Integrated catheter system for blood sampling

Abstract

The catheter system may include a catheter adapter, which may include a side port. The catheter system may include a catheter, a first extension tube having a distal end and a proximal end, and a second extension tube having a distal end and a proximal end. The distal end of the first extension tube may be integrated with the side port of the catheter adapter. The catheter system may include an access connector, which may include a distal port, a proximal port, and a side port. The proximal end of the first extension tube may be integrated with the distal port of the access connector. The distal end of the second extension tube may be integrated with the side port of the access connector. The first extension tube may be shorter than the second extension tube.

Description

[Technical Field]

[0001] background Arterial catheterization is a critical procedure used ubiquitously within hospitals for both critically injured and perioperative patients. It is estimated that more than 8 million arterial catheters are placed annually in the United States. Because arterial catheters can continuously and accurately measure not only blood pressure but also heart rate and pulse contours, hemodynamic abnormalities may be immediately recognized and appropriate treatment initiated. 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, putting the user at risk. Furthermore, current arterial catheters can be difficult to secure, maintain, and clean.

[0002] The subject matter claimed herein is not limited to embodiments that solve any shortcomings, nor does it operate only in environments such as those described above. Rather, this background is only provided to describe one example technology area in which some embodiments described herein may be practiced. Summary of the Invention

[0003] overview 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 arterial blood sampling, and related devices and methods. In some embodiments, the catheter systems may also be configured for blood pressure monitoring and / or blood gas sampling. Importantly, in some embodiments, the catheter systems may provide near-patient access 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.

[0004] In some embodiments, the catheter system may be referred to as an "integrated" catheter system, meaning that the catheter system includes an extension tube (e.g., an extension set) that provides a fluid pathway to the catheter. In some embodiments, the catheter system may be similar to the NEXIVA™ Closed IV Catheter System, the NEXIVA™ DIFFUSICS™ Closed IV Catheter System, or the PEGASUS™ Secure Closed IV Catheter System (all available from Becton Dickinson & Company, Franklin Lakes, New Jersey), or other suitable integrated catheter systems in one or more components and / or operation. 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 during insertion of the catheter into a patient's artery.

[0005] In some embodiments, the catheter system may include a catheter adapter, which may include 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. In some embodiments, the catheter adapter may also include a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter in fluid communication with the lumen. In some embodiments, the catheter system may include a catheter extending from the distal end of the catheter adapter.

[0006] In some embodiments, the catheter system may include a first extension tube, which may include a distal end and a proximal end. In some embodiments, the distal end of the first extension tube may be integral with the side port of the catheter adapter. More specifically, in some embodiments, the distal end of the first extension tube may be permanently or permanently coupled to the side port via, for example, adhesive, bonding, a non-luer connection, or another suitable permanent or non-removable connection.

[0007] In some embodiments, the catheter system may include an access connector, which may be configured to provide near-patient access. In some embodiments, the access 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 distal port and the proximal port may be aligned with a longitudinal axis of the access connector. In some embodiments, the side port may be angled relative to the longitudinal axis of the access connector. In some embodiments, the proximal end of the first extension tube may be integral with the distal port of the access connector.

[0008] In some embodiments, the catheter system may include a second extension tube, which may include a distal end and a proximal end. In some embodiments, the distal end of the second extension tube may be integrated with the side port of the access connector. In some embodiments, the first extension tube may be shorter than the second extension tube, such that the first extension tube facilitates advancement of a secondary catheter and / or sensor through the first extension tube. In some embodiments, the longitudinal axis of the access connector, the first extension tube, and the side port may be configured to align to form a linear path, which may facilitate advancement of the secondary catheter and / or sensor within the catheter system. In some embodiments, the first extension tube may be rigid or semi-rigid, which may facilitate advancement of the secondary catheter and / or sensor.

[0009] In some embodiments, the proximal port may include a female luer, which may facilitate connection of a blood sampling device to the access connector. In some embodiments, the proximal port may include another suitable connector. In some embodiments, a 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 PTVO™ needleless blood collection device available from Becton, Dickinson & Company, Inc., Franklin Lakes, New Jersey. In some embodiments, the blood sampling device may include another suitable blood sampling device.

[0010] In some embodiments, the catheter system may include a three-way stopcock valve, 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 and second ports. In some embodiments, the proximal end of the second extension tube may be coupled to the first port of the three-way stopcock valve. In some embodiments, the proximal end of the second extension tube may be integral with the first port, which may reduce the risk of fluid exposure to the user.

[0011] In some embodiments, the catheter system may include a fluid pathway within at least the catheter, the catheter adapter, the first extension tube, the access connector, and the second extension tube. In some embodiments, the second port, the third port, and the proximal port of the access 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 near-patient blood sample collection, the second port may be used to facilitate line cleaning with a single flush, and the third port may be used to temporarily withdraw blood from the patient to ensure a high-quality sample.

[0012] In some embodiments, the catheter system may include a pre-filled wash syringe coupled to a second port such that closing the second port, such as by rotating a central hub of the three-way stopcock valve, prevents fluid communication between the pre-filled wash syringe 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 a central hub of the 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 withdrawal.

[0013] In some embodiments, the catheter system may include a pressure monitoring device, which may be positioned between the second port and the pre-filled flush syringe, which may facilitate flushing of the catheter system with a single flush.

[0014] In some embodiments, the proximal end of the second extension tube may be integrated with an adapter, which may be configured to connect to one or more of a pre-filled wash syringe, a temporary waste sample syringe, and a three-way stopcock valve. In some embodiments, the adapter may be connected 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.

[0015] In some embodiments, the catheter system may be compact and easy to use and may improve workflow when collecting arterial or venous blood samples. In some embodiments, a method of blood collection may include connecting a prefilled wash syringe and a temporary waste 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 temporary waste sample syringe. In some embodiments, after drawing blood into the temporary waste sample syringe, the method may include closing the first port. In some embodiments, after closing the first port, the method may include collecting blood into a blood sampling device, which may be connected to a proximal port of the access 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) testing cartridge for point-of-care (POC) blood testing.

[0016] In some embodiments, the blood sampling device may include a catheter advancement device. In some embodiments, the method may include advancing a secondary catheter and / or a sensor of the catheter advancement device through a catheter of the catheter system. In some embodiments, after collecting blood with the blood sampling device coupled to the proximal port of the access connector, the method may include closing the second port at another time. In some embodiments, after closing the second port a second time, the method may include returning the drawn blood into the temporary waste syringe to the patient.

[0017] 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 depressing the pre-filled wash syringe to clean the catheter system in one flush. In some embodiments, the catheter system may include a pressure monitoring device, which may be located between the second port and the pre-filled wash syringe or in another suitable location.

[0018] In some embodiments, the method of blood collection may include inserting a catheter system into a blood vessel of a patient. In some embodiments, the method may include advancing a secondary catheter of the catheter advancement device through the catheter. In some embodiments, the catheter advancement device may be coupled to a proximal port of the access connector. In some embodiments, the longitudinal axis of the access connector, the first extension tube, and the side port are configured to align to form a linear path, and advancing the secondary catheter of the catheter advancement device through the catheter may include advancing the secondary catheter through the linear path. In some embodiments, the blood vessel may be an artery.

[0019] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as claimed. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality illustrated in the drawings. It is also to be understood that embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Accordingly, 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.

[0021] [Figure 1] FIG. 1 is a top perspective view of an exemplary catheter system 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 wash syringe, and an exemplary temporary waste 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, according to some embodiments. [Figure 2C] FIG. 2C is an enlarged top perspective view of a portion of the catheter system, according to some embodiments. [Figure 3A] FIG. 3A is a top perspective view of the catheter system showing the temporary waste sample syringe after a temporary waste sample has been taken, according to some embodiments. [Figure 3B] FIG. 3B is a top perspective view of the 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 the catheter system showing the ejection of blood from the blood sampling device onto an arterial blood gas (ABG) test cartridge for point-of-care (POC) blood testing, according to some embodiments. [Figure 3D] FIG. 3D is a top perspective view of the catheter system showing blood drawn into the temporary waste syringe being returned 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 the 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 monitoring device, according to some embodiments. [Figure 6B] FIG. 6B is a top perspective view of the catheter system showing an exemplary needleless connector between a pre-filled flush syringe and a pressure monitoring device, 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. DETAILED DESCRIPTION OF THE INVENTION

[0022] Description of the embodiment 1 , in some embodiments, the catheter system 10 may be configured for blood sampling, such as, for example, arterial blood sampling. In some embodiments, the catheter system 10 may also be configured for blood pressure monitoring and / or blood gas sampling. Importantly, in some embodiments, the catheter system 10 may provide near-patient access 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.

[0023] In some embodiments, the catheter system 10 may be referred to as an "integrated" catheter system, which may mean that the catheter system includes extension tubing (e.g., an extension set) that provides a fluid pathway to the catheter. In some embodiments, the catheter system 10 may be similar to the NEXIVA™ Closed IV Catheter System, the NEXIVA™ DIFFUSICS™ Closed IV Catheter System, or the PEGASUS™ Secure Closed IV Catheter System (all available from Becton Dickinson & Company, Franklin Lakes, NJ), or other suitable integrated catheter systems in one or more components and / or operation.

[0024] 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 comprise 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. Some existing arterial catheter systems, such as the Teleflex ARROW® integrated arterial catheter, may not provide effective arterial access confirmation or blood control, resulting in an insertion procedure with significant blood exposure risk, infection risk, cleanup costs, and patient discomfort. The Teleflex ARROW® integrated arterial catheter includes a non-rigid slotted tube that can leak significant blood, increasing the user's risk of blood exposure.

[0025] As described in further detail in this disclosure, 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 for use of secondary catheters and / or sensors; blood control configured to operate under arterial pressure; guidewires; and magnetic needle guidance technology.

[0026] 1 , in some embodiments, a 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 and the proximal end 16 of the catheter adapter 12. In some embodiments, the catheter adapter 12 may also include a side port 18 in fluid communication with the lumen between the distal end 14 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 other suitable catheter.

[0027] 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 comprise an "over-the-needle" catheter, and the introducer needle 21 may extend through the catheter 19 to aid 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 by visualization of blood in a flashback chamber or INSTAFLASH™), the needle hub 23 may be disconnected from the catheter adapter 12 and the introducer needle 21 may be removed.

[0028] In some embodiments, the catheter system 10 may include a first extension tube 20, which may include a distal end 22 and a proximal end 24. In some embodiments, the distal end 22 of the first extension tube 20 may be integrated with the side port 18 of the catheter adapter 12, which may reduce the risk of fluid exposure to the user. More specifically, in some embodiments, the distal end 22 of the first extension tube 20 may be permanently or permanently connected to the side port 18, for example, via adhesive, bonding, a non-luer connection, or another suitable permanent or permanent connection. In some embodiments, in response to insertion of the introducer needle 21 and entry of the catheter 19 into a blood vessel, blood may flow into the first extension tube 20. Thus, in some embodiments, the first extension tube 20 may improve confirmation of blood vessel entry.

[0029] In some embodiments, the catheter system 10 may include an access connector 26, which may be configured to provide near-patient access. In some embodiments, the access connector 26 may include a distal port 28, a proximal port 30, and a side port 32 between the distal port 28 of the access connector 26 and the proximal port 30 of the access connector 26. In some embodiments, the distal port 28 and the proximal port 30 may be aligned with a longitudinal axis 34 of the access connector 26. In some embodiments, the side port 32 may be angled relative to the longitudinal axis 34 of the access connector. For example, the side port 32 may be angled between 15 and 165 degrees relative to the longitudinal axis 34 and may form a T-shape or a Y-shape. In some embodiments, the side port 32 may be on the left or right side of the access connector 26 and / or may be configured to direct the second extension tube 36 away from the insertion site of the catheter into the blood vessel. In some embodiments, the proximal end 24 of the first extension tube 20 may be integral with the distal port 28 of the access connector 26, which may reduce the risk of fluid exposure to the user. More particularly, in some embodiments, the proximal end 24 of the first extension tube 20 may be permanently or permanently coupled to the distal port 28, for example, via adhesive, bonding, a non-luer connection, or other suitable permanent or non-removable connection.

[0030] In some embodiments, the catheter system 10 may include a second extension tube 36, which may include a distal end 38 and a proximal end 40. In some embodiments, the distal end 38 of the second extension tube 36 may be integral with the side port 32 of the access connector 26, which may reduce the risk of fluid exposure to the user. More specifically, in some embodiments, the distal end 38 of the second extension tube 36 may be permanently or permanently coupled to the side port 32, for example, via adhesive, bonding, a non-luer connection, or other suitable permanent or non-removable connection.

[0031] In some embodiments, the first extension tube 20 may be shorter than the second extension tube 36, which may facilitate the advancement of a secondary catheter and / or sensor therethrough. In some embodiments, the first extension tube 20 may be, for example, 1 inch (2.54 centimeters) or less, 2 inches (5.08 centimeters) or less, or 3 inches (7.62 centimeters) or less. In some embodiments, the longitudinal axis 34 of the access connector 26, the first extension tube 20, and the side port 18 may be configured to align to form a linear path, which may facilitate the advancement of a secondary catheter and / or sensor within the catheter system 10. In some embodiments, the first extension tube 20 may be rigid or semi-rigid and / or include a specific or targeted thickness, which may provide sufficient stiffness or non-compliance to facilitate the advancement of a secondary catheter and / or sensor therethrough and transmit more accurate pressure pulses, resulting in more accurate pressure measurements.

[0032] As shown in FIG. 1 , in some embodiments, proximal port 30 may include a female luer, which may facilitate connection of a blood sampling device to access connector 26. In some embodiments, proximal port 30 may include another type of connector. Referring now to FIG. 2A , in some embodiments, blood sampling device 42 may be coupled to proximal port 30. In some embodiments, proximal port 30 may be colored red to indicate that proximal port 30 provides arterial access. In some embodiments, blood sampling device 42 may include a vacuum tube or a syringe. In some embodiments, 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, a PIVO™ needleless 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, the blood sampling device 42 may be configured to advance a secondary catheter and / or sensor through a linear path and / or through the catheter 19 into a patient's blood vessel, such as an artery.

[0033] 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 is known in the art. In some embodiments, the proximal end 40 of the second 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 second extension tube 36 may be integral with the first port 46, which may reduce the risk of fluid exposure to a user. More specifically, in some embodiments, the proximal end 40 of the second extension tube 36 may be permanently or permanently coupled to the first port 46, for example, via adhesive, bonding, a non-luer connection, or other 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 may facilitate connection to a device.

[0034] In some embodiments, the catheter system 10 may include a fluid pathway within at least the catheter 19, the catheter adapter 12, the first extension tube 20, the access connector 26, and the second extension tube 36. In some embodiments, the second port 48, the third port 50, and the proximal port 30 of the access 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.

[0035] In some embodiments, one or more of the first port 46, the second port 48, and the third port 50 may be permanently attached to the body of the three-way stopcock valve 44 about which the central hub 52 rotates and / or may be integrally formed as a single unit. 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 blood sample collection, the second port 48 may be used to facilitate cleaning of the catheter system 10, including the fluid pathway, 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, the first port 46, the second port 48, and the third port 50 may include a vent plug or end cap.

[0036] In some embodiments, the catheter system 10 may include a pre-filled wash syringe 54 coupled to the second port 48 such that closing of 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 wash syringe 54 and the fluid pathway. In some embodiments, a temporary waste sample syringe 56 may be coupled to the third port 50 such that closing of the third port 50, such as by rotating the central hub 52 of the three-way stopcock valve 44, prevents fluid communication between the temporary waste sample syringe 56 and the fluid pathway. In some embodiments, the temporary waste sample syringe 56 may be configured to temporarily withdraw blood from a patient.

[0037] 2B-2C, in some embodiments, the proximal end 40 of the second extension tube 36 may be integral with an adapter 58, which may be configured to connect to one or more of a prefilled wash syringe 54, a temporary waste sample syringe 56, and a three-way stopcock valve 44. As shown in FIG. 2B, in some embodiments, the adapter 58 may be connected 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 other suitable detachable needleless connectors as known in the art, which may be designed to reduce the risk of bacterial contamination.

[0038] 3A-3E, in some embodiments, the catheter system 10 may include a pressure monitoring device 62, which may include a pressure transducer. In some embodiments, the pressure transducer may include a TRANSPAC® IV disposable pressure transducer (available from ICU Medical) or any other suitable pressure transducer. In some embodiments, the pressure monitoring device 62 may be positioned between the second port 48 and the pre-filled flush syringe 54, which may facilitate flushing of the catheter system 10 with a single flush. More specifically, in some embodiments, when the second port 48 is open, the temporary waste sample syringe 56 and blood sampling device 42 are removed, and the pre-filled wash syringe 54 is actuated by depressing the plunger of the pre-filled wash syringe 54, and fluid within the syringe may travel through the pressure monitoring device 62 to clean the second port 48, the third port 50, the first port 46, the second extension tube 36, the access 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 within the pre-filled wash syringe 54 may comprise saline or another suitable cleaning solution. In some embodiments, a configuration to clean the catheter system 10 in a single flush may reduce the amount of fluid required for cleaning.

[0039] In some embodiments, the catheter system 10 may be compact, easy to use, and may improve workflow when collecting arterial or venous blood samples. In some embodiments, a method of blood collection 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 monitoring device 62. In some embodiments, the method of blood collection may include coupling a pre-filled wash syringe 54 and / or a temporary waste sample syringe 56 to the catheter system 10. In some embodiments, the method may include closing the second port 48 (while leaving the third port 50 and the first port 46 open), as shown in FIG. 3A , for example. In some embodiments, after closing the second port 48, the method may include drawing blood from the blood vessel into the temporary waste sample syringe 56. This may be accomplished by pulling the plunger of the temporary waste sample syringe 56. 3B, in some embodiments, after drawing blood into temporary waste sample syringe 56, the method may include closing first port 46. In some embodiments, after closing first port 46, the method may include collecting the blood in blood sampling device 42, which may be coupled to proximal port 30 of access connector 26.

[0040] 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™ needleless blood collection device available from Becton Dickinson of Franklin Lakes, New Jersey, or other 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.

[0041] 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) testing cartridge for point-of-care (POC) blood testing.

[0042] 3D , in some embodiments, after drawing blood with blood sampling device 42 coupled to proximal port 30 of access connector 26, the method may include once again closing second port 48 (which may leave third port 50 and first port 46 open). In some embodiments, after once again closing second port 48, the method may include returning the blood drawn into temporary waste sample syringe 56 back into the patient, such as by depressing the plunger of temporary waste sample syringe 56.

[0043] 3E, in some embodiments, the method may include returning blood drawn into the temporary waste sample syringe 56 to the patient, then turning the three-way stopcock valve 44 to an open position (such that the third port 50, the second port 48, and the first port 46 are each open) and depressing the pre-filled wash syringe 54 to clean the catheter system 10 with a single wash. In some embodiments, the catheter system 10 may include a pressure monitoring device 62, which may be located between the second port 48 and the pre-filled wash syringe 54 or in another suitable location.

[0044] 4A-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., 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 air to escape but 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 promoting a secure connection.

[0045] In some embodiments, one of the dual ports at the proximal end 64 may be connected to a temporary waste sample syringe to temporarily withdraw a blood sample prior to blood sampling from the proximal port 30 of the access connector 26, to which a specific blood sampling device may be connected (e.g., the PIVO™ Needleless Blood Collection Device, available from Becton, Dickinson & Company, Franklin Lakes, New Jersey). In some embodiments, after blood sampling from the proximal port 30 of the access connector 26, the catheter system 10 may be cleaned with a single flush by actuating a pre-filled wash syringe. In some embodiments, the other of the dual ports at the proximal end 64 may be connected to a pre-filled wash syringe. In some embodiments, the dual port may allow a temporary waste sample syringe and a pre-filled wash syringe to be simultaneously connected to the proximal end 64.

[0046] In some embodiments, one or more 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 wash syringe and / or a temporary waste sample syringe may be coupled to the proximal end 64 via a needleless connector.

[0047] 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 promoting 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 PTVO™ needleless blood collection device, because a PTVO™ needleless blood collection device or other catheter advancement device may be coupled to the proximal port 30 of the access connector 26 and extend through the proximal port 30, the first extension tube 20, the side port 18, and the catheter 19 to access a blood vessel for blood sampling. Thus, in some embodiments, the second extension tube 36 may be more flexible than the first extension tube 20, which allows it to bend when a user couples a device to the proximal end 64, reducing the risk of disturbing the insertion site. In some embodiments, the second extension tube 36 may be longer than the first extension tube 20, reducing the risk of disturbing the insertion site when a user couples a device to the proximal end 64.

[0048] 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.

[0049] 5A-5B, in some embodiments, the dual port may include an offset side port 72 from 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 be non-planar with the axial port 74 and may promote cleaning by creating turbulent flow. In some embodiments, the offset side port 72 may correspond in one or more characteristics 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 characteristics 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 lumen of the adapter 58 may include one or more fluid deflection ramps 78, which may promote cleaning by creating turbulent flow. Additionally or alternatively, in some embodiments, a fluid deflection ramp 78 may be disposed within the proximal port 30 of the access connector 26 to create turbulence and enhance irrigation at the patient proximal port.

[0050] 6A-6B, the pressure monitoring device 62 may be operably coupled to a pressure transducer electrical connector 80, which may extend from the pressure monitoring device 62 (see also FIGS. 3A-3E). In some embodiments, the proximal end of the pressure monitoring device 62 may be coupled to the needleless connector 60, which may reduce the risk of bacterial contamination. In some embodiments, a pre-filled flush syringe 54 may be coupled to the pressure monitoring device 62 or the needleless connector 60, which may facilitate flushing of the catheter system 10 via a single flush. In some embodiments, the pressure monitoring device 62 may be coupled to the third port 50 or another suitable location. In some embodiments, the pressure monitoring device 62 may be coupled to the third port 50 or the proximal port 30 of the access connector 26 to provide accurate measurements due to its proximity to the blood vessel. In some embodiments, the needleless connector 60 and / or a fluid delivery line may be coupled to the pressure monitoring device 62. FIG. 6B illustrates a pre-filled flush syringe 54 coupled to the proximal end of the needleless connector 60, and FIG. 6A illustrates the proximal end of the needleless connector 60 free, according to some embodiments.

[0051] In some embodiments, the first extension tube 20 and / or the second extension tube 36 may be rigid or semi-rigid. In some embodiments, the second extension tube 36 may be rigid or semi-rigid, which may facilitate more accurate pressure measurements with the pressure monitoring device 62. In some embodiments, the pressure monitoring device 62 coupled to the three-way stopcock valve 44 may provide the advantage of monitoring arterial pressure much closer to the patient than existing systems, which may facilitate more accurate pressure measurements with the pressure monitoring device 62.

[0052] 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, a second sampling port 86 may provide an alternative or additional location for blood sampling other than the access connector 26. 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 access connector 26, negating the need for the second sampling port 86 in some embodiments.

[0053] In some embodiments, the temporary waste sample syringe 88 may be secured to the hemodynamic monitoring system 82, if desired, along with the hemodynamic monitoring system sensor 84. In some embodiments, the line 90, which may include pressure tubing, may be fluidly connected to the catheter system 10 via a connector 92.

[0054] 8 , in some embodiments, line 90 may be connected to a blood purification system 94, which may be near the patient and / or closed. In some embodiments, blood purification system 94 may be in-line and facilitate collection of a transient blood draw that can later be reinfused or pumped back into the patient. In some embodiments, after the transient blood draw is collected in a reservoir of blood purification system 94 by raising plunger 95 of blood purification system 94, isolation valve 97 may be closed to prevent fluid communication with line 90 and the withdrawal of blood from the reservoir. In some embodiments, with isolation valve 97 closed, a blood sample may be drawn 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, Inc. of Franklin Lakes, New Jersey. In some embodiments, after the blood sample is drawn, the isolation valve 97 is opened and the plunger 95 of the blood purification system 94 is compressed or depressed, and the temporary blood draw volume in the reservoir is reinfused into the patient. In some embodiments, the blood purification 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 near-patient blood collection and may facilitate use of the catheter system 10 with a catheter advancement device.

[0055] All examples and conditional language incorporated herein are intended for educational purposes to aid the reader in understanding the invention and the concepts contributed by the inventors to further develop the art, and should not be construed as being limited to such specifically incorporated 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. The catheter system 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; and a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter in fluid communication with the lumen; a catheter extending from the distal end of the catheter adapter; a first extension tube having a distal end and a proximal end, the distal end of the first extension tube being integral with the side port of the catheter adapter; an access 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 access connector, the side port being angled with respect to the longitudinal axis of the access connector, and the proximal end of the first extension tube being integral with the distal port of the access connector; and a second extension tube having a distal end and a proximal end, the distal end of the second extension tube being integral with the side port of the access connector, the first extension tube being shorter than the second extension tube; A catheter system comprising:

2. The catheter system of claim 1 , wherein the longitudinal axis of the access connector, the first extension tube, and the side port are configured to align and form a linear path.

3. The catheter system of claim 2 , wherein the first extension tube is rigid or semi-rigid.

4. The catheter system of claim 1 , wherein the proximal port comprises a female luer.

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

6. 2. The catheter system of claim 1, further comprising 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 second extension tube being connected to the first port of the three-way stopcock valve.

7. The catheter system of claim 6 , wherein the proximal end of the second extension tube is integral with the first port.

8. 7. The catheter system of claim 6, wherein the catheter system comprises a fluid pathway within the catheter, the catheter adapter, the first extension tube, the access connector, and the second extension tube, and wherein the second port, the third port, and the proximal port of the access connector are configured to provide access to the fluid pathway of the catheter system.

9. 9. The catheter system of claim 8, further comprising: a pre-filled wash syringe coupled to the second port, wherein closure of the second port prevents fluid communication between the pre-filled wash syringe and the fluid pathway; and a syringe coupled to the third port, wherein closure of the third port prevents fluid communication between the syringe and the fluid pathway, the syringe configured for temporary blood withdrawal.

10. The catheter system of claim 9, further comprising a pressure monitoring device disposed between the second port and the pre-filled flush syringe.

11. 10. The catheter system of claim 1, wherein the proximal end of the second extension tube is integral with an adapter, the adapter is connected to a needleless connector, and the proximal end of the adapter comprises a single port or a dual port.

12. 1. A method of blood collection comprising: connecting the pre-filled wash syringe and the temporary waste sample syringe to a catheter system, said 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; and a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter in fluid communication with the lumen; a catheter extending from the distal end of the catheter adapter; a first extension tube having a distal end and a proximal end, the distal end of the first extension tube being integral with the side port of the catheter adapter; an access 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 access connector, the side port being angled relative to the longitudinal axis of the access connector, and the proximal end of the first extension tube being integral with the distal port of the access connector; a second extension tube having a distal end and a proximal end, the distal end of the second extension tube being integral with the side port of the access connector, and the first extension tube being shorter than the second extension tube; and 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 second 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 access connector, and a fluid pathway within the second extension tube, the second port, the third port, and the proximal port of the access connector being configured to provide access to the fluid pathway of the catheter system; coupling the pre-filled wash syringe and the temporary waste sample syringe to the catheter system by coupling the pre-filled wash syringe to the second port and closing the second port to prevent fluid communication between the pre-filled wash syringe and the fluid pathway, and coupling the temporary waste sample syringe to the third port and closing the third port to prevent fluid communication between the syringe and the fluid pathway; closing the second port; and drawing blood into the temporary waste sample syringe after closing the second port; A method comprising:

13. closing the first port after drawing blood into the temporary waste sample syringe; and collecting blood in a blood sampling device coupled to the proximal port of the access connector after closing the first port; The method of claim 12 further comprising:

14. 14. The method of claim 13, wherein the blood sampling device comprises a catheter advancement device, and further comprising advancing a secondary catheter of the catheter advancement device through the catheter.

15. collecting blood in the blood sampling device coupled to the proximal port of the access connector, and then closing the second port again; and closing the second port again and then returning the blood drawn into the temporary waste syringe to the patient; 14. The method of claim 13, further comprising:

16. returning the blood drawn into the temporary waste syringe to the patient, then turning the three-way stopcock valve to an open position and depressing the pre-filled flush syringe to clean the catheter system in one flush; 16. The method of claim 15, further comprising:

17. 13. The method of claim 12, further comprising a pressure monitoring device disposed between the second port and the pre-filled flush syringe.

18. 1. A method of blood collection comprising: Inserting a catheter system into a blood vessel of a patient, the 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; and a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter in fluid communication with the lumen; a catheter extending from the distal end of the catheter adapter; a first extension tube having a distal end and a proximal end, the distal end of the first extension tube being integral with the side port of the catheter adapter; an access 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 access connector, the side port being angled with respect to the longitudinal axis of the access connector, and the proximal end of the first extension tube being integral with the distal port of the access connector; and a second extension tube having a distal end and a proximal end, the distal end of the second extension tube being integral with the side port of the access connector, and the first extension tube being shorter than the second extension tube; and advancing a secondary catheter of a catheter advancement device through the catheter, the catheter advancement device being coupled to the proximal port of the access connector.

19. 20. The method of claim 18, wherein the longitudinal axis of the access connector, the first extension tube, and the side port are configured to align to form a linear path, and advancing the secondary catheter of the catheter advancement device through the catheter comprises advancing the secondary catheter through the linear path.

20. 20. The method of claim 19, wherein the blood vessel is an artery.

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