Integrated catheter system configured for blood sampling

Abstract

A 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 distal 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

Background Art

[0001] Arterial catheterization is a critical procedure that is used extensively in hospital settings for both critically injured and perioperative patients. It is estimated that more than 8 million arterial catheters are placed in the United States each year. Arterial catheters allow for continuous and accurate measurement of blood pressure, heart rate, and pulse curves so that abnormal hemodynamic events can be immediately identified and appropriate treatment initiated. Arterial catheters also provide samples for blood gas analysis without the morbidity associated with repeated arterial punctures. However, during insertion into a patient's artery, the use of current arterial catheters can result in significant blood leakage, which can endanger the user. In addition, current arterial catheters can be difficult to secure, 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 provided merely to illustrate one example technology area in which some embodiments described herein may be practiced. Summary of the invention

[0003] The present disclosure generally relates to vascular access devices, systems and methods. In particular, the present disclosure relates to a catheter system and related devices and methods, wherein the catheter system is configured for blood sampling, such as arterial blood sampling. 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 near-patient access for more accurate hemodynamic measurements, as well as provide improvements in the delivery of instruments (e.g., auxiliary catheters and / or sensors) in a blood vessel, which can include an artery or a vein.

[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 kit) that provides fluid access to the catheter. In some embodiments, the catheter system may be similar to NEXIVA in one or more components and / or operation. TM Closed IV catheter system, NEXIVA TM DIFFUSICS TM Closed IV catheter system, or PEGASUS TM A secure closed IV catheter system (all available from Becton, Dickinson & Company of Franklin Lakes, NJ) or another suitable integrated catheter system. In some embodiments, the catheter system can include a guidewire for improving the success rate of catheter insertion. In some embodiments, the catheter system can reduce blood exposure when inserting a 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 an inner cavity 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 located between the distal end of the catheter adapter and the proximal end of the catheter adapter and in fluid communication with the inner cavity. 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 integrated with a side port of the catheter adapter. In more detail, in some embodiments, the distal end of the first extension tube may be permanently or non-removably coupled to the side port, for example, by an adhesive, a bond, a non-Luer connection, or another suitable permanent or non-removable connection.

[0007] In some embodiments, the catheter system may include an access connector that 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 the 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 integrated 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 a side port of the access connector. In some embodiments, the first extension tube may be shorter than the second extension tube so that the first extension tube facilitates the advancement of an auxiliary catheter and / or a 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 straight path, which may facilitate the advancement of an auxiliary catheter and / or a sensor within the catheter system. In some embodiments, the first extension tube may be rigid or semi-rigid, which may facilitate the advancement of an auxiliary catheter and / or a sensor through the first extension tube.

[0009] In some embodiments, the proximal port can include a female Luer connector, which can facilitate coupling the blood sampling device to the access connector. In some embodiments, the proximal port can include another suitable connector. In some embodiments, the blood sampling device can be coupled to the proximal port. In some embodiments, the blood sampling device can include a catheter advancement device, such as a PIVO TMA needle-free blood collection device, which can be obtained from Becton, Dickinson & Company, Franklin Lakes, N.J. In some embodiments, the blood sampling device can include another suitable blood sampling device.

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

[0011] In some embodiments, the catheter system may include at least a fluid channel within a catheter, a catheter adapter, a first extension tube, an access connector, and a 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 channel 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 channel. In some embodiments, the catheter system may not include other access points from the surrounding environment to the fluid channel, 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 cleaning of the pipeline by a single flush, and the third port may be used to temporarily draw blood from the patient to ensure high-quality samples.

[0012] In some embodiments, the catheter system can include a pre-filled flush syringe coupled to the second port, such that closing of the second port (e.g., by rotating the center hub of a three-way stopcock) prevents fluid communication between the pre-filled flush syringe and the fluid channel. In some embodiments, a temporary disposable sample syringe can be coupled to the third port, such that closing of the third port (e.g., by rotating the center hub of a three-way stopcock) prevents fluid communication between the temporary disposable sample syringe and the fluid channel. In some embodiments, the temporary disposable sample syringe can be configured for temporary blood draws.

[0013] In some embodiments, the catheter system may include a pressure monitoring device. In some embodiments, the pressure monitoring device may be disposed 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 can be integrated with an adapter that can be configured to be coupled to one or more of a prefilled flush syringe, a temporary disposable sample 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.

[0015] 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 can include connecting a prefilled flush syringe and a temporary disposable sample syringe to the catheter system and closing the second port. In some embodiments, after closing the second port, the method can include drawing blood into the temporary disposable sample syringe. In some embodiments, after drawing blood into the temporary disposable sample syringe, the method can include closing the first port. In some embodiments, after closing the first port, the method can include collecting blood in a blood sampling device, which can be connected to a proximal port of an access connector. In some embodiments, the blood sampling device can include a heparinized syringe, and the blood can then be dispensed into an arterial blood gas (ABG) test cartridge for point-of-care (POC) blood testing.

[0016] In some embodiments, the blood sampling device may include a catheter propulsion device. In some embodiments, the method may include propelling the auxiliary catheter and / or the sensor of the catheter propulsion device through the catheter of the catheter system. In some embodiments, after collecting blood in the blood sampling device connected to the proximal port of the access 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 the temporary disposable syringe to the patient.

[0017] In some embodiments, after returning the blood drawn into the temporary disposable syringe to the patient, the method may include turning the three-way stopcock to an open position and pushing the prefilled flush syringe to clean the catheter system with a single flush. In some embodiments, the catheter system may include a pressure monitoring device that may be disposed between the second port and the prefilled flush syringe or at another suitable location.

[0018] 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 an auxiliary catheter of a catheter advancement device through the catheter. In some embodiments, the catheter advancement device may be coupled to a proximal port of an 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 straight path, and advancing the auxiliary catheter of the catheter advancement device through the catheter may include advancing the auxiliary catheter through the straight path. In some embodiments, the blood vessel may be an artery.

[0019] It should be understood that the above general description and the following detailed description are exemplary and explanatory and are not limitations of the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that these embodiments may be combined, or 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 required. Therefore, the following detailed description is not intended to be limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Through the use of the accompanying drawings, exemplary embodiments will be described and explained with additional specificity and detail, in which:

[0021] Figure 1 is an upper perspective view of an exemplary catheter system according to some embodiments;

[0022] Figure 2A is an upper perspective view of a catheter system according to some embodiments, showing an exemplary three-way stopcock, an exemplary pre-filled flush syringe, and an exemplary temporary disposable sample syringe;

[0023] Figure 2B is an upper perspective view of a catheter system according to some embodiments, showing a three-way stopcock;

[0024] Figure 2C is an enlarged upper perspective view of a portion of a catheter system according to some embodiments;

[0025] Figure 3A is an upper perspective view of a catheter system according to some embodiments, showing a temporarily disposable sample syringe after collecting a temporarily disposable sample;

[0026] Figure 3B is an upper perspective view of a catheter system according to some embodiments, illustrating blood collection in an exemplary blood sampling device;

[0027] Figure 3Cis 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;

[0028] Figure 3D is an upper perspective view of a catheter system according to some embodiments, showing blood drawn into a disposable syringe returning to a patient;

[0029] Figure 3E is an upper perspective view of a catheter system according to some embodiments, illustrating flushing of the catheter system;

[0030] Figure 4A is an upper perspective view of a catheter system according to some embodiments, illustrating an exemplary adapter including a proximal end having dual ports;

[0031] Figure 4B is an upper perspective view of a catheter system according to some embodiments, showing an adapter dual Luer port;

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

[0033] Figure 4D is an upper perspective view of a catheter system according to some embodiments, showing a three-way stopcock;

[0034] Figure 5A is an upper perspective view of an adapter according to some embodiments, showing a proximal end having dual Luer ports;

[0035] Figure 5B is a cross-sectional view of an adapter showing a proximal end having dual Luer ports according to some embodiments;

[0036] Fig. 6A is an upper perspective view of a catheter system according to some embodiments, showing an exemplary needleless connector coupled to an exemplary pressure monitoring device;

[0037] Figure 6B is an upper perspective view of a catheter system according to some embodiments, showing an exemplary needleless connector between a prefilled flush syringe and a pressure monitoring device;

[0038] Figure 7 is an upper perspective view of a catheter system coupled to a hemodynamic monitoring system according to some embodiments;

[0039] 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. DETAILED DESCRIPTION

[0040] Reference now Figure 1 In some embodiments, the catheter system 10 can be configured for blood sampling, such as arterial blood sampling. In some embodiments, the catheter system 10 can also be configured for blood pressure monitoring and / or blood gas sampling. Importantly, in some embodiments, the catheter system 10 can provide near-patient access for more accurate hemodynamic measurements, as well as provide improved delivery of instruments (e.g., auxiliary catheters and / or sensors) in a blood vessel, which can include an artery or a vein.

[0041] In some embodiments, the catheter system 10 can be referred to as an "integrated" catheter system, meaning that the catheter system includes an extension tube (e.g., an extension kit) that provides fluid access to the catheter. In some embodiments, the catheter system 10 can be similar to the NEXIVA TM Closed IV catheter system, NEXIVA TM DIFFUSICS TM Closed IV catheter system, or PEGASUS TM A Safety Closed IV Catheter System (all available from Becton, Dickinson & Company, Franklin Lakes, NJ) or another suitable integrated catheter system.

[0042] In some embodiments, the catheter system 10 may include an arterial catheter system configured to be inserted 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 the user with improved arterial access confirmation, and improving the overall patient experience. Some existing arterial catheter systems, such as the Teleflex ARROW ® Integrated arterial catheters may not provide effective arterial access confirmation or blood control, which can result in significant blood exposure risk during the placement procedure, infection risk, cleaning costs, and a poor patient experience. Teleflex ARROW ® 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.

[0043] As explained in further detail in the present 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 with auxiliary catheters and / or sensors; blood control configured to operate at arterial pressure; a guidewire; and magnetic introducer needle guidance technology.

[0044] like Figure 1 As shown, 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 an inner cavity 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 adapter 12 may also include a side port 18, which is located between the distal end 14 of the catheter adapter 12 and the proximal end 16 of the catheter adapter 12 and is in fluid communication with the inner cavity. 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.

[0045] In some embodiments, catheter system 10 may include an introducer needle 21 coupled to a needle hub 23. In some embodiments, catheter 19 may include a "over-the-needle" type catheter, and introducer needle 21 may extend through catheter 19 to assist in inserting catheter 19 into a patient's blood vessel. In some embodiments, after catheter 19 is inserted into the blood vessel (which may be performed by the user in a flashback chamber or INSTAFLASH TM The needle hub 23 can be disconnected from the catheter adapter 12 and the introducer needle 21 can be removed.

[0046] 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. In more detail, in some embodiments, the distal end 22 of the first extension tube 20 may be permanently or non-removably connected to the side port 18, for example, by an adhesive, a bond, a non-Luer connection, or another suitable permanent or non-removable connection. In some embodiments, blood may flow into the first extension tube 20 in response to the insertion of the introducer needle 21 and the entry of the catheter 19 into the blood vessel. Therefore, in some embodiments, the first extension tube 20 may provide an improvement in confirmation of blood vessel entry.

[0047] In some embodiments, the catheter system 10 may include an access connector 26 that 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 the 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 at an angle of 15 to 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 guide the second extension tube 36 away from the insertion site of the catheter in the blood vessel. In some embodiments, the proximal end 24 of the first extension tube 20 may be integrated with the distal port 28 of the access connector 26, which may reduce the risk of fluid exposure to the user. In more detail, in some embodiments, the proximal end 24 of the first extension tube 20 can be permanently or non-removably coupled to the distal port 28, such as by an adhesive, bonding, a non-Luer coupling, or another suitable permanent or non-removable coupling.

[0048] 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 integrated with the side port 32 of the access connector 26, which may reduce the risk of fluid exposure to the user. In more detail, in some embodiments, the distal end 38 of the second extension tube 36 may be permanently or non-removably coupled to the side port 32, for example, by an adhesive, a bond, a non-Luer coupling, or another suitable permanent or non-removable coupling.

[0049] In some embodiments, the first extension tube 20 can be shorter than the second extension tube 36, which can facilitate advancing the auxiliary catheter and / or sensor through the first extension tube 20. In some embodiments, for example, the first extension tube 20 can be less than or equal to 1 inch, less than or equal to 2 inches, or less than or equal to 3 inches. In some embodiments, the longitudinal axis 34 of the access connector 26, the first extension tube 20, and the side port 18 can be configured to align to form a straight path, which can facilitate advancing the auxiliary catheter and / or sensor within the catheter system 10. In some embodiments, the first extension tube 20 can be rigid or semi-rigid, and / or can include a specific thickness or target thickness, which can facilitate advancing the auxiliary catheter and / or sensor through the first extension tube, as well as provide sufficient stiffness or non-compliance to transmit more accurate pressure pulses, thereby causing more accurate pressure measurements.

[0050] like Figure 1As shown, in some embodiments, the proximal port 30 can include a female Luer connector, which can facilitate coupling a blood sampling device to the access connector 26. In some embodiments, the proximal port 30 can include another type of connector. Figure 2A 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 a PIVO TM Needle-free blood collection device, which can be obtained from Becton, Dickinson & Company of Franklin Lakes, New Jersey. In some embodiments, blood sampling device 42 can include another suitable blood sampling device. In some embodiments, blood sampling device 42 can be configured to advance an auxiliary catheter and / or sensor through a straight path and / or through catheter 19 into a patient's blood vessel, such as an artery.

[0051] 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 may 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 second extension tube 36 may be coupled to the first port 46 of the three-way stopcock 44. In some embodiments, the proximal end 40 of the second extension tube 36 may be integrated with the first port 46, which may reduce the risk of fluid exposure to the user. In more detail, in some embodiments, the proximal end 40 of the second extension tube 36 may be permanently or non-removably coupled to the first port 46, for example, by 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 connector, such as a female Luer connector, which may facilitate the connection to a device.

[0052] In some embodiments, the catheter system 10 may include fluid pathways 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 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.

[0053] In some embodiments, one or more of the first port 46, the second port 48, and the third port 50 may be non-removable and / or integrally formed with the body of the three-way stopcock 44 as a single unit, 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 coupled to a 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 blood sample collection, 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 end cap.

[0054] In some embodiments, the catheter system 10 may include a pre-filled flush syringe 54 coupled to the second port 48, such that closing of the second port 48 (e.g., by rotating the central hub 52 of the three-way stopcock 44) prevents fluid communication between the pre-filled flush syringe 54 and the fluid channel. In some embodiments, a temporary disposable sample syringe 56 may be coupled to the third port 50, such that closing in the third port 50 (e.g., by rotating the central hub 52 of the three-way stopcock 44) prevents fluid communication between the temporary disposable sample syringe 56 and the fluid channel. In some embodiments, the temporary disposable sample syringe 56 may be configured to temporarily draw blood from a patient.

[0055] Reference now Figure 2B-2C In some embodiments, the proximal end 40 of the second extension tube 36 can be integrated with an adapter 58, which can be configured to be coupled to one or more of the pre-filled flushing syringe 54, the temporary disposable sample syringe 56, and the three-way stopcock 44. Figure 2BAs shown, in some embodiments, the adapter 58 can be coupled to a needleless connector 60, which can reduce the risk of bacterial contamination. As described in the present disclosure, the term "needleless connector" can refer to MAXZERO TM A needleless connector (available from Becton, Dickinson & Company) or another suitable removable needleless connector known in the art, which can be designed to reduce the risk of bacterial contamination.

[0056] Reference now Figures 3A-3E In some embodiments, the catheter system 10 may include a pressure monitoring device 62, which may include a pressure transmitter. In some embodiments, the pressure transmitter may include a TRANSPAC ® IV disposable pressure transmitter (available from ICU Medical) or any other suitable pressure transmitter. In some embodiments, the pressure monitoring device 62 can be disposed between the second port 48 and the pre-filled flush syringe 54, which can facilitate flushing of the catheter system 10 by a single flush. In more detail, in some embodiments, when the second port 48 is opened, the temporary disposable sample syringe 56 and the blood sampling device 42 are removed, and the pre-filled flush syringe 54 is actuated by depressing the plunger of the pre-filled flush syringe 54, the fluid in the syringe can travel through the pressure monitoring device 62 and 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 in the pre-filled flush syringe 54 can include saline or another suitable flushing solution. In some embodiments, the configuration of the catheter system 10 for cleaning by a single flush can reduce the amount of fluid required for flushing.

[0057] 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 blood collection method can 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 can be performed while monitoring arterial blood pressure via a pressure monitoring device 62. In some embodiments, the blood collection method can include connecting a pre-filled flush syringe 54 and / or a temporary disposable sample syringe 56 to the catheter system 10. In some embodiments, the method can include closing the second port 48 (which can leave the third port 50 and the first port 46 open), for example, as Figure 3AIn some embodiments, after closing the second port 48, the method may include drawing blood from the blood vessel into the temporary disposable sample syringe 56. This may be achieved by pulling the plunger of the temporary disposable sample syringe 56. For example, Figure 3B As shown, in some embodiments, after drawing blood into the disposable 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 in a blood sampling device 42, which may be coupled to the proximal port 30 of the access connector 26.

[0058] In some embodiments, the blood sampling device 42 may include a catheter advancement device configured to advance an auxiliary 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 TM A needleless blood collection device (which can be obtained from Becton, Dickinson & Company of Franklin Lakes, NJ) or another suitable catheter advancement device. In some embodiments, the method may include advancing the auxiliary catheter and / or the sensor of the catheter advancement device through the catheter 19 of the catheter system 10.

[0059] For example, Figure 3C As shown, in some embodiments, the blood sampling device 42 may include a heparinized syringe, and blood drawn into the heparinized syringe by withdrawing the plunger of the heparinized syringe may then be dispensed into an arterial blood gas (ABG) test cartridge for point-of-care (POC) blood testing.

[0060] For example, Figure 3D As shown, in some embodiments, after collecting blood in the blood sampling device 42 coupled to the proximal port 30 of the access 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 disposable sample syringe 56 to the patient, for example by depressing the plunger of the temporary disposable sample syringe 56.

[0061] For example, Figure 3EAs shown, in some embodiments, the method may include, after returning the blood drawn into the temporary disposable sample syringe 56 to the patient, 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 pushing the pre-filled flush syringe 54 to clean the catheter system 10 by a single flush. In some embodiments, the catheter system 10 may include a pressure monitoring device 62, which may be disposed between the second port 48 and the pre-filled flush syringe 54 or at another suitable location.

[0062] Reference now Figures 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., 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 connector to facilitate removable connection to another device. In some embodiments, a vent plug 70 may be disposed within the Luer port 66a, which may allow for ventilation of air 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 on the collar, so that the collar may facilitate a secure connection.

[0063] In some embodiments, one of the two ports at the proximal end 64 can be connected to a temporary disposable sample syringe to temporarily draw a blood sample before sampling blood from the proximal port 30 of the access connector 26, a specific blood sampling device (e.g., PIVO TM A needle-free blood collection device (available from Becton, Dickinson & Company of Franklin Lakes, NJ) can be coupled to the proximal port of the access connector. In some embodiments, after sampling blood from the proximal port 30 of the access connector 26, the catheter system 10 can be cleaned with a single flush by actuating a prefilled flush syringe. In some embodiments, the other of the dual ports of the proximal end 64 can be coupled to a prefilled flush syringe. In some embodiments, the dual ports can allow a temporary disposable sample syringe and a prefilled flush syringe to be coupled to the proximal end 64 at the same time.

[0064] In some embodiments, one or more of the dual ports can include a removable needleless connector that is coupled to a non-removable portion of a corresponding one of the dual ports. In some embodiments, the needleless connector can reduce the risk of bacterial contamination. In some embodiments, a prefilled flush syringe and / or a temporary disposable sample syringe can be coupled to the proximal end 64 via a needleless connector.

[0065] like Figure 4B As shown, in some embodiments, the proximal end 64 can include a dual port, which can include two Luer ports 66a, 66b. As shown, in some embodiments, the Luer port 66a and / or the Luer port 66b can be coupled to a connector, which can include a collar. In some embodiments, the collar can include one or more threads on the collar, so that the collar can facilitate a secure connection. In some embodiments, the proximal end 64 of the adapter 58 and / or the needleless connector connected thereto need not include a connector that is compatible with the PIVO TM Needle-free blood collection device compatible port, because PIVO TM A needle-free blood collection device or other catheter advancement device can be coupled to the proximal port 30 of the access connector 26 and can 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 can be more flexible than the first extension tube 20, which can allow the second extension tube to bend and reduce the risk of interfering with the insertion site when the user couples a device to the proximal end 64. In some embodiments, the second extension tube 36 can be longer than the first extension tube 20 to reduce the risk of interfering with the insertion site when the user couples a device to the proximal end 64.

[0066] like Figure 4C-4D As shown, in some embodiments, the first port 46 can include a Luer connector, such as a female Luer connector. In some embodiments, this can allow a needleless connector 60 (e.g., such as Figure 4D The adapter 58 is connected to the first port 46 and the adapter 58 and is disposed between the first port and the adapter, which can reduce the risk of bacterial contamination.

[0067] Reference now Figure 5A-5B In some embodiments, the dual port may include an offset side port 72 offset from an axial port 74 axially aligned with a longitudinal axis 76 of the adapter 58. In more detail, in some embodiments, the offset side port 72 may be non-planar with the axial port 74 and may facilitate flushing by creating turbulence. In some embodiments, the offset side port 72 may correspond to the axial port 74 in one or more features and / or operations. Figure 4A-4B Luer port 66a and / or Figure 4A-4BIn some embodiments, the axial port 74 may correspond to the Figure 4A-4B Luer port 66a and / or Figure 4A-4B In some embodiments, the inner cavity of the adapter 58 may include one or more fluid deflection ramps 78 that can generate turbulence and enhance flushing. Additionally or alternatively, in some embodiments, the fluid deflection ramp 78 can be disposed within the proximal port 30 of the access connector 26 to generate turbulence and enhance flushing near the patient port.

[0068] Reference now Figure 6A-6B , the pressure monitoring device 62 may be operably coupled to a pressure transmitter electrical connector 80, which may extend from the pressure monitoring device 62 (see also Figures 3A-3E ). In some embodiments, the proximal end of the pressure monitoring device 62 can be coupled to the needleless connector 60, which can reduce the risk of bacterial contamination. In some embodiments, the prefilled flush syringe 54 can be coupled to the pressure monitoring device 62 or the needleless connector 60, which can facilitate flushing of the catheter system 10 with a single flush. In some embodiments, the pressure monitoring device 62 can be coupled to the third port 50 or another suitable location. In some embodiments, the pressure monitoring device 62 can be coupled to the third port 50 or the proximal port 30 of the access 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 monitoring device 62. According to some embodiments, Figure 6B A pre-filled flush syringe 54 is shown coupled to the proximal end of the needleless connector 60. Fig. 6A The unoccupied proximal end of needleless connector 60 is shown.

[0069] In some embodiments, the first extension tube 20 and / or the second extension tube 36 can be rigid or semi-rigid. In some embodiments, the second extension tube 36 can be rigid or semi-rigid, which can facilitate more accurate pressure measurements at the pressure monitoring device 62. In some embodiments, the pressure monitoring device 62 coupled to the three-way stopcock 44 can provide the benefit of monitoring arterial pressure at a location closer to the patient than existing systems, which can facilitate more accurate pressure measurements at the pressure monitoring device 62.

[0070] Reference now Figure 7, the catheter system 10 is coupled to a hemodynamic monitoring system 82, which can be 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 relative to the access connector 26. In some embodiments, the second sampling port 86 can be used in perioperative environments and surgical environments. Due to the presence of the access connector 26, the second sampling port 86 can be eliminated, so that the second sampling port 86 is not required in some embodiments.

[0071] In some embodiments, if desired, a disposable sample syringe 88 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 a pressure tube) may be fluidly connected to the catheter system 10 via a connector 92.

[0072] Reference now Figure 8 In some embodiments, the line 90 can be coupled to a blood cleaning system 94, which can be proximal to the patient and / or closed. In some embodiments, the blood cleaning system 94 can be in-line and can facilitate the collection of a temporary blood draw volume that can be re-infused or pushed back into the patient later. In some embodiments, after the temporary blood draw volume is collected in the reservoir of the blood cleaning system 94 by lifting the plunger 95 of the blood cleaning system 94, the shut-off valve 97 can be closed to prevent fluid communication with the line 90 and to prevent blood from being drawn from the reservoir. In some embodiments, with the shut-off valve 97 closed, a blood sample can be collected from the proximal port 30 of the access connector 26. In some embodiments, a blood sampling device 42 can be used to collect a blood sample, which can include a catheter advancement device, such as a PIVO TM A needle-free blood collection device, which can be obtained from Becton, Dickinson & Company of Franklin Lakes, New Jersey. In some embodiments, after the blood sample is drawn, the shutoff valve 97 can be opened and the plunger 95 of the blood cleaning system 94 can be depressed or pushed downward to re-infuse the temporarily drawn blood volume in the reservoir into the patient. In some embodiments, the blood cleaning 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.

[0073] All examples and conditional language listed herein are intended for teaching purposes to help readers understand the conception contributed by the present invention to further advance the art, and should be interpreted as not being limited to these specifically recorded 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 to the present invention 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, and a side port located between the distal end of the catheter adapter and the proximal end of the catheter adapter and in fluid communication with the lumen; a catheter extending from a distal end of the catheter adapter; a first extension tube, the first extension tube comprising a distal end and a proximal end, wherein the distal end of the first extension tube is integrated with a side port of the catheter adapter; an access connector comprising a distal port, a proximal port, and a side port located between the distal port and the proximal port, wherein the distal port and the proximal port are aligned with a longitudinal axis of the access connector, wherein the side port of the access connector is angled relative to the longitudinal axis of the access connector, wherein the proximal end of the first extension tube is integral with the distal port of the access connector; and A second extension tube, the second extension tube comprising a distal end and a proximal end, wherein the distal end of the second extension tube is integrated with the side port of the access connector, wherein the first extension tube is shorter than the second extension tube.

2. The catheter system according to claim 1, wherein: A longitudinal axis of the access connector, the first extension tube, and the side port are configured to align to form a straight 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 includes a female Luer connector.

5. The catheter system of claim 1, wherein: The catheter system also includes a blood sampling device coupled to the proximal port.

6. The catheter system of claim 1, wherein: The catheter system also includes a three-way stopcock, wherein the three-way stopcock includes a first port, a second port opposite the first port, and a third port, wherein the proximal end of the second extension tube is coupled to the first port of the three-way stopcock.

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

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

9. The catheter system of claim 8, wherein: The catheter system also includes: a pre-filled flush syringe, which is connected to the second port so that closing of the second port prevents fluid communication between the pre-filled flush syringe and the fluid channel; and a syringe, which is connected 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 drawing.

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

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

12. A blood collection method, comprising: A pre-filled flush syringe and a temporarily disposable 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, and a side port located between the distal end of the catheter adapter and the proximal end of the catheter adapter and in fluid communication with the lumen; a catheter extending from a distal end of the catheter adapter; a first extension tube, the first extension tube comprising a distal end and a proximal end, wherein the distal end of the first extension tube is integrated with a side port of the catheter adapter; an access connector comprising a distal port, a proximal port, and a side port located between the distal port and the proximal port, wherein the distal port and the proximal port are aligned with a longitudinal axis of the access connector, wherein the side port of the access connector is angled relative to the longitudinal axis of the access connector, wherein the proximal end of the first extension tube is integral with the distal port of the access connector; a second extension tube, the second extension tube comprising a distal end and a proximal end, wherein the distal end of the second extension tube is integrated with a side port of the access connector, wherein the first extension tube is shorter than the second extension tube; and a three-way stopcock, wherein the three-way stopcock comprises a first port, a second port opposite the first port, and a third port, wherein a proximal end of the second extension tube is coupled to the first port of the three-way stopcock, wherein the catheter system comprises a fluid channel within the catheter, the catheter adapter, the first extension tube, the access connector, and the second extension tube, wherein the second port, the third port, and a proximal port of the access connector are configured to provide access to the fluid channel of the catheter system, wherein coupling a prefilled flush syringe and a temporary disposable sample syringe to the catheter system comprises coupling the prefilled flush syringe to the second port such that closing the second port prevents fluid communication between the prefilled flush syringe and the fluid channel, and coupling the temporary disposable sample syringe to the third port such that closing the third port prevents fluid communication between the temporary disposable sample syringe and the fluid channel; closing the second port; and After closing the second port, blood is drawn into the disposable sample syringe.

13. The blood collection method according to claim 12, further comprising: After blood is drawn into the temporary disposable specimen syringe, closing the first port; and After closing the first port, blood is collected in a blood sampling device coupled to the proximal port of the access connector.

14. The blood collection method according to claim 13, wherein: The blood sampling device includes a catheter advancement device, and the blood collection method further includes advancing an auxiliary catheter of the catheter advancement device through the catheter.

15. The blood collection method according to claim 13, further comprising: After collecting blood in a blood sampling device coupled to the proximal port of the access connector, closing the second port again; and After the second port is closed again, the blood drawn into the temporary disposable sample syringe is returned to the patient's body.

16. The blood collection method according to claim 15, further comprising: After the blood drawn into the disposable specimen syringe is returned to the patient, the three-way stopcock is turned to the open position and the pre-filled flush syringe is pushed to clean the catheter system with a single flush.

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

18. A blood collection method, comprising: The catheter system is inserted 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, and a side port located between the distal end of the catheter adapter and the proximal end of the catheter adapter and in fluid communication with the lumen; a catheter extending from a distal end of the catheter adapter; a first extension tube, the first extension tube comprising a distal end and a proximal end, wherein the distal end of the first extension tube is integrated with a side port of the catheter adapter; an access connector comprising a distal port, a proximal port, and a side port located between the distal port and the proximal port, wherein the distal port and the proximal port are aligned with a longitudinal axis of the access connector, wherein the side port of the access connector is angled relative to the longitudinal axis of the access connector, wherein the proximal end of the first extension tube is integral with the distal port of the access connector; and a second extension tube, the second extension tube comprising a distal end and a proximal end, wherein the distal end of the second extension tube is integrated with a side port of the access connector, wherein the first extension tube is shorter than the second extension tube; and An auxiliary catheter of a catheter advancement device is advanced through the catheter, wherein the catheter advancement device is coupled to a proximal port of the access connector.

19. The blood collection method according to 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 straight path, wherein advancing an auxiliary catheter of the catheter advancement device through the catheter includes advancing the auxiliary catheter through the straight path.

20. The blood collection method according to claim 19, wherein: The blood vessel is an artery.

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