Non-venting bodily fluid sample optimization device and system

Abstract

To provide a fluid sample optimization device for optimizing a fluid sample.SOLUTION: A fluid sample optimization device 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 an air permeable fluid resistor proximate to the outlet, and is arranged to receive, when a pressure differential is applied between the inlet and the outlet, a first portion of a fluid sample to displace air therein through the air permeable fluid resistor and the outlet, such that upon receipt of the first portion of the fluid sample and containment of contaminants in the contaminant containment reservoir, subsequent portions of the fluid sample can be conveyed by the sample path from the inlet to the outlet when subsequent pressure differentials are applied between the inlet and the outlet.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present disclosure relates generally to a fluid sample optimization device and system for optimizing a fluid sample. (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 62 / 827,783, filed April 1, 2019, which is incorporated herein by reference in its entirety. [Background technology]

[0002] Bacteremia is the presence of microorganisms in the blood. Sepsis, on the other hand, is bacteremia when clinical symptoms and signs such as fever, tachycardia, tachypnea, and hypotension are present. Bacteremia and sepsis are associated with high mortality and increased incidence and duration of hospitalization and associated costs. Many bacteremias, sepsis, fungemias, and other pathogens occur within hospitals or other healthcare facilities due to the contamination of catheters and venipunctures as potential carriers of these pathogens.

[0003] Blood culture is the 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, either from a peripheral site or from a central or arterial route, where blood is inoculated into one or more blood culture bottles or containers. One bottle is considered a blood culture, two or more are considered a set. Multiple sets may be obtained from multiple venipunctures, associated with different sites on the patient.

[0004] Although these methods allow for the performance of microbial identification and susceptibility testing, which are essential components in the management of sepsis, they do not provide rapid results and have reduced susceptibility to resistant pathogens, leading to the development of improved systems and complementary molecular or proteomic tests.

[0005] The collection of blood samples to perform blood cultures is a critical component of modern patient care and can either positively impact patient outcomes by providing an accurate diagnosis or negatively impact outcomes by providing false-positive results for infection, prolonging unnecessary antimicrobial therapy, increasing hospital stays, and increasing costs.

[0006] One of the consequences of blood culture collection is contamination. Blood culture contamination can lead to false positive culture results and / or a significant increase in healthcare-related costs. Causes of blood culture contamination include improper skin preparation, improper collection tube disinfection, and contamination of the initial blood volume at the time of collection, which can skew the results.

[0007] Blood culture collection kits generally consist of a "butterfly" set, infusion set, or other type of venipuncture device provided by companies such as BD, Smith, B.Braun, and aerobic and anaerobic blood culture bottles. A variety of bottles are also available depending on the test conditions. These bottles are specifically designed to optimize the return of both aerobic and anaerobic organisms. In conventional kits, the bottles used are commonly known as "Vacutainers", which are blood collection tubes formed from sterile glass or plastic tubing with a closure that is evacuated to create a vacuum within the tube to facilitate the aspiration of a predetermined amount of liquid, such as blood.

[0008] False positive blood cultures are typically the result of poor sampling technique. This leads to antibiotic use when not necessary, increasing hospital costs and patient anxiety. Blood cultures are drawn from a needle prick into the skin, and a Vacutainer is attached to collect the blood sample. Contamination can result from improper or incomplete disinfection of the puncture site and the surrounding skin area. It can also result from coring of the skin by the needle during insertion, drawing cored skin cells and any associated contaminants into the sample.

[0009] Because blood flow through a hypodermic needle is laminar, a flow velocity gradient can occur across the flow tube when a pressure drop is applied across the hypodermic needle. Using a strong blood draw or a very thin hypodermic needle can cause anomalies in the blood sample due to dissolution or release of potassium from red blood cells.

[0010] Various strategies have been implemented to reduce blood culture contamination rates, including training staff on aseptic collection technique, feedback on contamination rates, and implementation of blood culture collection kits. Skin antisepsis can reduce the amount of contamination, but more than 20% of microorganisms on the skin are located deep in the dermis and are not affected by antisepsis. Changing needles before bottle inoculation is not recommended as it does not reduce contamination rates but increases the risk of needle stick damage.

[0011] Some conventional systems and techniques for reducing blood culture contamination include discarding the first aliquot of blood collected from central venous catheters, venipunctures, and other vascular access systems, however, these systems require the user to mechanically manipulate an intravascular device or require a complex series of steps that are difficult and reduce the chances of being followed consistently. Summary of the Invention

[0012] This document describes a non-breathable bodily fluid sample optimization device and system for use in a blood sampling or blood culture collection system. According to the implementations described herein, the device has no moving parts, valves, state transition switches or diverters, or other mechanisms that move, shift, or transition from one operating mode to another, or from one state to another.

[0013] In some implementations, the fluid sample optimization device includes an inlet port, an outlet port, and a contaminant containment reservoir having a proximal end coupled to the inlet port and a distal end coupled to the outlet port. The fluid sample optimization device further includes an air permeable fluidic resistor disposed and secured within the contaminant containment reservoir, the air permeable fluidic resistor having a front face toward the proximal end of the contaminant containment reservoir and a back face toward the distal end of the contaminant containment reservoir. The fluid sample optimization device further includes a sample path having a proximal end connected to the inlet port near the proximal end of the contaminant containment reservoir and a distal end coupled to the outlet port.

[0014] A drawing or pulling force applied to the outlet port, such as vacuum pressure or withdrawal of a syringe plunger, draws a first amount of fluid, such as venous blood, into the inlet port and initially into the contaminant containment reservoir, where air is drawn through the air permeable fluid resistor. Eventually, the fluid fills the contaminant containment reservoir and eventually strikes the air permeable fluid resistor, where it is at least partially trapped for at least a known period of time. Before the fluid can pass through the air permeable fluid resistor and exit, a force (such as a vacuum) draws a second amount of fluid into a parallel or coexisting sample path fluidly connected between the inlet port and the outlet port, causing the second amount of fluid to bypass the contaminant containment reservoir and the fluid resistively maintained therein, at least temporarily. Subsequent amounts of fluid to the second amount of fluid may also bypass the first amount of fluid and the contaminant containment reservoir, be drawn through the sample path into the inlet port, and drawn out of the outlet port.

[0015] In some embodiments, the fluid sample optimization device includes an inlet configured to connect with a fluid source, an outlet configured to connect with a fluid collection device, and a sample pathway connected between the inlet and the outlet. The fluid sample optimization device further includes a contaminant containment reservoir connected between the inlet and the outlet. One or more of the inlet, outlet, contaminant containment reservoir, and sample pathway, and possibly other components, of the fluid sample optimization device may be contained within and / or defined by a housing.

[0016] The contaminant containment reservoir preferably further includes an air-permeable fluidic resistor connected to the sample pathway proximate the outlet. The contaminant containment reservoir is configured to receive a first portion of the fluid sample from the fluid source and displace air therein through the air-permeable fluidic resistor and the outlet upon application of a pressure differential between the inlet and the outlet. The air-permeable fluidic resistor may self-seal upon contact with a non-air fluid, such as blood or other bodily fluid.

[0017] Upon receiving a first portion of the fluid sample and containing contaminants within the contaminant containment reservoir, a subsequent portion of the fluid sample may be received by the sample pathway and transported from the inlet to the outlet when a subsequent pressure differential is applied between the inlet and the outlet. In some implementations, the fluid sample optimization apparatus includes a resistive plug that initially substantially blocks the sample pathway from the inlet while and until the first portion of the fluid is received within the contaminant containment reservoir.

[0018] Another aspect is a fluid sample optimization device for optimizing a fluid sample collected by a fluid collection device from a fluid source, where a first portion of the fluid sample potentially has contaminants, the fluid sample optimization device including an inlet configured to connect with the fluid source and an outlet configured to connect with the fluid collection device. The fluid sample optimization device further includes a sample path connected between the inlet and the outlet. The sample path has a resistive plug configured to block at least a portion of the first portion of the fluid sample and contaminants from entering the sample path.

[0019] The fluid sample optimization device further includes a contaminant containment reservoir connected between the inlet and the outlet, the contaminant containment reservoir having an air-permeable fluidic resistor proximate the outlet, the contaminant containment reservoir configured to receive a first portion of the fluid sample from the fluid source and displace air therein through the air-permeable fluidic resistor and the outlet when a pressure differential is applied between the inlet and the outlet, such that once the first portion of the fluid sample is received and contaminants are contained within the contaminant containment reservoir, a subsequent portion of the fluid sample may be forced through a resistive plug of the sample path and transported by the sample path from the inlet to the outlet when a subsequent pressure differential is applied between the inlet and the outlet.

[0020] 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.

[0021] These and other aspects will now be described in detail with reference to the following drawings. [Brief description of the drawings]

[0022] [Figure 1] 1A and 1B show a non-permeable fluid contaminant sample optimization apparatus according to implementations described herein. [Diagram 2] 1 illustrates a non-permeable fluid contaminant sample optimization apparatus according to implementations described herein. [Diagram 3] 1 illustrates a fluid sampling system that uses a fluid sample optimizer according to implementations described herein. [Figure 4] 4A-4D illustrate a process for withdrawing a first amount of bodily fluid from a patient and bypassing it to collect a second and / or subsequent amount of bodily fluid. [Diagram 5] 1 shows a fluid sample optimization device without a housing. [Figure 6]6A-6I show implementations of the non-permeable fluid sample optimization device, as well as various implementations of resistors. [Figure 7] 7A and 7B show yet another implementation of a resistor having a fusible material. [Figure 8] 8A and 8B show yet another implementation of a resistor having both a soluble material and a highly viscous non-soluble material. [Figure 9] 9A-9C show yet another implementation of a resistor having a penetrable member. [Figure 10] 10A and 10B show a particular configuration of a non-permeable fluid sample optimization device formed within a housing using an elongated air permeable fluidic resistor. [Figure 11] 11A and 11B show another particular configuration of a non-permeable fluid sample optimization device formed within a housing. [Figure 12] 12A-12C show various configurations of air permeable flow resistors for use in the implementations described herein. [Figure 13] 13A-13C show various configurations of resistive plugs for use in the implementations described herein. [Figure 14] 14A-14C show resistive plugs with an iris or opening that expands to open under certain pressure conditions.

[0023] Like reference symbols in the various drawings indicate like elements. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] This document describes a fluid sample optimization device for use in a fluid sampling or collection system, such as for blood culture or blood testing, for containing contaminants that may be in a first portion of the sampled or collected fluid. The fluid sample optimization device is configured for continuous fluid flow, i.e., to receive a first amount of bodily fluid from a patient, maintain at least a portion of the bodily fluid in a contaminant containment reservoir, receive a second amount of bodily fluid from the patient via a sample path, and automatically bypass the bodily fluid maintained in the contaminant containment reservoir. In some implementations, the bodily fluid is blood, and by way of example, the first amount of blood may include contaminants that may be obtained and mixed into the first amount of blood by venipuncture or other vascular access process.

[0025] As shown in FIG. 1A, the fluid sample optimization device 10 includes an inlet 12 and an outlet 14. The inlet 12 may include an inlet port, connector, or interface for connecting to an external device, such as a tube or an interface thereof. The inlet 12 may be connected to a patient or a patient's fluid source, such as via a venipuncture needle, where the fluid is supplied at a pressure P1, which may be the patient's own blood pressure. The outlet 14 may include an outlet port, connector, or interface for connecting to an external device, such as a tube or an interface thereof. For example, the outlet 14 may be connected to a fluid collection device, such as a vacuum tube, such as a Vacutainer® or a syringe, where the fluid is drawn by the fluid collection device from the fluid source by a pressure P2, which is lower than the pressure P1. The pressure difference between P1 and P2 allows the fluid sample optimization device 10 to be closed to the atmosphere and atmospheric pressure, i.e., the fluid sample optimization device 10 does not need to include any vent or path to the outside atmosphere, at least in use.

[0026] The fluid sample optimization device 10 further includes a contaminant containment reservoir 16 connected to the inlet 12 and outlet 14 and having an air permeable fluidic resistor 17 between a distal end of the contaminant containment reservoir 16 and the outlet 14. As described further herein, the contaminant containment reservoir 16 may be sized to hold a desired amount of fluid and may include an absorbent material that at least partially fills the contaminant containment reservoir 16. Also, as described further herein, the contaminant containment reservoir 16 may be configured as a tortuous path, a series of chambers of different cross-sections and volumes, and / or may include rifling or baffles extending from an interior surface to minimize backflow, i.e., flow toward the inlet 12.

[0027] The air permeable blood resistor 17 allows air to pass and displaces the air through the inlet 12 and a first portion or amount of fluid in the isolation chamber 16 when a pressure differential is applied between the inlet 12 and the outlet 14, i.e., when the negative pressure at the outlet 14 exceeds the pressure at the inlet 12. When the fluid contacts the air permeable fluid resistor 17, the flow of fluid into the contaminant containment reservoir 16 is at least partially stopped and at least a portion of the fluid is maintained within the contaminant containment reservoir 16.

[0028] The fluid sample optimization device 10 further includes a sample path 18 connected to the inlet 12 and the outlet 14. The sample path 18 includes a resistor 19 disposed proximate to the inlet 12. At the same time that the pressure P2 draws a first portion or amount of fluid into the contaminant containment reservoir 16, the resistor 19 is configured to resist, block, restrict or prevent the flow of fluid into the sample path 18 until the first portion or amount of fluid has entered the contaminant containment reservoir 16. As described further herein, the resistor 19 is configured to allow a second and / or subsequent portion or amount of fluid to flow from the inlet 12 through the sample path 18 to the outlet 14, still under the force of the pressure differential between P2 and P1, after the first portion or amount of fluid has entered the contaminant containment reservoir 16. Also, as described further herein, resistor 19 may be recessed into sample path 18 away from inlet 12 to allow vacuum pressure to build up and may include a pilot hole or small capillary, opening, iris, etc. to allow the soluble material to begin to dissolve as fluid continues to be drawn toward outlet 14.

[0029] As described further herein, resistor 19 may be formed from a composition including at least a portion of a dissolvable material. In certain implementations, the dissolvable material is dissolvable by contact with blood. Suitable materials for the dissolvable material may include any number of synthetic soluble polymers, such as, but not limited to, polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP). Polyvinylpyrrolidone, commonly also referred to as polyvidone or povidone, is a water-soluble polymer made from the monomers N-vinylpyrrolidone, polyethylene glycol (PEG), polyethylene oxide (PEO), and / or other synthetic soluble polymers. Materials for the dissolvable material may also include any number of natural soluble polymers, such as, but not limited to, hydroxypropermethylcellulose (HPMC), cellulose, corn starch or other starches, salt, and / or rice paper.

[0030] The key to the material used for the dissolving material is that it must be inert or non-reactive to laboratory testing of the sample or collected fluid specimen, which is often provided in culture to test for specific bacteria or viruses, or their antibodies, or other pathogens present in the fluid sample. In other words, the dissolving material should not contain any substances or materials that may significantly affect the testing or determination of the fluid sample. Furthermore, such dissolving material must be harmless to the patient in the very unlikely event of injection due to back pressure or exposure to the patient's venous system.

[0031] 1B shows an implementation of a fluid sample optimization device 20 that includes an inlet 22 and an outlet 24. As mentioned above, the inlet 22 may be connected to a patient or a patient's fluid source, such as via a venipuncture needle, where the fluid is provided at a pressure P1, which may be the patient's own blood pressure. The outlet 24 may be connected to a fluid collection device, such as a Vacutainer® or a syringe-like vacuum tube, where the fluid is drawn from the fluid source at a pressure P2, which is lower than pressure P1.

[0032] The fluid sample optimization device 20 further includes a contaminant containment reservoir 26 connected to the inlet 22 and the outlet 24 and having an air permeable fluidic resistor 27 between a distal end of the contaminant containment reservoir 26 and the outlet 24. The fluid sample optimization device 20 further includes a sample path 28 connected to the inlet 22 and the outlet 24. The sample path 28 includes a resistor 29 disposed proximate to the inlet 22.

[0033] In some implementations, as shown in FIG. 1B, the fluid sample optimization device 20 may include an acceleration section 30 to reduce the fluid pressure of the fluid moving therethrough, thereby increasing the velocity of the fluid, for example, from the inlet 22 to the contaminant containment reservoir 26. This further helps to preferentially direct a first portion or amount of the fluid from the inlet 22 to the contaminant containment reservoir 26 before a subsequent portion or amount of the fluid passes through the resistor 29 and is output through the outlet 24 for collection. The acceleration section may include a smaller cross-sectional area, or a constricted region, a choke point, etc., in a venturi path, for example. The acceleration section 30 may be followed by a larger cross-sectional area of ​​the contaminant containment reservoir 26, which may also be configured to hold a predetermined volume of fluid. In some implementations, the acceleration section 30 may be positioned proximate to the connection point from the inlet 22 to the sample path 28, such that when the contaminant containment reservoir 26 is filled, a subsequent portion or amount of blood overcomes the resistor 29, increasing the pressure within the acceleration section 30 to allow the subsequent portion or amount to flow through the sample path 28 to the outlet 24.

[0034] 2 shows a fluid sample optimization device 100 including an inlet port 102 and an outlet port 104. The inlet port 102 may be fluidly coupled to a bodily fluid sample access device such as a patient needle, tube, access port, catheter port, etc. The outlet port 104 may be fluidly coupled to a fluid collection device such as a Vacutainer® set, which may include a sealed sampling needle onto which a vacuum sealed collection tube may be placed to break the seal and provide vacuum based power from the inlet port 102 to the outlet port 104 through the fluid sample optimization device 100. 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 "pull" fluid from the patient through the fluid sample optimization device 100.

[0035] Additionally, the fluid sample optimization device 100 includes a contaminant containment reservoir 106 having a proximal end 107 coupled to the inlet port 102 and a distal end 109 fluidly coupled, such as by air, to or toward the outlet port 104. The contaminant containment reservoir 106 may have any shape and / or cross-sectional dimension. Additionally, the transition from the inlet port 102 to the contaminant containment reservoir 106 may be straight or curved. In some implementations, the contaminant containment reservoir 106 has a cylindrical or otherwise circular cross-section, as a smooth transition without sharp edges or corners may avoid hemolysis when the fluid traversing or bypassing the contaminant containment reservoir 106 is blood.

[0036] The fluid sample optimization device 100 further includes an air permeable fluidic resistor 108, also referred to herein as a "plug," disposed and secured within the contaminant containment reservoir 106. The air permeable fluidic resistor 108 may be a complete or partial resistor to the passage of fluid therein, depending on the time and pressure applied to the fluid. According to some preferred implementations, the air permeable fluidic resistor 108 has a front side that faces or faces toward the proximal end 107 of the contaminant containment reservoir 106 and a back side that faces or faces toward the distal end 109 of the contaminant containment reservoir 106. The air permeable fluidic resistor 108 passes air from the contaminant containment reservoir 106 through the air permeable fluidic resistor 108 toward and out of the outlet port 104 of the fluid sample optimization device 100 when a vacuum is applied to the outlet port 104 and pushed by a first amount of bodily fluid, such as blood.

[0037] As with the implementations described herein, the air permeable flow resistor 108 may have a thickness or length of less than 0.05 mm 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 containment reservoir 106, and more dense and less porous toward the distal end 109 of the contaminant containment reservoir 106. The diameter of the air permeable flow resistor 108 matches the internal dimensions of the contaminant containment reservoir 106 to prevent blood from passing between the outer portion of the air permeable flow resistor 108 and the inner wall of the contaminant containment reservoir 106. The air permeable flow resistor 108 may also be in the form of multiple components constructed from a variety of materials.

[0038] In some implementations, the air permeable fluidic resistor 108 can be impregnated with a material that expands upon contact with a fluid, such as blood. Although shown in FIG. 2 as being located toward the distal end 109 of the contaminant containment reservoir 106, the air permeable fluidic resistor 108 can be located anywhere along the length of the contaminant containment reservoir and can extend from the proximal end 107 to the distal end 109 depending on the degree of absorbency of the material forming the air permeable fluidic resistor 108. The filtration medium forming the air permeable fluidic resistor 108 can be surface modified or additives can be incorporated into the porous matrix to enhance functionality depending on specific performance requirements, such as, for example, timing and / or fluid volume.

[0039] In some implementations, the air permeable fluidic resistor 108 is formed of a material or combination of materials configured to pass air, which may be saturated with a portion of the first amount of bodily fluid. The air permeable fluidic resistor 108 may be formed, at least in part, of a porous polymer or plastic and / or a natural fiber material, such as cotton, linen, etc. In some implementations, the air permeable fluidic resistor 108 may be formed of two parts, a first part that is permeable to air and mostly impermeable to fluid at a distal end (towards the outlet 104) and a second part that includes an additive that seals upon contact with blood at a proximal end (towards the contaminant containment reservoir 106). This configuration may prevent the additive from mixing with the fluid flowing through the sample path to a collection bottle or the like. The air permeable fluidic resistor 108 may receive and capture at least a portion of the first portion of the fluid, thereby trapping contaminants therein.

[0040] The fluid sample optimization device 100 further includes a sample path 110 having a proximal end 111 connected to an inlet port near the proximal end 107 of the contaminant containment reservoir 106 and a distal end 113 coupled to the outlet port 104. The sample path 110 may be formed as a channel, tube, track, passage, section, cavity, housing, casing, or the like. The air permeable fluidic resistor 108 is configured to retain a first portion of the fluid for a sufficient time to allow a second portion of the bodily fluid to bypass the contaminant containment reservoir 106 via the sample path 110. As shown in FIG. 2, the sample path 110 may traverse the fluid sample optimization device 100 substantially parallel to the direction of the contaminant containment reservoir 106. In some implementations, the cross-sectional area of ​​the contaminant containment reservoir 106 may be larger than the cross-sectional area of ​​the sample path 110, which may help preferentially direct a first amount of fluid from the inlet 102 into the contaminant containment reservoir 106.

[0041] The inlet port 102, the proximal end of the contaminant containment reservoir 106, and the proximal end of the sample path 110 together form a junction 112. The junction 112 may include, for example, multiple curved passages leading to the proximal end of the sample path, which may be configured to facilitate fluid flow first into the contaminant containment reservoir 106 and then bypass the contaminant containment reservoir 106 through the sample path 110. Importantly, unlike various prior art blood diversion or blood sample optimization devices, the junction 112 relies on passive fluid control and does not include active switches, valves, or other mechanically movable devices to divert or switch fluid flow.

[0042] Hydrodynamically, the resistance to flow in the initial pathway (R1) must be less than the resistance to flow in the sample pathway (R2). When the contaminant containment reservoir fills, the resistance increases as blood is prevented from moving through the air permeable resistor. Air flows easily, but blood does not. At some point, R1 increases, the scale tops out and R1 becomes greater than R2. At that point, blood flows into the sample pathway. R2 can be increased depending on the changes applied to the length, diameter, and to some extent geometry. R1 can be reduced by the same means or modifications, and by managing the breathability of the plug, as described in more detail herein.

[0043] In some implementations, the fluid sample optimization device 100 includes a housing 120 that forms and provides one or more of the inlet port 102, the outlet port 104, the contaminant containment reservoir 106, and the sample path 110. For example, the housing 120 may be formed from an upper member that mates with a lower member, one or both of which are formed with grooves, channels, pathways, regions, or other features to define and provide one or more of the inlet port 102, the outlet port 104, the contaminant containment reservoir 106, and the sample path 110. The housing 120 may be made of a strong, resilient material such as plastic (polycarbonate acrylic, PVC, ABS, etc.), metal, etc., and may be sterilized prior to use to provide a clean, sterilized, and germ-free condition. The inlet port 102 and / or the outlet port 104 may further include or be fitted with a connector, such as a Luer connector or a threaded connection.

[0044] 3 shows a fluid sampling system 200 including a fluid sample optimizer 201 and a sample collector 205 connected to a blood sampling pathway having a patient needle 203, which in some implementations includes an adapter having a sealed sample collection needle that receives one or more evacuated sample bottles. The patient needle 203 may be a safety-type vascular access needle as described in U.S. patent application Ser. No. 16 / 045,321, entitled "Needle Assembly with Needle Safety Shield," the contents of which are incorporated herein by reference for all purposes.

[0045] 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 reservoir 206 having an air permeable fluidic resistor 208, and a sample pathway 210 having a proximal end fluidically coupled to the inlet port 202 and a distal end fluidically 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 reservoir 206, and the sample pathway 210. The housing 220 may be susceptible to sterilization or have antimicrobial properties, but may also be formed of any rigid material that is also capable of shielding the inlet port 202, the outlet port 204, the contaminant containment reservoir 206, and the sample pathway 210, and any components therein, from external contaminants.

[0046] Each of the contaminant containment reservoir 206 and the sample path 210 may be connected to the inlet 202 via a junction 212, which is sized and configured to allow a first portion of a fluid, such as blood, to be sucked, pulled, or otherwise flow into the contaminant containment reservoir 206, displacing air therein through the air permeable fluid resistor 208 so that at least a portion is maintained, at least temporarily, within the contaminant containment reservoir 206, and to allow a second portion of the blood to bypass the contaminant containment reservoir 206 and flow into the sample path 210 toward the outlet port 204 and sample collection device 205.

[0047] The sample collection device 205 may be a Vacutainer® type device, where the collection adapter has a collection needle sealed by an elastomeric seal that can be penetrated by a vacuum sealed collection bottle to expose the collection needle and allow insertion of the collection needle into the septum of the collection bottle. The vacuum in the collection bottle may be the force that assists in drawing bodily fluids from the patient through the fluid sample optimization device 201.

[0048] 4A-4D illustrate the operation of the fluid sample optimization device 100 / 201 and are described specifically in the context of blood sampling, although other types of bodily fluids may also be collected or sampled. Referring to Figure 3, as shown in Figure 4A, when the fluid collection device creates a low pressure at the outlet of the fluid sample optimization device, such as by a patient's venipuncture (or more specifically, the patient's vascular blood pressure), when a collection bottle or tube is inserted into the collection adapter, the pressure difference between the outlet and the inlet forces air out of the fluid sample optimization device and into the collection bottle, where blood fills behind it.

[0049] In the illustrated implementation, air can flow through two parallel paths, namely, through a plug in the contaminant containment reservoir and through the sample path. The flow rate through each path can be proportional to the resistance in each path. Thus, the optimal configuration of the fluid sample optimization device includes consideration of the volume of the contaminant containment reservoir, the placement of junctions connecting the inlet with the contaminant containment reservoir and the sample path, the relative cross-sectional dimensions of the inlet, contaminant containment reservoir and sample path, the resistivity of the plug, the location and size of the plug, the curvature of various transitions or interfaces between the inlet, contaminant containment reservoir and sample path, etc.

[0050] FIG. 4B shows blood filling the contaminant containment reservoir. If the air does not pass through the plug quickly enough, i.e., the resistance through the plug is not lower than the resistance through the sample path, pressure will build up in the contaminant containment reservoir and push the fluid into the sample path before the contaminant containment reservoir fills with fluid. FIG. 4C shows the contaminant containment reservoir filled. Once all the air has been pushed out of the contaminant containment reservoir (through the plug and sample path), the fluid will hit the plug and its progress through the plug will slow and possibly stop. This allows the fluid to be pushed to flow through the sample path and the initial volume of blood is captured in the contaminant containment reservoir. At this point, there may be no fluid flowing through the plug. FIG. 6 shows the fluid flow after the air has been flushed out of the device, particularly the contaminant containment reservoir. Subsequent blood volumes will flow into and through the sample path following the path of least resistance (lower pressure gradient) toward the distal end of the sample path and out toward the exit port.

[0051] Fluid flow may be stopped completely or allowed to slowly flow into the plug, but without reaching the other side and mixing with the sample path during use.

[0052] Achieving lower resistance to air flow through the plug than 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, and (2) making the sample path longer will increase resistance, but the air flow will be less effective than the fluid flow.

[0053] A first amount of fluid may initially fill the contaminant containment reservoir based on the geometry. As shown in FIGS. 4A-4D, the inertia of the fluid encourages the fluid to continue moving in a straight line into the contaminant containment reservoir, rather than turning a corner into the sample path. In some implementations, the contaminant containment reservoir and the sample path, or any of their inlets and outlets, may be coated differently to increase or decrease resistance to fluid flow. For example, coating the walls of the contaminant containment reservoir with a hydrophilic coating and coating the walls (or at least the inlet) of the sample path with a hydrophobic coating helps to initially fill the contaminant containment reservoir. The hydrophilic coating may include one or more of polyurethane (PU), polyvinylpyrrolidone (PVP), polyacrylic acid (PAA), and / or polyethylene oxide (PEO). The hydrophobic coating may include polytetrafluoroethylene (PTFE). The resistance in the sampling path can also be increased by inserting a dissolvable biocompatible material into the path that dissolves upon contact with blood or fluid, reducing the resistance to flow through the sample path when the contaminant containment reservoir fills with fluid.

[0054] In another implementation, a harmless inert or non-reactive biocompatible material, i.e., a material that does not affect blood test results, may be placed in the device, or at least at the junction to the contaminant containment reservoir, to block the sampling path. The material may be configured to dissolve upon contact with blood or fluid. Such a material may be sized and configured to impede blood flow for a fraction of a second as the contaminant containment reservoir fills nearly instantly.

[0055] 5 shows a housingless implementation of a fluid sample optimization device 300 with a contaminant containment reservoir 302 and a sample path 304 formed from tubing or other types of fluid transport mechanisms and forming parallel or similarly oriented paths via Y-site connectors 306A and 306B at either end of the device. The Y-site connectors 306A and 306B can be provided in any orientation or alignment and, when implemented as tubing with known cross-sectional diameter and length, can be spaced sufficiently apart to provide a predetermined volume of the contaminant containment reservoir 302. The contaminant containment reservoir 302 includes an air-permeable fluidic resistor 308 that is resistant to fluid flow but allows air to pass therethrough, such that after a first amount or aliquot of fluid fills the contaminant containment reservoir 302, subsequent amounts of fluid bypass the contaminant containment reservoir 302 and flow through the sample path 304 for eventual collection by a fluid collection device.

[0056] A system using the fluid sample optimization device 300 may include a patient needle 301 connected to a Y-site connector 306A and a sample collection device 303 having a sealed sampling needle connected to a Y-site connector 306B. The tubing of the fluid sample optimization device 300 may be flexible or rigid. At least a portion of the tubing may be made of a translucent material so that a clinician can see the blood flow therein. The fluid sample optimization device 300 may include a filter 308 that may be formed at least in part from an air-permeable blood-resistant material. The filter 308 allows air in the contaminant containment reservoir to be displaced from the sample collection device 301 through the filter 308 based on a vacuum force or other mechanism that creates a negative pressure differential between the sample collection device 303 and the contaminant containment reservoir 302.

[0057] In some implementations, the fluid sample optimization device 300 may function as a flash chamber, such that upon venipuncture of a patient, blood may be "flushed" or suddenly present into at least a portion of the contaminant containment reservoir 302 based at least in part on a vacuum force at an outlet junction of the fluid sample optimization device 300. The vacuum pressure preferentially draws contaminated blood across a resistor (without trapping the contaminated blood) and into the contaminant chamber.

[0058] FIG. 6A shows a fluid sample optimization device 400 including 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 tube or an interface thereof. The inlet 402 may be connected to a patient or a patient's fluid source, such as via a venipuncture needle, where the fluid is provided at a pressure P1, which may be the patient's own blood pressure. The outlet 404 may include an outlet port, connector or interface for connecting to an external device, such as a tube or an interface thereof. As mentioned above, for example, the outlet 404 may be connected to a fluid collection device, such as a vacuum tube, such as a Vacutainer® or a syringe, whereby fluid is drawn from the fluid source by the fluid collection device at a pressure P2, which is lower than the pressure P1. The pressure difference allows the fluid sample optimization device 400 to be closed to the atmosphere and atmospheric pressure, i.e., the fluid sample optimization device 400 does not need to include any vent or path to the outside atmosphere, at least in use.

[0059] The fluid sample optimization device 400 further includes a contaminant containment reservoir 406 connected to the inlet 402 and outlet 404 and having an air permeable fluidic resistor 407 between a distal end of the contaminant containment reservoir 406 and the outlet 404. As described further herein, the contaminant containment reservoir 406 may be sized to hold a desired amount of fluid and may include an absorbent material that at least partially fills the contaminant containment reservoir 406. Also, as described further herein, the contaminant containment reservoir 406 may be configured as a tortuous path, a series of chambers of different cross-sections and volumes, and / or may include rifling or baffles extending from an interior surface to minimize backflow, i.e., flow toward the inlet 402. For example, the contaminant containment reservoir 406 may include one or more channels 406A and one or more chambers 406B, all of which may be interconnected to receive, transport or contain a predetermined volume of fluid as well as contain any contaminants therein.

[0060] The air permeable blood resistor 407 allows a first portion or amount of fluid drawn from the fluid source by a pressure differential applied between the inlet 402 and the outlet 404 to flow into the contaminant containment reservoir 406, displacing air therein, until the fluid contacts the air permeable fluid resistor 407, at least partially stopping the flow of fluid into the contaminant containment reservoir 406.

[0061] The fluid sample optimization device 400 further includes a sample pathway 408 connected to the inlet 402 and the outlet 404. The sample pathway 408 includes a resistive plug 409 disposed proximate to the inlet 402. A pressure differential between the inlet 402 and the outlet 404 can draw a first portion or amount of fluid into the contaminant containment reservoir 406 while the resistive plug 409 is configured to resist, block, restrict or prevent the flow of fluid into the sample pathway 408 until the first portion or amount of fluid enters the contaminant containment reservoir 406.

[0062] The fluid sample optimization device 400 may further include a housing 401, which may define one or more of the inlet 402, the outlet 404, the contaminant containment reservoir 406, the sample path 408, or possibly other components such as an air permeable fluidic resistor 407 and a resistive plug 409. The housing 401 may be formed in one or more sections. For example, as shown in the example of FIG. 6A, the housing 401 may include an upper housing section 422 mating with a lower housing section 424, which may be mated and sealed together by sonic welding, thermal bonding, adhesives, etc.

[0063] As described herein, the resistance plug 409 is configured to 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 after a first portion or amount of fluid has entered the contaminant containment reservoir 406, still under the force of a pressure differential between the inlet 402 and the outlet 404. The resistance plug 409 may be recessed within the sample path 408 away from the inlet 402 to allow for a build-up of vacuum pressure, and may include pilot holes or small capillaries, openings, irises, etc. to allow the dissolvable material to begin to dissolve with the fluid continuing to be drawn towards the outlet 404. Thus, a portion of the sample path 408, the inlet 402, and / or the contaminant containment reservoir 406 may form a junction 411 adjacent to the resistive plug 409 and opposite a main portion of the sample path 408, thereby allowing vacuum pressure to build up for better fluid access through the resistive plug 409 after the contaminant containment reservoir 406 is filled.

[0064] As fluid fills the contaminant containment reservoir 406, a certain amount of air may become trapped at the junction 411 between the fluid and the resistive plug 409. Without a way for the air to escape, the fluid would not be able to reach the dissolvable material that forms at least a portion of the resistive plug 409 so that it could flow through the sample path 406. Thus, as shown in FIGS. 6B-6I, when fluid fills the contaminant containment reservoir 406 and blocks the air permeable fluidic resistor 407, an air path may be provided through or around the resistive plug 409 that allows air to flow only after exposure to the full vacuum pressure of the collection device, such that the fluid does not come into contact with the dissolvable material in the resistive plug 409 until the contaminant containment reservoir 406 is completely filled and / or contaminants are contained therein.

[0065] FIG. 6B shows a variation of the resistive plug 409 as a thin film 431 that may be formed as a thin film material. In some implementations, the film 431 may be formed, at least in part, by a dissolvable or easily torn material. The film 431 has a small orifice 432 or pilot hole as a mechanism to initiate the dissolving or tearing process. FIG. 6C shows the film 431 with slits 433 that are closed in a stationary steady state, but may open to allow fluid flow when pressure is applied to one or both opposing sides or surfaces of the resistor. In some implementations, the slits 433 may be formed as an "X" or other configurations such as linear slits, curved slits, star shaped slits, etc., as shown in FIG. 6D. As shown in FIG. 6E, the film 431 may be formed as a porous membrane that allows air to pass through, but not bodily fluids such as blood. As shown in FIG. 6F, the film 431 may be positioned between the upper housing portion 422 and the lower housing portion 424 at the entrance of the sample pathway 408 such that air "leaks" around the film 431 when a predetermined pressure is applied.

[0066] 6G-6I show the resistive plug 409 as a cylindrical plug member 435, the resistive plug 409 may be formed in other shapes, such as square, rectangular, or other shapes. The cylindrical plug member 435 may include a small pilot hole as shown in FIG. 6G, or may be porous to air as shown in FIG. 6H. Whether the resistive plug 409 is implemented as a cylindrical plug member 435 or other shape, it will operate at a predetermined pressure. A cylindrical plug member 435 may be disposed between the upper and lower housing portions 422, 424 at the entrance to the sample pathway 408 such that air will "leak" around the cylindrical plug member 435 when pressure is applied.

[0067] As described further herein and shown in FIG. 7, a resistive plug 500 for an opening to a sample pathway may be formed from a composition including at least a portion of a mesh 502 impregnated with a dissolvable material 504. In certain implementations, the resistive plug 500 may include a mesh material that supports the dissolvable material 502. The mesh material may be, for example, a plastic or nylon mesh, such as a mesh of 50-100 μm nylon or plastic threads. The dissolvable material 504 may not be formed as a rigid plug or film and may be impregnated into the mesh 502 or other porous material. The dissolvable material 504 is dissolvable upon contact with a fluid, such as blood. The dissolvable material 504 is created to be inert or non-reactive to laboratory testing of samples or collected fluid specimens, which are often provided with cultures to test for specific bacteria or viruses, or their antibodies, or other pathogens present in the fluid sample.

[0068] As shown in Fig. 8, the resistive plug 600 may be formed from a mesh 602 as described above, but overlaid or integrated with a non-dissolving viscous material 604, such as silicone grease. The viscous material 604 may be spread over the mesh 602 or other porous material. When the pressure difference across the resistive plug 600 is high enough, the viscous material 604 is pulled through the openings in the mesh 602 such that an opening is created for the fluid sample to flow, as shown in Fig. 8B. At most, only trace amounts of the viscous material 604 will exit the outlet, without interfering with any testing or culturing of the fluid sample.

[0069] As shown in FIGS. 9A-9C, the resistive plug 700 may be formed from a membrane 702 that is initially stretched or placed over and spaced from a piercing member 704. The piercing member 704 may include a spike, pin, blade, shard, etc., and may be held approximately centered in the opening to the sampling pathway, as shown in FIG. 9A, by a retention mechanism, as shown in FIG. 9B. The membrane 702 may be an elastic sheet of material, such as rubber or other elastic material. As shown in FIG. 9C, when the contaminant containment reservoir is filled with fluid, a certain amount of pressure is applied to the membrane 702, further stretching it to contact the piercing member 704. Once the membrane 702 and piercing member 704 are in contact, the membrane 702 is pierced or otherwise broken by the piercing member 704, opening a larger area for a subsequent amount or portion of fluid to flow into the sample pathway.

[0070] 10A-11B show various views of a fluid sample optimization device 800 and 900 for optimizing a fluid sample collected by a fluid collection device from a fluid source, a first portion of the fluid sample may have contaminants. As shown in FIG. 10A and FIG. 10B, the fluid sample optimization device 800 includes an inlet 802 configured to connect with a fluid source, an outlet 804 configured to connect with 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 containment reservoir 806 connected between the inlet 802 and the outlet 804. One or more of the inlet 802, the outlet 804, the contaminant containment reservoir 806, and the sample path 808, and possibly other components of the fluid sample optimization device 800, may be contained within and / or defined by a housing 820.

[0071] The contaminant containment reservoir 806 further includes an air permeable fluidic resistor 812 connected to the sample path 808, preferably near the outlet 804. The contaminant containment reservoir 806 is positioned to receive a first portion of a fluid sample from a fluid source and displace air therein through the air permeable fluidic resistor 812 and the outlet 804 upon application of a pressure differential between the inlet 802 and the outlet 804. The air permeable fluidic resistor 812 may be elongated and configured for a particular air flow range, as shown in FIG. 12A, and may self-seal upon contact with a non-air fluid, such as blood or other bodily fluids.

[0072] Upon receiving an initial portion of the fluid sample and containing contaminants within the contaminant containment reservoir 806, a subsequent portion of the fluid sample may be received by the sample pathway 808 and transported 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 implementations, the fluid sample optimization device 800 includes a resistive plug 810 that initially substantially blocks the sample pathway 808 from the inlet 802 while and until the initial portion of the fluid is received within the contaminant containment reservoir 806.

[0073] 11A and 11B, the fluid sample optimization device 900 includes an inlet 902 configured to connect with a fluid source, an outlet 904 configured to connect with a fluid collection device, and a sample pathway 908 connected between the inlet 902 and the outlet 904. The fluid sample optimization device 900 further includes a contaminant containment reservoir 906 connected between the inlet 902 and the outlet 904. One or more of the inlet 902, outlet 904, contaminant containment reservoir 906, and sample pathway 908, and possibly other components of the fluid sample optimization device 900, may be contained within and / or defined by a housing 920.

[0074] The contaminant containment reservoir 906 preferably further includes an air permeable fluidic resistor 912 connected to the sample path 908 near the outlet 904. The contaminant containment reservoir 906 is positioned to receive a first portion of a fluid sample from a fluid source and displace air therein via the air permeable fluidic resistor 912 and the outlet 904 upon application of a pressure differential between the inlet 902 and the outlet 904. The air permeable fluidic resistor 912 may be cylindrical and configured for a particular air flow range, and may be multi-layered to include a self-sealing layer that seals upon contact with a non-air fluid, such as blood or other bodily fluids, as shown in Figures 12B and 12C, respectively.

[0075] Upon receiving an initial portion of the fluid sample and containing contaminants within the contaminant containment reservoir 906, a subsequent portion of the fluid sample may be received by the sample path 908 and transported 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 implementations, the fluid sample optimization device 900 includes a resistive plug 910 that initially substantially blocks the sample path 908 from the inlet 902 while and until the initial portion of the fluid is received within the contaminant containment reservoir 906.

[0076] 13A-13C show various implementations and configurations of resistive plugs, such as a cylindrical plug (FIG. 13A), a film or membrane (FIG. 13B), or a flexible cap (FIG. 13C).

[0077] 14A-14C show a resistive plug having an opening 1000 or iris that is selectively activated / broken, either manually or automatically, to allow or prevent flow at different times based on different pressures acting on the resistive plug. In some implementations, the resistive plug is essentially an elastic membrane with a small opening 1000 in the center. When a pressure differential is applied to one side of the membrane forming the resistive plug, it deflects, increasing the size of the opening 1000 and allowing fluid to flow to the output. Alternatively, the resistive plug may include a rigid or semi-rigid plug member 1002 that covers the opening 1000 and moves out of the way when the opening 1000 is activated.

[0078] Although several embodiments have been described in detail above, other modifications are possible and may be within the scope of the following claims.

Claims

1. 1. 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 comprises a contaminant; an inlet configured to connect to the fluid source; an outlet configured to connect to the fluid collection device; a sample path connected between the inlet and the outlet; a contaminant containment reservoir connected between the inlet and the outlet; Equipped with the contaminant containment reservoir having an air permeable flow resistor proximate the outlet; The contaminant containment reservoir is positioned to receive a first portion of the fluid sample from the fluid source and move air therein through the air permeable fluid resistor and the outlet when a pressure differential is applied between the inlet and the outlet, whereby once the first portion of the fluid sample is received and the contaminants are contained within the contaminant containment reservoir, a subsequent portion of the fluid sample can be transported from the inlet to the outlet by the sample path when a subsequent pressure differential is applied between the inlet and the outlet.

2. 10. The fluid sample optimization device of claim 1, further comprising a housing that contains and / or defines one or more of the inlet, the outlet, the sample path, and the contaminant containment reservoir.

3. 10. The fluid sample optimization device of claim 1, wherein the air permeable fluidic resistor comprises a material that seals upon contact with the first portion of the fluid sample.

4. The fluid sample optimization apparatus of claim 1 , wherein the contaminant containment reservoir comprises a tortuous path.

5. each pressure differential being provided by a vacuum provided by the fluid collection device.

2. A fluid sample optimization device as described in claim 1.

6. 1. 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 comprises a contaminant; an inlet configured to connect to the fluid source; an outlet configured to connect to the fluid collection device; a sample pathway connected between the inlet and the outlet, the sample pathway further comprising a resistive plug configured to block at least a portion of the first portion of the fluid sample and the contaminants from entering the sample pathway; a contaminant containment reservoir connected between the inlet and the outlet; Equipped with the contaminant containment reservoir further comprising an air permeable flow resistor proximate the outlet; The contaminant containment reservoir is positioned to receive the first portion of the fluid sample from the fluid source and move air therein through the air permeable fluid resistor and the outlet when a pressure differential is applied between the inlet and the outlet, whereby once the first portion of the fluid sample is received and the contaminant is contained within the contaminant containment reservoir, a subsequent portion of the fluid sample can be forced through the resistive plug and transported by the sample path from the inlet to the outlet when a subsequent pressure differential is applied between the inlet and the outlet.

7. 7. The fluid sample optimization device of claim 6, further comprising a housing that contains and / or defines one or more of the inlet, the outlet, the sample path, and the contaminant containment reservoir.

8. 7. The fluid sample optimization device of claim 6, wherein the air permeable fluidic resistor comprises a material that seals upon contact with the first portion of the fluid sample.

9. The fluid sample optimization device of claim 6 , wherein the contaminant containment reservoir comprises a tortuous path.

10. 7. The fluid sample optimization device of claim 6, wherein each pressure differential is provided by a vacuum pressure provided by the fluid collection device.

11. 7. The fluid sample optimization device of claim 6, wherein the resistive plug comprises a film that is penetrable by a first subsequent pressure differential.

12. 12. The fluid sample optimization device of claim 11, wherein the resistive plug further comprises a piercing member configured to pierce the film when the first subsequent pressure differential is exerted on opposite sides of the film.

13. 7. The fluid sample optimization apparatus of claim 6, wherein the resistive plug comprises a mesh having a dissolvable material that dissolves upon contact with the first subsequent portion of the fluid sample.

14. 1. A fluid sample optimization apparatus for optimizing a fluid sample, the fluid sample having a first portion potentially comprising a contaminant, The entrance and The exit, a sample path connected between the inlet and the outlet; a contaminant containment reservoir connected between the inlet and the outlet; Equipped with the contaminant containment reservoir having an air permeable flow resistor proximate the outlet; A fluid sample optimization device, wherein the contaminant containment reservoir is positioned to receive the first portion of the fluid sample and move air therein through the air permeable fluid resistor and the outlet when a pressure differential is applied between the inlet and the outlet, such that once the first portion of the fluid sample is received and the contaminants are contained within the contaminant containment reservoir, a subsequent portion of the fluid sample can be transported from the inlet to the outlet by the sample path when a subsequent pressure differential is applied between the inlet and the outlet.

15. 15. The fluid sample optimization device of claim 14, wherein the sample path further includes a resistive plug configured to prevent at least a portion of the first portion of the fluid sample and the contaminant from entering the sample path while the first portion of the fluid sample is received and the contaminant is contained within the contaminant containment reservoir.

16. 15. The fluid sample optimization device of claim 14, further comprising a housing that contains and / or defines one or more of the inlet, the outlet, the sample path, and the contaminant containment reservoir.

17. 15. The fluid sample optimization apparatus of claim 14, wherein the air permeable fluidic resistor comprises a material that seals upon contact with the first portion of the fluid sample.

18. The fluid sample optimization apparatus of claim 14 , wherein the contaminant containment reservoir comprises a tortuous path.

19. 16. The fluid sample optimization device of claim 15, wherein the resistive plug comprises a film that is penetrable by a first subsequent pressure differential.

20. 20. The fluid sample optimization device of claim 19, wherein the resistive plug further comprises a piercing member configured to pierce the film when the first subsequent pressure differential is exerted on opposite sides of the film.

Images