Blood extraction device

Abstract

The present disclosure provides a blood extraction device comprising a housing defining a housing lumen and an interior volume proximal to the housing lumen, a coupling device, a catheter tube movably received within the housing, and an advancement member movable relative to the housing to move the catheter tube between a first position and a second position, the catheter tube has a first position in which the catheter tube is disposed within the housing and a second position in which the distal end of the catheter tube is disposed beyond the distal end of the housing. A first port is disposed on the housing in fluid communication with the housing lumen, and a second port is disposed proximal to the housing in fluid communication with the catheter tube. A seal is positioned in the housing lumen proximal to the first port, with the catheter tube proximal to the seal when in the first position and extending through the seal when in the second position.

Description

Technical Field

[0001] The present disclosure relates generally to blood drawing devices for use with intravenous (IV) catheters, and more particularly to blood drawing devices capable of multi-site paired blood drawing through an indwelling IV catheter. Background Art

[0002] Vascular access devices (VADs) are used in the medical field to access a patient's peripheral vasculature for the purpose of infusion therapy and / or blood withdrawal. Common types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs), and midline catheters. VADs can be indwelling for short-term (several days), medium-term (several weeks), or long-term (several months to several years).

[0003] A typical use of a VAD as described above is to obtain a blood sample for blood culture. Blood cultures detect, for example, bacteria or other microorganisms in the blood to detect bacteremia (i.e., blood infection). When performing such blood cultures, it is recognized that multiple blood samples need to be obtained for testing because a single blood culture may provide lower sensitivity for detecting bacteremia, as well as difficulty distinguishing contaminants from clinically important pathogens. Therefore, paired blood cultures are preferred over single blood cultures because paired blood cultures provide a higher yield of microorganisms, as well as improved sensitivity for detecting pathogens and time to positivity (TTP).

[0004] While it is recognized that paired blood cultures are superior to single blood cultures, paired blood cultures require obtaining two different blood samples at two different sites or locations in the vasculature. Existing products on the market allow clinicians to collect blood from one site for blood culture through an indwelling VAD; however, collecting blood from another site currently requires the clinician to puncture a vein at another location to obtain the second blood sample. This need to puncture a vein at another location results in increased patient discomfort and prolonged procedure time.

[0005] It would therefore be desirable to provide a blood withdrawal device for use with an indwelling VAD that would allow a clinician to withdraw blood from multiple sites through an indwelling IV catheter without the need for additional venipunctures. Utility Model Content

[0006] The present invention provides a blood extraction device for use with a catheter assembly. The blood extraction device includes a housing having a proximal end and a distal end, the housing defining a housing lumen at the distal end and defining an internal volume located proximal to the housing lumen. The blood extraction device also includes: a coupling device positioned at the distal end of the housing and configured to cooperate with the catheter assembly; a catheter tube movably received in the housing; and a propulsion member movably coupled to the housing and configured to move relative to the housing to move the catheter tube between a first position and a second position, in which the catheter tube is arranged in the housing and in which the distal end of the catheter tube is arranged to extend beyond the distal end of the housing. The blood extraction device also includes a first port arranged on the housing at the distal end and connected to the fluid of the housing lumen, a second port arranged proximally from the housing and connected to the fluid of the catheter tube, and a fluid flow prevention seal positioned in the housing lumen and proximal to the first port, wherein the distal 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.

[0007] In some embodiments, the housing cavity includes a primary channel extending from the coupling device to the interior volume and a secondary channel extending from the primary channel to the first port, the secondary channel joining to the primary channel at a T-junction.

[0008] In some embodiments, a fluid flow prevention seal is positioned within the main channel proximal to the T-junction.

[0009] In some embodiments, the fluid flow prevention seal is a split septum, and, when the catheter tube is in the first position, the distal end of the catheter tube is positioned proximal to the split septum such that the split septum is closed and prevents fluid from flowing into the interior volume and into the catheter tube and the second port, and when the catheter tube is in the second position, the catheter tube extends through the split septum.

[0010] In some embodiments, the coupling device is a male luer connector comprising an elongated member and a swivel collar configured to threadably engage a connector of the catheter assembly.

[0011] In some embodiments, the coupling device is a locking member comprising a blunt cannula and a pair of locking arms for connecting to a connector of the catheter assembly.

[0012] In some embodiments, the advancement member is a telescopic cylinder having a proximal end and a distal end, the distal end of the telescopic cylinder being positioned within the internal volume and engaging the proximal end of the catheter tube, and the telescopic cylinder being configured to move relative to the housing to move the catheter tube between the first position and the second position.

[0013] In some embodiments, the second port is connected to the proximal end of the telescoping barrel, and the telescoping barrel includes a fluid path formed therethrough that fluidly connects the catheter tube to the second port.

[0014] In some embodiments, the advancement member includes a first portion movably disposed along the upper surface of the shell and a second portion movably disposed within the internal volume, the advancement member being seated in a narrow groove formed in the upper surface of the shell and capable of moving through the narrow groove, and wherein the proximal end of the catheter tube is connected to the second portion.

[0015] In some embodiments, the blood extraction device includes a secondary conduit having a proximal end and a distal end, the distal end of the secondary conduit being coupled to the second portion and extending proximally from the second portion and out of the proximal end of the housing, wherein the second port is connected to the proximal end of the secondary conduit and is fluidly connected to the catheter tube via the secondary conduit.

[0016] In some embodiments, each of the first port and the second port is a vacuum container port including an outer collar and a needle positioned within the circumference of the outer collar and secured to the housing, the needle further comprising a needle lumen in fluid communication with the housing lumen, and a needle tip positioned to pierce a seal of a vacuum container connected to the vacuum container port, thereby placing an interior chamber of the vacuum container in fluid communication with the needle lumen.

[0017] In some embodiments, each of the first port and the second port is a female Luer connector configured to couple with a vacuum container via an intervening Luer lock access device.

[0018] In some embodiments, each of the first port and the second port further comprises a needleless connector attached to the female Luer connector, the needleless connector comprising a septum configured to seal the female Luer connector, and wherein the needleless connector is configured to couple with the vacuum container via an intervening Luer lock access device.

[0019] In some embodiments, the needleless connector is integral with or solvent bonded to the female Luer connector.

[0020] The present invention also provides a method for obtaining a pair of blood samples, the method comprising connecting a blood extraction device to a catheter assembly including an indwelling catheter, wherein the blood extraction device comprises: a housing having a proximal end and a distal end, the housing defining a housing lumen at the distal end and defining an internal volume located proximal to the housing lumen; a catheter tube that is movably received within the housing; and a propulsion member that is movably coupled to the housing and is configured to move relative to the housing to move the catheter tube between a first position and a second position, in which the catheter tube is arranged within the housing and in which the catheter tube is arranged within the housing. The method further comprises a method of providing a first vacuum container to connect the first vacuum container to the first port when the catheter tube is in the first position, wherein the first vacuum container is connected to the first port, the first blood sample is drawn into the first vacuum container once the first vacuum container is connected to the first port, and wherein the fluid flow prevention seal is closed when the catheter tube is in the first position to prevent blood from flowing into the catheter tube and flowing to the second port. The method also includes actuating the advancement member to move the catheter tube to a second position, and connecting a second vacuum reservoir to the second port with the catheter tube in the second position, wherein upon connecting a second blood sample to the second port, the second blood sample is drawn into the second vacuum reservoir. The first blood sample is obtained from a first location in the patient's vasculature adjacent to the distal end of the indwelling catheter, and the second blood sample is obtained from a second location in the patient's vasculature adjacent to the distal end of the catheter tube.

[0021] In some embodiments, connecting the blood withdrawal set to the catheter assembly includes engaging a rotatable collar of a coupling device of the blood withdrawal set to a connector of the catheter assembly.

[0022] In some embodiments, actuating the advancement member includes actuating a telescoping cylinder distally within the housing to move the catheter tube to the second position, the second port being connected to a proximal end of the telescoping cylinder.

[0023] In some embodiments, the actuation advancement member includes a first portion in the form of a tab that is actuated distally along an upper surface of the shell, wherein the first portion is engaged to a second portion that is movably disposed within the internal volume, and wherein actuation of the first portion causes the advancement member to move within a narrow groove formed in the upper surface of the shell.

[0024] In some embodiments, each of connecting the first vacuum reservoir to the first port and connecting the second vacuum reservoir to the second port includes connecting the corresponding vacuum reservoir to a vacuum reservoir port having an outer collar and a needle positioned within a circumference of the outer collar, the needle including a needle lumen. Upon connecting the corresponding vacuum reservoir to the vacuum reservoir port, the needle pierces a seal of the vacuum reservoir to place an interior chamber of the vacuum reservoir in fluid communication with the needle lumen and also in fluid communication with the housing lumen.

[0025] In some embodiments, each of connecting the first vacuum container to the first port and connecting the second vacuum container to the second port includes connecting a Luer lock access device to a female Luer connection of the corresponding port or to a female Luer connector of a needleless connector attached to the corresponding port, the Luer lock access device having a male Luer connection and a needle including a needle lumen, and also connecting the corresponding vacuum container to the Luer lock access device. When connecting the corresponding vacuum container to the Luer lock access device, the needle pierces the seal of the vacuum container so that the internal chamber of the vacuum container is in fluid communication with the needle lumen and also in fluid communication with the housing lumen. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a side view of a system including a catheter assembly and an associated blood extraction device usable therewith according to a non-limiting embodiment described herein;

[0027] Figure 2 is included in Figure 1 A perspective view of a blood extraction device in a system of FIG.

[0028] Figure 3 is taken along line 3-3 according to an embodiment described herein Figure 1 A partial cross-sectional view of the system;

[0029] Figure 4 Shows Figure 1 The system of claim 1, wherein the blood extraction device is in a first configuration and the vacuum container is connected to the first port;

[0030] Figure 5 Shows Figure 1 The system wherein the blood extraction device is in a second configuration and the vacuum container is connected to the second port;

[0031] Figure 6 is a side view of a system including a catheter assembly and an associated blood extraction device usable with the catheter assembly according to another non-limiting embodiment described herein;

[0032] Figure 7is a side view of a system including a catheter assembly and an associated blood extraction device usable therewith according to another non-limiting embodiment described herein;

[0033] Figure 8 is a side view of a system including a catheter assembly and an associated blood extraction device usable therewith according to a non-limiting embodiment described herein;

[0034] Fig. 9 According to the embodiments described herein, Figure 8 A cross-sectional view of a blood extraction device in a system taken along line 3-3;

[0035] Fig.10 Shows Figure 8 The system of claim 1, wherein the blood extraction device is in a first configuration and the vacuum container is connected to the first port;

[0036] Fig.11 Shows Figure 8 The system wherein the blood withdrawal device is in a second configuration and the vacuum container is connected to the second port. DETAILED DESCRIPTION

[0037] This application claims priority to U.S. Provisional Application No. 63 / 461,923, filed on April 26, 2023, entitled “Blood Draw Device and Method of Use Thereof for a Multi-Site, Paired Blood Draw,” the entire disclosure of which is incorporated herein by reference.

[0038] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for implementing the present invention. However, various modifications, equivalents, variations and substitutions will be apparent to those skilled in the art. Any and all of these modifications, equivalents, variations and substitutions are intended to fall within the spirit and scope of the present invention.

[0039] For the purpose of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall be related to the orientation of the present invention in the accompanying drawings. However, it should be understood that the present invention may take various alternative changes unless explicitly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0040] As used in this specification, the words "proximal" and "distal" refer to directions closer to and farther from the user who will bring the device into contact with the patient, respectively. Thus, for example, the end of the device that first contacts the patient's body will be the distal end, and the opposite end of the device that is manipulated by the user will be the proximal end of the device.

[0041] The terms "first", "second", etc. do not refer to any particular sequence or chronological order, but rather to different conditions, properties or elements.

[0042] As used herein, "at least one" is synonymous with "one or more". For example, the phrase "at least one of A, B, and C" refers to any one of A, B, or C, or any combination of any two or more of A, B, or C, for example, "at least one of A, B, and C" includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of A, B, and C.

[0043] Reference now Figure 1-5 , a non-limiting embodiment of a system 10 is shown that includes a catheter assembly 12 and a blood extraction device 14. The catheter assembly 12 includes a catheter hub 16 and a non-integrated extension kit 18, which includes a catheter connector 20 and (optionally) an extension tube 22. The catheter hub 16 receives a catheter 24 and is coupled to the catheter connector 20. In one aspect or embodiment, the catheter hub 16 is an AccuCath® available from Becton Dickinson Corporation. TM Catheter System. Catheter 24 may be used as a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter, and may be formed of any suitable material and may have any useful length, as known to those skilled in the art.

[0044] The catheter connector 20 is configured to contact the patient's skin surface at or near the insertion location of the catheter 24. Although not shown, it should be recognized that the catheter connector 20 may include stabilizing features (e.g., wings) thereon that help maintain the catheter connector 20 in place on the patient's skin. The catheter connector 20 includes a proximal port having a proximal coupler 26 and a distal port having a distal coupler 28, and defines at least one lumen 30 extending through the coupler 26 and the coupler 28 or otherwise in fluid communication therewith. The proximal coupler 26 and / or the distal coupler 28 may be, for example, a male or female Luer lock and / or any other suitable coupler, wherein, Figures 1 to 5The non-limiting embodiment of the present invention shows the proximal coupler 26 as a female Luer connector and the distal coupler 28 as a male Luer connector. The proximal coupler 26 can be physically and fluidically coupled to the blood extraction device 14 to enable multi-site blood extraction, as will be explained in further detail below. The distal coupler 28 can be physically and fluidically coupled to the catheter adapter 16 so that the lumen 30 of the catheter connector 20 is at least selectively in fluid communication with the catheter 24.

[0045] The catheter connector 20 may also 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 distally of the proximal coupler 26 and proximal to the distal coupler 28. The side port 32 is positioned between the couplers 26 and 28 along the length of the catheter connector 20, which may facilitate flushing and / or fluid transmission through the side port 32. The side port 32 defines a lumen 34 that is fluidly connected to the lumen 30 between the distal coupler 28 and the proximal coupler 26. In other words, the catheter connector 20 may include and / or define a first lumen 30 between the distal coupler 28 and the proximal coupler 26 and a second lumen 34 defined by the side port 32. Like this, the side port 32 may provide access to the lumen 30 between the distal coupler 28 and the proximal coupler 26, which in turn may provide access to the catheter adapter 12 (and the catheter 24) that is connected to the distal coupler 28.

[0046] In some embodiments, the arrangement of the side port 32 can make the catheter connector 20 form, for example, a Y-shaped connector or a T-shaped connector. More particularly, the side port 32 can be arranged to be substantially perpendicular to (for example, about 90 degrees) the lumen 30 of the catheter connector 20 and close to or adjacent to the proximal coupler 26. In a non-limiting embodiment, the side port 32 extends from the catheter connector 20 at an angle relative to the lumen 30 between the distal coupler 28 and the proximal coupler 26, and the angle is not 90 degrees (for example, the side port 32 extends at an angle of, for example, but not limited to, 15-165 degrees, including all values ​​and sub-ranges therebetween).

[0047] As previously mentioned, it can be appreciated that the extension kit 18 can 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 can be and / or can form at least a portion of a fluid line that can be used to deliver fluids, remove fluids, flush fluids, etc. In such embodiments, for example, an arrangement in which the side port 32 is disposed adjacent the proximal coupler 26 can enable flushing of the proximal coupler 26, any one or more valves included therein, and / or the space between any one or more valves and the inner surface of the catheter connector 20.

[0048] Continue to refer Figure 1-5, the blood extraction device 14 is shown to include: a housing 36 having a proximal end 38 and a distal end 40, and a pusher member 42 slidably received within the housing 36 (i.e., within the interior volume 44 of the housing 36). In the illustrated embodiment, the pusher member 42 is configured as one or more telescoping cylinders 42a, which are configured in a telescopic relationship with the housing 36 so that the pusher member 42 can be slidably received completely or nearly completely within the interior volume 44 of the housing 36. The pusher member 42 also includes a proximal end 46 and a distal end 48, and in a non-limiting embodiment, the pusher member 42 can have a variable diameter along its length. As an example, the distal end 48 of the pusher member 42 can have a larger diameter than other portions of the pusher member 42, so that when the pusher member 42 is retracted, one or more features on the housing 36 can interact with the enlarged portion of the pusher member 42 to prevent the pusher member 42 from being completely pulled out of the housing 36. As another example, the distal end 48 of the pusher member 42 can have a smaller diameter than other portions of the pusher member 42 to maintain the pusher member 42 in a forward blood extraction position so that the operator's hands are freed to manipulate other components (e.g., a vacuum blood collection tube).

[0049] The blood extraction device 14 also includes a catheter tube 50 having a proximal end 52 and a distal end 54. The catheter tube 50 is housed within the interior volume 44 of the housing 36 and can be advanced and / or retracted relative to the housing 36 by displacement of the propulsion member 42 relative to the housing 36. In some embodiments, the catheter tube 50 can be connected to the propulsion member 42 via a connector 56 disposed at the distal end 48 of the propulsion member 42, such that displacement of the propulsion member 42 relative to the housing 36 causes a corresponding displacement of the catheter tube 50. In a non-limiting embodiment, the catheter tube 50 can be moved from a proximal end 52 to a distal end 48 of the housing 36. Figure 4 The distal end 54 of the catheter tube 50 is shown in a first position within the housing 36 and is advanced to a position such as Figure 5 The distal end 54 of the catheter tube 50 is shown located distally of the housing 36 and also located at a second location distally of the catheter 24, as will be explained in further detail below.

[0050] like Figure 1-5As shown, a coupling device 58 is provided at the distal end 40 of the housing 36, by which the blood extraction device 14 can be coupled to the catheter assembly 12, i.e., to the connector 20. The coupling device 58 is exemplified as a male Luer connector that mates with the female Luer connector of the proximal connector 26 on the connector 20, wherein the male Luer connector of the coupling device 58 has an elongated member 60 surrounded by a rotating collar 62. The rotating collar 62 can be rotated to thread the male Luer connector to the female Luer connector of the proximal connector 26. However, it should be understood that alternative embodiments of the blood extraction device 14 may include other types of coupling devices 58 that secure the blood extraction device 14 to the catheter assembly 12, including Luer connections, clamps, blunt plastic sleeves, blunt metal sleeves, hybrid Luer (e.g., with sleeves) friction fit, etc.

[0051] As can be understood, Figure 4 The blood extraction device 14 is shown in a first state, wherein the catheter tube 50 is in a first position, received within the housing 36, and the advancement member 42 is in a first position, extending proximally from the housing 36. The advancement member 42 can then be advanced distally relative to the housing 36 by the user applying a distally directed force to the advancement member 42. As described above, the advancement member 42 is coupled to the catheter tube 50 (e.g., via the connector 56) and / or otherwise interacts with the catheter tube 50 such that when the advancement member 42 is advanced distally to the second position (e.g., Figure 5 ), the catheter tube 50 moves to a second position in which the distal end 54 of the catheter tube 50 extends beyond the housing 36 and may also extend past the distal tip 63 of the catheter 24.

[0052] According to an embodiment, the blood drawing device 14 includes two ports 64, 66, which are provided for connecting multiple blood collection devices to the blood drawing device 14 so that two separate blood samples (i.e., paired blood draws) can be collected through the blood drawing device 14. In one embodiment, as Figure 1-5 As shown, ports 64, 66 are configured as vacuum container ports configured to receive vacuum containers 68, 70 therein for collecting blood samples, wherein a first vacuum container port 64 is provided for receiving a first vacuum container 68 and a second vacuum container port 66 is provided for receiving a second vacuum container 70.

[0053] The first vacuum container port 64 is disposed on the housing 36 adjacent to the distal end 40 thereof. According to one embodiment, the first vacuum container port 64 may be disposed on the upper surface 72 of the housing 36 so that the first vacuum container 68 can be easily connected to the first vacuum container port. The first vacuum container port 64 includes an outer collar 74 positioned on the upper surface 72 of the housing 36 and extending outwardly from the upper surface. In some embodiments, the inner surface of the outer collar 74 may be configured as a threaded inner surface. The first vacuum container port 64 also includes a hollow needle 76 or cannula partially positioned within the circumference of the outer collar 74. The needle 76 is positioned so that the tip 78 of the needle 76 extends generally to the upper edge of the outer collar 74, from which the needle 76 extends downwardly through the bottom opening 80 of the outer collar 74 and is fixed to the housing 36. Within the housing 36, the inner cavity 82 of the needle 76 (hereinafter referred to as the "needle inner cavity 82") engages with the inner cavity 84 (hereinafter referred to as the "housing inner cavity 84") defined within the distal end 40 of the housing 36. The housing lumen 84 includes a primary channel 86 extending longitudinally between the coupling device 58 (and through the coupling device 58 so as to be in fluid communication with the lumen 30 in the catheter connector 20 when the blood withdrawal device 14 is coupled to the catheter connector 20) and the interior volume 44, and a secondary channel 88 oriented orthogonally to the primary channel 86 and joined thereto at a T-junction 90. The needle lumen 82 is joined to the secondary channel 88 of the housing lumen 84.

[0054] According to an embodiment of the present disclosure, a fluid flow preventing seal 92 can be disposed in the housing lumen 84 at a position proximal to the T-junction 90, which can prevent fluid (i.e., blood) from flowing from the housing lumen 84 into the internal volume 44 of the housing 36. In some embodiments, the fluid flow preventing seal 92 is formed as a split diaphragm (hereinafter referred to as "split diaphragm 92") located within the housing lumen 84 just proximal to the T-junction 90. According to one embodiment, the split diaphragm 92 can be formed of a flexible elastomeric material and include a slit 94 formed therein, through which the catheter tube 50 can pass when the catheter tube 50 advances from the first position to the second position. In some embodiments, the slit 94 is configured to be stretched larger when the catheter tube 50 passes therethrough. Based on the size of the slit 94, when the catheter tube 50 moves to the second position, a seal is formed between the slit 92 and the catheter tube 50 as the catheter tube 50 advances through the slit 94.

[0055] In attaching the first vacuum reservoir 68 to the first vacuum reservoir port 64, the front portion of the first vacuum reservoir 68 (which may include a pierceable seal or cover 96 thereon) is positioned within the outer collar 74 (and in some embodiments, threadably engaged with the outer collar 74) and pushed down onto the needle 76 such that the tip 78 of the needle 76 pierces the seal / cover 96. Once the needle 76 is inserted into the first vacuum reservoir 68, the needle lumen 82 is in fluid communication with the interior volume of the first vacuum reservoir 68, and thus, the first vacuum reservoir 68 is also in fluid communication with the housing lumen 84, and by extension, with the catheter 24 (via the catheter connector 20). Thus, once the first vacuum reservoir is connected to the first vacuum reservoir port 64 of the blood extraction device 14, a blood sample can be collected in the first vacuum reservoir 68.

[0056] The second vacuum container port 66 is disposed on the blood extraction device 14 proximally from the housing 36. According to one embodiment, the second vacuum container port 66 is positioned at and connected to the proximal end 46 of the push member 42 to allow the second vacuum container 70 to be connected to the second vacuum container port. According to another embodiment, the second vacuum container port 66 is positioned at and connected to the proximal end of a separate fluid tube (not shown) that passes through the push member 42 and extends proximally out of the push member. Similar to the first vacuum container port 64, the second vacuum container 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 so that the tip 78 of the needle 76 extends generally to the upper edge of the outer collar 74, from which the needle 76 extends downward to the bottom opening 80 of the outer collar 74 and is retained in the opening 80. The needle lumen 82 engages a lumen or fluid conduit 98 defined within the advancement member 42 (or a separate fluid tube) such that the needle lumen 82 is in fluid communication with the fluid conduit 98 in the advancement member 42 .

[0057] In connecting the second vacuum container 70 to the second vacuum container port 66, the front portion of the second vacuum container 70 (which may include a pierceable seal or cover 96 thereon) is positioned within the outer collar 74 and pressed down onto the needle 76 so that the tip 78 of the needle 76 pierces the seal / cover 96. Once the needle 76 is inserted into the second vacuum container 70, the needle lumen 82 is positioned in fluid communication with the interior volume of the second vacuum container 70, and thus, the second vacuum container is also in fluid communication with the fluid conduit 98 of the advancement member 42, and by extension, with the catheter tube 50. Thus, once the second vacuum container is connected to the second vacuum container port 66 of the blood extraction device 14, a blood sample can be collected in the second vacuum container 70.

[0058] For each of the first vacuum container port 64 and the second vacuum container port 66, a component for protecting and guarding the port when not in use may be provided. According to some embodiments, the cover 100 ( Figure 1 ) can be attached to the outer collar 74 of each port 64, 66 to provide protection thereto and keep the ports 64, 66 and their needles 76 clean. Additionally, a rubber sleeve (not shown) can be positioned over the needle 76 of each port 64, 66, which keeps the needle 76 clean and prevents accidental needle sticks when the blood drawing device 14 is operated by a clinician.

[0059] Reference now Figure 4 and Figure 5 , the operation of the blood extraction device 14 is shown and described in more detail herein to obtain the first and second blood extractions. In an initial step, the blood extraction device 14 is connected to the catheter assembly 12, which includes a catheter 24 that has been pre-placed in the patient's vascular system to provide an indwelling catheter. As previously mentioned, in one embodiment, the blood extraction device 14 is connected to the catheter assembly 12 by engaging the male Luer connection of the coupling device 58 disposed at the distal end 40 of the housing 36 with the female Luer connection of the proximal coupler 26 of the catheter connector 20. Once the coupling device 58 of the housing 36 is connected to the proximal coupler 26 of the catheter connector 20, the housing lumen 84 at the distal end 40 is fluidly connected to the lumen 30 in the catheter connector 20.

[0060] Once the blood extraction device 14 is connected to the catheter assembly 12, the first vacuum container 68 is connected to the first vacuum container port 64, and the front portion of the first vacuum container 68 is positioned within the outer collar 74 and pressed down onto the needle 76, so that the tip 78 of the needle 76 pierces the seal / cap 96 of the first vacuum container 68, as shown. Figure 4 As shown. Once the first vacuum container 68 is connected, the vacuum within the first vacuum container 68 causes blood to begin to flow through the catheter 24, through the catheter adapter 14, through the lumen 30 of the catheter connector 20, through a portion of the housing lumen 84 (i.e., through the distal portion of the main channel 86 and through the secondary channel 88), through the needle lumen 82 and into the first vacuum container 68, so that a first blood sample is collected therein. The first blood sample collected by the first vacuum container 68 is obtained from a location within the patient's vasculature at which the distal end 63 of the indwelling catheter 24 is positioned. It should be noted that during the collection of the first blood sample, the split septum 92 in the blood collection device (which is positioned in the main channel 86 from the proximal side of the T-junction 90) prevents blood from flowing proximally into the interior volume 44 of the housing 36.

[0061] Once the first blood sample has been collected, the first vacuum container 68 can be disconnected from the first vacuum container port 64 and the blood extraction device 14 can then be operated to obtain a second blood sample. Figure 5 As shown, in preparation for obtaining a second blood sample, the advancement member 42 of the blood extraction device 14 can be actuated (i.e., moved distally) to move the catheter tube 50 from a first position, in which the distal end 54 of the catheter tube 50 is within the housing 36 and proximal to the split septum 92, to a second position, in which the distal end 54 of the catheter tube 50 is advanced distally through the split septum 92 and out of the housing 36, and further distally out of the distal end 63 of the indwelling catheter 24, for example, as a non-limiting example, a distance of 10 mm.

[0062] Once the catheter tube 50 is advanced to the desired position (i.e., the distal tip 54 of the catheter tube 50 extends distally past the distal tip 63 of the indwelling catheter 24), the second vacuum reservoir 70 is connected to the second vacuum reservoir port 66, and the front portion of the second vacuum reservoir 70 is positioned within the outer collar 74 and pressed down onto the needle 76, causing the tip 78 of the needle 76 to pierce the seal / cap 96 of the second vacuum reservoir 70. Once the second vacuum reservoir 70 is connected, the vacuum within the second vacuum reservoir 70 causes blood to begin to flow through the catheter tube 50, through the fluid conduit 98 of the advancement member 42, and through the needle lumen 82 and into the second vacuum reservoir 70, causing a second blood sample to be collected therein. The second blood sample collected by the second vacuum reservoir 70 is obtained from a location within the patient's vasculature at which the distal tip 54 of the catheter tube 50 is located, which is different from the location at which the first blood sample was previously collected (at the tip 63 of the indwelling catheter 24). It should be noted that during collection of the second blood sample, advancement / positioning of catheter tubing 50 through split septum 92 and housing lumen 84 prevents blood from flowing proximally into interior volume 44 of housing 36 and also prevents blood from flowing into / out of first vacuum reservoir port 64 .

[0063] Thus, the blood drawing device 14 provides for blood drawing from multiple sites via an indwelling catheter without the need for additional venipuncture. Two separate blood samples can be obtained at two separate sites within the patient's vasculature, wherein a first sample is collected by the indwelling catheter 24 at the location of its distal tip 63 and provided to a first vacuum container 68 coupled to the blood drawing device 14, and a second sample is collected by the advanced catheter tube 50 at the location of its distal tip 54 and provided to a second vacuum container 70 coupled to the blood drawing device 14. Two separate blood samples drawn from different sites can, for example, be used as a paired blood culture set (PBC) that can be tested for bacteremia and / or other contaminants, wherein the paired blood culture set provides a high microbial yield and increased / improved sensitivity and time to positivity (TTP) for detecting pathogens compared to a single blood culture (SBC).

[0064] Reference now Figure 6 and Figure 7 , shows blood extraction devices 102, 104 according to other embodiments of the present disclosure. The blood extraction devices 102, 104 are similar in design and operation to Figure 1-5 The blood extraction device 14 is the same as the blood extraction device 14, except that the structure of the first port and the second port provided thereon is different from the ports of the blood extraction device 14, so that the structure of the vacuum container (and the accompanying passage member) connected thereto is also modified to match this structure. The positioning of the ports on the housing 36 and the advancement member 42 and the fluid connection of the ports with the fluid conduit 98 in the housing lumen 84 and the advancement member 42 are as described above, so it will not be repeated hereafter.

[0065] First reference Figure 6 , a blood extraction device 102 is provided, which includes a first port 106 and a second port 108 configured as a Luer connection. Specifically, each of the ports 106, 108 is configured as a female Luer connection 110, which may include a tapered cavity (not shown) configured to receive and engage a tapered rod or elongated member of a male Luer connection, and a threaded outer surface configured to engage the threads on the inner surface of the annular shield of the male Luer connection. As previously described, the first port 106 is positioned on the housing 36, adjacent to its distal end 40, and can be disposed on the upper surface 72 of the housing 36, while the second port 108 is positioned at the proximal end 46 of the advancement member 42.

[0066] According to aspects of the present invention, for example, a BD Vacutainer such as Becton Dickinson ○R Luer-Lok TMAn access device 112 of the access device can be coupled to the female Luer connection 110 of each of the first port 106 and the second port 108. The access device 112 generally includes an outer sleeve 114 configured to receive the vacuum reservoir 116, a male Luer connection 118 extending from the outer sleeve 114, and a needle 120 physically and fluidically connected to the male Luer connection 118, the needle extending into a cavity 122 defined by the outer sleeve 114. The male Luer connection 118 of the access device 112 can be coupled to the female Luer connection 110 of the corresponding first or second port 106, 108 to secure the access device 112 to the blood extraction device 102 and fluidly connect its needle 120 to the female Luer connection 110. Once the access device 112 is connected to the respective first port 106 or second port 108, the vacuum reservoir 116 can be inserted into the outer sleeve 114 of the access device 112 and pushed down onto the needle 120 of the access device so that the tip of the needle 120 pierces the seal / cover 124 of the vacuum reservoir 116. Once the needle 120 is inserted into the vacuum reservoir 116, the lumen 126 of the needle 120 is placed in fluid communication with the interior volume of the vacuum reservoir 116, and the vacuum reservoir 116 is therefore also in fluid communication with the blood extraction device 102. Specifically, the first vacuum reservoir 116 connected to the first port 106 is positioned in fluid communication with the housing lumen 84 at the distal end 40 of the housing 36 (and, by extension, via the catheter connector 20 and the catheter adapter 12, in fluid communication with the catheter 24), while the second vacuum reservoir 116 connected to the second port 108 is positioned in fluid communication with the fluid conduit 98 of the advancement member 42 (and, by extension, in fluid communication with the catheter tube 50). Thus, once the first and second vacuum containers 116 are connected to the respective first and second ports 106 , 108 of the blood drawing device 102 , blood samples may be collected in the first and second vacuum containers.

[0067] Reference now Figure 7, a blood drawing device 104 is provided, which includes a first port 106 and a second port 108, the first port and the second port being configured as a female Luer connection 110 on which a needleless connector (NFC) 128 is disposed. According to an embodiment, the NFC 128 may be integrated with or bonded to the female Luer connection 110, the integrated NFC 128 being permanently connected to the Luer connection 110, and the bonded NFC 128 being solvent-bonded to the Luer connection 110 by a suitable solvent (e.g., acetone, as a non-limiting example). The NFC 128 integrated / bonded with the female Luer connection 110 seals the corresponding ports 106, 108 on the blood drawing device 104. According to an embodiment, the NFC 128 on each of the first port 106 and the second port 108 may be a known NFC 128, including but not limited to BD Q-Syte® of Becton Dickinson. TM BD MaxZero TM ,BDMaxPlus TM or SmartSite TM Type needleless connector.

[0068] Generally, the NFC 128 may include a male Luer connection 130 and a female Luer connection 132. The male Luer connection 130 of the NFC 128 is connected to the female Luer connection 110 formed on the housing 36 and may include a tapered stem (not shown) received by a corresponding tapered cavity of the female Luer connection 110, and an annular shroud 134 extending around the tapered stem, the annular shroud including threads on an inner surface thereof configured to engage corresponding threads on an outer surface of the female Luer connection 110. The female Luer connection 132 of the NFC 128 includes an elongated proximal end portion having a cap or septum 136 (including a slit) positioned over the opening of the tapered cavity configured to receive and engage a corresponding tapered stem or elongated member of the male Luer connection (of the access device 112, as described below). The female luer connection 132 may also include an outer surface including threads 138 configured to engage with corresponding threads on an inner surface of the annular shield of the male luer connection.

[0069] Similar to Figure 6 Blood extraction device, access device 112 (such as BD Luer-Lok TMThe access device 112 may be coupled to the NFC 128 of each of the first port 106 and the second port 108. As previously described, the access device 112 generally includes an outer sleeve 114 configured to receive the vacuum container 116, and a male Luer connection 118 extending from the outer sleeve 114 and a needle 120 physically and fluidically connected to the male Luer connection 118, the needle extending into a cavity 122 defined by the outer sleeve 114. The male Luer connection 118 of the access device 112 may be coupled to the female Luer connection 132 of the NFC 128 provided at the corresponding first port 106 or second port 108 so as to secure the access device 112 thereto and fluidly connect its needle 120 to the blood extraction device 104. Once the access device 112 is connected to the respective first port 106 or second port 108, the vacuum reservoir 116 can be inserted into the outer sleeve 114 of the access device 112 and pushed down onto the needle 120 of the access device so that the tip of the needle 120 pierces the seal / cover of the vacuum reservoir 116. Once the needle 120 is inserted into the vacuum reservoir 116, the lumen 126 of the needle 120 is placed in fluid communication with the interior volume of the vacuum reservoir 116, and thus the vacuum reservoir 116 is also in fluid communication with the blood extraction device 104. Specifically, the first vacuum reservoir 116 connected to the first port 106 is positioned in fluid communication with the housing lumen 84 (and, by extension, via the catheter connector 20 and the catheter adapter 12, with the catheter 24), while the second vacuum reservoir 116 connected to the second port 108 is positioned in fluid communication with the fluid conduit 98 of the advancement member 42 (and, by extension, with the catheter tube 50). Therefore, once the first and second vacuum containers 116 are connected to the respective first and second ports 106 and 108 of the blood extraction device 104, blood samples may be collected in the first and second vacuum containers.

[0070] Reference now Figure 8-11 , another non-limiting embodiment of a system 140 including a catheter assembly 142 and a blood extraction 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 distal end 150 and a proximal end 152, and may include an additional adapter port 154 that may be disposed therebetween. The catheter 148 extends from the distal end 150 of the catheter adapter 146, with the distal end or tip 156 of the catheter 148 appropriately positioned within the patient's vasculature to enable blood extraction.

[0071] In some non-limiting embodiments or aspects, the catheter assembly 142 may include a fluid conduit 158 ​​extending from the port 154 and extending to the connector 160. The connector 160 may be a T-shaped connector (e.g., a side port is arranged at a 90 degree angle relative to the longitudinal axis of the connector 160), a Y-shaped connector (e.g., a side port is arranged at a 25, 60 or 75 degree angle relative to the longitudinal axis of the connector 160), or any other type of connector known in the art. In some non-limiting embodiments or aspects, the connector 160 may have a needleless access connector 162 coupled to its proximal end 164, wherein the needleless access connector 162 provides a near-patient access port to the catheter assembly 142. In some non-limiting embodiments or aspects, the catheter assembly 142 may also include an extension tube / extension kit 165 coupled to the port 154 of the connector 160, which may be used to provide fluid from, for example, a fluid source (e.g., an IV pole).

[0072] like Figure 8-11 As shown, according to one non-limiting embodiment, the blood extraction device 144 includes at least a housing 166, a coupling device 168, a catheter tube 170, and a propulsion member 172. As will be described in further detail below, the catheter tube 170 can be moved within the housing 166 to provide a portion of the catheter tube 170 from a first or retracted position ( Fig.10 ) to a second or advanced position outside of housing 166 ( Fig.11 ) is advanced so that the distal end 174 of the catheter tube 170 can be guided into the catheter assembly 142 and extended through the distal tip 156 of the catheter 148.

[0073] like Figure 8-11 As shown, the housing 166 of the blood drawing device 144 may be an elongated member having a proximal end 176 and a distal end 178 and defining an interior volume 180. The housing 166 may include one or more features or surface finishes on an exterior surface thereof that may be arranged to increase the ergonomics of the blood drawing device 144, which in some cases may allow a user to manipulate the blood drawing device 144 with one hand (i.e., one-handed use).

[0074] The coupling device 168 of the blood extraction device 144 is disposed at the distal end 178 of the housing 166, wherein the coupling device 168 provides a reversible connection of the blood extraction device 144 with the catheter assembly 142, such as via the needleless access connector 162. In some embodiments, the coupling device 168 is configured as a locking member 182 for coupling to the needleless access connector 162 of the catheter assembly 142, the locking member comprising a blunt sleeve 184 and a locking arm 186, wherein the blunt sleeve 184 and the locking arm 186 form three contact points with the needleless access connector. However, it will be understood by those skilled in the art that any connection or connection, such as a Luer, may be used as long as the distal end 174 of the catheter tube 170 can reach the catheter assembly 142 through the coupling device 168.

[0075] The advancement member 172 of the blood extraction device 144 includes a first portion 188 and a second portion 190. The first portion 188 is movably disposed along an upper surface 192 of the housing 166, and the second portion 190 is movably disposed within the interior volume 180 of the housing 166. The advancement member 172 and the housing 166 are arranged so that a connecting portion (not shown) of the advancement member 172 that engages the first portion 188 and the second portion 190 is seated within a slot 194 formed in the upper surface 192 of the housing 166, the slot 194 extending substantially the majority of the way between the proximal end 176 and the distal end 178 of the housing 166. When the first portion 86 and the second portion 88 are engaged together, movement of the first portion 188 along the upper surface 192 of the housing 166 results in corresponding movement of the second portion 190 within the interior volume 180.

[0076] like Fig. 9 , the first portion 188 of the advancement member 172 can be configured as a tab or protrusion having a contact surface 196a that can be engaged by a user and a lower side 196b that contacts the upper surface 192 of the housing 166. In such embodiments, the upper surface 192 of the housing 166 can include a track 198, such as a set of ribs, ridges, bumps, grooves, and / or the like, along which the lower side 196b of the tab or protrusion is advanced when the advancement member 172 is engaged by the user. In this manner, the user can engage the first portion 188 of the advancement member 172 and can move the advancement member 172 relative to the housing 166.

[0077] The second portion 190 includes an opening 200 extending therethrough that is configured to grip or retain a portion of the catheter tube 170. Because the portion of the catheter tube 170 is retained within the opening 200 of the second portion 190, movement of the advancement member 172 relative to the housing 166 results in corresponding movement of the catheter tube 170 relative to the housing 166. In this manner, the distal end 174 of the catheter tube 170 can be selectively moved out of or back into the interior volume 180 of the housing 166 as desired, such as by pushing the distal end 174 of the catheter tube 170 out of the housing 166 when the blood extraction device 144 has been coupled to the catheter assembly 142 and collection of a blood sample is to be performed.

[0078] like Figure 8-11 As further shown, the blood extraction device 144 includes a secondary conduit 202 disposed at the proximal end 176 of the housing 166. The secondary conduit 202 has a proximal end portion 204 and a distal end portion 206, and defines an inner cavity 208. A portion of the secondary conduit 202 is disposed in an opening 210 formed in the proximal end 176 of the housing 166 and extends through the opening. In this way, the proximal end portion 204 of the secondary conduit 202 is at least partially disposed outside the housing 166, the distal end portion 206 is at least partially disposed in the housing 166, and the distal end portion 206 is coupled to the second portion 190 of the advancement member 172. In some embodiments, the secondary conduit 202 may have a larger diameter than the catheter tube 170, so that when the catheter 66 and the secondary conduit 202 are coupled to the second portion 190 of the advancement member 172, the proximal end 212 of the catheter tube 170 is at least partially disposed in the inner cavity 208 defined by the secondary conduit 202.

[0079] as Figure 1-7 Like the blood drawing devices 14, 102, 104 of the present disclosure, the blood drawing device 144 includes two ports 214, 216 located thereon, which provide for connection of multiple blood collection devices to the blood drawing device 144 so that two separate blood samples (i.e., paired blood draws) can be collected through the device 144. According to an embodiment of the present disclosure, the ports 214, 216 can be constructed according to any of the ports described above for the blood drawing devices 14, 102, 104, wherein the ports 214, 216 are configured as vacuum container ports, female Luer connections, or female Luer connections with integrated / bonded NFC. The first port 214 is disposed on the housing 166, adjacent to the distal end 178 thereof, and is fluidically connected to the housing lumen 84 defined within the distal end 178 of the housing 166, as shown in FIG. Fig. 9The housing lumen 84 extends distally and proximally from the location of the T-junction 90, with the lumen 84 extending distally through the coupling device 168 (e.g., through a blunt cannula 184) to be in fluid communication with the catheter assembly 142 (when the blood extraction device 144 is coupled to the needleless access connector 162), and the housing lumen 84 extending proximally to engage the interior volume 180 of the housing 166.

[0080] According to an embodiment of the present disclosure, a split septum 92 may be provided in the housing lumen 84 at a position proximal to the T-junction 90, which may prevent fluid (i.e., blood) from flowing from the housing lumen 84 into the interior volume 180 of the housing 166. In some embodiments, the split septum 92 is positioned within the housing lumen 84, just proximal to the T-junction 90, and is formed of a flexible elastomeric material having a slit formed therein, through which the catheter tube 170 may pass when the catheter tube 170 is advanced from the first position to the second position.

[0081] Reference now Fig.10 and Fig.11 , the operation of blood extraction device 144 is shown and described in more detail herein, to obtain the first blood extraction and the second blood extraction. In the initial step, blood extraction device 144 is connected to catheter assembly 142, which includes catheter 148, which has been pre-placed in the patient's vascular system, so that an indwelling catheter is provided. As previously mentioned, in one embodiment, blood extraction device 144 is connected to catheter assembly 142 by the engagement of the coupling device 168 at the distal end 178 of housing 166 with the needleless access connector 162 of catheter assembly 142. Once coupling device 168 is connected to connector 162, the housing lumen 84 formed in housing 166 at the distal end 178 is connected to the lumen fluid in catheter connector 20.

[0082] Once the blood extraction device 144 is connected to the catheter assembly 142, a first vacuum container 218 (and associated access devices, if desired) is connected to the first port 214. Once the first vacuum container 218 is connected, the vacuum within the first vacuum container 218 causes blood to begin flowing through the catheter assembly 142, through a portion of the housing lumen 84 in the distal end 178 of the housing 166, and into the first vacuum container 218 through the first port 214, thereby collecting a first blood sample therein. The first blood sample collected by the first vacuum container 218 is obtained from a location within the patient's vasculature at which the distal end 156 of the indwelling catheter 148 is positioned. It should be noted that during the collection of the first blood sample, the septum 92 in the blood collection device 144 (which is located in the main channel 86 proximal to the T-junction 90) prevents blood from flowing proximally into the interior volume 180 of the housing 166, as shown in FIG. Fig. 9As shown, the catheter tube 170 is in a first position.

[0083] Once the first blood sample is collected, the first vacuum container 218 can be disconnected from the first port 214 and the blood extraction device 144 can then be operated to obtain a second blood sample. In preparation for obtaining the second blood sample, the advancement member 172 of the blood extraction device 144 can be actuated (i.e., moved distally) to move the catheter tube 170 from a first position in which the distal end 174 of the catheter tube 170 is within the housing 166 and proximal to the septum 92 to a second position in which the distal end 174 of the catheter tube 170 is advanced distally through the septum 92 and out of the housing 166 and further distally out of the distal end 156 of the indwelling catheter 148, such as a distance of 10 mm as a non-limiting example.

[0084] Once the catheter tube 170 is advanced to the desired position (i.e., the distal tip 174 of the catheter tube 170 extends distally past the distal tip 156 of the indwelling catheter 148), the second vacuum reservoir 220 is connected to the second port 216. Once the second vacuum reservoir 220 is connected, the vacuum within the second vacuum reservoir 220 causes blood to begin to flow through the catheter tube 170 and into the second vacuum reservoir 220 through the second port 216, thereby collecting a second blood sample therein. The second blood sample collected by the second vacuum reservoir 220 is obtained from a location within the patient's vasculature where the distal 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 distal tip 156 of the indwelling catheter 148). It should be noted that 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 proximally into the interior volume 180 of the housing 166, and also prevents blood from flowing into / out of the first port 214.

[0085] Advantageously, for Figure 1-11Each blood extraction device shown and described in the invention provides blood extraction from multiple sites via an indwelling catheter without the need for additional venipuncture. Two separate blood samples can be obtained at two separate sites within the patient's vascular system, wherein a first sample is collected by the indwelling catheter at a location at its distal end and provided to a first vacuum container connected to the blood extraction device at a first port, and a second sample is collected by an advanced catheter tube at a location at its distal end (distal to the indwelling catheter) and provided to a second vacuum container connected to the blood extraction device at a second port. Two separate blood samples drawn from different locations can be used, for example, as a paired blood culture set (PBC), which can be used for the detection of bacteremia and / or other contaminants, and PBC provides high microbial yield and increased / improved sensitivity for detecting pathogens and time to positivity (TTP) compared to a single blood culture (SBC).

[0086] Despite Figure 1-11 Although an exemplary catheter assembly and blood extraction device are shown and described in the drawings, it should be appreciated that embodiments of the present invention include blood extraction devices not described in detail herein. For example, the distal end and proximal port (for connecting a vacuum container thereto) can be provided on a blood extraction device that uses other alternative propulsion members or mechanisms, such as a blood extraction device that includes rotatable wheels on its housing for advancing the catheter tube.

[0087] Although the present disclosure is described in detail based on what are currently considered to be the most practical and preferred embodiments or aspects for the purpose of illustration, it should be understood that such details are only for this purpose, and the present disclosure is not limited to the disclosed embodiments or aspects, but on the contrary, it is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. A blood extraction device, used together with a catheter assembly, characterized in that: The blood extraction device comprises: a housing having a proximal end and a distal end, the housing defining a housing lumen at the distal end and defining an interior volume proximal to the housing lumen; a coupling device positioned at the distal end of the housing and configured to mate with the catheter assembly; a catheter tube movably received within the housing; an advancement member movably coupled 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 disposed within the housing and a second position in which a distal end of the catheter tube is disposed beyond the distal end of the housing; a first port disposed on the housing at the distal end, the first port being in fluid communication with the housing lumen; a second port disposed proximally from the housing, the second port being in fluid communication with the catheter tube; and A fluid flow prevention seal is positioned within the housing lumen and proximal to the first port, wherein the distal 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.

2. The blood extraction device according to claim 1, characterized in that: The housing cavity includes a primary channel extending from the coupling device to the interior volume and a secondary channel extending from the primary channel to the first port, the secondary channel joining to the primary channel at a T-junction.

3. The blood extraction device according to claim 2, characterized in that: The fluid flow prevention seal is positioned within the main channel proximal to the T-junction.

4. The blood extraction device according to claim 1, characterized in that: The fluid flow prevention seal comprises a split diaphragm, and wherein: When the catheter tube is in the first position, the distal end of the catheter tube is positioned proximal to the split septum such that the split septum is closed and prevents fluid from flowing into the interior volume and into the catheter tube and the second port; and When the catheter tube is in the second position, the catheter tube extends through the split septum.

5. The blood extraction device according to claim 1, characterized in that: The coupling device includes a male luer connector including an elongated member and a swivel collar configured to threadably engage a connector of the catheter assembly.

6. The blood extraction device according to claim 1, characterized in that: The coupling device includes a locking member including a blunt cannula and a pair of locking arms for coupling to a connector of the catheter assembly.

7. The blood extraction device according to claim 1, characterized in that: The advancement member includes a telescoping cylinder having a proximal end and a distal end, the distal end of the telescoping cylinder being positioned within the interior volume and engaging the proximal end of the catheter tube, and the telescoping cylinder being configured to move relative to the housing to move the catheter tube between the first position and the second position.

8. The blood extraction device according to claim 7, characterized in that: The second port is connected to the proximal end of the telescoping barrel, and wherein the telescoping barrel includes a fluid path formed therethrough that fluidly connects the catheter tube to the second port.

9. The blood extraction device according to claim 1, characterized in that: The advancement member includes a first portion movably disposed along the upper surface of the shell and a second portion movably disposed within the internal volume, the advancement member being disposed in a slot formed in the upper surface of the shell and being movable through the slot, and wherein the proximal end of the catheter tube is connected to the second portion.

10. The blood extraction device according to claim 9, characterized in that: The blood extraction device also includes a secondary conduit having a proximal end and a distal end, the distal end of the secondary conduit being coupled to the second portion and extending proximally from the second portion and out of the proximal end of the housing, wherein the second port is connected to the proximal end of the secondary conduit and fluidly connected to the catheter tube via the secondary conduit.

11. The blood extraction device according to claim 1, characterized in that: Each of the first port and the second port comprises a vacuum container port, the vacuum container port comprising: an outer collar; and a needle positioned within the circumference of the outer collar and secured to the housing, the needle comprising: a needle lumen in the needle in fluid communication with the housing lumen; and A needle tip is positioned to pierce a seal of a vacuum container connected to the vacuum container port, thereby placing an interior chamber of the vacuum container in fluid communication with the needle lumen.

12. The blood extraction device according to claim 1, characterized in that: Each of the first port and the second port includes a female Luer connector configured to couple with a vacuum container via an intervening Luer lock access device.

13. The blood extraction device according to claim 12, characterized in that: Each of the first port and the second port also includes a needleless connector attached to the female Luer connector, the needleless connector including a septum configured to seal the female Luer connector, and wherein the needleless connector is configured to be coupled to a vacuum container via an intervening Luer lock access device.

14. The blood extraction device according to claim 13, characterized in that: The needleless connector is integral with or solvent bonded to the female Luer connector.

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