25] 1A-1D are various views of a fluid control device, according to one embodiment. [Figure 26] 1A-1D are perspective views of a fluid control device according to different embodiments. [Figure 27] 1A-1D are perspective views of a fluid control device according to different embodiments. [Figure 28] 1A-1D are perspective views of a fluid control device according to different embodiments. [Figure 29] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 30] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 31]1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 32] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 33] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 34] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 35] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 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. [Diagram 40] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 41] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 42] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 43] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 44] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 45] 1A-1D are various views of a fluid control device, according to one embodiment. [Diagram 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] FIG. 2 is a cross-sectional view of a fluid control device, according to one embodiment. [Figure 52] FIG. 2 is a cross-sectional view of a fluid control device, according to one embodiment. [Diagram 53] 1 is a flow chart illustrating a method of using a fluid control device, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] An initial volume of fluid is collected, diverted, isolated, or separated, and then subsequently acquired. 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, obtain, and / or transfer the first fluid. The channel, flow path, or portion of the device is capable of accepting an initial volume of a flow of bodily fluid. and then directing the flow of bodily fluid into or from a first reservoir or first portion of the device. By means of these measures, substantial or complete isolation (e.g., containment or retention, avoidance, (separate, separate, sequester, vapor-tight, separate, and / or the like) In some cases, contaminants, such as microorganisms present on the skin, may be present in the initial volume of fluid. and / or may become contaminated by the first reservoir or the first portion of the device. Once the initial volume is isolated, the subsequent volume of any fluid flow will be , into a second reservoir, a second portion of the device, and / or any additional flow channel(s). Can be steered, guided, directed, flow-controlled (manual, automatic, and / or (semi-automatically). Thus, by isolating the initial volume, any additional and / or the subsequent amount(s) may be inaccurate, occurring in some diagnoses and / or tests. Contaminants that may produce different results, such as abnormal, poor quality, false positive, or false negative. 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 deficiency, can be reinjected 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 feature , 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 to capture the fluid flow; Limit the pressure difference (e.g., blood pressure relative to ambient air pressure) sufficient to transition to a concentration device. (2) overcoming physical patient problems that may prevent and / or prevent clinical Properly filling the isolation chamber with a reasonably verified and / or desired amount of bodily fluid; (3) The fluid collection process is efficient, timely, and / or user-acceptable. and / or (4) to manipulate and / or automatically transfer fluid flow. A means for performing a desired action (e.g., movement of a physical component of a system, or a desired fluid flow force) change, switch, engage, and / or otherwise adopt or achieve) to provide an initial sample The objective of the present invention is to enable isolation and / or separation of infected individuals 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 disposed in a liquid supply. 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 inlet to the isolation and / or diversion portion of the fluid control device (the portion (capable of being formed by or in, or of being attached to, The fluid control device has a first state. (1) The isolation chamber isolates the initial volume, and (2) 2) the negative pressure differential directs a subsequent volume of substantially contaminant-free fluid from the fluid source to the fluid control device; It has a second state which draws the fluid through the device and into the fluid collection device.

[0019] In some embodiments, the system includes 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 second state transitioning to a first state transitioning to a second state; The fluid collection device is fluidly coupled to the outlet and is configured to accommodate at least one of the housing. The negative pressure differential is configured to generate a negative pressure differential within the portion of 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, a 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 includes a housing and an actuator coupled to the housing. The housing includes an inlet adapted to be in fluid communication with a source of bodily fluid. and an outlet configured to be 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 is arranged so that the first fluid flow path is inlet and the isolation portion is fluidly connected to the inlet. The first configuration and the second configuration in which the second fluid flow path is arranged to allow fluid communication between the inlet and the outlet. The fluid collection device is disposed in fluid communication with the outlet, and includes: (1) an actuator; When the device is in the first configuration, the device is operable to draw an initial volume of bodily fluid into the isolation portion. and (2) creating a negative pressure differential in the first fluid flow path when the actuator is in the second configuration. a second fluid collection device operable to draw a volume of the bodily fluid sample into the fluid collection device; It is configured to create a negative pressure differential in the fluid flow path.

[0021] In some embodiments, the fluid control device is used to control bodily fluids with reduced contamination. The method of 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 cavity. In response to a negative pressure differential, bodily fluid is received from the inlet and into the isolated portion of the fluid control device. In response to contacting a portion of the initial volume of the The flow controller allows 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 in which the flow of gas and body fluid is prevented. 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 isolated portion.

[0022] As used in this specification and claims, the singular forms "a," "an," and "th" are used interchangeably. "e" includes multiple referents unless the context clearly dictates otherwise. Thus, For example, the term "an 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 a combination thereof.

[0023] As used herein, the terms "about," "approximately," and / or "substantially" When used in conjunction with stated values ​​and / or other geometric relationships, they are so defined. A defined structure is nominally a set of 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, about 0.01 can be considered to be greater than 0.009 and / or generally assumed to be greater than 0. 0.5 includes 0.45 and 0.55, and about 10 includes 9 to 11; About 1000 includes 900 to 1100. The stated values ​​may be preferred in some cases, e.g. Manufacturing tolerances or other practical considerations (e.g., through portions of devices, conduits, lumens, etc.) Some variation may occur as a result of the temperature, pressure or force applied to the As such, the terms "about," "approximately," and / or "substantially" are used herein. Such tolerances and / or considerations may be accounted for in the specification.

[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, Lymphatic fluid, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous humor, air, etc., or Any combination of these may be included, 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, respectively. 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, For example, diversion of a "pre-sample" volume of bodily fluid prior to collection of a "sample" volume of bodily fluid. This allows a body fluid sample to be obtained 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 body fluid. It can refer to a specified, desired, or given volume, portion, or amount. For example, 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 particular 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., an isolation The total volume of any number of lumens that form 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 administration 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 bodily fluids The volume can be from about 10 mL to about 60 mL. In another embodiment, the desired bodily fluid sample is The volume may be less than 10 mL or more than 60 mL. The volume may include one or more tests, chemical analyses, analyses, and / or processes that are 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 deliver bodily fluid to one or more fluid collection device(s). In some embodiments, the fluid collection device can be configured to transfer The device may be any suitable vessel, container, reservoir, bottle, adapter, dish, vial, syringe, device, These may include, but are not limited to, medical devices, diagnostic and / or testing equipment, and / or the like. As a specific example, in some embodiments, the present invention is not limited to the above. systems and methods for Parenterally Proc uring Bodily-Fluid Samples with Reduced U.S. Patent No. 8,197,420 ("'420"), entitled "U.S. Patent No. Any of those detailed in "Permits" (the disclosure of which is incorporated by reference in its entirety). Any of the embodiments and / or methods described herein may be used to sample the control volume. 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 culture bottle for receiving a body fluid sample. The body fluid sample can then be analyzed for, for example, gram-positive and gram-negative bacteria. , yeast, fungi, and / or any other organisms (e.g., in vitro). via an IVD test, and / or any other suitable test). The culture flask is capable of receiving a body fluid sample and the culture medium therein may be any suitable The culture medium may be tested for the presence of any suitable organism. A positive result from such testing is If so, the culture medium can then be tested using a PCR-based system to identify specific organisms. Additionally, as described in more detail herein, some In the example, a pre-test or initial volume of fluid is diverted to avoid inaccurate test results. To reduce and / or substantially eliminate contaminants in bodily 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 container may be empty prior to receiving the test volume or may be filled with any suitable additive, e.g. 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 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 In some embodiments, the at least one occupies at least a portion of an interior volume defined by the cavity. The sample reservoir may be filled with, for example, heparin, citrate, ethylenediaminetetraacetic acid (EDT A), including any suitable additives such as oxalates, SPS, and / or the like. Similarly, the additive may be added to the internal volume defined by the sample reservoir. In another embodiment, the sample reservoir comprises at least a portion of a The container may be any suitable container used for such purposes.

[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 any substance that is added to a body. are configured 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 present invention may include substances, liquids, solids, powders, lyophilized compounds, gases, and the like. Furthermore, when referring to the "additive" in the sample reservoir, the additive is contained in the culture flask. Culture media, such as aerobic and / or anaerobic culture media, culture flasks, such as those described above, and / or any other suitable reservoir of additives and / or any other suitable substance. or a combination of materials. The 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 Prior to accepting the flow of fluid, the volume of the fluid may be diluted with culture medium, additives, and / or any other suitable additives. The substance can be transferred to an uncontaining reservoir (etc.).

[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. Thus, 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 can be, for example, rigid, Selected based on one or more properties of the construction material, 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. The polymeric material may be They may be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactides, Polyglycolide, Polylactide-co-glycolide (PLGA), Polyanhydrides, Polyols Polyester, polyether ester, polycaprolactone, polyester amide, poly( poly(butyric acid), poly(valeric acid), polyurethanes, and / or mixtures and copolymers thereof Examples of non-biodegradable polymers include nylon, polyester, polycarbonate, etc. , polyacrylates, ethylene-vinyl acetate and other acyl-substituted cellulose acetates Polymers of cellulose, non-degradable polyurethanes, polystyrene, polyvinyl chloride, polyvinyl fluoride Poly(vinyl imidazole), 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 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 a number of pieces or features. When referring to a structure such as a component or a chamber, the structure may refer to a number of parts or components that are bonded together to form the structure. It may be considered a singular structure having multiple individual substructures, etc., combined together. A structure built into the body may, for example, include a set of substructures. A substructure may include multiple portions that are contiguous or discontinuous with one another. The set of substructures is fabricated separately and later joined together (e.g., by welding, adhesive, or may also be made up of 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") is The device (also called a "device") is configured to extract bodily fluids from a patient. The first portion or amount of bodily fluid (e.g., the initial amount) is greater than the second portion or amount of bodily fluid (e.g., the initial amount) that is collected. The fluid may then be used for additional testing or may be discarded. and / or reinjected into the patient. In this manner, 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 a biological sample for one or more tests (e.g. blood cultures, etc.) for therapeutic purposes The first portion or amount of the body fluid may 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 reinjected 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 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-containing 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. As described in more detail herein, As shown, bodily fluid enters housing 13 from a patient and / or other bodily fluid source via inlet 131. The outlet(s) 136 may be connected to a fluid collection device 180 (e.g., a fluid reservoir). A fluid can be in fluid communication with a reservoir or sample reservoir, syringe, vacuum vessel, etc. To this end, the control device 100 may be used and / or Operate to direct a volume of bodily fluid from a bodily fluid source through the inlet 131, the housing 130, and the outlet(s). The fluid can be selectively transported through 136 to a fluid collection device 180 .

[0037] The housing 130 defines one or more fluid flow paths 132 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 a volume of bodily fluid to be at least temporarily stored within the As described in more detail herein, the control device 100 and and / or housing 130, where bodily fluid is passing 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 (eg, by 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 chambers are arranged to allow fluid to flow therethrough. The bath 134 (1) receives a flow and / or volume of body 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 may have any suitable arrangement, such as those described herein with respect to the embodiments. However, the control device 100 and / or the housing 130 may be isolated in any suitable arrangement. The chamber 134 may include, but is not limited to, those shown and described herein. It should be understood that this is not intended to be a limitation of the present invention. For example, in some embodiments, an isolation chamber 134 may be at least partially formed by the housing 130. The isolation chamber 134 may be located 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 inlet 131 may define one or more lumens and / or may receive the flow of bodily fluid from the inlet 131. one or more lumen-defining devices configured to be inserted into the cavity, thereby defining a fluid flow path 133. 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 an isolation chamber 134. can be and / or can be prescribed.

[0039] The isolation chamber 134 may have any suitable volume and / or fluid capacity. For example, in some embodiments, the isolation chamber 134 may have a volume of between about 0.25 mL and about 5.0 mL. In some embodiments, the isolation chamber may have a volume and / or fluid capacity of 100 L. The chamber 134 may be configured to receive a volume of bodily fluid (e.g., The volume can be measured by the initial or first amount of bodily fluid. For example, 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 sufficient to accommodate any suitable volume (or any other suitable volume). In other embodiments, the isolation chamber 134 may be up to, e.g., about 5.0 mL, 10.0 mL, or less. L, 15mL, 20mL, 30mL, 40mL, 50mL or more of fluid In some embodiments, the isolation chuck may have a volume sufficient to accommodate the volume of the isolation chuck. The chamber 134 includes one or more lumens (e.g., a plurality of lumens) that fluidly connect the isolation chamber 134 to a source of bodily fluid. (a) having a volume equal to a fraction and / or a plurality of the volume of at least some of the can be done.

[0040] Although not shown in FIG. 1, in some embodiments, the isolation chamber 134 may include any and / or the isolation chamber 134 may include any suitable arrangement, configuration, and / or feature. formed of one or more materials configured to interact with a portion of the bodily fluid transferred into the For example, in some embodiments, the housing 130 may include a separation chamber 134. The present invention may 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, spread, or absorb at least a portion of the bodily fluid. and / or otherwise interact therewith, thereby causing at least an initial portion of the bodily fluid to The components may be isolated and / or held within 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) to a second state (e.g., 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 applied to the housing. 130 and / or transition the device 100 from a first state, position, configuration, etc. to a second state, position, configuration, etc. , 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 bodily 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 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 present invention 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 130) and / or otherwise control the flow of bodily fluids through the fluid flow passages 133 and and / or 154. The flow controller 120 may be, for example, a valve, membrane, diaphragm, restrictor, vent, selectively permeable A member (e.g., a fluid-permeable member) that at least selectively permits the passage of air or gas therethrough. impermeable barriers or seals), ports, joints, actuators, and / or the like or any suitable combination thereof. The controller 120 may be configured to control the flow of fluid through the isolation chamber 134 and / or the housing 1 30. Selectively control the amount of the signal in and / or out of any other suitable portion of 30 (at least a portion of In this context, for example, a fluid flow may be water, oil, dandelion, etc. The liquid may be a liquid, such as a peeing 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 may be a gas, such as any other suitable gas. 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 filter disposed in or around the opening. A flexible member or membrane that selectively allows air or gas to flow through the openings while The device is capable of restricting or substantially preventing the flow of fluid (e.g., bodily fluids such as blood) through the Cut.

[0042] In some embodiments, one or more flow controllers 120 or the like are control devices. 100. The device may be configured to facilitate the displacement of air (or other fluid) through one or more portions of 100. 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 allowing for equalization of pressure over a period of time. In some embodiments, the control device 100 can be configured to adjust the volume of bodily fluid to 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 can 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 or potential energy). In embodiments, the pressure differential 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 and / or other suitable portion). In some embodiments, the pressure differential may be generated automatically from: Or it may be established through direct or indirect intervention (eg, by a user).

[0043] Furthermore, the flow of fluids (e.g., gases and / or liquids) resulting from pressure differences can be, for example, One or more flow controllers capable of transitioning between one or more operating conditions to control the flow of a fluid. In some embodiments, the control may be selectively controlled via the controller 120. 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 flow control 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 is moved from a first state, in which it prevents the flow of gases and liquids therethrough, to a second state, in which it substantially prevents the flow of gases and liquids therethrough. In another embodiment, the flow controller 120 may be configured to transition to a state where one or more valves In some embodiments, the flow channel may include a flow duct, 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 these are presented as examples and not as a set of specific flow control techniques. Although a controller is described herein, the flow of fluid may be controlled by any suitable means. It should be understood that the above-mentioned components may be controlled 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, stop, seal, coupler, valve (e.g. For example, one-way, check valves, duckbill valves, and / or the like) and the like, 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 the transfer device. In another embodiment, 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 connection, drilling or puncturing 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 fluidly connect an interior volume defined by the fluid collection device 180 to 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 pre-coupled to the fluid collection device 180. 36 may 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 may be transitioned from a sealed configuration to a non-sealed 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 small amounts of bodily fluids, such as any of those described in detail above. The device may be any suitable device for temporarily housing the device. In some embodiments, the fluid collection device 180 may include a single-use disposable collection tube(s), a syringe, , collection tube(s) of a vacuum system, an 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. (e.g., in a container such as a vial, microvial, microlitter, etc.) and / or any suitable reservoir, vial, microvial, microlitter, etc. tor vials, nanoliter vials, containers, microcontainers, nanocontainers, and / or the like In some embodiments, the sample container may be substantially similar to or identical to known sample containers, such as those described in US Pat. In one embodiment, the fluid collection device 180 may include a sample reservoir, as described in more detail herein. A sample reservoir containing a vacuum seal that maintains a negative pressure condition (vacuum condition) inside the reservoir. The sample reservoir may be connected to a control device via vacuum or suction, so that the sample reservoir can be connected to a control device via vacuum or suction, so that the control device can be connected to a control device via suction. 100 and into a sample reservoir. In embodiments in which 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 to be isolated by the isolation chamber 134. and / or otherwise diverting fluid from the isolation chamber 134 into the fluid collection device 180. To allow for flow, the user couples a fluid collection device 180 to the outlet 136 to allow for flow of fluid from the patient. The flow of fluids can be initiated.

[0046] The outlet 136 of the control device 100 and / or the housing 130 may be connected to the fluid collection device 1 80 and / or otherwise fluidly connected thereto. However, 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, entitled "'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., the '510 and reducing contaminants in subsequent volumes of bodily fluids. The device may be capable of receiving and isolating 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 It is possible to obtain bodily fluid samples with reduced contamination from microorganisms such as those described above. For example, in some instances, users such as physicians, physicians, nurses, phlebotomists, and technicians may The device 100 is operated to couple the inlet 131 to a source of fluid (e.g., a patient's blood vessel, cerebrospinal fluid from the spinal cavity, Establishing fluid communication between the patient and the cerebrospinal fluid (CSF), urine collection, and / or the like. As a specific example, in some instances, the inlet 131 may be configured to pierce the patient's skin to allow the entry of a needle. At least a portion of the inlet 131 is manipulated to be inserted into a blood vessel of a patient, thereby allowing the inlet 131 to communicate with the body fluids. A source (e.g., blood vessel, IV catheter, PICC, etc.) and a fluid can flow through it. The catheter 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 can receive 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 defines 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 provide a fluid flow path 133 and and / or at least a portion of 154 are selectively exposed to negative pressure, thereby Operable to draw bodily fluid from a patient (e.g., a patient) through inlet 131 and into housing 130. A negative pressure difference is generated.

[0049] In some embodiments, the housing 130 is configured to receive a volume of bodily fluid at the inlet 131 and / or The initial portion of the volume of bodily fluid (referred to herein as the "initial volume" or "volume") as it is transported therethrough The first volume (also referred to as the “first volume”) is a volume of fluid that flows from the inlet 131 through at least a portion of the fluid flow path 133. In some embodiments, the separator 134 is arranged to flow into the separator 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 The fluid may be in a first or initial state in which it can flow. For example, in some embodiments The initial state of the control device 100 and / or the housing 130 may include one or more flow controllers. Controller 120 (e.g., a valve, membrane, diaphragm, restrictor, vent, air permeable and fluid impermeable barriers, ports, actuators, and / or the like, or combinations thereof) However, 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 the 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 separation chamber 134. .

[0050] For example, in some embodiments, the flow controller 120 may be 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 a gas or air a fluid-impermeable barrier or seal that allows selective passage of a fluid through a membrane, a selectively permeable membrane, a diaphragm, and / or the like. In some embodiments, The above example flow controller 120 may be, for example, a The components may be known commercially available components used in medical devices, but in other embodiments, - Controller 120 may be custom, 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, the flow control may allow the flow of fluid through the The flow controller 120 or any portion or component thereof is configured such that only the flow of air or gas is controlled. The flow controller 120 is configured to allow the flow of the fluid through the roller 120. configured to restrict and / or substantially prevent the flow of liquid (e.g., bodily fluid) through Therefore, the flow controller 120 is configured to direct the initial portion of the bodily fluid into the fluid flow path 154. and / or otherwise not allowing flow outside of the isolation chamber 134. When in the initial state, the fluid collection device 180 sequesters an initial portion and / or amount of bodily fluid. creating a negative pressure differential within the isolation chamber 134 that is operable to draw pressure into the isolation chamber 134; It can be achieved.

[0051] Although not shown in FIG. 1, in some embodiments, the control device 100 and / or the handheld device 102 may include a 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 include a valve, a membrane, a porous material, a restrictor, an orifice, and / or a pressure adjusting device. The present invention may include 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. By controlling and / or adjusting the amount of pressure exerted on the patient's bodily fluids and / or blood vessels, In some instances, such pressure adjustments can be used to adjust, for example, The possibility of hemolysis of the blood sample and / or collapsing blood vessels can be reduced (e.g. , requiring microbiological and / or other diagnostic testing in conjunction with the use of the control device 100. (This is especially important for frail patients.) In addition, the regulation of negative pressure can be achieved by, for example, the control device 100. at least in part, to determine the rate at which the device transitions between a first configuration or state and a 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 may be opened by adjusting the negative pressure. The amount or volume of bodily fluid transferred into 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 may be any suitable amount of bodily fluid. For example, in some instances, the control device 100 and / or the housing 130 may be and / or a desired volume (e.g., an 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 is filled with the 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 in 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 the embodiment, the initial volume is the volume of the isolation chamber 134 that is filled with the fluid collection device 180 (i.e., air Selective negative pressure of a flow controller 120, such as a liquid-impermeable member or membrane 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 fluid that is present may be related to and / or based at least in part on the amount or volume of bodily fluid present. 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 otherwise reduce the volume of bodily fluid (e.g., The initial volume may 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, separated, or separated within the isolation chamber 134. For example, in some embodiments, one or more of the flow controllers 120 The initial flow of the body fluid in the isolation chamber 134 is controlled by transitioning the state from the first state to the second state. The portions may be operable to be isolated and / or retained. As will be described in detail, in some instances, for example, the presence of skin that is expelled during venipuncture Contaminants such as microorganisms present in the sample, other external sources of contamination, the catheter used to collect the sample, Catheterization and PICC line colonization, etc., may result in contamination and / or inclusion of the initial volume of fluid. 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 is / are present in at least one of the fluid flow paths 133 and / or 154. transition to a second state in which flow can occur through the portion from the inlet 131 to the outlet 136 In some embodiments, the control device 100 and / or the housing 13 may be 0 indicates that the first state changes to the second state when an initial volume of bodily fluid is isolated within the isolation chamber 134. Able to transition to a different 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 the removal or diversion of negative pressure, and / or In other embodiments, the control device 100 and / or The housing 130 may be moved manually or at least with indirect interaction by a user. For example, in some embodiments, a user may actuate an actuator, etc. (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 may 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 may include, for example, a port, a flow passage, and / or One or more flow controllers 120 (e.g., actuators) that can open the outlets. In yet another embodiment, the ion exchanger 10 can be used to transfer and / or replace the ion exchanger 10 (e.g., ethanol). The user may use such a flow controller 120 (e.g., a switch, a valve, a port, an actuator, etc.) and operating a power supply (e.g., a power supply control unit) 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 the 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 assembly (or assembly(ies)) may 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 collection or acquisition of a test volume of one or more bodily fluids, isolation By isolating the initial volume of bodily fluid in chamber 134, contamination in one or more test volumes is prevented. The amount of contaminating material 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 within 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 at least in form and / or function similar to the fluid control device described above with reference to FIG. 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 (also referred to herein as a “control device” or The device includes 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 flow of body fluid is guided therefrom (e.g., through a needle, IV To accept via lumen containing devices such as catheters, PICC lines, etc. The outlet 236 may be, for example, a sample reservoir, a syringe, and / or other An intermediate fluid transfer device or container (e.g., a transfer device similar to those described in the '510 disclosure) and / or the like. It is being done.

[0058] As described above with reference to housing 130, housing 230 is isolating inlet 231. One or more fluid flow paths 233 and / or an inlet 231 and an outlet 236 between the chamber 234. The housing 230 of the device 200 defines one or more fluid flow paths 254 therebetween. The electrodes 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 functional as described above with reference to FIG. The isolation chamber 234 of the housing 230 may be substantially similar to the housing 130. is 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, the fluid may be arranged to flow through the opening.

[0059] As described in more detail herein, the isolation chamber 234 is adapted to: (1) prevent the flow of bodily fluids; (2) receiving a flow and / or volume of bodily fluid therefrom; To be constructed so as to separate (e.g., separate, spaced, 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 FIGS. 2-5, the isolation chamber 234 can have a fluid volume. The housing 230 may be formed, at least in part, by a lumen or flow passage. In some embodiments, at least a portion of the fluid flow path 233 is a part of the housing 230. 234 extending through the cavity 232 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 the 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 an isolation chamber formed by a flexible tube or the like that may be adapted to accommodate the suction of the fluid.

[0060] In some embodiments, the housing 230 and / or the isolation chamber 234 may include a flow The flow control may include, form, and / or define a controller 242. 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 the selective passage of gas or air, such as a liquid barrier, and / or the like. The fluid may be a body-impermeable barrier or seal, a port, or the like (collectively referred to herein as a "fluid"). More specifically, in the embodiment shown in FIGS. The flow controller 242 selectively permits the flow of gas but prevents the flow of liquid therethrough. A selectively permeable fluid barrier comprising and / or formed of a porous material configured to (e.g. blood barrier).

[0061] The flow controller 242 is positioned within the housing 230 to control the flow of the isolation chamber 2 34 and the fluid flow passage 254. As will be described in more detail below, the flow controller 242 is configured as a semi-permeable member. By this, the flow controller 242 is isolated from the gas or air flow path 254. The device may be configured to be at least temporarily transported between the storage chamber 234 and the storage chamber 234. 254 and the isolation chamber 234. It can be configured as follows.

[0062] The outlet 236 of the housing 230 is in fluid communication with the fluid flow paths 233 and / or 254. and / or are arranged so that a fluid can flow between them. As such, outlet 236 may be connected to a sample reservoir, syringe, container, and / or other sample outlet. 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 fluid collection device may be at least temporarily coupled to the chair or may be integrally formed with the chair. The fluid collection device may be, for example, any of those 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 first portion or first portion of the bodily fluid can be configured to couple to a bodily fluid reservoir. The final portion is transferred into and isolated by the isolation chamber 234. and any subsequent portions or volumes of bodily fluid are bypassed and / or otherwise isolated from the chamber. The user may direct the sample to flow away from the sample reservoir 234 and into the sample reservoir. The 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 adapted 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 actuator 250 and a part of the flow path 254. At a distance from, away from, the junction between the flow path 233 and the isolation chamber 234, and / or Although shown positioned downstream, in other embodiments, the actuator 250 , may be provided in any suitable location within the housing 230. For example, in some embodiments In the embodiment, the actuator 250 includes a fluid flow path 233, a separation 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 present invention may be any suitable member or device configured to transition between the above-mentioned components. In this embodiment, when the actuator 250 is in the first state, it is in communication with the fluid flow path 233. Separate, isolate, separate, and / or otherwise provide fluid communication between the body flow passage 254 and the When in the second state, the fluid passage 233 is configured to block the fluid passage 254. In some embodiments, e.g., The actuator 250 may be a valve, a plunger, a seal, a membrane, a flap, a plate, and / or a 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, The actuator 250 may actuate the flow channels 233 and 25 4. 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 enables fluid communication between the fluid flow paths 233 and 254. The actuator may include any suitable actuator or device configured to: Therefore, although specifically illustrated in FIGS. 2 to 5, the control device 200 is not limited to the above. It should be understood that this is presented as an example. For example, actuator 250 is shown in FIG. Although the actuators are shown in a given position in FIG. The actuator 250 may be located 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 a first state, the flow of bodily fluid is from the inlet 231 to the isolation chamber 2 34 when the actuator 250 is in the second state. 231 directly into the fluid flow path 254. In other words, the actuator 2 When the actuator 250 is in the first state, the actuator 250 causes bodily fluid to flow from the inlet to the isolation chamber 2. A portion of the isolation chamber 234 may be formed to flow directly into the access 34. When activating, positioning, and / or transitioning the actuator 250 to the 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 move the isolation chamber 234 Operable to at least partially isolate the inlet 231 and / or the fluid flow path 233. could be.

[0066] Further, 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. The actuator 2 can transition between the first and second states. 50, 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 a 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 rate, etc. Examples of actuators and / or ways in which actuators can transition are provided herein. Although provided in the specification, they are presented only as examples and not as limitations. It should be understood that the control device 200 may therefore be adapted to transition in any suitable manner. The actuator may include any suitable actuator configured.

[0067] As described above, the device 200 can be used to detect, for example, microorganisms present on the skin and / or similar. It is possible to obtain a body fluid sample having reduced contamination from microorganisms such as those of For example, in some instances, users such as doctors, physicians, nurses, phlebotomists, and technicians may The chair 200 may be operated to provide 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 passage 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 exposed to negative pressure, which draws bodily fluid from a bodily 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 is adapted to accommodate 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 The initial volume (also called the “initial volume” or “first volume”) is a volume that flows from the inlet 231 through the fluid flow path 233. , through at least a portion of the separation chamber 234. That is, in some embodiments, the control device 200 and / or the housing 230 , an initial portion or volume of bodily fluid is introduced 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 is capable of flowing into the segregation 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 the control device 200 are in an initial state. Therefore, the actuator 250 is directly connected between the fluid flow paths 233 and 254. Separate, separate, separate, isolate, and / or otherwise prevent the flow of fluid therethrough. 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 increased by the housing 230 and / or the control device 200 being first or initial state, an initial flow of body fluid is directed from the inlet 233 to the isolation chamber 234. A negative pressure (or negative pressure) is provided within at least a portion of the isolation chamber 234 that is operable to draw in It is possible to generate a pressure difference.

[0070] When the flow controller 242 is in a first or initial state, the housing 130 As described above with reference to a fluid collection device (e.g., a sample reservoir, a 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 a fluid (e.g., gas or air) therethrough. In some instances, it may be desirable to regulate 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 control unit 242 defines a fluid flow passage 254 and a restricting flow passage 232 through which a fluid can flow. More specifically, the restricted flow passage 232 has a diameter smaller than at least the fluid flow passage 254. A fluid flow path having a

[0071] For example, in some embodiments, the restricted flow passage 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 may have a diameter less than 0.0005 inches or greater than 0.5 inches. In some embodiments, the restricted flow passage 232 is about 0.01 inches, about 0.05 inches, about 0.06 inches, about 0.08 inches, about 0.09 inches, about 1.0 ... 0.1 inch, about 0.15 inch, about 0.2 inch, about 0.5 inch or more of a given and / or can have any desired length. In other embodiments, the restriction channel 232 is 0.01 may have a predetermined and / or desired length of less than about 0.5 inches or more than about 0.5 inches. Further, in some embodiments, the restricted flow path 232 is at least one of the control device 200. The diameter and length to allow and / or provide desirable flow characteristics through the portion. The thickness may have any suitable combination of thicknesses.

[0072] In this embodiment, when the restrictive flow passage has a larger diameter, the The restriction flow path 232 is configured to reduce the amount of negative pressure applied through the isolation chamber by more than the amount of 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 the 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 at or substantially near atmospheric pressure at sea level (e.g., negative magnitude) In some embodiments, a fluid collection device, such as a vacuum vessel, may be used to generate 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 restriction flow path 232 may be used to increase the flow rate of the separation chamber. There may be a delay or build-up of negative pressure applied to or within the isolation chamber.

[0073] Further, in this embodiment, the restricted flow path 232 may be configured to restrict the flow of liquid (e.g., bodily fluids), for example. Rather, it is a gas flow path configured to receive a flow of gas or air. In this embodiment, the diameter of the restriction passage 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 is substantially blocked by a trap 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 described, 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, a valve, a membrane, a diaphragm, a specific restriction, a vent, a deformable member or a flow passage and / or In other embodiments, the control device may include any suitable number of each restriction flow passage 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 an embodiment, each restriction The flow passage 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 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 permit 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 can be configured to adjust 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 overcome physiological difficulties. so that sudden forces can be applied to facilitate collection of bodily fluids, e.g. blood. Not flattened, collapsed, invaginated, and / or otherwise impaired in its patency and blood collection ability 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 for a wide range of patients, many of whom do not have sufficient It is Noh.

[0076] As described in detail 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 completely 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., In some implementations, the volume may be sufficient to transition the liquid to a saturated or fully wetted state. In one embodiment, 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 is 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. 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 its second state or mode of operation. To isolate, separate, hold, contain, or separate the initial volume within 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 applied otherwise on or through the isolation chamber 234 Here, on 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 236. 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. Each of the transitions to the second state causes an initial portion of the bodily fluid in the isolation chamber 234 to be isolated. As described in more detail herein, In some cases, such as 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 thus 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 handheld device 202. When the housing 230 is in a second state (e.g., an initial volume of bodily fluid is in or around the isolation chamber 234), 2, any subsequent volume(s) of body fluid is / are 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, a test volume of one or more 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. Further, 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 may be arranged so that they cannot transition to the second state. .

[0079] The control device 200 may be configured to switch between a first state and a second state (e.g., by a user). The actuator 250 is configured to move the actuator 250 (through a force applied to the actuator 250). 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. For example, Figures 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. The device 100 and / or the fluid control device 200 described above with reference to FIGS. The fluid control device 100 and the fluid control device 110 may be similar in form and / or function. and / or 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 may be configured to couple a source of bodily fluid with the fluid. and a catheter adapted to receive a flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle). The outlet 336 is configured to receive a fluid collection device (see FIG. 6-8 ). The fluid communication device is configured to be fluidly coupled to a fluid communication port (not shown).

[0081] As described above with reference to housings 130 and / or 230, housing 330 may include: The inlet 331 is selectively arranged in fluid communication with the isolation chamber 334 and / or the outlet 336. The fluid passages 333, 354A, and 354B are 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 following configuration and / or or function may be substantially similar to the housings 130 and / or 230 described above. In some embodiments, the housing 330 may include at least one separator 334, for example. 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 via the fluid passage(s). 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 have at least air or gas therebetween. 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 adapted to: (1) prevent the flow of bodily fluids; (2) receiving a flow and / or volume of bodily fluid from an inlet 331; To be constructed so as to separate (e.g., separate, spaced, 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 the isolation chamber 334 may be , a flow controller 342, which may be substantially similar to the flow controller 242 described above. As such, as described in more detail herein, Additionally, a flow controller 342 is positioned within the housing 330 to control the flow of the isolation chamber. 334 and fluid flow passage 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 disposed in fluid communication with the fluid. 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 ). ) or the like. and the fluid collection device each have the outlet 236 and The fluid collection devices may be substantially similar to each other. The body collection device is not described in further detail herein.

[0084] As shown in FIGS. 6-8, the housing 330 is adapted 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 form and / or function. 2-5, which may be substantially similar to the actuator 250 described above. However, in this embodiment, the actuator 350 is arranged as a plunger. A set of seals 365 are provided 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 actuator 350 is in communication with the fluid flow passage 333 and the fluid flow passage 340. Separate, isolate, separate, and / or otherwise impede fluid communication between the passage 354B and the passage 354C. 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, the device 300 can be used to detect, for example, microorganisms present on the skin and / or similar. It is possible to obtain a body fluid sample having reduced contamination from microorganisms such as those of In some instances, users such as doctors, physicians, nurses, phlebotomists, and technicians may The sensor 300 may be operated to provide fluid communication between the inlet 331 and a source of bodily fluid (e.g., a patient's blood vessel). An inlet 331 can be established to allow fluid communication with a source of bodily fluid (e.g., a portion of a patient). Once enabled, the outlet 336 may be fluidly coupled to a fluid collection device. In the embodiment shown in FIGS. 6-8, the fluid collection device may be, for example, a vacuum reservoir, a syringe, and / or may be any vessel that defines a negative pressure.

[0086] By coupling outlet 336 to a fluid collection device, fluid flow paths 354A and 354B are 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, the actuator 350 separates the fluid flow path 354B from the fluid flow path 333, Therefore, the fluid flow path 333 is not subjected to a negative pressure differential generated by the fluid collection device. As described above, the flow controller 342 is arranged to A and is in fluid communication with the isolation chamber 334. More specifically, the 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, e.g., FIG. 8). Thus, by coupling the 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 body fluid source (e.g., a patient) through inlet 331 and into housing 330. A negative pressure difference is generated that is operable when retracting. As discussed above, the housing 330 is adapted to allow a volume of bodily fluid to enter and / or pass through the inlet 331. When the fluid is transferred through the first portion of the volume of the body fluid (referred to herein as the "initial volume" or "first volume"), " (also referred to as "flow suction") is arranged to flow from inlet 331 and into isolation chamber 334. That is, in some embodiments, the housing 330 may accommodate 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 may 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 the 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, keep separate, spaced apart, 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 in 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 the inlet 331 and into the isolation chamber 334. A negative pressure (or negative pressure differential) can be created within at least a portion of the chamber 334. As discussed in detail 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 the 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 fluid that is present may be related to and / or based at least in part on the amount or volume of bodily fluid present. In other words, in some embodiments, the initial volume of bodily fluid is The volume may be sufficient to transition to state 2 (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 a second state, the flow through the flow controller 342 is , isolated, blocked, separated, kept separate, spaced apart, and / or otherwise Be prevented.

[0089] After the initial volume of bodily fluid has been transferred and / or diverted into the sequestration chamber 334, the control device The device 300 and / or housing 330 are transitioned to its 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 sealing configuration. Thus, substantially preventing the flow of fluid therethrough. The flow controller 350 is connected to the flow controller 342 when 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. , thereby causing the actuator 350 to transition from its first state to its second state. For example, in some embodiments, , the negative pressure causes the actuator 350 to move from a first position (e.g., a first state) to a second position ( 3B, thereby eliminating fluid communication between fluid flow paths 333 and 354B. The device is operable to establish communication.

[0090] More specifically, moving (or otherwise) the actuator 350 to its second position. , by transitioning the actuator 350 to its second state) to cause a fluid to flow therebetween. The seal 365 is moved relative to the fluid flow paths 333 and 354B to allow flow of the Therefore, the separation chamber 334 may be moved onto or through the separation chamber 334. The negative pressure otherwise applied by the flow passage 333 and 354B or by the flow passage 333 In response, the body fluid is directed from the inlet 331 through the 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 can be By transitioning from each of the first states to each of the second states, the isolation chamber The device is operable such that an initial portion of the bodily fluid within 334 is isolated and / or retained. As described in more detail herein, in some instances, for example, the ejection during venipuncture may be Contaminants, such as microorganisms, present on the exposed skin may be mixed and / or contained in the initial volume of body fluid. Thus, when the initial volume is isolated therein, the separation chamber 334 will 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 the housing 330 is in a second state (e.g., an initial volume of bodily fluid is in or around the isolation chamber 334), 3) is isolated by a chamber of any subsequent volume(s) of body fluid through inlet 3. 31, through fluid flow paths 333 and 354B, through outlet 336, and through a 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 prior to collection or acquisition of the bodily fluid. Thus, the amount of contaminants in one or more test volumes is reduced and / or substantially eliminated. Further, in some embodiments, the housing 330 may be configured to include 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 corresponds, at least 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. The fluid control device 300 may be similar to that described above with reference to FIG. A fluid control device 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 a housing 430 coupled thereto. As described above with reference to 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 described 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 inlet 431 and directs the flow of body fluid and / or To isolate a volume (e.g., to 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 430. 34. The size of the device is based at least in part on the volume of fluid to be at least temporarily stored within the device. For example, the embodiment shown in Figures 9 and 10 may include the As described above, the housing 430 may be configured to accommodate a syringe-like device or the like (at least (partially) are also arranged.

[0095] The housing 430 is in selective fluid communication with the outlet 436 to allow the flow of fluid therethrough. Fluid flow paths 433 and 454 for selectively accepting 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 disposed in fluid communication therewith. Additionally, the 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 be connected to a control device. 200. Thus, the outlet 436 and the fluid collection device are further described herein as does not go into 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 an actuator 450 configured as a The actuator 450 is movably disposed within the housing 430 and is configured to A first plunger 460 and a second plunger 470 configured to at least partially define a More specifically, the actuator 450 includes an inlet 431 that is an isolation channel. In a first state (FIG. 9) in which the chamber 434 is arranged to be in fluid communication with the chamber 434, the inlet 431 is in a fluid flow state. 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 through a 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 the isolation chamber. A spring 434 is formed on the side of the first plunger 460 opposite the spring 434 by the housing 430. As shown, the damping chamber 437 is positioned so that the The port 435 is configured to be disposed so as to be capable of communicating with the fluid flow path 433. at least selectively allowing fluid communication between the fluid flow passage 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 be When in the first state, the damping chamber 437 contains a gas (compressed or uncompressed) and / or a liquid. A 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 passage 454. Located within the housing 430 to separate, separate, and / or isolate In addition, the second plunger 461 and / or a seal formed or attached thereto may 465 fluidly separates the fluid flow passage 454 from the isolation chamber 434. When the actuator 450 and / or the control device 400 are in a first state, the inlet 431 is in fluid communication with isolation chamber 434 and includes fluid flow paths 433 and 454 and 9. The outlet 436 is fluidly isolated from the outlet 436 (see FIG. 9). Thus, the actuator 450 and / or the control device 400 may be configured to control the isolation chamber 434 so that The inlet 431 is arranged in fluid communication with the fluid passage 454. The state can be configured to transition to a second state that is determined by the first 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. It is possible to obtain a body fluid sample having reduced contamination from microorganisms such as those of In some instances, users such as doctors, physicians, nurses, phlebotomists, and technicians may The sensor 400 may be operated to provide fluid communication between the inlet 431 and a source of bodily fluid (e.g., a patient's blood vessel). An inlet 431 can be established to allow fluid communication with a source of bodily fluid (e.g., a portion of a patient). 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, for example, a true It may be an empty reservoir or container.

[0100] As shown in FIG. 9, the actuator 450 and / or the 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 in fluid communication with damping chamber 437. , is fluidly isolated from the inlet 431 and the isolation chamber 434 (e.g., As described above, the outlet 436 can be coupled to a fluid collection device. 4, at least a portion of the fluid flow paths 433 and 454 are exposed to the negative pressure in the fluid collection device. The actuator 450 and / or the control device 400 are in a first state. When the second plunger 461 is in the housing 430 and / or the isolation chamber 434, the second plunger 461 may be driven to flow through the housing 430 and / or the isolation chamber 434. 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 to , 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 can be 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 a 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 housing 430 and the spacer 461 increases (i.e., the isolation chamber). 434) (the volume of the 434 increases). In this embodiment, the increase in the volume of the isolation chamber 434 creates a negative pressure therein, which 4, when drawing an initial volume of bodily fluid through inlet 431 and into isolation chamber 434. In other words, the negative pressure of the fluid collection device can sequester the initial volume of bodily fluid. An inlet 431 operable to retract 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 1 moves in the same manner. For example, in some embodiments, the actuator 450 After the plunger 460 has moved a predetermined amount (and / or the volume of the isolation chamber 434 has a predetermined amount) and after the initial volume of bodily fluid is drawn into the isolation chamber 434, To move the plunger 461 from a first position and / or configuration to a second position and / or configuration The actuator 450 is arranged to provide a transition between the isolated and The second state is such that the second valve 434 is isolated from the inlet 431. The plunger 461 and / or a seal 465 coupled thereto may couple the inlet 431 to the fluid flow passage 4 54 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 further detail herein, in some examples For example, contaminants such as microorganisms present on the skin that are expelled during venipuncture may be present in the initial may be mixed and / or contained in the initial volume, thus isolating the initial volume therein. When the liquid is absorbed, 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, an 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. Further, in some embodiments, the housing 430 is preferably a housing 4 30 transitions to a second state before collecting and isolating the initial volume in the isolation chamber 434. It can be placed so that it cannot be.

[0104] As described above with reference to the 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 The amount of negative pressure applied is adjusted. The damping fluid 456 in the chamber 437 damps the negative pressure applied to the first plunger 460. Therefore, the actuator 450 and / or the control device 400 are 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 bodily 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 a 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 attenuating and / or regulating the magnitude of the negative pressure may be used to control the actuator. The transition of the air 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 include: 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 may be 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”) 5, also referred to as an actuator 550, has an inlet 531 and an outlet 536. The control device 100, 200, 300, and / or 400 includes a housing 530. As mentioned above with reference to the above, the inlet 531 is in fluid communication with a source of bodily fluid, The needle is configured to receive bodily fluid (e.g., via a lumen-containing device such as a needle) from the The outlet 536 is fluidly connected 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 therefore will not be described in further detail herein. stomach.

[0106] As described 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 inlet 531 and directs the flow of body fluid 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 configuration. 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 in 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 therethrough ( 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 is adapted to allow the flow of bodily fluid through the housing 530. and / or comprising 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 includes an inlet 531 that is connected to the isolation chamber 5 11 in which the inlet 531 is disposed in a fluid flow path 55 and the inlet 532 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 thereto. 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 by a housing 540 defined between a diaphragm 576 and one or more seals 565. 30. Additionally, as described above with reference to housing 430, Thus, the diaphragm 576 is disposed on the opposite side of the attenuation chamber 537 from the isolation chamber 534. The damping tube 520 is disposed in a first state as defined by the housing 530 on the side of the damping tube 520. 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 passage 533 and the damping chamber 537. An opening, a valve, a membrane, a septum, and / or a catheter configured to at least selectively establish bodily communication. The actuator 550 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 and / or liquids (e.g., water, oil, damping fluids, and / or any other suitable The control device 400 may include and / or contain a damping fluid, such as a damping fluid (e.g., a liquid). As described above, the arrangement of the damping chamber 537, damping fluid, and port 535 is controlled by the actuator. The amount of negative pressure applied to the diaphragm 576 when the actuator 550 is in the first state is adjusted. 11 and 12 are shown as adjusting the negative pressure via a damping fluid. However, it should be understood that this is provided by way of example only and not by way of limitation. Any other suitable means for attenuating and / or regulating the magnitude of 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 may be fluidly separated, distinct, and / or configured to be fluidly separated from the fluid flow passage 554. The seals 530 are positioned in the housing 530 to isolate the seals 530. 65 fluidly separates the fluid flow passage 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 a fluid passage 554 through which the fluid The second state can be configured to transition to a second state in which the second state is circulated (see FIG. 12). ).

[0110] As described in detail above, device 500 can be used to detect microorganisms present on, for example, the skin. and / or the like. 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 550 may be 00 is in a first or initial state prior to coupling the outlet 536 to a fluid collection device. Therefore, as described in detail above with reference to the control device 400 of FIGS. As such, fluid flow passage 533 is in fluid communication with damping chamber 537, and fluid flow passage 554 is in fluid communication with damping chamber 537. Fluidically isolated from the inlet 531 and the isolation chamber 534 (e.g., by one or more seals via 565).

[0111] The outlet 536 is coupled to a fluid collection device to allow for the flow of fluid through the fluid channels 533 and 554. At least a portion of the fluid collection device is selectively exposed 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 the isolation chamber 534 against the fluid flow path. 554. Conversely, negative pressure applied through fluid flow path 533 At least a portion of the negative pressure is directed onto the damping chamber 537 (e.g., via port 535). In some embodiments, for example, the port 535 may be operable to receive 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 be used to force damping fluid out of the damping chamber 537 and into the fluid flow. In addition, the negative pressure draws the diaphragm 576 from the first configuration or state (FIG. 11). 12) to a second configuration or state (FIG. 13), or As described above with reference to the actuator 450, the diaphragm 576 is first The transition from the first state to the second state causes 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 534 531 and into the 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 move against the diaphragm 57. 6, one or more seals 565 are similarly moved to be provided on the same side of the inlet 531 as Thus, the isolated chamber 534 is isolated within the housing 530. In addition, one The above seal 565 is configured to establish fluid communication between the inlet 531 and the fluid flow passage 554. Therefore, the fluid flow path 533 may be moved to the other side of the fluid flow path 533. Negative pressure is now applied on or through the fluid flow path 554. As described in detail above, bodily fluid passes from inlet 531 through fluid flow path 554 to outlet 536. and into the fluid collection device. In some embodiments, By transitioning the actuator 550 from a first state to a second state, the isolation channel and operable to isolate and / or retain an initial portion of the bodily fluid within chamber 534. The initial portion of the fluid is contaminated with 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 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 500 and / or the housing 530 may include a control The control device 500 and / or the housing 530 collects an initial volume in the isolation chamber 534. and isolating the first state from the second state.

[0113] 13-15 show a fluid control device 600 according to one embodiment. The device 600 may be any of the fluid control devices 100, 100A, 100B, 100C, 100D, 100E, 100F, 100G, 100H ... 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. As shown in FIGS. 13 to 15, a fluid control device 600 (also 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 bodily fluid (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 described above, the housing 630 of the control device 600 is configured to: (1) control the flow of bodily fluids and / or (2) a volume is received from inlet 631; and (3) a volume is contained within and / or attached to housing 630. The flow and / or volume of bodily fluids within the isolation 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 segregation chamber 6 34. The size of the device is based at least in part on the volume of fluid to be at least temporarily stored within the device. For example, in the embodiment shown in FIGS. 13 to 15, the housing 630 may include: 11 and 12. That is, the housing 630 includes an actuator 650 arranged as a diaphragm. nothing.

[0115] The housing 630 is in selective fluid communication with an outlet 636 for allowing a fluid (e.g. A set of fluid flow paths configured to selectively receive a flow of a fluid (e.g., liquid and / or gas) through the fluid flow paths. The housing 630 defines a flow passage 633 and a flow passage 654. The housing 630 defines a flow passage 633 and a flow passage 654. 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 a segregation chamber 634. More specifically, the control device 500 includes a diaphragm 676 formed thereon. As described above, the actuator 650 is configured to allow the inlet 631 to communicate with the isolation chamber 634 in fluid communication. In the first state, the inlet 631 is arranged to be in a position where the fluid flows through the fluid passage 654 and the outlet 636. The fluidly disposed second state is configured to move between the fluidly disposed second state.

[0116] As shown in FIGS. 14 and 15, when actuator 650 and / or 600 is in a first state, At one time, the inlet 631 is a housing defined between a diaphragm 676 and one or more seals 665. 5. The housing 530 is in fluid communication with a portion of the housing 630. As described above, the diaphragm 676 is disposed 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 damping chamber 637 is connected to a port 635 (such as that described above). 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 configured to include and / or contain a damping fluid, such as a damping fluid, and adjust the amount of negative pressure applied to the diaphragm. Although it is described as adjusting the negative pressure via a damping fluid, this is not a limitation. It should be understood that the present invention is not limited to the above and is presented merely as an example. 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. from the fluid flow path 654. In addition, a seal 665 is provided at a location within the housing 630 to isolate the fluid flow path 654. The actuator 650 and / or the device 634 are therefore fluidly isolated from each other. When the vice 600 is in a first state, the inlet 631 is in fluid communication with the isolation chamber 634. 10 and is fluidly isolated from the fluid flow passage 654 and the outlet 636. The isolation chamber 634 isolates the heater 650 and / or the 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 steps shown in FIGS. In a manner substantially similar to the device 500 described above with reference to the A bodily 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 any of the fluid control devices 100, at least in form and / or function. 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, from which the body fluid The fluid is adapted to receive the 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, the outlet 736, and the fluid collection device are configured as described above. and therefore will not be described in further detail herein.

[0119] As described 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 inlet 731 and directs the flow of bodily fluid 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 shape. 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 in the reservoir 734. For example, in the embodiment shown in FIGS. 16 to 18, the housing 730 can be arranged substantially similarly to the housings 530 and / or 630. the housing 530 includes an actuator 750 arranged as a diaphragm; and / or is attached to it.

[0120] The housing 730 is in selective fluid communication with an outlet 736 (see, e.g., FIG. 17A and 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 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 within the housing 730 and defines the isolation chamber 734 at least 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 adapted to actuate the inlet 731 in the isolation chamber. In a first state, the inlet 731 is disposed so as to be capable of communicating with the member 734, and in a second state, the inlet 731 is disposed so as to have a fluid flow path 754. configured to move between a first state in which the outlet 736 is disposed in fluid communication with the first state 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 a diaphragm 776 and a 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 is provided between the flow controller 710 and the flow control unit 720 (any other flow controller, such as any other flow controller). The diaphragm 77 is in fluid communication with an isolation chamber 734 formed by the diaphragm 77. 6 is provided in a first state such 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 A diaphragm 776 and / or a seal 765 fluidly separates the inlet 731 from the fluid flow passage 754. The housing 730 may be provided at a location such that the In addition, the diaphragm 776 and / or the seal 765 separate the fluid flow passage 754 from the isolation chamber 73. 4. Thus, 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 passage 754 .

[0122] For example, as described above with reference to the control device 200, the actuator 750 and / or Alternatively, when the device 700 is in the first state, a negative pressure difference in the isolation chamber 734 can This can occur by coupling a collection device to the outlet 736. More specifically, the 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 600 may be configured as described in detail above with reference to the device 600. The isolation chamber 734 is configured to house the ionizer 750 and / or the control device 700 in the housing 730. and in a second state in which the inlet 731 is arranged to be in fluid communication with the fluid flow path 754. More specifically, the initial volume of bodily fluid can be configured to transition to an isolation chamber. 734, thereby transitioning the flow controller 742 to the first state or can be saturated, wetted, or can be converted from an open state to a second state or closed state. In some embodiments, the flow control The transition of the filter 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 can Transitioning, switching, or inverting diaphragm 776 so that eta 750 is in its second state The device may be operable to change, move, transform, and / or otherwise reconfigure. 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 used to obtain bodily fluid samples that are less contaminated by 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 assemblies or integrated devices. 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 devices can be opened and the control devices 100, 200, 3 A device as described above with reference to 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 automatically adjust 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 to the collection path(s) and connection interface(s) (e.g. , where the control device couples to the fluid collection device) to prevent touch point contamination from external sources. Maintaining the closed system mechanical flow diversion device in a sterile environment free from contamination. In order for a user to transfer a test volume to a fluid collection device, the user must determine an initial volume of bodily fluid. or first forcing the isolating, isolating, and / or isolating at least a portion of the stream. In some embodiments, the fluid control device is coupled to the fluid collection device. The connection and / or installation must be performed by removing (physically disconnecting, especially and / or to separate the control device from the fluid collection device. other techniques used to obtain a fluid collection device, The fluid collection device is then positioned in an incubator and / or any other type of analytical machine. The information 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 prior to use. In another embodiment, the fluid control may be The device and the 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 used based on desired use, preferences, patient, etc. The system may include one or more modular components that can be selected by the user. In such an embodiment, a user may select 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. 1 shows a fluid control device 800, which may be at least The fluid control device may be similar to the fluid control device described herein. More specifically, 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 (not shown) includes a housing 830 and an actuator 850. The sensor 800 may be at least partially integrally formed or may be preassembled during manufacture. In another embodiment, the control device 800 can be mounted on the housing 8 30 and actuator 850 are physically and fluidly coupled to form control device 800. The device 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, for example, relatively thin. In some embodiments, a portion of the housing 830 may be substantially rectangular. 2-5, at least in form and / or function. Therefore, although such parts are specified, the same configuration may be used. Some 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 insulating chamber 834 selectively fluidly communicates with the port 846 . The first port 845 and the second port 846 are at least one port that is connected to a portion of the actuator 850. 8. The actuator 850 may be fluidly coupled to the housing 830. As described in more detail herein, the isolation Chamber 834 includes: (1) a first port 845 for selectively allowing the flow of bodily fluid and / or the flow of bodily fluid therethrough; (2) to receive the load from a portion of the actuator 850; and (3) to receive the load from an isolation chamber 83. 4. The flow and / or volume of fluid (e.g., the initial or second flow of fluid or any portion thereof) in the to separate (e.g., separate, separate, contain, hold) one flow and / or volume The isolation chamber 834 may be configured to have any suitable shape. The shape, size, and / or configuration of the ion exchange membrane may be any shape, size, and / or configuration. For example, in some embodiments, Isolation chamber 834 may include any suitable ion exchanger, 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 that passes through at least a portion of the housing 830. A fluid flow path 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 are not described in further detail herein.

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

[0130] As shown, the housing 830 defines a restricted flow path 832 that is in fluid communication with a second port 846. The second port 846 is in fluid communication with the flow controller 842 (or 842) is positioned between the housing 830 and the 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 is a fluid flow path having a diameter smaller than the 32 is about 0.0005 inches to about 0.5 inches, as described above with reference to the restricted flow passage 232. The diameter of the tube may be about 0.01 inches to about 0.5 inches. As described above, the smaller diameter of the restriction passage 832 allows the restriction passage 832 to flow more efficiently. When the diameter of the separator 834 is larger than the magnitude of the negative pressure being applied through the separator 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. Further, in this embodiment, the restricted flow path 832 can be configured to, for example, allow the liquid (e.g., a gas flow path configured to receive a flow of gas or air rather than a flow of liquid , sufficient to adequately collect an initial amount of bodily fluid, and / or at least A negative pressure difference sufficient to transition at least a portion of the body to the second state can be provided, 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 231 and the outlet 236 may be substantially similar to those described above with reference to FIG. Inlet 852 is in fluid communication with a source of bodily fluid and allows the flow of bodily fluid therefrom (e.g., (through lumen-containing devices such as needles, IV catheters, PICC lines, etc.) The exit 853 may be configured, for example, as 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 25. The fluid collection device 880, such as a ... an adapter, or a reservoir (see, for example, 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 The first port 858 includes and / or defines a second port 859. The first port 858 is in communication with 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 configured to be at least fluidly coupled to each of the first and second ports 846. As described in more detail herein, the actuator 850 is a first operating mode. 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 fluids into and / or out of 834 can be selectively controlled.

[0133] In some embodiments, ports 858 and 859 of actuator 850, and The arrangement 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 may Ports 845 and 846 of housing 830 may be fitted with a friction fit, press fit, or interference fit. , and / or the like. 50 ports 858 and 859 may be fitted with adhesives, mechanical fasteners, elastic joints, gaskets, O 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. The ports 858 and 859 of the etrator 850 may be, for example, one or more sterile, flexible The housing 830 is connected to ports 845 and 846 via an intervening structure such as a 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 example, have one or more desirable properties based on the objective and / or use of the assembled device The housing (or actuator) that is used can be selected by the user. The modular arrangement allows one or more components having desired properties to be combined during manufacturing. It may be possible and / or easy to make and / or assemble. For example, In some instances, a handheld 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 the device is used to obtain bodily fluids from a patient (for example), an apparently healthy adult patient When using the device to obtain fluid from a When it is desirable to select a housing that defines and / or includes an isolation chamber having Therefore, such a modular configuration allows users (e.g., physicians, For example, doctors, nurses, technicians, phlebotomists, etc. may use the device based on its intended use. Allows selection of a housing or actuator with one or more desired characteristics In another example, the modular arrangement can be used to A housing or a device that has one or more desired characteristics can be produced during manufacturing without significant modification. 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 a body 862 of the actuator 850 having an actuator rod 862. At least one of the ribs 851 extending beyond 51 is provided within the body 851 (see, for example, FIG. 23 and 24). A portion of the actuator rod 862 includes a pair of seals 865. and / or coupled thereto. The seal 865 may be, for example, an O-ring, an elastomeric overmolding, The actuator may be a flange, a protruding or raised feature or fitting, and / or the like. The inner portion of the seal 865 is a seal 862 and a body 851 of the actuator 850. , which forms 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 may include and / or be coupled to three seals 865.

[0136] The actuator rod 862 is movable between a first position or configuration and a second position or configuration. The body 851 is configured to be moved or translated relative to the body 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. In this manner, the actuator rod 862 can be positioned in its first position and / or configuration. The force applied to the first end 863 of the actuator rod 862 may 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. or configuration, the inlet 852 of the actuator 850 is in fluid communication with the first fluid flow passage 833. The actuator 850 has an outlet 853 in fluid communication with a second fluid flow path 854. In some examples, as shown in FIG. 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 first fluid passage 850 is in fluid communication with a second fluid passage 854. , while the first fluid flow path is isolated or separated from the inlet 852 and the outlet 853. and / or otherwise not fluid-permeable. The first port 858 is in fluid communication with the first fluid flow passage 833 and is connected to the actuator 8 The second port 859 of 50 is in fluid communication with the second fluid passage 854. As described in more detail herein, an actuator rod 862 (or generally, an actuator Moving and / or transitioning the input device 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 50 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, for example, skin, outside of bodily fluid sources. Obtaining body fluid samples that have 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, can operate device 800 to couple inlet 852 to a source of bodily fluid (e.g., a patient's blood vessels). ) can be established in fluid communication with a source of bodily fluid (e.g., a patient's When the outlet 853 is placed in fluid communication with the fluid collection device 880, In the embodiment shown in FIGS. 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 to accommodate a fluid collection system, 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 In addition, the second port 859 of the actuator 850 is connected to the second fluid flow path 854 and the The housing 830 is in fluid communication with a second port 846. 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 liquid (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 is generated 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 spaced apart. 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 is collected, the negative pressure in the fluid collection device 880 reduces the initial flow, portion, amount, or volume of the bodily fluid. From the inlet 852, 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. In this manner, the flow controller 842 and / or the restriction flow path 832 may be disposed in the isolation chamber 83. Limit or restrict the amount or magnitude of negative pressure applied onto 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 It may be related to and / or based at least in part on. In other words, some 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 the liquid 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 completely 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 To be isolated, blocked, separated, set apart, set apart, and / or otherwise hindered It will be stopped.

[0141] After the initial volume of bodily fluid has been transferred and / or diverted 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 the 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 Thus, the actuator rod 862 can be actuated to transition to the first flow. a second state, position, and / or location of the body passageway 833 isolated and / or separated from the inlet 852; and / or moved and / or transferred to the configuration. The flow controller 842 is in a sealing configuration in response to an initial volume of bodily fluid, and the inlet 852. An initial volume of bodily fluid may be obtained by an initial fluid flow path 833 that is isolated and / or separated from the is isolated within the isolation chamber 834. As described in detail above, in some instances, e.g. For example, contaminants such as microorganisms present on the skin that are expelled during venipuncture may increase the initial volume of fluid. may be mixed and / or contained within the initial volume and thus become sequestered therein. 834.

[0142] As shown in FIG. 24, the control device 800 and / or the actuator 850 may be 8. The second fluid flow path 854 is then moved and / or transitioned to a state or configuration of Thus, fluid communication is established 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 is directed from inlet 852 to fluid flow path 854. , through outlet 853 and into fluid collection device 880. Thus, as described above, prior to collection or acquisition of one or more test volumes of bodily fluid, a separation By isolating an initial volume of bodily fluid in the isolation chamber 834, one or more test volumes The amount of contaminants is reduced and / or substantially eliminated. The control device 800 is configured to adjust the initial volume in the isolation chamber 834. Before consolidation and isolation, the second state can be arranged so that it cannot be transitioned 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 to activate the actuator The 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 arranged such that the outlet 853 is substantially isolated or spaced from the remainder 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 impede 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 described above, a novel fluid collection device 880 coupled to the outlet 853 may be used. 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. and / or transitions.

[0144] A fluid collection device 880 coupled to the device 800 is 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 is 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, e.g. configured to be coupled to one or more reservoirs, such as a vacuum vessel, a sample bottle, a culture bottle, etc. In such an embodiment, the reservoir is a 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 outlet 953 is pierced or displaced to expose the outlet 953 to the negative pressure in the reservoir. , deformed, and / or otherwise unsealed. 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, store a sample reservoir, container, A fluid collection device, such as a vial, can be filled and two or more samples can be collected. If desired, the user may, for example, insert the inlet 952 into the lumen containing device and / or otherwise The port 952 may 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 receiving device and / or or the like, as described above with reference to control device 800. One or more additional samples may 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 FIGS. 19-25 includes 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. 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. The housing 1030 forms and / or has an inlet 1052 and an outlet 1053. The device 1000 includes the control device 80 described in detail above. 0, but with the housing 1030 being spaced apart from the actuator 1050 The electrodes 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 the "device") includes a separation chamber. The housing 1130 defines and / or defines the inlet 1152 and the outlet 1134. and an actuator 1150 forming and / or having a casing 53. 1. The control device 110 may be substantially similar to the control device 800 described in detail above, but may include a housing 11 30 may be 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 disposed in 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, and / or otherwise. A modular fluid control device is described herein. While examples of 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 described herein, However, the devices and / or concepts described herein are not intended to be limiting. It is not intended to

[0148] The housings 230, 330, 830, 930, 1030, and 1130 have a serpentine configuration. The present invention is illustrated and described herein as including and / or defining a separation chamber disposed in a structure. However, in other embodiments, any other suitable portion of the housing and / or control device may be used. 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 above-mentioned fluid control devices 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 further detail herein. Not yet.

[0149] A 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 provided with a housing 1230 and an actuator. The controller 1200 may be physically and fluidly coupled to the controller 1250 to form the control device 1200. In another embodiment, 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 the 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 construction. For example, in some embodiments, the housing 1230 comprises at least 10 and 11 are 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 include 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 or the like, (unlikely to be used or otherwise unintended). First port 1245 and the second port 1246 is at least fluidly coupled to a portion of the actuator 1250. 1230 and the actuator 1250. As described in more detail herein, the isolation chamber 1 234 (1) controls the selective flow and / or volume of bodily fluid through a first port 1245. (1) to receive the actuator 1250 from a portion of the actuator 1250; and (2) to receive the actuator 1250 from a portion of the actuator 1250. 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 The system is configured to (i) 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 can have, for example, For example, the housing 1230 may extend through at least a portion of the housing 1230 and / or may be In some embodiments, the fluid flow path may be defined by at least a portion of 230. In the embodiment, the isolation chamber 1234 is 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 FIG. , 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 isolator, for example The second port 1246 is in fluid communication with an outer portion of the chamber. The isolation chamber 834 and / or the housing 830 may be different in size and shape. In some embodiments, the isolation chamber 1234 may be a portion of the housing 1230, for example. The insulating layer may be a channel formed in a portion.

[0153] In some embodiments, the channel that forms at least a portion of the isolation chamber 1234 The volume of the initial body fluid drawn into the isolation chamber 1234 (channel) and the volume of the isolation chamber The volume of air within chamber 1234 (e.g., as described in more detail herein) is exhausted. Reduce and / or substantially prevent 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 separation A surface of the housing 1230 that forms the isolation chamber 1234 and a surface of the housing 1230 that forms 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 a cover 1238, thereby isolating chamber 1234 The cover 1238 may 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, press fitting 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 a 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 the cover 1238 may be , for example, a device that can facilitate one or more manufacturing processes and / or a control device This makes the 1200 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 passage 1232. and / or in any other suitable portion of the separation chamber 1234 and / or housing 1230. or configured to selectively control (at least in part) the flow of a fluid through, for example, a valve, membrane, septum, It may be a membrane, a restrictor, a vent, 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 comprising and / or formed of a porous material configured to Therefore, the flow controller 1242 may be a barrier (e.g., a blood barrier). In response to a negative pressure differential within a portion of the control device 1200, a diaphragm is pumped through the flow controller 1242. 12. Configuring the device 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 be achieved. a separation chamber 1234 operable to draw in an initial volume of bodily fluid by Suction force and / or negative pressure differential applied and / or exerted within or on the isolation chamber 1234. Furthermore, the use of a selectively permeable fluid barrier can reduce the volume of bodily fluids that flow. Air is evacuated without being allowed to pass through the controller 1242 and / or Thus, in some embodiments, the flow controller 124 2 is substantially similar to flow controller 242 described in detail above with reference to FIGS. As such, they are not described in further detail herein.

[0156] The actuator 1250 of the control device 1200 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the actuator 1250 may include: 8. An actuator 850 substantially similar in form and / or function to the actuator 850 described in detail above. Such similar portions of the actuator 1250 may therefore be These are identified below but may not be described in further detail herein.

[0157] As shown in FIGS. 32 to 34, the actuator 1250 includes a main body 1251 and an actuator The actuator 1250 includes a body 1251 having an inlet 1252 and a The inlet 1252 and the outlet 1253 may be at least In the above-described embodiment, the inlet 852 and the outlet 853 are respectively implemented with reference to FIGS. The inlet 1252 may be disposed in fluid communication with a source of bodily fluid. The flow of fluid from the catheter (e.g., the lumen of a needle, IV catheter, PICC line, etc.) The outlet 1253 is configured to receive, for example, a 5' 10 and a similar transfer device, such as a sample reservoir, a syringe, etc. , and / or other intermediate fluid transfer devices, adapters, or fluid collection devices such as reservoirs (see FIG. 29-34 are configured to be fluidly coupled to the In embodiments, such a transfer device may provide negative pressure and / or control External energy that enables 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. 259. 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 is configured and 1259, and the arrangement of ports 1245 and 1246 in housing 1230. The housing 1230 is physically coupled to the actuator 1250 and the housing 123 12 to the actuator 1250; and 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 another embodiment, the housing 1230 and And / or the actuator 1250 need not be modular.

[0159] In some embodiments, the body 1251 and the actuator rod 1262 are actuated. The actuator 1250 includes a locking portion configured to at least temporarily lock the actuator 1250. For example, in some embodiments, the body 1251 and the actuator 1252 may be formed collectively. The actuator rod 1262 is also fitted into an opening 1257 in which a locking member can be placed. can each be defined through an 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 the 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 can be prevented from being moved. The actuator rod 1262 can 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 removed from the main body 1251. A collection of features and / or configurations that can limit and / or substantially prevent the creation of In such an embodiment, the features may include, but are not limited to, snap, lock, and / or collectively form a It may be a stop, a clasp, and / or any other suitable feature and / or arrangement.

[0160] As shown in FIGS. 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 include, for example, For example, O-rings, overmolded elastomeric materials, raised protrusions, and / or the like. As described above with reference to actuator 850, actuator 12 62 and the body 1251 of the actuator 1250, a seal 1265 is provided between the actuator 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 and / or forming a second fluid flow path 1254 within the body 1251 of the actuator 1250; or includes three seals 1265 defining 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 may be used to, for example, treat the 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, the actuator rod 1262 is moved relative to the 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 is automatic in response to the negative pressure and associated flow forces within the device 1200. and / or other actions may be achieved by user interaction and manipulation of the 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 passage 1233, thereby forming a first port 12 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. Thus, the actuator 1250 and / or the actuator rotor When the head 1262 is in a first position and / or configuration (e.g., when the control device 1200 When in a first state or mode of operation, a fluid collection device (not shown in FIGS. 29-34 ). The negative pressure in the inlet 1252 directs at least a portion of the initial flow, amount, or volume of bodily fluid through the inlet 1252 and into the first 1 through the fluid flow path 1233 and into the isolation chamber 1234. 1234. A negative pressure (or negative pressure differential) is created within at least a portion of isolation chamber 1234, where Further, in some instances, for example, bodily fluids disposed within the isolation chamber 1234 may be -Controller 1242 in an open or unsealed configuration or state (e.g., gas or air) The configuration or state of the seal (e.g., gas and liquid) from the state in which flow can be drawn into it. The initial volume and / or volume of fluid in the body until the body transitions to a state where the body cannot draw in any fluid. Or the initial flow can be transferred into the segregation chamber 1234 .

[0162] In some examples, as shown in FIG. 3, a force is applied to the actuator rod 1262 and / or the actuator 1250. As mentioned above, in some examples, 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 be When the control device 1200 is positioned in a second position and / or configuration (e.g., When the actuator 1250 is in a non-operating state or transitioned to an operating mode, the inlet 1252 and outlet Each of the first fluid channels 1253 is in fluid communication with a second fluid channel 1254, while the first The fluid flow path 1233 is isolated or separated from the inlet 1252 and the outlet 1253, and and / or is otherwise not in fluid communication with the inlet 1252 and the outlet 1253. As noted above, in some instances, for example, during venipuncture or throughout the entire fluid collection process. Contaminants such as microorganisms present on the skin that are expelled from the body may be mixed into the initial volume of body fluid. and / or may be contained within the initial volume, thus forming an isolation chamber when the initial volume is isolated therein. Therefore, the liquid is isolated in the isolation chamber 1234. 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 is directed from the inlet 1252 to the second fluid flow path 1254. Through passage 1254, through outlet 1253, and through a fluid collection device coupled to outlet 1253. Thus, device 1200 has the functionality of device 800. The functionality of device 1200 may be substantially similar to that of the device 1200 described herein. The report does not go into further detail.

[0163] 35-40 show a fluid control device 1300 according to one embodiment. Device 1300 may be any of the fluid control devices 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 another embodiment, 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 as described above. can.

[0165] The housing 1330 of the control device 1300 may be of any suitable shape, size, and / or shape. 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 defines 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 The port 1346 is at least fluidly coupled to a portion of the actuator 1350. 13A to allow selective fluid flow between the housing 1330 and the actuator 1350. As described in more detail herein, the isolation chamber 1334 is configured to 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. and / or volume (e.g., at least an initial or first flow and / or volume of bodily fluid) to isolate (e.g., separate, 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 structure and / or configuration. 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 has at least the form and / or 29-34. Accordingly, the housing 1330 will be described in further detail herein. does not state.

[0166] The actuator 1350 of the control device 1300 may be of any suitable shape, size, and / or For example, in some embodiments, the actuator 1350 may include: At least in form and / or function, the actuator 850 and / or can be substantially similar to 1250. Thus, such an actuator 1350 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 actuator 1350 includes a body 1351 having an inlet 1352 and a The inlet 1352 and the outlet 1353 may be at least as shaped and / or functional as In the above-described embodiment, the inlet 852 and the outlet 853 are respectively implemented with reference to FIGS. The inlet 1352 may be disposed in fluid communication with a source of bodily fluid. and directs the flow of fluid from it (e.g., through needles, IV catheters, surgical tubing, or other standard (via a lumen-containing device such as a fluid transfer device, PICC line, etc.) The exit 1353 may be configured, for example, as a transfer device similar to that described in the '510 disclosure. For example, sample reservoirs, syringes, and / or other intermediate fluid transfer devices. 35-40) into a fluid collection device, such as a 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 configured to be at least fluidly coupled to each of the first and second ports 1346. In some embodiments, the ports 1358 and 13 59, and the arrangement of ports 1345 and 1346 in the housing 1330. 1330 to the actuator 1350 and the housing 1330 to the actuator. The actuator 1350 may be provided with a means for fluidly coupling to the actuator 1350 and / or may be otherwise That is, in some embodiments, the actuator 1350 may be Ports 1358 and 1359, and ports 1345 and 134 of the housing 1330 6 allows for a modular configuration or arrangement as 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 have to be modular.

[0169] As shown in FIGS. 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 discussed 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 manner, 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 1341 in the body 1351 of the actuator 1350. 354 and / or 356. The casing is coupled to two seals 1365 .

[0170] As described above with reference to device 800, device 1300 may be used to, for example, treat the 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, the actuator rod 1362 is moved relative to the body 1351 between a first position or configuration and a second position or configuration. As shown in FIG. 13, the inlet 1352 of the actuator 1350 is in fluid communication with the first fluid flow path 1333. 13B, whereby the first fluid flow passage 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, negative pressure in the fluid collection device (not shown in FIGS. 35-40) The first flow, amount, or volume of the bodily fluid is at least partially guided from the inlet 1352 to the first flow. Operable in drawing fluid through the body flow passage 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 passed through a flow control 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 based on the initial volume and / or initial volume of fluid until the body transitions to a state where it cannot draw fluid into it. The phase flow can be transferred into the isolation chamber 1334.

[0171] In some examples, as shown in FIG. 35, a first end of the actuator rod 1362 A force is applied to the actuator rod 1362 and / or the actuator 135 0 in its second position, state, mode of operation, and / or configuration. As described 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 state. In some embodiments, the actuator may transition to a different configuration or state. The transition of head 1362 is automatic due to the negative pressure and associated flow forces within device 1300. Accordingly, the actuator rod 1362 is actuated by user interaction and manipulation. and / or otherwise generate and / or cause the actuator rod 1362 to move. This may be performed by or in response to an external energy source generating energy.

[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 flow paths is in fluid communication with the second fluid flow path 1354, while the first fluid flow path 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 separation chamber 1334 is isolated from the surroundings. The negative pressure applied otherwise is now on or through the second fluid flow path 1354. In response, bodily fluid flows from the inlet 1352 through the second fluid flow path 1354. 1353, through the outlet 1353 and into the fluid collection device 1353. Thus, device 1300 may function substantially similarly to the functions 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 bodily fluids using a negative pressure source (e.g., a 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 actuator 1350 to A force is applied to the second end 1364 of the actuator rod 1362 to cause 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 can move and / or transition toward the second fluid flow path 13. 54 does not place the inlet 1352 in fluid communication with the outlet 1353. The flow controller 1342 is configured such that the outlet 1353 is substantially separated from the remainder of the control device 1300. A sealed state or configuration (e.g., , completely saturated, wetted, and / or otherwise impeding flow therethrough) In some instances, the user then removes the filled fluid collection device. A new fluid collection device can then 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 a first end 1363 of the actuator rod 1362. to return the actuator rod 1362 to the second position, state, and / or configuration. can move and / or transition to.

[0174] 41-44 show a fluid control device 1400, according to one embodiment. Device 1400 may be any of the fluid control devices described herein, at least in form and / or function. 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 further detail herein. It does not state that.

[0175] A 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 embodiment, 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 to form the control device 1400. In another embodiment, 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 as described above. can.

[0176] The housing 1430 of the control device 1400 may be of any suitable shape, size, and / or shape. The housing 1430 has a first port 1458 and a second port 1459. 59 and configured to selectively fluidly communicate 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 is adapted to transition 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, thereby allowing the isolation chamber 1434 to be actuated via the first port 1458. The sensor 1450 is 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 separator 1434 may be configured to adjust the flow and / or volume of bodily fluid within the separator 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., 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 support may be made of a material that is compliant with the requirements of the present invention and / or any other suitable material. In terms of 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 device may have any suitable shape, size, and / or configuration. The housing 1430 may be at least in form and / or function similar to that of FIGS. Substantially similar to housings 1230 and 1330 described in detail above with reference to FIGS. Accordingly, the housing 1430 will 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 / or For example, in some embodiments, the actuator 1450 may include: The actuators 850, 125 may be any of the actuators described in detail above, at least in form and / or function. 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.

[0179] As shown in FIGS. 41 to 44, the actuator 1450 includes a main body 1451 and an actuator The actuator 1450 includes a body 1451 having an inlet 1452 and a The inlet 1452 and the outlet 1453 may be at least as shaped and / or functional as In this case, 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 catheter and allows the flow of fluid from it (e.g., a needle, IV catheter, surgical tubing, or other target) via a standard fluid transfer device, PICC line, or other lumen-containing device The outlet 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. The fluid is then dispensed into a fluid collection device, such as a vice, adapter, or reservoir (not shown in FIGS. 41-44). The device is configured to be effectively coupled to the input / output terminals.

[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 an inlet port 1459. 452, and the second port 1459 is in fluid communication with the outlet 1453. In addition, the first port 1458 is configured to allow the body to flow through the housing 14 30, more specifically, 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 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 separation chamber 1434 is separated and / or partitioned from the interior volume of the bladder 1478. The separated portions of the housing 1430 are in fluid communication with each other. The arrangement of the ports 1458 and 1459 of the actuator 1450 is similar to that of the housing 1430. a means for physically coupling the housing 1430 to the actuator 1450; Means for fluidly coupling to the ethanol 1450 may be provided and / or may be otherwise That is, in some embodiments, the actuator 1450 poles The arrangement of ports 1458 and 1459 corresponds to the modules described above with reference to control device 800. In another embodiment, the housing 1430 may be configured or arranged in a modular fashion. And / or the actuator 1450 need not be modular.

[0181] As shown in FIGS. 41-44, a portion of the actuator rod 1462 includes a pair of seals. The seal 1365 includes and / or is coupled to the seal 1265 and / or the seal 13 As described above with reference to 65, for example, an O-ring, an elastic material, silicone, or any other suitable material may be used. 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 50 is fitted with a seal between the actuator rod 1462 and the inner surface of the body 1451. The anode and cathode can be arranged to form one or more fluid-tight seals between the anode and the cathode. 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. A first fluid flow path (e.g., in a first position, state, in an operational mode, configuration), and to fluidly connect the inlet 1452 to the outlet 1453. a second fluid-flow path configured (e.g., when in a second position, state, mode of operation, or configuration) (c) selectively forming and / or defining a

[0182] As described above with reference to devices 800, 1200, and / or 1300, the device 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 having reduced contamination from microorganisms such as those of As described above with reference to devices 1200 and / or 1300, the actuator lock The guide 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 transitioned. When the actuator 1450 is inlet 1452, the actuator 1450 may be in fluid communication with, for example, the first fluid flow path. 41. The first fluid flow path is thereby in fluid communication with the first port 1458 (FIG. 41). The outlet 1453 of the actuator 1450 is connected to the second fluid flow path 14 54, whereby the second fluid flow path 1454 is in fluid communication with the 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 When in a first state or mode of operation, a fluid collection device (not shown in FIGS. 41-44 ). A negative pressure within the housing 1430 is defined 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 before being inserted into the block. The ladder 1478 is inverted, upside down, 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. and configured to transition from a first state and / or configuration to a second state and / or configuration in response to the In other words, the negative pressure differential can cause the bladder 1478 to move in a contracted or unexpanded configuration. may be operable to transition from a configured configuration and / or state to an extended configuration and / or state. For example, in some embodiments, the transition of the bladder 1478 may be as shown in FIGS. This may be similar to the transition and / or "flipping" of membrane 576 discussed 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 the internal volume causes the separation chamber 1434 defined by the bladder 1478 to A negative pressure differential is created between the port 1452 and the first flow, amount, or volume of the bodily fluid. At least a portion of the inlet 1452 is passed through the first port 1458 and into the isolation chamber. In some examples, the body may be operable to retract into the chamber 1434. 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 migrated into

[0185] As described above in detail with reference to devices 1200 and / or 1300, an initial flow of bodily fluid After transferring the volume to the isolation chamber 1434, the first end 1 A force is applied to 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. Prior to activation, the actuator 1450 must be unlocked from a locked configuration or state. In some embodiments, the actuator rod 146 may be moved to a different configuration or state. The transition between the two is automatic in response to the negative pressure and associated flow forces within the device 1400. and / or otherwise accomplished by user interaction and manipulation of actuator rod 1462. and / or an external force that generates a force that causes the actuator rod 1462 to move. The energy source may be internal 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 transitions to 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 passage (not shown) and / or a first port 1458 may be connected to the inlet 1452 and / or the outlet 14 53, isolated, separated, and / or otherwise not capable of passing fluid therethrough. As noted above, in some instances, for example, during venipuncture or throughout the entire fluid collection process. Contaminants such as microorganisms present on the skin that are expelled from the body may be mixed into the initial volume of body fluid. and / or may be contained within the initial volume, thus forming an isolation chamber when the initial volume is isolated therein. Therefore, the housing 1430 or the housing 1430 is isolated in the bath 1434. Negative pressure that is otherwise applied through the outlet 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, the device 1400 can be used in conjunction with the devices 800, 1200, and / or 1 The functions of device 1400 may be substantially similar to those of device 300, and therefore the functions of device 1400 are not limited to those described herein. The fine print does not go into further detail.

[0187] The device 1400 includes a housing 1430 and an actuator 1450. Although the fluid control device is described above as a 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 control devices described above with reference to FIGS. 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) includes an actuator body 1551 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 described herein. It may not be stated in detail.

[0189] As shown in FIGS. 45 to 50, the actuators 1550 are each in fluid communication with a body 1551. The inlet 1552 and the outlet 1553 are 29-34, at least in form and / or function. 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, and / or other intermediate fluid transfer devices, adapters, or fluid collection devices such as reservoirs (FIG. 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 provide a second configuration and / or state for the isolation chamber 1534. The bladder 1578 may be formed and / or defined. As will be described in detail, the bladder 1578 is adapted to transition from a first configuration and / or state (FIG. 48) to a second configuration and / or state (FIG. 49). 49 and 50) to form the isolation chamber 1534. and / or configured to define an inlet 155 2. The bladder is configured to receive a selective flow and / or volume of bodily fluid from the 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 at least 41-44. As they may be substantially similar, they are not described in further detail herein.

[0191] As shown in FIGS. 46 and 48 to 50, the main body 1551 of the actuator 1550 is It includes and / or defines a port 1559 configured to be in fluid communication with 1553 . In addition, 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 actuator rod 1562 includes and / or is coupled to a set of seals 1565. Seal 1565 may be configured as described above with reference to seals 1265 and / or 1365. For example, an O-ring, an elastomeric 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 may be arranged to form a fluid-tight seal. As described above with reference to 50 and / or 1350, the set seal 1565 is and / or arranged along the eta rod 1562 to selectively form the fluid flow passage 1554. The fluid flow path can be defined when 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, the actuator rod 1562 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 external to a body fluid source, and / or the like. For example, as described above with reference to devices 1200, 1300, and / or 1400, Then, the actuator rod 1562 is moved between a first position or configuration and a second position or configuration. The first 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. A fluid passage is provided 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 the bladder 1578 are moved to the second configuration and / or state, 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 In the embodiment, when the device is in a fluid collection or operational mode, the device Negative pressure within the device (not shown in FIGS. 45-50) is applied to the inner surface of the body 1551 and the bladder 15 Negative pressure (or negative pressure) is generated within a portion of actuator body 1551 defined between the outer surface of It is possible to generate 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 before being inserted into the block. The ladder 1578 is inverted, upside down, before coupling the fluid collection device to the outlet 1553. The actuator lock can 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. A first state 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. In some embodiments, the transition of the bladder 1578 may be accomplished by the spacing described above with reference to FIGS. This may be similar to the transition and / or "inversion" of membrane 576. 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 be transitioned from a first state and / or configuration to a second state and / or configuration.

[0195] As described above, the bladder 1578 can be adapted to transition from a first configuration and / or state to a second configuration and / or state. or transition to a state to form and / or define the isolation chamber 1534. In some embodiments, the bladder 1578 may be transitioned to The internal volume of the isolation chamber 1578 (i.e., the isolation chamber 1534) increases. The increase in pressure causes the separation chamber 1534 defined by the bladder 1578 and the inlet 15 52, which creates a negative pressure difference that reduces the initial flow, amount, or volume of the bodily fluid. at least a portion of the inlet 1552 and a portion of the actuator body 1551. It may be operable to draw into the chamber 1534. Further, 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 migrated into 4.

[0196] As described above in detail with reference to devices 1200 and / or 1300, an initial flow of bodily fluid After transferring the mass to the isolation chamber 1534, the first end 1 A force is applied to 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 3, the actuator 1550 is locked out of the locked configuration or state. In some embodiments, the actuator rod may be moved to a configuration or state where the actuator rod is not in a position to move the actuator rod. The transition of 1562 is automatic in response to the negative pressure and associated flow forces within the device 1500. and / or otherwise accomplished by user interaction and manipulation of actuator rod 1562. and / or an external force that produces a force that causes the actuator rod 1562 to move. The energy source may be internal or in response to an external energy source.

[0197] The actuator rod 1562 and / or the actuator 1550 are in their second position and When the control device 1500 is positioned in a second state or operation and / or configuration (e.g., When the actuator 1550 is in the operating mode, the inlet 1552 and the outlet 1553 of the actuator 1550 The inlet port 1532 is in fluid communication with the fluid flow passage 1554, while the isolation chamber 1534 is in fluid communication with the inlet 1552 and the outlet 1553 may be isolated, separated, and / or otherwise configured to be inlet 1552 and is not in fluid communication with outlet 1553. As detailed above, in some instances For example, the presence of skin flicked during venipuncture or throughout the fluid collection process Contaminants, such as microorganisms that can cause infection, may be introduced and / or contained in the initial volume of body fluid. Thus, when the initial volume is isolated therein, it is isolated in the isolation chamber 1534. .

[0198] As described above with reference to devices 1200 and / or 1300, the actuator lock Transitioning the cap 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. By transitioning the motor rod 1562 to a second position and / or configuration, the fluid flow path 15 54 is disposed 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 that would otherwise be applied to the outer surface of the fluid passage 1554 now flows 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 out the outlet. The fluid can then flow into the associated fluid collection device 1553. Device 1500 may implement the functions of devices 800, 1200, 1300, and / or 1400. Since the functions of device 1500 may be qualitatively similar, the functions of device 1500 will not be described in further detail herein. It doesn't go into detail.

[0199] The actuators 850, 1250, 1350, 1450, and 1550 are, for example, Although the transition has been described in detail above as occurring in response to an external force, such as a force applied by a 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 at least in form and / or function a fluid control device as described herein. More specifically, a portion of the fluid control device 1600 may be similar to at least one of the above-mentioned At least similar to corresponding portions of fluid control devices 500, 600, and / or 700 or substantially the same. Thus, such portions of the fluid control device 1600 is 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 “sensor” or “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 a 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 such as a needle. 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. at least partially into a volume of bodily fluid configured to be at least temporarily stored within the portion; As described 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 an inlet 1631 and (2) Isolation included in and / or formed at least in part by housing 1630 Isolating (e.g., separating, isolating) a flow and / or volume of bodily fluid within chamber 1634 In 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 may be In a first state, 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 6 and / or 776. Thus, the diaphragm 1676 may be similar to the diaphragm 1676 in the housing 16 30 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 the initial volume of bodily fluid. The isolation chamber 1634 may be adapted to draw the isolation chamber 1634 into and / or, once therein, to The chamber 1634 may be operable to isolate an initial volume of bodily fluid within the chamber 1634. As shown at 1 and 52, the diaphragm 1676 can include a flow controller 1642. The flow controller 1642 may be any of the flow controllers described herein. The flow controller may be any suitable flow controller, such as any of those described in In some embodiments, the flow controller 1642 may include 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 flow control is a device that prevents the flow of fluid (e.g., body fluids) through a first condition. The flow controller 1642 restricts the flow of gas and liquid through the flow controller 1642 and and / or substantially prevents the device from transitioning to a second state. In an embodiment, the flow controller 1642 may, for example, be configured to: The first state can be configured to transition to a second state (e.g., when the body fluid is first At least a portion of the initial volume wets or saturates the flow controller 1642 to allow the flow The row controller 1642 can be placed in a second state.

[0205] The diaphragms 576, 676, and 776 may each include one or more seals (e.g., seals 5 65, 665, and 765, etc.) and / or pins, rods, etc. Although shown and described above as including posts, in the embodiment shown in Figs. The diaphragm 1676 does not include a seal and / or a pin 1677 that is not coupled thereto. (e.g., rods, extensions, protrusions, hooks, latches, and / or any other suitable For example, in this embodiment, the features, members, and / or features described herein may further include As will be described in detail below, the pin 1677 extends through a portion of the housing 1630. 1662, selectively engaging a portion of the actuator rod 1662, thereby A portion of the 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 disposed within the housing 163. 0, an energy storage member 1667 such as a spring provided within the actuator portion 1639. In the embodiment shown in Figures 51 and 52, the actuator 1650 is 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 following arrangement is possible:

[0207] As shown in FIG. 51, when the actuator 1650 is in a first state, the diaphragm 1676 The pin 1677 engages the actuator rod 1662 to rotate the actuator rod 1662. 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 spring may be held in the first or initial state and / or position. Further, a first actuator coupled to and / or provided on the actuator 1662 may be provided. The seal 1665 is configured to close the fluid flow passage 1633 when the actuator 1650 is in the first state. A first or initial fluid passageway 1632 allows fluid communication between the inlet 1631 and the isolation chamber 1634. As shown, similarly, a and / or a coupling to the actuator rod 1662 Alternatively, the second seal 1666 may be provided such that the second seal 1666 is in contact with the housing 1630. 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 restriction channel 1632 may be at least in form and / or function in any manner as described herein. (e.g., restriction channels 232, 832, 1232, and / or 1332) Thus, the restriction flow path 1632 may be located above or in 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 another embodiment, the outlet 1636 can be configured to adjust the rate at which the outlet 1636 is increased. 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 tether rod 1662 has a fluid passage 1633 that connects the inlet 1631 to an isolation chamber 1634 and a fluid The fluid flow passage 1654 may be maintained in a first state or position that allows fluid to flow through the fluid passage 1654. 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 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 of the fluid, the fluid may be transitioned to a second state and / or configuration. 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 barrier membrane, the fluid may be drawn into the isolation chamber 1634. In some examples, at least a portion of the bodily fluid drawn into the isolation chamber 1634 may be The flow controller 1642 can then be contacted by the flow controller 16 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, (See FIG. 52.) In some embodiments, the transition of the septum 1676 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., completely wetted, as described in detail above). transition occurs 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 be a flow control. The diaphragm 1676 need not include a filter 1642, and may be adapted to provide a negative pressure differential generated by the fluid collection device. 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 subjected to a predetermined negative pressure difference or 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 2, so that 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 shifted, moved, inverted, etc. The pin 1677 moves within the housing 1630 and relative to the actuator rod 1662. More specifically, the transition of the diaphragm 1676 can cause the pin 167 7 is disengaged from 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 As a specific example, in this embodiment, moving pin 1677 causes spring 1667 can be expanded from a first state or compressed state to a second state or substantially uncompressed state. The energy storage member 1667 (e.g., a spring) transitions from a first state to a second state. By this, the actuator rod 1662 in the actuator portion 1639 is 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 inlet, the first seal 1665 closes the isolation chamber 1634. 1631. Similarly, the second seal may be positioned at a second or subsequent location spaced apart from 1631. 1666 is pressed against the sealing surface 1640 (e.g., the energy storage member 166 7) at a second or subsequent location, thereby The roller 1642 is isolated from the fluid flow path 1654. Additionally, the actuator rod 166 When the first seal 1665 and the second seal 1662 are in the second state and / or position, 66 is positioned so that the fluid flow path 1633 is arranged to be able to communicate with the fluid flow path 1654. Thus, 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 bodily fluid as described in detail above, the contaminants are eliminated. 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 bodily fluid sample while in a fluid control device. 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., a needle, IV, The inlet may be physically and / or fluidly coupled to a catheter (such as a PICC line).

[0214] In step 12, a fluid collection device is coupled to the outlet of the fluid control device. As described above, the fluid collection device can be coupled to the outlet of the fluid control device. In some embodiments, a negative pressure differential is generated within at least a portion of the device. For example, the fluid collection device may be a sample bottle or container that defines a negative pressure. In an embodiment, the fluid collection device is a syringe that can be operated to generate negative pressure. Thus, 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 may be created within these sections.

[0215] In step 13, an initial volume of body fluid is delivered from the inlet to the fluid control device in response to the negative pressure differential. For example, in some embodiments, the isolation portion is received within the isolation portion as shown in FIG. 34. The isolation chamber 1234 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 can be the same as the isolation chamber described herein. Further, in some instances, the composition of the body fluid may be similar and / or substantially the same as any of the above. The initial volume may contain contaminants that have been entrained within it, and these contaminants may This can otherwise cause erroneous results during pull checking.

[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 flow controller that passes through the flow controller. 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 flow of gases and body fluids through the flow controller. For example, in some embodiments, as described above with reference to flow controller 242, In addition, the flow controller may include 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 flow - the controller limits the flow of gases and liquids (e.g., body fluids) therethrough; and / or For example, the flow controller may 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 may be a bladder and / or a diaphragm. The roller is adapted to release the negative pressure applied to the surface of the bladder and / or diaphragm when the negative pressure differential exceeds a threshold negative pressure. 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 include a flow control device. - The controller is positioned in its second configuration to sequester an initial volume of fluid before transitioning and / or any other suitable features or mechanisms configured to In some embodiments, the actuator may be, for example, actuator 1650. As described above with reference to the first state, the first state is changed to the second state to cause an initial flow of the body fluid in the isolated portion. In other embodiments, the actuator 8 may automatically isolate the target volume. As described above with reference to 50, the actuator is adapted to move into a first state in response to a force applied by a user. In yet another embodiment, the fluid control device can transition from a first state to a second state. may be used to isolate 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, a subsequent volume of fluid is pumped from the inlet through the outlet. As described in detail above, in some instances, By isolating the initial volume of bodily fluid within an isolated portion of the fluid control device, Contaminants that are received can be similarly sequestered. Thus, contamination in subsequent volumes of body fluid can be prevented. 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 be arranged in a particular orientation or position. When specific components are shown, the arrangement of the components may be modified. Although the present invention has been specifically illustrated and described, it will be understood that various changes can be made in form and details. 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 present invention may be used with any suitable device configured to establish a 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 include a pre-charged isolation chamber, an exhaust an isolation chamber; a manual activation device configured to generate a negative pressure; and 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. Further, as described above, the control device may include a means for inputting a user (e.g., a physician, nurse, technician, physician, etc.) may be coupled to such a collection device; Or may be bonded or assembled during manufacture. Pre-assembly of 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 isolation of the initial volume of body fluid. 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, In some embodiments, when the diaphragm transitions or flips from the first state to the second state, the diaphragm 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 overmoldings. 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. In one embodiment, the fluid control device comprises an elastic 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) extends through an opening 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 an actuator (e.g., a membrane) 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 elastic sheet moves relative to a portion of the control device such that the elastic sheet is substantially fixed relative to a portion of the control device. In some embodiments, a removable portion or part 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, provide a desirable fluid-tight seal. The amount of friction associated with the control device can be reduced, thereby allowing the fluid-tight seal to Eliminates the need for lubricants that are otherwise used to facilitate movement of the seal within the vice. It is possible.

[0221] The diaphragms (e.g., diaphragms 576, 676, and 776) are configured to have a surface area that exceeds a threshold negative pressure. transition, move, invert, and / or otherwise reconfigure 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 in More specifically, the actuator may include a movable part. The member or the like may include a first member having a movable member or the like and / or otherwise blocking the opening. From the state and / or position, a second state and / or position in which the movable member or the like is removed from the opening. In such an embodiment, negative pressure may 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 adapted to receive a volume of fluid by an initial volume of 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 applied to the surface of the moving part is determined by the amount of negative pressure that opens the moving part. The force may increase sufficiently to withdraw or move the movable member from the mouth, thereby In this way, the movable The member is configured to transition or flip from a first state to a second state. 5. The diaphragm 576, 676, and / or 776 may function similarly to any of the diaphragms described in In such an embodiment, the movable member may be arranged to move such an opening or can be moved or "pulled out" of a part, e.g. elastic plugs, corks, It may be a plunger, and / or any other suitable member.

[0223] Some of the above-described embodiments include a separation 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 or pump fluid through the device in response to a negative pressure differential generated from any suitable portion or portions of the device. For example, the control device 200 may be configured to transfer a flow. until the flow controller 242 is transitioned to a sealed or closed state (e.g., 242 is sufficiently wetted) and 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 the flow path. 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. Establishing bodily communication creates 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 include a and / or until the pressure is otherwise substantially equalized. Further, in some such embodiments, the isolation channel may be configured to 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; This 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 The actuator, such as the actuator, allows an initial volume of bodily fluid to flow from an inlet to a segregated chamber or portion. From the first state in which the isolation chamber or portion can be physically and / or mechanically isolated, (1) and (2) transitioning 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 include portions that allow an initial volume of bodily fluid to flow from the inlet into the segregation chamber or portion. from a first state in which the isolation chamber or portion is physically and / or mechanically isolated (or separated) ) to a second state in which the inlet is arranged to be able to communicate with the outlet. When such a control device is in a second state, one or more characteristics of the control device and The shape and / or shape may cause preferential flow of fluid from the inlet to the outlet, and the initial flow of fluid The initial volume is separated into the isolation chamber without being physically and / or mechanically isolated or separated. 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 in the The amount of negative pressure applied through the portion of the device described above may be adjusted and / or controlled. However, in other embodiments, the control device may include a controller that controls the control of at least a portion of the control device. configured to regulate, create, and / or otherwise control one or more pressure differentials through 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 control a control device. The size of one or more portions of a fluid flow path or a fluid flow interface within a portion of the device. to vary (e.g., reduce or increase) the amount or pressure of negative pressure within one or more portions of the control device. may be manually sized and / or otherwise controlled.

[0226] Various embodiments may include combinations of particular features, concepts, and / or components. Although described above, 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 may 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 locking portion or other suitable feature configured to hold the device in place for a period of time. As such, any of the embodiments described herein may be implemented using, for example, the spacing described above with reference to FIG. and / or including an isolation chamber and / or isolation portion configured similarly to isolation chamber 1234. In other words, any of the fluid control devices described herein can include isolation chambers arranged and / or formed as channels. In some embodiments, the isolation chamber may be a casing, as described above with reference to isolation chamber 1234. The channel forming at least a portion of the reservoir is adapted to allow an initial volume of body fluid to be drawn into the channel. When the air is blown into the body, the air is blown into the body fluid. Further, such channels may have a small cross-sectional shape and / or size. 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 include a flow control 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 and / or comprising a flow controller formed at least in part from a selectively permeable material. In such an embodiment, the flow controller may be (as described above) Evacuate the volume of the isolation chamber and / or portion 634 in response to being exposed 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 pumped through the flow controller to the isolation chamber 63. 4. In the example, a 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 would be an isolation chamber since the air is drained or purged through the controller. This may allow for a reduction in size and / or volume of the bath 634.

[0228] As another example, any of the embodiments described herein may include 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 of the embodiments may include one or more of the controllers. An actuator rod (e.g., an actuator rod) configured to be moved to a Although the actuator rod 1262 of the eta 1250 is described as including the In embodiments, any actuator described herein may be configured to have a first position and a second position. Transition between the exit of the device and at least temporarily from one or more other parts of the device. The actuator may include an actuator rod 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 calculator can be used with any suitable collection device.

[0229] In some embodiments, the specific configuration of the various components may also be changed. For example, the size and specific shapes of the various components may vary from the illustrated embodiment, but may be different from those described herein. For example, in Figs. 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 the bladder 1578 can have any suitable shape and / or size. In some embodiments, the size and / or shape of such components may be altered. This allows the overall size of the device 1500 to be reduced without changing the functionality of the device 1500. The size of the device 1500 may be reduced and / or the ergonomics of the device 1500 may be improved. In some embodiments, 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 being exposed to a negative pressure differential, similar to the diaphragm described above. In another embodiment, 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 examples, 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.

[0230] In other embodiments, the device may be a similar size to the housing 1230 and / or 1330. A bladder (147) disposed within a housing having a size, shape, and / or configuration. 8 and / or 1578 in form and / or function similar to that of 1578. 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 can 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 be left in place and used with respect to the 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 passage may include a bladder disposed within at least a portion of the channel. In such an embodiment, the bladder expands in response to being exposed 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 another embodiment, 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. In this manner, the flow can collectively define a volume that the device is configured to receive. The body control device may be configured with any suitable shape, feature, channel, or configuration of a housing in which the bladder is disposed. The device may include a bladder configured to conform to the configuration. In the embodiment, the size and shape of the various components are adjusted to accommodate the flow of bodily fluids into the fluid reservoir. The desired rate and / or volume of the injection may 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 and administering devices such as those described herein to or in conjunction with 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 for pediatric patients. In such embodiments, the device includes a second volume that is less than the first volume (e.g., less than about 0.5 ml). The embodiment and / or the like may include an isolation chamber having a volume of 2. The size, shape, and / or arrangement of the components of It should be understood that the present invention may be adapted for a given application, so long as the present invention is adapted to the particular application.

[0232] Although not shown, any of the devices described herein may include an isolation chamber and a fluid flow passage. Accessible openings, ports, couplers, septa, Luer-Lok, gas sockets, valves, threaded connectors, standard fluid interfaces, etc. (for brevity, we will call them "ports"). In some such embodiments, the port may include any suitable The device can 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 a vacuum vessel, a pump, a syringe, , and / or the like to provide a negative pressure source to the isolation chamber, channel, reservoir, and 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) in the initial volume. Probes, sampling instruments, testing devices, and / or or the like, while the initial volume is an isolation chamber. In yet another embodiment, the port is located in the isolation chamber. configured to reinfuse the initial volume of bodily fluid isolated in the patient and / or into the bodily fluid source. Any suitable pressure source or infusion device can be coupled (e.g., for pediatric patients, critically ill In another embodiment, the isolation channel is The chamber, chamber, and / or reservoir may be configured to receive the initial body fluid for use in the test. It is possible to add other diagnostic test components (e.g., paper tests) integrated into the database. 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 Design, size, and provide access to other types of body fluid testing typically performed using For example, patients suspected of having sepsis will usually undergo lactate testing, Blood samples will be taken for procalcitonin testing and blood culture testing. Remove all of the 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, passages, etc., configured to selectively allow wherein the initial amount or volume of the body fluid is introduced into a lumen, channel, flow passage, etc., from an inlet. , bypassing the isolation 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 the first state, the bodily fluid can flow from the inlet to the isolation chamber. In a second state, the body fluid is introduced from the inlet after isolating an 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 above in detail 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 may be included, configured to transition the device to a bypass configuration, or the like. In yet another embodiment, the control device may include a second actuator. The device is configured to selectively position the fluid control device in a bypass configuration or state. Any suitable device, feature, component, mechanism, actuator, controller, etc. It is possible.

[0235] Any of the embodiments described herein may be used in combination with any of the fluids described in the '420 patent, for example. 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 Any of the devices described in, for example, the '510 publication and / or the March 2015 publication Apparatus and Methods for Disinfe 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 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 "Amplifying a Digital Signal Processor," filed December 2, 2013 "Syringe-Based Fluid Diversion Mechanism" U.S. Patent No. 9,103,333, entitled "U.S. Patent No. 9,103,333 for Bodily-Fluid Sampling" 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 "Odily-Fluid Sampling" No. 1006, filed November 20, 2017, for Sample Collection with Reduced Hemo No. 2018 / 0140240, entitled "U.S. Patent Publication No. 2016 / 0140240," Apparatus and Methods for Maintaining a Battery aining Sterility of a Specimen Container No. 2017 / 0065733, entitled "Methods for Producing and Handling Electrostatic Disorders in a Microcircuit-Based Microscope," the disclosures of each of which are incorporated herein by reference in their entirety. (which is 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, a method for using a fluid control device such as those described herein The method includes providing fluid communication between a source of bodily fluid (e.g., a patient's blood vessel) and an inlet of a fluid control device. Then, the fluid control device can include an ordered set of steps that enable The outlet may be in fluid communication with and / or otherwise in engagement with a negative pressure source. The negative pressure source may be a sample reservoir, a syringe, a vacuum vessel, an intermediate transfer device, 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 within an isolation chamber, and (2) fluid communication between an inlet and an outlet. A first state or mode of operation may be established between the device and the user, either automatically or through user intervention. 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 fluid in isolation within the chamber and with 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 provided comprising 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 following 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 as parallel processes. The steps may be performed simultaneously in the process 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 discrete action. Although the devices described herein are described as being in a first state, 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 first state to the second state occurs in some cases when the last part of the initial volume of fluid enters the sequestration chamber. When the housing is being transferred into the chamber, the housing begins to transition from the first state to the second state. In some examples, the transition from the first state to the second state may be relatively gradual. Selectively control the rate of change when a transition occurs 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 may be and / or The transition from the first state to the second state can thus be prevented or substantially prevented. This may occur over a given period of time, but the isolation chamber may still have a 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, substantially prevent fluid flow into at least a portion of the collection flow path; a selectively permeable blood barrier disposed within the housing and fluidly coupling between the containment flow path and the outlet; the selectively permeable blood barrier is configured such that suction applied to the outlet causes gas to flow from the containment flow path through the selectively permeable blood barrier and 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 a 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 passage between an end of the containment passage and the outlet; The apparatus of claim 2 , wherein at least a portion of the flow path is configured to modulate 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 a gas-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. The device of claim 1 , wherein the local increase in suction force in 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 flow path; 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 substantially prevent fluid flow into at least a portion of the collection flow path in a first state; a selectively permeable blood barrier disposed within the housing and fluidly coupled between the containment flow path and the outlet; the selectively permeable blood barrier is configured such that suction applied to the outlet causes gas to flow from the containment flow path through the selectively permeable blood barrier and blood to flow into the containment flow path; The flow controller transitions from a first state to a second state in response to an amount of blood in the containment channel until the suction force in the collection channel increases.

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

11. At least a portion of the collection flow path is a first portion; The device of claim 9 , wherein a second portion of the collection channel is physically and fluidly disposed between the containment channel and the outlet.

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

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

14. At least a portion of the collection flow path is a first portion; The device of claim 9 , wherein the flow controller is configured to at least temporarily define a second portion of the collection flow path.

15. The apparatus of claim 9 , wherein the flow controller is configured to be maintained at least temporarily in the second position.

16. 10. The device of claim 9, wherein the flow controller is configured to transition from a first state to a 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 flow path limits the flow of gas through the selectively permeable blood barrier.

18. The device of claim 9 , wherein each of the containment and collection channels is fluidly disposed between the inlet and the outlet.

19. 10. The device of claim 9, wherein a portion of the suction force in the collection flow path moves at least a portion of the flow controller from a first position to a second position, thereby transitioning the flow controller from a first state to a second state.

20. 10. The device of claim 9, wherein the flow controller is configured such that in the second state, the collection flow path 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, the housing defining 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 the containment flow path are configured to form at least a portion of a flow path; a selectively permeable blood barrier configured such that suction applied to the outlet allows gas to flow from the containment flow path through the selectively permeable blood barrier to the outlet and allows blood to flow from the inlet into the containment flow path; a flow controller disposed within the housing and configured to, in a first state, substantially prevent fluid flow into at least a portion of the collection flow path and configured to transition from the first state to a second state in response to a local increase in suction force within the collection flow path; The partial increase in suction force occurs due to an amount of blood within the containment flow path.

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

23. The apparatus of claim 21 , wherein the outlet is configured to be fluidly coupled 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. At least a portion of the collection flow path is a first portion; 22. The device of claim 21, wherein a second portion of the collection channel is physically and fluidly disposed between the containment channel and the outlet.

26. At least a portion of the collection flow path is a first portion; The device of claim 21 , wherein the second portion of the collection channel forms the second portion of the channel.

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

28. 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.

29. 22. The device of claim 21, wherein a portion of the suction force in the collection flow path moves at least a portion of the flow controller from a first position to a second position, thereby transitioning the flow controller from a first state to a second state.

30. 22. The device of claim 21, wherein the flow controller is configured such that in a second state, the collection flow path forms part of a subsequent blood-receiving flow path between the inlet and the outlet.

31. 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 substantially prevent fluid flow into at least a portion of the collection flow path in a first state; a selectively permeable blood barrier disposed within the housing and fluidly coupling between the containment flow path and the outlet; the selectively permeable blood barrier is configured such that suction applied to the outlet directs gas 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 accumulation of a portion of suction force in the collection channel in response to the amount of blood in the containment channel, thereby causing the flow controller to transition from a first state to a second state.

32. 32. The device of claim 31, wherein a suction force is applied to the outlet by fluidly connecting the outlet to the fluid collection device.

33. At least a portion of the collection flow path is a first portion; the selectively permeable blood barrier is disposed at an end of the containment flow path; 32. The device of claim 31, wherein a second portion of the collection flow path is physically and fluidly disposed between the selectively permeable blood barrier and the outlet.

34. 32. The device of claim 31, wherein the selectively permeable blood barrier comprises a gas-permeable, blood-impermeable material.

35. 32. The apparatus of claim 31, wherein the flow controller comprises at least one of a plunger, a seal, a moveable plug, or a resilient material.

36. 32. The device of claim 31, wherein an increase in the amount of blood in the containment flow path stops the flow of gas from the containment flow path through the selectively permeable blood barrier.

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

38. the containment channel is configured to contain the blood and separate subsequent blood within the containment channel; 32. The device of claim 31, 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, and is configured to bypass at least a portion of blood separated in the containment channel, when the flow controller is in the second state.

39. a housing having an inlet and an outlet and defining 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 gas in response to a first suction force applied to the outlet; a flow controller disposed within the housing and configured to, in a first state, block blood flow through at least a portion of the collection flow path and transition from the first state to a second state in response to an increase in a second suction force within the collection flow path; The apparatus, wherein the second increase in suction force is caused by blood within the containment flow path.

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

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

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

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

44. 44. The device of claim 43, 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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