Blood aspiration device for multi-site, paired blood aspiration and method of using the same

Abstract

Provided herein is a blood aspiration device comprising a housing defining a housing lumen and a proximal internal volume relative to the housing lumen, a coupling device, a catheter tube movably received within the housing, and a forward member movable relative to the housing and moving the catheter tube between a first position in which the catheter tube is positioned within the housing and a second position in which the distal end of the catheter tube is positioned beyond the distal end of the housing. A first port is provided in the housing in fluid communication with the housing lumen, and a second port is provided in fluid communication with the catheter tube from the housing to the proximal end. A seal is positioned in the housing lumen at the proximal end relative to the first port, and the catheter tube is proximal to the seal in the first position and extends through the seal in the second position.

Description

Technical Field

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[0001] Reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 461,923, filed April 26, 2023, entitled "Blood Aspiration Device and Method of Use Thereof for Multi-Site, Paired Blood Aspiration", the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] Background of the Invention Field of the Invention The present disclosure generally relates to blood aspiration devices for use with intravenous (IV) catheters, and more particularly to blood aspiration devices that enable multi-site, paired blood aspiration via indwelling IV catheters.

[0003] Description of Related Art Vascular access devices (VADs) are used in the medical field to access a patient's peripheral blood vessels for purposes of infusion therapy and / or blood aspiration. Exemplary types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central venous catheters (PICCs), central venous catheters (CVCs), and midline catheters. VADs may be indwelling for short (several days), intermediate (several weeks), or long (months to years) periods.

[0004] One exemplary use of a VAD as described above is to obtain a blood sample for the purpose of performing a blood culture. A blood culture examines bacteria and other microorganisms in the blood for the purpose of detecting bacteremia (i.e., blood infection). When performing such a blood culture, the detection sensitivity of bacteremia may be reduced in a single blood culture, and it is also difficult to distinguish clinically important pathogens from contaminants. Therefore, it is recognized that obtaining multiple blood samples is desirable. Thus, paired blood cultures are preferred over single blood cultures, as paired blood cultures provide a higher microbiological yield and improve the detection sensitivity of pathogens and the time to positivity (TTP).

[0005] While it is recognized that paired blood cultures are preferable to single blood cultures, paired blood cultures require the collection of two different blood samples from different sites or locations within the vascular system. Current products on the market allow practitioners to collect blood for culture from one site via an indwelling VAD. However, collecting blood from another location currently requires the practitioner to puncture a vessel at a different location to obtain the second blood sample. This need to puncture a vessel at a different location leads to increased patient discomfort and prolonged procedure time.

[0006] Therefore, there is a need to provide a blood aspiration device that can be used with an indwelling VAD, allows the operator to aspirate blood from multiple sites via an indwelling IV catheter, and does not require puncture of additional drains. [Overview of the project]

[0007] Provided herein is a blood aspiration device for use with a catheter assembly. The blood aspiration device includes a housing having a proximal end and a terminal end, the housing defining a housing lumen at the terminal end and an internal volume at the proximal end relative to the housing lumen. The blood aspiration device further includes a coupling device positioned at the terminal end of the housing and configured to connect (mate) with the catheter assembly, a catheter tube movably housed within the housing, and a forwarding member movably connected to the housing and configured to move relative to the housing to move the catheter tube between a first position in which the catheter tube is positioned within the housing and a second position in which the terminal end of the catheter tube is positioned beyond the terminal end of the housing. The blood collection device further includes a first port provided at the terminal end of the housing and in fluid communication with the housing lumen, a second port provided from the housing to the proximal end and in fluid communication with the catheter tube, and a fluid-blocking seal located within the housing lumen and proximal to the first port, wherein the terminal end of the catheter tube is proximal to the fluid-blocking seal in the first position and extends through the fluid-blocking seal in the second position.

[0008] In some embodiments, the housing lumen includes a main channel extending from the coupling device to the internal volume section and a secondary channel extending from the main channel to the first port, the secondary channel being coupled to the main channel at the T-junction.

[0009] In some embodiments, the fluid flow prevention seal is positioned within the main channel at the base end relative to the T-junction.

[0010] In some embodiments, the fluid flow prevention seal is a split septum, and when the catheter tube is in a first position, the end of the catheter tube is located proximal to the split septum, so that the split septum is closed and prevents fluid flow into the internal volume and into the catheter tube and second port, and when the catheter tube is in a second position, the catheter tube extends through the split septum.

[0011] In some embodiments, the coupling device is a male Luer connector, which includes an elongated member and a rotating collar, the rotating collar being configured to engage with the connector of the catheter assembly by screwing.

[0012] In some embodiments, the coupling device is a lock that includes a blunt cannula and a pair of locking arms for coupling to the connector of a catheter assembly.

[0013] In some embodiments, the advancing member is a telescopic cylinder having a proximal end and a distal end, the distal end of the telescopic cylinder positioned within an internal volume and engaging with the proximal end of the catheter tube, and the telescopic cylinder is configured to move relative to the housing to move the catheter tube between a first position and a second position.

[0014] In some embodiments, the second port is connected to the proximal end of a telescopic cylinder, which includes a fluid path through which a catheter tube is fluidly connected to the second port.

[0015] In some embodiments, the forward member includes a first portion movably positioned along the upper surface of the housing and a second portion movably positioned within an internal volume, wherein the forward member is seated in and movable through a slot formed in the upper surface of the housing, and the proximal end of a catheter tube is connected to the second portion.

[0016] In some embodiments, the blood aspiration device includes a secondary catheter having a proximal end and a terminal end, the terminal end of the secondary catheter being connected to a second portion extending from there to the proximal end and exiting from the proximal end of the housing, and a second port being connected to the proximal end of the secondary catheter and fluidly connected to a catheter tube via the secondary catheter.

[0017] In some embodiments, each of the first and second ports is a vacuum tenor port including an outer collar and a needle positioned within the circumference of the outer collar and fixed to the housing, the needle further including a needle lumen that is in fluid communication with the housing lumen and a needle tip positioned to puncture the seal of the vacuum tenor connected to the vacuum tenor port, thereby creating fluid communication between the inner chamber of the vacuum tenor and the needle lumen.

[0018] In some embodiments, each of the first and second ports is a female Luer connector configured to connect to a VacuTenna via an intermediate Luer lock access device.

[0019] In some embodiments, each of the first and second ports includes a needleless connector attached to a female Luer connector, the needleless connector further includes a septum configured therein to isolate and seal the female Luer connector, and the needleless connector is configured to connect to a Vacutener via an intermediate Luer lock access device.

[0020] In some embodiments, the needleless connector is integrally formed with the female Luer connector or solvent-bonded to the female Luer connector.

[0021] Also provided herein is a method for obtaining a pair of blood samples, comprising connecting a blood aspiration device to a catheter assembly including an indwelling catheter, the blood aspiration device comprising a housing having a proximal end and a terminal end, the housing defining a housing lumen at the terminal end and a proximal internal volume relative to the housing lumen, the catheter tube being movably received within the housing, and a forward member being movably connected to the housing and configured to move relative to the housing, the forward member comprising a first port provided at the terminal end of the housing and in fluid communication with the housing lumen, a second port provided at the proximal end of the housing and in fluid communication with the catheter tube, and a proximal fluid-blocking seal located within the housing lumen and relative to the first port, wherein the terminal end of the catheter tube is at the proximal end relative to the fluid-blocking seal in the first position and extends through the fluid-blocking seal in the second position. The method also includes connecting a first vacuum tanker to a first port while the catheter tube is in a first position, with a first blood sample being aspirated into the first vacuum tanker upon connection to the first port, and closing a fluid flow prevention seal while the catheter tube is in the first position to prevent blood from flowing into the catheter tube and into the second port. The method further includes acting an advancement member to move the catheter tube to a second position, connecting a second vacuum tanker to a second port while the catheter tube is in the second position, with a second blood sample being aspirated into the second vacuum tanker upon connection to the second port. The first blood sample is taken from a first location in the patient's vascular system adjacent to the terminal end of the indwelling catheter, and the second blood sample is taken from a second location in the patient's vascular system adjacent to the terminal end of the catheter tube.

[0022] In some embodiments, connecting the blood aspiration device to the catheter assembly involves engaging a rotatable collar of the blood aspiration device's coupling mechanism with the connector of the catheter assembly.

[0023] In some embodiments, acting the forward member involves moving a telescopic cylinder to its terminal end within the housing to move the catheter tube to a second position, the second port of which is connected to the proximal end of the telescopic cylinder.

[0024] In some embodiments, acting the forward member involves acting a first portion having the form of a tab along the upper surface of the housing toward its end, the first portion being coupled with a second portion movably positioned within an internal volume, and the acting of the first member causes the forward member to move within a slot formed in the upper surface of the housing.

[0025] In some embodiments, connecting a first vacuum tener to a first port and a second vacuum tener to a second port each involves connecting each vacuum tener to a vacuum tener port having an outer collar and a needle positioned within the circumference of the outer collar, the needle having a needle lumen. When connecting each vacuum tener to a vacuum tener port, the needle punctures the seal of the vacuum tener, creating fluid communication between the inner chamber of the vacuum tener and the needle lumen, and further with the housing lumen.

[0026] In some embodiments, connecting a first vacuum tener to a first port and a second vacuum tener to a second port respectively involves connecting a Luer lock access device to the female Luer connector of each port or to the female Luer connector of a needleless connector attached to each port, the Luer lock access device having a male Luer connector and a needle including a needle lumen, and connecting each vacuum tener to the Luer lock access device. When connecting each vacuum tener to the Luer lock access device, the needle punctures the seal of the vacuum tener, creating fluid communication between the inner chamber of the vacuum tener and the needle lumen, and further creating fluid communication between the inner chamber and the housing lumen.

Brief Description of the Drawings

[0027] [Figure 1] FIG. 1 is a side view of a system including a catheter assembly and an associated blood suction device that can be used therewith, according to the non-limiting embodiments described herein. [Figure 2] FIG. 2 is a perspective view of the blood suction device included in the system of FIG. 1. [Figure 3] FIG. 3 is a partial cross-sectional view of the system of FIG. 1 taken along line 3-3, according to the embodiment described herein. [Figure 4] FIG. 4 shows the system of FIG. 1 with the blood suction device in a first configuration and a Vacutainer attached to the first port. [Figure 5] FIG. 5 shows the system of FIG. 1 with the blood suction device in a second configuration and a Vacutainer attached to the second port. [Figure 6] FIG. 6 is a side view of a system including a catheter assembly and an associated blood suction device that can be used therewith, according to another non-limiting embodiment described herein. [Figure 7] FIG. 7 is a side view of a system including a catheter assembly and an associated blood suction device that can be used therewith, according to another non-limiting embodiment described herein. [Figure 8] FIG. 8 is a side view of a system including a catheter assembly and an associated blood collection device that can be used therewith, according to the non-limiting embodiments described herein. [Figure 9] FIG. 9 is a cross-sectional view of the blood suction device included in the system of FIG. 8 taken along line 3-3, according to the embodiment described herein. [Figure 10] FIG. 10 shows the system of FIG. 8 with the blood suction device in a first configuration and a Vacutainer attached to the first port. [Figure 11] FIG. 11 shows the system of FIG. 8 with the blood suction device in a second configuration and a Vacutainer attached to the second port. [Modes for carrying out the invention]

[0028] Description of the Invention The following description is provided to enable those skilled in the art to manufacture and use the described embodiments envisioned for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. All such modifications, equivalents, variations, and alternatives are intended to be within the spirit and scope of the invention.

[0029] For the purposes described below, “up,” “down,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “side,” “vertical,” and their derivatives shall be used in relation to the orientation of the invention as described herein in the drawings. However, it should be understood that the invention may take various alternative modifications unless expressly otherwise specified. It should also be understood that the particular devices shown in the accompanying drawings and described below are merely embodiments of the invention. Therefore, the specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0030] As used in this specification, the terms “proximal end” and “terminal end” refer to the direction closer to the user who brings the device into contact with the patient and the direction away from the user, respectively. Therefore, for example, the end of the device that first comes into contact with the patient's body is the terminal end, and the end of the device operated by the user on the opposite side is the proximal end.

[0031] Terms such as "first," "second," etc., do not refer to a specific order or chronological sequence, but rather to different conditions, characteristics, or elements.

[0032] In this context, "at least one" is synonymous with "one or more." For example, the expression "at least one of A, B, and C" means one of A, B, or C, or any combination of two or more of A, B, or C. For instance, "at least one of A, B, and C" includes one or more A's, one or more B's, one or more C's, one or more A's and one or more B's, one or more A's and one or more C's, one or more B's and one or more C's, or one or more of all of A, B, and C.

[0033] Referring to Figures 1-5, a non-limiting embodiment 10 of a system including a catheter assembly 12 and a blood aspiration device 14 is shown. The catheter assembly 12 includes a catheter hub 16 and a non-integrated extension set 18 including a catheter connector 20 and (optionally) an extension tube 22. The catheter hub 16 receives a catheter 24 and connects to the catheter connector 20. In one embodiment, the catheter hub 16 is the AccuCath® catheter system, commercially available from Becton Dickinson. The catheter 24 can be used as a peripheral venous catheter, a midline catheter, or a peripherally inserted central venous catheter, and the catheter 24 may be formed from any suitable material known to those skilled in the art and may have any useful length.

[0034] The catheter connector 20 is configured to be positioned so as to be in contact with the patient's skin surface at or near the insertion site of the catheter 24. Although not shown, it is recognized that the catheter connector 20 may include stabilizing features (e.g., wings) to help hold the catheter connector 20 in place on the patient's skin. The catheter connector 20 includes a proximal port having a coupler 26 and a terminal port having a terminal coupler 28, defining at least one lumen 30 extending through or fluidly communicating with the couplers 26 and 28. The proximal coupler 26 and / or terminal coupler 28 may be, for example, male or female Luer locks and / or other suitable couplers, and in the non-limiting embodiments shown in Figures 1-5, the proximal coupler 26 is shown as a female Luer connector and the terminal coupler 28 is shown as a male Luer connector. The proximal coupler 26 may be physically and fluidly connected to the blood aspiration device 14 to enable multi-site blood aspiration as described later. The terminal connector 28 can be physically and fluidly connected to the catheter hub 16, and the lumen 30 of the catheter connector 20 is configured to be in fluid communication with the catheter 24, at least selectively.

[0035] The catheter connector 20 may include and / or define one or more additional ports, such as a side port 32. In some embodiments, the side port 32 may be located distal to the proximal connector 26 and proximal to the terminal connector 28. Positioning the side port 32 between the connectors 26 and 28 along the length of the catheter connector 20 can facilitate irrigation and / or fluid transfer through the side port 32. The side port 32 defines a lumen 34 that is in fluid communication with a lumen 30 between the terminal connector 28 and the proximal connector 26. That is, the catheter connector 20 may include and / or define a first lumen 30 between the terminal connector 28 and the proximal connector 26 and a second lumen 34 defined by the side port 32. Thus, the side port 32 can provide access to the lumen 30 between the terminal connector 28 and the proximal connector 26, which can provide access to the catheter hub 12 (and catheter 24) connected to the terminal connector 28.

[0036] In some embodiments, the arrangement of the side port 32 may be such that the catheter connector 20 forms, for example, a Y-connector or a T-connector. More specifically, the side port 32 may be positioned substantially perpendicular (e.g., about 90 degrees) to the lumen 30 of the catheter connector 20 and in the vicinity of or adjacent to the proximal connector 26. In non-limiting embodiments, the side port 32 extends from the catheter connector 20 at an angle other than 90 degrees to the lumen 30 between the terminal connector 28 and the proximal connector 26 (for example, the side port 32 may extend at an angle of, for example, 15 to 165 degrees, including all values ​​and partial ranges in between).

[0037] As noted above, the extension set 18 may include an extension tube 22 connected to the side port 32 and in fluid communication with the lumen 34 of the side port 32. In some embodiments, the side port 32 and / or the extension tube 22 may be and / or form at least a part thereof a fluid line that can be used for supplying, removing, cleaning, etc. For example, in such embodiments, a configuration in which the side port 32 is positioned adjacent to the proximal connector 26 allows for cleaning of the space between the proximal connector 26, the valve(s) contained therein, and / or the valve(s) and the inner surface of the catheter connector 20.

[0038] Referring to Figures 1-5, the blood aspiration device 14 is shown to include a housing 36 having a proximal end 38 and a distal end 40, and a forward member 42 slidably housed within the housing 36 (i.e., within the internal volume 44 of the housing 36). In the illustrated embodiment, the forward member 42 is provided as one or more telescopic cylinders 42a in a telescopic relationship with the housing 36, so that the forward member 42 may be slidably received completely or almost completely within the internal volume 44 of the housing 36. The forward member 42 also includes a proximal end 46 and a distal end 48, and in a non-limiting embodiment, the forward member 42 may have a variable diameter along its length. For example, the distal end 48 of the forward member 42 may have a larger diameter than the rest of the forward member 42 so that when the forward member 42 is retracted, one or more features on the housing 36 interact with the enlarged portion of the forward member 42 to prevent the forward member 42 from being completely withdrawn from the housing 36. As another example, the terminal end 48 of the forward member 42 may have a smaller diameter than the rest of the forward member 42 to hold the forward member 42 in place during the blood aspiration forward state, freeing the operator's hands to manipulate additional components (e.g., a vacuum tube).

[0039] The blood aspiration device 14 further comprises a catheter tube 50 having a proximal end 52 and a distal end 54. The catheter tube 50 is received within the internal volume 44 of the housing 36 and may be advanced and / or retracted relative to the housing 36 by the displacement of a forward member 42 relative to the housing 36. In some embodiments, the catheter tube 50 may be coupled to the forward member 42 via a joint 56 provided at the distal end 48 of the forward member 42, such that the displacement of the forward member 42 relative to the housing 36 causes a corresponding displacement of the catheter tube 50. In non-limiting embodiments, the catheter tube 50 may be advanced from a first position in which the distal end 54 of the catheter tube 50 is inside the housing 36, as shown in Figure 4, to a second position in which the distal end 54 of the catheter tube 50 is positioned at the distal end of the housing 36 and also at the distal end of the catheter 24, as shown in Figure 5, as will be described in more detail later.

[0040] As shown in Figures 1-5, a coupling device 58 may be provided at the terminal end 40 of the housing 36, thereby connecting the blood aspiration device 14 to the catheter assembly 12, i.e., to the connector 20. The coupling device 58 is exemplified as a (mate) male Luer connector that connects to the female Luer connector of the proximal coupler 26 on the connector 20, and the male Luer connector of the coupling device 58 has an elongated member 60 surrounded by a rotating collar 62. The rotating collar 62 may be rotated to screw and engage the male Luer connector with the female Luer connector of the proximal coupler 26. However, it is understood that alternative embodiments of the blood aspiration device 14 may include another type of coupling device 58, including Luer connections, clips, blunt plastic cannulas, blunt metal cannulas, hybrid Luer (e.g., with cannula), friction mating, etc., to secure the blood aspiration device 14 to the catheter assembly 12.

[0041] To make it clear that Figure 4 shows the blood aspiration device 14 in a first state, where the catheter tube 50 is in a first position housed within the housing 36, and the advance member 42 is in a first position extending from the housing 36 to its proximal end. The advance member 42 may then be advanced terminally relative to the housing 36 by the user applying a terminal force to the advance member 42. As described above, the advance member 42 is connected to and / or interacts with the catheter tube 50 (e.g., by a fitting 56), and when the advance member 42 is advanced terminally to a second position as shown in Figure 5, the catheter tube 50 is moved to the second position, and the terminal end 54 of the catheter tube 50 may extend beyond the housing 36 and also beyond the terminal tip 63 of the catheter 24.

[0042] According to one embodiment, the blood aspiration device 14 includes two ports 64, 66 thereon, providing connection of multiple blood collection devices to the blood aspiration device 14, enabling the collection of two separate blood samples (i.e., paired blood aspirations) via the device 14. In one embodiment, as shown in Figures 1-5, the ports 64, 66 are configured as vacuum tenor ports, on which vacuum tenors 68, 70 used for blood sample collection are to be received, with the first vacuum tenor port 64 provided for receiving the first vacuum tenor 68 and the second vacuum tenor port 66 provided for receiving the second vacuum tenor 70.

[0043] The first vacuum tenor port 64 is provided in the housing 36 adjacent to its terminal end 40. According to one embodiment, the first vacuum tenor port 64 may be provided on the upper surface 72 of the housing 36 to provide easy connection of the first vacuum tenor 68 thereto. The first vacuum tenor port 64 includes an outer collar 74 positioned on the upper surface 72 of the housing 36 and extending outward therefrom. In some embodiments, the inner surface of the outer collar 74 may be configured as a threaded inner surface. The first vacuum tenor port 64 also includes a hollow needle or cannula 76 partially positioned within the circumference of the outer collar 74. The needle 76 is positioned such that its tip 78 extends to approximately the upper edge of the outer collar 74, from which the needle 76 extends downward through a bottom opening 80 of the outer collar 74 and is secured to the housing 36. Within the housing 36, the lumen 82 of the needle 76 (hereinafter referred to as "needle lumen 82") is connected to a lumen 84 (hereinafter referred to as "housing lumen 84") defined within the terminal end 40 of the housing 36. The housing lumen 84 includes a main channel 86 and a secondary channel 88. The main channel 86 extends longitudinally between the coupling device 58 (and through the coupling device 58 to fluidly communicate with the lumen 30 of the catheter connector 20 when the blood aspiration device 14 is connected to the catheter connector 20) and the internal volume section 44. The secondary channel 88 is oriented perpendicular to the main channel 86 and connects with it at the T-junction 90. The needle lumen 82 is connected to the secondary channel 88 of the housing lumen 84.

[0044] According to embodiments of the present disclosure, the fluid flow prevention seal 92 may be located within the housing lumen 84 at a position that may prevent fluid (i.e., blood) from flowing from the housing lumen 84 into the internal volume portion 44 of the housing 36, i.e., at a position proximal to the T-junction 90. In some embodiments, the fluid flow prevention seal 92 is formed as a split septum (hereinafter referred to as "split septum 92") located within the housing lumen 84 at a proximal end to the T-junction 90. In one embodiment, the split septum 92 may be formed of a flexible elastomer material and include a slit 94 formed therein through which the catheter tube 50 may pass as it is advanced from a first position to a second position. In some embodiments, the slit 94 is configured to stretch as the catheter tube 50 passes through it. Based on the size of the slit 94, a seal is formed between the septum 92 and the catheter tube 50 as the catheter tube 50 advances through the slit 94 when the catheter tube 50 is moved to the second position.

[0045] When the first vacuum tener 68 is attached to the first vacuum tener port 64, the front portion of the first vacuum tener 68—which may include a punctureable seal or cover 96—is positioned within the outer collar 74 (in some embodiments, it engages with the outer collar 74 in a screw-in manner) and pushed down onto the needle 76 so that the tip 78 of the needle 76 punctures the seal / cover 96. Once the needle 76 is inserted into the first vacuum tener 68, the needle lumen 82 is placed in fluid communication with the internal volume of the first vacuum tener 68, and the vacuum tener 68 is also in fluid communication with the housing lumen 84, and therefore in fluid communication with the catheter 24 (via the catheter connector 20). Thus, a blood sample may be collected in the first vacuum tener 68 by connecting it to the first vacuum tener port 64 of the blood aspiration device 14.

[0046] A second vacuum tenor port 66 is provided on the blood aspiration device 14 at the proximal end from the housing 36. According to one embodiment, the second vacuum tenor port 66 is positioned and connected to the proximal end 46 of the forward member 42, allowing a second vacuum tenor 70 to be connected thereto. According to another embodiment, the second vacuum tenor port 66 is positioned and connected to the proximal end of a separate fluid tube (not shown), which passes through the forward member 42 and extends therefrom to the proximal end. Similar to the first vacuum tenor port 64, the second vacuum tenor port 66 includes an outer collar 74 and a hollow needle 76 partially positioned within the circumference of the outer collar 74. The needle 76 is positioned such that its tip 78 extends to approximately the upper edge of the outer collar 74, from there extending downward to a bottom opening 80 of the outer collar 74 and held within the opening 80. The needle lumen 82 is connected to a defined lumen or fluid conduit 98 within the forward member 42 (or a separate fluid tube), so that the needle lumen 82 is in fluid communication with the fluid conduit 98 within the forward member 42.

[0047] When the second vacuum tener 70 is attached to the second vacuum tener port 66, the front portion of the second vacuum tener 70—which may include a puncturable seal or cover 96—is positioned within the outer collar 74 and pushed down onto the needle 76 so that the tip 78 of the needle 76 punctures the seal / cover 96. Once the needle 76 is inserted into the second vacuum tener 70, the needle lumen 82 is placed in fluid communication with the internal volume of the second vacuum tener 70, and thus the vacuum tener is also in fluid communication with the fluid conduit 98 of the forward member 42, and thus in fluid communication with the catheter tube 50. Thus, a blood sample may be collected in it by connecting the second vacuum tener 70 to the second vacuum tener port 66 of the blood aspiration device 14.

[0048] Each of the first vacuum tenor port 64 and the second vacuum tenor port 66 may be provided with a component that serves to shield and protect the port when not in use. According to some embodiments, a cap 100 (Figure 1) may be attached to the outer collar 74 of each port 64, 66 to provide protection and maintain the cleanliness of the ports 64, 66 and their needles 76. Furthermore, a rubber sleeve (not shown) may be positioned on the needle 76 of each port 64, 66 to maintain the cleanliness of the needle 76 and protect it from accidental needle stick injuries when the blood aspiration device 14 is handled by the operator.

[0049] Referring to Figures 4 and 5, the operation of the blood aspiration device 14 for obtaining first and second blood aspirations is shown and described in more detail here. In the initial step, the blood aspiration device 14 is connected to a catheter assembly 12 which includes a catheter 24 that has been pre-placed in the patient's blood vessel, thereby providing the indwelling catheter. As previously stated, in one embodiment, the blood aspiration device 14 is connected to the catheter assembly 12 by engaging the male Luer connector of a coupling device 58 provided at the terminal end 40 of the housing 36 with the female Luer connector of the proximal connector 26 of the catheter connector 20. When the coupling device 58 of the housing 36 is connected to the proximal connector 26 of the catheter connector 20, the housing lumen 84 at the terminal end 40 is in fluid connection with the lumen 30 in the catheter connector 20.

[0050] When the blood aspiration device 14 is connected to the catheter assembly 12, the first vacuum tener 68 is connected to the first vacuum tener port 64, and the anterior portion of the first vacuum tener 68 is positioned within the outer collar 74 and pushed down onto the needle 76 as shown in Figure 4, so that the tip 78 of the needle 76 penetrates the seal / cover 96 of the first vacuum tener 68. When the first vacuum tener 68 is connected, the vacuum inside the first vacuum tener 68 begins to cause a flow of blood through the catheter 24, through the catheter hub 14, through the lumen 30 of the catheter connector 20, through a portion of the housing lumen 84 (i.e., through the terminal portion of the main channel 86 and the secondary channel 88), through the needle lumen 82 into the first vacuum tener 68, so that a first blood sample is collected therein. The first blood sample collected by the first vacuum tener 68 is obtained from the location in the patient's vascular system where the terminal tip 63 of the indwelling catheter 24 is positioned. During the collection of the first blood sample, a segmented septum 92 within the blood collection device (located within the main channel 86 from the T confluence 90 to the proximal end) prevents blood from flowing to the proximal end into the internal volume section 44 of the housing 36.

[0051] During the collection of the first blood sample, the first vacuum tener 68 may be detached from the first vacuum tener port 64, and the blood aspiration device 14 may then be operated to obtain a second blood sample. As shown in Figure 5, in preparation for obtaining a second blood sample, the forward member 42 of the blood aspiration device 14 may be actuated (i.e., moved to the terminal) to cause the catheter tube 50 to move from a first position where the terminal end 54 of the catheter tube 50 is inside the housing 36, to a first position where it is proximal to the split septum 92, to a second position where the terminal end 54 of the catheter tube 50 is advanced terminally through the split septum 92 and exits the housing 36, and further to a second position where the terminal end 63 of the indwelling catheter 24 is extended terminally by a distance of, for example, 10 mm.

[0052] Once the catheter tube 50 is advanced to the desired position (i.e., the terminal tip 54 of the catheter tube 50 extends beyond the terminal tip 63 of the indwelling catheter 24), the second vacuum tanker 70 is connected to the second vacuum tanker port 66, the anterior portion of the second vacuum tanker 70 is positioned within the outer collar 74 and pushed down onto the needle 76, so that the tip 78 of the needle 76 punctures the seal / cover 96 of the second vacuum tanker 70. Upon connection of the second vacuum tanker 70, the vacuum inside the second vacuum tanker 70 causes blood to begin flowing through the catheter tube 50, through the fluid conduit 98 of the advance member 42, through the needle lumen 82, and into the second vacuum tanker 70, so that a second blood sample is collected inside the second vacuum tanker 70. The second blood sample is obtained from a location within the patient's blood vessel where the distal tip 54 of the catheter tube 50 is positioned, which is different from the location where the first blood sample was previously collected (the tip 63 of the indwelling catheter 24). During the collection of the second blood sample, the advancement / positioning of the catheter tube 50 through the split septum 92 and the housing lumen 84 prevents blood from flowing into the internal volume 44 of the housing 36 at the proximal end, and also prevents blood from flowing into / out of the first vacuum tena port 64.

[0053] Therefore, the blood aspiration device 14 provides that blood aspiration can be performed from multiple sites through an indwelling catheter without additional vascular puncture. Two separate blood samples may be obtained from two separate sites within the patient's vascular system—a first sample is collected through the indwelling catheter 24 at its terminal tip 63 location and supplied to a first vacuum tank 68 connected to the blood aspiration device 14, and a second sample is aspirationed from the terminal tip 54 location of an inserted catheter tube 50 and supplied to a second vacuum tank 70 connected to the blood aspiration device 14. The two separate blood samples aspirationed from different locations may be used as a paired blood culture set (PBC) which may be tested for, for example, bacteremia and / or other contaminants, and PBCs offer higher microbiological yield and improved sensitivity and time to positivity (TTP) for pathogen detection compared to single blood cultures (SBCs).

[0054] Referring to Figures 6 and 7, additional embodiments of the blood aspiration devices 102 and 104 of the present disclosure are shown. The blood aspiration devices 102 and 104 are identical in design and operation to the blood aspiration device 14 of Figures 1 to 5, but the structure of the first and second ports provided therein differs from that of the blood aspiration device 14, and the structure of the vacuum tenter (and associated access member) connected thereto is also modified to accommodate this structure. The positions of the ports on the housing 36 and the forward member 42, and the fluid connections between the ports and the fluid conduits 98 in the housing lumen 84 and the forward member 42, are as described above and will therefore not be repeated below.

[0055] Referring to Figure 6, a blood aspiration device 102 is provided, which includes a first port 106 and a second port 108 configured as Luer connectors. Specifically, each of the ports 106 and 108 is configured as a female Luer connector 110 and may include a tapered cavity (not shown) configured to receive and engage with a tapered stem or extension member of a male Luer connector, and a threaded outer surface configured to engage with a threaded portion on the inner surface of the annular shield of the male Luer connector. As described above, the first port 106 is located on the housing 36 adjacent to its terminal end 40 and may be provided on the upper surface 72 of the housing 36, while the second port 108 is located on the base end 46 of the forward member 42.

[0056] According to aspects of this disclosure, an access device 112, such as the BD Vacutainer® Luer-Lok® access device of Becton Dickinson & Company, is connectable to the female Luer connectors 110 of the first port 106 and the second port 108, respectively. The access device 112 generally includes an outer sleeve 114 configured to receive a vacutainer 116, a male Luer connector 118 extending from the outer sleeve 114, and a needle 120 extending into a cavity 122 defined by the outer sleeve 114 and physically and fluidly connected to the male Luer connector 118. The male Luer connector 118 of the access device 112 may be connected to the female Luer connectors 110 of the first or second port 106, 108, respectively, to fix the access device 112 to the blood aspiration device 102 and to fluidly connect its needle 120 to the female Luer connector 110. When the access device 112 is connected to the respective first or second ports 106, 108, the vacuum tener 116 is inserted into the outer sleeve 114 of the access device 112 and pushed down onto its needle 120 so that the tip of the needle 120 penetrates the seal / cover 124 of the vacuum tener 116. Once the needle 120 is inserted into the vacuum tener 116, the lumen 126 of the needle 120 is in fluid communication with the internal volume of the vacuum tener 116, and the vacuum tener 116 is also in fluid communication with the blood aspiration device 102. Specifically, the first vacuum tanker 116 connected to the first port 106 is in fluid communication with the housing lumen 84 at the terminal end 40 of the housing 36 (and thus in fluid communication with the catheter 24 via the catheter connector 20 and catheter hub 12), while the second vacuum tanker 116 connected to the second port 108 is in fluid communication with the fluid conduit 98 of the forward member 42 (and thus in fluid communication with the catheter tube 50). Therefore, blood samples may be collected in the first and second vacuum tankers 116 when connected to the first and second ports 106 and 108, respectively, of the blood aspiration device 102.

[0057] Referring to Figure 7, a blood aspiration device 104 is provided, which includes a first port 106 and a second port 108, configured as a female Luer connector 110 having a needleless connector (NFC) 128 provided thereon. According to the embodiment, the NFC 128 is integrally formed with or coupled to the female Luer connector 110, the integrally formed NFC 128 is permanently connected to the Luer connector 110, and the coupled NFC 128 is solvent-bonded to the Luer connector 110 via a suitable solvent (such as acetone, in non-limiting examples). The NFC 128 integrally formed / coupled to the female Luer connector 110 isolates and seals the respective ports 106 and 108 on the blood aspiration device 104. According to the embodiment, the NFC128 on each of the first port 106 and the second port 108 may be a known NFC128, including but not limited to BDQ-Syte®, BDMaxZero®, BDMaxPlus®, or SmartSite® needleless connectors manufactured by Becton Dickinson & Company.

[0058] Generally, the NFC128 may include a male luer connector 130 and a female luer connector 132. The male luer connector 130 of the NFC128 may include not only a tapered stem (not shown) that connects to a female luer connector 110 formed in the housing 36 and is received in a corresponding tapered cavity of the female luer connector 110, but also an annular shield 134 extending around the tapered stem, which includes a threaded portion on its inner surface configured to engage with a corresponding threaded portion on the outer surface of the female luer connector 110. The female luer connector 132 of the NFC128 includes an elongated proximal end portion at its tip, the tip of which is positioned beyond the opening of a tapered cavity configured to receive and engage with the tapered stem or elongated member of the corresponding male luer connector (of the access device 112 described later). The female lure connector 132 may include an outer surface that includes a threaded portion 138 configured to engage with a corresponding threaded portion on the inner surface of the annular shield of the male lure connector.

[0059] Similar to the blood aspiration device in Figure 6, the access device 12 (e.g., BD Vacutainer® Luer-Lok® access device) may be connected to the NFC 128 of the first port 106 and the second port 108, respectively. As previously mentioned, the access device 112 generally includes an outer sleeve 114 configured to receive the vacutainer 116, a male Luer connector 118 extending from the outer sleeve 114, and a needle 120 extending into a cavity 122 defined by the outer sleeve 114 and physically and fluidly connected to the male Luer connector 118. The male Luer connector 118 of the access device 112 may be connected to a female Luer connector 132 of the NFC 128 provided on the respective first or second ports 106, 108, fixing the access device 112 thereto and fluidly connecting its needle 120 to the blood aspiration device 104. When the access device 112 is connected to the first or second ports 106, 108, the vacuum tener 116 is inserted into the outer sleeve 114 of the access device 112 and may be pushed down onto the needle 120 so that the tip of the needle 120 punctures the seal / cover of the vacuum tener 116. Once the needle 120 is inserted into the vacuum tener 116, the lumen 126 of the needle 120 is placed in fluid communication with the internal volume of the vacuum tener 116, thereby also creating fluid communication between the vacuum tener 116 and the blood aspiration device 104. Specifically, the first vacuum tanker 116 connected to the first port 106 is in fluid communication with the housing lumen 84 (and thus in fluid communication with the catheter 24 via the catheter connector 20 and catheter hub 12), while the second vacuum tanker 116 connected to the second port 108 is in fluid communication with the fluid conduit 98 of the forward member 42 (and thus in fluid communication with the catheter tube 50). Thus, blood samples may be collected in the first and second vacuum tankers 116 connected to the first and second ports 106 and 108, respectively, of the blood aspiration device 104.

[0060] Referring to Figures 8-11, another non-limiting embodiment of the system 140, including a catheter assembly 142 and a blood aspiration device 144, is shown. The catheter assembly 142 may include a catheter adapter 146 and an associated catheter 148. The catheter adapter 146 includes a terminal end 150 and a proximal end 152, and may include an additional adapter port 154 located between them. The catheter 148 extends from the terminal end 150 of the catheter adapter 146, and the terminal end or tip 156 of the catheter 148 is appropriately positioned in the patient's blood vessel to enable blood aspiration.

[0061] In some non-limiting embodiments or aspects, the catheter assembly 142 may include a fluid conduit 158 ​​extending from the port 154 to a connector 160. The connector 160 may be a T-connector (e.g., one side port positioned at a 90-degree angle to the longitudinal axis of the connector 160), a Y-connector (e.g., one side port positioned at a 25, 60, or 75-degree angle to the longitudinal axis of the connector 160), or other types of connectors known to those skilled in the art. In some non-limiting embodiments or aspects, the connector 160 may have a needleless access connector 162 connected to its proximal end 164, which provides a proximal patient access port to the catheter assembly 142. In some non-limiting embodiments or aspects, the catheter assembly 142 may include an extension tube / extension set 165 connected to the port 154 of the connector 160, which may be used, for example, to supply fluid from a fluid source (e.g., an IV bar).

[0062] As shown in Figures 8-11, according to a non-limiting embodiment, the blood aspiration device 144 includes at least a housing 166, a coupling device 168, a catheter tube 170, and a forward member 172. As will be described in more detail below, the catheter tube 170 is movable within the housing 166 and may provide forward movement of a portion of the catheter tube 170 from a first or retracted position inside the housing 166 (Figure 10) to a second or advanced position outside the housing 166 (Figure 11), and the terminal end 174 of the catheter tube 170 may be connected to the catheter assembly 142 and exit past the terminal tip 156 of the catheter 148.

[0063] As shown in Figures 8-11, the housing 166 of the blood aspiration device 144 can be an elongated member having a proximal end 176 and a distal end 178 that define an internal volume 180. The housing 166 has one or more features or surface finishes on its outer surface, which may be arranged to improve the ergonomic characteristics of the blood aspiration device 144 and, in some cases, may allow the user to operate the blood aspiration device 144 with one hand (i.e., one-handed operation).

[0064] The coupling device 168 of the blood aspiration device 144 is provided at the terminal end 178 of the housing 166, and the coupling device 168 provides a reversible connection of the blood aspiration device 144 to the catheter assembly 142, for example, via a needleless access connector 162. In some embodiments, the coupling device 168 is configured as a lock 182 including a blunt needle cannula 184 and a locking arm 186 for connecting the catheter assembly 142 to the needleless access connector 162, the blunt needle cannula 184 and the locking arm 186 forming a three-point contact with it. However, those skilled in the art will understand that any connection or coupling, such as a Luer, may be used, as long as the terminal end 174 of the catheter tube 170 can pass through the coupling device 168 to reach the catheter assembly 142.

[0065] The forward member 172 of the blood aspiration device 144 includes a first portion 188 and a second portion 190. The first portion 188 is movably positioned along the upper surface 192 of the housing 166, and the second portion 190 is movably positioned within the internal volume 180 of the housing 166. The arrangement of the forward member 172 and the housing 166 is configured such that a connecting portion (not shown) that joins the first and second portions 188, 190 of the forward member 172 is seated in a slot 194 formed in the upper surface 192 of the housing 166—the slot 194 extends over most of the housing 166 between the proximal end 176 and the distal end 178. When the first portion 188 and the second portion 190 are joined together, the movement of the first portion 188 along the upper surface 192 of the housing 166 results in a corresponding movement of the second portion 190 within the internal volume 180.

[0066] As most clearly shown in Figure 9, the first portion 188 of the forward member 172 may be configured as a tab or as a tab having a user-engageable contact surface 196a and a lower portion 196b that contacts the upper surface 192 of the housing 166. In such an embodiment, the upper surface 192 of the housing 166 may include, for example, a set of ribs, bumps, projections, grooves, and / or similar tracks 198 along which the lower portion 196b of the tab or projection advances when the forward member 172 is operated by the user. In this manner, the user can engage the first portion 188 of the forward member 172 to move the forward member 172 relative to the housing 166.

[0067] The second portion 190d includes an opening 200 extending through it, which is configured to grasp or hold a portion of the catheter tube 170. Since the portion of the catheter tube 170 is held within the opening 200 of the second portion 190, the movement of the forward member 172 relative to the housing 166 causes a corresponding movement of the catheter tube 170 relative to the housing 166. In this way, the terminal end 174 of the catheter tube 170 can be moved to selectively move out or back from the internal volume 180 of the housing 166 as desired, for example, when a blood aspiration device 144 is connected to the catheter assembly 142 to collect a blood sample, the terminal end 174 of the catheter tube 170 can be moved out of the housing 166.

[0068] As further shown in Figures 8-11, the blood aspiration device 144 includes a secondary catheter 202 provided at the proximal end 176 of the housing 166. The secondary catheter 202 has a proximal end 204 and a terminal end 206, defining a lumen 208. The portion of the secondary catheter 202 is located within and extends through an opening 210 formed in the proximal end 176 of the housing 16. Thus, the proximal end 204 of the secondary catheter 202 is located at least partially outside the housing 166, and the terminal end 206 is located at least partially inside the housing 166, with the terminal end 206 connected to a second portion 190 of the forward member 172. In some embodiments, the secondary catheter 202 may have a larger diameter than the catheter tube 170, and when the catheter 66 and the secondary catheter 202 are connected to the second portion 190 of the forward member 172, the proximal end 212 of the catheter tube 170 is at least partially positioned within the lumen 208 defined by the secondary catheter 202.

[0069] Similar to the blood aspiration devices 14, 102, and 104 in Figures 1-7, the blood aspiration device 144 includes two ports 214, 216 on it, which provide connections to multiple blood aspiration devices for the blood aspiration device 144, enabling the collection of two separate blood samples (i.e., paired blood aspiration) through the device 144. According to embodiments of the present disclosure, the ports 214, 216 may be configured according to any of the ports described above for the blood aspiration devices 14, 102, and 104, and the ports 214, 216 are provided as vacuum tener ports, female Luer connectors, or female Luer connectors with integrated / bonded NFCs. The first port 214 is provided on the housing 166 adjacent to its terminal end 178 and is fluidly connected to the housing lumen 84 defined within the terminal end 178 of the housing 166, as shown in Figure 9. The housing lumen 84 extends both proximal and terminal from the location of the T confluence 90, and the lumen 84 extends to the terminal through the coupling device 168 (for example, through the blunt needle cannula 184) to fluidly communicate with the catheter assembly 142 (when the blood aspiration device 144 is connected to the needleless access connector 162), and the housing lumen 84 extends to the proximal end to connect with the internal volume 180 of the housing 166.

[0070] According to embodiments of the present disclosure, the split septum 92 may be located in the housing lumen 84 at a position proximal to the T confluence 90, which may prevent the flow of fluid (i.e., blood) from the housing lumen 84 to the internal volume 180 of the housing 166. In some embodiments, the split septum 92 may be located in the housing lumen 84 immediately proximal to the T confluence 90, be formed of a flexible elastomer material, and have a slit formed therein through which the catheter tube 170 passes as it is advanced from a first position to a second position.

[0071] Referring to Figures 10 and 11, the operation of the blood aspiration device 144 for obtaining first and second blood aspirations is shown and explained in more detail. In the initial step, the blood aspiration device 144 is connected to a catheter assembly 142, which contains a catheter 148 pre-placed in the patient's blood vessel, providing an indwelling catheter. As previously stated, in one embodiment, the blood aspiration device 144 is connected to a needleless access connector 162 of the catheter assembly 142 by engagement of a coupling device 168 provided at the terminal end 178 of the housing 166 to the catheter assembly 142. When the coupling device 168 is connected to the connector 162, the housing lumen 84 formed within the housing 166 at the terminal end 178 becomes fluidly connected to the lumen in the catheter connector 20.

[0072] When the blood aspiration device 144 is connected to the catheter assembly 142, the first vacuum tanker 218 (and any associated access devices as needed) is connected to the first port 214. Once the first vacuum tanker 218 is connected, the vacuum within the first vacuum tanker 218 initiates a flow of blood through the catheter assembly 142, through the portion of the housing lumen 84 at the terminal end 178 of the housing 166, through the first port 214, and into the first vacuum tanker 218, where a first blood sample is collected. The first blood sample collected by the first vacuum tanker 218 is obtained from the location within the patient's vascular system where the terminal tip 156 of the indwelling catheter 148 is positioned. During the first blood sample collection, the septum 92 in the blood collection device 144 (located within the main channel 86 from the T confluence 90 to the proximal end) prevents blood from flowing proximal to the internal volume section 180 of the housing 166 while the catheter tube 170 is in the first position, as shown in Figure 9.

[0073] When collecting the first blood sample, the first vacuum tener 218 may be disconnected from the first port 214, and the blood aspiration device 144 may then be operated to obtain a second blood sample. In preparation for obtaining the second blood sample, the advancing member 172 of the blood aspiration device 144 is activated (i.e., moved to the end) to move the catheter tube 170 from a first position where the end end 174 of the catheter tube 170 is inside the housing 166 and proximal to the septum 92, to a second position where the end end 174 of the catheter tube 170 is advanced to the end through the septum 92 and exits the housing 166, and the end end 156 of the indwelling catheter 148 is further extended distally by, for example, 10 mm.

[0074] When the catheter tube 170 is advanced to the desired position (i.e., the terminal tip 174 of the catheter tube 170 extends beyond the terminal tip 156 of the indwelling catheter 148), the second vacuum tanker 220 is connected to the second port 216. Once the second vacuum tanker 220 is connected, the vacuum inside the second vacuum tanker 220 causes blood to begin flowing through the catheter tube 170 and through the second port 216 to the second vacuum tanker 220, where a second blood sample is collected. The second blood sample collected by the second vacuum tanker 220 is obtained from a location within the patient's blood vessel where the terminal tip 174 of the catheter tube 170 is positioned, which is different from the location where the first blood sample was previously collected (at the terminal tip 156 of the indwelling catheter 148). During the collection of the second blood sample, the advancement / positioning of the catheter tube 170 through the septum 92 and the housing lumen 84 prevents blood from flowing proximal to the internal volume 180 of the housing 166, and also prevents blood from flowing into / out of the first port 214.

[0075] Beneficially, for each of the blood aspiration devices shown and described in Figures 1–11, the blood aspiration device provides blood aspiration from multiple sites via an indwelling catheter without additional vascular puncture. Two separate blood samples may be obtained from two separate sites within the patient's vascular system—a first sample collected through an indwelling catheter at its terminal foci and fed into a first vacuum tener connected to the blood aspiration device at a first port, and a second sample collected through a catheter tube advanced at its terminal foci (terminal to the indwelling catheter) and fed into a second vacuum tener connected to the blood aspiration device at a second port. The two separate blood samples aspirationed from different foci may be used as a paired culture set (PBC) which may be tested for, for example, bacteremia and / or other contaminants, and PBCs offer higher microbiological yield and improved sensitivity and time to positive determination (TTP) for pathogen detection compared to single blood cultures (SBCs).

[0076] Figures 1-11 show and illustrate exemplary catheter assemblies and blood aspiration devices, but it is recognized that embodiments of the present invention also encompass blood aspiration devices not described in detail herein. For example, blood aspiration devices using other alternative advancement members or mechanisms, such as blood aspiration devices equipped with a rotatable wheel on the housing for advancing the catheter tube, can also be provided with terminal and proximal ports for vacuum connection.

[0077] While this disclosure is described in detail based on the most practical and preferred embodiments or aspects currently available, it should be understood that such details are for illustrative purposes only and that this disclosure is not limited to the disclosed embodiments or aspects, but rather intended to encompass modifications and equivalent configurations within the spirit and scope of the appended claims. For example, it should be understood that, to the extent possible, it is assumed in this disclosure that one or more features of any embodiment may be combined with one or more features of other embodiments.

Claims

1. A blood aspiration device for use with a catheter assembly, wherein the blood aspiration device is A housing having a proximal end and a distal end, wherein the housing defines a housing lumen at the distal end and defines an internal volume portion at the proximal end relative to the housing lumen, A coupling device positioned at the terminal end of the housing and configured to connect to the catheter assembly, A catheter tube movably received within the housing, A forward member is configured to be movably connected to the housing and to move relative to the housing to move the catheter tube between a first position in which the catheter tube is positioned within the housing and a second position in which the end end of the catheter tube is positioned beyond the end end of the housing. A first port provided in the housing at the terminal end, wherein the first port is in fluid communication with the lumen of the housing, A second port provided at the base end of the housing, wherein the second port is in fluid communication with the catheter tube, and A fluid flow prevention seal positioned within the lumen of the housing and proximal to the first port, wherein the end end of the catheter tube is proximal to the fluid flow prevention seal when in the first position and extends through the fluid flow prevention seal when in the second position, A blood aspiration device equipped with the following features.

2. The blood aspiration device according to claim 1, wherein the housing lumen comprises a main channel extending from the connecting device to the internal volume section and a sub-channel extending from the main channel to the first port, and the sub-channel is coupled to the main channel at the T-junction.

3. The blood aspiration device according to claim 2, wherein the fluid flow prevention seal is positioned within the main channel at its base end relative to the T-junction.

4. The fluid flow prevention seal comprises a split septum, and When the catheter tube is in the first position, the end of the catheter tube is positioned at the proximal end relative to the split septum, so that the split septum is closed and prevents fluid flow into the internal volume and into the catheter tube and the second port, and The blood aspiration device according to claim 1, wherein when the catheter tube is in the second position, the catheter tube extends through the split septum.

5. The blood aspiration device according to claim 1, wherein the coupling device comprises a male Luer connector, the male Luer connector includes an elongated member and a rotating collar, and the rotating collar is configured to engage with the connector of the catheter assembly in a screw-in manner.

6. The blood aspiration device according to claim 1, wherein the coupling device comprises a lock including a blunt cannula and a pair of locking arms for coupling the catheter assembly to a connector.

7. The blood aspiration device according to claim 1, wherein the forward member comprises a telescopic cylinder having a proximal end and a distal end, the distal end of the telescopic cylinder is positioned within the internal volume and engaged with the proximal end of the catheter tube, and the telescopic cylinder is configured to move relative to the housing to move the catheter tube between a first position and a second position.

8. The blood aspiration device according to claim 7, wherein the second port is connected to the proximal end of the telescopic cylinder, and the telescopic cylinder includes a fluid path formed therethrough, which fluidly connects the catheter tube and the second port.

9. The blood aspiration device according to claim 1, wherein the forward member comprises a first portion movably disposed along the upper surface of the housing and a second portion movably disposed within the internal volume, the forward member is seated in and movable through a slot formed in the upper surface of the housing, and the proximal end of the catheter tube is connected to the second portion.

10. The blood aspiration device according to claim 9, further comprising a secondary catheter having a proximal end and a terminal end, wherein the terminal end of the secondary catheter is connected to the second portion and extends therefrom to the proximal end and exits from the proximal end of the housing, and the second port is connected to the proximal end of the secondary catheter and is fluidly connected to the catheter tube via the secondary catheter.

11. Each of the first port and the second port is equipped with a vacuum tena port, and the vacuum tena port is Outer color, and A needle positioned within the circumference of the outer collar and fixed to the housing, wherein the needle is The needle lumen is in fluid communication with the housing lumen, and The needle tip is positioned to puncture the seal of the vacutena connected to the vacutena port, so that the inner chamber of the vacutena is in fluid communication with the needle lumen, A needle equipped with A blood aspiration device according to claim 1, including the following:

12. The blood aspiration device according to claim 1, wherein each of the first port and the second port is provided with a female Luer connector, and the female Luer connector is configured to be connected to a vacuum tener via an intermediate Luer lock access device.

13. The blood aspiration device according to claim 12, wherein each of the first port and the second port comprises a needleless connector attached to the female Luer connector, the needleless connector includes a septum configured to isolate and seal the female Luer connector, and the needleless connector is configured to connect to a vacuum tener via an intermediate Luer lock access device.

14. The blood aspiration device according to claim 13, wherein the needleless connector is integrally formed with the female Luer connector or is solvent-bonded to the female Luer connector.

15. A method for obtaining a pair of blood samples, Connecting a blood aspiration device to a catheter assembly including an indwelling catheter, wherein the blood aspiration device is A housing having a proximal end and a distal end, wherein the housing defines a housing lumen at the distal end and defines an internal volume portion at the proximal end relative to the housing lumen, A catheter tube movably received within the housing, A forward member, movably connected to the housing and configured to move relative to the housing to move the catheter tube between a first position in which the catheter tube is positioned within the housing and a second position in which the end of the catheter tube is positioned beyond the end of the housing and beyond the end of the indwelling catheter, A first port provided in the housing at the terminal end, wherein the first port is in fluid communication with the lumen of the housing, A second port provided at the base end of the housing, wherein the second port is in fluid communication with the catheter tube, and A fluid flow prevention seal positioned within the lumen of the housing and proximal to the first port, wherein the end end of the catheter tube is proximal to the fluid flow prevention seal at the first position and extends through the fluid flow prevention seal at the second position. Equipped with, With the catheter tube in the first position, the first vacuum container is connected to the first port, and when the first vacuum container is connected to the first port, the first blood sample is aspirated into it, and with the catheter tube in the first position, the fluid flow prevention seal is closed, preventing blood flow into the catheter tube and to the second port. To operate the forward member to move the catheter tube to the second position, and With the catheter tube in the second position, connect the second vacuum container to the second port, and aspirate the second blood sample into the second vacuum container when it is connected to the second port. Includes, A method wherein the first blood sample is obtained from a first location in the patient's blood vessel adjacent to the terminal end of the indwelling catheter, and the second blood sample is obtained from a second location in the patient's blood vessel adjacent to the terminal end of the catheter tube.

16. The method according to claim 15, wherein connecting the blood aspiration device to the catheter assembly includes engaging a rotatable collar of the coupling device of the blood aspiration device with a connector of the catheter assembly.

17. The method according to claim 15, wherein acting the forward member includes acting a telescopic cylinder to its end within the housing to move the catheter tube to the second position, and the second port is connected to the proximal end of the telescopic cylinder.

18. The method according to claim 15, wherein acting the forward member includes acting a tab-shaped first portion toward its end along the upper surface of the housing, the first portion being coupled to a second portion movably disposed within the internal volume, and the actuation of the first member causes the forward member to move within a slot formed in the upper surface of the housing.

19. Each of connecting the first vacuum tener to the first port and the second vacuum tener to the second port includes connecting each vacuum tener to a vacuum tener port comprising an outer collar and a needle positioned within the circumference of the outer collar, wherein the needle has a needle lumen. The method according to claim 15, wherein when connecting each of the aforementioned vacuum teners to a vacuum tener port, the needle punctures the seal of the vacuum tener, thereby bringing the inner chamber of the vacuum tener into fluid communication with the needle lumen and further into fluid communication with the housing lumen.

20. Each of the following is: connecting the first vacuum tenter to the first port and connecting the second vacuum tenter to the second port Connecting a Luer lock access device to the female Luer connector of each of the aforementioned ports or to the female Luer connector of a needleless connector attached to each of the aforementioned ports, wherein the Luer lock access device comprises a male Luer connector and a needle having a needle lumen, and Each vacuum tenter is connected to the Luer lock access device. Includes, The method according to claim 15, wherein when connecting each vacuum tenter to the Luer lock access device, the needle punctures the seal of the vacuum tenter, bringing the inner chamber of the vacuum tenter into fluid communication with the needle lumen, and further bringing it into fluid communication with the housing lumen.

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