Arterial line patency indicator devices, systems, and methods

Abstract

A patency indicator for use with an arterial line may include a body that 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 a vent disposed within the body between the first end and the second end. The vent may be configured to pass air and not blood. In response to arterial blood entering the lumen at the first end, the cavitation is configured to be formed between the second end and the vent, and the transparent portion is configured to align with a leading edge of the arterial blood for making the leading edge of the arterial blood visible.

Description

Background Art

[0001] Arterial catheterization is an important operation commonly used in seriously injured and perioperative patients in hospital environments. It is estimated that more than 8 million arterial catheters are placed in the U.S. every year. Arterial catheters can continuously and accurately measure blood pressure, heart rate and pulse contour, so that abnormal hemodynamic events can be identified immediately and appropriate treatment can be initiated. Arterial catheters also provide samples for blood gas analysis without the morbidity associated with repeated arterial punctures. However, when the pressure transducer connected to the arterial line stops working, a common problem will occur, it is difficult to know whether the pressure transducer itself fails or whether there is a blockage in the arterial line.

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

[0003] The present disclosure generally relates to vascular access devices, systems and methods. In particular, the present disclosure relates to a patency indicator for use with an arterial line, 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 may be configured for blood pressure monitoring.

[0004] In some embodiments, the patency indicator for use with an arterial line may include a body. In some embodiments, the body may include a first end that 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.

[0005] In some embodiments, the patency indicator may include a lumen extending through the first end and toward the second end. In some embodiments, the patency indicator may include a vent disposed within the body between the first end and the second end. In some embodiments, the vent may provide ventilation of the lumen and may be configured to allow air to pass without allowing blood to pass. In some embodiments, the vent may include a hydrophobic membrane, and when the hydrophobic membrane is wetted by blood, it may lose its ability to vent and become a barrier to prevent atmospheric air from entering the lumen.

[0006] In some embodiments, in response to arterial blood entering the lumen at the first end, an air pocket can be configured to form between the second end and the vent, and the transparent portion can be configured to align with the leading edge of the arterial blood for making the leading edge of the arterial blood visible. In some embodiments, the second end can be closed, thereby preventing air from leaving the second end, and an air pocket can form near the second end without ventilation. In some embodiments, arterial blood can enter the lumen at the first end until the vent is wetted, leaving the air pocket in the patency indicator.

[0007] In some embodiments, the leading edge of the arterial blood may pulsate in response to the heartbeat, which may compress the air within the cavitation. In some embodiments, the pulsation of the arterial blood may indicate that the arterial line distal to the patency indicator is patency. In some embodiments, the patency indicator may provide a quick, cost-effective way to assess the patency of the arterial line. In some embodiments, the patency indicator may provide continuous and / or long-term monitoring of the arterial line.

[0008] In some embodiments, the Luer adapter may include a Luer slip adapter that can facilitate coupling to a port of an arterial line. In some embodiments, the Luer adapter may include a Luer lock adapter that can facilitate removable coupling to a port. In some embodiments, the Luer lock adapter may include a collar that may be threaded for securely and removably mating with the port. In some embodiments, the first end may be coupled to the arterial line so that the patency indicator is permanently or non-removably coupled to the arterial line. In some embodiments, the patency indicator may be coupled to the arterial line in another suitable manner.

[0009] In some embodiments, the port of the arterial line that can be coupled to the patency indicator can include a port distal to the pressure sensor coupled to the arterial line. In some embodiments, the port of the arterial line that can be coupled to the patency indicator can include a sampling port proximal to the catheter assembly in the arterial line. In these embodiments, the patency indicator can facilitate detection of obstructions distal to the sampling port. In other embodiments, the port of the arterial line that can be coupled to the patency indicator can be disposed on a catheter adapter of the catheter assembly. In these embodiments, the patency indicator can facilitate detection of obstructions in the catheter assembly.

[0010] In some embodiments, the transparent portion may be formed of a transparent material, which may facilitate visibility of the leading edge within the lumen. In some embodiments, the body, which may include an annular wall, may be formed entirely or partially of a transparent material. In these embodiments, the transparent portion may be integrally formed with the first end and the second end to form a single unit, so that the entire body is transparent. In some embodiments, the transparent portion may include a lens, which may improve visibility of the leading edge within the lumen. In some embodiments, the lens may include a magnifying glass. In some embodiments, the vent may be disposed closer to the first end than the lens is to the first end, because arterial blood may travel slightly beyond the vent before the vent is wetted, causing air to be trapped in the air pocket.

[0011] In some embodiments, the diameter of the first portion of the lumen between the vent and the first end is greater than the diameter of the second portion of the lumen between the vent and the second end. In these embodiments, because the second portion has a narrower diameter than the first portion and is elongated, the leading edge can move a greater distance in response to the heartbeat, which can facilitate the clinician to see the leading edge. In some embodiments, the second portion of the lumen between the vent and the second end can be generally cylindrical, which can facilitate the movement of the leading edge in response to the heartbeat to be visible. In some embodiments, the vent can be annular and surround the second portion of the lumen. In some embodiments, in response to arterial blood entering the lumen at the first end, the leading edge and cavitation of arterial blood can be disposed in the second portion. In some embodiments, the transparent portion can be aligned with the second portion of the lumen.

[0012] In some embodiments, the arterial line may include a catheter assembly that 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.

[0013] In some embodiments, the port may include a Luer adapter, such as, for example, a female Luer adapter, which is configured to receive a patency indicator. In some embodiments, the catheter adapter may include a port, and the 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 the 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 may be configured for blood sampling.

[0014] In some embodiments, a method of detecting an obstruction may include coupling a patency indicator to an arterial line. In some embodiments, the method may include making a leading edge of arterial blood visible through a transparent portion in response to arterial blood entering the lumen at a first end. In some embodiments, if a clinician is able to see the leading edge of arterial blood through the transparent portion, and the leading edge of arterial blood may pulsate in response to a heartbeat, the clinician may determine that the problem may be with the pressure transducer rather than the arterial line. On the other hand, if the clinician cannot see the leading edge of arterial blood through the transparent portion and the pulsation of the leading edge in response to a heartbeat, the clinician may determine that placement of the catheter within the artery has failed and / or the arterial line is obstructed.

[0015] It should be understood that the foregoing general description and the following detailed description are examples and explanations and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means illustrated in the accompanying drawings. It should also be understood that these embodiments can be combined, or other embodiments can be utilized, and unless so claimed, structural changes can be made without departing from the scope of the various embodiments of the present invention. Therefore, the following detailed description should not be regarded as limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0017] Figure 1A is a schematic diagram of an example arterial line according to some embodiments;

[0018] Figure 1B is an upper perspective view of another example arterial line according to some embodiments;

[0019] Figure 2A is an upper perspective view of an example patency indicator according to some embodiments;

[0020] Figure 2B According to some embodiments Figure 2A Top view of the patency indicator;

[0021] Figure 2C is coupled to an example port according to some embodiments Figure 2A A longitudinal cross-sectional view of a patency indicator of the invention illustrating an example leading edge;

[0022] Figure 2D is a longitudinal cross-sectional view of another patency indicator according to some embodiments;

[0023] Figure 3A is an upper perspective view of an example patency indicator according to some embodiments;

[0024] Figure 3BAccording to some embodiments, Figure 3A a second end view of the patency indicator;

[0025] Figure 3C According to some embodiments Figure 3A Another upper perspective view of the patency indicator;

[0026] Figure 3D According to some embodiments, the port is connected to Figure 3A Longitudinal cross-sectional view of the patency indicator. DETAILED DESCRIPTION

[0027] Reference now Figure 1A , an arterial line 10 is illustrated, according to some embodiments. In some embodiments, the arterial line 10 may include a catheter assembly 12, which may include a catheter 14, such as an arterial catheter, which is 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.

[0028] In some embodiments, the patency indicator 22 may be coupled to the port. In some embodiments, the port may include a Luer adapter, such as, for example, a female Luer adapter, which is configured to receive the patency indicator 22. In some embodiments, the port may be a port 24 of the catheter adapter 16, which may include a side port of the catheter adapter 16 or any suitable port. In some embodiments, the port may be 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 if the patency indicator 22 is removed, the sampling port 26 may be configured for blood sampling. In some embodiments, the extension tube 28 may be coupled to the catheter adapter 16 or extend from the catheter adapter 16, and / or may include a clamp 30.

[0029] In some embodiments, pressure transducer 20 may include any suitable pressure transducer known in the art that is configured to measure blood pressure. 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 saline bag 36.

[0030] Reference Figure 1B According to some embodiments, the configuration of arterial line 10 may vary. Figure 1B is another example of an arterial line 10. In some embodiments, the arterial line 10 can be coupled to a hemodynamic monitoring system 38, which can be operatively coupled to one or more hemodynamic monitoring system sensors 40. In some embodiments, the second sampling port 42 can provide an alternative or additional port in addition to the access connector 44 for coupling to the patency indicator 22. In some embodiments, the second sampling port 42 can be used in perioperative and surgical environments. Due to the presence of the access connector 44, the second sampling port 42 can be eliminated, so that the second sampling port 42 is not required in some embodiments.

[0031] In some embodiments, if desired, the temporarily discarded sample syringe 46 can be secured to the hemodynamic monitoring system 38 along with the hemodynamic monitoring system sensor 40. In some embodiments, the extension tube 28 can be fluidly connected to the catheter assembly 12 via a connector 48, which can be coupled to another extension tube 49. In some embodiments, another extension tube 50 can be disposed between the access connector 44 and the catheter adapter 16, as further described in U.S. Patent Application No. 63 / 405,700, filed on September 12, 2022, entitled "INTEGRATED CATHETER SYSTEM CONFIGURED FOR BLOOD SAMPLING." In some embodiments, a blood sampling device 51 can be coupled to the access connector 44.

[0032] Reference now FIG. 2A to FIG. 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, which 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.

[0033] In some embodiments, the patency indicator 22 may include a lumen 62 extending through the first end 54 and 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 provide ventilation of the lumen 62 and may be configured to allow air to pass without allowing blood to pass. In some embodiments, the vent 64 may include a hydrophobic membrane, and when the hydrophobic membrane is wetted by blood, it may lose its ability to vent and become a barrier to prevent atmospheric air from entering the lumen. In some embodiments, the vent 64 may include any other suitable type of vent known in the art.

[0034] In some embodiments, in response to arterial blood entering the lumen 62 at the first end 54, the air pocket 66 is configured to form between the second end 58 and the vent 64, and the transparent portion 60 is configured to align with the arterial blood leading edge 68 for making the arterial blood leading edge 68 visible. In some embodiments, the second end 58 can be closed so that air is prevented from leaving the second end 58, and the air pocket 66 can form near the second end 58 without ventilation. In some embodiments, arterial blood can enter the lumen 62 at the first end 54 until the vent 64 is wetted, leaving the air pocket 66 in the patency indicator 22.

[0035] In some embodiments, the leading edge 68 of the arterial blood may pulsate in response to the heartbeat, which may compress the air within the air pocket 66. In some embodiments, the pulsation of the arterial blood may indicate that the arterial line distal to the patency indicator 22 is patent. In some embodiments, the patency indicator 22 may provide a quick, cost-effective way to assess the patency of the arterial line. In some embodiments, the patency indicator 22 may provide continuous and / or long-term monitoring of the arterial line.

[0036] In some embodiments, the Luer adapter may include, for example FIG. 2A to FIG. 2D , which can facilitate coupling to a port of an arterial line. In some embodiments, the Luer adapter can taper inwardly and approach a generally cylindrical portion that can include a second end 58. In some embodiments, the first end 54 can alternatively be coupled to the arterial line such that the patency indicator is permanently or non-removably coupled to the arterial line.

[0037] In some embodiments, the transparent portion 60 may include, for example FIG. 2A to FIG. 2B, which can improve visibility of leading edge 68 within lumen 62. In some embodiments, the lens can include a magnifying lens. In some embodiments, vent 64 can be positioned closer to first end 54 than the lens is to first end 54 because arterial blood can travel slightly beyond vent 64 before vent 64 is wetted, causing air to be trapped within air pocket 66.

[0038] In some embodiments, port 74 of the arterial line to which patency indicator 22 may be coupled may be located at a pressure transducer coupled to the arterial line, such as, for example, Figure 1A Or distal to the pressure transducer 20 of 1B. In some embodiments, the port 74 of the arterial line to which the patency indicator may be coupled may include a sampling port, such as, for example Figure 1A to Figure 1B Sampling port 26 or Figure 1B In some embodiments, the sampling port can be proximal to the catheter assembly within the arterial line. In these embodiments, the patency indicator 22 can facilitate detection of blockage distal to the port 74. In other embodiments, the port 74 of the arterial line to which the patency indicator can be coupled can be disposed, for example, at a Figure 1A In these embodiments, the patency indicator 22 can facilitate detection of blockages within the catheter assembly.

[0039] Reference Figure 2D In some embodiments, instead of a lens, the transparent portion 60 may be formed of a transparent material, which may facilitate visibility of the leading edge 68 within the lumen 62. In some embodiments, the body 52, which may include the annular wall 76, may be formed entirely or partially of a transparent material. In these embodiments, the transparent portion may be integrally formed with the first end 54 and the second end 58 as a single unit, such that the entire body 52 is transparent.

[0040] Reference FIG. 3A to FIG. 3B , according to some embodiments, a patency indicator 22 is illustrated. In some embodiments, with respect to one or more features and / or operations, FIG. 3A to FIG. 3D The patency indicator 22 can be used with FIG. 2A to FIG. 2D The patency indicator 22 of the arterial line can be similar or identical. In some embodiments, the Luer adapter 56 can include a Luer lock adapter that can be easily removably connected to the port of the arterial line. In some embodiments, the Luer lock adapter can include a collar 77 that can be threaded for securely and removably mating with the port 74.

[0041] In some embodiments, the diameter 78 of the first portion 80 of the lumen 62 between the vent 64 and the first end 54 can be greater 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 than the first portion 80 and is elongated, the leading edge 68 can move a greater distance in response to the heartbeat, which can facilitate the clinician to see the leading edge 68. In some embodiments, the second portion 84 of the lumen 72 between the vent 64 and the second end 58 can be generally cylindrical, which can facilitate making the movement of the leading edge 68 in response to the heartbeat visible. In some embodiments, the vent 64 can be annular and surround the second portion 84 of the lumen 72. In some embodiments, in response to arterial blood entering the lumen 62 at the first end 54, the leading edge 68 of arterial blood and the air pocket 66 can be disposed within the second portion 84. In some embodiments, the transparent portion 60 can be aligned with the second portion 84 of the lumen 62. In some embodiments, a portion of the body 52 forming the second portion 84 and / or a portion of the body 52 forming the first portion 80 can be substantially cylindrical. In some embodiments, the diameter of the portion of the body 52 forming the second portion 84 can be smaller than the diameter of the portion of the body 52 forming the first portion 80.

[0042] Return to reference Figure 1A to Figure 1B In some embodiments, a method of detecting an obstruction may include coupling a patency indicator 22 to an arterial line 10. In some embodiments, the method may include making a leading edge of arterial blood visible through a transparent portion in response to arterial blood entering the lumen of the patency indicator 22 at a first end. In some embodiments, if a clinician is able to see the leading edge of the arterial blood through the transparent portion, and the leading edge of the arterial blood may pulsate in response to a heartbeat, the clinician may determine that the problem may be with the pressure transducer rather than the arterial line. On the other hand, if the clinician cannot see the leading edge of the arterial blood through the transparent portion and the leading edge pulsates in response to a heartbeat, the clinician may determine that placement of the catheter 14 within the artery has failed and / or the arterial line 10 is obstructed.

[0043] All examples and conditional language described herein are for teaching purposes, to help readers understand the present invention and the concepts contributed by the inventor to promote this field, and should be interpreted as not being limited to these specific examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions and modifications may be made thereto without departing from the spirit and scope of the present invention.

Claims

1. A patency indicator for use with an arterial line, the patency indicator comprising: A subject, the subject comprising: a first end portion, the first end portion comprising a Luer adapter; a second end opposite the first end, wherein the second end is closed; and a transparent portion between the first end and the second end; a lumen extending through the first end and toward the second end; and A vent is disposed within the body between the first end and the second end, wherein the vent is configured to allow air to pass but not blood to pass.

2. The patency indicator of claim 1 , wherein in response to arterial blood entering the lumen at the first end, a pocket of air is configured to form between the second end and the vent, and the transparent portion is configured to align with a leading edge of the arterial blood for making the leading edge of the arterial blood visible.

3. The patency indicator of claim 1, wherein: The luer adapter comprises a luer slip adapter.

4. The patency indicator of claim 1, wherein: The luer adapter comprises a luer lock adapter.

5. The patency indicator of claim 1, wherein the transparent portion is integrally molded with the first end and the second end as a single unit, wherein the body is comprised of a transparent material. The patency indicator of claim 1 , wherein the transparent portion comprises a lens.

7. The patency indicator of claim 1, wherein the vent is disposed closer to the first end than the lens is to the first end.

8. The patency indicator of claim 1, wherein a first portion of the lumen between the vent and the first end has a diameter that is greater than a second portion of the lumen between the vent and the second end.

9. The patency indicator of claim 8, wherein the second portion of the lumen between the vent and the second end is generally cylindrical.

10. The patency indicator of claim 8, wherein: The vent is annular and surrounds the second portion of the lumen.

11. The patency indicator of claim 8, wherein in response to arterial blood entering the lumen at the first end, the leading edge of the arterial blood and the cavitation are disposed within the second portion.

12. The patency indicator of claim 11, wherein the transparent portion is aligned with the second portion of the lumen.

13. An arterial line comprising: A catheter assembly, the catheter assembly comprising a catheter; Pressure transducer; A patency indicator, the patency indicator being disposed between the catheter assembly and the pressure transducer, the patency indicator comprising: A subject, the subject comprising: a first end portion, the first end portion comprising a Luer adapter; a second end opposite the first end, wherein the second end is closed; and a transparent portion between the first end and the second end; a lumen extending through the first end and toward the second end; and A vent is disposed within the body between the first end and the second end, wherein the vent is configured to allow air to pass but not blood to pass.

14. The arterial line according to claim 13, wherein: In response to arterial blood entering the lumen at the first end, a pocket of air is configured to form between the second end and the vent, and the transparent portion is configured to align with a leading edge of the arterial blood for visualization of the leading edge of the arterial blood.

15. The arterial line according to claim 13, wherein: The catheter assembly includes a catheter adapter, wherein the catheter extends from a distal end of the catheter adapter, wherein the catheter adapter includes a port, wherein the patency indicator is coupled to the port.

16. The arterial line of claim 13, further comprising a sampling port disposed between the catheter assembly and the pressure transducer, wherein the patency indicator is coupled to the sampling port.

17. A method for detecting a blockage, the method comprising: A patency indicator is coupled to the arterial line, wherein the patency indicator comprises: A subject, the subject comprising: a first end portion, the first end portion comprising a Luer adapter; a second end opposite the first end, wherein the second end is closed; and a transparent portion between the first end and the second end; a lumen extending through the first end and toward the second end; and a vent disposed within the body between the first end and the second end, wherein the vent is configured to allow air to pass but not blood to pass; and In response to arterial blood entering the lumen at the first end, a leading edge of the arterial blood is made visible through the transparent portion.

18. The method according to claim 17, wherein: The luer adapter comprises a luer slip adapter.

19. The method according to claim 17, wherein: The luer adapter comprises a luer lock adapter.

20. The method of claim 17, wherein the transparent portion comprises a lens or is formed of a transparent material.

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