Fluid optimization device, contaminant containment device and method using a movable plug

Abstract

The present invention provides a fluid sample optimization device for optimizing fluid samples collected from a fluid source by a fluid collection device, where the initial portion potentially contains contaminants. [Solution] The device comprises an inlet configured to connect to a fluid source, an outlet configured to connect to a fluid collection device, 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 has an air-permeable fluid resistor located near the outlet and is configured to receive the first portion of the fluid sample from the fluid source and replace the air in the reservoir, and is configured to receive the first portion of the fluid sample and contain contaminants. The fluid sample optimization device further comprises a movable plug provided between the inlet and the sample path, which is displaced by the next pressure difference to allow the next portion of the fluid sample to be transported through the sample path.

Description

Technical Field

[0001] (Cross - reference to related applications) This application claims the priority of U.S. Provisional Application No. 63 / 033,196, filed on June 1, 2020, the entire content of which is incorporated herein by reference.

Background Art

[0002] Bacteremia is the presence of microorganisms in the blood. On the other hand, sepsis is bacteremia in the presence of clinical symptoms and signs such as fever, tachycardia, tachypnea, and hypotension. Bacteremia and sepsis have a high mortality rate, often require hospitalization, tend to have a long hospital stay, and are accompanied by an increase in related costs. Many cases of bacteremia, sepsis, fungemia, and other pathogens actually occur within hospitals or other medical facilities, and catheters and venipunctures can serve as sources of contamination as potential carriers of these pathogens.

[0003] 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 performing a single venipuncture from a peripheral site or a central line or an arterial line and culturing the collected blood in one or more blood culture bottles or containers. One bottle is considered one blood culture, and two or more are considered a set. Multiple sets may be obtained from multiple venipunctures and are related to different sites of the patient.

[0004] These methods enable microbial identification and susceptibility testing, which are important elements in managing sepsis. However, due to the inability to obtain rapid results and the low sensitivity to highly pathogenic pathogens, it has led to the development of improved systems and complementary molecular or proteomic tests.

[0005] Collecting blood samples for blood cultures is a crucial element of modern patient care. Accurate diagnosis can positively impact patient prognosis, while unnecessary antibiotic therapy, prolonged hospital stays, and increased costs can negatively affect prognosis.

[0006] One potential consequence of blood culture collection is contamination. Contamination of blood cultures can lead to false-positive culture results and a significant increase in healthcare costs. Sources of blood culture contamination include improper skin disinfection, improper disinfection of blood collection tubes, and contamination of the initial blood collection, all of which can distort the results.

[0007] Blood culture collection kits typically consist of venipuncture devices such as "butterfly" sets and intravenous injection sets, provided by companies like BD, Smiths, and B. Braun, along with aerobic and anaerobic blood culture bottles. Various types of bottles are available depending on the specific test. These bottles are specially designed to optimally collect both aerobic and anaerobic bacteria. In conventional kits, the bottles used are commonly known as "vacutainers." These are blood collection tubes made of sterile glass or plastic tubing with a sealed space from which air has been removed to create a vacuum, facilitating the collection of a predetermined volume of liquid, such as blood.

[0008] False positives in blood cultures are generally due to inadequate sample collection techniques. This leads to the unnecessary use of antibiotics, increasing hospital costs and patient anxiety. In blood cultures, blood is drawn by pricking the skin with a needle and then collected in a vacuum container. Contamination can occur due to inadequate or incomplete disinfection of the puncture site and surrounding skin area. It can also occur when the needle punctures the skin, drawing in perforated skin cells and associated sources of contamination into the sample.

[0009] Because blood flow through a subcutaneous injection needle is laminar, a pressure drop in the subcutaneous injection needle can cause a velocity gradient in the flow tube. Furthermore, forcibly aspirating blood or using an extremely thin subcutaneous injection needle can cause red blood cells to dissolve, releasing potassium and potentially leading to abnormal blood sample readings.

[0010] Furthermore, some patients have delicate veins, and depending on the patient's condition, pulling the syringe plunger too quickly can cause a drop in pressure or a vacuum, leading to vein collapse. Since the condition of these veins cannot be known in advance, venous collapse is a risk and is very difficult to control.

[0011] To reduce the contamination rate of blood cultures, various strategies have been implemented, such as training staff on sterile collection techniques, providing feedback on contamination rates, and introducing blood culture collection kits. While skin disinfection can reduce the burden of contamination, more than 20% of skin bacteria reside deep in the dermis and are unaffected by disinfection. Changing needles before bottle inoculation is not recommended as it not only fails to reduce contamination rates but also increases the risk of needle stick injuries.

[0012] Some conventional systems and techniques for reducing blood culture contamination involve discarding the initial certain amount of blood taken from central venous catheters, venipunctures, and other vascular access systems. However, these systems require the user to operate mechanical intravascular devices or perform a complex series of steps that are difficult to perform reliably.

[0013] Recent technologies have proposed new methods for reducing blood contamination using the method outlined in U.S. Patent No. 9,820,682. U.S. Patent No. 9,820,682 manages blood contamination by using the patient's own blood pressure to guide an initial certain amount of blood into a channel that discharges it into the atmosphere. While this method works well, if the patient's blood pressure is too low, it can prolong the filling time of the contaminant containment reservoir.

[0014] Another method disclosed in U.S. Patent Publication No. 2019 / 0365303, which appears to be inspired by the concept of U.S. Patent No. 9,820,682, utilizes vacuum pressure from a syringe or vacuum bottle to reduce blood sample contamination using a dissolving membrane, a flow control or flow limiting unit, and other mechanically displaced components. While this method may solve the problem of long filling times for contaminant containment reservoirs, which are thought to be caused by the drive mechanism relying on the patient's blood pressure, there are other problems with the second flow path, the sample flow path. Firstly, the substances being dissolved may affect the test results of the sample, and it is difficult to understand all the possible variability factors in the test that may occur. Secondly, flow control or flow limiting units, such as those described in U.S. Patent Publication No. 2019 / 0365303, obstruct the flow, and such restriction may cause hemolysis, which adversely affects the test results. Furthermore, flow limiting may increase the waiting time to fill the fluid collection device, which is also undesirable. [Overview of the project]

[0015] This specification describes non-permeable body fluid sample optimization devices and systems for use in blood sample collection or blood culture collection systems. According to the embodiments described herein, the devices do not have permanently attached and statically positioned displaceable parts such as valves, state transition switches or flow dividers, or other mechanisms that move, shift or transition from one operating mode to another or from one state to another.

[0016] In one embodiment, a fluid sample optimization device is described for optimizing a fluid sample in which the initial portion collected by a fluid collection device from a fluid source potentially contains contaminants. The fluid sample optimization device comprises an inlet configured to be connected to a fluid source, an outlet configured to be connected to a fluid collection device, and a sample path connected between the inlet and the outlet. The fluid sample optimization device further comprises a contaminant containment reservoir connected between the inlet and the outlet. The contaminant containment reservoir has an air-permeable fluid resistor adjacent to the outlet and is configured such that when a pressure difference is applied between the inlet and the outlet, it receives the initial portion of the fluid sample from the fluid source, thereby replacing the air in the contaminant containment reservoir through the air-permeable fluid resistor and the outlet, receiving the initial portion of the fluid sample and containing the contaminants, and is configured such that when a subsequent pressure difference is applied between the inlet and the outlet, the next portion of the fluid sample is transported by the sample path from the inlet to the outlet. The fluid sample optimization device further includes a movable plug provided between the inlet and the sample path, which is displaced by the following pressure difference, thereby allowing the next portion of the fluid to be transported through the sample path.

[0017] In another embodiment, the fluid sample optimization device comprises an inlet configured to connect to a fluid source and an outlet configured to connect to a fluid collection device that provides a negative differential pressure between the inlet and the outlet. The fluid sample optimization device further comprises a sample path connected between the inlet and the outlet, the junction between the inlet and the sample path having a movable plug configured to prevent at least a portion of the initial part of the fluid sample and contaminants from entering the sample path. The fluid sample optimization device further comprises a contaminant containment reservoir connected between the inlet and the outlet and located close to the outlet, having an air-permeable fluid resistance. The contaminant containment reservoir is configured such that when a pressure difference is applied between the inlet and the outlet, it receives the first portion of the fluid sample from the fluid source, thereby replacing the air in the contaminant containment reservoir through the air-permeable fluid resistor and the outlet, receiving the first portion of the fluid sample and containing the contaminant, and when a subsequent pressure difference is applied between the inlet and the outlet, the next portion of the fluid sample moves the movable plug so that the next portion is transported from the inlet to the outlet via the sample path.

[0018] Details of the embodiments are described in the accompanying drawings and the following description. Other features and advantages will become apparent from the following detailed description, drawings, and claims. [Brief explanation of the drawing]

[0019] Next, these and other embodiments will be described in detail with reference to the following drawings.

[0020] [Figure 1] This shows a blood sample optimization system.

[0021] [Figure 2] A blood sample optimization system according to another embodiment is shown.

[0022] [Figure 3]Shows a blood sample optimization system according to yet another alternative embodiment.

[0023] [Figure 4] Shows a blood sample optimization system according to yet another alternative embodiment.

[0024] [Figure 5] Shows a blood sample optimization system according to yet another alternative embodiment.

[0025] [Figure 6] Shows a blood sample optimization system according to another alternative embodiment.

[0026] [Figure 7] Is a flowchart of a method for optimizing the quality of blood cultures.

[0027] [Figure 8A] Shows a blood isolation system for contamination-free blood collection according to an embodiment. [Figure 8B] Shows a blood isolation system for contamination-free blood collection according to an embodiment. [Figure 8C] Shows a blood isolation system for contamination-free blood collection according to an embodiment. [Figure 8D] Shows a blood isolation system for contamination-free blood collection according to an embodiment. [Figure 8E] Shows a blood isolation system for contamination-free blood collection according to an embodiment.

[0028] [Figure 9] Shows a path splitter used in a blood isolation system.

[0029] [Figure 10A] Shows a blood isolation system for contamination-free blood collection according to another alternative embodiment. [Figure 10B] Shows a blood isolation system for contamination-free blood collection according to another alternative embodiment. [Figure 10C]Another embodiment of a blood isolation system for non-contaminated blood collection is shown. [Figure 10D] Another embodiment of a blood isolation system for non-contaminated blood collection is shown.

[0030] [Figure 11A] A blood isolation system for non-contaminated blood collection according to yet another embodiment is shown. [Figure 11B] A blood isolation system for non-contaminated blood collection according to yet another embodiment is shown. [Figure 11C] A blood isolation system for non-contaminated blood collection according to yet another embodiment is shown. [Figure 11D] A blood isolation system for non-contaminated blood collection according to yet another embodiment is shown. [Figure 11E] A blood isolation system for non-contaminated blood collection according to yet another embodiment is shown.

[0031] [Figure 12A] A blood sample optimization system including a blood isolation device according to yet another embodiment is shown. [Figure 12B] A blood sample optimization system including a blood isolation device according to yet another embodiment is shown. [Figure 12C] A blood sample optimization system including a blood isolation device according to yet another embodiment is shown. [Figure 12D] A blood sample optimization system including a blood isolation device according to yet another embodiment is shown.

[0032] [Figure 13A] A blood sample optimization system 1300 according to yet another embodiment is shown. [Figure 13B] A blood sample optimization system 1300 according to yet another embodiment is shown. [Figure 13C] A blood sample optimization system 1300 according to yet another embodiment is shown. [Figure 13D] A blood sample optimization system 1300 according to yet another embodiment is shown.

[0033] [Figure 14A] Another embodiment of a blood collection system is presented that isolates an initial volume or sample contaminants to reduce false positives in blood cultures or tests performed on patient blood samples. [Figure 14B] Another embodiment of a blood collection system is presented that isolates an initial volume or sample contaminants to reduce false positives in blood cultures or tests performed on patient blood samples. [Figure 14C] Another embodiment of a blood collection system is shown that isolates an initial volume or sample contaminants to reduce false positives in blood cultures or tests performed on patient blood samples. [Figure 14D] Another embodiment of a blood collection system is shown that isolates an initial volume or sample contaminants to reduce false positives in blood cultures or tests performed on patient blood samples. [Figure 14E] Another embodiment of a blood collection system is shown that isolates an initial volume or sample contaminants to reduce false positives in blood cultures or tests performed on patient blood samples.

[0034] [Figure 15A] Further embodiments of a blood isolation device and a method of using the same are shown. [Figure 15B] Further embodiments of a blood isolation device and a method of using the same are shown. [Figure 15C] Further embodiments of a blood isolation device and a method of using the same are shown. [Figure 15D] Further embodiments of a blood isolation device and a method of using the same are shown. [Figure 15E] Further embodiments of a blood isolation device and a method of using the same are shown. [Figure 15F] Further embodiments of a blood isolation device and a method of using the same are shown. [Figure 15G]Further embodiments of a blood isolation device and a method of using the same are shown.

[0035] [Figure 16A] A blood isolation device according to yet another embodiment is shown. [Figure 16B] A blood isolation device according to yet another embodiment is shown. [Figure 16C] A blood isolation device according to yet another embodiment is shown. [Figure 16D] A blood isolation device according to yet another embodiment is shown.

[0036] [Figure 17A] This shows the lower component of the housing for a blood isolation device. [Figure 17B] This shows the lower component of the housing for a blood isolation device. [Figure 17C] This shows the lower component of the housing for a blood isolation device. [Figure 17D] This shows the lower component of the housing for a blood isolation device. [Figure 17E] This shows the lower component of the housing for a blood isolation device.

[0037] [Figure 18A] This shows the upper component of the housing for a blood isolation device. [Figure 18B] This shows the upper component of the housing for a blood isolation device. [Figure 18C] This shows the upper component of the housing for a blood isolation device. [Figure 18D] This shows the upper component of the housing for a blood isolation device. [Figure 18E] This shows the upper component of the housing for a blood isolation device. [Figure 18F] This shows the upper component of the housing for a blood isolation device.

[0038] [Figure 19A] This shows a blood isolation device having an upper member that fits into a lower member. [Figure 19B]This shows a blood isolation device having an upper member that fits into a lower member.

[0039] [Figure 20] This shows a blood sample optimization system including a blood isolation device.

[0040] [Figure 21] This shows a blood isolation device without ventilation openings, using a wick chamber.

[0041] [Figure 22A] This shows the material composition of the filter used to isolate blood in the isolation chamber of a blood isolation device. [Figure 22B] This shows the material composition of the filter used to isolate blood in the isolation chamber of a blood isolation device.

[0042] [Figure 23A] Another embodiment of a blood isolation device that utilizes vacuum force from a blood collection device is shown. [Figure 23B] Another embodiment of a blood isolation device that utilizes vacuum force from a blood collection device is shown. [Figure 23C] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 23D] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 23E] Another embodiment of a blood optimization system and a blood isolation device is shown.

[0043] [Figure 24A] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 24B] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 24C] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 24D] Another embodiment of a blood optimization system and a blood isolation device is shown.

[0044] [Figure 25A] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 25B] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 25C] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 25D] Another embodiment of a blood optimization system and a blood isolation device is shown.

[0045] [Figure 26A] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 26B] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 26C] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 26D] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 26E] Another embodiment of a blood optimization system and a blood isolation device is shown.

[0046] [Figure 27A] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 27B] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 27C] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 27D] Another embodiment of a blood optimization system and a blood isolation device is shown.

[0047] [Figure 28A] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 28B] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 28C] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 28D] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 28E] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 28F] Another embodiment of a blood optimization system and a blood isolation device is shown.

[0048] [Figure 29A] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 29B] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 29C] Another embodiment of a blood optimization system and a blood isolation device is shown.

[0049] [Figure 30A] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 30B] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 30C] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 30D] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 30E] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 30F] Another embodiment of a blood optimization system and a blood isolation device is shown. [Figure 30G] Another embodiment of a blood optimization system and a blood isolation device is shown.

[0050] [Figure 31] This specification shows an optimization apparatus for non-permeable fluid contaminant samples according to embodiments described herein.

[0051] [Figure 32A]A fluid sample optimization apparatus comprising a housing, an air-permeable fluid barrier, and a movable plug, consistent with the embodiments described herein, is shown. [Figure 32B] A fluid sample optimization apparatus comprising a housing, an air-permeable fluid barrier, and a movable plug, consistent with the embodiments described herein, is shown. [Figure 32C] A fluid sample optimization apparatus comprising a housing, an air-permeable fluid barrier, and a movable plug, consistent with the embodiments described herein, is shown.

[0052] [Figure 33A] A fluid sample optimization apparatus consistent with the embodiments described herein is shown. [Figure 33B] A fluid sample optimization apparatus consistent with the embodiments described herein is shown. [Figure 33C] A fluid sample optimization apparatus consistent with the embodiments described herein is shown. [Figure 33D] A fluid sample optimization apparatus consistent with the embodiments described herein is shown.

[0053] [Figure 34A] Various alternative embodiments of a movable plug or movable stopper are shown, represented by the shape of a ball or a rounded object. [Figure 34B] Various alternative embodiments of a movable plug or movable stopper are shown, represented by the shape of a ball or a rounded object. [Figure 34C] Various alternative embodiments of a movable plug or movable stopper are shown, represented by the shape of a ball or a rounded object.

[0054] [Figure 35A] Various alternative embodiments of a movable plug or movable stopper, shown in disc shape, are illustrated. [Figure 35B] Various alternative embodiments of a movable plug or movable stopper, shown in disc shape, are illustrated.

[0055] [Figure 36A] Further various alternative embodiments of the movable plug or movable stopper, consistent with the apparatus described herein, are shown. [Figure 36B] Further various alternative embodiments of the movable plug or movable stopper, consistent with the apparatus described herein, are shown. [Figure 36C] Further various alternative embodiments of the movable plug or movable stopper, consistent with the apparatus described herein, are shown.

[0056] [Figure 37A] This shows a modified example of the fluid flow path after the movable plug has been displaced. [Figure 37B] This shows a modified example of the fluid flow path after the movable plug has been displaced.

[0057] [Figure 38A] Another fluid sample optimization apparatus consistent with the embodiments described herein is shown. [Figure 38B] Another fluid sample optimization apparatus consistent with the embodiments described herein is shown. [Figure 38C] Another fluid sample optimization apparatus consistent with the embodiments described herein is shown.

[0058] Similar symbols in drawings indicate elements of the same type. [Modes for carrying out the invention]

[0059] This specification describes a blood sample optimization system and method for reducing or eliminating contaminants in collected blood samples, thereby reducing or eliminating false positive results in blood cultures or other tests of collected blood samples. In one embodiment, the blood sample optimization system comprises a patient needle inserted into a blood vessel to reach the patient's blood flow, a sample needle supplying the blood sample to a blood collection container or other blood collection device such as a vacuum blood collection container or vacuum blood collection tube, such as a Vacutainer®, and a blood isolation device located between the patient needle and the sample needle. Since the initial certain amount of fluid sample contains contaminants, the amount of contaminants in the fluid sample collected afterward can be reduced to zero by bypassing the initial certain amount.

[0060] Figure 1 shows a blood sample optimization system according to a partial implementation. The system comprises a patient needle 1 for puncturing the patient's skin to access the patient's vein and the blood within the vein. The system further comprises a resealable cover 10, a sample needle 5 (i.e., a resealable sealed needle for use with a Vacutainer®, etc.) which is initially sealed and housed in a Luer operating valve or another blood collection interface or device. By using a Vacutainer® bottle (not shown) for collecting the patient's blood, the resealable cover 10 can be pushed next to or around the sample needle 5. The system may further comprise a small volume chamber 30 leading to the sample needle 5, and may also comprise a hole or one or more channels 45 leading to an isolation chamber 55 formed by the housing 50.

[0061] The isolation chamber 55 is a chamber, channel, passage, recess, or other structure for receiving and holding a predetermined or measured amount of the patient's first blood, depending on the volume of the isolation chamber 55. The first blood in a blood collection is generally more likely to contain microorganisms or other pathogens that cause bacteremia and sepsis than the later blood. The isolation chamber 55 may be a container housed in a rigid housing, or a container formed in or defined by the housing itself, or it may be implemented as a tube or lumen. Regardless of its form and implementation, the isolation chamber 55 may have a predetermined volume. In some embodiments, the predetermined volume is based on the volume of the patient needle; that is, it may be less than the volume of the patient needle, or more than 20 times the volume of the patient needle, and may have any volume within this range. The predetermined volume of the isolation chamber 55 may be set to conserve or minimize the amount of blood that is isolated and disposed of.

[0062] The isolation chamber 55 may be formed, contained, or housed within the chamber housing 50 and may be made of plastic, rubber, steel, aluminum, or other suitable material. For example, the isolation chamber 55 may be made of a flexible tube or other elastic material. The isolation chamber 55 further has an air-permeable blood barrier 20 that allows air to be discharged from the isolation chamber 55. As used herein, the term “air-permeable blood barrier” means a substance, material, or structure that allows air to pass through but substantially prevents blood from passing through. Typical examples include hydrophobic membranes and hydrophobic coatings, hydrophilic membranes or hydrophilic coatings in combination with hydrophobic membranes or hydrophobic coatings, meshes, filters, mechanical valves, antimicrobial materials, or any other means that allows air to be discharged from the isolation chamber 55 when the isolation chamber 55 is filled with blood. In various exemplary embodiments, the air-permeable blood barrier may be formed of one or more materials that allow air to pass through until it comes into contact with the liquid, and such materials are completely or partially sealed to prevent or block the passage of air and / or liquid. In other words, before coming into contact with the liquid, the material forms an air-permeable barrier. After contact with a liquid, such a material substantially or completely prevents further passage of air and / or liquid.

[0063] The hole or channel 45 may have any desired length, cross-sectional shape or size, and / or may be formed to be spaced apart from the small volume chamber 30 at any desired angle or orientation. The hole or channel 45 may also include a one-way flap or one-way valve 60 for holding an initial fixed amount of blood sample into the isolation chamber 55. In some specific embodiments, the hole or channel 45 may include a "duckbill" valve or flapper valve 60, etc., for one-way blood flow from the small volume chamber 30 to the isolation chamber 55. The air-permeable blood barrier 20 may also be made of a material that allows air to be expelled while simultaneously sealing upon contact with blood, thereby preventing outside air from entering the isolation chamber 55. This seal eliminates the need for a valve.

[0064] The valve 60 may be any type of valve or opening / closing mechanism. The chamber 30 is designed to leave virtually no blood residue and may be configured to hold or pass a specific volume or percentage of blood into or through the isolation chamber 55. Similarly, the isolation chamber 55 may have any type of coating, such as an antimicrobial coating or a coating to assist in the identification and / or diagnosis of the initial certain volume of isolated blood collection.

[0065] The housings 50, 40 may be formed from any suitable material, including plastics such as acrylonitrile butadiene styrene (ABS) or other thermoplastic or polymer materials, rubber, steel, or aluminum. The air-permeable blood barrier 20 may include a coloring agent or other signaling mechanism that is activated when it comes into contact with the first blood sample, when the exhaust is stopped, or when any combination of events relating to blood in the isolation chamber 55 occurs. The air-permeable barrier may also have an outer layer, such as a hydrophobic membrane or cover, to prevent or stop the filter from being unintentionally sealed or sealed prematurely by an external fluid source or splash, etc. The isolation chamber 55 may also be translucent or transparent so that the user can visually confirm that the chamber is filled.

[0066] Figure 2 shows a blood sample optimization system according to another embodiment. In the embodiment shown in Figure 2, an isolation chamber 55 or waste chamber surrounds the patient needle 1, and an open-ended cuff or housing is connected to the waste chamber and surrounds the sample needle housing base and housing. The patient needle 1 and the sample needle 5 are connected to each other by a boot 56, forming a continuous blood collection channel that passes through the boot 56. The boot 56 has a single hole or channel leading from the blood collection channel to the isolation chamber 55. In another embodiment, the device may have multiple holes or channels. Each hole or channel may include a one-way valve and may be sized to suit a predetermined amount of blood flow.

[0067] The isolation chamber 55 is equipped with an air-permeable blood barrier. The filter may have a sensor or indicator to sense and / or indicate that a predetermined volume of blood has been collected in the isolation chamber 55. The indicator may prompt the user to attach a vacuum blood collection tube or bottle, such as a Vacutainer®, to the sample needle 5. The housing for the isolation chamber 55 may be of any size or shape and may be formed of any kind of material that defines the internal space or volume of the housing. The internal space is initially filled only with air, but may be coated with a drug or substance such as a decontamination agent or coagulant. When the vacuum blood collection tube is attached to the sample needle 5, blood automatically enters the patient needle 1 and flows through the blood collection channel and sample needle 5 into the bottle. The sample needle 5 is covered with a resealable cover, coating, or membrane that seals the sample needle when the blood collection bottle is not attached to the sample needle.

[0068] Figure 3 shows a blood sample optimization system according to another embodiment. In the illustrated embodiment, the sample needle 5 is surrounded by a resealable cover or membrane and connected to the patient needle 1. A blood flow path is formed through the sample needle and the patient needle. The connection between the sample needle and the patient needle includes a T-shaped or Y-shaped connector 102 which includes a channel, port, or opening that leads from the main blood flow path to the isolation chamber 104.

[0069] The T-type or Y-type connector 102 has a flap or a one-way valve and has dimensions designed to accommodate a predetermined flow rate of blood and has a fitted opening. The isolation chamber 104 may be formed by a tube or by a rigid housing and is initially filled with air. The isolation chamber 104 automatically receives the blood flowing out of the patient, i.e., under pressure from the patient's own blood pressure. The isolation chamber 104 preferably has an air-permeable blood barrier 106 at the distal end of the tube forming the isolation chamber 104, the proximal end of which is connected to the T-type or Y-type connector 102. The T-type or Y-type connector 102 may branch at any desired angle to obtain the most efficient blood flow, and the connector may be formed to minimize contact between the opening and the flow path and the main blood flow path in order to minimize or eliminate mixing of the initial fixed amount of blood with the majority of the remaining blood sample.

[0070] In one alternative embodiment, as shown in Figure 4, the sample needle may be attached to a tube of any length, with its opposite end connected to a T-type or Y-type connector 102. The isolation chamber 104 may have any shape or volume, as long as it can accommodate a predetermined amount of blood sample in a given initial blood collection. The T-type or Y-type connector 102 may also have an opening or flow path parallel to the main blood flow path. The air-permeable blood barrier may further have an indicator 10 or other mechanism to indicate that a predetermined amount of blood has been collected in the isolation chamber or that the amount of air released has reached a certain threshold, i.e., zero. The tube may also have a clip 109 that can be used to clamp and prevent the flow of fluid through the tube.

[0071] Once the air-permeable blood barrier and primary chamber are sealed, the initial volume of blood collected is trapped in the isolation chamber 104, and a vacuum blood collection tube, such as a Vacutainer® bottle, is attached to the sample needle 5 to obtain the sample. The blood collection tube can be removed, and the sample needle 5 is resealed. Any number of blood collection tubes can then be attached for further blood collection or sample collection. Once all blood collection is complete, the system is discarded with the initial volume of blood collected trapped in the isolation chamber 104.

[0072] Figure 5 shows a blood sample optimization system according to another embodiment. In the illustrated embodiment, the sample needle 5 is connected to the patient needle by a tube. A T-shaped or Y-shaped connector 120 is added at any desired position along the tube and has an opening, port, or flow path leading to the isolation chamber 204 as described above.

[0073] Figure 6 shows a blood sample optimization system according to an alternative embodiment, in which an isolation chamber 304, formed as the main collection channel and receiving the first certain amount of blood collected, is provided adjacent to the blood sample channel. The isolation chamber 304 may be formed to surround the blood sample channel, patient needle 1 and / or sample needle 5. The main collection channel may include a T-type or Y-type connector 120 or other type of opening or channel. The isolation chamber 304 is equipped with an air-permeable blood barrier and may be equipped with an indicator to show when a fluid such as blood has come into contact with it, as described above.

[0074] In some embodiments, either the patient needle 1 or the sample needle 5, or both, can be replaced with a Luer-lock male or female connector. However, in various embodiments, the connector at the end of the sample needle of the blood sample optimization system may be sealed first, and an initial fixed amount of blood pressurized by ambient air pressure may be guided into an isolation chamber having an air outlet of an air-permeable blood barrier. In this way, the system passively and automatically uses the patient's blood pressure to push the air through the air-permeable blood barrier, overcoming the ambient air pressure in the isolation chamber, and replaces the air in the isolation chamber with blood.

[0075] Figure 7 is a flowchart of a method for optimizing the quality of blood cultures. At 702, a clinician inserts a needle into the patient's vein. At 704, blood flows into the isolation chamber, and air within the isolation chamber is pushed out through an air-permeable blood barrier. In one embodiment, the volume of the isolation chamber may be less than 0.1 cubic centimeters (cc) or greater than 5 cubic centimeters (cc). The dimensions of the isolation chamber are set and adapted to collect the first portion of the blood sample, which is more contaminated than the second and subsequent portions of the blood sample or subsequent collected blood. The isolation chamber has an air-permeable blood barrier, and air can be exhausted through the blood barrier by the blood pushed out from the patient's vein, so such blood inevitably and automatically flows into the isolation chamber after being drawn into or placed in a Vacutainer® or other bottle for receiving and storing the blood sample.

[0076] When the isolation chamber is filled, blood collects in or comes into contact with an air-permeable blood barrier that blocks or prevents the blood from passing through. In 706, when the blood comes into contact with the entire inner surface area of ​​the air-permeable blood barrier, the air-permeable blood barrier closes and air no longer flows in or out. In 708, the clinician can check for an indicator that a vacuum blood collection tube, such as a Vacutainer®, can be attached, or visually check the chamber to confirm that it is filled with blood. The indicator may include visibility of the chamber that allows confirmation of whether the primary chamber is completely filled, for example, a blood barrier that changes color or other indicators. Since the time of filling the isolation chamber may be substantially instantaneous, such indicators, if present, may only indicate that the isolation chamber is completely filled.

[0077] Before the vacuum blood collection tube is attached, communication between the needle, sample flow path, and isolation chamber is restricted by the sealing of the blood barrier in the isolation chamber, and this isolation thus prevents air from re-entering the system. Sealing of the communication path is achieved by a small hole or meandering path, achieved by physical twisting or other action, and does not require a separately provided valve or physical action or operation by a medical professional. In 710, when the vacuum blood collection tube is removed, the sample needle is sealed by a self-sealing membrane. In 712, the next vacuum blood collection tube to be filled can be attached. In 714, once the sample has been collected, the device is removed from the patient and discarded.

[0078] Figures 8A–8E show an exemplary blood sample optimization system 800 for non-contaminated blood collection, according to some embodiments. The blood sample optimization system 800 comprises an inlet port 802 which can be connected to a tube, a patient needle (or both) or other vascular or venous access device, and a route splitter 804 having a first outlet to an isolation chamber tube 806 and a second outlet to a sample collection tube 808. One or both of the isolation chamber tube 806 and the sample collection tube 808 may be formed from a tube. In some embodiments, the isolation chamber tube 806 is sized to accommodate the first specific amount of blood sample in blood collection. Once the isolation chamber tube 806 is filled to capacity, the sample collection tube 808 accepts the blood sample. The sample collection tube 808 can be connected to a Vacutainer® base or housing 810 or other blood sample collection device.

[0079] The blood isolation system 800 further comprises a blood isolation device 812. The blood isolation device 812 comprises a housing 818, as shown in detail in Figures 8B to 8D. The housing 818 has a sample channel 820 that defines a path for a non-contaminated sample collection tube 808, or one end of which is connected to the non-contaminated sample collection tube 808. The sample channel 820 may bend as it passes through the housing 818 to better fix and stabilize the housing 818 in place along the non-contaminated sample collection tube 808.

[0080] The blood isolation device 812 further comprises an isolation chamber 822 connected to an isolation chamber tube 806 or other chamber. The isolation chamber 822 is terminated by an air-permeable blood barrier 824. The air-permeable blood barrier 824 may also contain a coloring agent that changes color upon full contact with blood, as an indicator that normal collection of a blood sample (i.e., an uncontaminated blood sample) can be initiated. Other indicators, such as a small light source or a sound-generating mechanism, may also be used. In some embodiments, the air-permeable blood barrier is positioned perpendicular to the direction of the isolation chamber 822, but it may be positioned at any distance or orientation to conserve space and material used by the housing 818. The housing 818 and elements within the housing may be formed from any rigid material, semi-rigid material, or a set of materials.

[0081] Figure 9 shows a route splitter 900 used in a blood isolation system, for example, as shown in Figures 8A-8E. The route splitter 900 has an inlet port 902, a main channel outlet port 904, and an isolation channel outlet port 906. The inlet port 902 may be connected to a main tube connected to a patient needle system or directly to a patient needle. The main channel outlet port 904 may be connected to a main tube to a blood collection system, such as a Vacutainer® base or housing, or directly to such a blood collection system. The isolation channel outlet port 906 may be connected to an isolation tube that receives and isolates a first sample of blood up to a measured volume or a predetermined threshold. Alternatively, the isolation channel outlet port 906 may be connected to an isolation chamber. The isolation channel outlet port 906 is preferably positioned at an angle of 20 to 70 degrees from the main channel outlet port 904, while preferably being in a straight line with the inlet port 902. Once the initial blood sample of a predetermined volume is isolated in an isolation tube or isolation chamber according to the mechanisms and techniques described herein, subsequent blood samples from the blood collection flow directly out of the main line outlet port 904 without being obstructed by entering the inlet port 902.

[0082] Figures 10A to 10D show a blood isolation device 1000 according to another embodiment. The blood isolation device 1000 comprises an inlet port 1002, a main outlet port 1004, and an isolation channel port 1006. The inlet port 1002 may be connected to a patient needle or associated tubing. The main outlet port 1004 may be connected to a blood sample collection device such as a Vacutainer®, associated tubing, or a Luer-operated valve. The isolation channel port 1006 branches off from the main outlet port 1004 to an isolation chamber 1008. In some embodiments, the isolation chamber 1008 is formed as a helical channel within a housing or other container 1001.

[0083] As described above, the isolation chamber 1008 is connected to the air-permeable blood barrier 1010 at its distal end. The air inside the isolation chamber 1008 is expelled through the air-permeable blood barrier 1010 by the first certain amount of blood collected and guided to the isolation flow channel port 1006. Once the isolation chamber 1008 is filled, any further blood samples from blood collection pass through the main outlet port 1004, and these samples remain uncontaminated.

[0084] Figures 11A to 11E show a blood isolation device 1100 according to other alternative embodiments. The blood isolation device 1100 includes an inlet port 1102 similar to the inlet port described above, a main outlet port 1104, and isolation channel ports 1106 branching from the main outlet port 1104 and the inlet port 1102. The isolation channel ports are connected to an isolation chamber 1108. In the embodiments shown in Figures 11A to 11E, the blood isolation device includes a base member 1101 having a channel inside that functions as an isolation chamber 1108. The channel is formed as a meandering path passing through the base member 1101, while the base member 1101 is shaped to rest on the limbs of a patient.

[0085] A portion of the isolation chamber 1108 protrudes from or near the top surface of the base member just before it enters the air-permeable blood barrier 1110, to function as a blood isolation indicator 1109. The indicator 1109 may be formed of a transparent material or a material that changes color upon contact with blood.

[0086] In some embodiments, the blood isolation device 1100 may include a blood collection device 1120, such as a normally closed needle, a Vacutainer® shield, or other collection device. The blood isolation device 1100 may be equipped to isolate the initial amount of blood collected, which may be contaminated by the patient needle insertion process, and may be manufactured and sold together with the blood collection device 1120 for efficiency and convenience. Thus, the blood collection device 1120 can collect and obtain an uncontaminated blood sample, thereby reducing the risk of false positives in testing.

[0087] Figures 12A to 12D show a blood sample optimization system 1200 according to yet another alternative embodiment. The system 1200 comprises a blood isolation device 1202 attached to a blood collection device 1204, such as a Vacutainer® or other collection and sample collection device. The blood isolation device 1202 is configured and positioned to receive an initial fixed amount of blood from a blood collection and to isolate that initial fixed amount of blood within the isolation channel of the blood isolation device 1202 before the Vacutainer® container or vial is attached to the collection needle of the blood collection device 1204.

[0088] In some embodiments, the blood isolation device 1202 has an inlet port 1212, a main outlet port, and an isolation channel port. The inlet port 1212 may be connected to a patient needle or associated tubing. The main outlet port 1214 may be connected to a needle or device that is normally closed to allow connection to other collection devices such as a vacuum blood collection container or Vacutainer®, associated tubing, Luer connectors, syringes, Luer valves, etc. The isolation channel port branches off from the main outlet port to an isolation chamber 1218.

[0089] In some embodiments, the isolation chamber 1218 is formed as a flow path within the body of the isolation device 1202. The isolation chamber 1218 may be a U-shaped flow path, an S-shaped flow path, a spiral flow path, or any other meandering flow path. The isolation device 1202 may comprise a housing or other containment and one or more flow paths formed therein. As shown in Figures 12A and 12B, the isolation device 1202 comprises a body 1206 and a cap 1208. One or more cavities or flow paths are formed in the body 1206, and one or more arms 1210 extending from the cap 1208 are further formed in the cavities or flow paths. One or more arms 1210 abut against the cavities or flow paths of the body 1206 to form a primary sampling port and a main outlet port.

[0090] Figures 13A to 13D show a blood sample optimization system 1300 according to further alternative embodiments. The system 1300 comprises a blood isolation device 1302 attached to a blood collection device 1304, such as a Vacutainer® or other bodily fluid collection and sample collection device. The blood isolation device 1302 is configured and positioned to receive the first certain amount of blood collected and to isolate that blood or other bodily fluid within the isolation channel of the blood isolation device 1302 before the Vacutainer® container or vial is attached to the blood collection needle of the blood collection device 1304.

[0091] The blood isolation device 1302 comprises a housing 1301 having an inlet port 1314, a main outlet port 1312, and an isolation flow path port 1316. The inlet port 1314 may be connected to a patient needle or associated tubing. The main outlet port 1312 may be connected to a needle or device that is normally closed to allow connection to other collection devices such as a vacuum blood collection container or Vacutainer®, associated tubing, Luer connectors, syringes, Luer valves, etc. The isolation flow path port 1316 branches off from the main inlet port 1314 to an isolation chamber 1318.

[0092] In the embodiments shown in Figures 13A to 13D, the isolation chamber 1318 is formed as a cavity or chamber within the housing 1301, or by a wall defining the housing 1301. The isolation chamber 1318 may be a meandering channel such as a U-shaped channel, an S-shaped channel, a spiral channel, or other meandering channel defined by the cooperation and connection of the housing 1301 and the cap 1307. The cap 1307 may have projections 1305 that provide one or more walls or directors defining the meandering channel within the isolation chamber 1318. The projections 1305 protruding from the cap 1307 may be straight or curved and may have various channels, openings or grooves formed therein. They may also extend from the cap 1307 at any angle or orientation. When the cap 1307 is connected to the housing 1301, the projections 1305 form at least a portion of the meandering channel, completing the formation of the isolation chamber 1318. Within the isolation chamber 1318, a certain amount of blood or other bodily fluids collected are isolated in an isolation channel that forms a meandering channel.

[0093] The isolation chamber 1318 has an air-permeable blood barrier 1310 as described above. The air inside the isolation chamber 1318 is pushed out through the air-permeable blood barrier 1310 by the initial amount of blood supplied into the isolation chamber 1318 by the patient's blood pressure. After the isolation chamber 1318 is filled and the air inside is expelled, the patient's blood pressure is insufficient to bring or supply further blood to or to the blood isolation device 1302, in particular to the outlet port 1312, and it will not reach the outlet port 1312 until a force such as vacuum or other pressure provided by a blood sample collection device such as a Vacutainer® is provided to draw out a certain amount of blood or body fluid for the next blood collection. Further blood collection can be performed by passing through the main outlet port 1312, and the blood sample is not contaminated because any contaminants are isolated inside the isolation chamber 1318 along with the initial amount of blood collected.

[0094] Figures 14A to 14E show yet another embodiment of a blood collection system 1400 that isolates contaminants in the initial amount of blood collected or in a certain amount of sample to reduce false positives in blood cultures or tests performed on patient blood samples. The blood collection system 1400 comprises a blood isolation device 1401 which may be connected between a blood sample collection device 1403 and a patient needle (not shown). The blood sample collection device 1403 may be a Vacutainer® or the like. The blood isolation device 1401 has an inlet port 1402 which can be connected to a patient needle that is inserted into the patient's vascular system for access to the blood sample and for blood sample collection. The inlet port 1402 may also be connected to a tube or other conduit which is connected to the patient needle.

[0095] The inlet port 1402 defines an opening to the blood isolation device 1401, which may have the same cross-sectional dimensions as the tube or other conduit connected to the patient needle or the patient needle itself. For example, the opening may be circular with a diameter of approximately 0.045 inches (1.143 mm), or it may have a diameter of 0.01 inches (0.254 mm) to 0.2 inches (5.08 mm) or larger. The blood isolation device 1401 further has an outlet port 1404 defining an opening from the blood isolation device 1401 and to the blood sample collection device 1403. The outlet port 1404 may also be connected to a tube or other conduit connected to the blood isolation device 1403. The outlet port 1404 may further have connector devices such as a threaded cap, a Luer connector (male or female), an unthreaded shim, or an adhesive fitting for attaching various devices including, but not limited to, tubes.

[0096] The blood isolation device 1401 further comprises a sample channel 1406 between the inlet port 1402 and the outlet port 1404. The sample channel 1406 functions as a blood sample pathway after the initial certain amount of blood collected has been isolated. The sample channel 1406 may be a channel or conduit of any size, shape, or configuration. In some embodiments, the sample channel 1406 has substantially the same cross-sectional area as the opening of the inlet port 1402. In other embodiments, the sample channel 1406 may gradually widen in diameter from the inlet port 1402 to the outlet port 1404.

[0097] The blood isolation device 1401 further comprises an isolation chamber 1408. The isolation chamber 1408 is connected to the sample channel 1406 at any position between the inlet port 1402 and the outlet port 1404, and branches off from or separates from the sample channel 1406. Preferably, it is connected to the proximal end of the sample channel 1406 near the inlet port 1402 and is arranged to branch off from or separate from that proximal end. The isolation chamber 1408 is initially maintained at atmospheric pressure and has an air outlet 1412 at or near the distal end of the isolation chamber 1408, located opposite the position where it separates from the sample channel 1406. The air outlet 1412 has an air-permeable blood barrier 1412. As shown in Figure 14B, the air-permeable blood barrier 1412 may be covered with a protective cover 1416. The protective cover 1416 is designed and configured to be sized to prevent the user from touching the air-permeable blood barrier 1412 with their fingers or other external instruments, while allowing air to be exhausted from the air-permeable blood barrier 1412 when air is expelled from the isolation chamber by the patient's own blood pressure as blood is naturally supplied into the isolation chamber 1408. The protective cover 1416 may also be configured to prevent or block the air-permeable blood barrier from being accidentally exposed to ambient fluid or splashes. This can be done by a variety of mechanical methods, including but not limited to adding a hydrophobic membrane to the protective cover.

[0098] As shown in Figures 14C and 14D, the sample channel 1406 may be cylindrical or frustoconical in shape, gradually increasing in diameter from small to large, to minimize the possibility of red blood cell lysis. Similarly, the sample channel 1406 is formed such that there is a minimum amount of sharp curves or acute angles that could potentially cause red blood cell lysis. The sample channel 1406 branches off to the isolation chamber 1408 near the inlet port 1402 via a diversion channel 1409. The diversion channel 1409 can have any cross-sectional shape or size, but is preferably similar in cross-sectional shape to at least a portion of the inlet port 1402.

[0099] In some embodiments, the sample channel 1406 and isolation chamber 1408 are formed by grooves, channels, locks or other paths formed in the housing 1414. The housing 1414 may be made of plastic, metal or other rigid or semi-rigid material. The housing 1414 may have a lower member that fits tightly to an upper member. One or both of the lower and upper members may include the sample channel 1406 and isolation chamber 1408, and may also include a diversion channel 1409, an inlet port 1402, and an outlet port 1404. In other embodiments, one or more of the diversion channel 1409, the inlet port 1402, and / or the outlet port 1404 may be at least partially formed by a cap member connected to any end of the housing 1414. In some embodiments, the upper and lower members and the cap member may be connected to each other by laser welding, thermal fusion, bonding, snap fastening, screwing, bolting, etc. In another embodiment, part or all of the inner surface of the diversion channel 1409 and / or the isolation chamber 1408 may be coated or filled with a drug or substance such as a decontaminant or coagulant. For example, if a coagulant is placed in the diversion channel 1409, when the isolation chamber 1408 is filled and the first certain amount of blood collected returns to the diversion channel 1409, the last amount of isolated blood will coagulate, creating a barrier between the isolation chamber 1408 and the sample channel 1406.

[0100] Figures 15A to 15G show the blood isolation device 1500. The blood isolation device 1500 may be connected to a normally closed needle or device to allow connection to other collection devices such as a vacuum blood collection container or Vacutainer®, associated tubing, Luer connectors, syringes, Luer valves, etc.

[0101] The blood isolation device 1500 has an inlet port 1502 that can be connected to a patient needle inserted into the patient's vascular system for access to and collection of a blood sample. The inlet port 1502 may also be connected to a tube or other conduit that connects to the patient needle. The inlet port 1502 defines an opening to the blood isolation device 1500, which may have the same cross-sectional dimensions as the tube or other conduit connected to the patient needle or the patient needle itself. For example, the opening may be circular with a diameter of about 0.045 inches (1.143 mm), or it may have a diameter of 0.01 inches (0.254 mm) to 0.2 inches (5.08 mm) or larger.

[0102] The inlet port 1502 may also have a sealing portion or a fluid-sealing connector or connection portion, such as a screw thread or Luer fitting. In some embodiments, the tube or other conduit that is coupled to the patient needle may be integrated with the inlet port 1502 by co-molding, bonding, laser welding or thermal bonding of the components. With this configuration, the blood isolation device 1500 can be manufactured and sold as a single unit together with the patient needle, eliminating the need to connect the patient needle to the blood isolation device 1500 during blood collection or sample collection.

[0103] The blood isolation device 1500 further has an outlet port 1504 that defines an opening from the blood isolation device 1500 and to a blood sample collection device. The outlet port 1504 may be connected to a tube or other conduit that connects to the blood isolation device and may have a sealing part or fluid-sealed connector or connection part such as a screw thread or Luer fitting. As described above, the blood isolation device 1500 may be manufactured and sold as a single unit together with a patient needle and / or tube and a blood collection device, eliminating the need to connect the patient needle and blood sample collection device to the blood isolation device 1500 during blood collection or sample collection.

[0104] The blood isolation device 1500 further comprises a sample channel 1506 between the inlet port 1502 and the outlet port 1504. The sample channel 1506 functions as a blood sample pathway after the initial certain amount of blood collected has been isolated. The sample channel 1506 may be a channel or conduit of any size, shape, or configuration. In some embodiments, the sample channel 1506 has substantially the same cross-sectional area as the opening of the inlet port 1502. In other embodiments, the sample channel 1506 may gradually widen in diameter from the inlet port 1502 to the outlet port 1504.

[0105] The blood isolation device 1500 further comprises an isolation chamber 1508. The isolation chamber 1408 is connected to the sample channel 1506 at any position between the inlet port 1502 and the outlet port 1504 and branches off from or separates from the sample channel 1506. Preferably, it is connected to the proximal end of the sample channel 1406 near the inlet port 1502 and is arranged to branch off from or separate from that proximal end. In some embodiments, the branching channel includes a Y-junction. The isolation chamber 1508 is preferably maintained at atmospheric pressure and has a vent 1510 at or near its distal end. The vent 1510 has an air-permeable blood barrier 1512. Figure 15C shows the blood isolation device 1500 with the isolation chamber 1508 filled with the first certain amount of blood or blood sample collected from a patient.

[0106] The air-permeable blood barrier 1512 may be covered with a protective cover 1516. The protective cover 1516 is designed and configured to be sized to prevent a user from touching the air-permeable blood barrier 1512 with their fingers or other external instruments, while allowing air to be exhausted from the air-permeable blood barrier 1512 when air is expelled from the isolation chamber by the patient's own blood pressure as blood is naturally supplied into the isolation chamber 1508. The protective cover 1516 may also be configured to prevent or block accidental exposure of the filter to ambient fluid or splashes. This can be done by a variety of mechanical methods, including but not limited to adding a hydrophobic membrane to the protective cover.

[0107] Figure 15B is a perspective view of the blood isolation device 1500 from the top of the housing 1501, including the outlet port 1504 and the vent 1510, showing that the initial amount of blood collected fills the isolation chamber 1508 while the sample channel 1506 is empty before the sample collection device is activated. Figure 15G is a perspective view of the blood isolation device 1500 from the bottom of the housing 1501, including the outlet port 1504, showing that the initial amount of blood collected fills the isolation chamber 1508 while the sample channel 1506 is empty before the sample collection device is activated. Figure 15C is another perspective view of the blood isolation device 1500 from the top of the housing 1501, including the inlet port 1502 and the vent 1510, showing that blood is collected through the sample channel 1506 while the isolated blood remains substantially within the isolation chamber 1508.

[0108] Figure 15D is a cross-sectional view of a blood isolation device 1500 according to one embodiment, showing a housing 1501 defining a sample flow path 1506 and an isolation chamber 1508. Figures 15E and 15F show various form factors of the housing of a blood isolation device according to one or more embodiments described herein.

[0109] The isolation chamber 1508 may have a larger cross-sectional area than the sample channel 1506, and the cross-sectional area or length may be set so that a predetermined or specific amount of blood is isolated or locked. The sample channel 1506 may be sized to fit one or both of the tubing of the patient needle and the tubing of the blood collection device.

[0110] The housing 1501 may be formed from multiple parts or a single part. In some embodiments, as shown in Figure 15D, the housing 1501 includes an upper member 1520 and a lower member 1522 that fit together, one or both of which have grooves, channels, locks, conduits or other paths that are pre-formed, for example, by an injection molding process or by etching, cutting, drilling, etc. The upper member 1520 may be connected to the lower member 1522 by any fitting structure or connection mechanism using laser welding, thermal bonding, ultrasonic welding, adhesive, screws, rivets, bolts, etc., or by other fitting mechanisms such as latches, grooves, tongues, pins, flanges, etc.

[0111] In some embodiments, as shown in Figure 15D, the upper member 1520 may include grooves, channels, locks, conduits, or other pathways. The lower member 1522 may have projections 1524 that are sized and adapted to fit into at least one of the grooves, channels, locks, and other pathways of the upper member 1520. The projections 1524 may provide surface structures such as partial grooves or partial channels that complete either the sample channel 1506 and / or the isolation chamber 1508. In some embodiments, the projections 1524 may be formed to have one or more inclined sides or surfaces that fit snugly into the corresponding grooves, channels, locks, or other pathways. In yet another embodiment, both the upper member 1520 and the lower member may have grooves, channels, locks, or other pathways, and one or more projections 1524.

[0112] In some embodiments, the sample channel 1506 and isolation chamber 1508 are formed by grooves, channels, locks or other paths formed in the housing 1501. The housing 1501 may be formed of any suitable material, which may be rubber, plastic, metal or other materials. The housing 1501 may be formed of a transparent or translucent material, or of an opaque or non-translucent material. In other embodiments, the housing 1501 is mostly opaque or non-translucent, but the housing surface directly adjacent to the sample channel 1506 and / or isolation chamber 1508 may be transparent or translucent. This configuration provides the practitioner with a visual cue or sign that the isolation chamber 1508 is initially filled to the required or desired extent, and / or that the isolated blood remains isolated while an uncontaminated blood sample is subsequently taken through the sample channel 1506. Other visual cues or signs of isolation may include, but are not limited to, the air permeable blood barrier 1512 changing color upon contact, penetration, or partial penetration of blood; color-coded tabs or indicators located along or adjacent to the isolation chamber; audible signals; vibration signals or other signals.

[0113] After venipuncture with a patient needle (not shown) that may collect a large number of pathogens from the patient's skin, the first certain amount of the patient's blood containing pathogens enters the blood isolation device 1500 inlet port 1502 and flows into the isolation chamber 1508 via the path of least resistance, as the patient's own blood pressure overcomes the atmospheric pressure in the isolation chamber 1508 and expels the air through the air-permeable blood barrier 1512. The patient's blood pressure is not sufficient to overcome the rising air pressure within the sealed sample channel 1506. Eventually, the isolation chamber 1508, having a predetermined volume, is filled with blood that has expelled air through the air-permeable blood barrier 1512. As the blood collides with the air-permeable blood barrier, it interacts with the material of the air-permeable blood barrier 1512 to completely or partially seal the vent 1510. The operator may provide a signal or indicator that the next amount of the patient's blood can be obtained for collection using a Vacutainer® capsule or other blood sample collection device. At this time, the blood in isolation chamber 1508 is effectively isolated within the isolation chamber.

[0114] After the blood isolation channel 1508 is filled and before the use of a Vacutainer® or other blood sample collection device, the patient's blood pressure causes compression of the air in the sample channel 1506, which may cause a small amount of blood to pass the diversion point to the isolation chamber 1508 and move into the sample channel 1506, where uncontaminated collected blood is waiting.

[0115] In some embodiments, as shown in Figure 15H, the inlet port 1532 may be equipped with a male Luer connector for connecting to a removable patient needle, and the outlet port 11534 may be equipped with a female Luer connector for connecting to a syringe. This embodiment of the inlet and outlet ports can be used with any of the devices described herein to avoid the tendency of the vacuuminer device to puncture the patient's vein. In this embodiment, the clinician may use a syringe in an adjusted manner to obtain a blood sample. During blood collection, the syringe is attached to the outlet port 1004 and the needle is attached to the inlet port 1002. Venipuncture is performed using the needle without the clinician pulling the syringe. After the initial certain amount of blood has filled the isolation chamber, the syringe can be used to bypass the isolated blood in the isolation chamber and take a blood sample from the collection channel.

[0116] Figures 16–19 show yet another embodiment of the blood isolation device. Figures 16A–16D show a blood isolation device 1600 that can be connected between a blood sample collection device, such as a vacuum blood collection container like a Vacutainer® (not shown), and a patient needle (not shown) and / or associated tubing. Figure 17 shows the lower member of the blood isolation device, and Figure 18 shows the upper member of the blood isolation device, the upper and lower members which may mate together to form an inlet port, an outlet port, an isolation chamber, and a sample flow path, as will be described in more detail below. Figures 19A and 19B show the upper and lower members which mate together. Figures 16–19 show one exemplary way of configuring the blood isolation device described herein, and it is clear that other forms of configuration are also possible.

[0117] As shown in Figures 16A to 16D, the blood isolation device 1600 has an inlet port 1602 to which a patient needle can be connected to be inserted into the patient's vascular system for access to and collection of a blood sample. The inlet port 1602 may also be connected to a tube or other conduit that connects to the patient needle. The inlet port 1602 defines an opening to the blood isolation device 1600, which may have the same cross-sectional dimensions as the tube or other conduit that connects to the patient needle or the patient needle itself. For example, the opening may be circular with a diameter of about 0.045 inches (1.143 mm), or it may have a diameter of 0.01 inches (0.254 mm) to 0.2 inches (5.08 mm) or larger.

[0118] The inlet port 1602 may also have a sealing portion or fluid-sealing connector or connection portion, such as a screw thread or Luer fitting. In some embodiments, the tube or other conduit that is coupled to the patient needle may be integrated with the inlet port 1602 by co-molding, bonding, laser welding or thermal bonding of the components. With this configuration, the blood isolation device 1600 can be manufactured and sold as a single unit together with the patient needle and / or tube, eliminating the need to connect the patient needle to the blood isolation device 1600 during blood collection or sample collection.

[0119] The blood isolation device 1600 further has an outlet port 1604 that defines an opening from the blood isolation device 1600 and to a blood sample collection device. The outlet port 1604 may be connected to a tube or other conduit that connects to the blood isolation device and may have a sealing part or fluid-sealed connector or connection part such as a screw thread or Luer fitting. As described above, the blood isolation device 1600 may be manufactured and sold as a single unit together with a patient needle and / or tube and a blood collection device, eliminating the need to connect the patient needle and blood sample collection device to the blood isolation device 1600 during blood collection or sample collection.

[0120] The blood isolation device 1600 further comprises a sample channel 1606 between an inlet port 1602 and an outlet port 1604, and an isolation chamber 1608 connected to and branching or diverting from the sample channel 1606 at any point between the inlet port 1602 and the outlet port 1604. The sample channel 1606 functions as a blood collection route after the first certain amount of collected blood has been isolated in the isolation chamber 1608. The sample channel 1606 may be a channel or conduit of any size, shape, or configuration. In some embodiments, the sample channel 1606 has substantially the same cross-sectional area as the opening of the inlet port 1602. In other embodiments, the sample channel 1606 may gradually widen in diameter from the inlet port 1602 to the outlet port 1604. As shown in more detail in Figures 17 and 19, the isolation chamber 1608 may have a large cross-section forming a large reservoir toward the isolation channel route so that blood enters the reservoir first rather than entering the small diameter on the sample channel 1606.

[0121] In some exemplary embodiments, the diversion of flow between the sample channel 1606 and the isolation chamber 1608 is performed by a diversion junction 1607. The diversion junction 1607 may be substantially Y-shaped, T-shaped, or U-shaped. In some preferred exemplary embodiments, as shown in Figures 17A-17B, the diversion junction 1607 is configured such that the flow from the inlet port 1602 is preferentially directed to the isolation chamber 1608. The isolation chamber 1608 may also have or have a curved section or ramp for directing the initial blood flow from the blood collection toward and into the isolation chamber 1608.

[0122] The isolation chamber 1608 is preferably maintained at atmospheric pressure and has a vent 1610 at or near its distal end. The vent 1610 may include an air-permeable blood barrier 1612 as described above.

[0123] The blood isolation device 1600 may include a housing 1601 which may be formed from multiple or a single part. In some embodiments, as shown in Figures 17A-17D and 18A-18F, the housing 1601 has an upper member 1620 and a lower member 1622 which fit together. The blood isolation device 1600 may have a gasket or other sealing member (not shown) such that when the upper member 1620 is mechanically attached to the lower member 1622, the joint between them is sealed by a gasket or sealing member. Figures 17A-17D show the lower member 1622 of the housing of the blood isolation device 1600. The lower member 1622 may have grooves, channels, locks, conduits or other paths that are pre-formed by an injection molding process or by etching, cutting, drilling, etc., to form a sample channel 1606, an isolation chamber 1608, and a diversion junction 1607.

[0124] The isolation chamber 1608 may have a larger cross-section than the sample channel 1606 so that blood preferentially moves into the isolation chamber rather than into the smaller diameter of the sample channel 1606.

[0125] The upper member 1620 shown in Figures 18A to 18F may be connected to the lower member 1622 by any fitting structure or connection mechanism using laser welding, thermal bonding, adhesive, screws, rivets, bolts, etc., or by other fitting mechanisms such as latches, grooves, tongues, pins, flanges, etc. The upper member 1620 may have some or all of the grooves, channels, locks, conduits, or other paths to form the sample channel 1606, isolation chamber 1608, and diversion junction 1607. In yet another embodiment, both the upper member 1620 and the lower member 1622 may have grooves, channels, locks, or other paths.

[0126] In some embodiments, the sample channel 1606 and isolation chamber 1608 are formed by grooves, channels, locks or other paths formed in the housing 1601. The housing 1601 may be made of rubber, plastic, metal or other suitable material. The housing 1601 may be made of a transparent or translucent material, or of an opaque or non-translucent material. In other embodiments, the housing 1601 is mostly opaque or non-translucent, but the housing surface directly adjacent to the sample channel 1606 and / or isolation chamber 1608 may be transparent or translucent. This configuration provides the practitioner with a visual cue or sign that the isolation chamber 1608 is initially filled to the required or desired extent, and / or that the isolated blood remains isolated while an uncontaminated blood sample is subsequently taken through the sample channel 1606. Other visual cues or signs of isolation may include, but are not limited to, a change in color of the air-permeable blood barrier 1612 upon contact, penetration, or partial penetration of blood; color-coded tabs or indicators located along or adjacent to the isolation chamber; audible signals; vibration signals or other signals.

[0127] As shown in Figures 18A to 18F, the air-permeable blood barrier 1612 may be covered by or surrounded by a protective member 1616. The protective member 1616 is designed and configured to be sized to prevent a user from touching the air-permeable blood barrier 1612 with their fingers or other external instruments, while still allowing air to be exhausted from the air-permeable blood barrier 1612 when air is forced out of the isolation chamber 1608. In some embodiments, the protective member 1616 has a projection that protrudes upward from the top surface of the upper member 1620 and extends around the air-permeable blood barrier 1612. The protective cover 1616 may also be configured to prevent or block accidental exposure of the filter to ambient fluid or splashes. This can be done by a variety of mechanical methods, including, but not limited to, adding a hydrophobic membrane to the protective cover.

[0128] When in use, the blood isolation device 1600 comprises a sample pathway 1606 and an isolation chamber 1608. Both pathways are initially filled with air at atmospheric pressure, but the sample pathway 1606 is directed towards an outlet port 1604 which is initially sealed by a Vacutainer® or other similar sealed blood collection device, and the isolation chamber 1608 terminates at an air vent 1610 to the outside air having an air-permeable blood barrier 1612.

[0129] Following venipuncture with a patient needle (not shown) that may collect numerous pathogens from the patient's skin, an initial certain volume of blood collected from the pathogen-containing patient passes through the inlet port 1602 of the blood isolation device 1600. This initial volume of potentially contaminated blood finds the least resistant path and preferentially flows into the isolation chamber 1608. The patient's own blood pressure overcomes the atmospheric pressure within the vented isolation chamber 1608 and expels air from within the isolation chamber 1608 through the air-permeable blood barrier 1612, but the patient's blood pressure is insufficient to overcome the rising air pressure within the sealed sample channel 1606. In various exemplary embodiments, the isolation chamber 1608 and sample channel 1606 may be configured such that the force generated by the patient's blood pressure is sufficient to overcome the effects of gravity, regardless of the orientation of the blood isolation device.

[0130] Ultimately, the isolation chamber 1608 is filled with blood, expelling air through the air-permeable blood barrier 1612. Upon contact of the blood with the air-permeable blood barrier, the blood interacts with the material of the air-permeable blood barrier 1612 to completely or partially seal the vent 1610. The operator may provide a signal or indicator that a Vacutainer® or other blood collection device is ready for use.

[0131] After the blood isolation channel 1608 is filled and before the use of a Vacutainer® or other blood sample collection device, the patient's blood pressure causes compression of air in the sample channel 1606, which may cause a small amount of blood to pass the diversion point and move into the sample channel 1606, leaving uncontaminated collected blood waiting in the sample channel 1606.

[0132] Figure 19A is a side view of the blood isolation device 1600, and Figure 19B is a cross-sectional view of the blood isolation device 1600, showing the upper member 1620 that fits with the lower member 1622.

[0133] Figure 20 shows a blood sample optimization system 2000 comprising a patient needle 2002 into a blood vessel for accessing the patient's blood flow, a blood sample collection device 2004 for facilitating the collection of one or more blood samples, and a conduit 2006 providing a fluid connection between the patient needle 2002 and the blood sample collection device 2004. In some embodiments, the blood sample collection device 2004 includes a protective shield containing a sealed collection needle, a sealed vacuum container placed on the collection needle, and when the container is punctured by the collection needle, a blood sample is drawn from the patient needle 2002 through the conduit 2006 by vacuum pressure or vacuum force.

[0134] The blood sample optimization system 2000 further comprises a blood isolation device 2008 positioned at any location on the conduit 2006 between the patient needle 2002 and the blood sample collection device 2004, as described herein.

[0135] Figure 21 shows a ventless blood isolation device 2100 using a wick chamber. The blood isolation device 2100 comprises a housing 2101 having a sample channel 2104 that is at least partially surrounded by or in contact with an isolation chamber 2102 filled with wick material (a material that carries moisture by capillary action). The first certain amount of blood collected is drawn from the patient needle into the sample channel 2104, and the blood is immediately carried by capillary action into the wick material of the isolation chamber 2102 within the sample channel 2104. The wick material and / or isolation chamber 2102 are sized and fitted to receive and hold a predetermined amount of blood so that blood from subsequent blood collections passes through the wick material and flows directly through the sample channel 2104 to a blood collection device such as a Vacutainer®. The wick material may contain substances such as solidifying agents, decontaminating agents or other additives.

[0136] As described herein, air permeable blood barriers can be made using a variety of structures and materials. As shown in Figures 22A and 22B, the air permeable blood barrier 2202 of the blood isolation device 2200 may include a polymer bead matrix 2204, where at least some of the beads may be treated to be hydrophilic. The air permeable blood barrier 2202 further includes a self-sealing material 2206 such as carboxymethylcellulose (CMC) or cellulose gum, or other sealing material. The air permeable blood barrier 2202 may have voids 2208 that allow airflow before or during partial contact with a fluid such as blood. As shown in Figure 22B, upon contact with the fluid, the self-sealing material 2206 expands to occlude the voids 2208, blocking the airflow through the voids 2208 and resulting in a complete or partial seal.

[0137] Figures 23A and 23B show yet another embodiment of the blood isolation device 2300, comprising an inlet port 2302 for connecting to a patient needle, an outlet port 2304 for connecting to a blood sample collection device, an isolation chamber 2306, and a sampling channel 2308 that bypasses the isolation chamber 2306 once the isolation chamber is filled with the first certain amount of potentially contaminated blood to be isolated. The isolation chamber 2306 has a hydrophobic stopper 2312 at the distal end of the isolation chamber 2306, furthest from the inlet port 2302. Blood is drawn directly into the inlet port 2302 and into the isolation chamber 2306 by a vacuum or other suction force applied from the outlet port 2304, for example, a Vacutainer®. There, the first certain amount of blood from the blood collection comes into contact with the hydrophobic movable stopper 2312, and the first certain amount of blood from the blood collection is returned to the isolation chamber 2306 for isolation. Initially, a small amount of blood may enter the sample channel 2308, which is closed by valve 2308. When valve 2308 is released, the subsequent amount of blood collected flows into the inlet port 2302 due to the additional force of the vacuum or other forces, bypasses the isolation chamber 2306, passes through the sample channel 2308, and flows towards the outlet port 2304, where it is sent to the collection device.

[0138] The sample channel 2308 may have any suitable shape and can be formed from a plastic tube or other suitable material. The valve 2308 may be a clip or other sealing device for clamping, shunting, bending, or otherwise closing the sample channel 2308 before the first certain amount of blood collected is isolated in the isolation chamber 2306. For example, the valve 2308 may be formed as a flap, door, or closable window or barrier within the sample channel 2308.

[0139] Figures 23C to 23E show an alternative embodiment of the blood isolation device 2300', in which the isolation chamber 2320 branches off from the main collection channel 2322 between an inlet port 2316 for connecting to a patient needle and an outlet port 2318 for connecting to a blood sample collection device such as a Vacutainer® or syringe. The isolation chamber 2320 has an air-permeable and blood-impermeable blood barrier 2324, such as a movable stopper made of hydrophobic material or a filter formed of one or more layers. The valve 2324 closes and opens the collection channel 2322, and the device 2300' can be used in the same manner as described above.

[0140] Figures 24–24D show a blood sample optimization system 2400 comprising a patient needle 2402 into a blood vessel for accessing the patient's blood flow, a blood sample collection device 2404 for facilitating the collection of one or more blood samples for blood testing or blood culture, and a conduit 2406 providing a fluid connection between the patient needle 2402 and the blood sample collection device 2404. In some embodiments, the blood sample collection device 2404 includes a protective shield containing a sealed collection needle, a sealed vacuum container placed on the collection needle, and when the container is punctured by the collection needle, a blood sample is drawn from the patient needle 2402 through the conduit 2406 by vacuum pressure or vacuum force.

[0141] The blood sample optimization system 2400 further comprises a blood isolation device 2408 positioned at any location on the conduit 2406 between the patient needle 2402 and the blood sample collection device 2404. The position of the blood isolation device 2408 may be based on the length of the conduit between the blood isolation device 2408 and the patient needle 2402 and the volume associated with that length.

[0142] The blood isolation device 2408 comprises an inlet port 2412 for directing a patient needle 2402 and connecting to a conduit 2406, an outlet port 2414 for directing a blood sample collection device 2404 and connecting to the conduit 2406, and a housing 2416. The housing 2416 is shown as substantially cylindrical in Figures 24A to 24D, but can be of any shape. The inlet port 2412 and the outlet port 2414 are shown as being located at opposing ends of the housing 2416, but may be located anywhere on the housing.

[0143] The blood isolation device 2408 further comprises a blood isolation chamber 2418 connected to an inlet port 2412. The blood isolation chamber 2418 is defined by an inner chamber that is movable from a first position to a second position, where it receives and isolates the first predetermined amount of blood collected. In the second position, one or more openings 2424 are exposed at the proximal end of the inner chamber housing 2419, allowing blood to flow around and / or bypass the inner chamber housing 2419 and through a blood sample channel 2422 defined by the outer surface of the inner chamber housing 2419 and the inner surface of the housing 2416. The blood isolation chamber 2418 has an air-permeable blood barrier 2420 at its distal end.

[0144] During operation, the inner chamber housing 2419 is positioned in a first position facing the inlet port 2412, and the blood isolation chamber 2418 is positioned in the pathway from the patient needle, so that one or more openings 2424 are closed. During venipuncture of the patient and collection of blood using a syringe or a Vacutainer® or other blood collection device 2404, the first certain amount of blood collected flows into the blood isolation chamber 2418. Once the first certain amount of blood collected flows into the blood isolation chamber, the air in the blood isolation chamber is replaced, and the blood eventually comes into contact with the blood barrier 2420, moving the inner chamber housing to a second position. The inner chamber housing 2419 and / or housing 2416 may have one or more small tabs, grooves, stoppers, protrusions, ridges, or other locking mechanisms to maintain the inner chamber housing 2419 in the first position until the blood isolation chamber 2418 is filled. Once the blood isolation chamber 2418 is fully filled, the inner chamber housing 2419 is able to overcome the locking mechanism and move to the second position. In the second position, the initial certain amount of blood collected is isolated in the blood isolation chamber 2418, and one or more openings 2424 are opened to create a path from the inlet port 2412 to the blood sample flow path 2422, allowing the blood to bypass and / or flow around the blood isolation chamber 2418.

[0145] As described above, the housing 2416 and / or the inner chamber housing 2419 can be formed in a cylindrical and concentric shape, but may have a square, rectangular, elliptical, or other cross-sectional shape. The outer surface of the distal end of the inner chamber housing 2419 has one or more outwardly projecting projections 2421, with gaps formed between the projections. The projections 2421 contact the inner surface of the housing 2416, helping to define the blood sample flow path 2422 between them and helping to stop the inner chamber housing 2419 in a second position. The gaps between the projections 2421 allow blood to flow through the blood sample flow path 2422 to the outlet port 2414. Once the inner chamber housing 2419 is in the second position and the blood isolation chamber 2418 is filled with the first certain amount of blood collected, further blood samples automatically flow through the inlet port 2412, through one or more openings 2424, through the blood sample flow path 2422, through the gaps between the protrusions 2421, and finally through the outlet port 2414 to be collected by the blood collection device 2404.

[0146] Figures 25A–25D show a blood optimization system 2500 and a blood isolation device 2502, which are formed substantially as described in Figures 15, 16, 17, 18, and 19, but are formed to prevent the user or other objects from touching or blocking the air venting mechanism from the blood isolation chamber 2520. The air initially present in the blood isolation chamber 2520 is replaced by the initial certain amount of blood drawn during venipuncture, and the patient's blood pressure overcomes the ambient air pressure inside the blood isolation chamber 2520. The air venting mechanism has an air-permeable blood barrier 2506, such as a porous material or set of materials, that allows air to escape but prevents blood from leaving the blood isolation chamber 2520.

[0147] The air venting mechanism comprises an inner wall 2516 that at least partially surrounds or encloses the air-permeable blood barrier 2506, and an outer wall 2504 positioned at a distance from the inner wall 2516. The outer wall 2504 may have one or more vents 2514 formed in the outer wall. The outer wall 2504 extends above the inner wall 2516, and a lid 2510, such as a cap, stopper, or cover, is attached to the outer wall 2504 and positioned a small distance from the top of the inner wall 2516. A seal 2508, in the form of a silicon wafer or other elastic material, fits within the outer wall 2504, covers the air-permeable blood barrier 2506, and abuts against the top of the inner wall 2516. The seal 2508 covers and seals the air-permeable blood barrier 2506, preventing air from passing through the air-permeable blood barrier 2506 into the blood isolation chamber 2520. By providing a lower pivot point 2512 on the lid 2510, when the seal 2508 is pressed by the air exhausted from the blood isolation chamber 2520, the seal 2508 flexes and detaches from the top of the inner wall 2516, allowing the air to be exhausted from the air permeable blood barrier 2506 and through one or more vents 2514 in the outer wall 2504.

[0148] Figures 26A–26D show a blood sample optimization system 2600 comprising a patient needle 2602 into a blood vessel for accessing the patient's blood flow, a blood sample collection device 2604 for facilitating the collection of one or more blood samples for blood testing or blood culture, and a conduit 2606 providing a fluid connection between the patient needle 2602 and the blood sample collection device 2604. The conduit 2606 may include a flexible tube. In a preferred embodiment, the blood sample collection device 2604 includes a protective shield 2605 containing a sealed collection needle, a sealed vacuum container placed on the collection needle, and when the container is punctured by the collection needle, a blood sample is drawn from the patient needle 2602 through the conduit 2606 by vacuum pressure or vacuum force.

[0149] The blood sample optimization system 2600 further comprises a blood isolation device 2608 positioned at any location on the conduit 2606 between the patient needle 2602 and the blood sample collection device 2604. The position of the blood isolation device 2608 may be based on the length of the conduit between the blood isolation device 2608 and the patient needle 2602 and the volume associated with that length.

[0150] The blood isolation device 2608 includes an inlet port 2612 for directing a patient needle 2602 and connecting to a conduit 2606, and an outlet port 2614 for directing a blood sample collection device 2604 and connecting to the conduit 2606. The blood isolation device 2608 includes an outer housing 2616 and an inner housing 2617, both of which are cylindrical and concentrically connected. The outer housing 2616 has an outer wall 2618 and an inner conduit 2620 that defines a blood sample flow path 2622 for transporting blood through the conduit 2606 to the blood collection device 2604. The inner housing 2617 fits snugly between the inner conduit 2620 and the outer wall 2618 of the outer housing and is rotatable relative to the outer housing 2616. The fit between the outer housing 2616 and the inner housing 2617 may be a friction fit that maintains the housing in a specific position. The inner housing 2617 defines a helical or corkscrew-shaped flow path located around the outer surface of the inner conduit 2620 of the blood isolation chamber 2624, preferably the outer housing 2616, which terminates at a vent 2628 having an air-permeable blood barrier, as shown in Figure 26E.

[0151] The blood isolation chamber 2624 is connected to the blood sample channel 2622 via a diversion junction 2624 formed in the inner conduit 2620 when the blood isolation device, as illustrated in Figure 26C, is in a first state. A protective shield 2606 covering the collection needle 2604 provides a barrier to air or blood, allowing the initial amount of blood to be dispensed into the blood isolation chamber 2624 when the patient's blood pressure overcomes the ambient air pressure in the blood isolation channel 2624 and the air is replaced with blood through the vent 2628.

[0152] When the inner housing 2617 is rotated relative to the outer housing 2616, or the outer housing 2616 is rotated relative to the inner housing 2617, to a second state as shown in Figure 26D, the blood isolation chamber 2624 is isolated from the diversion junction 2624, forming a direct passage from the patient needle through the conduit 2606 to the collection needle 2604 via the blood sample flow path 2622. The outer housing 2616 and / or the inner housing 2617 may have ridges or grooves formed within parts of their surfaces to facilitate relative rotation from the first state to the second state.

[0153] Figures 27A–27D show a blood optimization system 2700 and a blood isolation device 2702, which are formed substantially as described with reference to Figures 15, 16, 17, 18, 19, and 25, but are formed to prevent the user or other objects from touching or blocking the air venting mechanism from the blood isolation chamber 2720. The air initially present in the blood isolation chamber 2720 is replaced by the initial certain amount of blood drawn during venipuncture, and the patient's blood pressure overcomes the ambient air pressure inside the blood isolation chamber 2720. The air venting mechanism has an air-permeable blood barrier 2706, such as a porous material or set of materials, that allows air to escape but prevents blood from leaving the blood isolation chamber 2720.

[0154] The venting mechanism includes an inner wall 2716 that at least partially surrounds or encloses the air-permeable blood barrier 2706, and an outer wall 2704 positioned at a distance from the inner wall 2716. Preferably, a cap 2722 is positioned within the venting mechanism and has a lower cap wall 2728 that fits between the inner wall 2716 and the outer wall 2704 of the venting mechanism, and contacts either or both of the inner wall 2716 and the outer wall 2704 with friction. The cap 2722 further has one or more venting holes 2724 or slits, openings, holes, etc. that extend through the upper surface of the cap 2722 around a stopper 2726 that extends downward. The stopper 2726 is sized and fitted to fit snugly within the space defined by the inner wall 2716.

[0155] In the first position shown in Figure 27C, the cap 2722 extends from the venting mechanism, allowing air from the blood isolation chamber 2720 to pass through the air-permeable blood barrier 2706 and exit through one or more vents 2724. Once air has been vented from the blood isolation chamber 2720, i.e., once the blood isolation chamber 2720 is filled with the first volume of potentially contaminated blood drawn from the patient, the cap 2722 is then pushed down into the venting mechanism to the second position shown in Figure 27D, allowing the stopper 2726 to fit into the inner wall 2716 on the air-permeable blood barrier 2706 and seal the venting mechanism. In either the first or second position, the cap 2722 protects the air-permeable blood barrier 2706 from outside air or from being touched by the user.

[0156] Figures 28A–28F show a blood optimization system 2800 and a blood isolation device 2802 that are substantially formed with reference to at least Figures 15, 16, 17, 18, 19, 25, and 26, but utilize multilayer filters for an air-permeable blood barrier, and in some embodiments utilize filters that capture reactive material. As shown in Figures 28C and 28D, the air-permeable blood barrier 2803 includes a first layer 2804 of a material that is permeable to air but impermeable to blood, and a second layer 2806 containing a reactive material such as a hydrophobic material that repels blood, allowing air to pass through both layers. As shown in Figures 28E and 28F, the air-permeable blood barrier 2803 may include any number of layers, for example, a third layer 2808 formed of the same air-permeable but blood-impermeable material as the first layer 2804, and the second layer 2806 contains captured or embedded blood-reactive material.

[0157] Figures 29A–29C illustrate a blood optimization system 2900 and a blood isolation device 2902 that are substantially formed as described with reference to at least Figures 15, 16, 17, 18, 19, 25, and 26, wherein the blood isolation chamber 2904 is at least partially filled with a blood absorbent material 2906. The blood absorbent material 2906 functions as a wick to further draw in the blood to be isolated before using a blood collection device such as a Vacutainer® or syringe during venipuncture of a patient.

[0158] Figures 30A–30G show a blood optimization system 3000 and a blood isolation device 3002 substantially formed as described with reference to at least Figures 15, 16, 17, 18, 19, 25, and 26. The blood isolation device 3000 has an inlet port 3002 which can be connected to a patient needle that is inserted into the patient's vascular system for access to and collection of a blood sample. The inlet port 3002 may also be connected to a tube or other conduit that is connected to the patient needle. The inlet port 3002 defines an opening to the blood isolation device 3000, which may have the same cross-sectional dimensions as the tube or other conduit connected to the patient needle or the patient needle itself. For example, the opening may be circular with a diameter of about 0.045 inches (1.143 mm), or it may have a diameter of 0.01 inches (0.254 mm) to 0.2 inches (5.08 mm) or larger.

[0159] The inlet port 3002 may also have a sealing portion or a fluid-sealing connector or connection portion, such as a screw thread or Luer fitting. In some embodiments, the tube or other conduit that is coupled to the patient needle may be integrated with the inlet port 3002 by co-molding, bonding, laser welding or thermal bonding of the components. With this configuration, the blood isolation device 3000 can be manufactured and sold as a single unit together with the patient needle and / or tube, eliminating the need to connect the patient needle to the blood isolation device 3000 during blood collection or sample collection.

[0160] The blood isolation device 3000 further has an outlet port 3004 that defines an opening from the blood isolation device 3000 and to a blood sample collection device. The outlet port 3004 may be connected to a tube or other conduit that connects to the blood isolation device and may have a sealing part or fluid-sealed connector or connection part such as a screw thread or Luer fitting. As described above, the blood isolation device 3000 may be manufactured and sold as a single unit together with a patient needle and / or tube and a blood collection device, eliminating the need to connect the patient needle and blood sample collection device to the blood isolation device 3000 during blood collection or sample collection.

[0161] The blood isolation device 3000 further comprises a sample channel 3006 between an inlet port 3002 and an outlet port 3004, and an isolation chamber 3008 connected to and branching or diverting from the sample channel 3006 at any point between the inlet port 3002 and the outlet port 3004. The sample channel 3006 functions as a blood collection route after the first certain amount of collected blood has been isolated in the isolation chamber 3008. The sample channel 3006 may be a channel or conduit of any size, shape, or configuration. In some embodiments, the sample channel 3006 has substantially the same cross-sectional area as the opening of the inlet port 3002. In other embodiments, the sample channel 3006 may gradually widen in diameter from the inlet port 3002 to the outlet port 3004. The isolation chamber 3008 may have a large cross-section forming a large reservoir toward the isolation channel route so that blood enters the reservoir first rather than the small diameter of the sample channel 3006.

[0162] In some exemplary embodiments, the diversion of flow between the sample channel 3006 and the isolation chamber 3008 is performed by a diversion junction 3007. The diversion junction 3007 may be substantially Y-shaped, T-shaped, or U-shaped. In some preferred exemplary embodiments, as shown in Figures 17A-17B, the diversion junction 3007 is configured such that the flow from the inlet port 3002 is preferentially directed to the isolation chamber 3008. The isolation chamber 3008 may also have or have a curved section or ramp for directing the initial blood flow from the blood collection towards the isolation chamber 3008 and into the isolation chamber 1608.

[0163] The isolation chamber 3008 is preferably maintained at atmospheric pressure and has a vent 3010 at or near its distal end. The vent 3010 may include an air-permeable blood barrier 3012 as described above.

[0164] The blood isolation device 3000 may include a housing 3001 which can be formed from multiple or a single part. In some embodiments, as shown in Figure 30F, the housing 3001 has an upper member 3020 and a lower member 3022 which fit together. The blood isolation device 3000 may have a gasket or other sealing member (not shown) such that when the upper member 3020 is mechanically attached to the lower member 3022, the joint between them is sealed by a gasket or other sealing member. The lower member 3022 may have grooves, channels, locks, conduits or other paths that are pre-formed by an injection molding process or by etching, cutting, drilling, etc., to form a sample channel 3006, an isolation chamber 3008, and a diversion junction 3007.

[0165] The isolation chamber 3008 may have a larger cross-section than the sample channel 3006 so that blood preferentially moves into the isolation chamber rather than into the smaller diameter of the sample channel 3006.

[0166] In some embodiments, the sample channel 3006 and isolation chamber 3008 are formed by grooves, channels, locks or other paths formed in the housing 3001. The housing 3001 may be made of rubber, plastic, metal or other suitable material. The housing 3001 may be made of a transparent or translucent material, or of an opaque or non-translucent material. In other embodiments, the housing 3001 is mostly opaque or non-translucent, but the housing surface directly adjacent to the sample channel 3006 and / or isolation chamber 3008 may be transparent or translucent. This configuration provides the practitioner with a visual cue or sign that the isolation chamber 3008 is initially filled to the required or desired extent, and / or that the isolated blood remains isolated while an uncontaminated blood sample is subsequently taken through the sample channel 3006. Other visual cues or signs of isolation may include, but are not limited to, the change in color of the air-permeable blood barrier 3012 upon contact, penetration, or partial penetration of blood; color-coded tabs or indicators located along or adjacent to the isolation chamber; audible signals; vibration signals or other signals.

[0167] The air-permeable blood barrier 3012 may be covered with or surrounded by a cap 3032. The cap 3032 is designed and configured to be sized to prevent a user from touching the air-permeable blood barrier 3012 with their fingers or other external instruments, while still allowing air to be exhausted from the air-permeable blood barrier 3012 when air is forced out of the isolation chamber 3008. The cap 3032 may also be configured to prevent or block accidental exposure of the filter to ambient fluid or splashes. This can be done by a variety of mechanical methods, including but not limited to adding a hydrophobic membrane to the protective cover.

[0168] The air venting mechanism includes a wall 3030 that at least partially surrounds or encloses the air-permeable blood barrier 3012. The wall 3030 may have one or more vents 2514 formed in the wall. The cap 3032 can be attached in place by snapping, adhesive or other means to cover the wall 3030. A seal 3017, in the form of a silicon wafer or other elastic material, fits inside the wall 3030, covers the air-permeable blood barrier 3012, and abuts against the top of the wall 3030. The seal 3017 covers and seals the air-permeable blood barrier 3012, preventing air from passing through the air-permeable blood barrier 3012 into the blood isolation chamber 3008. By providing a lower pivot point 3012 on the cap 3032, when the seal 3017 is pressed by the air exhausted from the blood isolation chamber 3008, the seal 3017 flexes and detaches from the top of the inner wall 3016, allowing air to be exhausted from the air-permeable blood barrier 3012 through one or more vents in the wall 3030 and / or cap 3032.

[0169] When in use, the blood isolation device 3000 comprises a sample pathway 3006 and an isolation chamber 3008. Both pathways are initially filled with air at atmospheric pressure, but the sample pathway 3006 is directed towards an outlet port 3004 which is initially sealed by a Vacutainer® or other similar sealed blood collection device, and the isolation chamber 3008 terminates at an air vent 3010 with an air-permeable blood barrier 3012.

[0170] Following venipuncture with a patient needle (not shown) that may collect numerous pathogens from the patient's skin, a certain initial volume of blood collected from the pathogen-containing patient passes through the inlet port 3002 of the blood isolation device 3000. This initial volume of potentially contaminated blood finds the least resistant path and preferentially flows into the isolation chamber 3008. The patient's own blood pressure overcomes the atmospheric pressure within the vented isolation chamber 3008 and expels air from within the isolation chamber 3008 through the air-permeable blood barrier 3012, but the patient's blood pressure is insufficient to overcome the rising air pressure within the sealed sample channel 3006. In various exemplary embodiments, the isolation chamber 3008 and sample channel 3006 may be configured such that the force generated by the patient's blood pressure is sufficient to overcome the effects of gravity, regardless of the orientation of the blood isolation device.

[0171] Ultimately, the isolation chamber 3008 is filled with blood, expelling air through the air-permeable blood barrier 3012. Upon contact of the blood with the air-permeable blood barrier, the blood interacts with the material of the air-permeable blood barrier 3012 to completely or partially seal the vent 3010. The operator may provide a signal or indicator that a Vacutainer® or other blood collection device is ready for use.

[0172] After the blood isolation channel 3008 is filled and before the use of a Vacutainer® or other blood sample collection device, the patient's blood pressure causes compression of air in the sample channel 3006, which may cause a small amount of blood to pass the diversion point and move into the sample channel 3006, leaving uncontaminated collected blood waiting in the sample channel 3006.

[0173] In yet another embodiment, the blood isolation chamber and / or blood sample channel or other components of any embodiment described herein may be configured to display a visually recognizable warning or result on a component that is in operative fluid communication with the flush chamber of the intravenous catheter introduction into the patient's blood vessel. Such apparatus and methods can provide a visually identifiable warning by visually changing when blood from the patient comes into contact with a test component that reacts with plasma. The reaction with the blood or plasma occurs by one or more reagents configured to examine the contents of the blood, substances or the height or lowness of their threshold, resulting in a visually altered appearance.

[0174] In yet another embodiment, the blood isolation chamber and / or blood sample flow path may be sized and adapted to provide a predetermined volume flow of blood during either the isolation process and / or the blood collection process.

[0175] In yet another embodiment, non-permeable body fluid sample optimization devices and systems for use in blood collection or blood culture collection systems are shown and described. According to the embodiments described herein, body fluid sample optimization devices overcome the problems of conventional devices having permanently attached and statically positioned displaceable parts such as valves, state transition switches or shunts, or other mechanisms that move, shift or transition from one operating mode to another or from one state to another.

[0176] As shown in Figure 31, the fluid sample optimization device 3100 has an inlet 3112 and an outlet 3114. The inlet 3112 may include an inlet port, connector, or interface for connecting to an external device such as a tube or its interface. For example, via a venipuncture needle, the inlet 3112 can be connected to a patient or a fluid source of the patient, in which case the fluid is supplied at a pressure P1, which may be the patient's blood pressure (which may vary between 0 and 150 mmHg or more).

[0177] The outlet 3114 may have an outlet port, connector, or interface for connecting to an external device such as a tube or interface. For example, the outlet 3114 can be connected to a vacuum tube such as a Vacutainer® or a fluid collection device such as a syringe, by which the fluid collection device draws fluid from the fluid source at a pressure P2 lower than pressure P1, i.e., a negative pressure. The differential pressure between P1 and P2 can then provide the driving force for the fluid sample optimization device 3100 to close off to the atmosphere and atmospheric pressure, i.e., the fluid sample optimization device 3100 does not need to include a vent or path to the outside atmosphere, at least when in use.

[0178] The fluid sample optimization device 3100 further comprises a contaminant containment reservoir 3116 connected to an inlet 3112 and an outlet 3114, and having an air-permeable fluid resistor 3117 between the distal end of the contaminant containment reservoir 3116 and the outlet 3114. As further described herein, the contaminant containment reservoir 3116 can be formed to a size that holds a desired amount of fluid and may contain an absorbent material that at least partially fills the contaminant containment reservoir 3116. Also as further described herein, the contaminant containment reservoir 3116 may be configured as a series of chambers having meandering paths, multiple different cross-sectional areas and volumes, and / or may have furring grooves or baffles extending from its inner surface to minimize backflow, i.e., flow toward the inlet 3112.

[0179] The air-permeable blood resistor 3117 allows the first portion, first amount, or first constant amount of fluid such as blood to pass through the inlet 3112 and isolation chamber 3116 and be replaced by air when a pressure difference is applied between the inlet 3112 and the outlet 3114, i.e., when the negative pressure at the outlet 3114 is lower than the pressure at the inlet 3112. When the fluid comes into contact with the air-permeable fluid resistor 3117, the flow of fluid to the contaminant containment reservoir 3116 is at least partially stopped, and at least a portion of the fluid in the contaminant containment reservoir 3116 is retained.

[0180] The fluid sample optimization device 3100 further includes a sample path 3118 connected to an inlet 3112 and an outlet 3114. The sample path 3118 includes a movable plug or stopper 3119 provided on a seat adjacent to the inlet 3112 at the junction between the inlet and the sample path 3118. The seat may be part of the junction, and the movable plug 3119 may be friction-fitted to the seat. Alternatively, the seat may have an edge or flange, and the movable plug may abut against the edge or flange until it is displaced, deflected, or compressed by the pressure difference. As pressure P2 draws the first certain amount or initial portion of the fluid into the contaminant containment reservoir 3116, the movable plug 3119 is configured to resist, inhibit, limit or prevent the fluid from flowing into the sample path 3118 until the first certain amount or initial portion of the fluid enters the contaminant containment reservoir 3116, and / or to block the air-permeable fluid resistance body 3117.

[0181] As further described herein, the movable plug 3119 is configured such that the pressure difference across the movable plug 3119 increases after an initial fixed amount or initial portion of fluid enters the contaminant containment reservoir 3116 and / or blocks the air-permeable fluid resistance 3117. The higher pressure on the inlet side of the movable plug 3119 causes the movable plug 3119 to flex, at least on a portion of its outer surface, thereby moving or loosening the movable plug and displacing or moving it from its seat to the movable plug holder 20. The movable plug holder 3120 may be a cavity or chamber sized to receive the movable plug 3119 after displacement, or it may be an extending member extending from the inner wall of the sample path 3118. The movable plug holder 3120 is sized and configured so that fluid can flow without being restricted beyond the uniform cross-sectional area of ​​the sample path 3118. When the movable plug 3119 is removed from its seat, a second and / or subsequent amount or quantity of fluid can flow from the inlet 3112 through the sample path 3118 to the outlet 3114, also under the force of the pressure difference between P2 and P1.

[0182] The movable plugs described herein can be formed from any compressible or elastic material such as silicone, EPDM (ethylene propylene diene monomer), or PVC (polyvinyl chloride). The movable plugs may also be formed from a more rigid polymer such as polycarbonate, ABS, or acetal, having walls thin enough to form a seal and bend away from its seat. Furthermore, to reduce the friction required to slide the movable plug away from its seat when exposed to a pressure difference, a lubricant can be applied to the surface of the movable plug that seals the seat (or the material itself can be impregnated with a lubricating material). Any suitable material such as rubber, synthetic rubber, thermoplastic resin, or other elastic material can be used.

[0183] In some embodiments, the fluid sample optimization device 3110 may have an acceleration section between the inlet 3112 and the contaminant containment reservoir 3116, above or near the movable plug 3119, to increase the fluid velocity and thereby reduce the pressure of the fluid moving through it. This may help to preferentially guide the first portion or initial fixed amount of fluid from the inlet to the contaminant containment reservoir by reducing the pressure difference across the movable plug before the contaminant containment reservoir is fully filled.

[0184] Figures 32A to 32C show another embodiment of the fluid sample optimization device 3200 having three basic components. The fluid sample optimization device 3200 comprises: 1) a housing 3220 that houses, forms or defines an inlet 3202, an outlet 3204, a contaminant containment reservoir 3206, and a sample channel 3208; 2) an air-permeable fluid barrier 3212 located in or at the location of a first conduit (hereinafter referred to as the "first conduit") between the contaminant containment reservoir 3206 and the sample channel 3208 adjacent to the outlet 3204; and 3) a movable plug 3214 located in or at the location of a second conduit (hereinafter referred to as the "second conduit") between the contaminant containment reservoir 3206 adjacent to the inlet 3202 and the sample channel 3208.

[0185] The inlet 3202 may include an inlet port for connecting to a fluid source such as a patient needle and tubing. The inlet port itself may include a port connector such as a Luer lock member, threads, or a truncated conical opening for friction fitting. Similarly, the outlet 3204 may include an outlet port for connecting to a fluid collection device such as a Vacutainer®, syringe, pump, and associated tubing. The fluid collection device provides vacuum or negative pressure to the inlet 3202 at the outlet 3204. The inlet port itself may include a port connector such as a Luer lock member, threads, or a truncated conical opening for friction fitting. Alternatively, the inlet 3202 and / or outlet 3204 may be permanently connected using tubing by adhesive, heat welding, laser welding, etc.

[0186] The contaminant containment reservoir 3206 is fluidly connected to the inlet 3202 and may have a main reservoir or tank, and any conduits, channels, or paths between the main reservoir or tank and the inlet 3202. In some embodiments, the contaminant containment reservoir 3206 is formed as a single elongated chamber having an opening connected to the inlet 3202. The contaminant containment reservoir 3206 is fluidly isolated from the outlet 3204 or the sample channel 3208 by an air-permeable fluid barrier 3212 in a first conduit between the contaminant containment reservoir 3206 and the outlet 3204 or the sample channel 3208 adjacent to the outlet 3204. As will be further described below, the air-permeable fluid barrier seals by coming into contact with the initial portion of liquid flowing into the contaminant containment reservoir 3206 to replace the air in it through the air-permeable fluid barrier 3212.

[0187] The sample channel 3208 is fluidically connected to the outlet 3204, and the movable plug blocks, inhibits, restricts or seals the second conduit between the sample channel 3208 and the inlet 3202 or the contaminant containment reservoir 3206 adjacent to the inlet 3202, so that at least initially the sample channel 3208 is sealed from the inlet 3204 or not fluidly connected to the inlet 3204. Preferably, the sample channel 3208 is formed from or defined as a tube, channel or path having any size, cross-sectional shape or shape. As will be described in more detail below, when the pressure difference between the outlet 3204 and the inlet 3202 moves the movable plug away from the second conduit as the contaminant containment reservoir 3206 receives and contains the first volume of fluid, the sample channel 3208 may have a projection or protrusion above the movable plug 3214 for receiving and holding the movable plug 3214. Furthermore, the sample channel 3208 may include one or more blocks, recesses, side grooves, cavities, etc., for receiving the movable plug 3214.

[0188] In some embodiments, depending on the orientation of the apparatus 3200 as shown in the figure, the housing 3220 may include or be formed from a lower housing portion 3222 mated with an upper housing portion 3224. The lower housing portion 3222 may include, form or define a contaminant containment reservoir 3206, an inlet 3202, and first portions of the first and second conduits. The upper housing portion 3224 may include, form or define a sample channel 3208, an outlet 3204, and second portions of the first and second conduits. The lower housing portion 3222 and the upper housing portion 3224 may be mated with adhesive, thermal welding (ultrasonic, laser, friction, etc.), screws, bolts, or any other connecting mechanism or process to seal the fluid path.

[0189] As shown in Figure 2A, when a negative pressure difference is applied between the outlet 3204 and the inlet 3202, the sample channel 3208 is initially blocked or restricted by the movable plug 3214, so the initial certain amount of fluid, which is likely to contain contaminants, is "drawn" into the inlet 3202 by the negative pressure and moves to or toward the contaminant containment reservoir 3206. Then, because the movable plug 3214 is present in the second conduit to the sample channel 3208, the initial certain amount of fluid bypasses the movable plug 3214 and the sample channel 3208. The negative pressure difference continues to draw the fluid into the contaminant containment reservoir 3206 until all the air in the contaminant containment reservoir is replaced by the fluid and the fluid comes into contact with the air-permeable fluid barrier 3212 and is effectively sealed from the negative pressure.

[0190] Once the contaminant containment reservoir 3206 is filled with the first portion of the fluid and the air-permeable fluid barrier 3212 is sealed, the entire pressure difference between the inlet and outlet is applied to the movable plug 3214 (see Figure 2B), applying force to the movable plug 3214, causing it to deform, collapse inward, loosen, and displace it from the second conduit into the sample channel 3208, as shown in Figure 2C. Even after the movable plug has displaced from the second conduit into the sample channel 3208 and to the proximal end of the sample channel 3208, the movable plug 3214 may be maintained by a projection or protrusion on the inner surface of the sample channel 3208 above the second conduit, as shown in Figure 2C. The displacement of the movable plug 3214 allows a subsequent amount of fluid to enter the sample channel 3208, bypassing an initial fixed amount of fluid, and to be drawn out through the sample channel 3208 from the outlet 3204. A subsequent fixed amount of fluid enters the sample channel 3208 from the inlet 3202 and flows through the sample channel, displacing the movable plug away from the second conduit and maintaining it in that position. For example, to facilitate displacement from the second conduit, the movable plug 3214 may have a flat and circular bottom or a slightly curved bottom. The curvature may be concave or convex. In some embodiments, the bottom of the movable plug 3214 may be coated with a hydrophobic layer to facilitate the flow of the initial amount of fluid passing through the movable plug 3214, and also to facilitate the flow through the movable plug 3214 and through the sample channel 3208 when the movable plug 3214 is displaced.

[0191] Figures 33A to 33D illustrate another embodiment of the fluid sample optimization device 3300, having an inlet 3302 and an outlet 3304. The fluid sample optimization device 3300 further comprises a contaminant containment reservoir 3306, which is fluidically coupled to the inlet 3302 and connected to the outlet 3304 via a first conduit having an air-permeable fluid barrier 3312. The fluid sample optimization device 3300 further comprises a sample channel 3308, which is fluidically coupled to the outlet and connected to the inlet via a second conduit having a movable plug 3314 that seals the second conduit in its initial state. The outlet 3304 is fluidically coupled to a fluid sample collection device that provides vacuum or negative pressure at the outlet 3304. The inlet is fluidically coupled to a fluid source, such as a patient needle configured for patient venipuncture.

[0192] When a vacuum or negative pressure is activated at outlet 3304, a negative pressure difference is formed between outlet 3304 and inlet 3302. As shown in Figure 3B, the negative pressure from outlet 3304 draws fluid from inlet 3302 into contaminant containment reservoir 3306, where the fluid replaces air through the air-permeable membrane 3312, and the second conduit is blocked by the movable plug 3314, diverting the second conduit between inlet 3302 and outlet 3302.

[0193] Once the initial volume of fluid flows into and is contained in the contaminant containment reservoir 3306, the fluid sample collection device constricts or collapses the movable plug 3314 due to the vacuum or negative pressure still present at the outlet 3304, pulling the movable plug 3314 out of the second conduit as shown in Figure 3C, thus opening the second conduit. This allows the subsequent volume of fluid to be drawn into the inlet 3302, through the second conduit, into the sample channel 3308, and then out of the outlet 3304.

[0194] Figure 33D shows a movable plug 3314 having a post 3332 having a cross-sectional area smaller than that of the second conduit. The movable plug 3334 further has a hollow or tubular upper 3334 that is collapsible when negative pressure is applied to the side of the movable plug opposite the post 3332. The movable plug 3334 is configured to collapse when the pressure reaches a minimum threshold. Configuring the movable plug 3314 to collapse under pressure is possible by the length of the upper 3334, the thickness of the walls of the upper 3334, the elasticity of the material forming the movable plug 3314, or any combination thereof. The movable plug 3314 may further include a set of vertical ribs 3336 or projections, etc., to form a space or conduit between them to ensure fluid flow through it when the movable plug 3314 is displaced.

[0195] Figures 34A to 34C show various other embodiments of the movable plug 3402 or stopper, which are shown in the form of a ball or a rounded object (i.e., oval or egg-shaped), but can be any shape, such as cylindrical, bullet-shaped, disc-shaped, curved cap, or flat plug. The movable plug 3402 is held in place at the joint 3410 of the device by a seat 3404 or seat member until it is displaced by a pressure difference. The seat can be an elastic, semi-rigid, or rigid body. For example, the seat 3404 can be an O-ring for the movable plug with a circular or semi-circular cross-section (Figure 34A), a thin sheet with a hole or opening (Figure 34B), or a short tube (Figure 34C) that holds the movable plug 3402 in place until it is displaced. The seat 3404 may be held stationary between the upper and lower housing members of the device.

[0196] In some cases, structures such as shelves 3412 or lips in the housing or sample path or sample flow path, particularly as shown in Figures 34A and 34B, may cooperate with the seat member to keep the movable plug in place, i.e., to prevent reverse displacement toward the inlet or contaminant containment reservoir. The dimensions and shape of the movable plug, the seat member and / or the path in which the seat member and the movable plug are located may be designed to prevent the movable plug from being pulled too early, i.e., not while the sample is flowing into the contaminant containment reservoir, but when the contaminant containment reservoir is full and the pressure difference across the stopper becomes large, the movable plug may be pulled upward to allow the sample to flow through the path and over the seat member.

[0197] Figures 35A and 35B illustrate another embodiment of a disc-shaped movable plug 3502 or stopper having shoulders 3503, 3505 that hold the movable plug 3502 or stopper within the joint 3510 or in the path between the inlet and the sample path or sample collection channel until a pressure difference overcomes the force on the shoulders 3503, 3505 within the joint 3510, allowing the movable plug 3502 to be displaced and disengaged from its seat within the joint 3510. The path between the inlet and the sample path or sample collection path may have a small ring or one or more small projections or protrusions such as flanges that are engaged with the shoulders of the movable plug until such a fitting is disengaged by pressure.

[0198] Figure 35A shows a movable plug in the form of an integrated elastic disc having an enlarged shoulder portion 3503 that prevents the movable plug from moving in the path until a pressure difference is applied. Figure 35B shows a disc-shaped movable plug to which a thin flexible sheet 3505 that deforms when pushed upward is attached. In this case, the movable plug can be formed from a single piece of material, or from multiple pieces of material each having different hardness, elasticity, or flexibility. For example, the disc in Figure 35B may be formed from a rigid material that is hollow or non-hollow. A flexible sheet with a larger diameter may be formed from a flexible material that is tuned to flex when a pressure is applied to a range of the disc or sheet.

[0199] Although Figures 35A and 35B show a round disc shape, it is clear that the movable plug can have any cross-sectional shape or shape. For example, in some mounting configurations, the flexible sheet or extension ridge portion may have a rounded shape, and the upper disc or upper movable plug member may have one or more inclined surfaces such as a pyramidal, square, or conical shape. These inclined surfaces are configured to fit into corresponding receiving portions of similar shape within the sample path, using friction fitting or the like.

[0200] Figures 36A to 36C illustrate various further alternative embodiments of a movable plug or stopper consistent with the apparatus described herein. Figure 36A shows a thin, elastic disc or membrane-like movable plug having a circumferential O-ring member, such as a gasket. The circumferential O-ring member has a thickness or cross-section greater than the thickness of the disc and is positioned adjacent to or within the seat. In some implementations, the disc may be formed in the shape of an umbrella. When subjected to differential pressure (i.e., a pressure or positive pressure where the pressure on the lower side of the movable plug is relatively higher than the pressure on the upper side), the membrane deforms, and the entire movable plug is displaced from the seat. The membrane curves, for example, upward. In some embodiments, the movable plug may have only one or more circumferential contact portions or parts.

[0201] Figure 36B shows a configuration in which the movable plug 3602 is formed as a hollow elastic stopper that deforms easily under a threshold pressure in order to release the movable plug 3602 so that it is displaced from the seat. Figure 36C shows a configuration in which the movable plug 3602 is formed as a soft, compressible member such as a closed-cell structure and is press-fitted or friction-fitted into a joint or path. The movable plug 3602 may also be formed from an open-cell structure and is preferably covered by a fluid barrier.

[0202] One challenge of the apparatus described herein is to provide a location or component to which a stopper can move or connect so as not to obstruct the flow through the sample path or to a collection device downstream, such as a Vacutainer® bottle. In one embodiment, a screen or grid can be used or placed in the sample path downstream from the joint or path seat to receive the stopper after it has shifted away from the seat. Alternatively, the shape of the sample path can be configured to have a uniform cross-sectional area along the sample path, and its shape can be modified so that the stopper cannot move in a direction traversing the longitudinal direction of the sample path.

[0203] Figures 37A and 37B show modified configurations of the junction to the sample path, where a stopper 3702 or movable plug, which is not permanently attached to any wall or other structure of the apparatus, can move to a position where it can flow through another path defined by the partition 3710 in the sample path or sample flow channel. In some embodiments, the housing of the apparatus can be formed to allow the stopper 3702 or movable plug to move freely from a receiving portion such as a seat in the junction between the inlet and the sample path, a recess formed on the inner surface of the sample path, a cavity, a pin or other protrusion. Preferably, as a result of the displacement of the stopper or movable plug, the path through the sample path is configured to allow a free flow of fluid from the inlet through the sample path, i.e., an unobstructed or unrestricted flow.

[0204] Figure 38A is a side cross-sectional view, Figure 38B is a front-to-back cross-sectional view, and Figure 38C is an exploded perspective view of another embodiment of the fluid sample optimization device 3800. The fluid sample optimization device 3800 comprises: 1) a housing 3820 that houses, forms, or defines an inlet 3802, an outlet 3804, a contaminant containment reservoir 3806, and a sample channel 3808; 2) an air-permeable fluid barrier 3812 located in or within a first conduit between the contaminant containment reservoir 3806 adjacent to the outlet 3804 and the sample channel 3808; and 3) a movable plug 3814 located in or within a second conduit between the contaminant containment reservoir 3806 adjacent to the inlet 3802 and the sample channel 3808.

[0205] The inlet 3802 may include an inlet port for connecting to a fluid source such as a patient needle and tubing. The inlet port itself may include a port connector such as a Luer lock member, threads, or a truncated conical opening for friction fitting. Similarly, the outlet 3804 may include an outlet port for connecting to a fluid collection device such as a Vacutainer®, syringe, pump, and associated tubing. The fluid collection device provides vacuum or negative pressure to the inlet 3802 at the outlet 3804. The inlet port itself may include a port connector such as a Luer lock member, threads, or a truncated conical opening for friction fitting. Alternatively, the inlet 3802 and / or outlet 3804 may be permanently connected using tubing by adhesive, heat welding, laser welding, etc.

[0206] The contaminant containment reservoir 3806 is fluidly connected to the inlet 3802 and may have a main reservoir and associated conduits, channels or paths between the main reservoir and the inlet 3802. In some embodiments, the contaminant containment reservoir 3806 is formed as a single elongated chamber having an opening connected to the inlet 3802. The contaminant containment reservoir 3806 is fluidly isolated from the outlet 3804 or the sample channel 3808 by an air-permeable fluid barrier 3812 in a first conduit between the contaminant containment reservoir 3806 and the outlet 3804 or a sample channel 3808 adjacent to the outlet 3804. As will be further described below, the air-permeable fluid barrier seals by coming into contact with the initial portion of liquid flowing into the contaminant containment reservoir 3806 to replace the air in it through the air-permeable fluid barrier 3812.

[0207] The sample channel 3808 is fluidically connected to the outlet 3804, and the movable plug blocks, inhibits, restricts or seals the second conduit between the sample channel 3808 and the inlet 3802 or the contaminant containment reservoir 3806 adjacent to the inlet 3802, so that at least initially the sample channel 3208 is sealed from the inlet 3804 or not fluidly connected to the inlet 3204. Preferably, the sample channel 3808 is formed from or defined as a tube, channel or path having any size, cross-sectional shape or shape. As will be described in more detail below, when the pressure difference between the outlet 3804 and the inlet 3802 moves the movable plug away from the second conduit as the contaminant containment reservoir 3806 receives and contains the first volume of fluid, the sample channel 3808 may have a projection or protrusion above the movable plug 3814 for receiving and holding the movable plug 3814. Furthermore, the sample channel 3808 may include one or more blocks, recesses, side grooves, cavities, etc., for receiving the movable plug 3814.

[0208] In some embodiments, depending on the orientation of the apparatus 3800 as shown in the figure, the housing 3820 may include or be formed from a lower housing portion 3822 mated with an upper housing portion 3824. The lower housing portion 3822 may include, form or define a contaminant containment reservoir 3806, an inlet 3802, and first portions of the first and second conduits. The upper housing portion 3824 may include, form or define a sample channel 3808, an outlet 3804, and second portions of the first and second conduits. The lower housing portion 3822 and the upper housing portion 3824 may be mated with adhesive, thermal welding (ultrasonic, laser, friction, etc.), screws, bolts, or any other connecting mechanism or process to seal the fluid path.

[0209] Similar to the apparatus shown in Figures 32A and 32B, when a negative pressure difference is applied between the outlet 3804 and the inlet 3802, the sample channel 3808 is initially blocked or restricted by the movable plug 3814, so the initial certain amount of fluid, which is likely to contain contaminants, is "drawn" into the inlet 3802 by the negative pressure and moves towards or into the contaminant containment reservoir 3806. Then, because the movable plug 3814 is present in the second conduit to the sample channel 3808, the initial certain amount of fluid bypasses the movable plug 3814 and the sample channel 3808. The negative pressure difference continues to draw the fluid into the contaminant containment reservoir 3806 until all the air in the contaminant containment reservoir is replaced by the fluid and the fluid comes into contact with the air-permeable fluid barrier 3812 and is effectively sealed from the negative pressure.

[0210] Once the contaminant containment reservoir 3806 is filled with the first portion of the fluid and the air-permeable fluid barrier 3812 is sealed, the entire pressure difference between the inlet and outlet is applied to the movable plug 3814 (as shown in Figures 32A-32C), applying force to the movable plug 3814, causing it to deform, collapse inward, loosen, and displace the movable plug from the second conduit to the sample channel 3808. Even after the movable plug has displaced from the second conduit to the sample channel 3808 and to the proximal end of the sample channel 3808, the movable plug 3814 may maintain its position by projections or protrusions on the inner surface of the sample channel 3808 above the second conduit. The displacement of the movable plug 3814 allows a subsequent amount of fluid to enter the sample channel 3808, bypassing an initial amount of fluid, and to be drawn out through the sample channel 3208 to the outlet 3804.

[0211] A subsequent fixed amount of fluid enters the sample channel 3808 from the inlet 3802 and flows through the sample channel, displacing the movable plug away from the second conduit and maintaining it in that position. For example, to facilitate displacement from the second conduit, the movable plug 3814 may have a flat and circular bottom or a slightly curved bottom. The curve may be concave or convex. In some embodiments, the bottom of the movable plug 3814 may be coated with a hydrophobic layer to facilitate the flow of the initial amount of fluid passing through the movable plug 3814, and also to facilitate the flow through the movable plug 3814 and through the sample channel 3808 when the movable plug 3814 is displaced.

[0212] Although various embodiments have been described in detail above, other modifications are also possible. Other embodiments may fall within the scope of the following claims.

Claims

1. A fluid sample optimization device for optimizing a fluid sample collected from a fluid source by a fluid collection device, wherein the initial portion of the fluid sample potentially contains contaminants, and the fluid sample optimization device, An inlet configured to be connected to the aforementioned fluid source, An outlet configured to be connected to the aforementioned fluid collection device, A sample path connected between the aforementioned inlet and outlet, A contaminant containment reservoir connected between the inlet and the outlet, having an air-permeable fluid resistor adjacent to the outlet, configured such that when a pressure difference is applied between the inlet and the outlet, the air in the contaminant containment reservoir is replaced through the air-permeable fluid resistor and the outlet by receiving the first portion of the fluid sample from the fluid source, thereby receiving the first portion of the fluid sample and containing the contaminant, and configured such that when a subsequent pressure difference is applied between the inlet and the outlet, the next portion of the fluid sample is transported from the inlet to the outlet via the sample path, A movable plug provided between the inlet and the sample path, which, by being displaced by the subsequent pressure difference, allows the subsequent portion of the fluid sample to be transported through the sample path, A fluid sample optimization device equipped with the following features.

2. The fluid sample optimization apparatus according to claim 1, further comprising a housing that accommodates and defines one or more of the inlet, outlet, sample path, and contaminant containment reservoir.

3. The fluid sample optimization apparatus according to claim 1, wherein the air-permeable fluid resistor includes a material that seals by contacting the first portion of the fluid sample.

4. The fluid sample optimization apparatus according to claim 1, wherein the contaminant containment reservoir has a main tank and a flow path connecting the main tank and the inlet.

5. The fluid sample optimization apparatus according to claim 1, wherein the pressure difference is generated by the vacuum pressure from the fluid collection device.

6. A fluid sample optimization device for optimizing a fluid sample collected from a fluid source by a fluid collection device, wherein the initial portion of the fluid sample potentially contains contaminants, and the fluid sample optimization device, An inlet configured to be connected to the aforementioned fluid source, An outlet configured to be connected to the aforementioned fluid collection device, A sample path connected between the inlet and the outlet, the sample path having a movable plug configured to prevent at least a portion of the first part of the fluid sample and the contaminants from entering the sample path, A contaminant containment reservoir connected between the inlet and the outlet, having an air-permeable fluid resistor adjacent to the outlet, configured such that when a pressure difference is applied between the inlet and the outlet, the air in the contaminant containment reservoir is replaced through the air-permeable fluid resistor and the outlet by receiving the first portion of the fluid sample from the fluid source, thereby containing the contaminant, and when a subsequent pressure difference is applied between the inlet and the outlet, the next portion of the fluid sample is transported from the inlet to the outlet by the sample path, displacing the movable plug. A fluid sample optimization device equipped with the following features.

7. The fluid sample optimization apparatus according to claim 6, further comprising a housing that accommodates and defines one or more of the inlet, outlet, sample path, and contaminant containment reservoir.

8. The fluid sample optimization apparatus according to claim 6, wherein the air-permeable fluid resistor includes a material that seals by contacting the first portion of the fluid sample.

9. The fluid sample optimization apparatus according to claim 6, wherein the contaminant containment reservoir has a meandering path.

10. The fluid sample optimization apparatus according to claim 6, wherein the pressure difference is generated by the vacuum pressure from the fluid collection device.

11. The fluid sample optimization apparatus according to claim 6, wherein the movable plug frictionally fits into a part of the sample path.

12. The fluid sample optimization apparatus according to claim 11, wherein the portion of the sample path into which the movable plug frictionally fits is a seat portion.

13. The fluid sample optimization apparatus according to claim 12, wherein the seat portion includes an elastic O-ring.

14. A fluid sample optimization apparatus for optimizing a fluid sample, wherein the initial portion of the fluid sample potentially contains contaminants, and the fluid sample optimization apparatus, The entrance and Exit and A contaminant containment reservoir connected between the inlet and the outlet, having an air-permeable fluid resistor adjacent to the outlet, wherein when a pressure difference is applied between the inlet and the outlet, the air in the contaminant containment reservoir is replaced through the air-permeable fluid resistor and the outlet by receiving the first portion of the fluid sample, thereby containing the contaminant; A sample path connected between the inlet and the outlet, the sample path having a movable plug configured to prevent at least a portion of the initial part of the fluid sample and the contaminant from entering the sample path while the contaminant containment reservoir receives the initial part of the fluid sample and contains the contaminant, A fluid sample optimization device wherein, when the following pressure difference is applied between the inlet and the outlet, the following portion of the fluid sample is transported from the inlet to the outlet via the sample path.

15. The fluid sample optimization apparatus according to claim 14, wherein the movable plug is initially fixed by an elastic seat at a position close to the inlet of the sample path.

16. The fluid sample optimization apparatus according to claim 14, further comprising a housing that accommodates and defines one or more of the inlet, outlet, sample path, and contaminant containment reservoir.

17. The fluid sample optimization apparatus according to claim 14, wherein the air-permeable fluid resistor includes a material that seals by contacting the first portion of the fluid sample.

18. The fluid sample optimization apparatus according to claim 14, wherein the contaminant containment reservoir has a main tank that is fluidly connected to the inlet by a conduit.

19. The fluid sample optimization apparatus according to claim 15, wherein the movable plug frictionally fits into a part of the sample path.

20. The fluid sample optimization apparatus according to claim 19, wherein the movable plug is formed of an elastic material.

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