Arterial line patency indicator devices, systems and methods

Abstract

A patency indicator for use with an arterial line is disclosed. The patency indicator for use with an arterial line may include a body, the body may include a first end and a second end opposite the first end. The first end may include a luer adapter. The second end may be closed. The patency indicator may include a transparent portion between the first end and the second end. The patency indicator may include an air hole disposed within the body between the first end and the second end. The air hole may be configured to allow air to pass but not blood to pass through. When arterial blood flows into the lumen from the first end, an air pocket is formed between the second end and the air hole, and the transparent portion is configured to align with the leading edge of the arterial blood to visualize the leading edge of the arterial blood.

Description

[Technical Field]

[0001] The present invention relates to arterial line patency indicator devices, systems and methods. [Background technology]

[0002] Arterial catheterization is a critical procedure widely used in hospital settings for both critically ill and perioperative patients. It is estimated that more than 8 million arterial catheters are inserted annually in the United States. Arterial catheters provide continuous and accurate measurement of blood pressure, heart rate, and pulse shape, allowing for immediate recognition of abnormal hemodynamic events and the introduction of appropriate therapy. Arterial catheters also collect samples for blood gas analysis without the complications associated with repeated arterial punctures. However, a common problem occurs when a pressure sensor connected to an arterial line stops functioning, making it difficult to know whether the pressure sensor itself has failed or whether there is a blockage in the arterial line.

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

[0004] [Patent Document 1] U.S. Patent Application No. 63 / 405,700 Summary of the Invention

[0005] TECHNICAL FIELD The present disclosure relates generally to vascular access devices, systems, and methods. In particular, the present disclosure relates to patency indicators for use with arterial lines and related devices, systems, and methods. In some embodiments, the arterial line may include a catheter configured for blood sampling and / or blood gas sampling. In some embodiments, the arterial line may include a pressure transducer and be configured for blood pressure monitoring.

[0006] In some embodiments, a patency indicator for use with an arterial line may include a body. In some embodiments, the body may include a first end, which may include a luer adapter. In some embodiments, the body may include a second end opposite the first end. In some embodiments, the second end may be closed. In some embodiments, the body may include a transparent portion between the first end and the second end.

[0007] In some embodiments, the patency indicator can include a lumen extending through the first end toward the second end. In some embodiments, the patency indicator can include a vent hole disposed within the body between the first end and the second end. In some embodiments, the vent hole can be configured to provide venting of the lumen, allowing air to pass but not blood to pass. In some embodiments, the vent hole can include a hydrophobic membrane that, when wetted with blood, loses its ability to vent air and can provide a barrier preventing atmospheric air from entering the lumen.

[0008] In some embodiments, an air pocket is formed between the second end and the vent hole when arterial blood enters the lumen at the first end, and the transparent portion may be aligned with the leading edge of the arterial blood to allow visualization of the leading edge of the arterial blood. In some embodiments, the second end may be closed such that air is not evacuated from the second end and a non-vented air pocket is formed near the second end. In some embodiments, arterial blood may enter the lumen from the first end until the vent hole is wetted, and the air pocket may remain within the patency indicator.

[0009] In some embodiments, the tip of the arterial blood may pulsate in response to a heartbeat, thereby compressing the air in the air pocket. In some embodiments, the pulsation of the arterial blood may indicate that the arterial line distal to the patency indicator is patent. In some embodiments, the patency indicator may provide a rapid and cost-effective method of assessing the patency of the arterial line. In some embodiments, the patency indicator may provide continuous and / or long-term monitoring of the arterial line.

[0010] In some embodiments, the Luer adapter may include a Luer slip adapter, which may facilitate connection of the arterial line to the port. In some embodiments, the Luer adapter may include a Luer lock adapter, which may facilitate detachable connection to the port. In some embodiments, the Luer lock adapter may include a collar, which may be threaded for secure, detachable mating with the port. In some embodiments, the first end may be coupled to the arterial line such that the patency indicator is permanently or non-detachably coupled to the arterial line. In some embodiments, the patency indicator may be coupled to the arterial line in any other suitable manner.

[0011] In some embodiments, the port in the arterial line to which the patency indicator is coupled may include a port distal to a pressure transducer coupled to the arterial line. In some embodiments, the port in the arterial line to which the patency indicator is coupled may include a sampling port proximal to a catheter assembly in the arterial line. In these embodiments, the patency indicator may facilitate detection of an occlusion distal to the sampling port. In other embodiments, the port in the arterial line to which the patency indicator is coupled may be located on a catheter adapter of a catheter assembly. In these embodiments, the patency indicator may facilitate detection of an occlusion in the catheter assembly.

[0012] In some embodiments, the transparent portion may be constructed of a transparent material, which may facilitate visualization of the distal end within the lumen. In some embodiments, the body, which may include the annular wall, may be constructed entirely or partially of a transparent material. In these embodiments, the transparent portion may be integrally molded with the first end and the second end such that the entire body is transparent. In some embodiments, the transparent portion may include a lens, which may enhance visualization of the distal end within the lumen. In some embodiments, the lens may include a magnifying lens. In some embodiments, the vent may be positioned closer to the first end than the lens. This is because arterial blood may briefly pass through the vent before it becomes wet, potentially trapping air in an air pocket.

[0013] In some embodiments, the diameter of the first portion of the lumen between the vent and the first end may be larger than the diameter of the second portion of the lumen between the vent and the second end. In these embodiments, the second portion may have a narrower diameter and be elongated compared to the first portion, allowing the tip of the arterial blood to travel a greater distance in response to the heartbeat and facilitating visualization of the tip by a clinician. In some embodiments, the second portion of the lumen between the vent and the second end may be generally cylindrical, which may facilitate visualization of the tip's movement in response to the heartbeat. In some embodiments, the vent may be annular and surround the second portion of the lumen. In some embodiments, when arterial blood enters the lumen from the first end, the tip of the arterial blood and an air pocket may be located in the second portion. In some embodiments, the transparent portion may be positioned in registration with the second portion of the lumen.

[0014] In some embodiments, the arterial line may include a catheter assembly, which may include a catheter such as an arterial catheter configured for insertion into an artery of a patient. In some embodiments, the arterial line may include a pressure transducer. In some embodiments, the arterial line may include a patency indicator disposed between the catheter assembly and the pressure transducer. In some embodiments, the catheter assembly may include a catheter adapter, and the catheter may extend from a distal end of the catheter adapter.

[0015] In some embodiments, the port may include a luer adapter, for example, a female luer adapter configured to receive a patency indicator. In some embodiments, the catheter adapter may include a port, and a patency indicator may be coupled to the port. In some embodiments, the arterial line may include a sampling port disposed between the catheter assembly and the pressure transducer, and a patency indicator may be coupled to the sampling port. In some embodiments, the sampling port may be separated from the catheter adapter by one or more extension tubes and configured for blood sample collection.

[0016] In some embodiments, a method for detecting an occlusion can include coupling a patency indicator to an arterial line. In some embodiments, the method can include visualizing the leading edge of the arterial blood through the transparent portion as the arterial blood enters the lumen from the first end. In some embodiments, if the clinician can visualize the leading edge of the arterial blood pulsating in response to the heartbeat through the transparent portion, the clinician can determine that the problem is likely with the pressure transducer rather than the arterial line. On the other hand, if the clinician cannot visualize the leading edge of the arterial blood through the transparent portion and cannot see the leading edge pulsating in response to the heartbeat, the clinician can determine that the catheter was not inserted properly into the artery and / or that an occlusion of the arterial line has occurred.

[0017] It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not intended to limit the invention as claimed. It should also be understood that various embodiments are applicable and are not limited to the arrangements and instrumentality shown in the drawings. Furthermore, it should be understood that the embodiments may be combined, other embodiments may be employed, and structural changes may be made, except as claimed, without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description should not be taken in a limiting sense. [Brief explanation of the drawings]

[0018] The embodiments are described in additional specific detail using the accompanying drawings.

[0019] [Figure 1A] FIG. 1A is a schematic diagram of an exemplary arterial line according to some embodiments. [Figure 1B] FIG. 1B is a top perspective view of another exemplary arterial line according to some embodiments. [Figure 2A] FIG. 2A is a top perspective view of an exemplary patency indicator according to some embodiments. [Figure 2B] FIG. 2B is a plan view of the patency indicator of FIG. 2A. [Figure 2C] FIG. 2C is a longitudinal cross-sectional view of the patency indicator of FIG. 2A coupled to an exemplary port, showing an example tip. [Figure 2D] FIG. 2D is a longitudinal cross-sectional view of another patency indicator according to some embodiments. [Figure 3A] FIG. 3A is a top perspective view of an exemplary patency indicator according to some embodiments. [Figure 3B] FIG. 3B is a view of the patency indicator of FIG. 3A from the second end. [Figure 3C] FIG. 3C is another top perspective view of the patency indicator of FIG. 3A. [Figure 3D] FIG. 3D is a longitudinal cross-sectional view of the patency indicator of FIG. 3A coupled to a port. DETAILED DESCRIPTION OF THE INVENTION

[0020] Referring to FIG. 1A , an arterial line 10 is shown according to some embodiments. In some embodiments, the arterial line 10 may include a catheter assembly 12. The catheter assembly 12 may include a catheter 14, such as an arterial catheter, configured for insertion into an artery of a patient. In some embodiments, the catheter assembly 12 may include a catheter adapter 16, and the catheter 14 may extend from a distal end 18 of the catheter adapter 16. In some embodiments, the arterial line 10 may include a pressure transducer 20. In some embodiments, the arterial line 10 may include a patency indicator 22 disposed between the catheter assembly 12 and the pressure transducer 20. In some embodiments, the patency indicator 22 may be in fluid communication with a fluid path extending through the arterial line 10.

[0021] In some embodiments, the patency indicator 22 may be coupled to a port. In some embodiments, the port may include a luer adapter, such as a female luer adapter, configured to receive the patency indicator 22. In some embodiments, the port is a port 24 of the catheter adapter 16, which may include a side port or any suitable port of the catheter adapter 16. In some embodiments, the port is a sampling port 26 disposed between the catheter assembly 12 and the pressure transducer 20, and the patency indicator 22 may be coupled to the sampling port 26. In some embodiments, the sampling port 26 may be separated from the catheter adapter 16 by an extension tube 28 or multiple extension tubes and may be configured for blood sample collection when the patency indicator 22 is removed. In some embodiments, the extension tube 28 may be coupled to or extend from the catheter adapter 16 and / or may include a clamp 30.

[0022] In some embodiments, pressure transducer 20 may include any suitable pressure transducer configured for measuring blood pressure known in the art. In some embodiments, arterial line 10 may include a squeezable fast flush valve 32 and / or a slow flush valve 34. In some embodiments, arterial line 10 may include a pressurized bag 36 of saline.

[0023] 1B, according to some embodiments, the configuration of the arterial line 10 may vary. FIG. 1B is another example of an arterial line 10. In some embodiments, the arterial line 10 may be coupled to a hemodynamic monitoring system 38, which may be operatively coupled to one or more hemodynamic monitoring system sensors 40. In some embodiments, the second sampling port 42 may provide a different or additional port than the access connector 44 for coupling of the patency indicator 22. In some embodiments, the second sampling port 42 may be used in perioperative and surgical settings. The presence of the access connector 44 makes the second sampling port 42 unnecessary, and in some embodiments, the second sampling port 42 may be omitted.

[0024] In some embodiments, a temporary waste sample syringe 46 may be secured to the hemodynamic monitoring system 38 along with the hemodynamic monitoring system sensor 40, if desired. In some embodiments, the extension tube 28 may be fluidly connected to the catheter assembly 12 via a connector 48 that may be coupled to another extension tube 49. In some embodiments, another extension tube 50 may be disposed between the access connector 44 and the catheter adapter 16, as further described in U.S. Patent Application Publication No. 2022 / 0122222 entitled "Integrated Catheter System Configured for Blood Sample Collection." In some embodiments, a blood collection device 51 may be coupled to the access connector 44.

[0025] 2A-2C, in some embodiments, a patency indicator 22 for use with an arterial line 10 may include a body 52. ​​In some embodiments, the body 52 may include a first end 54 that may include a luer adapter 56. In some embodiments, the body 52 may include a second end 58 opposite the first end 54. In some embodiments, the second end 58 may be closed. In some embodiments, the body 52 may include a transparent portion 60 between the first end 54 and the second end 58.

[0026] In some embodiments, the patency indicator 22 may include a lumen 62 extending from the first end 54 toward the second end 58. In some embodiments, the patency indicator 22 may include a vent 64 disposed within the body 52 between the first end 54 and the second end 58. In some embodiments, the vent 64 may be configured to provide venting for the lumen 62, allowing air to pass through but not blood. In some embodiments, the vent 64 may include a hydrophobic membrane that, when wetted by blood, loses its ability to vent air and may provide a barrier preventing atmospheric air from entering the lumen. In some embodiments, the vent 64 may include any other suitable type of vent known in the art.

[0027] In some embodiments, when arterial blood flows into lumen 62 from first end 54, an air pocket 66 is configured to form between second end 58 and vent hole 64, and transparent portion 60 may be configured to align with arterial blood leading edge 68 for visualization of arterial blood leading edge 68. In some embodiments, second end 58 may be closed to prevent air from escaping from second end 58, and unvented air pocket 66 may form near second end 58. In some embodiments, arterial blood may flow into lumen 62 from first end 54 until vent hole 64 is wetted, and air pocket 66 may remain within patency indicator 22.

[0028] In some embodiments, arterial blood tip 68 may pulsate in response to a heartbeat, which may compress the air in air pocket 66. In some embodiments, the pulsation of the arterial blood may indicate that the arterial line distal to patency indicator 22 is patent. In some embodiments, patency indicator 22 may provide a quick and cost-effective method for assessing the patency of the arterial line. In some embodiments, patency indicator 22 may provide continuous and / or long-term monitoring of the arterial line.

[0029] In some embodiments, the luer adapter may include a luer slip adapter, which may facilitate connection to a port on an arterial line, for example, as shown in FIGS. 2A-2D. In some embodiments, the luer adapter may be inwardly tapered and proximate a generally cylindrical portion. This cylindrical portion may include second end 58. In some embodiments, first end 54 may instead be coupled to the arterial line such that the patency indicator is permanently or non-removably coupled to the arterial line.

[0030] In some embodiments, transparent portion 60 may include a lens that may enhance visualization of tip 68 within lumen 62, as shown, for example, in Figures 2A and 2B. In some embodiments, the lens may include a magnifying lens. In some embodiments, vent 64 may be positioned closer to first end 54 than the lens would be relative to first end 54. This is because arterial blood may pass through vent 64 slightly before wetting it, resulting in air being trapped within air pocket 66.

[0031] In some embodiments, the arterial line port 74 to which the patency indicator 22 is coupled may be located distal to a pressure transducer, such as pressure transducer 20 shown in FIG. 1A or FIG. 1B. In some embodiments, the arterial line port 74 to which the patency indicator is coupled may include a sampling port, such as sampling port 26 shown in FIGS. 1A-1B or access connector 44 shown in FIG. 1B. In some embodiments, the sampling port may be located proximal to a catheter assembly within the arterial line. In these embodiments, the patency indicator 22 may facilitate detection of an occlusion distal to the port 74. In other embodiments, the arterial line port 74 to which the patency indicator is coupled may be located on a catheter adapter of a catheter assembly, such as shown in FIG. 1A. In these embodiments, the patency indicator 22 may facilitate detection of an occlusion within the catheter assembly.

[0032] 2D , in some embodiments, as an alternative to a lens, transparent portion 60 may be constructed of a transparent material that may facilitate visualization of tip 68 within lumen 62. In some embodiments, body 52, including annular wall 76, may be constructed entirely or partially of a transparent material. In these embodiments, transparent portion may be integrally formed with first end 54 and second end 58 as a single unit, and the entire body 52 may be transparent.

[0033] 3A and 3B, patency indicator 22 is shown, according to some embodiments. In some embodiments, patency indicator 22 of FIGS. 3A-3D may be similar or identical in one or more features and / or operation to patency indicator 22 of FIGS. 2A-2D. In some embodiments, luer adapter 56 may include a luer lock adapter that may facilitate releasable coupling to an arterial line port. In some embodiments, luer lock adapter 56 may include a threaded collar 77 for secure, releasable engagement with port 74.

[0034] In some embodiments, the diameter 78 of the first portion 80 of the lumen 62 between the vent 64 and the first end 54 may be larger than the diameter 82 of the second portion 84 of the lumen 62 between the vent 64 and the second end 58. In these embodiments, because the second portion 84 has a narrower diameter and is elongated compared to the first portion 80, the tip 68 may move a greater distance in response to a heartbeat, which may facilitate visualization of the tip 68 by a clinician. In some embodiments, the second portion 84 of the lumen 72 between the vent 64 and the second end 58 may be generally cylindrical, which may facilitate visualization of the movement of the tip 68 in response to a heartbeat. In some embodiments, the vent 64 may be annular and surround the second portion 84 of the lumen 72. In some embodiments, when arterial blood flows into the lumen 62 from the first end 54, the tip 68 of the arterial blood and the air pocket 66 may be disposed within the second portion 84. In some embodiments, the transparent portion 60 may be aligned with the second portion 84 of the lumen 62. In some embodiments, the portion of the body 52 forming the second portion 84 and / or the portion of the body 52 forming the first portion 80 may be generally cylindrical. In some embodiments, the diameter of the portion of the body 52 forming the second portion 84 may be smaller than the diameter of the portion of the body 52 forming the first portion 80.

[0035] 1A-1B , in some embodiments, a method for detecting an occlusion may include coupling patency indicator 22 to arterial line 10. In some embodiments, the method may include visualizing the leading edge of arterial blood through the transparent portion as the arterial blood flows into the lumen from the first end of patency indicator 22. In some embodiments, if the clinician can visualize the leading edge of the arterial blood pulsating in response to the heartbeat through the transparent portion, the clinician may determine that the problem is likely with the pressure transducer rather than arterial line 10. On the other hand, if the clinician cannot visualize the leading edge of the arterial blood through the transparent portion and cannot confirm the leading edge pulsating in response to the heartbeat, the clinician may determine that the catheter 14 was not inserted properly into the artery and / or that an occlusion of arterial line 10 has occurred.

[0036] All examples and conditional expressions described in this specification are for educational purposes to help readers understand the invention and the concepts presented by the inventor to contribute to the development of technology, and should be interpreted without limitation to these specific examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the present invention.

Claims

1. 1. A patency indicator for use in an arterial line, comprising: The patency indicator comprises: a first end comprising a luer adapter; a closed second end opposite the first end; and a body including a transparent portion disposed between the first end and the second end; a lumen extending from the first end toward the second end; a vent disposed within the body between the first end and the second end, the vent configured to allow air to pass therethrough but not blood to pass therethrough. Patency indicator.

2. When arterial blood flows into the lumen from the first end, an air pocket is formed between the second end and the vent hole; The transparent portion is configured to align with the leading edge of the arterial blood to visualize the leading edge of the arterial blood.

10. The patency indicator of claim 1.

3. The luer adapter comprises a luer slip adapter 10. The patency indicator of claim 1.

4. The luer adapter includes a luer lock adapter.

10. The patency indicator of claim 1.

5. the transparent portion is integrally formed with the first end and the second end as a single unit; The body is made of a transparent material.

10. The patency indicator of claim 1.

6. The transparent portion includes a lens.

10. The patency indicator of claim 1.

7. The vent is positioned closer to the first end than the lens is positioned relative to the first end.

10. The patency indicator of claim 1.

8. A diameter of a first portion of the lumen between the vent and the first end is greater than a diameter of a second portion of the lumen between the vent and the second end.

10. The patency indicator of claim 1.

9. The second portion of the lumen between the vent and the second end is generally cylindrical.

9. The patency indicator of claim 8.

10. The vent is annular and surrounds the second portion within the lumen.

9. The patency indicator of claim 8.

11. When arterial blood flows into the lumen from the first end, the tip of the arterial blood and the air pocket are disposed within the second portion.

9. The patency indicator of claim 8.

12. The transparent portion is configured to align with the second portion within the lumen.

12. The patency indicator of claim 11.

13. a catheter assembly comprising a catheter; a pressure transducer; a patency indicator disposed between the catheter assembly and the pressure transducer; The patency indicator comprises: a first end having a luer adapter; a closed second end opposite the first end; and a body including a transparent portion disposed between the first end and the second end; a lumen extending from the first end toward the second end; a vent disposed within the body between the first end and the second end, the vent configured to allow air to pass therethrough but not blood to pass therethrough. Arterial line.

14. When arterial blood flows into the lumen from the first end, an air pocket is formed between the second end and the vent hole, and the transparent portion is configured to align with a leading edge of the arterial blood to visualize the leading edge of the arterial blood.

14. The arterial line of claim 13.

15. The catheter assembly includes a catheter adapter, the catheter extending from a distal end of the catheter adapter, the catheter adapter including a port, and the patency indicator coupled to the port.

14. The arterial line of claim 13.

16. and a sampling port disposed between the catheter assembly and the pressure transducer, the patency indicator being coupled to the sampling port.

14. The arterial line of claim 13.

17. coupling a patency indicator to the arterial line; The patency indicator comprises: a first end comprising a luer adapter; a closed second end opposite the first end; and a body including a transparent portion disposed between the first end and the second end; a lumen extending from the first end toward the second end; a vent disposed within the body between the first end and the second end, the vent configured to allow air to pass through but not blood to pass through; Equipped with and visualizing a front end of the arterial blood through the transparent portion when the arterial blood flows into the lumen from the first end. How to detect blockages.

18. The luer adapter comprises a luer slip adapter 18. The method of claim 17.

19. The luer adapter includes a luer lock adapter.

18. The method of claim 17.

20. The transparent portion includes a lens or is made of a transparent material.

18. The method of claim 17.

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