Catheter Exhaust Assembly and Related Systems and Methods

Abstract

A catheter system that can include a needleless connector, the needleless connector can include a distal end, a proximal end, and a valve disposed between the distal end of the needleless connector and the proximal end of the needleless connector. The catheter system can include an exhaust assembly, the exhaust assembly can include a proximal member and a distal member. The proximal member can include a male luer adapter, the male luer adapter can include a male luer. The distal member can include a distal end coupled to the proximal end of the needleless connector and a proximal end coupled to the male luer adapter. In response to the proximal member moving from a proximal position to a distal position relative to the distal member, the male luer of the male luer adapter can open the valve to exhaust air inside the catheter system.

Description

Technical Field

[0001] The present disclosure relates to a catheter exhaust assembly and related systems and methods. Background Art

[0002] Catheters are commonly used in various injection therapies. For example, catheters can be used to infuse fluids into a patient (e.g., saline solution, various drugs, and total parenteral nutrition). Catheters can also be used to draw blood from a patient's body.

[0003] One common type of catheter is an over-the-needle peripheral intravenous catheter (“PIVC”). As the name implies, an over-the-needle PIVC can be mounted on a guide needle having a sharp distal end. The PIVC and the guide needle can be assembled such that the distal end of the guide needle extends beyond the distal end of the PIVC while the bevel of the needle faces away from the patient's skin. The PIVC and the guide needle are typically inserted into the patient's vasculature through the skin at a small angle.

[0004] To verify the correct placement of the guide needle and / or PIVC in a blood vessel, typically a clinician confirms a “flashback” of blood in the flashback chamber of the PIVC assembly. Once the placement of the needle is confirmed, the clinician can temporarily occlude the flow in the vasculature and remove the guide needle, leaving the PIVC in place for future blood draws and / or infusions. The PIVC assembly can be coupled to an extension set, which can allow the coupling of an infusion or blood draw device at a location removed from the PIVC insertion site.

[0005] In some cases, a catheter for infusion can be pre-perfused to remove air before insertion into a patient's vasculature. If air bubbles are allowed to enter the patient's vasculature, an embolism may form, which can cause serious harm to the patient.

[0006] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or operate only in environments such as those described above. Rather, this background art is provided only to illustrate an example technical field in which some of the embodiments described herein may be practiced. Summary of the Invention

[0007] In some embodiments, a catheter system can include a catheter assembly and a needle assembly coupled to the catheter assembly. In some embodiments, the needle assembly can include a needle hub and a guide needle. In some embodiments, the proximal end of the guide needle can be fixed within the needle hub.

[0008] In some embodiments, the catheter assembly may include a catheter adapter that may include a distal end and a proximal end. In some embodiments, the catheter adapter may include a side port disposed between the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter assembly may include an extension tube extending from and / or integrated within the side port. In some embodiments, an adapter (e.g., a Y-adapter or a T-adapter) may be coupled to the extension tube.

[0009] In some embodiments, the catheter assembly may include a catheter that may extend from the distal end of the catheter adapter and may be fixed within the catheter adapter. In some embodiments, the catheter may include a peripheral intravenous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter.

[0010] In some embodiments, a guide needle may extend through the catheter. In some embodiments, in response to the guide needle and / or the catheter being inserted into a patient's vasculature, the guide needle may be withdrawn proximally from the catheter and removed from the catheter assembly. In some embodiments, the catheter may remain within the patient's vasculature for blood drawing and / or infusion.

[0011] In some embodiments, the catheter system may include a needleless connector that may include a distal end, a proximal end, and a valve disposed between the distal end of the needleless connector and the proximal end of the needleless connector. In some embodiments, the distal end of the needleless connector may be coupled to the catheter assembly. In some embodiments, the distal end of the needleless connector may be coupled to the adapter.

[0012] In some embodiments, the catheter system may include a venting assembly that may include a proximal member and a distal member. In some embodiments, the proximal member may include a male Luer adapter that may include a male Luer. In some embodiments, the distal member may include a distal end that may be coupled to the proximal end of the needleless connector. In some embodiments, the distal member may include being coupled to the proximal end of the male Luer adapter. In some embodiments, in response to movement of the proximal member from a proximal position to a distal position relative to the distal member, the male Luer of the male Luer adapter may open the valve.

[0013] In some embodiments, the male Luer adapter may include a first set of threads. In some embodiments, the distal end of the distal member may include a second set of threads. In some embodiments, the first set of threads may be disposed with a different hand of thread than the second set of threads. For example, the first set of threads may be left-handed threads and the second set of threads may be right-handed threads. Thus, in response to moving the proximal member from the proximal position to the distal position by further screwing the proximal member onto the distal member, the likelihood of the distal member becoming detached from the needleless connector may be reduced.

[0014] In some embodiments, the outer surface of the distal component may include a third set of threads. In some embodiments, the third set of threads may have the same hand of helix as the first set of threads such that the proximal component and the distal component may be threadedly coupled together. For example, the third set of threads may be left-handed.

[0015] In some embodiments, the outer surface of the needleless connector may include a fourth set of threads. In some embodiments, the fourth set of threads may have the same hand of helix as the second set of threads such that the needleless connector and the distal component may be threadedly coupled together. For example, the fourth set of threads may be right-handed.

[0016] In some embodiments, the inner surface of the proximal component may include a first protrusion. In some embodiments, the outer surface of the distal component may include a second protrusion and a third protrusion proximal to the second protrusion. In some embodiments, in response to movement of the proximal component from a proximal position to a distal position, the first protrusion may move proximal to the third protrusion. In some embodiments, in response to the proximal component being in the distal position, the first protrusion may be proximal to the second protrusion.

[0017] In some embodiments, the outer surface of the distal component may include a channel. In some embodiments, the second protrusion and the third protrusion may be disposed within the channel. In some embodiments, in response to movement of the proximal component from a proximal position to a distal position, the first protrusion may move proximally within the channel. Thus, in some embodiments, the channel may provide alignment of the proximal component relative to the distal component. [[ID=eleven]]

[0018] The original text has a misspelling in this line. It should be "In some embodiments, the outer surface of the distal component may include a channel. In some embodiments, the second protrusion and the third protrusion may be disposed within the channel. In some embodiments, in response to movement of the proximal component from a proximal position to a distal position, the first protrusion may move proximally within the channel. Thus, in some embodiments, the channel may provide alignment of the proximal component relative to the distal component." In some embodiments, the proximal component may include a male Luer, a proximal protrusion extending from the male Luer, and a distal protrusion extending from the male Luer. In some embodiments, the male Luer may extend through the proximal end of the distal component. In some embodiments, the inner surface of the distal component may include another protrusion. In some embodiments, in response to movement of the proximal component from a proximal position to a distal position, the proximal protrusion may move distal to another protrusion. In some embodiments, in response to the proximal component being in the proximal position, the distal protrusion may be distal to another protrusion and the proximal protrusion may be proximal to another protrusion.

[0019] In some embodiments, a method may include actuating an exhaust assembly that may be coupled to a needleless connector. In some embodiments, actuating the exhaust assembly may include moving a proximal member from a proximal position to a distal position, which may open a valve. In some embodiments, the method may include priming a catheter assembly after actuating the exhaust assembly, which may allow air to be removed through a path extending through the needleless connector, the distal member, and the proximal member. In some embodiments, the method may include inserting the catheter assembly into a patient's vasculature after priming the catheter assembly. In some embodiments, the method may include inserting the catheter assembly into a patient's vasculature and priming the catheter assembly with blood. In some embodiments, the catheter assembly may be primed with blood in response to insertion of the catheter assembly into the vasculature. In some embodiments, after inserting the catheter assembly into the vasculature and priming the catheter assembly with blood, the blood may be flushed back into the vasculature.

[0020] It should be understood that, as claimed, the foregoing general description and the following detailed description are both exemplary and explanatory and are not restrictive of the invention. It should be understood that the various embodiments are not limited to the arrangements and measures shown in the drawings. It should also be understood that, unless so protected, embodiments may be combined without departing from the scope of the various embodiments of the invention, or other embodiments may be utilized and structural changes may be made. Accordingly, the following detailed description should not be construed as restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Example embodiments will be described and explained with additional features and details by using the drawings, in which:

[0022] Figure 1 is an upper perspective view of an example catheter system in accordance with some embodiments;

[0023] Figure 2A is an exploded view of components of an example exhaust assembly and an example needleless connector in accordance with some embodiments.

[0024] Figure 2B is in accordance with some embodiments Figure 2A of an exploded view and a cross-sectional view of an exhaust assembly and a needleless connector.

[0025] Figure 2C is in accordance with some embodiments coupled to Figure 2A of a cross-sectional view of an exhaust assembly with a needleless connector.

[0026] Figure 3A is another example exhaust assembly in accordance with some embodiments and Figure 2A an exploded view of components of a needleless connector.

[0027] Figure 3B of an exhaust assembly and Figure 3A a component exploded view and cross-sectional view of a needleless connector according to some embodiments. Figure 2A

[0028] Figure 3C of a needleless connector coupled to Figure 2A an exhaust assembly according to some embodiments. Figure 3A Cross-sectional view

[0029] Figure 4A Another exemplary exhaust assembly and Figure 2A a component exploded view of a needleless connector according to some embodiments.

[0030] Figure 4B of an exhaust assembly and Figure 4A a component exploded view and cross-sectional view of a needleless connector according to some embodiments. Figure 2A

[0031] Figure 4C of a needleless connector coupled to Figure 2A an exhaust assembly according to some embodiments. Figure 4A Cross-sectional view

[0032] Figure 4D of an exhaust assembly according to some embodiments, showing an exemplary proximal component in a proximal position. Figure 4A

[0033] Figure 4E of an exhaust assembly according to some embodiments, showing a proximal component in a distal position. Figure 4A

[0034] Figure 5A Another exemplary exhaust assembly and Figure 2A a component exploded view of a needleless connector according to some embodiments.

[0035] Figure 5B of a needleless connector coupled to Figure 2A an exhaust assembly according to some embodiments, showing another exemplary proximal component in a proximal position. Figure 5A Cross-sectional view

[0036] Figure 5C of a needleless connector coupled to Figure 2A an exhaust assembly according to some embodiments, showing a proximal component in a distal position. Figure 5A Cross-sectional view

[0037] Figure 5D of an exhaust assembly according to some embodiments, Figure 5B a cross-sectional view of a portion of the exhaust assembly.

[0038] Figure 5E is part of an exhaust assembly according to some embodiments Figure 5C A cross-sectional view of a part of the exhaust assembly Detailed Description

[0039] Now refer to Figure 1 In some embodiments, the catheter system 10 may include a catheter assembly 12 and a needle assembly 14 coupled to the catheter assembly 12. In some embodiments, the needle assembly 14 may include a needle hub 16 and a guide needle 18. In some embodiments, the proximal end of the guide needle 18 may be fixed within the needle hub 16

[0040] In some embodiments, the catheter assembly 12 may include a catheter adapter 20, which may include a distal end 22 and a proximal end 24. In some embodiments, the catheter adapter 20 may include a side port 26 disposed between the distal end 22 of the catheter adapter 20 and the proximal end 24 of the catheter adapter 20. In some embodiments, the catheter assembly 12 may include an extension tube 28 extending from and / or integrated within the side port 26. In some embodiments, an adapter 30 (e.g., a Y-type adapter or a T-type adapter) may be coupled to the extension tube 28 at the proximal end of the extension tube 28

[0041] In some embodiments, the catheter assembly 12 may include a catheter 32, which may extend from the distal end 22 of the catheter adapter 2 and may be fixed within the catheter adapter 20. In some embodiments, the catheter 32 may include a peripheral intravenous catheter (PIVC), a midline catheter, or a peripherally inserted central catheter

[0042] In some embodiments, the guide needle 18 may extend through the catheter 32. In some embodiments, in response to insertion of the guide needle 18 and / or the catheter 32 into a patient's vasculature, the guide needle 18 may be withdrawn proximally from the catheter 32 and removed from the catheter assembly 12. In some embodiments, the catheter 32 may remain within the patient's vasculature for blood drawing and / or infusion

[0043] In some embodiments, the catheter system 10 may include one or more needleless connectors 34, which may be coupled to a specific port of the adapter 30. In some embodiments, the needleless connector 34 may include a MAXZERO TM needleless connector available from Becton, Dickinson and Company of Franklin Lakes, New Jersey or another suitable needleless connector. In some embodiments, a cap 36 may be coupled to the proximal end of a specific needleless connector 34. In some embodiments, the distal end 38 of the needleless connector 34 may be coupled to the adapter 30

[0044] Now refer to Figures 2A - 2C, in some embodiments, the needleless connector 34 can include a distal end 38, a proximal end 40, and a valve 42 disposed between the distal end 38 of the needleless connector 34 and the proximal end 40 of the needleless connector 34. In some embodiments, the distal end 38 of the needleless connector 34 can be coupled to the catheter assembly 12 (e.g., see Figure 1 ).

[0045] In some embodiments, the catheter system 10 can include an exhaust assembly 44, which can include a proximal member 46 and a distal member 48. In some embodiments, the proximal member 46 can include a male Luer adapter 50, which can include a male Luer 52. In some embodiments, the proximal member 46 can include an exhaust membrane 54, which can be permeable to air but not to liquid. In some embodiments, the exhaust membrane 54 can be disposed at the proximal end 56 of the proximal member 46. In some embodiments, a fluid path can extend through the male Luer 52 and can terminate at the exhaust membrane 54 that can be aligned with the male Luer 52.

[0046] In some embodiments, the distal member 48 can include a distal end 58, which can be coupled to the proximal end 40 of the needleless connector 34. In some embodiments, the distal member 48 can include a proximal end 60 coupled to the male Luer adapter 50. In some embodiments, in response to movement of the proximal member 46 relative to the distal member 48 from a proximal position to a distal position, the male Luer 52 of the male Luer adapter 50 can open the valve 42, e.g., as Figure 2C shown.

[0047] In some embodiments, the male Luer adapter 50 can include a first set of threads 62. In some embodiments, the distal end 58 of the distal member 48 can include a second set of threads 64. In some embodiments, the first set of threads 62 can be arranged with a different hand of thread than the second set of threads 64. For example, the first set of threads 62 can be left-handed threads, and the second set of threads 64 can be right-handed threads. Thus, in response to moving the proximal member 46 from a proximal position to a distal position by further screwing the proximal member 46 onto the distal member 48, the likelihood that the distal member 48 becomes stuck to the needleless connector 34 when attempting to unscrew the exhaust assembly 44 from the needleless connector 34 can be reduced. Thus, the first set of threads 62 and the second set of threads 64 with different hands of thread can allow the exhaust assembly 44 to be easily detached from the needleless connector 34.

[0048] In some embodiments, the outer surface of the distal member 48 can include a third set of threads 66. In some embodiments, the third set of threads 66 can have the same hand of thread as the first set of threads 62, such that the proximal member 46 and the distal member 48 can be threadedly coupled together. For example, the third set of threads 66 can be left-handed.

[0049] In some embodiments, the outer surface of the needleless connector 34 may include a fourth set of threads 68. In some embodiments, the fourth set of threads 68 may have the same hand as the second set of threads 64 such that the needleless connector 34 and the distal component 48 may be threadably coupled together. For example, the fourth set of threads 68 may be right-handed.

[0050] In some embodiments, a method may include actuating an exhaust assembly 44 that may be coupled to the needleless connector 34. In some embodiments, actuating the exhaust assembly 44 may include moving the proximal component 46 from a proximal position to a distal position, which may open the valve 42. In some embodiments, the valve 42 may include a bellows valve or any other suitable type of valve. In some embodiments, the blunt cannula 69 may extend through the valve 42 and may include one or more flow holes such that air may be removed through a path extending through the needleless connector 34, the distal component 48, and the proximal component 46.

[0051] In some embodiments, the method may include pre-perfusing the catheter assembly 12 after actuating the exhaust assembly 44, which may remove air from the catheter assembly 12 that may be harmful to the patient. In some embodiments, the catheter assembly 12 may be pre-perfused with a pre-perfusion solution (e.g., saline). In some embodiments, the method may include inserting the catheter assembly 12 into a patient's vasculature after pre-perfusing the catheter assembly 12.

[0052] In some embodiments, the method may include pre-perfusing the catheter assembly 12 with blood after actuating the exhaust assembly 44, which may remove air from the catheter assembly 12 that may be harmful to the patient. In some embodiments, the catheter assembly 12 may be inserted into a patient's vasculature and may allow blood to fill the catheter assembly 12 to expel air through the exhaust assembly 44. In some embodiments, the blood filling the catheter assembly 12 may be flushed back into the patient's vasculature with a flush solution (e.g., saline).

[0053] In these embodiments, during pre-perfusion of the catheter assembly 12, the catheter assembly 12 and one or more of the following may be filled with blood: the extension tube 28 (see Figure 1 ), the adapter 30 (see Figure 1 ), the needleless connector 34, the distal component 48, and the proximal component 46. In some embodiments, after inserting the catheter assembly 12 into the vasculature and pre-perfusing the extension tube 28 (see Figure 1 ), the adapter 30 (see Figure 1 ), the needleless connector 34, the distal component 48, and the proximal component 46, and one or more of the catheter assembly with blood, the blood may be flushed back into the vasculature with a flush solution. In some embodiments, a flushing device may be coupled to the proximal component 46 to flush the blood back into the vasculature.

[0054] Now refer to Figures 3A - 3B , in some embodiments, the first set of threads 62 may be provided with the same hand of helix as the second set of threads 64. In some embodiments, when the proximal member 46 is in the distal position, the first set of threads 62 and the third set of threads 66 may be permanently locked / or locked with a force greater than the unscrewing force between the distal member 48 and the needleless connector 34. Thus, in response to moving the proximal member 46 from the distal position (where the valve 42 may be open) to the proximal position by unscrewing the proximal member 46 until it disengages from the needleless connector 34, the likelihood that the distal member 48 gets stuck on the needleless connector 34 when attempting to unscrew the exhaust assembly 44 from the needleless connector 34 can be reduced.

[0055] Now refer to Figures 4A - 4E , in some embodiments, the inner surface of the proximal member 46 may include a first protrusion 70. In some embodiments, the outer surface of the distal member 48 may include a second protrusion 72 and a third protrusion 74 located distal to the second protrusion 72. In some embodiments, in response to the movement of the proximal member 46 from the proximal position to the distal position, the first protrusion 70 may move distal to the third protrusion 74. In some embodiments, in response to the proximal member 46 being in the distal position, the first protrusion 70 may be located distal to the second protrusion 72 and between the second protrusion 72 and the third protrusion 74. In some embodiments, in response to the first protrusion 70 moving distal to the second protrusion 72, the proximal member 46 may snap onto the distal member 48.

[0056] In some embodiments, the outer surface of the distal member 48 may include a channel 76. In some embodiments, the second protrusion 72 and the third protrusion 74 may be disposed within the channel 76. In some embodiments, in response to the movement of the proximal member from the proximal position to the distal position, the first protrusion 70 may move distally within the channel 76. Thus, in some embodiments, the channel 76 may provide alignment of the proximal member 46 relative to the distal member 48.

[0057] In some embodiments, one or more of the first protrusion 70, the second protrusion 72, and the third protrusion 74 may be annular. In some embodiments, the proximal member 46 may include at least two first protrusions 70. In some embodiments, the distal member 48 may include at least two second protrusions 72 and / or at least two third protrusions 74. In some embodiments, the distal member 48 may include at least two channels 76. In some embodiments, one or more of the following may be opposite to each other: two first protrusions 70, two second protrusions 72, two third protrusions 74, and two channels 76. In some embodiments, the distal member 48 may be integrally formed as a single unit. In some embodiments, the proximal member 46 may be integrally formed as a single unit.

[0058] Now referring to Figures 5A - 5E Figures 5A - 5E , in some embodiments, the proximal component 46 may include a male Luer 78, a proximal projection 80 extending from the male Luer 78, and a distal projection 82 extending from the male Luer 78. In some embodiments, the male Luer 78 may extend through the proximal end 60 of the distal component 48. In some embodiments, the inner surface of the distal component 48 may include another projection 84. In some embodiments, in response to movement of the proximal component from a proximal position to a distal position, the proximal projection 80 may move distal to the other projection 84. In some embodiments, in response to the proximal component 46 being in the proximal position, the distal projection 82 may be distal to the other projection 84 and the proximal projection 80 may be proximal to the other projection 84.

[0059] In some embodiments, one or more of the proximal projection 80, the distal projection 82, and the other projection 84 may be annular. In some embodiments, the proximal component 46 may include at least two proximal projections 80 and / or at least two distal projections 82. In some embodiments, the distal component 48 may include at least two of the other projections 84. In some embodiments, one or more of the following may be opposite each other: two proximal projections 80, two distal projections 82, and two of the other projections 84.

[0060] In some embodiments, the outer diameter of the proximal component 46 at the distal projection 82 and the proximal projection 80 may be greater than the inner diameter of the distal component 48 at the other projection 84 such that the distal projection 82 and the proximal projection 80 may be configured to be slightly compressed to pass through the other projection 84. In some embodiments, the distal projection 82 and the proximal projection 80 may be configured to snap over the other projection 84, which may increase the difficulty of removing the proximal component 46 from the distal component 48 and / or the difficulty of movement of the proximal component 46 from a distal position (where the valve 42 may be open) to a proximal position. In some embodiments, in response to the proximal component 46 being in the distal position, the proximal projection 80 may contact the other projection 84.

[0061] In some embodiments, actuating the exhaust assembly (which includes the distal component 48 and the proximal component 46) coupled to the needleless connector 34 may include moving the proximal component 46 from a proximal position to a distal position. In some embodiments, in response to movement of the proximal component 46 from a proximal position to a distal position, the proximal projection may move distal to the other projection 84.

[0062] All of the examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the invention and the concepts contributed by the inventors to further the art, and are to be construed as not being limited to such specifically recited examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made hereto without departing from the spirit and scope of the invention.

Claims

1. A catheter system, characterized in that, The catheter system includes: A needleless connector, the needleless connector including a distal end, a proximal end, and a valve disposed between the distal end of the needleless connector and the proximal end of the needleless connector; An exhaust assembly, the exhaust assembly including: A proximal member, the proximal member including a male Luer adapter having a male Luer, wherein the proximal member includes an exhaust membrane that is permeable to air but not permeable to liquid; and A distal member, the distal member including: A distal end coupled to the proximal end of the needleless connector; and A proximal end coupled to the proximal end of the male Luer adapter, wherein the proximal member is movable relative to the distal member between a proximal position and a distal position, and wherein, in response to movement of the proximal member from the proximal position to the distal position, the male Luer of the male Luer adapter opens the valve, wherein the male Luer adapter includes a first set of threads, wherein the distal end of the distal member includes a second set of threads, and wherein the hand of the first set of threads is different from the hand of the second set of threads.

2. The catheter system according to claim 1, wherein, The first set of threads is a left-handed thread, and the second set of threads is a right-handed thread.

3. The catheter system according to claim 2, wherein The outer surface of the distal member includes a third set of threads, and the third set of threads is left-handed.

4. The catheter system according to claim 3, wherein The outer surface of the needleless connector includes a fourth set of threads, and the fourth set of threads is right-handed.

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