Catheter system with extension kit for blood sampling

Abstract

A 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

Background Art

[0001] Arterial catheterization is an important procedure commonly used in hospital environments in severely injured and perioperative patients. It is estimated that more than eight million arterial catheters are placed in the U.S. each year. Arterial catheters can continuously and accurately measure blood pressure, as well as heart rate and pulse contours, so as to immediately identify abnormal hemodynamic events and initiate appropriate treatment. Arterial catheters also provide samples for blood gas analysis without the morbidity associated with repeated arterial punctures. However, the use of current arterial catheters can cause significant blood leakage during insertion into a patient's artery, which may endanger the user. In addition, current arterial catheters may be difficult to fix, maintain and flush.

[0002] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is merely provided to illustrate one example technology area in which some implementations described herein may be practiced. Summary of the invention

[0003] The present disclosure generally relates to vascular access devices, systems and methods. Specifically, the present disclosure relates to a catheter system configured for blood sampling (such as, for example, arterial blood sampling), and related devices and methods. In some embodiments, the catheter system can also be configured for blood pressure monitoring and / or blood gas sampling. Importantly, in some embodiments, the catheter system can provide a near-patient access for making hemodynamic measurements more accurate and more conducive to delivering instruments (such as secondary catheters and / or sensors, etc.) to blood vessels (which may include arteries or veins). In some embodiments, the catheter system may include a guidewire for improving the success rate of catheter insertion. In some embodiments, the catheter system can reduce blood exposure when the catheter is inserted into the patient's artery.

[0004] 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.

[0005] In some embodiments, the catheter system may include a three-port connector, which may be configured to provide access to the patient. In some embodiments, the three-port connector may include a distal port, a proximal port, and a side port between the distal port and the proximal port. In some embodiments, the three-port connector may include more than three ports. In other embodiments, the three-port connector may just include three ports. In some embodiments, the distal port and the proximal port may be aligned with the longitudinal axis of the three-port connector. In some embodiments, the side port and / or extension tube may be at a 90° angle relative to the longitudinal axis of the three-port connector, or at an angle 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.

[0006] In some embodiments, the catheter system may include an extension tube, which 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 facilitates coupling a blood sampling 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 sampling device may include a catheter advancement device, such as, for example, a PIVO available from Beckton Dickinson, Inc. of Franklin Lakes, New Jersey. （商标） Needle-Free Blood Collection Device. In some embodiments, the blood sampling device may include another suitable blood sampling device.

[0007] In some embodiments, the catheter system may include a three-way stopcock, which 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 port and the second port. In some embodiments, the proximal end of the extension tube may be coupled to the first port of the three-way stopcock. In some embodiments, the proximal end of the extension tube may be integrated with the first port, which may reduce the risk of fluid exposure to the user.

[0008] In some embodiments, the catheter system may include fluid passages at least in a catheter, a catheter adapter, a three-port connector, and an extension tube. In some embodiments, the proximal port of the second port, the third port, and the three-port connector may be configured to provide access to the fluid passages of the catheter system. In some embodiments, the catheter system may include one or more other access points from the surrounding environment to the fluid passages. In some embodiments, the catheter system may not include other access points from the surrounding environment to the fluid passages, which may limit potential bacterial contamination. In some embodiments, the proximal port may be used for near-patient blood sample collection, the second port may be used to facilitate line cleaning by a single flush, and the third port may be used to temporarily draw blood from the patient to ensure high-quality samples.

[0009] In some embodiments, the catheter system may include a pre-filled flushing device coupled to the second port such that the second port is closed, such as by rotating the central hub of the three-way stopcock, preventing fluid communication between the pre-filled flushing device and the fluid channel. In some embodiments, a temporary discard sample syringe may be coupled to the third port such that the third port is closed, such as by rotating the central hub of the three-way stopcock, preventing fluid communication between the temporary discard sample syringe and the fluid channel. In some embodiments, the temporary discard sample syringe may be configured for temporary blood withdrawal.

[0010] In some embodiments, the catheter system may include a pressure transducer. In some embodiments, the pressure transducer may be disposed between the second port and the pre-filled flushing device, which may facilitate flushing the catheter system via a single flush.

[0011] In some embodiments, the proximal end of the extension tube can be integrated with an adapter that can be configured to be coupled to one or more of a prefilled flushing device, a temporary sample discard syringe, and a three-way stopcock. In some embodiments, the adapter can be coupled to a needleless connector, which can reduce the risk of bacterial contamination. In some embodiments, the proximal end of the adapter can include a single port or a dual port.

[0012] In some embodiments, the catheter system can be compact, easy to use, and can improve workflow when collecting arterial or venous blood samples. In some embodiments, a blood collection method may include connecting a prefilled flushing device and a temporary discard sample syringe to the catheter system and closing a second port. In some embodiments, after closing the second port, the method may include drawing blood into a temporary discard sample syringe. In some embodiments, after drawing blood into the temporary discard sample syringe, the method may include closing the first port. In some embodiments, after closing the first port, the method may include collecting blood in a blood sampling device that can be connected to a proximal port of a 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 box for point-of-care (POC) blood testing.

[0013] In some embodiments, the blood sampling device may include a catheter propulsion device. In some embodiments, the method may include propelling a secondary catheter and / or a sensor of the catheter propulsion device through a catheter of the catheter system. In some embodiments, after collecting blood in a blood sampling device coupled to a proximal port of a three-port connector, the method may include closing the second port again. In some embodiments, after closing the second port again, the method may include returning the blood drawn into a temporarily discarded syringe to the patient.

[0014] In some embodiments, after returning the blood drawn into the temporarily discarded syringe to the patient, the method may include turning the three-way stopcock to an open position and activating the pre-filled flushing device to clear the catheter system with a single flush. In some embodiments, the catheter system may include a pressure transducer that may be disposed between the second port and the pre-filled flushing device or at another suitable location.

[0015] In some embodiments, a blood collection method may include inserting a catheter system into a patient's blood vessel. In some embodiments, the method may include advancing a secondary catheter of a catheter propulsion device through the catheter. In some embodiments, the catheter propulsion device may be coupled to a proximal port of a three-port connector. In some embodiments, the blood vessel may be an artery.

[0016] In some embodiments, the catheter system further comprises a pressure transducer, which may be disposed between the second port and the pre-filled flushing device. In some embodiments, the method may include monitoring arterial blood pressure via the pressure transducer while or simultaneously with advancing the secondary catheter of the catheter advancement device through the catheter. In some embodiments, the method may include coupling the pre-filled flushing device to the pressure transducer and activating the pre-filled flushing device such that fluid from the pre-filled flushing device flows through the pressure transducer.

[0017] It should be understood that the above summary description and the detailed description below are examples and explanations, and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means illustrated in the accompanying drawings. It should also be understood that these embodiments can be combined, or other embodiments can be utilized, and unless so advocated, structural changes can be made without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description should not be regarded as restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0019] Figure 1A is an upper perspective view of an example catheter system according to some embodiments;

[0020] Figure 1B is an upper perspective view of an example three-port connector according to some embodiments;

[0021] Figure 2A is an upper perspective view of a catheter system according to some embodiments, illustrating an example three-way stopcock, an example pre-filled flushing device, and an example temporary discard sample syringe;

[0022] Figure 2B is an upper perspective view of a catheter system illustrating a three-way stopcock and an example needleless connector according to some embodiments;

[0023] Figure 2C is an upper perspective view of a catheter system according to some embodiments, with a needleless access connector located between a three-way stopcock and an example adapter;

[0024] Figure 3A is an upper perspective view of a catheter system according to some embodiments, illustrating a temporarily discarded sample syringe when collecting a temporarily discarded sample;

[0025] Figure 3B is an upper perspective view of a catheter system according to some embodiments, illustrating blood collection in an example blood sampling device;

[0026] Figure 3C is an upper perspective view of a catheter system according to some embodiments, illustrating the dispensing of blood from a blood sampling device onto an arterial blood gas (ABG) test cartridge for point-of-care (POC) blood testing;

[0027] Figure 3D is an upper perspective view of a catheter system according to some embodiments, illustrating blood drawn into a temporarily discarded syringe being returned to a patient;

[0028] Figure 3E is an upper perspective view of a catheter system according to some embodiments, illustrating flushing of the catheter system;

[0029] Figure 4A is an upper perspective view of a catheter system according to some embodiments, illustrating an example adapter including a proximal end with dual ports;

[0030] Figure 4B is an upper perspective view of a catheter system illustrating an adapter dual Luer port according to some embodiments;

[0031] Figure 4C is an upper perspective view of a catheter system according to some embodiments, illustrating a three-way stopcock;

[0032] Figure 4D is an upper perspective view of a catheter system according to some embodiments, illustrating a three-way stopcock;

[0033] Figure 5A is an upper perspective view of an adapter according to some embodiments, illustrating a proximal end with dual Luer ports;

[0034] Figure 5B is a cross-sectional view of an adapter according to some embodiments, illustrating a proximal end with a dual Luer port;

[0035] Fig. 6A is an upper perspective view of a catheter system according to some embodiments, illustrating an example needleless connector coupled to an example pressure transducer;

[0036] Figure 6B is an upper perspective view of a catheter system according to some embodiments, showing an example needleless connector between a prefilled irrigation device and a pressure transducer;

[0037] Figure 7 is an upper perspective view of a catheter system according to some embodiments, the catheter system being coupled to a hemodynamic monitoring system;

[0038] Figure 8 is an upper perspective view of a catheter system coupled to a closed, proximal patient arterial blood sampling system according to some embodiments;

[0039] Fig. 9 is an upper perspective view of a catheter system according to some embodiments, illustrating a pressure transducer;

[0040] Fig.10 is an upper perspective view of a catheter system according to some embodiments, illustrating a pre-filled flushing set and a temporary discard sample syringe coupled to an adapter. DETAILED DESCRIPTION

[0041] Reference Figures 1A to 2A In some embodiments, the catheter system 10 can be configured for blood sampling, such as, for example, arterial blood sampling. In some embodiments, blood sampling can be used to determine blood gas content. In some embodiments, the catheter system 10 can also be configured for blood pressure. Importantly, in some embodiments, the catheter system 10 can provide near-patient access for more accurate hemodynamic measurements and more conducive to the delivery of instruments (such as secondary catheters and / or sensors, etc.) to blood vessels (which can include arteries or veins).

[0042] 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 significantly reducing blood exposure and infection risks, providing improved arterial access confirmation to the user, and improving the overall patient experience. Some existing arterial catheter systems, such as the Teleflex ARROW （注册商标） Integrated arterial catheters may not provide effective arterial access confirmation or blood control, which can result in a placement procedure with significant blood exposure risk, infection risk, removal costs, and a poor patient experience. Teleflex ARROW （注册商标） The integrated arterial catheter includes a non-rigid slotted tube from which a large amount of blood may leak, thereby 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 the prior art: arterial blood sampling with reduced blood exposure; blood pressure monitoring; blood gas sampling; near-patient access to use secondary catheters and / or sensors; blood controls configured to operate at arterial pressure; guidewires; and magnetic introducer needle guidance technology.

[0043] like Figure 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.

[0044] 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, and the introducer needle 21 may extend through the catheter 19 to assist in inserting 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 performed by the user by viewing a flashback chamber or INSTAFLASH （商标） The needle hub 23 can be separated from the catheter adapter 12 and the introducer needle 21 can be removed. In some embodiments, the catheter adapter 12 may include blood control technology, such as a septum, which can prevent blood from leaking from the catheter adapter 12 after the introducer needle 21 is removed.

[0045] In some embodiments, the catheter system 10 may include a three-port connector 26 that may be configured to provide near-patient access. In some embodiments, the three-port connector 26 may include a distal port 28, a proximal port 30, and a side port 32 located 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.

[0046] 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 non-removably coupled to the side port 32, such as, for example, via an adhesive, a bond, a non-Luer coupling, or another suitable permanent or non-removable coupling.

[0047] In some embodiments, the side port 32 and / or the extension tube 36 may be at an angle of about 90° relative to the longitudinal axis 34 of the three-port connector 26 and may form a T-shaped or T-type connector. In these and other embodiments, in one or more features and / or operations, the three-port connector 26 may be similar or identical to one or more stabilizing connectors further described in U.S. Patent No. 11,191,939, filed on November 30, 2018, entitled "Stabilized Connector Device for Vascular Access and Method of Use thereof," which is incorporated herein by reference in its entirety. In some embodiments, the T-shape may facilitate flushing of the catheter assembly 10 when flushing the catheter assembly 10 from the proximal end 40 of the extension tube 36. In some embodiments, the side port 32 and / or the extension tube 36 may be at an angle of less than or greater than 90° relative to the longitudinal axis 34, which may form a Y-shape. In some embodiments, the side port 32 and / or the extension tube 36 can be at an angle between 15° and 165° relative to the longitudinal axis 34 of the three-port connector 26, so that the extension tube 36 extends in a distal direction or a proximal direction. In some embodiments, the side port 32 can be on the left or right side of the three-port connector 26, and / or can be configured to guide the extension tube 36 to a location away from the catheter insertion site in the blood vessel. In some embodiments, the proximal end 16 of the catheter adapter 12 can be coupled to the distal port 28 of the three-port connector 26.

[0048] In some embodiments, the catheter system 10 can be a non-integrated catheter system, meaning that the catheter system does not include an extension tube (e.g., an extension kit) extending from a side port of the catheter adapter 12 that provides fluid access to the catheter 19. In some embodiments, the three-port connector 26 can alternatively provide an extension kit including an extension tube 36.

[0049] like Figure 1A to Figure 1B As shown in , in some embodiments, the proximal port 30 may include a connector that can facilitate coupling the 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, such as, for example, via an adhesive, a bond, a non-Luer coupling, or another suitable permanent or non-removable coupling. In some embodiments, the connector may be integrally formed with the three-port connector 26 as a single unit. As shown in FIG. Figure 2AAs shown in FIG. 1 , in some embodiments, a blood sampling device 42 can be coupled to the proximal port 30. In some embodiments, the proximal port 30 can be red to indicate that the proximal port 30 provides access to the artery. In some embodiments, the blood sampling device 42 can include a vacuum tube or a syringe. In some embodiments, the blood sampling device 42 can include a probe and / or a sensor. In some embodiments, the blood sampling device 42 can include a catheter advancement device, such as, for example, a PIVO® available from Becton Dickinson, Inc. of Franklin Lakes, New Jersey. （商标） Needle-free blood collection device. In some embodiments, the blood sampling device 42 may include another suitable blood sampling device. In some embodiments, the blood sampling device 42 may be configured to advance the secondary catheter and / or sensor through a linear path and / or through the catheter 19 into a patient's blood vessel (such as, for example, an artery).

[0050] In some embodiments, the catheter system 10 may include a three-way stopcock 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, the central hub 52 of the three-way stopcock 44 can be rotated to selectively open or close the flow of fluid 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 can be coupled to the first port 46 of the three-way stopcock 44. In some embodiments, the proximal end 40 of the extension tube 36 can be integrated with the first port 46, which can reduce the risk of fluid exposure to the user. More specifically, in some embodiments, the proximal end 40 of the extension tube 36 can be permanently or non-removably coupled to the first port 46, such as, for example, via an adhesive, a bond, a non-Luer connection, or another suitable permanent or non-removable connection. 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 can facilitate coupling to the device.

[0051] In some embodiments, the catheter system 10 may include fluid pathways 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 pathways of the catheter system 10. In some embodiments, the catheter system 10 may include one or more other access points to the fluid pathways from the surrounding environment. In some embodiments, the catheter system 10 may not include other access points to the fluid pathways from the surrounding environment, which may limit potential bacterial contamination.

[0052] In certain embodiments, one or more of the second port 48, the third port 50, and the proximal port 30 may be non-removable and / or integrally formed as a single unit with the body of the three-way stopcock 44, in 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 that is coupled to the non-removable portion of the corresponding 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 cleaning of the catheter system 10 (including the fluid channel) by a single flush, and the third port 50 may be used to temporarily draw blood from the patient to ensure a high-quality sample. In some embodiments, one or more of the adapter 58, the first port 46, the second port 48, and the third port 50 may include a vent plug or an end cap.

[0053] In some embodiments, the catheter system 10 may include a pre-filled flush device 54 coupled to the second port 48, such that the second port 48 is closed by rotating the central hub 52 of the three-way stopcock 44, preventing fluid communication between the pre-filled flush device 54 and the fluid channel. 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 temporary discard sample syringe 56 may be coupled to the third port 50, such that the third port 50 is closed, such as by rotating the central hub 52 of the three-way stopcock 44, preventing fluid communication between the temporary discard sample syringe 56 and the fluid channel. In some embodiments, the temporary discard sample syringe 56 may be configured for temporary blood extraction from a patient.

[0054] Reference Figure 2B to Figure 2C In some embodiments, the proximal end 40 of the extension tube 36 can be integrated with an adapter 58, which can be configured to be coupled to one or more of the prefilled flushing device 54, the temporary sample discard syringe 56, and the three-way stopcock 44. More specifically, in some embodiments, the proximal end 40 of the extension tube 36 can be permanently or non-removably coupled to the adapter 58, such as, for example, via an adhesive, a bond, a non-Luer connection, or another suitable permanent or non-removable connection. Figure 2B As shown in FIG. 1 , in some embodiments, the adapter 58 can be coupled to a needleless connector 60, which can reduce the risk of bacterial contamination. As referred to in the present disclosure, the term "needleless connector" can refer to MAXZERO （商标）A needleless connector (available from Becton Dickinson) or another suitable removable needleless connector known in the art, which may be designed to reduce the risk of bacterial contamination.

[0055] Reference FIG. 3A to FIG. 3E In some embodiments, the catheter system 10 can be compact, easy to use, and can improve workflow when collecting arterial or venous blood samples. In some embodiments, a method of blood collection may include inserting a 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 to the pressure transducer. In some embodiments, the method of blood collection may include coupling a prefilled flushing device 54 and / or a temporarily discarded sample syringe 56 to the catheter system 10. In some embodiments, the method may include closing the second port 48 (which may leave the third port 50 and the first port 46 open), such as, for example Figure 3A In some embodiments, after closing the second port 48, the method may include drawing blood from the blood vessel into the temporary discard sample syringe 56. This may be accomplished by pulling the plunger of the temporary discard sample syringe 56. For example, Figure 3B As shown in FIG. 5 , in some embodiments, after drawing blood into the temporary discard 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 blood into a blood sampling device 42, which may be coupled to the proximal port 30 of the three-port connector 26.

[0056] In some embodiments, the blood sampling device 42 may include a catheter advancement device configured to advance the 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 available from Becton Dickinson, Inc. of Franklin Lakes, New Jersey. （商标） A needle-free blood collection device, or another suitable catheter advancement device. In some embodiments, the method may include advancing a secondary catheter and / or a sensor of the catheter advancement device through the catheter 19 of the catheter system 10 .

[0057] For example Figure 3C As shown in FIG. , in some embodiments, the blood sampling device 42 may include a heparinized syringe, and the blood drawn into the heparinized syringe by drawing the plunger of the heparinized syringe is then dispensed into an arterial blood gas (ABG) test cartridge for point-of-care (POC) blood testing.

[0058] For example Figure 3D, in some embodiments, after collecting blood into the blood sampling device 42 coupled to the proximal port 30 of the three-port connector 26, the method may include closing the second port 48 again (which may leave the third port 50 and the first port 46 open). In some embodiments, after closing the second port 48 again, the method may include returning the blood drawn into the temporary discard sample syringe 56 to the patient, for example by depressing the plunger of the temporary discard sample syringe 56.

[0059] For example, in Figure 3E As illustrated in , in some embodiments, the method may include, after returning the blood drawn into the temporary discard sample syringe 56 to the patient's body, turning the three-way stopcock 44 to an open position (so that each of the third port 50, the second port 48 and the first port 46 is open), and starting the pre-filled flushing device 54 to clean the catheter system 10 through a single flush.

[0060] Reference FIG. 4A to FIG. 4D In some embodiments, the proximal end 64 of the adapter 58 may include a single port or a dual port. 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., Figure 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 air ventilation but reduce the risk of bacterial contamination. In some embodiments, the Luer port 66b may include a diaphragm 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 on the collar, and therefore, the collar may facilitate a secure connection.

[0061] In some embodiments, one of the dual ports of the proximal end 64 can be coupled to a temporary discard sample syringe to temporarily draw a blood sample from the proximal port 30 of the three-port connector 26 prior to blood sampling, to which a specific blood sampling device can be coupled (such as, for example, the PIVO available from Becton Dickinson, Inc. of Franklin Lakes, New Jersey). （商标）Needle-free blood collection device). In some embodiments, after blood sampling from the proximal port 30 of the three-port connector 26, the catheter system 10 can be cleaned by a single flush by activating the prefilled flush device. In some embodiments, the other of the dual ports of the proximal end 64 can be connected to the prefilled flush device. In some embodiments, the dual port can allow a temporary discard of the sample syringe and the prefilled flush device to be connected to the proximal end 64 at the same time.

[0062] In some embodiments, one or more of the dual ports may include a removable needleless connector that is coupled to the non-removable portion of the corresponding port in the dual port. In some embodiments, the needleless connector can reduce the risk of bacterial contamination. In some embodiments, a prefilled flushing device and / or a temporarily discarded sample syringe can be coupled to the proximal end 64 via the needleless connector.

[0063] like Figure 4B As shown in FIG. 5 , in some embodiments, the proximal end 64 may include a dual port, which may include two Luer ports 66a, 66b. As shown, in some embodiments, the Luer port 66a and / or 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 on the collar, and thus, the collar may facilitate 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 connector that is compatible with the PIVO. （商标） Needle-free blood collection device compatible port, because PIVO （商标） A needleless blood collection device or other catheter advancement device can be coupled to the proximal port 30 of the three-port connector 26 and can extend through the proximal port 30, the catheter adapter 12, and the catheter 19 to access a blood vessel for blood sampling. In some embodiments, the extended length of the extension tube 36 can reduce the risk of interference with the insertion site when the user couples the device to the proximal end 64.

[0064] like FIG. 4C to FIG. 4D As shown in FIG. 1 , in some embodiments, the first port 46 may include a Luer, such as a female Luer. In some embodiments, this may allow a needleless connector 60 (such as, for example, Figure 4D ) is connected and disposed between the first port 46 and the adapter 58, which can reduce the risk of bacterial contamination.

[0065] Reference FIG. 5A to FIG. 5BIn some embodiments, the dual port may include a side port 72 that is offset relative to an axial port 74 that is axially aligned with a longitudinal axis 76 of the adapter 58. More specifically, in some embodiments, the offset side port 72 may not be coplanar with the axial port 74 and may facilitate flushing by creating turbulence. In some embodiments, in one or more features and / or operational aspects, the offset side port 72 may correspond to FIG. 4A to FIG. 4B Luer port 66a and / or FIG. 4A to FIG. 4B In some embodiments, in one or more features and / or operational aspects, the axial port 74 may correspond to FIG. 4A to FIG. 4B Luer port 66a and / or FIG. 4A to FIG. 4B Luer port 66b. In some embodiments, the inner lumen of the adapter 58 may include one or more fluid deflection ramps 78, which may generate turbulence and enhance flushing. Additionally or alternatively, in some embodiments, the fluid deflection ramp 78 may be disposed within the three-way connector 26 to generate turbulence 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 generate turbulence and enhance flushing near the patient port. (One or more) example internal flushing features within the three-way connector 26 may include features, walls, through grooves, flow paths, protrusions, and / or any other suitable features configured to generate turbulence, reduce the amount of perfusion volume, or reduce the amount of dead space within the three-way connector 26, and may be further described in U.S. Patent No. 11,191,939, entitled "Stabilized Connector Device for Vascular Access and Method of Use Thereof," filed on November 30, 2018, which is incorporated herein by reference in its entirety.

[0066] Reference FIG. 6A to FIG. 6B In some embodiments, the catheter system 10 may include a pressure transducer 62, which may be disposed between the second port 48 and the pre-filled flushing device 54 or at 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 （注册商标）IV disposable pressure transducer (available from ICU Medical) or any other suitable pressure transducer. In some embodiments, the pressure transducer 62 may be disposed between the second port 48 and the prefilled flushing device 54, which may facilitate flushing the catheter system 10 via a single flush. More specifically, in some embodiments, when the second port 48 is opened, the temporarily discarded sample syringe 56 and the blood sampling device 42 are removed, and the prefilled flushing device 54 is activated by depressing the plunger of the prefilled flushing device 54, and 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 tube 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 prefilled flushing device 54 may include saline or another suitable flushing solution. In some embodiments, the configuration of the catheter system 10 that is cleaned by a single flush can reduce the amount of fluid required for flushing.

[0067] In some embodiments, the pressure transducer 62 can be operably coupled to a pressure transducer electrical connector 80, which can extend from the pressure transducer 62. In some embodiments, the proximal end of the pressure transducer 62 can be coupled to the needleless connector 60, which can reduce the risk of bacterial contamination. In some embodiments, the prefilled flushing device 54 can be coupled to the pressure transducer 62 or the needleless connector 60, which can facilitate flushing the catheter system 10 via a single flush. In some embodiments, the pressure transducer 62 can be coupled to the third port 50 or another suitable location. In some embodiments, the pressure transducer 62 can be coupled to the third port 50 or the proximal port 30 of the three-port connector 26 to provide accurate measurements due to proximity to the blood vessel. In some embodiments, the needleless connector 60 and / or the fluid delivery line can be coupled to the pressure transducer 62. According to some embodiments, Figure 6B The prefilled flushing device 54 is shown coupled to the proximal end of the needleless connector 60, and Fig. 6A The proximal end of the needleless connector 60 is shown free.

[0068] In some embodiments, extension tube 36 may be rigid or semi-rigid, and / or may include a specific or targeted thickness that may provide sufficient stiffness or non-compliance to transmit more accurate pressure pulses and thereby more accurate pressure measurements at pressure transducer 62. In some embodiments, pressure transducer 62 coupled with three-way stopcock 44 may provide the benefit of monitoring arterial pressure at a point closer to the patient than prior systems, which may facilitate more accurate pressure measurements at pressure transducer 62.

[0069] Reference Figure 7, the catheter system 10 is coupled to a hemodynamic monitoring system 82, which is operably coupled to one or more hemodynamic monitoring system sensors 84. In some embodiments, the second sampling port 86 can provide an alternative or additional location for blood sampling in addition to the three-port connector 26. In some embodiments, the second sampling port 86 can be used in perioperative and surgical environments. Due to the presence of the three-port connector 26, the second sampling port 86 can be eliminated, so that the second sampling port 86 is not required in some embodiments.

[0070] In some embodiments, if desired, the temporary discard sample syringe 56 may be secured to the hemodynamic monitoring system 82 along with the hemodynamic monitoring system sensor 84. In some embodiments, a line 90, which may include pressure tubing, may be fluidly connected to the catheter system 10 via a connector 92.

[0071] Reference Figure 8 In some embodiments, the line 90 may be coupled to a blood cleaning system 94, which may be proximal to the patient and / or closed. In some embodiments, the blood cleaning system 94 may be in-line and may facilitate the collection of a temporary blood draw volume, which may be later reinfused or pushed back into the patient. In some embodiments, after the temporary blood draw volume is collected in a reservoir of the blood cleaning system 94 by raising the plunger 95 of the blood cleaning system 94, the shutoff valve 97 may be closed, preventing fluid communication with the line 90 and drawing blood from the reservoir. In some embodiments, with the shutoff valve 97 closed, a blood sample may be collected from the proximal port 30 of the access connector 26. In some embodiments, a blood sample may be collected using a blood sampling device 42, which may include a catheter advancement device, such as, for example, a PIVO® available from Beckton Dickinson, Inc. of Franklin Lakes, New Jersey. （商标） Needle-free blood collection device. In some embodiments, after the blood sample is drawn, the shutoff valve 97 can be opened and the plunger 95 of the blood removal system 94 can be depressed or pushed down to reinfuse the temporarily drawn blood volume in the reservoir into the patient. In some embodiments, the blood removal 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 can provide near-patient blood collection and can also facilitate the use of the catheter system 10 with a catheter advancement device.

[0072] Reference Fig. 9 In some embodiments, a pressure transducer 62 may be coupled to the proximal port 30, which may provide accurate pressure readings due to its proximity to the catheter 19 and the blood vessel.

[0073] Reference Fig.10In some embodiments, the prefilled flushing device 54 and the temporary discard sample syringe 56 can be simultaneously connected to the adapter 58, which can facilitate easy use by clinicians.

[0074] All examples and conditional language described herein are for teaching purposes, to help readers understand the creative concept of the present invention and the concepts contributed by the inventors of the present invention to expand the art, and should be interpreted as not being limited to these specific examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and modifications may be made thereto without departing from the spirit and scope of the present invention.

Claims

1. A catheter system, comprising: a catheter adapter comprising 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; a catheter extending from a distal end of the catheter adapter; a three-port connector comprising a distal port, a proximal port, and a side port therebetween, wherein the distal port and the proximal port are aligned with respect to a longitudinal axis of the three-port connector, wherein the proximal end of the catheter adapter is coupled to the distal port of the three-port connector; and an extension tube comprising a distal end and a proximal end, wherein the distal end of the extension tube is integrated with a side port of the three-port connector; and A three-way stopcock, wherein the three-way stopcock comprises a first port, a second port and a third port, the second port being opposite to the first port, wherein the proximal end of the extension tube is coupled to the first port of the three-way stopcock.

2. The catheter system according to claim 1, wherein: The proximal port includes an integrated connector.

3. The catheter system of claim 1, wherein: The catheter system also includes 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 integrated with the first port.

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

6. The catheter system according to claim 5, further comprising a prefilled flushing device and a syringe, wherein the prefilled flushing device is coupled to the second port so that closing of the second port prevents fluid communication between the prefilled flushing device and the fluid channel; and the syringe is coupled to the third port so that closing of the third port prevents fluid communication between the syringe and the fluid channel, wherein The syringe is 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 flushing device.

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

9. A blood collection method, the method comprising: A prefilled flushing device and a temporary discarded sample syringe are coupled to a catheter system, wherein the catheter system comprises: a catheter adapter comprising 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; a catheter extending from a 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, wherein the distal port and the proximal port are aligned with a longitudinal axis of the three-port connector, wherein the proximal end of the catheter adapter is coupled to the distal port of the three-port connector; an extension tube comprising a distal end and a proximal end, wherein the distal end of the extension tube is integrated with a side port of the three-port connector; and a three-way stopcock, wherein the three-way stopcock comprises a first port, a second port and a third port, the second port being opposite the first port, wherein a proximal end of the extension tube is coupled to the first port of the three-way stopcock, wherein the catheter system comprises a fluid passage in the catheter, the catheter adapter, the first extension tube, the three-port connector and the extension tube, wherein the second port, the third port and a proximal port of the three-port connector are configured to provide access to the fluid passage of the catheter system; wherein coupling a prefilled flushing device and a temporary sample discard syringe to the catheter system comprises connecting the prefilled flushing device to the second port such that closure of the second port prevents fluid communication between the prefilled flushing device and the fluid passage, and coupling of the temporary sample discard syringe to the third port such that closure of the third port prevents fluid communication between the syringe and the fluid passage; closing the second port; After closing the second port, blood is drawn into the temporary discard sample syringe.

10. The method according to claim 9, further comprising: After drawing blood into the temporarily discarded sample syringe, closing the first port; After closing the first port, blood is collected into a blood sampling device coupled to the proximal port of the three-port connector.

11. The method according to claim 10, wherein: The blood sampling device includes a catheter advancement device, and the method further includes advancing a secondary catheter of the catheter advancement device through the catheter.

12. The method according to claim 10, further comprising: After collecting blood into a blood sampling device coupled to the proximal port of the three-port connector, closing the second port again; as well as After the second port is closed again, the blood drawn into the temporary disposal syringe is returned to the patient.

13. The method according to claim 12, further comprising: After the blood drawn into the temporary disposal syringe is returned to the patient, the three-way stopcock is turned to the open position and the prefilled flushing device is activated to clear the catheter system with a single flush.

14. The method according to claim 9, wherein: The catheter system further includes a pressure transducer disposed between the second port and the pre-filled flushing device.

15. A blood collection method, comprising: Inserting a catheter system into a blood vessel of a patient, wherein the catheter system comprises: a catheter adapter comprising 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; a catheter extending from a 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, wherein the distal port and the proximal port are aligned with a longitudinal axis of the three-port connector, wherein a proximal end of a first extension tube is integrated with the distal port of the three-port connector; an extension tube comprising a distal end and a proximal end, wherein the distal end of the extension tube is integrated with a side port of the three-port connector; and A secondary catheter of a catheter advancement device is advanced through the catheter, wherein the catheter advancement device is coupled to a proximal port of the three-port connector.

16. The method according to claim 15, wherein: The blood vessel is an artery.

17. The method according to claim 15, wherein: The catheter system further includes a pressure transducer disposed between the second port and the pre-filled flushing device.

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

19. The method according to claim 15, wherein: The catheter system also includes a three-way stopcock, wherein the three-way stopcock includes a first port, a second port, and a third port, the second port being opposite to the first port, wherein the proximal end of the extension tube is connected to the first port of the three-way stopcock, and wherein the pressure transducer is connected to the second port.

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

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