CATHETER SYSTEM HAVING AN EXTENSION SET FOR BLOOD SAMPLING
20240082547 ยท 2024-03-14
Inventors
Cpc classification
A61B5/150992
HUMAN NECESSITIES
International classification
Abstract
A catheter system may include a catheter adapter, which may include a side port. The catheter system may include a catheter, and an extension tube having a distal end and a proximal end. The catheter system may include a three-port connector, which may include a distal port, a proximal port, and a side port. The proximal end of the catheter adapter may be coupled to the distal port of the three-port connector. The distal end of the extension tube may be integrated with the side port of the three-port connector.
Claims
1. A catheter system, comprising: a catheter adapter, comprising a distal end, a proximal end, a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; a three-port connector, comprising a distal port, a proximal port, and a side port between the distal port and the proximal port, wherein the distal port and the proximal port are aligned with a longitudinal axis of the three-port connector, with respect to the longitudinal axis of the three-port connector, wherein the proximal end of the catheter adapter is coupled to the distal port of the three-port connector; and an extension tube comprising a distal end and a proximal end, wherein the distal end of the extension tube is integrated with the side port of the three-port connector; and a three-way stopcock valve, wherein the three-way stopcock valve comprises a first port, a second port opposite the first port, and a third port, wherein the proximal end of the extension tube is coupled to the first port of the three-way stopcock valve.
2. The catheter system of claim 1, wherein the proximal port comprises an integrated connector.
3. The catheter system of claim 1, further comprising a blood sampling device coupled to the proximal port.
4. The catheter system of claim 1, wherein the proximal end of the extension tube is integrated with the first port.
5. The catheter system of claim 1, wherein the catheter system comprises a fluid pathway within the catheter, the catheter adapter, the first extension tube, the three-port connector, and the extension tube, wherein the second port, the third port, and the proximal port of the three-port connector are configured to provide access to the fluid pathway of the catheter system.
6. The catheter system of claim 5, further comprising a pre-filled flush device coupled to the second port such that closing of the second port prevents fluid communication between the pre-filled flush device and the fluid pathway, and a syringe coupled to the third port such that closing of the third port prevents fluid communication between the syringe and the fluid pathway, wherein the syringe is configured for temporary blood withdrawal.
7. The catheter system of claim 6, further comprising a pressure transducer disposed between the second port and pre-filled flush device.
8. The catheter system of claim 1, wherein the proximal end of the extension tube is integrated with an adapter, wherein the adapter is coupled to a needleless connector, wherein a proximal end of the adapter comprises a single port or a dual port.
9. A method of blood collection, comprising: coupling a pre-filled flush device and a temporary discard sample syringe to a catheter system, wherein the catheter system comprises: a catheter adapter, comprising a distal end, a proximal end, a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; a three-port connector, comprising a distal port, a proximal port, and a side port between the distal port and the proximal port, wherein the distal port and the proximal port are aligned with a longitudinal axis of the three-port connector, wherein the proximal end of the catheter adapter is coupled to the distal port of the three-port connector; an extension tube comprising a distal end and a proximal end, wherein the distal end of the extension tube is integrated with the side port of the three-port connector; and a three-way stopcock valve, wherein the three-way stopcock valve comprises a first port, a second port opposite the first port, and a third port, wherein the proximal end of the extension tube is coupled to the first port of the three-way stopcock valve, wherein the catheter system comprises a fluid pathway within the catheter, the catheter adapter, the first extension tube, the three-port connector, and the extension tube, wherein the second port, the third port, and the proximal port of the three-port connector are configured to provide access to the fluid pathway of the catheter system, wherein coupling the pre-filled flush device and the temporary discard sample syringe to the catheter system comprises coupling the pre-filled flush device to the second port such that closing the second port prevents fluid communication between the pre-filled flush device and the fluid pathway and coupling the temporary discard sample syringe to the third port such that closing of the third port prevents fluid communication between the syringe and the fluid pathway; closing the second port; and after closing the second port, pulling blood into the temporary discard sample syringe.
10. The method of claim 9, further comprising: after pulling blood into the temporary discard sample syringe, closing the first port; and after closing the first port, collecting blood in a blood sampling device coupled to the proximal port of the three-port connector.
11. The method of claim 10, wherein the blood sampling device comprises a catheter advancement device, further comprising advancing a secondary catheter of the catheter advancement device through the catheter.
12. The method of claim 10, further comprising: after collecting blood in the blood sampling device coupled to the proximal port of the three-port connector, closing the second port another time; and after closing the second port the other time, returning the blood pulled into the temporary discard syringe into a patient.
13. The method of claim 12, further comprising: after returning the blood pulled into the temporary discard syringe into the patient, turning the three-way stopcock valve to an open position and activating the pre-filled flush device to clear the catheter system with a single flush.
14. The method of claim 9, wherein the catheter system further comprises a pressure transducer disposed between the second port and pre-filled flush device.
15. A method of blood collection, comprising: inserting a catheter system into a blood vessel of a patient, wherein the catheter system comprises: a catheter adapter, comprising a distal end, a proximal end, a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; a three-port connector, comprising a distal port, a proximal port, and a side port between the distal port and the proximal port, wherein the distal port and the proximal port are aligned with a longitudinal axis of the three-port connector, wherein the proximal end of the first extension tube is integrated with the distal port of the three-port connector; and an extension tube comprising a distal end and a proximal end, wherein the distal end of the extension tube is integrated with the side port of the three-port connector; and advancing a secondary catheter of a catheter advancement device through the catheter, wherein the catheter advancement device is coupled to the proximal port of the three-port connector.
16. The method of claim 15, wherein the blood vessel is an artery.
17. The method of claim 15, wherein the catheter system further comprises a pressure transducer disposed between the second port and a pre-filled flush device.
18. The method of claim 17, further comprising monitoring arterial blood pressure via the pressure transducer while advancing the secondary catheter of the catheter advancement device through the catheter.
19. The method of claim 15, wherein the catheter system further comprises a three-way stopcock valve, wherein the three-way stopcock valve comprises a first port, a second port opposite the first port, and a third port, wherein the proximal end of the extension tube is coupled to the first port of the three-way stopcock valve, wherein the pressure transducer is coupled to the second port.
20. The method of claim 19, further comprising coupling a pre-filled flush device to the pressure transducer and activating the pre-filled flush device such that fluid from the pre-filled flush device flows through the pressure transducer.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0019] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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DESCRIPTION OF EMBODIMENTS
[0042] Referring now to
[0043] In some embodiments, the catheter system 10 may include an arterial catheter system configured for insertion into an artery. In these embodiments, the catheter system 10 may include significant improvements to existing arterial catheter systems by dramatically reducing blood exposure and infection risk, providing a user with improved artery access confirmation, and improving an overall experience of a patient. Some existing arterial catheter systems, such as, for example, the Teleflex ARROW Integrated Arterial Catheter, may not provide effective artery access confirmation or blood control, which may result in placement procedures with significant blood exposure risk, infection risk, clean-up costs, and poor patient experience. The Teleflex ARROW Integrated Arterial Catheter includes a non-rigid, slotted tube out of which significant amounts of blood may leak, increasing the risk of blood exposure to the user. The catheter system 10 may include one or more of the following, which may provide advantages over the prior art: arterial blood sampling with reduced blood exposure; blood pressure monitoring; blood gas sampling; near-patient access for use of a secondary catheter and/or sensor; blood control configured to operate under arterial pressure; a guidewire; and magnetic introducer needle guidance technology.
[0044] As illustrated in
[0045] In some embodiments, the catheter system 10 may include an introducer needle 21 coupled to a needle hub 23. In some embodiments, the catheter 19 may include an over-the-needle catheter, and the introducer needle 21 may extend through the catheter 19 to assist in insertion of the catheter 19 into the blood vessel of the patient. In some embodiments, after the catheter 19 is inserted into the blood vessel (which may be confirmed by the user through visualization of blood in a flashback chamber or INSTAFLASH), the needle hub 23 may be uncoupled from the catheter adapter 12, and the introducer needle 21 may be removed. In some embodiments, the catheter adapter 12 may include blood control technology, such as a septum, which may prevent blood leakage from the catheter adapter 12 after removal of the introducer needle 21.
[0046] In some embodiments, the catheter system 10 may include a three-port connector 26, which may be configured to provide near-patient access. In some embodiments, the three-port connector 26 may include a distal port 28, a proximal port 30, and a side port 32 between the distal port 28 of the three-port connector 26 and the proximal port 30 of the three-port connector 26. In some embodiments, the distal port 28 and the proximal port 30 may be aligned with a longitudinal axis 34 of the three-port connector 26.
[0047] In some embodiments, the catheter system 10 may include an extension tube 36, which may include a distal end 38 and a proximal end 40. In some embodiments, the distal end 38 of the extension tube 36 may be integrated with the side port 32 of the three-port connector 26, which may reduce a risk of fluid exposure to the user. In further detail, in some embodiments, the distal end 38 of the extension tube 36 may be permanently or non-removably coupled to the side port 32, such as, for example, via adhesive, bonding, a non-luer coupling, or another suitable permanent or non-removable coupling.
[0048] In some embodiments, the side port 32 and/or the extension tube 36 may be angled at about 90 with respect to the longitudinal axis 34 of the three-port connector 26 and may form a T-shape or T-connector. In these and other embodiments, the three-port connector 26 may be similar or identical in terms of one or more features and/or operation to one or more stabilizing connectors further described in U.S. Pat. No. 11,191,939, filed Nov. 30, 2018, entitled STABILIZING CONNECTOR DEVICES FOR VASCULAR ACCESS AND METHODS OF USING THE SAME, which is hereby incorporated by reference in its entirety. In some embodiments, the T-shape may facilitate flushing of the catheter assembly 10 when flushed from the proximal end 40 of the extension tube 36. In some embodiments, the side port 32 and/or the extension tube 36 may be angled at less than or greater than 90 with respect to the longitudinal axis 34, which may form a Y-shape. In some embodiments, the side port 32 and/or the extension tube 36 may be angled between 15 to 165 with respect to the longitudinal axis 34 of the three-port connector 26, such that the extension tube 36 extends in a distal direction or a proximal direction. In some embodiments, the side port 32 may be on a left side or a right side of the three-port connector 26 and/or may be configured to direct the extension tube 36 away from an insertion site of the catheter into the blood vessel. In some embodiments, the proximal end 16 of the catheter adapter 12 may be coupled to the distal port 28 of the three-port connector 26.
[0049] In some embodiments, the catheter system 10 may be a non-integrated catheter system, meaning that the catheter system does not include extension tubing (e.g., an extension set) extending from a side port of the catheter adapter 12 that provides a fluid pathway to the catheter 19. In some embodiments, the three-port connector 26 may instead provide an extension set that includes the extension tube 36.
[0050] As illustrated in
[0051] 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 extension tube 36 may be coupled to the first port 46 of the three-way stopcock valve 44. In some embodiments, the proximal end 40 of the extension tube 36 may be integrated with the first port 46, which may reduce a risk of fluid exposure to the user. In further detail, in some embodiments the proximal end 40 of the extension tube 36 may be permanently or non-removably coupled to the first port 46, such as, for example, via adhesive, bonding, a non-Luer coupling, or another suitable permanent or non-removable coupling. In some embodiments, the second port 48 and/or the third port 50 may include luers, such as, for example, female luers, which may facilitate coupling to a device.
[0052] In some embodiments, the catheter system 10 may include a fluid pathway within at least the catheter 19, the catheter adapter 12, the three-port connector 26, and the extension tube 36. In some embodiments, the second port 48, the third port 50, and the proximal port 30 of three-port connector 26 may be configured to provide access to the fluid pathway of the catheter system 10. In some embodiments, the catheter system 10 may include one or more other access points to the fluid pathway from a surrounding environment. In some embodiments, the catheter system 10 may not include other access points to the fluid pathway from a surrounding environment, which may limit potential bacterial contamination.
[0053] In some embodiments, one or more of the second port 48, the third port 50, and the proximal port 30 may be non-removable and/or monolithically formed as a single unit with a body of the three-way stopcock valve 44 in which the central hub 52 rotates. In some embodiments, one or more of the second port 48, the third port 50, and the proximal port 30 may include a removable needleless connector coupled to a non-removable portion of the respective port. In some embodiments, needleless connector may reduce a risk of bacterial contamination. In some embodiments, the proximal port 30 may be used for near-patient access, including blood sample collection. In some embodiments, the second port 48 may be used to facilitate clearance of the catheter system 10, including the fluid pathway, with a single flush, and the third port 50 may be used for temporarily withdrawing blood from the patient to ensure a high-quality sample. In some embodiments, one or more of the adapter 58, the first port 46, the second port 48, and the third port 50 may include a vent plug or an end cap.
[0054] In some embodiments, the catheter system 10 may include a pre-filled flush device 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 flush device 54 and the fluid pathway. In some embodiments, the pre-filled flush device 54 may include a pre-filled flush syringe, an IV line, or another suitable device. In some embodiments, a temporary discard 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 discard sample syringe 56 and the fluid pathway. In some embodiments, the temporary discard sample syringe 56 may be configured for temporary blood withdrawal from the patient.
[0055] Referring now to
[0056] Referring now to
[0057] In some embodiments, the blood sampling device 42 may include a catheter advancement device configured to advance a secondary catheter to extend a life of the catheter 19 and/or provide blood sampling. In some embodiments, the catheter advancement device may include the PIVO Needle-Free Blood Collection Device, available from Becton, Dickinson & Company of Franklin Lakes, New Jersey, or another suitable catheter advancement device. In some embodiments, the method may include advancing the secondary catheter and/or a sensor of the catheter advancement device through the catheter 19 of the catheter system 10.
[0058] As illustrated, for example, in
[0059] As illustrated, for example, in
[0060] As illustrated, for example, in
[0061] Referring now to
[0062] In some embodiments, one of the dual ports of the proximal end 64 may be coupled to the temporary discard sample syringe to temporarily withdraw a blood sample prior to blood sampling from the proximal port 30 of the three-port connector 26, to which a particular blood sampling device may be coupled (such as, for example, the PIVO Needle-Free Blood Collection Device, available from Becton, Dickinson & Company of Franklin Lakes, New Jersey). In some embodiments, after the blood sampling from the proximal port 30 of the three-port connector 26, the catheter system 10 may be cleared with the single flush by activating the pre-filled flush device. In some embodiments, another of the dual ports of the proximal end 64 may be coupled to the pre-filled flush device. In some embodiments, the dual ports may allow the temporary discard sample syringe and the pre-filled flush device to be coupled to the proximal end 64 at a same time.
[0063] In some embodiments, one or more of the dual ports may include a removable needleless connector coupled to a non-removable portion of a respective one of the dual ports. In some embodiments, the needleless connector may reduce a risk of bacterial contamination. In some embodiments, the pre-filled flush device and/or the temporary discard sample syringe may be coupled to the proximal end 64 via the needleless connector.
[0064] As illustrated in
[0065] As illustrated in
[0066] Referring now to
[0067] Referring now to
[0068] In some embodiments, the pressure transducer 62 may be operatively coupled to a pressure transducer electrical connector 80, which may extend from the pressure transducer 62. In some embodiments, a proximal end of the pressure transducer 62 may be coupled to a needleless connector 60, which may reduce a risk of bacterial contamination. In some embodiments, the pre-filled flush device 54 may be coupled to the pressure transducer 62 or the needleless connector 60, which may facilitate flushing of the catheter system 10 via the single flush. In some embodiments, the pressure transducer 62 may be coupled to the third port 50 or another suitable location. In some embodiments, the pressure transducer 62 may be coupled to the third port 50 or the proximal port 30 of the three-port connector 26 to provide accurate measurements due to proximity to the blood vessel. In some embodiments, the needleless connector 60 and/or a fluid delivery line may be coupled to the pressure transducer 62.
[0069] In some embodiments, the extension tube 36 may be rigid or semi-rigid and/or may include a particular or targeted thickness, which may provide sufficient stiffness or noncompliance to transmit a more accurate pressure pulse, resulting in a more accurate pressure measurement at the pressure transducer 62. In some embodiments, the pressure transducer 62 coupled to the three-way stopcock valve 44 may provide a benefit of monitoring arterial pressure at a point much closer to the patient than existing systems, which may facilitate a more accurate pressure measurement at the pressure transducer 62.
[0070] Referring now to
[0071] In some embodiments, the temporary discard sample syringe 56 may be secured to the hemodynamic monitoring system 82 along with the hemodynamic monitoring system sensors 84, if desired. In some embodiments, a line 90, which may include pressure tubing, may be fluidically connected to the catheter system 10 via a connector 92.
[0072] Referring now to
[0073] Referring now to
[0074] Referring now to
[0075] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.