Non-exhaust body fluid sample optimization device and system

Abstract

A non-exhaust body fluid sample optimization device and system includes an inlet, an outlet, a sample path connected between the inlet and the outlet, and a contaminant containment reservoir connected between the inlet and the outlet. The contaminant containment reservoir includes a gas permeable flow resistor near the outlet, the contaminant containment reservoir being arranged to receive a first portion of the fluid sample to displace air therein through the gas permeable flow resistor and the outlet when a pressure differential is applied between the inlet and the outlet, and the contaminant containment reservoir being arranged to displace the first portion of the fluid sample through the gas permeable flow resistor and the outlet when the pressure differential is applied between the inlet and the outlet. The sample path is configured such that when a first portion of a fluid sample is received and a contaminant is contained in the contaminant containing reservoir, a subsequent portion of the fluid sample can be transferred from the inlet to the outlet by the sample path when a subsequent pressure differential is applied between the inlet and the outlet.

Description

[0001] This application is a divisional application of the invention patent application with application number 202080000666.0 filed on April 1, 2020 and invention name “Non-exhaust body fluid sample optimization device and system”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 827,783, filed April 1, 2019. The entire contents of that application are incorporated herein by reference. Technical Field

[0004] The present application relates to a blood sample collection device. Background Art

[0005] Bacteremia is the presence of microorganisms in the blood. Sepsis, on the other hand, is bacteremia with the presence of clinical signs and symptoms such as fever, tachycardia, tachypnea, and hypotension. Bacteremia and sepsis are associated with high mortality, increased length and duration of hospital stay, and associated costs. In fact, many cases of bacteremia, sepsis, fungal diseases, and other pathogens actually occur in hospitals or other healthcare facilities, and catheters and venipunctures are potential carriers of these pathogens and are a source of contamination.

[0006] Blood culture is a standard test used to detect microbial pathogens associated with bacteremia and sepsis in a patient's blood. The term "blood culture" refers to a single venipuncture from a peripheral site or central or arterial line that inoculates blood into one or more blood culture bottles or containers. One bottle is considered a blood culture, and two or more are considered a set. Multiple collections can be obtained from multiple venipunctures and associated with different sites on the patient.

[0007] These methods allow for microbial identification and susceptibility testing, which are key components of sepsis management, but the lack of rapid results and reduced sensitivity for pathogenic agents have led to the development of improved systems and adjunctive molecular or proteomic assays.

[0008] Blood sampling for blood cultures is an essential component of modern patient care and can positively impact patient outcomes by providing an accurate diagnosis, or negatively impact outcomes by providing false-positive results for infection, leading to unnecessary prolonged antimicrobial therapy, prolonged hospital stays, and increased costs.

[0009] One of the outcomes of collecting blood cultures is contamination. Blood culture contamination can lead to false-positive culture results and / or significant increases in healthcare-related costs. Sources of blood culture contamination include improper skin antiseptics, improper collection tube sterilization, and contamination of the blood that was initially drawn, which can skew the results.

[0010] Blood culture collection kits typically consist of a "butterfly" kit, an infusion kit, or other type of venipuncture device, and aerobic and anaerobic blood culture bottles, provided by companies such as BD, Smiths, B.Braun, etc. A variety of different bottles are also available, depending on the test requirements. These bottles are specifically designed to optimize the recovery of aerobic and anaerobic organisms. In traditional test kits, the bottle used is usually called a "Vacutainer", which is a blood collection tube consisting of a sterile glass or plastic tube with a evacuated closure device to create a vacuum in the tube, thereby facilitating the extraction of a predetermined volume of liquid, such as blood.

[0011] False-positive blood cultures are often the result of poor sampling technique. They lead to the use of antibiotics when they are not needed, increasing hospital costs and patient anxiety. Blood cultures are drawn from a needle prick into the skin, and a Vacutainer is attached to capture the blood sample. Contamination can occur from improper or incomplete disinfection of the puncture site and the surrounding skin area. It can also result from the needle piercing the skin during insertion, where the cored skin cells and any associated contaminants are pulled into the sample.

[0012] Blood flow through a hypodermic needle is laminar, so when a pressure drop is applied to the hypodermic needle, a velocity gradient is created across the flow tube. Forced aspiration of blood or use of a very small hypodermic needle can cause lysis and release of potassium from red blood cells, potentially making the blood sample abnormal.

[0013] Various strategies have been implemented to reduce the contamination rate of blood cultures, such as training of staff on aseptic collection technique, feedback on contamination rates, and implementation of blood culture collection kits. Although skin antisepsis can reduce the burden of contamination, 20% or more of skin organisms reside deep in the dermis and are not affected by antisepsis. Changing the needle before inoculating the bottle is not recommended because it increases the risk of needlestick injury without reducing the contamination rate.

[0014] Some conventional systems and techniques for reducing blood culture contamination include discarding an initial aliquot of blood drawn from central venous catheters, venipunctures, and other vascular access systems. However, these systems require the user to mechanically manipulate the intravascular device or require a series of complex steps that are difficult and reduce the chances that they will be followed consistently. Summary of the invention

[0015] The present invention describes a non-exhaust body fluid sample optimization device and system for a blood sampling or blood culture collection system. According to the embodiments described herein, the device has no moving parts, valves, state conversion switches or diverters, or other mechanisms for moving, converting or transitioning from one operating mode to another operating mode, or from one state to another state.

[0016] In some embodiments, the fluid sample optimization device includes an inlet, an outlet, and a contaminant holding reservoir having a proximal end coupled to the inlet and a distal end coupled to the outlet. The fluid sample optimization device also includes a gas-permeable flow resistor, which is positioned and fixed in the contaminant holding reservoir, and the front surface of the gas-permeable flow resistor is toward the proximal end of the contaminant holding reservoir, and the rear surface is toward the distal end of the contaminant holding reservoir. The fluid sample optimization device also includes a sample path, the proximal end of the sample path is coupled to the inlet near the proximal end of the contaminant holding reservoir, and the distal end is coupled to the outlet.

[0017] A pulling force or traction force (e.g., vacuum pressure or the pull of a syringe) applied to the outlet port draws a first amount of fluid (e.g., venous blood) into the inlet port and then first into the contaminant containment reservoir, where the air in them is pulled through the air-permeable flow resistor. Eventually, the fluid fills the contaminant containment reservoir and eventually encounters the air-permeable flow resistor, where it is at least partially trapped for at least a known time. Before the fluid can pass through and leave the air-permeable flow resistor, the force (e.g., vacuum) draws a second amount of fluid into a parallel or concurrent sample path in which the fluid is connected in parallel between the inlet port and the outlet port, thereby allowing the second amount of fluid to bypass the contaminant containment reservoir and at least temporarily retain the resistance therein. Subsequent amounts of fluid to the second amount of fluid may also bypass the first amount of fluid and the contaminant containment reservoir, thereby being drawn into the inlet port through the sample path and being drawn out of the outlet port.

[0018] In some aspects, the fluid sample optimization device includes an inlet configured to be connected to the fluid source, an outlet configured to be in contact with a fluid collection device, and a sample path connected between the inlet and the outlet. The fluid sample optimization device also includes a contaminant holding reservoir connected between the inlet and the outlet. One or more of the inlet, outlet, contaminant holding reservoir, and sample path, and possible other components of the fluid sample optimization device can be contained in the housing and / or defined by the housing.

[0019] The contaminant containment reservoir also includes a permeable flow resistor connected to the sample path (preferably near the outlet). When a pressure differential is applied between the inlet and the outlet, the contaminant containment reservoir is arranged to receive a first portion of the fluid sample from the fluid source to displace air therein through the permeable flow resistor and the outlet. The permeable flow resistor can automatically seal when in contact with a non-air fluid (e.g., blood or other body fluids).

[0020] When a first portion of the fluid sample is received and contaminants are contained in the contaminant containment reservoir, a subsequent portion of the fluid sample can be received and conveyed by the sample path from the inlet to the outlet when a subsequent pressure differential is applied between the inlet and the outlet. In some embodiments, the fluid sample optimization device includes a resistance plug that initially substantially blocks the sample path from the inlet until the first portion of the fluid is contained in the contaminant containment reservoir.

[0021] In other aspects, a fluid sample optimization device for optimizing a fluid sample collected by a fluid collection device from a fluid source, wherein a first portion of the fluid sample potentially has contaminants, comprises an inlet configured to be connected to the fluid source and an outlet configured to be in contact with the fluid collection device. The fluid sample optimization device also includes a sample path connected between the inlet and the outlet. The sample path has a resistance plug configured to inhibit at least a portion of the first portion of the fluid sample and contaminants from entering the sample path.

[0022] The fluid sample optimization device also includes a contaminant holding reservoir connected between the inlet and the outlet. The contaminant holding reservoir has a permeable flow resistor near the outlet. When a pressure differential is applied between the inlet and the outlet, the contaminant holding reservoir is arranged to receive a first portion of the fluid sample from the fluid source to displace air therein through the permeable flow resistor and the outlet, so that when the first portion of the fluid sample is received and contaminants are contained in the contaminant holding reservoir, when a subsequent pressure differential is applied between the inlet and the outlet, a subsequent portion of the fluid sample can be forced through the resistance plug of the sample path and transmitted from the inlet to the outlet by the sample path.

[0023] According to one aspect of the present invention, there is provided a fluid sample optimization device for optimizing a fluid sample collected by a fluid collection device from a fluid source, wherein a first portion of the fluid sample potentially has contaminants, and the fluid sample optimization device comprises: an inlet configured to be connected to the fluid source; an outlet configured to be in contact with the fluid collection device; a sample path connected between the inlet and the outlet; a sample path connected between the inlet and the outlet; and a contaminant containing reservoir connected between the inlet and the outlet, the contaminant containing reservoir having an air-permeable flow resistor near the outlet, and when a pressure differential is applied between the inlet and the outlet, the contaminant containing reservoir is arranged to receive the first portion of the fluid sample from the fluid source to displace air therein through the air-permeable flow resistor and the outlet, so that when the first portion of the fluid sample is received and contaminants are contained in the contaminant containing reservoir, when a subsequent pressure differential is applied between the inlet and the outlet, a subsequent portion of the fluid sample can be transmitted from the inlet to the outlet by the sample path.

[0024] In one embodiment, the fluid sample optimization device further comprises a housing, which accommodates and / or defines one or more of the inlet, the outlet, the sample path and the contaminant holding reservoir.

[0025] According to another embodiment of the fluid sample optimization device, the gas permeable flow resistor comprises a material that seals when in contact with the first portion of the fluid sample.

[0026] According to another embodiment of the fluid sample optimization device, the contaminant holding reservoir comprises a tortuous path.

[0027] According to another embodiment of the fluid sample optimization device, each pressure differential is provided by a vacuum pressure provided by the fluid collection device.

[0028] According to one aspect of the present invention, there is provided a fluid sample optimization device for optimizing a fluid sample collected by a fluid collection device from a fluid source, wherein a first portion of the fluid sample potentially has contaminants, and the fluid sample optimization device comprises: an inlet configured to be connected to the fluid source; an outlet configured to be in contact with the fluid collection device; a sample path connected between the inlet and the outlet, the sample path also having a resistance plug, the resistance plug being configured to inhibit at least a portion of the first portion of the fluid sample and contaminants from entering the sample path; and a contaminant containing reservoir connected between the inlet and the outlet, the contaminant containing reservoir also having an air-permeable flow resistor near the outlet, when a pressure difference is applied between the inlet and the outlet, the contaminant containing reservoir is arranged to receive the first portion of the fluid sample from the fluid source to displace air therein through the air-permeable flow resistor and the outlet, so that when the first portion of the fluid sample is received and contaminants are contained in the contaminant containing reservoir, when a subsequent pressure difference is applied between the inlet and the outlet, a subsequent portion of the fluid sample can be forced to pass through the resistance plug and be transmitted from the inlet to the outlet by the sample path.

[0029] According to one embodiment, the fluid sample optimization device further includes a housing that accommodates and / or defines one or more of the inlet, the outlet, the sample path, and the contaminant holding reservoir.

[0030] According to another embodiment of the fluid sample optimization device, the gas permeable flow resistor comprises a material that seals when in contact with the first portion of the fluid sample.

[0031] According to another embodiment of the fluid sample optimization device, the contaminant holding reservoir comprises a tortuous path.

[0032] According to another embodiment of the fluid sample optimization device, each pressure differential is provided by a vacuum pressure provided by the fluid collection device.

[0033] According to another embodiment of the fluid sample optimization device, the resistive plug comprises a membrane pierceable by a subsequent first pressure differential.

[0034] According to another embodiment of the fluid sample optimization device, the resistance plug further comprises a piercing member configured to pierce the membrane when the subsequent first pressure differential is applied on opposite sides of the membrane.

[0035] According to another embodiment of the fluid sample optimization device, the resistance plug comprises a mesh having a dissolvable material that dissolves upon contact with a subsequent first portion of the fluid sample.

[0036] According to one aspect of the present invention, a fluid sample optimization device for optimizing a fluid sample is provided, wherein a first portion of the fluid sample potentially has contaminants, and the fluid sample optimization device comprises: an inlet; an outlet; a sample path connected between the inlet and the outlet; and a contaminant containing reservoir connected between the inlet and the outlet, wherein the contaminant containing reservoir has an air-permeable flow resistor near the outlet, and when a pressure difference is applied between the inlet and the outlet, the contaminant containing reservoir is arranged to receive the first portion of the fluid sample to displace air therein through the air-permeable flow resistor and the outlet, so that when the first portion of the fluid sample is received and contaminants are contained in the contaminant containing reservoir, when a subsequent pressure difference is applied between the inlet and the outlet, a subsequent portion of the fluid sample can be transferred from the inlet to the outlet by the sample path.

[0037] According to one embodiment, a fluid sample optimization device, wherein the sample path further comprises a resistance plug configured to inhibit at least a portion of the first portion of the fluid sample and contaminants from entering the sample path during receipt of the first portion of the fluid sample and containing the contaminants in the contaminant containing reservoir.

[0038] According to another embodiment, the fluid sample optimization device further includes a housing that accommodates and / or defines one or more of the inlet, the outlet, the sample path, and the contaminant holding reservoir.

[0039] According to another embodiment of the fluid sample optimization device, the gas permeable flow resistor comprises a material that seals when in contact with the first portion of the fluid sample.

[0040] According to another embodiment of the fluid sample optimization device, the contaminant holding reservoir comprises a tortuous path.

[0041] According to another embodiment of the fluid sample optimization device, the resistive plug comprises a membrane pierceable by a subsequent first pressure differential.

[0042] According to another embodiment of the fluid sample optimization device, the resistance plug further comprises a piercing member configured to pierce the membrane when the subsequent first pressure differential is applied on opposite sides of the membrane.

[0043] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] These and other aspects will now be described in detail with reference to the following drawings.

[0045] Figure 1A and 1B A non-evacuated fluid contamination sample optimization device according to embodiments described herein is shown.

[0046] Figure 2 A non-exhaust fluid contaminant sample optimization apparatus is shown according to embodiments described herein.

[0047] Figure 3 A fluid sampling system using a fluid sample optimization device according to embodiments described herein is shown;

[0048] Figure 4 A-4D illustrates a process for withdrawing a first amount of bodily fluid from a patient and bypassing it to collect second and / or subsequent amounts of bodily fluid.

[0049] Figure 5 The fluid sample optimization device is shown without the housing.

[0050] Figure 6 A-6I shows an embodiment of a non-exhaust fluid sample optimization device and various embodiments of a resistor.

[0051] Figure 7 A and 7B show other embodiments of resistors having dissolvable materials.

[0052] Figure 8 A and 8B show other embodiments of resistors having a dissolvable material and a highly viscous insoluble material;

[0053] Fig. 9 A-9C shows another embodiment of a resistor having a pierceable member.

[0054] Fig.10 A and Fig.10 B shows a specific construction of a non-exhaust fluid sample optimization device formed in a housing using an elongated gas-permeable flow resistor.

[0055] Fig.11 A and Fig.11 B shows another specific configuration of a non-exhaust fluid sample optimization device formed in a housing;

[0056] Fig.12 A-12C shows various configurations of gas permeable flow resistors used in the embodiments described herein;

[0057] Fig.13 A-13C shows various configurations of resistance plugs for use with the embodiments described herein;

[0058] Fig.14A-14C shows a resistive plug having an iris or hole that widens to open under certain pressure conditions.

[0059] Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION

[0060] The document describes a fluid sample optimization device for use in a fluid sampling or fluid collection system, such as for blood culture or blood testing, and for containing contaminants that may be in a first portion of the sampled or collected fluid. The fluid sample optimization device is configured for sequential fluid flow, i.e., receiving a first body fluid from a patient, retaining at least a portion of the body fluid in a contaminant holding container, and receiving a second amount of body fluid from the patient through a sampling path, and automatically bypassing the body fluid retained in the contaminant holding container. In some embodiments, the body fluid is blood, and, for example, the first amount of blood may contain contaminants that may be picked up by venipuncture or other vascular access procedures and mixed with the first amount of blood.

[0061] like Figure 1A As shown, the fluid sample optimization device 10 includes an inlet 12 and an outlet 14. The inlet 12 may include an inlet port, a connector or an interface for connecting to an external device such as a pipe or an interface thereof. The inlet 12 may be connected to a patient or a source of fluid for the patient, for example, via a venous puncture needle, wherein the fluid is provided at a pressure P1 and the fluid may be the patient's own blood pressure. The outlet 14 may include an outlet port, a connector or an interface for connecting to an external device such as a pipe or an interface thereof. For example, the outlet 14 may be connected to a fluid collection device, such as a or an evacuated tube of a syringe, wherein the fluid collection device draws fluid from the fluid source at a pressure P2 that is lower than the pressure P1. The pressure difference between P1 and P2 can allow the fluid sample optimization device 10 to be sealed to atmospheric pressure and atmospheric pressure, that is, the fluid sample optimization device 10 does not need to include any vents or passages to the outside atmosphere, at least when in use.

[0062] The fluid sample optimization device 10 also includes a contaminant holding container 16 connected to the inlet 12 and the outlet 14 and having a gas-permeable flow resistor 17 between the distal end of the contaminant holding container 16 and the outlet 14. Herein, the contaminant holding container 16 can be sized to hold a desired amount of fluid and can include an absorbent material that at least partially fills the contaminant holding container 16. Also as further described herein, the contaminant holding container 16 can be configured as a tortuous path, a series of chambers of varying cross-sections and volumes, and / or include rifling or baffles extending from an inner surface thereof to minimize backflow, i.e., flow toward the inlet 12.

[0063] When a pressure differential is applied between the inlet 12 and the outlet 14, i.e., the negative pressure at the outlet 14 exceeds the pressure at the inlet 12, the air-permeable blood resistor 17 allows air to pass through the inlet 12 and be displaced by the first portion or amount of fluid in the isolation chamber 16. Once the fluid contacts the air-permeable flow resistor 17, the flow of the fluid into the contaminant-holding container 16 is at least partially stopped, thereby retaining at least a portion of the fluid in the contaminant-holding container 16.

[0064] The fluid sample optimization device 10 also includes a sample path 18 that is also connected to the inlet 12 and the outlet 14. The sample path includes 18, and a resistor 19 is disposed near the inlet 12. At the same time that the pressure P2 draws the first portion or amount of fluid into the contaminant holding container 16, the resistor 19 is configured to resist, inhibit, restrict or prohibit the fluid from flowing into the sample path 18 until the first portion or amount of fluid has entered the contaminant holding container 16. As further described herein, the resistor 19 is configured so that after the first portion or amount of fluid has entered the contaminant holding container 16, the resistor 19 will still allow the second and / or subsequent portions or amounts of fluid to flow from the inlet 12 through the sample path 18 to the outlet 14 under the action of the pressure differential between P2 and P1. Also as further described herein, the resistor 19 can be recessed away from the inlet 12 in the sample path 18 to allow vacuum pressure to be established, and can also include a guide hole or small capillary, small hole, iris, etc. to allow the soluble material to begin to be dissolved by the fluid that continues to be drawn toward the outlet 14.

[0065] As further described herein, the resistor 19 can be formed from a composition including at least a portion of a soluble material. In a particular embodiment, the soluble material is soluble by contact with blood. Suitable materials for the soluble material can include, but are not limited to, any number of synthetic soluble polymers, such as: polyvinyl alcohol (PVA); polyvinyl pyrrolidone (PVP), also commonly referred to as povidone or povidone, is a water-soluble polymer made from the monomer N-vinyl pyrrolidone; polyethylene glycol (PEG); polyethylene oxide (PEO); and / or other synthetic soluble polymers. Materials for the soluble material may also include, but are not limited to, any number of natural soluble polymers, such as: hydroxypropyl methylcellulose (HPMC), cellulose, corn starch or other starches, salts and / or rice paper.

[0066] The key to the material used for the dissolvable material is that it must be inert or non-reactive to the laboratory testing of the sampled or collected fluid, which is usually provided with a culture to test for the presence of specific bacteria or viruses, or antibodies thereto or other pathogens in the fluid sample. In other words, the dissolvable substance should not include any substance or material that could significantly affect the fluid sample test or assay. In addition, such dissolvable substances must not be harmful to the patient in the extremely unlikely event of back pressure or exposure to the patient's venous system.

[0067] and Figure 1A Consistent, Figure 1B An embodiment of a fluid sample optimization device 20 is shown that includes an inlet 22 and an outlet 24. As described above, the inlet 22 can be connected to a patient or a source of fluid in the patient through a venous puncture needle, wherein the fluid is provided at a pressure P1 and can be the patient's own blood pressure. The outlet 24 can be connected to a fluid collection device, such as or a vacuum tube of a syringe, wherein the fluid collection device draws fluid from a fluid source at a pressure P2 that is lower than pressure P1.

[0068] The fluid sample optimization device 20 further includes a contaminant holding container 26, which is connected to the inlet 22 and the outlet 24, and has a gas-permeable flow resistor 27 between the distal end of the contaminant holding container 26 and the outlet 24. The fluid sample optimization device 20 further includes a sample path 28 also connected to the inlet 22 and the outlet 24. The sample path 28 includes a resistor 29 disposed near the inlet 22.

[0069] In some embodiments, Figure 1B As shown in , the fluid sample optimization device 20 may include an acceleration portion 30 to reduce the fluid pressure of the fluid moving through it, thereby increasing the velocity of the fluid, such as from the inlet 22 to the contaminant holding container 26. This can further help to preferentially guide a first portion or amount of fluid from the inlet 22 to the contaminant holding container 26 before a subsequent portion or amount of fluid passes through and through the resistor 29 to be output through the outlet 24 for collection. The acceleration portion can include a smaller cross-sectional area or a constriction area, a choke point, etc., such as in a venturi path. The acceleration portion 30 can be followed by a larger cross-sectional area of ​​the contaminant holding container 26, which in turn can be configured to accommodate a predetermined volume of fluid. In some embodiments, the acceleration portion 30 can be located close to the connection point from the inlet 22 to the sample path 28, whereby once the contaminant holding container 26 is filled, the subsequent portion or amount of blood will build up pressure within the acceleration portion 30 to overcome the resistor 29 to allow the subsequent portion or amount of blood to pass through the sample path 28 to the outlet 24.

[0070] Figure 2 A fluid sample optimization device 100 is shown, which includes an inlet port 102 and an outlet port 104. The inlet port 102 can be fluidically coupled to a fluid sample entry device such as a patient needle, tube, inlet port, catheter port, or catheter port. The outlet port 104 can be coupled to a fluid sample entry device such as a patient needle, tube, inlet port, catheter port, or catheter port. The fluid collection device of the set is fluidically coupled, and the device may include a sealed sampling needle, on which a vacuum-sealed collection tube may be placed to break the seal and provide a vacuum-based motive force for the fluid to pass through the fluid sample optimization device 100 from the inlet port 102 to the outlet port 104. The outlet port 104 may also be connected to any other collection device, such as a syringe, which may or may not use a plunger to create a pressure differential to "draw" fluid from the patient through the fluid sample optimization device 100.

[0071] The fluid sample optimization device 100 also includes a contaminant holding container 106 having a proximal end 107 and a distal end 109, wherein the proximal end 107 is connected to the inlet 102 port and the distal end 109 is connected to at least, for example, air in a fluid manner or to the outlet port 104. The contaminant holding container 106 can have any shape and / or cross-sectional size. In addition, the transition from the inlet port 102 to the contaminant holding container 106 can be straight or curved. In some embodiments, the contaminant holding container 106 is cylindrical or otherwise has a circular cross-section because if the fluid traversing or bypassing the contaminant holding container 106 is blood, a smooth transition without sharp edges or corners can avoid hemolysis.

[0072] The fluid sample optimization device 100 also includes a gas-permeable flow resistor 108, also referred to herein as a "plug," positioned and fixed within the contaminant holding container 106. The gas-permeable flow resistor 108 may be all or part of the resistance to the passage of fluid therethrough, depending on the time and pressure provided to the fluid. According to some preferred embodiments, the gas-permeable flow resistor 108 has a front surface facing or toward the proximal end 107 of the contaminant holding container 106, and a rear surface facing or toward the distal end 109 of the contaminant holding container 106. When a vacuum is applied to the outlet port 104 and is pushed by a first amount of bodily fluid, such as blood, the gas-permeable flow resistor 108 allows air from the contaminant holding container 106 to pass through the gas-permeable flow resistor 108 and toward and be drawn out of the outlet port 104 of the fluid sample optimization device 100.

[0073] As with the embodiments described herein, the thickness or length of the air-permeable flow resistor 108 may be between less than 0.05 mm and up to 5 cm or more, and may have a uniform or varying density. For example, the air-permeable flow resistor 108 may be less dense and more porous on the side facing the proximal end 107 of the contaminant-holding container 106, and may have a higher density and less porosity toward the distal end 109 of the contaminant-holding container 106. The diameter of the air-permeable flow resistor 108 will match the internal dimensions of the contaminant-holding container 106 in a manner that prevents blood from passing between the exterior of the air-permeable flow resistor 108 and the inner wall of the contaminant-holding container 106. The air-permeable flow resistor 108 may also be in the form of multiple components made of multiple materials.

[0074] In some embodiments, the air permeable flow resistor 108 may be impregnated with a material that swells when in contact with a fluid such as blood. Figure 2 106, but the air permeable flow resistor 108 may be positioned anywhere along the length of the contaminant containment vessel and may extend from the proximal end 107 to the distal end 109, depending on the absorbency of the material forming the air permeable flow resistor 108. The filter media forming the air permeable flow resistor 108 may be surface modified, or additives may be incorporated into the porous matrix to enhance functional performance requirements, such as timing and / or fluid volume, as appropriate.

[0075] In some embodiments, the air-permeable flow resistor 108 is formed by a material or a combination of materials that is configured to allow air to pass through but can be saturated with a portion of the first body fluid. The air-permeable flow resistor 108 can be formed at least in part by a porous polymer or plastic and / or a natural fiber material such as cotton, linen, etc. In some embodiments, the air-permeable flow resistor 108 can be formed by two parts: the first part is permeable to air and is mostly impermeable to fluid at the distal end (towards the outlet 104); the second part contains an additive that is sealed when in contact with blood at the proximal end (towards the contaminant holding container 106). This construction can prevent the additive from mixing with the fluid flowing through the sample path and out to a collection bottle, etc. The air-permeable flow resistor 108 can receive and capture at least a portion of the first portion of the fluid, thereby capturing any contaminants therein.

[0076] The fluid sample optimization device 100 also includes a sample path 110, the proximal end 111 of the sample path 110 is connected to the inlet port near the proximal end 107 of the contaminant holding container 106, and the proximal end 113 is connected to the outlet port 104. The sample path 110 can be formed as a channel, a pipe, a track, a channel, a portion, a cavity, a housing, a housing, etc. The air-permeable flow resistor 108 is configured to retain a portion of the first portion of the fluid for a sufficient time to allow the second portion of the main body fluid to bypass the contaminant holding container 106 via the sample path 110. Figure 2 As shown, the sample path 110 can traverse the fluid sample optimization device 100 substantially parallel to the direction of the contaminant holding container 106. In some embodiments, the cross-sectional area of ​​the contaminant holding container 106 can be larger than the cross-sectional area of ​​the sample path 110, which can help preferentially introduce the first amount of fluid from the inlet port 102 into the contaminant holding container 106.

[0077] The inlet port 102, the proximal end of the contaminant holding container 106, and the proximal end of the sample path 110 together form a junction 112. The junction 112 may include a plurality of tortuous passages, such as leading to the proximal end of the sample path, and may be configured to facilitate fluid flow first into the contaminant holding container 106, then around the contaminant holding container 106 and into and through the sample path 110. Importantly, unlike various prior art blood transfer or blood sample optimization devices, the junction 112 relies on passive fluid control and does not include an active switch, valve, or other mechanically movable device for diverting or switching fluid flow.

[0078] In terms of fluid dynamics, the resistance to flow in the initial path (R1) must be less than the resistance to flow in the sample path (R2). As the contaminant containment container fills, the resistance increases because blood is blocked from flowing through the air permeable resistor. Air flows easily through it, but no blood passes through. When R1 increases at a certain point, the scale tilts and R1 becomes greater than R2. At this point, blood will flow into the sample path. R2 can be increased by changing the length, diameter, and to some extent the geometry. R1 can be reduced in the same manner or variations and by controlling the permeability of the plug, as described in further detail herein.

[0079] In some embodiments, the fluid sample optimization device 100 includes a housing 120 that forms and provides one or more of an inlet port 102, an outlet port 104, a contaminant holding container 106, and a sample path 110. For example, the housing 120 can be formed by a top member that cooperates with a bottom member, wherein one or both of the top member and the bottom member are formed with grooves, channels, paths, areas, or other features to define and provide one or more of the inlet port 102, the outlet port 104, the contaminant holding container 106, and the sample path 110. The housing 120 can be made of a strong, resilient material, such as plastic (polycarbonate acrylic, PVC, ABS, etc.), metal, etc.; it can be sterilized before use so that it can be used in a clean, sterile state and free of microorganisms. The inlet port 102 and / or the outlet port 104 can further include or be equipped with a connector, such as a Luer connector or a threaded connection.

[0080] Figure 3 A fluid sampling system 200 is shown, which includes a fluid sample optimization device 201 connected to a blood sampling path having a patient needle 203 and a sample collection device 205, which in some embodiments includes an adapter with a sealed sample collection needle that receives one or more vacuum sample bottles. The patient needle 203 can be a safety vascular access needle, such as described in U.S. Patent Application No. 16 / 045,321, entitled "Needle Assembly with Needle Safety Shield", the contents of which are incorporated herein by reference for all purposes.

[0081] The fluid sample optimization device 201 includes an inlet port 202 connected to a patient needle 203, an outlet port 204 connected to a sample collection device 205, a contaminant containment container 206 having a gas-permeable flow resistor 208, and a sample path 210, a proximal end of which is fluidly connected to the inlet port 202 and a distal end of which is fluidly connected to the outlet port 204. The fluid sample optimization device 201 may further include a housing 220 that contains and defines one or more of the inlet port 202, the outlet port 204, the contaminant containment container 206, and the sample path 210. The housing 220 may be formed of any rigid material that is easily sterilizable or may have antimicrobial properties, but may also shield the inlet port 202, the outlet port 204, the contaminant containment container 206, and the sample path 210 and any components therein from external contamination.

[0082] Each of the contaminant holding container 206 and the sample path 210 can be connected to the inlet port 202 via a joint 212, the size and structure of which are designed to allow a first portion of fluid (e.g., blood) to be drawn, pulled, or otherwise flow into the contaminant holding container 206 to displace the air therein through the air-permeable flow resistor 208 and be at least temporarily retained in the contaminant holding container 206 for at least a portion, and allow a second portion of blood to bypass the contaminant holding container 206 and flow to the outlet port 204 and the sample path 210 of the sample collection device 205.

[0083] The sample collection device 205 may be a collection adapter. The type of device, the collection adapter is pierced by the vacuum-sealed collection bottle to expose the collection needle and allow the collection needle to be inserted into the septum of the collection bottle. The vacuum in the collection bottle can be a force that helps to draw body fluid from the patient through the fluid sample optimization device 201.

[0084] Figure 4 A-4D illustrate the operation of the fluid sample optimization device 100 / 201 and are specifically described in the context of blood sampling, although other types of bodily fluids may be collected or sampled. Figure 3 , and if Figure 4 As shown in A, when the fluid collection device generates a low pressure at the outlet of the fluid sample optimization device, such as when a collection bottle or collection tube is inserted into a collection adapter, the pressure difference between the outlet and the inlet (such as through the patient's venous puncture (or more specifically, the patient's vascular blood pressure)) will force air to flow out of the fluid sample optimization device and into the collection bottle, and blood will fill behind it.

[0085] In the illustrated embodiment, air can flow through two parallel paths - through the stopper in the contaminant holding container and the sample path. The flow through each channel can be proportional to the resistance in each path. Therefore, the optimal configuration for the fluid sample optimization device includes considerations: the volume of the contaminant holding container, the arrangement of the connection of the connection of the inlet to the contaminant holding container and the sample path, the relative cross-sectional dimensions of the inlet, the contaminant holding container and the sample path, the resistance of the stopper, the position and size of the stopper, the curvature of the various transitions or interfaces between the inlet, the contaminant holding container and the sample path, etc.

[0086] Figure 4 B shows blood filling the contaminant containment container. If the air does not pass through the stopper quickly enough, that is, if the resistance through the stopper is not lower than the resistance through the sample path, the pressure in the contaminant containment container will increase and force the fluid down the sample path before the contaminant containment container fills with fluid. Figure 4C shows the filled contaminant holding container. Once all the air is expelled from the contaminant holding container (through the stopper and sample path), the fluid will hit the stopper and progress through the stopper will slow and may stop. This may force the fluid to flow down the sample path, leaving the initial volume of blood in the contaminant holding container. No fluid may flow through the stopper at this point. Figure 6 Fluid flow is shown once air is flushed from the device, particularly from the contaminant containment container. The subsequent blood volume will flow along the path of least resistance (lower pressure gradient) toward and through the sample path, toward the distal end of the sample path and toward and out of the outlet port.

[0087] Fluid flow can be stopped completely or allowed to flow slowly into the stopper – during use it cannot reach the other side and mix with the sample path.

[0088] Making the resistance to airflow through the plug lower than the resistance through the sample path can be achieved by: 1) cross-sectional area – if the area of ​​the plug is much larger than the area of ​​the sample path, the resistance will be lower; 2) lengthening the sample path will increase the resistance, but the effect on air flow is much lower than that on fluid flow.

[0089] Depending on the geometry, the first fluid may first fill the contaminant containment vessel - e.g. Figure 4 Shown in A-4D, the inertia of fluid will prompt fluid to keep it straight into the pollutant holding container, rather than turning the corner into the sample path.In some embodiments, the pollutant holding container and the sample path or any inlet and outlet thereof can be coated differently to provide more or less resistance to fluid flow.For example, coating the wall of the pollutant holding container with a hydrophilic coating and coating the wall (or at least inlet) of the sample path with a hydrophobic coating can help first fill the pollutant holding container.Hydrophilic coating can include one or more of polyurethane (PU), polyvinyl pyrrolidone (PVP), polyacrylic acid (PAA) and / or polyethylene oxide (PEO).Hydrophobic coating can include polytetrafluoroethylene (PTFE).By inserting a soluble biocompatible material in the soluble biocompatible material dissolved when contacting with blood or fluid, the resistance in the sample path can be increased, once the pollutant holding container is filled with fluid, the resistance flowing through the sample path can be reduced.

[0090] In another embodiment, a benign, inert or non-reactive biocompatible material that does not affect the blood test results can be placed in the device, or at least at the connection with the contaminant containment container, to block the sampling path. The material can be configured to dissolve upon contact with blood or liquid. Such a material can be sized and configured to inhibit blood flow for a fraction of a second, because the contaminant containment container will fill almost immediately.

[0091] Figure 5 An embodiment of a fluid sample optimization device 300 without a housing is shown, the device having a contaminant holding container 302 and a sample path 304, which are formed by a tube or other type of fluid transport mechanism and form parallel or similarly oriented paths through Y-position connectors 306A and 306B at opposite ends of the device. The Y-position connectors 306A and 306B can be arranged in any orientation or alignment and can be sufficiently spaced to provide the contaminant holding container 302, if implemented as a tube with a known cross-sectional diameter and length, with a predetermined volume. The contaminant holding container 302 includes a gas-permeable flow resistor 308 that resists fluid flow but allows air to pass through, so that after a first amount or aliquot of fluid fills the contaminant holding container 302, subsequent amounts of fluid bypass the contaminant holding container 302 and flow through the sample path 304 to be ultimately collected by the fluid collection device.

[0092] A system using the fluid sample optimization device 300 may include: a patient needle 301 connected to a Y-position connector 306A, and a sample collection device 303 having a sealed sampling needle connected to a Y-position connector 306B. The conduit of the fluid sample optimization device 300 may be flexible or rigid. At least a portion of the tube may be made of a translucent material so that a clinician can observe the blood flow therein. The fluid sample optimization device 300 may include a filter 308, which may be at least partially formed of an anti-blood agent material that is permeable to blood. The filter 308 allows the air in the contaminant holding container 302 to be discharged therefrom through the filter 308 under vacuum force or other mechanisms that generate a negative pressure difference in the sample collection device 303.

[0093] In some embodiments, the fluid sample optimization device 300 can be used as a flash chamber, wherein upon venipuncture of a patient, blood can "flash" or suddenly be present in at least a portion of the contaminant containment vessel 302 based at least in part on vacuum forces at the outlet connection of the fluid sample optimization device 300. The vacuum pressure preferentially draws contaminated blood through the resistor (without capturing the contaminated blood) into the contaminant chamber.

[0094] Figure 6 A shows a fluid sample optimization device 400, which includes an inlet 402 and an outlet 404. The inlet 402 may include an inlet port, connector, or interface for connecting to an external device such as a pipe or its interface. The inlet 402 may be connected to a patient or a source of fluid for the patient, for example, via a venous puncture needle, wherein the fluid is provided at a pressure P1 and the fluid may be the patient's own blood pressure. The outlet 404 may include an outlet, connector, or interface for connecting to an external device such as a pipe or its interface. For example, as described above, the outlet 404 may be connected to a fluid collection device, such as or a vacuum tube of a syringe, wherein the fluid collection device draws fluid from the fluid source at a pressure P2 that is lower than the pressure P1. The pressure differential can allow the fluid sample optimization device 400 to be sealed to the atmosphere and atmospheric pressure, i.e., the fluid sample optimization device 400 need not include any vents or paths to the outside atmosphere, at least when in use.

[0095] The fluid sample optimization device 400 also includes a contaminant holding container 406 connected to the inlet 402 and the outlet 404, and having a gas-permeable flow resistor 407 between the distal end of the contaminant holding container 406 and the outlet 404. Herein, the contaminant holding container 406 can be sized to hold a desired amount of fluid and can include an absorbent material that at least partially fills the contaminant holding container 406. Also as further described herein, the contaminant holding container 406 can be configured as a tortuous path, a series of chambers having different cross-sections and volumes, and / or include rifling or baffles extending from the inner surface thereof to minimize backflow, i.e., flow toward the inlet 402. For example, the contaminant holding container 406 can include one or more channels 406A and one or more chambers 406B, all of which can be interconnected to receive, transport, or hold a predetermined volume of fluid, and any contaminants contained therein.

[0096] The air permeable blood resistor 407 allows a first portion or amount of fluid to be drawn from the fluid source by a pressure differential applied between the inlet 402 and the outlet 404 to enter the inlet 402 and the contaminant containment container 406, thereby displacing air therein until the fluid contacts the air permeable flow resistor 407, where the flowing fluid entering the contaminant containment container 406 is at least partially stopped.

[0097] The fluid sample optimization device 400 also includes a sample path 408 that is also connected to the inlet 402 and the outlet 404. The sample path 408 includes a resistance plug 409 disposed near the inlet 402. At the same time, the pressure difference between the inlet 402 and the outlet 404 can draw a first portion or a certain amount of fluid into the contaminant holding container 406, and the resistance plug 409 is configured to resist, inhibit, limit or prohibit the flow of fluid into the sample path 408 until the first portion or a certain amount of fluid has entered the contaminant holding container 406.

[0098] The fluid sample optimization device 400 may further include a housing 401, which may define one or more of an inlet 402, an outlet 404, a contaminant containment container 406, a sample path 408, or possibly other components (e.g., a gas permeable flow resistor 407 and a resistance plug 409). The housing 401 may be formed in one or more parts. For example, Figure 6As shown in the example of FIG. 4A , the housing 401 may include a top housing portion 422 that mates with a bottom housing portion 424 and may be mated and sealed together by sonic welding, thermal bonding, gluing, etc.

[0099] As described herein, the resistance plug 409 is configured such that after a first portion or amount of fluid has entered the contaminant holding container 406, the resistance plug 409 will still allow a second and / or subsequent portion or amount of fluid to flow from the inlet 402 through the sample path 408 to the outlet 404 under the pressure differential between the inlet 402 and the outlet 404. The resistance plug 409 can be recessed in the sample path 408 away from the inlet 402 to allow vacuum pressure to be established, and can also include a guide hole or small capillary, small hole, iris, etc. to allow soluble substances to begin to be dissolved by the fluid that continues to be drawn toward the outlet 404. Accordingly, a portion of the sample path 408 of the inlet 402 and / or the contaminant holding container 406 can form a junction 411 at a location near the resistance plug 409 and opposite the main portion of the sample path 408 to allow vacuum pressure to be established after the contaminant holding container 406 is filled to better allow fluid to enter through the resistance plug 409.

[0100] Once the fluid fills the contaminant containment vessel 406, a certain amount of air may be trapped in the junction 411 between the fluid and the resistance plug 409. If there is no way for the air to escape, the fluid will not reach the dissolvable material that forms at least a portion of the resistance plug 409 so as to be able to flow down the sample path 406. Figure 6 As shown in B-6I, an air path can be provided through or around the resistance plug 409 which will allow air to flow only when the air is exposed to the full vacuum pressure of the collection device because the fluid fills the contaminant holding container 406 and blocks the air permeable flow resistor 407, so that the fluid does not come into contact with the soluble material in the resistance plug 409 until the contaminant holding container 406 is completely filled and / or contains contaminants therein.

[0101] Figure 6 B shows a variation of the resistance plug 409 as a membrane 431, which can be formed as a thin film of material. In some embodiments, the membrane 431 can be at least partially formed of a dissolvable or easily tearable material. The membrane 431 has a small orifice 432 or guide hole as a mechanism to start the dissolution or tearing process. Figure 6 C shows a membrane 431 with a slit 433 that is closed in a static, stable state, but can open and allow fluid flow when pressure is applied to one or two opposing sides or surfaces of the resistor. Figure 6As shown in FIG. 4D , the slits 433 may be formed in an “X” or other configurations, such as linear slits, curved slits, star-shaped slits, etc. Figure 6 As shown in FIG. E, the membrane 431 may be formed as a porous membrane that allows air to flow through but does not allow body fluids such as blood to flow through. Figure 6 As shown in FIG. 4F , a membrane 431 may be positioned between the top housing portion 422 and the bottom housing portion 424 at the entrance to the sample path 408 so as to allow air to “leak” around the membrane 431 when a predetermined pressure is applied thereto.

[0102] Although the resistance plug 409 can be formed in other shapes, such as square, rectangular or other shapes, Figure 6 G-6I shows the resistance plug 409 as a cylindrical plug member 435. Figure 6 As shown in FIG. 4, the cylindrical plug member 435 may be provided with a small guide hole, or as shown in FIG. Figure 6 H, the plug 435 is porous to air. The resistive plug 409, whether implemented as a cylindrical plug member 435 or other shape, can be positioned between the top housing portion 422 and the bottom housing portion 424 at the entrance of the sample path 408 to allow air to "leak" around the cylindrical plug member 435 when a predetermined pressure is applied thereto.

[0103] As further described herein and as Figure 7 As shown, a resistance plug 500 for an opening to a sample path can be formed from a composition including a mesh 502 at least a portion of which is impregnated with a soluble material 504. In some specific embodiments, the resistance plug 500 can include a mesh material that supports the soluble material 502. The mesh material can be, for example, a mesh of plastic or nylon, such as a mesh of 50-100 μm nylon or plastic thread. The soluble material 504, which may not be formed into a rigid plug or film, can be impregnated into the mesh 502 or other porous material. The soluble material 504 can be dissolved by contact with a fluid such as blood. The soluble material 504 is formulated to be inert or non-reactive to laboratory testing of sampled or collected fluid samples, which are typically provided with cultures to test for specific bacteria or viruses, or antibodies thereto, or other pathogens present in the fluid sample.

[0104] like Figure 8 As shown, the resistance plug 600 can also be formed from the mesh 602 as described above, but it is covered with an insoluble viscous material 604, such as silicone grease, or integrated therewith. The viscous material 604 can be spread on the mesh 602 or other porous material. Once the pressure difference across the resistance plug 600 is high enough, the viscous material 604 is pulled through the openings in the mesh 602 to form an opening for the fluid sample to flow through, such as Figure 8B. At most only trace amounts of viscous material 604 will exit the outlet and thus will not interfere with any testing or culturing of the fluid sample.

[0105] like Fig. 9 As shown in FIG. 9C , the resistance plug 700 may be formed by a membrane 702 that is stretched or positioned above and spaced from the piercing member 704 in an initial state. The piercing member 704 may include spikes, pins, blades, fragments, etc., and may be formed by, for example, Fig. 9 The holding mechanism shown in B is substantially held in the center of the opening to the sampling path, such as Fig. 9 As shown in A. The membrane 702 can be a sheet of elastic material, such as rubber or other elastic materials. Fig. 9 As shown in Figure C, once the contaminant holding container is filled with fluid, a certain pressure is applied to the membrane 702 to further stretch it so as to contact the piercing member 704. Once contact is formed between the membrane 702 and the piercing member 704, the membrane 702 is pierced or otherwise broken by the piercing member 704 to open a larger area so that a certain amount or portion of the fluid can subsequently flow into the sample path.

[0106] Fig.10 A-11B shows various views of fluid sample optimization devices 800 and 900 for optimizing a fluid sample collected by a fluid collection device from a fluid source, and wherein a first portion of the fluid sample potentially has contaminants. Fig.10 As shown in FIGS. 10A and 10B, the fluid sample optimization device 800 includes an inlet 802 configured to be connected to a fluid source, an outlet 804 configured to be connected to a fluid collection device, and a sample path 808 connected between the inlet 802 and the outlet 804. The fluid sample optimization device 800 further includes a contaminant holding container 806 connected between the inlet 802 and the outlet 804. One or more of the inlet 802, the outlet 804, the contaminant holding container 806, and the sample path 808, as well as possible other components of the fluid sample optimization device 800, can be housed in and / or defined by a housing 820.

[0107] The contaminant containment container 806 also includes an air-permeable flow resistor 812 connected to the sample path 808, preferably adjacent to the outlet 804. When a pressure differential is applied between the inlet 802 and the outlet 804, the contaminant containment container 806 is arranged to receive a first portion of the fluid sample from the fluid source to displace air therein through the air-permeable flow resistor 812 and the outlet 804. Fig.12 As shown in A, the air permeable flow resistor 812 can be elongated and configured for a specific air flow range and can be self-sealing when in contact with non-air fluids such as blood or other body fluids.

[0108] Upon receiving the first portion of the fluid sample and containing the contaminant in the contaminant-holding container 806, subsequent portions of the fluid sample may be received by the sample path 808 and transferred from the inlet 802 to the outlet 804 when a subsequent pressure differential is applied between the inlet 802 and the outlet 804. In some embodiments, the fluid sample optimization device 800 includes a resistive plug 810 that initially substantially blocks the sample path 808 from the inlet 802 while remaining until the first portion of the fluid is contained in the contaminant-holding container 806.

[0109] like Fig.11 As shown in FIGS. 11A and 11B, the fluid sample optimization device 900 includes an inlet 902 configured to be connected to a fluid source, an outlet 904 configured to be connected to a fluid collection device, and a sample path 908 connected between the inlet 902 and the outlet 904. The fluid sample optimization device 900 also includes a contaminant holding container 906 connected between the inlet 902 and the outlet 904. One or more of the inlet 902, the outlet 904, the contaminant holding container 906, and the sample path 908, and possible other components of the fluid sample optimization device 900 can be housed in and / or defined by a housing 920.

[0110] The contaminant containment vessel 906 also includes an air-permeable flow resistor 912 connected to the sample path 908, preferably proximate the outlet 904. When a pressure differential is applied between the inlet 902 and the outlet 904, the contaminant containment vessel 906 is arranged to receive a first portion of the fluid sample from the fluid source to displace air therein through the air-permeable flow resistor 912 and the outlet 904. The air-permeable flow resistor 912 can be cylindrical and configured for a specific air flow range, and can be multi-layered to include a self-sealing layer that seals when in contact with a non-air fluid (e.g., blood or other body fluids), respectively. Fig.12 B and 12C.

[0111] Upon receiving the first portion of the fluid sample and containing the contaminants in the contaminant-holding container 906, subsequent portions of the fluid sample may be received by the sample path 908 and transferred from the inlet 902 to the outlet 904 when a subsequent pressure differential is applied between the inlet 902 and the outlet 904. In some embodiments, the fluid sample optimization device 900 includes a resistance plug 910 that is initially inserted into the sample path 908 substantially from the inlet 902 until the first portion of the fluid is contained in the contaminant-holding container 906.

[0112] Fig.13 A-13C shows various embodiments and configurations of resistance plugs, such as a cylindrical plug ( Fig.13 A), membrane or film ( Fig.13 B) or flexible cover ( Fig.13 C).

[0113] Fig.14 A-14C shows a resistance plug having an aperture 1000 or iris that is selectively manually or automatically actuated / destroyed to allow or prevent flow at different times based on different pressures applied to the resistance plug. In some embodiments, the resistance plug is an elastomeric membrane with a small hole 1000 at the center. When a pressure differential is applied to one side of the membrane forming the resistance plug, the pressure differential will deflect and increase the size of the aperture 1000, allowing fluid to flow to the output. Alternatively, the resistance plug can include a rigid or semi-rigid plug member 1002 that will cover the orifice 1000 and will not fall out once the orifice 1000 is activated.

[0114] Although a few embodiments have been described in detail above, other modifications are possible. Other embodiments may be within the scope of the following claims.

Claims

1. A device comprising: an inlet port for receiving a blood sample; Exit port; a chamber connected to the inlet port and the outlet port and configured to collect a first portion of the blood sample, the chamber comprising a material that is permeable to air and impermeable to blood; a sampling channel connected to the inlet port and configured to transfer a subsequent portion of the blood sample to the outlet port; and A resistive plug configured to inhibit at least a portion of a first portion of the blood sample from entering a sample path and having a structural feature configured to control the resistance of the resistive plug to allowing a subsequent portion of the blood sample to enter the sample path.

2. The device according to claim 1, wherein: The resistance plug comprises a dissolvable material and the structural feature is a guide hole that passes through the resistance plug to allow blood to begin the lysis process.

3. The device according to claim 1, wherein: The resistance plug comprises a tearable material and the structural feature is a guide hole that passes through the resistance plug to allow blood to initiate the tearing process.

4. The device according to claim 1, wherein: The structural feature is a slit that is configured such that, when pressure is applied, the slit opens and allows blood to flow into the sample path.

5. The device according to claim 1, wherein: The resistance plug comprises a dissolvable material and the structural feature is a porous membrane that allows air to flow through the resistance plug but does not allow blood to flow through the resistance plug.

6. The device according to claim 1, wherein: The structural feature is an air path around the resistive plug to allow blood to contact the resistive plug to begin the lysis process.

7. The device according to claim 1, wherein: The resistive plug includes a dissolvable material configured to be inert or non-reactive to one or more laboratory tests to be performed on the blood sample.

8. The device according to claim 1, wherein: The walls of the chamber are coated with a hydrophilic coating to provide less resistance to fluid flow and facilitate filling of the chamber with the first portion of the blood sample.

9. The device according to claim 1, wherein: The walls of the sample path are coated with a hydrophobic coating, thereby providing greater resistance to fluid flow and facilitating blood to fill the chamber first.

10. The device according to claim 1, wherein: The walls of the chamber are coated with a hydrophilic coating, and the walls of the sample path are coated with a hydrophobic coating.

11. The device of claim 1, wherein the resistive plug is an elastic membrane and its structural features include holes in the elastic membrane, the holes configured to increase in size to allow fluid to flow to the outlet port.

12. The device of claim 11, wherein the resistive plug is configured to be manually actuated to allow or prevent the fluid flow.

13. The device according to claim 11, wherein: The resistive plug is configured to be automatically actuated to allow or prevent the fluid flow.

14. The device according to claim 13, wherein: The resistance plug is configured to actuate based on pressure applied to the resistance plug.

15. The device according to claim 11, wherein The structural features also include a plug member that is shaped to cover the hole and that falls away once the hole increases in size sufficiently.

16. An apparatus comprising: an inlet port for receiving a blood sample; Exit port; a chamber connected to the inlet port and the outlet port and configured to collect a first portion of the blood sample; the chamber comprising a material that is permeable to air and impermeable to blood; a sampling channel connected to the inlet port and configured to transfer a subsequent portion of the blood sample to the outlet port; Therein, the wall of the chamber and / or the wall of the sampling channel comprises one or more coatings which facilitate the blood to first fill the chamber.

17. The device according to claim 16, wherein: The wall of the chamber is coated with a hydrophilic coating to provide less resistance to liquid flow and facilitate filling of the chamber with the first portion of the blood sample.

18. The fluid sample optimization device according to claim 16, wherein: The walls of the sample path are coated with a hydrophobic coating, thereby providing greater resistance to fluid flow and facilitating blood to fill the chamber first.

19. The device according to claim 16, wherein: The walls of the chamber are coated with a hydrophilic coating, and the walls of the sample path are coated with a hydrophobic coating.

20. An apparatus comprising: an inlet port for receiving a blood sample; Exit port; a chamber connected to the inlet port and the outlet port and configured to collect a first portion of the blood sample; the chamber comprising a material that is permeable to air and impermeable to blood; a constriction region after the inlet port, after the constriction region is a larger cross-sectional area in the chamber; as well as A sampling channel is connected to the inlet port and is configured to transfer a subsequent portion of the blood sample to the outlet port.

21. The device of claim 20, further comprising a resistive plug configured to inhibit at least a portion of the first portion of the blood sample from entering the sample path during receipt of the first portion of the blood sample into the chamber, wherein The constricted region facilitates preferentially directing a first portion of the blood sample from the inlet port through the resistive plug to the chamber.

22. The device according to claim 20, wherein: The constriction region is proximate a point of connection from the inlet port to the sample path.

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