Catheter system with extension set for blood sampling - Patent application

Abstract

The catheter system may include a catheter adapter that may include a side port. The catheter system may include a catheter and an extension tube having a distal end and a proximal end. The catheter system may include a three-port connector that may include a distal port, a proximal port, and a side port. The proximal end of the catheter adapter may be coupled to the distal port of the three-port connector. The distal end of the extension tube may be integrated with the side port of the three-port connector.

Description

[Technical Field]

[0001] TECHNICAL FIELD The present disclosure relates generally to vascular access devices, systems and methods. In particular, the present disclosure relates to catheter systems configured for blood sampling, such as, for example, arterial blood sampling, and related devices and methods. [Background technology]

[0002] Arterial catheterization is a critical procedure used universally in hospital settings, both in critically injured and perioperative patients. It is estimated that more than 8 million arterial catheters are placed annually in the United States. Arterial catheters can continuously and accurately measure blood pressure, as well as heart rate and pulse contour, allowing for immediate recognition of abnormal hemodynamic events and initiation of appropriate treatment. Arterial catheters also provide samples for blood gas analysis without the morbidity associated with repeated arterial punctures. However, current use of arterial catheters can result in significant blood leakage during insertion into a patient's artery, which can put the user at risk. Furthermore, current arterial catheters can be difficult to secure, maintain, and flush.

[0003] The subject matter claimed herein is not limited to embodiments that solve the problems or that operate only in the contexts described above. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 11,191,939 Summary of the Invention

[0005] In some embodiments, the catheter system may also be configured for blood pressure monitoring and / or blood gas sampling. Importantly, in some embodiments, the catheter system may provide closer access to the patient for more accurate hemodynamic measurements and improved delivery of instruments, such as secondary catheters and / or sensors, into blood vessels, which may include arteries or veins. In some embodiments, the catheter system may include a guidewire to improve the success rate of catheter insertion. In some embodiments, the catheter system may reduce blood exposure when inserting the catheter into a patient's artery.

[0006] In some embodiments, the catheter system may include a catheter adapter, which may include a distal end, a proximal end, a lumen extending through the distal end of the catheter adapter, and the proximal end of the catheter adapter. In some embodiments, the catheter system may include a catheter extending from the distal end of the catheter adapter.

[0007] In some embodiments, the catheter system may include a three-port connector that can be configured to provide near-patient access. In some embodiments, the three-port connector may include a distal port, a proximal port, and a side port between the distal and proximal ports. In some embodiments, the three-port connector may include more than three ports. In other embodiments, the three-port connector may include exactly three ports. In some embodiments, the distal and proximal ports may be aligned with the longitudinal axis of the three-port connector. In some embodiments, the side port and / or extension tube may be angled 90° relative to the longitudinal axis of the three-port connector or between 15° and 165° relative to the longitudinal axis of the three-port connector. In some embodiments, the proximal end of the catheter adapter may be coupled to the distal port of the three-port connector.

[0008] In some embodiments, the catheter system may include an extension tube that may include a distal end and a proximal end. In some embodiments, the distal end of the extension tube may be integrated with a side port of the three-port connector. In some embodiments, the proximal port may include a connector that may facilitate coupling of a blood collection device to the three-port connector. In some embodiments, the proximal port may include another suitable connector. In some embodiments, the blood sampling device may be coupled to the proximal port. In some embodiments, the blood collection device may include a catheter advancement device, such as, for example, the PIVO® needle-free blood collection device available from Becton, Dickinson & Company of Franklin Lakes, New Jersey. In some embodiments, the blood sampling device may include another suitable blood sampling device.

[0009] In some embodiments, the catheter system may include a three-way stopcock valve that may include a first port, a second port opposite the first port, and a third port. In some embodiments, the third port may be perpendicular to the first and second ports. In some embodiments, the proximal end of the extension tube may be coupled to the first port of the three-way stopcock valve. In some embodiments, the proximal end of the extension tube may be integral with the first port, which may reduce the risk of fluid exposure to the user.

[0010] In some embodiments, the catheter system may include at least a catheter, a catheter adapter, a three-port connector, and a fluid pathway within the extension tube. In some embodiments, the second port, the third port, and the proximal port of the three-port connector may be configured to provide access to the fluid pathway of the catheter system. In some embodiments, the catheter system may include one or more other access points to the fluid pathway from the surrounding environment. In some embodiments, the catheter system may not include other access points to the fluid pathway from the surrounding environment, which may limit potential bacterial contamination. In some embodiments, the proximal port may be used for proximal patient blood sample collection, the second port may be used to facilitate line clearance with a single flush, and the third port may be used to temporarily withdraw blood from the patient to ensure a high-quality sample.

[0011] In some embodiments, the catheter system may include a pre-filled flush device coupled to a second port, such that closing the second port, such as by rotating the central hub of a three-way stopcock valve, prevents fluid communication between the pre-filled flush device and the fluid pathway. In some embodiments, a temporary waste sample syringe may be coupled to a third port such that closing the third port, such as by rotating the central hub of a three-way stopcock valve, prevents fluid communication between the temporary waste sample syringe and the fluid pathway. In some embodiments, the temporary waste sample syringe may be configured for temporary blood draws.

[0012] In some embodiments, the catheter system can include a pressure transducer, which can be disposed between the second port and the pre-filled flush device, which can facilitate flushing of the catheter system via a single flush.

[0013] In some embodiments, the proximal end of the extension tube may be integrated with an adapter that may be configured to couple to one or more of a pre-filled flush device, a temporary discarded sample syringe, and a three-way stopcock valve. In some embodiments, the adapter may be coupled to a needleless connector, which may reduce the risk of bacterial contamination. In some embodiments, the proximal end of the adapter may include a single port or a dual port.

[0014] In some embodiments, the catheter system may be compact, facilitate use, and improve workflow when collecting arterial or venous blood samples. In some embodiments, the blood collection method may include coupling a pre-filled flush device and a temporarily discarded sample syringe to the catheter system and closing the second port. In some embodiments, after closing the second port, the method may include drawing blood into the temporarily discarded sample syringe. In some embodiments, after drawing blood into the temporarily discarded sample syringe, the method may include closing the first port. In some embodiments, after closing the first port, the method may include drawing blood into a blood collection device, which may be coupled to the proximal port of the three-port connector. In some embodiments, the blood sampling device may include a heparinized syringe, and the blood may then be dispensed into an arterial blood gas (ABG) test cartridge for point-of-care (POC) blood testing.

[0015] In some embodiments, the blood sampling device may include a catheter advancing device. In some embodiments, the method may include advancing a secondary catheter and / or a sensor of the catheter advancing device through a catheter of the catheter system. In some embodiments, after collecting blood in a blood collection device coupled to the proximal port of the three-port connector, the method may include closing the second port at another time. In some embodiments, after closing the second port at another time, the method may include returning the drawn blood into a temporary waste syringe to the patient.

[0016] In some embodiments, after returning the blood drawn into the temporary waste syringe to the patient, the method may include turning the three-way stopcock valve to an open position and activating a pre-filled flush device to clear the catheter system with a single flush. In some embodiments, the catheter system may include a pressure transducer that may be positioned between the second port and the pre-filled flush device or another suitable location.

[0017] In some embodiments, the blood sampling method can include inserting a catheter system into a patient's blood vessel. In some embodiments, the method can include advancing a secondary catheter of a catheter advancement device through the catheter. In some embodiments, the catheter advancement device can be coupled to a proximal port of a three-port connector. In some embodiments, the blood vessel can be an artery.

[0018] In some embodiments, the catheter system further includes a pressure transducer that can be disposed between the second port and the pre-filled flush device. In some embodiments, the method can include monitoring arterial blood pressure via the pressure transducer during or simultaneously with advancing the secondary catheter of the catheter advancement device through the catheter. In some embodiments, the method can include coupling the pre-filled flush device to the pressure transducer and activating the pre-filled flush device such that fluid from the pre-filled flush device flows through the pressure transducer.

[0019] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. Also, it is to be understood that embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0020] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1A] FIG. 1A is a top perspective view of an exemplary catheter system, according to some embodiments. [Figure 1B] FIG. 1B is a top perspective view of an exemplary three-port connector, according to some embodiments. [Figure 2A] FIG. 2A is a top perspective view of a catheter system showing an exemplary three-way stopcock valve, an exemplary pre-filled flush device, and an exemplary discarded sample syringe, according to some embodiments. [Figure 2B] FIG. 2B is a top perspective view of the catheter system showing a three-way stopcock valve and an exemplary needleless connector, according to some embodiments. [Figure 2C] FIG. 2C is a top perspective view of a catheter system with a needleless access connector between a three-way stopcock valve and an exemplary adapter, according to some embodiments. [Figure 3A] FIG. 3A is a top perspective view of a catheter system showing a temporarily discarded sample syringe when a temporarily discarded sample has been taken, according to some embodiments. [Figure 3B] FIG. 3B is a top perspective view of a catheter system showing blood collection in an exemplary blood sampling device, according to some embodiments. [Figure 3C] FIG. 3C is a top perspective view of a catheter system, according to some embodiments, showing the distribution of blood from a blood collection device to an arterial blood gas (ABG) test cartridge for point-of-care (POC) blood testing. [Figure 3D] FIG. 3D is a top perspective view of the catheter system showing blood drawn into the temporary waste syringe returning to the patient, according to some embodiments. [Figure 3E] FIG. 3E is a top perspective view of the catheter system showing flushing of the catheter system, according to some embodiments. [Figure 4A] FIG. 4A is a top perspective view of a catheter system showing an exemplary adapter including a proximal end with dual ports, according to some embodiments. [Figure 4B] FIG. 4B is a top perspective view of the catheter system showing an adapter dual luer port, according to some embodiments. [Figure 4C] FIG. 4C is a top perspective view of the catheter system showing a three-way stopcock valve, according to some embodiments. [Figure 4D] FIG. 4D is a top perspective view of the catheter system showing a three-way stopcock valve, according to some embodiments. [Figure 5A] FIG. 5A is a top perspective view of an adapter showing a proximal end having dual luer ports, according to some embodiments. [Figure 5B] FIG. 5B is a cross-sectional view of an adapter showing a proximal end having dual luer ports, according to some embodiments. [Figure 6A] FIG. 6A is a top perspective view of a catheter system showing an exemplary needleless connector coupled to an exemplary pressure transducer, according to some embodiments. [Figure 6B] FIG. 6B is a top perspective view of a catheter system showing an exemplary needleless connector between a pre-filled flush device and a pressure transducer, according to some embodiments. [Figure 7] FIG. 7 is a top perspective view of a catheter system coupled to a hemodynamic monitoring system, according to some embodiments. [Figure 8] FIG. 8 is a top perspective view of a catheter system coupled to a closed, near-patient arterial blood sampling system, according to some embodiments. [Figure 9] FIG. 9 is a top perspective view of a catheter system showing a pressure transducer, according to some embodiments. [Figure 10] FIG. 10 is a top perspective view of a catheter system showing a pre-filled flush device and a temporarily discarded sample syringe coupled to an adapter, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0021] 1A-2A, in some embodiments, the catheter system 10 may be configured for blood sampling, such as, for example, arterial blood sampling. In some embodiments, the blood sampling may be used for determining blood gas content. In some embodiments, the catheter system 10 may also be configured for blood pressure. Importantly, in some embodiments, the catheter system 10 may provide closer access to the patient for more accurate hemodynamic measurements and improved delivery of instruments, such as secondary catheters and / or sensors, to blood vessels, which may include arteries or veins.

[0022] In some embodiments, the catheter system 10 may include an arterial catheter system configured for insertion into an artery. In these embodiments, the catheter system 10 may include a significant improvement over existing arterial catheter systems by dramatically reducing blood exposure and infection risk, providing improved arterial access confirmation to the user, and improving the overall patient experience. For example, some existing arterial catheter systems, such as the TeleflexARROW® integrated arterial catheter, may not provide effective arterial access confirmation or blood control, resulting in a placement procedure with significant blood exposure risk, infection risk, cleanup costs, and a poor patient experience. The TeleflexARROW® integrated arterial catheter includes a non-rigid slotted tube that can leak significant amounts of blood, increasing the risk of blood exposure to the user. The catheter system 10 may include one or more of the following, which may provide advantages over conventional technology: arterial blood sampling with reduced blood exposure, blood pressure monitoring, blood gas sampling, near-patient access for use of secondary catheters and / or sensors, blood control configured to operate under arterial pressure, guidewires, and magnetic introducer needle guidance technology.

[0023] 1A, in some embodiments, the catheter system 10 may include a catheter adapter 12, which may include a distal end 14, a proximal end 16, and a lumen extending through the distal end 14 of the catheter adapter 12 and the proximal end 16 of the catheter adapter 12. In some embodiments, the catheter system 10 may include a catheter 19 extending from the distal end 14 of the catheter adapter 12. In some embodiments, the catheter 19 may include an arterial catheter, a peripherally inserted central catheter, a midline catheter, a peripheral intravenous catheter, or another suitable catheter.

[0024] In some embodiments, the catheter system 10 may include an introducer needle 21 coupled to a needle hub 23. In some embodiments, the catheter 19 may include an "over-the-needle" catheter, where the introducer needle 21 may extend through the catheter 19 to assist in insertion of the catheter 19 into a patient's blood vessel. In some embodiments, after the catheter 19 is inserted into the blood vessel (which may be confirmed by the user through visualization of the blood in a flashback chamber or INSTAFLASH®), the needle hub 23 may be detached from the catheter adapter 12 and the introducer needle 21 may be removed. In some embodiments, the catheter adapter 12 may include blood control technology, such as a septum, which may prevent blood leakage from the catheter adapter 12 after removal of the introducer needle 21.

[0025] In some embodiments, the catheter system 10 may include a three-port connector 26, which may be configured to provide access near the patient. In some embodiments, the three-port connector 26 may include a distal port 28, a proximal port 30, and a side port 32 between the distal port 28 of the three-port connector 26 and the proximal port 30 of the three-port connector 26. In some embodiments, the distal port 28 and the proximal port 30 may be aligned with a longitudinal axis 34 of the three-port connector 26.

[0026] In some embodiments, the catheter system 10 may include an extension tube 36, which may include a distal end 38 and a proximal end 40. In some embodiments, the distal end 38 of the extension tube 36 may be integrated with the side port 32 of the three-port connector 26, which may reduce the risk of fluid exposure to the user. More specifically, in some embodiments, the distal end 38 of the extension tube 36 may be permanently or permanently coupled to the side port 32, for example, via adhesive, glue, non-luer coupling, or another suitable permanent or non-removable coupling.

[0027] In some embodiments, the side port 32 and / or extension tube 36 may be angled at approximately 90° relative to the longitudinal axis 34 of the three-port connector 26, forming a T-shape or T-shaped connector. In these and other embodiments, the three-port connector 26 may be similar or identical in one or more features and / or operation to one or more stabilizing connectors further described in U.S. Patent Application Publication No. 2018 / 0129994, filed November 30, 2018, entitled "Stabilizing Connector Device for Vascular Access and Method of Using Same," which is incorporated herein by reference in its entirety. In some embodiments, the T-shape may facilitate flushing of the catheter assembly 10 when flushed from the proximal end 40 of the extension tube 36. In some embodiments, the side port 32 and / or extension tube 36 may be angled less than or more than 90° relative to the longitudinal axis 34, which may form a Y-shape. In some embodiments, the side port 32 and / or extension tube 36 may be angled between 15° and 165° relative to the longitudinal axis 34 of the three-port connector 26 so that the extension tube 36 extends distally or proximally. In some embodiments, the side port 32 may be on the left or right side of the three-port connector 26 and / or may be configured to guide the extension tube 36 away from the catheter insertion site into the blood vessel. In some embodiments, the proximal end 16 of the catheter adapter 12 may be coupled to the distal port 28 of the three-port connector 26.

[0028] In some embodiments, the catheter system 10 may be a non-integrated catheter system, meaning that the catheter system does not include an extension tube (e.g., an extension set) extending from a side port of the catheter adapter 12 that provides a fluid path to the catheter 19. In some embodiments, the three-port connector 26 may instead provide an extension set that includes the extension tube 36.

[0029] As shown in FIGS. 1A-1B, in some embodiments, the proximal port 30 may include a connector that can facilitate coupling of a blood sampling device to the three-port connector 26. In some embodiments, the connector of the proximal port 30 may include a female Luer or another type of connector. In some embodiments, the connector of the proximal port 30 may be integrated with the three-port connector 26. More specifically, in some embodiments, the connector of the proximal port 30 may be permanently or non-removably coupled to the three-port connector via, for example, adhesive, glue, a non-Luer coupling, or another suitable permanent or non-removable coupling. In some embodiments, the connector may be monolithically formed as a single unit with the three-port connector 26. As shown in FIG. 2A, in some embodiments, the blood sampling device 42 may be coupled to the proximal port 30. In some embodiments, the proximal port 30 may be red to indicate that the proximal port 30 provides access to an artery. In some embodiments, the blood sampling device 42 may include a vacuum tube or a syringe. In some embodiments, the blood sampling device 42 may include a probe and / or a sensor. In some embodiments, blood sampling device 42 may include a catheter advancement device such as, for example, the PIVO® needle-free blood collection device available from Becton, Dickinson & Company of Franklin Lakes, New Jersey. In some embodiments, blood sampling device 42 may include another suitable blood sampling device. In some embodiments, blood sampling device 42 may be configured to advance a secondary catheter and / or sensor through a linear path and / or catheter 19 into a patient's blood vessel, such as an artery.

[0030] In some embodiments, the catheter system 10 may include a three-way stopcock valve 44, which may include a first port 46, a second port 48 opposite the first port 46, and a third port 50. In some embodiments, a central hub 52 of the three-way stopcock valve 44 may be rotated to selectively open or close fluid flow through the first port 46, the second port 48, and the third port 50, as known in the art. In some embodiments, the proximal end 40 of the extension tube 36 may be coupled to the first port 46 of the three-way stopcock valve 44. In some embodiments, the proximal end 40 of the extension tube 36 may be integral with the first port 46, which may reduce the risk of fluid exposure to the user. More specifically, in some embodiments, the proximal end 40 of the extension tube 36 may be permanently or non-removably coupled to the first port 46, for example, via adhesive, glue, non-luer coupling, or another suitable permanent or non-removable coupling. In some embodiments, the second port 48 and / or the third port 50 may include a luer, such as, for example, a female luer, which may facilitate coupling to a device.

[0031] In some embodiments, the catheter system 10 may include a fluid pathway within at least the catheter 19, the catheter adapter 12, the three-port connector 26, and the extension tube 36. In some embodiments, the second port 48, the third port 50, and the proximal port 30 of the three-port connector 26 may be configured to provide access to the fluid pathway of the catheter system 10. In some embodiments, the catheter system 10 may include one or more other access points to the fluid pathway from the surrounding environment. In some embodiments, the catheter system 10 may not include other access points to the fluid pathway from the surrounding environment, which may limit potential bacterial contamination.

[0032] In some embodiments, one or more of the second port 48, the third port 50, and the proximal port 30 may be non-removable and / or monolithically formed as a single unit with the body of the three-way stopcock valve 44 around which the central hub 52 rotates. In some embodiments, one or more of the second port 48, the third port 50, and the proximal port 30 may include a removable needleless connector coupled to the non-removable portion of the respective port. In some embodiments, the needleless connector may reduce the risk of bacterial contamination. In some embodiments, the proximal port 30 may be used for near-patient access, including blood sample collection. In some embodiments, the second port 48 may be used to facilitate clearance of the catheter system 10, including a fluid path with a single flush, and the third port 50 may be used to temporarily withdraw blood from the patient to ensure a high-quality sample. In some embodiments, the adapter 58, one or more of the first port 46, the second port 48, and the third port 50 may include a vent plug or end cap.

[0033] In some embodiments, the catheter system 10 may include a pre-filled flush device 54 coupled to the second port 48 such that closing the second port 48, such as by rotating the central hub 52 of the three-way stopcock valve 44, prevents fluid communication between the pre-filled flush device 54 and the fluid pathway. In some embodiments, the pre-filled flush device 54 may include a pre-filled flush syringe, an IV line, or another suitable device. In some embodiments, a temporarily discarded sample syringe 56 may be coupled to the third port 50 such that closing the third port 50, such as by rotating the central hub 52 of the three-way stopcock valve 44, prevents fluid communication between the temporarily discarded sample syringe 56 and the fluid pathway. In some embodiments, the temporarily discarded sample syringe 56 may be configured to temporarily withdraw blood from a patient.

[0034] 2B-2C, in some embodiments, the proximal end 40 of the extension tube 36 may be integral with an adapter 58, which may be configured to couple to one or more of a pre-filled flush device 54, a temporary waste sample syringe 56, and a three-way stopcock valve 44. More specifically, in some embodiments, the proximal end 40 of the extension tube 36 may be permanently or permanently coupled to the adapter 58, for example, via adhesive, glue, a non-luer coupling, or another suitable permanent or non-removable coupling. As shown in FIG. 2B, in some embodiments, the adapter 58 may be coupled to a needleless connector 60, which may reduce the risk of bacterial contamination. As referred to in this disclosure, the term "needleless connector" may refer to a MAXZERO® needleless connector (available from Becton, Dickinson & Company) or another suitable detachable needleless connector as known in the art, which may be designed to reduce the risk of bacterial contamination.

[0035] 3A-3E, in some embodiments, the catheter system 10 may be compact, facilitate use, and improve workflow when collecting arterial or venous blood samples. In some embodiments, a blood collection method may include inserting the catheter 19 of the catheter system 10 into a blood vessel, such as a vein or artery, of a patient. In some embodiments, one or more steps of the method may be performed while monitoring arterial blood pressure via a pressure transducer and a pressure monitoring system coupled thereto. In some embodiments, the blood collection method may include coupling a pre-filled flush device 54 and / or a temporarily discarded sample syringe 56 to the catheter system 10. In some embodiments, the method may include, for example, closing the second port 48 (the third port 50 and the first port 46 may remain open), as shown in FIG. 3A. In some embodiments, after closing the second port 48, the method may include drawing blood from the blood vessel into the temporarily discarded sample syringe 56. This may be accomplished by pulling the plunger of the temporarily discarded sample syringe 56. 3B, in some embodiments, after drawing blood into a temporarily discarded sample syringe 56, the method may include closing the first port 46. In some embodiments, after closing the first port 46, the method may include collecting the blood in a blood sampling device 42, which may be coupled to the proximal port 30 of the three-port connector 26.

[0036] In some embodiments, the blood sampling device 42 may include a catheter advancement device configured to advance a secondary catheter to extend the life of the catheter 19 and / or provide blood sampling. In some embodiments, the catheter advancement device may include a PIVO® needle-free blood collection device available from Becton, Dickinson & Company of Franklin Lakes, New Jersey, or another suitable catheter advancement device. In some embodiments, the method may include advancing a sensor of the secondary catheter and / or catheter advancement device through the catheter 19 of the catheter system 10.

[0037] For example, as shown in FIG. 3C, in some embodiments, the blood sampling device 42 may include a heparinized syringe, and blood drawn into the heparinized syringe by withdrawing the plunger of the heparinized syringe may then be dispensed into an arterial blood gas (ABG) test cartridge for point-of-care (POC) blood testing.

[0038] 3D , in some embodiments, after collecting blood in blood collection device 42 coupled to proximal port 30 of three-port connector 26, the method may include closing second port 48 at another time (which may leave third port 50 and first port 46 open). In some embodiments, after closing second port 48 at another time, the method may include returning blood drawn into temporary waste sample syringe 56 to the patient, such as by depressing the plunger of temporary waste sample syringe 56.

[0039] For example, as shown in FIG. 3E, in some embodiments, the method may include returning blood drawn into the temporarily discarded sample syringe 56 to the patient, then turning the three-way stopcock valve 44 to the open position (so that the third port 50, the second port 48, and the first port 46 are each open) and activating the pre-filled flush device 54 to clear the catheter system 10 with a single flush.

[0040] 4A-4D, in some embodiments, the proximal end 64 of the adapter 58 may include a single port or dual ports. In some embodiments, the proximal end 64 may include a dual port, which may include a luer port 66a and a luer port 66b (e.g., as shown in FIG. 4A). In some embodiments, the dual port may include a T-shape or a Y-shape. In some embodiments, the luer port 66a and / or the luer port 66b may include a female luer to facilitate removable connection to another device. In some embodiments, a vent plug 70 may be disposed within the luer port 66a, which may allow for the escape of air but may reduce the risk of bacterial contamination. In some embodiments, the luer port 66b may include a septum therein, which may reduce the risk of bacterial contamination. In some embodiments, the luer port 66b may be coupled to a connector, which may include a collar. In some embodiments, the collar may include one or more threads thereon, thus facilitating a secure connection.

[0041] In some embodiments, one of the dual ports on the proximal end 64 may be temporarily coupled to a waste sample syringe to temporarily withdraw a blood sample prior to blood collection from the proximal port 30 of the three-port connector 26, and this syringe may be coupled to a specific blood sampling device (e.g., the PIVO® Needleless Blood Collection Device, available from Becton, Dickinson & Company of Franklin, La., New Jersey). In some embodiments, after blood sampling from the proximal port 30 of the three-port connector 26, the catheter system 10 may be cleared with a single flush by activating a pre-filled flush device. In some embodiments, another of the dual ports on the proximal end 64 may be coupled to a pre-filled flush device. In some embodiments, the dual ports may allow a temporary waste sample syringe and a pre-filled flush device to be simultaneously coupled to the proximal end 64.

[0042] In some embodiments, one or more of the dual ports may include a removable needleless connector coupled to a respective non-removable portion of the dual ports. In some embodiments, the needleless connector may reduce the risk of bacterial contamination. In some embodiments, a pre-filled flush device and / or a temporarily discarded sample syringe may be coupled to the proximal end 64 via the needleless connector.

[0043] As shown in FIG. 4B , in some embodiments, the proximal end 64 may include a dual port, which may include two Luer ports 66 a, 66 b. As shown, in some embodiments, the Luer port 66 a and / or the Luer port 66 b may be coupled to a connector, which may include a collar. In some embodiments, the collar may include one or more threads thereon, thus facilitating a secure connection. In some embodiments, the proximal end 64 of the adapter 58 and / or the needleless connector coupled thereto need not include a port compatible with a PIVO® needleless blood collection device, as a PIVO® needleless blood collection device or other catheter advancement device may be coupled to the proximal port 30 of the three-port connector 26 and extend through the proximal port 30, the catheter adapter 12, and the catheter 19 to access a blood vessel for blood collection. In some embodiments, the extended length of the extension tube 36 may reduce the risk of a user obstructing the insertion site when coupling a device to the proximal end 64.

[0044] 4C-4D, in some embodiments, first port 46 may include a luer, such as a female luer, which may allow a needleless connector 60 (e.g., as shown in FIG. 4D) to be coupled and disposed between first port 46 and adapter 58, which may reduce the risk of bacterial contamination.

[0045] 5A-5B, in some embodiments, the dual port may include an offset side port 72 from an axial port 74 axially aligned with a longitudinal axis 76 of the adapter 58. More specifically, in some embodiments, the offset side port 72 may be non-planar with the axial port 74 and may facilitate flushing by creating turbulent flow. In some embodiments, the offset side port 72 may correspond in one or more features and / or operation to the luer port 66A of FIGS. 4A-4B and / or the luer port 66B of FIGS. 4A-4B. In some embodiments, the axial port 74 may correspond in one or more features and / or operation to the luer port 66A of FIGS. 4A-4B and / or the luer port 66B of FIGS. 4A-4B. In some embodiments, the inner lumen of the adapter 58 may include one or more fluid deflection ramps 78 that may create turbulent flow and enhance flushing. Additionally or alternatively, in some embodiments, a fluid deflection ramp 78 may be disposed within the three-way connector 26 to create turbulent flow and enhance flushing. In some embodiments, the fluid deflection ramp 78 may be disposed within the proximal port 30 of the three-way connector 26 to create turbulent flow and enhance flushing at the port closer to the patient. Exemplary internal flushing features within the three-way connector 26 may include features, walls, channels, flow paths, protrusions, and / or any other suitable characteristics configured to create turbulent flow, reduce the amount of prime volume, or reduce the amount of dead space within the three-way connector 26, and may be further described in U.S. Patent Application Publication No. 2018 / 0122999, filed November 30, 2018, entitled "Stabilized Connector Device for Vascular Access and Method of Using Same," which is incorporated herein by reference in its entirety.

[0046] 6A-6B, in some embodiments, the catheter system 10 may include a pressure transducer 62 that may be positioned between the second port 48 and the pre-filled flush device 54 or another suitable location. In some embodiments, the pressure transducer 62 may be included at any point along the fluid path of the catheter system 10. In some embodiments, the pressure transducer may include a Transpac® IV disposable pressure transducer (available from ICUMedical) or any other suitable pressure transducer. In some embodiments, the pressure transducer 62 may be positioned between the second port 48 and the pre-filled flush device 54, which may facilitate flushing of the catheter system 10 via a single flush. More specifically, in some embodiments, when the second port 48 is open, the temporarily discarded sample syringe 56 and blood sampling device 42 are removed, and the pre-filled flush device 54 is actuated by depressing the plunger of the pre-filled flush device 54, the fluid in the syringe may travel through the pressure transducer 62 and clear the second port 48, the third port 50, the first port 46, the extension tubing 36, the three-port connector 26 (including the side port 32, the proximal port 30, and the distal port 28), the catheter adapter 12, and the catheter 19. In some embodiments, the fluid in the pre-filled flush device 54 may include saline or another suitable flush solution. In some embodiments, configuring the catheter system 10 for clearing with a single flush can reduce the amount of fluid required for flushing.

[0047] In some embodiments, the pressure transducer 62 may be operably coupled to a pressure transducer electrical connector 80, which may extend from the pressure transducer 62. In some embodiments, the proximal end of the pressure transducer 62 may be coupled to the needleless connector 60, which may reduce the risk of bacterial contamination. In some embodiments, the pre-filled flush device 54 may be coupled to the pressure transducer 62 or the needleless connector 60, which may facilitate flushing of the catheter system 10 via a single flush. In some embodiments, the pressure transducer 62 may be coupled to the third port 50 or another suitable location. In some embodiments, the pressure transducer 62 may be coupled to the third port 50 or the proximal port 30 of the three-port connector 26 to provide accurate measurements due to its proximity to the blood vessel. In some embodiments, the needleless connector 60 and / or fluid delivery line may be coupled to the pressure transducer 62. FIG. 6B shows the pre-filled flush device 54 coupled to the proximal end of the needleless connector 60, according to some embodiments, and FIG. 6A shows the proximal end of the needleless connector 60 loose.

[0048] In some embodiments, extension tube 36 may be rigid or semi-rigid and / or may include a specific or targeted thickness, which may provide sufficient stiffness or non-compliance to transmit more accurate pressure pulses, resulting in more accurate pressure measurements at pressure transducer 62. In some embodiments, pressure transducer 62 coupled to three-way stopcock valve 44 may offer the advantage of monitoring arterial pressure at a point much closer to the patient than existing systems, which may facilitate more accurate pressure measurements at pressure transducer 62.

[0049] 7 , the catheter system 10 is coupled to a hemodynamic monitoring system 82, which may be operably coupled to one or more hemodynamic monitoring system sensors 84. In some embodiments, the second sampling port 86 may provide an alternative or additional location than the three-port connector 26 for blood sampling. In some embodiments, the second sampling port 86 may be used in perioperative and surgical settings. The second sampling port 86 may be eliminated due to the presence of the three-port connector 26, and in some embodiments, negates the need for the second sampling port 86.

[0050] In some embodiments, the temporarily discarded sample syringe 56 may be secured to the hemodynamic monitoring system 82, along with the hemodynamic monitoring system sensor 84, if desired. In some embodiments, a line 90, which may include pressure tubing, may be fluidly connected to the catheter system 10 via a connector 92.

[0051] Referring now to FIG. 8 , in some embodiments, line 90 may be coupled to a blood clearing system 94, which may be proximal to the patient and / or closed. In some embodiments, blood clearing system 94 may be in-line and facilitate the collection of a temporary blood draw volume that can later be reinfused or pushed back into the patient. In some embodiments, after the temporary blood draw volume is collected in a reservoir of blood clearing system 94 by elevating plunger 95 of blood clearing system 94, shut-off valve 97 may be closed, preventing fluid communication with line 90 and the aspiration of blood from the reservoir. In some embodiments, with shut-off valve 97 closed, a blood sample may be collected from proximal port 30 of access connector 26. In some embodiments, the blood sample may be collected using a blood sampling device 42, which may include a catheter advancement device such as, for example, the PIVO® needleless blood collection device available from Becton, Dickinson & Company of Franklin Lakes, New Jersey. In some embodiments, after the blood sample is drawn, the shut-off valve 97 may be opened, the plunger 95 of the blood clearing system 94 may be depressed, and the temporary blood volume in the reservoir may be reinfused into the patient. In some embodiments, the blood clearing system 94 in the catheter system 10 may not include a blood sampling port other than the proximal port 30 of the access connector 26, which may provide for nearby patient blood collection and may also facilitate use of the catheter system 10 with a catheter advancement device.

[0052] Referring now to FIG. 9, in some embodiments, a pressure transducer 62 may be coupled to the proximal port 30, which may provide accurate pressure measurements due to its proximity to the catheter 19 and blood vessel.

[0053] Referring now to FIG. 10, in some embodiments, the pre-filled flush device 54 and the temporarily discarded sample syringe 56 may be simultaneously coupled to an adapter 58, which may facilitate easy use by the clinician.

[0054] All examples and conditional language described herein are intended for educational purposes to help the reader understand the present invention and the concepts provided by the inventors to facilitate the present technology, and should be construed as not being limited to the specifically recited examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. 1. A catheter system comprising: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; a three-port connector comprising a distal port, a proximal port, and a side port between the distal port and the proximal port, the distal port and the proximal port being aligned with the longitudinal axis of the three-port connector, and the proximal end of the catheter adapter being coupled to the distal port of the three-port connector; an extension tube including a distal end and a proximal end, the distal end of the extension tube being integral with the side port of the three-port connector; a three-way stopcock valve including a first port, a second port opposite the first port, and a third port, the proximal end of the extension tube being coupled to the first port of the three-way stopcock valve.

2. The catheter system of claim 1 , wherein the proximal port comprises an integrated connector.

3. The catheter system of claim 1 , further comprising a blood sampling device coupled to the proximal port.

4. The catheter system of claim 1 , wherein the proximal end of the extension tube is integral with the first port.

5. 2. The catheter system of claim 1, wherein the catheter system includes the catheter, the catheter adapter, the first extension tube, the three-port connector, and a fluid pathway within the extension tube, and wherein the second port, the third port, and the proximal port of the three-port connector are configured to provide access to the fluid pathway of the catheter system.

6. 6. The catheter system of claim 5, further comprising: a pre-filled flush device coupled to the second port such that closure of the second port prevents fluid communication between the pre-filled flush device and the fluid pathway; and a syringe coupled to the third port such that closure of the third port prevents fluid communication between the syringe and the fluid pathway, the syringe configured for temporary blood withdrawal.

7. The catheter system of claim 6 , further comprising a pressure transducer disposed between the second port and the pre-filled flush device.

8. The catheter system of claim 1 , wherein the proximal end of the extension tube is integrated with an adapter, the adapter is coupled to a needleless connector, and the proximal end of the adapter comprises a single port or a dual port.

9. A blood collection method comprising: coupling the pre-filled flush device and the temporarily discarded sample syringe to a catheter system, said catheter system comprising: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; a three-port connector comprising a distal port, a proximal port, and a side port between the distal port and the proximal port, the distal port and the proximal port being aligned with a longitudinal axis of the three-port connector, and the proximal end of the catheter adapter being coupled to the distal port of the three-port connector; an extension tube including a distal end and a proximal end, the distal end of the extension tube being integral with the side port of the three-port connector; a three-way stopcock valve comprising a first port, a second port opposite the first port, and a third port, the proximal end of the extension tube being coupled to the first port of the three-way stopcock valve; the catheter system comprising the catheter, the catheter adapter, the first extension tube, the three-port connector, and a fluid path within the extension tube, the second port, the third port, and the proximal port of the three-port connector being configured to provide access to the fluid path of the catheter system; and coupling the pre-filled flush device and the temporarily discarded sample syringe to the catheter system comprising: coupling the pre-filled flush device to the second port to prevent fluid communication between the pre-filled flush device and the fluid path; and coupling the temporarily discarded sample syringe to the third port to prevent fluid communication between the third port and the fluid path; closing the second port; and drawing blood into a temporarily discarded sample syringe after closing the second port.

10. drawing blood into the temporarily discarded sample syringe and then closing the first port; 10. The method of claim 9, further comprising the step of: after closing the first port, drawing blood into a blood draw device coupled to the proximal port of the three-port connector.

11. The method of claim 10 , wherein the blood sampling device comprises a catheter advancing device, and further comprising advancing a secondary catheter of the catheter advancing device through the catheter.

12. drawing blood in the blood sampling device coupled to the proximal port of the three-port connector and then closing the second port at another time; 11. The method of claim 10, further comprising the step of returning the blood drawn into the temporarily discarded syringe to the patient after closing the second port at another time.

13. 13. The method of claim 12, further comprising turning the three-way stopcock valve to an open position after returning the blood drawn into the temporarily discarded syringe to the patient, and activating a pre-filled flush device to clear the catheter system with a single flush.

14. 10. The method of claim 9, wherein the catheter system further comprises a pressure transducer disposed between the second port and a pre-filled flush device.

15. A blood collection method comprising: Inserting a catheter system into a patient's blood vessel, the catheter system comprising: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; a three-port connector comprising a distal port, a proximal port, and a side port between the distal port and the proximal port, the distal port and the proximal port being aligned with a longitudinal axis of the three-port connector, and the proximal end of the first extension tube being integral with the distal port of the three-port connector; an extension tube including a distal end and a proximal end, the distal end of the extension tube being integrated with the side port of the three-port connector; advancing a secondary catheter of a catheter advancement device through the catheter, the catheter advancement device being coupled to the proximal port of the three-port connector.

16. 16. The method of claim 15, wherein the blood vessel is an artery.

17. 16. The method of claim 15, wherein the catheter system further comprises a pressure transducer disposed between the second port and a pre-filled flush device.

18. 18. The method of claim 17, further comprising monitoring arterial blood pressure via the pressure transducer while advancing the secondary catheter of the catheter advancement device through the catheter.

19. 16. The method of claim 15, wherein the catheter system further includes a three-way stopcock valve, the three-way stopcock valve comprising a first port, a second port opposite the first port, and a third port, the proximal end of the extension tube being coupled to the first port of the three-way stopcock valve and the pressure transducer being coupled to the second port.

20. 20. The method of claim 19, further comprising coupling a pre-filled flush device to the pressure transducer; and actuating the pre-filled flush device such that fluid from the pre-filled flush device flows through the pressure transducer.

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